They’re safe, effective, and backed by decades of solid research. So why has California made their sale illegal unless accompanied by a scary and verbose warning label? A state Action Alert!

Both pregnenolone and DHEA are naturally produced “parent” hormones to a variety of other hormones, including the sex hormones estrogen, progesterone, and testosterone, as well as hormones vital for controlling blood mineral content and metabolism. And both DHEA and pregnenolone have a number of startling benefits.

Pregnenolone aids in the development of new brain cells, produces significant improvements in both depression and schizophrenia, and shows promise in mitigating memory loss and even some of the abnormal structures in Alzheimer’s disease.

DHEA supplementation helps create improvements in muscle strength and bone mineral density, with a reduction in body fat mass, and there is substantial support for DHEA supplementation in adrenal insufficiency, hypopituitarism, osteoporosis, systemic lupus, depression, schizophrenia, and balancing the overproduction of cortisol produced by excessive stress. Too much cortisol ages us rapidly; a little extra DHEA can make all the difference.

Despite the overwhelmingly positive scientific research (last year alone, 380 new papers were published about DHEA), and despite their having been shown to be both safe and effective in decades of continued use by millions of people, California now mandates a warning on both DHEA and pregnenolone saying, in a lengthy text, that exceeding recommended serving may cause “serious adverse health effects” like rapid heartbeat, dizziness, blurred vision, or seizure. Such a warning will scare consumers away from these important supplements. No peer-reviewed studies have ever shown that DHEA or pregnenolone are associated with rapid heartbeat, dizziness, or blurred vision. No published studies have shown any risk of seizure from pregnenolone supplementation unless the patient already had a history of seizures.

Research on pregnenolone began in the 1930s. Studies in the 1940s showed that pregnenolone was effective on autoimmune disorders, including rheumatoid arthritis. But it was discarded when Merck’s newly introduced pharmaceutical agent, cortisone, was announced as a cure-all for rheumatoid arthritis in 1949. Sound familiar?

If you are a California resident, please contact your legislators and ask them to create an exemption for DHEA and pregnenolone in Section 110423(b) of the California Health and Safety Code.

If employed by Chicago, you’ll take whatever “preventive” medicine the city demands—or pay far more in insurance premiums!

Under Mayor Rahm Emanuel’s plan, unveiled last week, city employees must enroll in a conventional medicine–structured “wellness program” to manage chronic health problems such as obesity, diabetes, and high blood pressure. Employees who do not participate in the program will be required to pay an extra $50 per month in insurance premiums for each family member covered.

The Chicago program includes “enhanced screening and wellness training to establish benchmarks and long-term goals, including weight loss, medication, exercise, and kicking the smoking habit.” A form of this plan appears in the healthcare reform act as well—which should be no surprise, as Rahm Emanuel was one of its chief architects.

So imagine this picture. Conventional medical doctors tell you to take your blood pressure medication, whether you think it wise or not, whether you want to try natural alternatives or not. And if you don’t, you pay. Same for taking statins for high cholesterol, medications which many medical professionals agree are really dangerous to your health.

Preventive medicine is a hotly debated topic, as it should be. But for Rahm Emmanuel, it’s one-size-fits-all. You had better have your blood sugar at a specified level, or you will be required to take highly dangerous diabetes drugs. At least they won’t fire you or put you in jail if you don’t comply—it will just cost you money. So far.

This kind of incipient medical fascism is mainly a gift to Big Pharma, and we can be sure that Big Pharma is cheering Emmanuel on.

Who can we trust for accurate info?

Yale researchers working with Russian scientists have discovered a new tick-borne disease affecting thousands of Americans each year. It’s a bacterium called Borrelia miyamotoi, and it’s a distant relative of the spirochete that causes Lyme disease. It’s found in the same deer tick that transmits Lyme.

The new bacterium causes higher fevers than Lyme disease does, and the fevers often disappear and reappear after a week or two. It was actually discovered over a decade ago, though Dr. Durland Fish, the lead Yale researcher, was repeatedly refused a study grant from NIH until the Russian scientists proved it caused illness.

We are worried, frankly. If the NIH, the Centers for Disease Control, and the major media respond to this new illness as they did with Lyme disease, consumers have very little hope of receiving helpful, truthful information about how best to treat the disease if they become infected.

The New York Times article makes numerous incorrect statements about Lyme disease and its treatment—then says the new disease should probably be treated the same way. It says, for example, that two weeks of antibiotics “normally cures Lyme.” But many US and European studies demonstrate that short-course antibiotics actually fail to eradicate the Lyme spirochete—and result in up to a 40% relapse rate.

Moreover, mainstream medicine disagrees wildly on the best course of treatment; long-term IV antibiotics are recommended by many highly regarded authorities, though as we noted in February, chronic Lyme disease (CLD) is a systemic, debilitating condition that often persists despite antibiotic therapy. Integrative physicians are finding success with more holistic protocols.

The Times article then makes outrageously inflammatory statements such as “Most medical authorities, including the Centers for Disease Control and Prevention and the Infectious Disease Society of America, take the position that ‘chronic Lyme disease’ does not exist and that those victims either have other illnesses or are hypochondriacs. They oppose the solution demanded by some self-proclaimed victims: long-term intravenous antibiotics.”

Yes, the Infectious Disease Society of America believes chronic Lyme disease “does not exist.” But to say that “most medical authorities” agree is totally false. The International Lyme and Associated Diseases Society is filled with respected medical experts who say that chronic Lyme is a widespread, serious, and complex disease. To dismiss chronic Lyme suffers as merely “hypochondriacs” and “self-proclaimed victims” is not only offensive, it is unacceptably sloppy journalism.

The Times article quotes Dr. Fish talking about the difficulties in getting the study completed: “It’s been like pulling teeth. Go ask the NIH why.” But the reporter never went to NIH to ask the question. Was it just laziness on his part? Or is mainstream media so beholden to drug company advertisers and conventional medicine that no other view is considered?

If media reporting has been this untrustworthy with Lyme disease (which affects up to ten times as many people, though the statistics are unreliable and the real totals may be higher), how can it be relied upon with this new disease?

Unfortunately, we can’t trust the government’s Centers for Disease Control (CDC) either—the agency is ill-equipped to detect Lyme disease at all, much less chronic Lyme disease. Dr. Joseph Burrascano, who has treated the disease for over 30 years, says, “If you rely exclusively on the CDC diagnostic criteria, you’ll miss about 90% of cases, as very few patients fit the strict ‘classic’ profile defined by CDC.”

Nor can we trust the government’s National Institute of Health (NIH). It took them ten years to agree to study this new disease, and they are consistently behind cutting-edge medicine. For example, NIH refuses to study intravenous vitamin C, one of the most important adjunct treatments both for tick-borne diseases and for cancer.

If we’re to successfully tackle this new illness, we will need to rely on integrative physicians who understand and treat complex diseases with whole-body approaches. Treatment must be tailored to the individual. Dr. David Jernigan, a leading Lyme expert, has a fact-filled website on the treatment of Lyme disease and other tick-borne diseases. While we cannot recommend specific treatments, readers may wish to know what some respected integrative Lyme practitioners recommend:

• Frequently mentioned Lyme-specific protocols include hyperbaric oxygen therapy (but only if one does not have the co-infection Bartonella), intravenous vitamin C, samento (Cat’s Claw), colloidal silver, and artemisia. Some integrative doctors prescribe long-term antibiotics; if yours does, it is important to maintain a healthy GI tract with probiotics and digestive enzymes, as antibiotics wipe out the natural gut flora, which is an important part of the immune system.

• Another component of a whole body Lyme protocol is detoxification and building a strong immune system. Sweating, eating lots of cruciferous vegetables, taking dandelion, milk thistle, detoxifying herbal teas, chlorella, garlic, etc., are all excellent detox protocols. Diet: whole foods, fresh vegetables, and clean sources of protein. Maintain a low glycemic load: Lyme and co-infections like Candida thrive on sugar. Maintain high levels of nutrients: Lyme sufferers may be particularly deficient in magnesium and CoQ10.
• It is important to get daily exercise, to keep the lymph moving and increase body heat—Lyme seems to be sensitive to heat. Hot detox baths may also be helpful, and can speed healing. Dr. Jernigan recommends several specific baths in his book Beating Lyme Disease.

But major media continue their astonishing cover up of the government’s safety data on Merck’s vaccine. A new Action Alert!

On Thursday, Michele Bachmann once again attacked Rick Perry for his 2007 executive order mandating the HPV vaccine for all young girls in Texas—despite his attempts to dismiss serious medical concerns about the vaccine, as we reported last week.

At one point, Fox News journalist and debate host Chris Wallace told Bachmann that the American Academy of Pediatrics says the HPV vaccine has “an excellent safety record.” This is indeed what the AAP said in its recent press release.

We have discussed AAP’s ties to industry, among other failings, in earlier articles. The Academy’s claim about the HPV vaccine is demonstrably incorrect, but the organization is certainly in prominent company. The National Cancer Institute, a division of NIH, says on its website that “Thus far, no serious side effects have been shown to be caused by the vaccines.” The site also says, “A recent safety review by the FDA and the Centers for Disease Control and Prevention (CDC) considered adverse side effects related to Gardasil immunization that have been reported to the Vaccine Adverse Events Reporting System since the vaccine was licensed. The rates of adverse side effects in the safety review were consistent with what was seen in safety studies carried out before the vaccine was approved and were similar to those seen with other vaccines.”

The fact is, the CDC has received tens of thousands of adverse event reports after administration of the Gardasil HPV vaccine. Serious side effects like blood clots and Guillain-Barre Syndrome have been reported—as well as 68 reports of death from the vaccine. This is not “an excellent safety record” by any means—and if this is “similar to those [side effects] seen with other vaccines,” then vaccines are far more dangerous than anyone suspects.

Despite the potentially deadly side effects, the CDC is considering vaccinating boys for HPV as well. HPV also causes genital warts, and like many other viruses is widespread in the male population. According to Science Daily, one study showed that giving the vaccine to males could prevent as many as 90 percent of genital warts cases, although many wart viruses are not targeted by the vaccine, which casts doubt on the claim. Keep in mind also that the vaccine requires multiple shots to work.

What is in these shots? An excellent article in Natural News, citing SANE Vax and other sources, addressed this topic a few days ago. The HPV vaccine includes among its ingredients polysorbate 80 and sodium borate. Although polysorbate 80 is used as a food additive to increase the water solubility of oils, injection is quite different. According to the Polysorbate 80 Material Safety Data Sheet, it may be both carcinogenic and mutagenic. When injected into prepubescent rats, polysorbate 80 caused abnormal growth of reproductive organs and made the rats sterile. When used intravenously with vitamins it has caused anaphylactic shock. And polysorbate 80 is one of the ingredients in the swine flu vaccine as well.

Sodium borate (a salt of boric acid) is widely known as a roach pesticide. The US National Library of Medicine and NIH declared sodium borate to be a dangerous poison. Due to deaths from its use for disinfecting wounds and cleaning nurseries, its medical use has been discontinued. Side effects include: vomiting, diarrhea, skin rash, blisters, collapse, coma, convulsions, drowsiness, fever, low blood pressure, decreased urine output, sloughing of the skin, and twitching of facial muscles, arms, hands, legs, and feet.

The FDA’s review of the vaccine found that 73.3% participants in the Gardasil group experienced new medical conditions within fifteen days of receiving the HPV vaccination. The placebo group noted a similar percentage, because they were given the vaccine carrier solution (with the polysorbate 80 and the sodium borate) rather than the plain saline solution usually used in such trials.

If that weren’t enough, the vaccination safety organization SANE Vax discovered that Gardasil has been contaminated with HPV recombinant viral DNA (rDNA), a substance many government health and safety agencies classify as a biohazard. It was found in 100% of the thirteen samples tested, which had different lot numbers; the samples came from New Zealand, Australia, Spain, Poland, France, and three states in the US.

NaturalNews.com further reports that due to a lack of prescribing information furnished to doctors by Merck, doctors are reluctant to report adverse events and other factors; actual deaths and adverse events for Gardasil are hugely underreported. It has been estimated that only 10% of adverse events for other vaccines are reported, but with Gardasil the estimates range as low as 1%.

ANH-USA has been issuing corrections to Chris Wallace, the Huffington Post, the New York Times, CNN, and other media outlets that keep claiming that the HPV vaccine isn’t controversial and is in fact safe. So far none of these major media have acknowledged our correction or agreed even to acknowledge the government’s own extremely serious CDC adverse event data.

This is a total and complete cover up. Through our Action Alert, we invite you to add your voice to demand that major media at least acknowledge the existence of the very serious CDC adverse events safety data. Please take action now!

It’s supposed to help organic farmers. But it’s more likely to be just another sneaky way to help Monsanto. New Action Alert!

Last week, USDA secretary Tom Vilsack gave a clear directive to his department’s new Advisory Committee on Biotechnology and 21st Century Agriculture (AC21): come up with a plan to compensate organic and conventional farmers whose crops become contaminated because of genetically engineered foods.

This directive is clearly intended to sound like it will help farmers. But we think it is actually intended to help Monsanto. To see why we think this, a bit of background.

The committee is comprised of a broad spectrum of interested parties: organic scientists and organic trade organizations, conventional farming industry reps (including makers of high-fructose corn syrup), DuPont, agriculture experts, genetic engineering companies, lawyers, and a few concerned individuals.

As we reported recently, courts have increasingly been siding against GE and biotech farming when surrounding farms and products become contaminated. Bayer CropScience recently agreed to pay up to $750 million to farmers in the Midwest to settle lawsuits over its contamination of the US rice supply.

This is in sharp contrast to the past when Monsanto was suing nearby farmers whose crops were contaminated for theft of product and using the threat of suit to intimidate and silence.

Could this possibly mean, asks Marion Nestle in her Food Politics blog, that instead of Monsanto suing organic or conventional farmers whose crops get intermingled with patented GM varieties, Monsanto might now have to treat organic farmers fairly and pay them for the damage caused by the contamination? Or does the USDA actually have in mind a new protection scheme for Monsanto—a legal shelter that will limit Monsanto’s future monetary damages?

This isn’t the first time that our crony capitalist-inclined government has created a system protecting industry from liability. You may recall our stories on “vaccine courts” like the National Vaccine Injury Compensation Program, a no-fault system that compensates individuals harmed by vaccines. By denying the right to file lawsuits, it’s a way to protect the vaccine industry from potentially huge financial damages. Will this USDA compensation plan for GE crop contamination be just another gift to the biotech farming industry?

Tom Vilsack does not admit to being a crony of the biotech industry. The secretary was quoted as saying, “I have no favorite [type of agriculture] here,” but other statements—and past actions—make it clear that this is not a truthful statement. Today’s USDA acts virtually as an agent of Monsanto and other big GE companies. So do other government agencies which want to promote the export of this “American” product, as Wikileaks documents show.

Consumers, by contrast, have been voicing their objections to genetically engineered foods, and some elected officials are listening. In June, the House of Representatives amended the agriculture spending bill and prohibited the FDA from spending money to approve genetically engineered salmon. Sen. Lisa Murkowski (R-AK) recently said she would attempt to do the same for the Senate version of the bill.

ANH-USA strongly advocates for clear labeling on all genetically modified foods to give consumers an informed choice, a position which the American public strongly supports. Citizen activists have organized the Right2Know March—a massive sixteen-day march from New York City all the way to the White House to demand GMO labeling. The march takes place from October 1 to October 16; they are looking for walkers, bikers, drivers, volunteers, cheerleaders, hosts, and supporters, so be sure to visit their website for details.

Today please contact Congress and USDA secretary Tom Vilsack and tell them America will not stand for any USDA’s attempt to shield the GMO industry from liability when their products contaminate surrounding organic and conventional crops. Please take action now!

Do Perry and most of the media think they can get away with a complete cover up of the government’s own CDC data?

In the past few days, Governor Perry has tried to dismiss serious medical concerns over the HPV vaccine that he attempted to mandate in Texas. His strategy has been to keep the focus solely on rival GOP candidate Michele Bachmann’s story of a woman who claimed her daughter became mentally retarded after receiving the vaccine: “I think that was a statement that had no truth in it, no basis in fact.”

Perry intentionally ignored the shocking statistics about the HPV vaccine available at the CDC’s Vaccine Adverse Event Reporting System website. The Center received a total of 18,727 reports of adverse events following Gardasil HPV vaccination, with 1,498 of them (8%) considered “serious”—such as blood clots, the neurological disorder Guillain-Barre Syndrome, and 68 reports of death.

The fact that the data come from the government’s Center for Disease Control is particularly ironic, since the CDC’s former director, Dr. Julie Gerberding—who was essentially in charge of federal government decision-making about vaccines and disease-response programs—resigned in 2010 to become president of Merck Pharmaceuticals’ vaccine division. Merck is the maker of the HPV vaccine.

Perry isn’t the only party covering up the damning CDC data. Mainstream media and university spokespeople have also failed to do basic research on the HPV vaccine. In a recent Associated Press story, a reporter wrote, “Studies have found no serious side effects, with the most common reactions being redness or swelling at the injection site.” This is an incredible misstatement of fact, one which has not been corrected by the AP. And there have been other stories like it: the New York Times is saying the evidence shows the vaccine is safe—without mentioning the CDC at all.

Arthur Caplan, a bioethicist at the University of Pennsylvania, erroneously claimed that “The data show that the vaccine is safe and effective” and said that “It’s ethically obscene” to scare parents away from the vaccine. While the most common reactions might be redness or swelling at the injection site, to omit the existence of serious possible side effects (including death!) seems to us to be—well, “ethically obscene” is the phrase that comes to mind.

Vaccine Safety Isn’t the Only Area Where Perry Hasn’t Told the truth

This all took off at the September 12 Republican presidential candidate debate, when Michele Bachmann attacked Rick Perry for taking “thousands of dollars in political donations” from Merck, the global pharmaceutical and chemical company, and noted that the governor’s former chief of staff was the chief lobbyist for the drug company. She implied that those deep connections led to Perry’s executive order mandating human papillomavirus (HPV) vaccine be given to all pre-teen girls in Texas. Perry then said “It was [just] a $5,000 contribution that I had received from them.”

The truth is very different. Perry received tens of thousands of dollars from the Merck PAC during his tenure as governor (Bloomberg says “at least $23,500,” while the Washington Post says it was “nearly $30,000,” including $5,000 in 2006, one year before his HPV executive order). Merck also donated somewhere between $380,000 and $500,000 to the Republican Governors Association, which Perry chaired twice and which is a major Perry campaign contributor.

The executive order was issued when his chief of staff, Mike Toomey, was working for the Texas Lobby Group, which is retained by Merck. Merck paid Toomey as much as $535,000 in lobbying fees to promote Gardasil between 2005 and 2010. And where is Toomey today? He’s Perry’s “super PAC” coordinator.

Sarah Palin, commenting on the debate, called Perry’s involvement with Merck “crony capitalism.” Of course, she doesn’t seem to realize that this is just the tip of the iceberg when it comes to vaccine crony capitalism, as we pointed out recently. With many lucrative drug patents expiring, pushing vaccines is a good way for Big Pharma to restore their profits.

Ron Paul slammed Perry for the executive order in the September 7 debate, calling it “not good medicine…not good social policy,” and objected to the mandate being done through executive order despite protests from the Texas legislature—who voted overwhelmingly to repeal the order.

The bottom line here: Governor Perry isn’t telling the truth either about the safety record of the HPV vaccine or about the money he has received from Merck.

The HPV vaccine is not the only issue which ties Governor Perry to special interests and “dirty deals” in medicine.

Another scandal involves the Texas State Medical Board. Many people have wondered why the TMB has been able to harass integrative doctors so aggressively and in such an underhanded way. This too involves Perry quite directly.

Last year we reported on the allegations against the Texas State Medical Board from the Association of American Physicians and Surgeons. The AAPS charged the board with manipulation through anonymous complaints; conflicts of interest; violations of due process; breaches of privacy; and retaliation against those who speak out. We also reported on the board’s attacks on Dr. Bill Rea, a leading researcher and clinician in the field of environmental medicine and chemical sensitivity.

It was Governor Perry who made each and every appointment to the current Texas Medical Board, even reappointing six of them after the scandal broke.

In 2007, Perry reappointed Roberta Kalufut to the board, even though she was specifically charged in the AAPS lawsuit as follows: “[Kalufut] arranged for her husband to file anonymous complaints against other physicians, including her competitors in Abilene [and] worked inside the TMB, with other defendants, to discipline doctors based on anonymous complaints filed by her physician husband.” Kalufut resigned in 2008.

It might seem that ANH-USA is piling onto Perry. But we aren’t political partisans—we have no involvement in the GOP nomination process nor are we endorsing anybody. What we are concerned about is crony capitalism in medicine, which underlies the present medical system and leads to so many bad outcomes, including the legal suppression of integrative therapies, along with exorbitant costs, needless suffering, and unnecessary death.

It is clear to us that Gov. Perry is part of this problem, and voters need to understand that he doesn’t extend his professed small government stance to medicine. Indeed, his overall small government persona seems to be masking a bloated, big government approach to healthcare—one tightly allied with special interests.

It’s the latest in a series of the candidate’s bills supporting health freedom and our access to natural health remedies. A new Action Alert!

The Testimonial Free Speech Act, HR 2908, is a brief bill that would allow the dissemination of testimonials “containing a consumer’s actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer’s experience with that food or dietary supplement.”

To some extent, the bill addresses the FDA’s contention that only drugs can show real benefit—because, by the agency’s definition, only drugs can cure, mitigate, or treat disease. Any mention of the therapeutic benefits of supplements, whether through personal testimonials, citied scientific literature, etc., is automatically considered “misbranding.”

We applaud Ron Paul for this bill, and for some other closely related free speech in healthcare/health freedom bills he has introduced in the current Congress:

• HR 2044, the Health Freedom Act: Prohibits FDA from preventing a disease claim unless it is “false and misleading in a material respect.” Amends the FD&C Act to say, “A food or dietary supplement for which a claim is made…is not a drug solely because of such claim.”
• HR 2045, the Freedom of Health Speech Act: Increases the burden of proof required by the FTC to prove false advertising cases against dietary supplement manufacturers. Excerpted scientific studies will not be considered advertising.

There are many other important Paul bills as well. You may recall our recent Action Alert on HR 1830, Ron Paul’s bill to allow raw milk to be sold across state lines. There is a bill, HR 1101, to repeal the federal healthcare mandate. For a complete list of Paul bills, go here.

Ron Paul also has our sincere thanks for introducing the dangerous HVP vaccine mandate into the Republican presidential candidate debates. For more on this, see our story in this issue.

Action Alert! Please contact your congressional representative today and urge his or her support of Ron Paul’s free speech in healthcare bills.

Increasingly Pharma is funding the FDA. No wonder the agency seems to dance to their tune.

The Prescription Drug User Fee Act (PDUFA) authorizes the FDA to collect fees from companies, allegedly to fund and expedite the drug approval process, but really to pay the agency’s bills. Under this authority, pharmaceutical companies pay fees for certain new human drug applications, biologics applications, and supplements submitted to the agency for review—and the FDA’s review of an application cannot begin until the fee has been submitted.

The law was enacted in 1992, and Congress needs to renew it every ten years; the next deadline for renewal is September 2012. To make this happen, the FDA has been performing its usual ritual of begging and blustering at the same time.

The FDA has been discussing a raise in the FDA “user” fees with industry since July 2010; in fact, Big Pharma had already agreed to a 6% increase in fees for new drugs through 2017. The increase is expected to produce an additional $40.4 million in user fee revenue in fiscal 2012, bringing the fiscal 2013 total to $712.8 million. But FDA still hasn’t arrived at a deal with companies on user fees for medical devices—the FDA made a proposal, but industry rejected it, so the negotiations continue.

According to the FDA itself, drug companies provide fully 60% of the FDA’s drug review costs—which means that the FDA’s review and regulation of pharmaceutical drugs is largely funded by the very drug companies under review!

Could this brand of crony capitalism be part of the reason why the FDA is apparently so biased against supplements, which it regards as competition for drugs? Or why the drugs the FDA approves are so dangerous that, as we reported last year, they kill 50,000 Americans and send more than 700,000 more to emergency rooms each year?

PDUFA is what is known as a “must-pass” bill. Such bills become vehicles for other, smaller bills looking to slide through unnoticed as riders. We will keep a close watch on that—as well as on the FDA’s so-called negotiations with its friends in the pharmaceutical industry.

Part Two of our recent article on the laws threatening integrative doctors and integrative medicine—one of our most popular articles last month!

(If you’d like to read Part One, our discussion of the legal problems threatening physicians who use integrative medicine, click here.)

Federal Law for Sellers of Food, Supplements, and Medical Devices

The Federal Food, Drug, and Cosmetic Act (FD&C) gives authority to the FDA to regulate interstate commerce of supplements, drugs, and devices. According to the FD&C, by definition, only drugs can claim to cure, prevent, mitigate, or treat a disease [section 201(g)]. Nothing else may make that claim—certainly not a food or supplement.

To legally market a drug (that is, any substance that can claim to cure, prevent, mitigate, or treat a disease), it must go through the lengthy and expensive FDA drug approval process. Any violation—that is, any sale of a “drug” that is not FDA-approved—can lead to seizure of the product, injunctions against its sale and distribution, and criminal penalties, including imprisonment, for the manufacturer.

And as we have noted many times before, if a substance is natural, it is not patentable, and companies can only recoup their huge investment (as much as a billion on average, although estimates vary) in FDA approval if they can make it up through the high prices that patent protection makes possible. Therefore, natural products in supplement form will never be able to claim to treat disease, including cancer [section 201(ff)].

Why Only Patentable Drugs Are Considered “Safe”

The FDA’s control over patients’ access to cancer drugs was challenged in a 1979 lawsuit, United States v. Rutherford. Terminally ill cancer patients sued to stop the FDA from preventing the interstate shipment and sale of Laetrile—a modified form of amygdalin, a naturally occurring substance found in apricot pits as well as in other plants. The Supreme Court determined that the FD&C “makes no express exceptions for drugs used by the terminally ill…Exceptions to clearly delineated statutes will be implied only where essential to prevent ‘absurd results’ or consequences obviously at variance with the policy of the enactment as a whole.”

The Court supported FDA’s position that terminally ill cancer patients must be ensured therapeutic gain, which is only “guaranteed” by FDA approval. What this means in effect is that only non-natural and therefore patentable drugs which can be brought through the FDA process are “safe” enough to be used, even though natural remedies, which our bodies have evolved with, are generally safer or at least more predictable in their effects.

The further irony here, of course, is that the FDA has often approved drugs that are outrageously unsafe, causing so many deaths that they are subsequently pulled from the market and banned. The US National Poison Data System’s latest report records only a single death concurrent with supplement use—an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. On the other hand, it shows that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% of fatalities—with 122 deaths attributed just to acetaminophen—an over-the-counter pain reliever sold under the brand name Tylenol.

Even though supplements cannot claim to prevent or treat disease, everyone knows that they may often be used for this purpose, either by consumers who have studied the scientific research, or by doctors themselves.

FTC Currently Violating the Law

The Federal Trade Commission code contains both a general prohibition of unfair or deceptive acts or practices affecting commerce [15 USC 45(s)] and a provision specifically prohibiting false or deceptive advertising of foods, drugs, devices, or cosmetics [15 USC 52]. In other words, the FTC has authority to stop false advertising of drugs and supplements as well as unconventional treatments it deems to be false medical cures—including cancer treatments.

Unfortunately, as we reported this past April, the FTC has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. The FTC is now requiring two random-controlled human trials for any health-related claim—even so-called structure/function claims, which are permitted under the Dietary Supplement Health and Education Act of 1994 (DSHEA) without such trials. In response, ANH-USA and our co-plaintiffs, Durk Pearson and Sandy Shaw, filed a Petition for Rulemaking before the FTC. This petition, if denied, will lead to a litigation phase.

Often the FDA and the FTC work together to target supplement and food companies, which is precisely why the Free Speech About Science Act is so important. There are also federal criminal statutes that might affect the marketing and advertising of unconventional cancer treatments, like the wire fraud statute, which prohibits use of telephone, radio, or television to make “false representations for products and services,” and the federal smuggling statute.

Given all these legal risks, producers of natural food, supplements, and devices deserve our thanks.

A reader asks us to clarify.

In response to Part One of our article on laws threatening integrative physicians and integrative medicine, Chad wrote:

Your article explains the difficulties that doctors encounter when [prescribing] compounded drugs for their patients that have not been approved by the FDA. But it also implies (quoting federal law) that it is legal for doctors to do so. This runs counter to stories I have heard about what a doctor really can and cannot [do]. Would you please provide further clarification?

Thank you, Chad, for highlighting an important area of the law as applies to doctors’ ability to prescribe “unapproved” drugs. In our article, we noted the following:

Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.

There are problems, however. While practitioners might have the theoretical right to manufacture their own drugs, from the practical point of view the FDA takes a very expansive view of its authority and jurisdiction. For example, the rule stated above has been narrowly defined in at least the area of cancer treatment to apply only to intrastate activities. A report from the congressional Office of Technology Assessment, “Unconventional Cancer Treatments,” outlines the law at that time: “It is legal for physicians to prescribe treatments they manufacture that are unapproved by FDA, but only in the State in which they manufacture the treatments. It is illegal to transport unapproved drugs across State lines and laws pertaining to good manufacturing practices apply to physicians as well as to commercial medical manufacturers.”

It gets worse. The FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient—even one test tube—used in the compounding of an unapproved drug was purchased out of state, the FDA would in its view have jurisdiction, as they would if the final product were to travel across state lines.

This report may or may not reflect the FDA’s current position on prescribing unapproved drugs as it was published several years ago, and we simply won’t know the FDA’s current thinking until they officially weigh in again. Any doctor wondering about this must consult with his or her own legal counsel and try to make sense of what is really senseless.

This is unfortunately part of a much larger problem. The FDA has shown us historically that it acts as a law unto itself, acting as executive agency, legislator, and judge all in one, although clearly forbidden to do so by the Constitution. If you don’t like it, you can sue, but the FDA has an unlimited legal budget and you don’t. That is part of the agency’s scare tactics—if you oppose us, we will bankrupt you or, if possible, put you in jail.

The crony capitalism in vaccines just gets worse. And don’t expect any help from so-called small government candidate Gov. Rick Perry. A state-
based action alert!

The US Department of Health & Human Services (HHS) has unveiled a new roadmap for increased vaccination and immunization for the 21st century, the National Vaccine Plan or NVP. It calls for new vaccines, at a time when children already get far too many vaccinations, especially when given all at once and at too young an age.

Why are the vaccines piled on top of each other in one doctor visit? Because the medical establishment is afraid to ask parents to bring their children back over and over again. So for reasons of “compliance” and “convenience” the child’s immune system  is assaulted all at once.

As we have pointed out, HHS would have more credibility if the government had not entered the vaccine business itself as a partner of major drug companies. Much of the funding for new vaccine facilities as well as new vaccines  is coming from the government itself; the government then legally requires parents to “consume” more and more of these products for their children.

This is a bailout for the drug industry, which is  financially ailing at the moment. It is crony capitalism at its worst, and it directly affects the most vulnerable population of all, our children.

Just before the NVP was unveiled, the Institute of Medicine released its first comprehensive safety review of vaccines in seventeen years. This was not a coincidence, of course. Predictably, the IOM said that vaccines can cause “certain side effects,” but serious ones appear to be “very rare”—with no link to autism.

Conspicuously, the evidence provided by around 5,000 families who had submitted cases to the US vaccine court claiming their children had developed autism following exposure to the MMR vaccine was quietly disposed of, the report indicating that the MMR/autism link “favors rejection.”

The report also avoided dealing with the case of ten-year-old Bailey Banks, which in 2007 proved a link between his MMR vaccine, a seizure sixteen days later, the subsequent development of “Pervasive Developmental Disorder (Not Otherwise Specified)” which the court—fully aware of the potential financial consequences for the vaccine industry—decided  was not an autism spectrum disorder (ASD). The fact remains that anyone observing Bailey would, from the medical records given in the case,  be unable to distinguish Bailey’s symptoms from other kids who had been diagnosed with ASD. This was simply another cover-up.

Despite the claim that vaccines are “generally safe,” even the IOM found convincing evidence of fainting, fever-triggered seizures, anaphylactic shock, a rare form of brain inflammation, shingles, pneumonia, hepatitis, meningitis, or, in the case of the chicken pox vaccine, chicken pox! There is no mention in the report of mercury in the flu vaccines, even in children’s shots or nasal inoculations, or the evidence that some vaccines do more harm than good. All this  suggests that the report is just another example of whitewashing for pharmaceutical interests.

(Keep in mind that the IOM is the agency that Senator Durbin would like to do the risk assessment on supplements and mandate labels—despite drug company money flowing to some scientists relied on by IOM, not to mention their abysmal lack of knowledge about supplements.)

One of the New Vaccine Plan’s objectives is to increase routine vaccination coverage levels for adolescents. For example, they want girls to have received three doses of human papillomavirus vaccine (HPV) by age 13 to 15 as means of preventing cervical cancer. This sounds reasonable until you realize of the 100 different types of HPV, only fifteen might someday develop into cancer; moreover, the Journal of the American Medical Association says the relationship between infection with HPV at a young age and later development of cancer is unknown. Of those fifteen potential cancer-causing strains, the vaccine targets only two: HPV-16 and HPV-18. In other words, the vaccine will have no effect on 87% of the HPV viruses that might potentially cause cancer, and the causal link between HPV and cervical cancer is far from definitive.

On top of the shocking lack of proof of the vaccine’s effectiveness are the mounting number of reports of “adverse reactions” from it. Dr. Diane Harper, lead developer of Gardasil^®, one of the HPV vaccines, has stated that the HPV vaccine is associated with Guillain-Barré Syndrome, and has resulted in deaths. And she actually questions the effectiveness of the vaccine, and says, “Please push for full disclosure in consent forms so that parents and potential vaccinated persons can weigh the benefits and risks of the HPV vaccination from their own perspective.”

The HPV vaccine was approved by the FDA and was recommended by the CDC in 2006. In January of this year, the head of the CDC since 2006, Dr Julie Gerberding, resigned to become president of the Merck vaccine division, which makes Gardasil. In the meantime, legislators in at least 41 states and the District of Columbia have introduced legislation to require inoculation with, fund, or educate the public about HPV. Fortunately, many of the bills have not passed.

In 2007, Texas governor Rick Perry mandated the HPV vaccine by executive order—an unusual action from a presidential candidate who says he is against big government. It was noted at the time that he had received campaign support from drug interests.

When Perry more recently received spinal fusion and nerve decompression surgery to treat a recurring injury, he underwent an experimental injection of his own stem cells, a therapy that isn’t FDA approved, has mixed evidence of success, and can cost upwards of tens of thousands of dollars. Perry’s chief of staff said, “He feels [it] is certainly his right to determine the best course of treatment for him.” If so, why would he require HPV vaccines for young girls against their and their parents’ wishes? Does health freedom work for him but not others? Thankfully, Texas legislators passed a bill overriding the executive order, and Perry withheld his veto.

Unfortunately, Virginia now mandates the HPV vaccine for girls on or after their 11th birthday, and Washington, DC, mandates that all girls enrolling in 6th grade for the first time receive the HPV vaccine. Both jurisdictions have opt-out provisions, since HPV is not communicable in a school setting. Opt-out provisions are good, but they’re not enough. Many parents do not know their rights, are not educated about the relative dangers of the HPV or about the vaccine against it, or are scared or pressured into making their child take the vaccination anyway.

There is an HPV bill pending in New York. If you’re a New York resident, please contact your legislators immediately and stand up for parental freedom of choice in vaccines. People should be able to choose whether to vaccinate their children or not, and to make that choice on a case-by-case basis. New York’s bill, for example, doesn’t offer an option to opt out of just the HPV vaccine—you have to opt out of all vaccines through a philosophical exemption. This is especially galling to parents who feel that some vaccines are safe while others are dangerous, and would like to be selective in their choices.

In New York, AB 699 requires that all children born after January 1, 1996, be vaccinated against HPV (in addition to the already mandated vaccines against polio, mumps, measles, diphtheria, rubella, chicken pox, meningitis, pertussis, tetanus, pneumococcal disease, and hepatitis B). New York residents, take action now!

Would creating a new federal agency just for supplements make things better or worse?

In our recent article on Sen. Durbin’s bill and his credibility problem, we wrote, “Assuming that Sen. Durbin is sincere—and we assume he is, despite his misleading arguments—he should create a new federal agency to be in charge of supplements. That would at least begin to make possible sensible federal oversight of the supplement industry.”

Lone Voice responded:

“Whoa, back up! ANH, I agreed with every word you wrote, before this paragraph. But I have to react with raised eyebrows to the above statement. HUH? The Feds should create another agency to…“be in charge of supplements”?…Why on earth would another government entity be any more effective than the FDA?…What we need, ANH, is less regulation and not more of it. To play musical chairs is only to play one more game….

“Can you please explain your thinking to us in your above statement? This strikes me as being at odds with all that, up until this very moment, I have always perceived you to be. Thank you for your open-book response and for your clarification. Sometimes impressions can be wrong, and when they are, they need to be corrected. I will look forward to your posted response, here. Thank you for all that you do, I have been following (and forwarding) your articles, with keen interest and appreciation for your brave and ethical work.”

Dear Lone Voice,

Thanks for an excellent question. And also for your belief in us.

This is not actually the first time we have suggested moving supplements out of the FDA. Here is what we said in an earlier article: “[We need] to move supplements out of the drug agency and into their own agency under Health and Human Services. It doesn’t work for the supplement regulator (currently FDA) to be so beholden to drug companies, since drug companies are very afraid of supplement competition, despite the current government gag orders forbidding supplement makers from explaining their medical prevention and treatment uses.”

Here are some of our other readers’ responses to that idea:

Charlene: “Please move supplements out of the drug agency into their own….It doesn’t work for the supplement regulator to be so beholden to drug companies, since drug companies don’t like the competition. Thank you.”

md: “Removing FDA from having any control over supplements has been my dream for years. What can ANH-USA members do to help move this notion forward?”

Gmic: “Your suggestion to move oversight of supplements from the purview of the FDA to its own agency is fabulous. Thanks for battling on all of our behalf!”

But Kathy had a doubt:

“Are you sure supplements would be safe under [a new agency]?”

Kathy and Lone Star are right to have their doubts. But we still think it would be a good idea to move supplements out of FDA. Here is the main point for us: Big Pharma is currently paying for a large part of the FDA budget. FDA employees’ salaries are indirectly paid by drugs, and they know it. When FDA employees leave the agency, they often hope to be hired by drug companies at much higher salaries. FDA outside experts are commonly paid by drug companies. The FDA has even had the gall recently to announce that it would suspend the few remaining conflict-of-interest rules so that it could hire more experts paid by drug companies.

Drug companies are afraid of competition from supplements, which are so much cheaper, usually safer, and often more effective. They know the only thing that limits competition from supplements is FDA censorship of supplement advertising—in particular, the refusal to allow any reference to valid, documented scientific research if it relates to a disease. But it isn’t just the drug companies that fear supplement competition—so does the FDA, apparently, because the agency depends so completely on drugs for funding.

Under these circumstances, it would help to get supplements out of the FDA. Would it solve everything? No. Would it help? Yes. To be cynical, the employees of this new agency would only have their jobs because there is a supplement industry! If the FDA thinks it has an economic incentive to suppress or kill the supplement industry or to turn supplements into drugs, these employees would have the opposite incentive.

Of course, this could all go wrong. Drug interests could somehow get control of the new agency anyway. Or it could be filled with FDA-trained personnel who just can’t shake the old thinking. But it could hardly be worse than the status quo.

We hope that explains our thinking a bit. It would be nice if government employees could be expected to devote themselves to public service and to the best possible outcome for the public without any thought of their own economic future. In the real world, we can’t expect that. And getting supplements out of the FDA would at least be a step in the right direction.

We need to ask Congress to review the FDA’s absurd claims and carefully watch over the FDA’s draft NDI (supplement) guidance process. Please join us in this nationwide campaign!

Previously we announced a Call-In Lobbying Day for Thursday, September 8. We’re asking each of you—members, grassroots activists, readers, and friends—to set some time aside on September 8 to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. Tell them why you’re upset over the NDI guidance, and ask them to direct the FDA to carefully review their draft guidance and hold hearings at the end of the review process unless the FDA amends the guidance to reflect DSHEA (and Congress’s) stated values and goals. The FDA is clearly overreaching its authority, and the logic of its arguments in the guidance is questionable at best. Congress has FDA oversight and needs to review the agency’s actions in creating this new guidance.

Just go to this page—it will give you talking points for your conversation with your legislators’ offices, and has an interactive feature to look up your senators’ and representative’s names and phone numbers just by typing in your ZIP code.

We recently submitted our comments to the FDA in response to the first of two requests from the FDA for information, outlining the immense burden created by the dietary supplement draft guidance. Other concerned parties submitted comments in this first round as well. FDA responded with some pretty ludicrous logic.

The agency claims it will take only 20 hours per NDI notification. This is an absurd claim, considering the extensive paperwork and safety studies they require in the new draft guidance. Furthermore, as we have mentioned many times before, FDA refuses to file (that is, approve) most of the NDI notifications that are submitted, claiming that the notifications are “incomplete” or “inadequate.” So even though FDA rejects the majority of applications because they are incomplete, they really expect a supplement company to take only 20 hours per notification?

In addition, the FDA expects only 55 new NDI notifications per year. This is after officials stated in the guidance that there are 55,600 dietary supplements on the market. Something is very wrong with their math! Experts predict as many as 125,000 notifications.

Moreover, the FDA has not accounted for any of the costs to hire the expert consultants, scientists, etc., who will be required to successfully draft the NDI notifications. And they seriously think this won’t add any significant burden to industry?

Of course the ultimate issue here isn’t the cost or burden on supplement producers. The NDI guidance is really the first step toward an FDA approval process that will change the law governing supplements—and in the long run both sharply reduce the number of supplements sold and sharply increase the cost of those surviving.

We need Congress’s involvement, oversight, and correction. Join your fellow Americans in phoning your legislators on September 8 and asking them to stand against the FDA’s new supplement guidance!

Maybe they’re so caught up in the system that they just can’t imagine the best remedies sometimes only cost pennies.

Late summer is when kids go back to school and start spending hours playing sports in hot, humid weather. This can easily lead to heat exhaustion, which may lead to throwing up but also sometimes fatal complications. Just this past month, two Georgia high school student football players died. The American Academy of Pediatrics is concerned. It has issued new guidelines to help schools avoid heat illnesses of all kinds.

The key recommendations are not to exercise too long or frequently and not to wear hot uniforms and pads too long. Another recommendation is to drink plenty of water. This is commonsense advice, but it neglects an important warning: to avoid ice water, which can trigger the throwing up.

The pediatricians also recommend sports drinks for their electrolytes and salt. Is this more common sense? Hardly! The chief cause of heat exhaustion isn’t water. We can usually tell if we need water. It is lack of salt. What athletes really need is to take some additional salt both before and sometimes during play.

So why don’t the pediatricians mention this? A little salt costs only pennies. Why recommend unhealthy sports drinks, which cost too much and are often loaded with sweeteners (like high fructose corn syrup) and artificial ingredients (like bromated vegetable oil and glycerol ester of wood rosin), when the real answer is right in the kitchen cabinet and costs so little?

It is a tragic fact that many schools and coaches say absolutely nothing to their students and athletes about the importance of salt. Many students think that extra salt is bad for you. It certainly isn’t if you are playing in the kind of hot weather that can lead to heat exhaustion. The pediatricians could have helped this situation but chose not to. Why not? Is it because sports drinks are a 2.1 billion industry?

This is not the first time that the American Academy of Pediatrics has seemed to some to be a marketing agent for Big Food interests, selling expensive and doubtful products. Last year it was criticized for teaming up with Nestlé to make a series of nutrition messages intended to combat childhood obesity. Nestlé, of course, is the manufacturer of foods like KitKat, Haagen-Dazs, Hot Pockets, Baby Ruth bars, and Gerber baby foods—which, ironically, have been charged with containing too much salt.

But junk food and sports drinks are the least of the pediatricians’ sins. Too much of their income comes from administering childhood vaccines at too early ages in too large doses, and often containing dangerous ingredients such as the mercury in flu shots. We are afraid the pediatrics profession needs to do a lot more than cutting the ties to Nestlé or Coca-Cola.

Recent court decisions may help. Plus, new research shows how dangerous Monsanto’s GMOs really are.

Natural organic crops need to be protected from potential contamination by synthetic, genetically engineered seeds—especially in the face of less government oversight of GMOs. Natural seeds face the same Catch-22 as supplements: they cannot be patented, whereas synthetic seeds (and drugs) can be—and are therefore huge profit centers for Big Agro and Big Pharma, not to mention the government agencies in bed with them. They also need protection from the increased use of pesticides used on GE crops, which are also carried by the winds.

Our colleagues at ANH International reported recently that two court cases in the US might be turning the tide in favor of organic farmers over GE crops:

• Last December, the California Court of Appeal found the Western Farm Service guilty of “negligence, trespass, and nuisance” against Jacobs Organic Farm and the Del Cabo Organic Cooperative. In 2006 Western Farm applied GE organophosphate (OP) pesticides to Brussels sprouts grown on land neighboring the organic farms. Winds carried these pesticides onto the organic produce and contaminated it—making it unsalable as organic. Even though Western Farm claimed to have taken precautions to avoid pesticide drift, it still happened—and fortunately the court found them guilty.
• Last month, after ten years of futile complaints to the Minnesota Department of Agriculture, the Minnesota Court of Appeals found the Paynesville Farmers Union Cooperative Oil Company guilty of negligence, trespass, and nuisance on Oluf and Debra Johnson’s organic farm. Once again the pesticides sprayed on the oil company’s farms spread to the Johnsons’ land.

One of the big problems with GE crops is that they are responsible for the greatly increased use of pesticides which can easily contaminate organic crops. Now organic farms have legal precedents to sue conventional farms (and those using GMOs) for pesticide contamination.

Assuming EPA continues to approve more and more synthetic herbicides, these precedents will be an important tool in our arsenal. EPA recently approved a new herbicide called Imprelis. It’s billed as “environmentally friendly” but it is the leading suspect in the death of thousands trees all across the country.

Speaking of environmentally unfriendly GMOs, NPR reported this week that a type of genetically modified corn from Monsanto, which was developed to be impervious to a specific type of worm, may actually be causing the bugs to adapt and turn into “superbugs,” making the corn vulnerable to the very worms it was engineered to resist. Researchers at Iowa State University found that farmers who grew the Monsanto corn three years in a row got infested with “super” corn rootworms—and the damage they do could begin to reduce corn yields and raise corn prices.

Why are some of your legislators refusing emails from you—and what are we doing about it?

What does it tell us when our elected officials seal themselves up in Washington and refuse to take emails from the people who elected them?

No, we’re not making this up. Nor is it just an isolated case here and there. A surprising number of senators and representatives refuse to listen to American citizens by making it extremely difficult for them to provide public comments. So much for the democratic process!

We believe citizens should have the right to quickly, simply, and easily contact Congress to make their voices and opinions heard. But certain legislators refuse to accept email messages submitted by third parties like ANH-USA or other nonprofit advocacy groups. Instead, they set up complicated web forms as a way to discourage comment.

Here are the offenders, in alphabetical order:

Rep. Joe Barton (R-TX, District 6)
Rep. Judy Biggert (R-IL, District 13)
Rep. Ken Calvert (R-CA, District 44)
Sen. Mike Crapo (R-ID)
Rep. Wally Herger (R-CA, District 2)
Rep. Darrell E. Issa (R-CA, District 49)
Rep. Walter B. Jones Jr. (R-NC, District 3)
Rep. Connie Mack IV (R-FL, District 14)
Rep. Kevin McCarthy, (R-CA, District 22)
Sen. Jerry Moran (R-KS)
Rep. Devin G. Nunes (R-CA, District 21)
Sen. James E. Risch (R-ID)
Sen. Pat Roberts (R-KS)
Rep. David Schweikert (R-AZ, District 5)
Rep. Pete Sessions (R-TX, District 32)
Sen. Richard C. Shelby (R-AL)

Sen. Mark Warner (D-VA) was on that list, but after we contacted him about the issue, he is now accepting our alerts. We thank him, and applaud his willingness to listen to his constituents.

In addition to the above elected officials, Regulations.gov, the website used by federal agencies to receive comments on proposed rules, guidance, etc., changed its interface last year to ensure that third-party organizations like ANH-USA could not supply comments from our members and readers. Every time our software company would fix the issue, Regulations.gov would change their interface again. After speaking with Regulations.gov directly, they admitted that they didn’t want to receive comments from third-party websites.

Readers, rest assured that we’ve been mailing in your comments so they’re received by the agencies—whether they like it or not!

Please phone your elected officials today and tell them to remove obstacles to democratic participation! Our Call-In Action Alert lets you look up your legislators’ phone numbers, and gives you guidelines and a script outline you can refer to when you call. Or, if you prefer, go to the legislator’s website and send in a message using their form. But don’t be surprised if it isn’t possible to send in any message you want. Some of the forms require that you comment on a specified list of topics—another barrier to free communication.

Even if your elected officials are not on the list, you can still participate. Please phone Regulations.gov at 1-877-378-5457 and tell them you want your voice to be heard! You can use the same Action Alert—you won’t need to adapt the talking points very much to tailor them for a government agency instead of a legislator’s office.

Refuse to be silenced!

It isn’t just the FDA that wants to censor science in America. Three major plastic bag manufacturers are suing eco-friendly ChicoBag simply for citing scientific facts and statistics. Strike back with our new Action Alert!

Plastic grocery bags are not biodegradable. They clog waterways, spoil the landscape, pollute the soil and water (and therefore us), and choke birds and marine mammals who mistake them for food. Once they end up in landfills, they may take 1,000 years or more to break down into ever smaller particles that continue to pollute the environment.

These are facts.

Three large plastic bag makers—Hilex Poly Company, LLC; Superbag Operating, LTD; and Advance Polybag, Inc. apparently don’t like these kind of facts and have filed a lawsuit in South Carolina. They are suing the ChicoBag Company, claiming that it has caused harm to their businesses.

ChicoBag is trying to help eliminate the unnecessary use of single-use paper and plastic bags. They have designed reusable bags that are durable, tasteful, and convenient: they are small enough to tote in a pocket and have features that allow them to be clipped anywhere.

The three single-use plastic bag manufacturers accuse ChicoBag of unfair advertising and unfair competition. What did ChicoBag do that was so wrong? The company merely cited the effects of plastic bags on the environment on its Learn the Facts web page:

• “A reusable bag needs only to be used eleven times to have a lower environmental impact than using eleven disposable bags.” Source: EPA
• “Only one percent of plastic bags are recycled.” Source: EPA
• “Somewhere between 500 billion and a trillion plastic bags are consumed worldwide each year.” Source: National Geographic

Note that none of these facts come from ChicoBag. The company is simply citing well-known information from reputable sources. The same information has been used in countless publications, news stories, and websites over many years; ChicoBag is one of the few organizations that actually provides documented sources for the facts they use. In other words, the plastic bag industry seems to be angry that ChicoBag quoted the Environmental Protection Agency and National Geographic and told the truth. (We see this kind of behavior all the time from the FDA but it’s less usual in commerce.)

The lawsuit was conveniently filed in South Carolina because that state has no so-called anti-SLAPP laws—laws that protect against lawsuits “intended to censor, intimidate and silence critics by burdening them with the cost of a legal defense until they abandon their criticism or opposition.” The plaintiffs are citing the Lanham Act, a piece of trademark legislation which says a company can sue over claims which merely point to their product in general.

The discovery process (where both sides trade pertinent information with each other) is currently underway, and a jury trial is scheduled for sometime in early 2012.

Andy Keller, the owner and president of ChicoBag, has posted a detailed timeline showing the history and tactics of the single-use plastic bag industry against eco-friendly alternatives.

Plasticbaglaws.org is an excellent resource for staying vigilant on the issue. They also have a listing of all federal, state, and local laws and pending legislation pertaining to plastic bags on their website.

We have seven different Action Alerts for residents of those states with pending legislation about single-use plastic bags. None of the bills ask for an out-and-out ban. Many place a fee on single-use disposable bags, and some require that the plastic bags meet certain environmental standards. Further, some of the bills require that retailers sell reusable bags at the check-out counter. Supporting these bills is a good way to stand up to the plastic bag industry and let them know we don’t like their predatory tactics of intimidation. We also have a general Action Alert for residents of the other 43 states to ask their state legislators to introduce similar bills. Please take action today!

Indiana • Maryland • Oregon • Pennsylvania • Vermont • Virginia • Washington •

All Other States

The FDA says all new supplements since 1994 must be approved, but this will result in only 55 new applications. Huh? Experts predict as many as 125,000, and sale of these supplements will be illegal while the FDA decides what to do with them all.

If you’re new to this issue, please read about the FDA’s new scheme here. And if you haven’t already done so, please contact Congress immediately and voice your opposition to it!

Our analysis was created in response to an FDA statement in the Federal Register which grossly underestimated the burden of the proposed new guidance. It was drafted by renowned constitutional law attorney Jonathan Emord, with economic analysis by Dr. Joanna Shepherd Bailey, Associate Professor of Law at Emory University. Here are some additional findings:

• The FDA’s new guidance can be expected to cause major disruption in the dietary supplement industry, forcing significant numbers of products off the market, losing over $1 billion in revenue, and forcing over 100,000 Americans to lose their jobs.
• Rather than the 20 employee hours the FDA says are needed to do an NDI submission, our analysis shows it will cost between 100 and 350 hours of employee time. This will place the total cost to prepare these supplement approval applications (“notifications”) at between $845 million and $6.1 billion in employee wages.
• Animal and human product safety studies will cost between $450,000 and $6.6 million per notification, for a total cost to industry of between $2 billion and $165 billion.
• Where will industry be expected to get this money except from price increases? Supplements are already expensive. Millions more Americans won’t be able to afford them—just what the FDA and the drug industry would seem to want. It is a one-two thrust: Fail to approve many supplements, then make the rest too expensive for the average consumer.
• The federal government will lose between $1.84 billion to $3.54 billion in federal tax revenues; state and local governments will lose between $1.64 billion and $3.07 billion in taxes.
• Natural health is a huge growth industry. It is an area in which America has a competitive advantage. It can save billions in medical costs. But the federal government in the form of the FDA seems to want to shut it down. It is up to us, citizens and consumers, to tell them no.

Save the Date!

We are organizing a Call-In Lobbying Day on Thursday, September 8. This will be a coordinated effort and we are asking each of you—members, grassroots activists, readers, and friends—to set some time aside on that day to phone your senators and representatives and voice your opposition to the NDI (dietary supplement) guidance. We will have full details for you soon, including contact information and clear talking points so you can make your phone calls with confidence.

A humane society director warns that dogs addicted to Prozac become unadoptable.

Shirley Moore, director of Save a Dog of Sudbury, Massachusetts, writes:

I’m not surprised that the pet-loving population is not warned about Prozac. I just took a call from a woman last week whose dog was biting the kids and of course, the dog was on Prozac and she was told nothing about the side effects. She wanted to turn the dog over to the humane society, but I had to tell her that we can’t take dogs who are on Prozac because you can’t get them off of it. It’s designed to keep you coming back for more, just like all the other pharmaceuticals foisted on the pet owners.

There is disagreement and dissent within the veterinary community over a number of such medications. The American Veterinary Medical Association’s annual convention in New Orleans, attended by more than 10,000 of the country’s leading vets, saw a heated debate about the doggie antidepressants Clomicalm and Reconcile, and Slentrol, the world’s first canine anti-obesity pill.

The veterinarian at Eli Lilly, the company that makes Reconcile, says, “Behavior modification by itself works. There’s not any question about that. But if you use behavior modification in conjunction with Reconcile, it works quicker and it works better.” Yet Eli Lilly’s own study showed that short-term side effects include lethargy, depression, and loss of appetite. Is that an example of “working better”?

As we pointed out in our article and Shirley Moore underlined, it is easy to start antidepressant medications. But as with any highly addictive substance, it can be difficult to impossible to get off them.

Now Fido can have the same violent and psychotic breaks from SSRIs as humans. Please support our new Citizen Petition to the FDA!

The FDA has approved a reformulated version of the much-prescribed SSRI (selective serotonin reuptake inhibitor) Prozac, but this one is just for dogs. Reconcile was created to treat canine separation anxiety. It is a once-daily, chewable, dog-treat-flavored drug that is supposed to be used “in conjunction with a behavior modification plan.”

Reconcile’s full product label, which by law includes complete safety information, does not contain the black box warning that is mandatory on the drug for humans. Of course, that black box notice merely warns of increased risk of suicidal thinking and behavior in children, adolescents, and young adults. The label doesn’t make any mention of the documented connection between antidepressants and violence towards others, nor the drug’s propensity for causing mania, or increased feelings of hostility or anxiety in humans. Withdrawal from SSRIs can be similarly dangerous, ranging from nausea to suicidal ideations.

Given the tremendous risk of humans having a psychotic break when they take Prozac, what are the risks associated with animal use? No one knows—certainly not the FDA, which approved it. What if the dogs turn inexplicably violent? What if the breed is naturally aggressive (which would include the very breeds most prone to canine separation disorder)—will the drug heighten the aggression?

ANH-USA is submitting a Citizen Petition to the FDA to ask that information be added to the black box warning label for humans about the increased risk of violence from SSRIs, and to create a similar black box warning label for Reconcile for dogs as well.

A recent high-profile article in the New York Review of Books (links: part 1 and part 2) discusses the symbiotic relationship between the pharmaceutical industry and psychiatrists to push antidepressants. Some of the revelations:

• Many psychiatric drugs were created first, and then psychological abnormalities were postulated to fit the drug (not the other way around as is usually the case).
• The evidence that these drugs actually work is decidedly mixed, especially in the long term. Pharmaceutical companies have to provide the FDA with two clinical trials to prove efficacy of the drugs—and usually these successful trials are widely published. However, they never publish—and never make public—all the trials that were outright failures.
• Many pharmaceutical companies have close links with both the FDA (as we have reported in these pages many times before) as well as the medical industry.

Antidepressants, whether for humans or for pets, is a massive industry. According to the CDC, antidepressants are now among the top three classes of human medications prescribed in the US.

In fact, antidepressants are being increasingly prescribed for people who have never been diagnosed with any actual psychiatric disorder, according to a new study published in the journal Health Affairs. Nearly three-quarters of prescriptions written for antidepressants in 2007 came from non-psychiatrists, up from 60 percent a decade earlier. The percentage of patients prescribed antidepressants without having been formally diagnosed with a mental health condition more than doubled during that period—up from 2.5 to more than 6 percent of visits to non-psychiatrist providers.

Sometimes the antidepressant is just one ingredient in a combination pill; the patient may never even know what he or she is getting. An example of this, which we recently criticized, was the proposed diet pill Contrave—a drug the FDA has at least temporarily rejected. How many people wanting to lose weight would know that they are getting onto a highly addictive antidepressant?

Pushing drugs on animals is driven by the same profit incentive that we see with humans. Americans will spend over $50.8 billion on pet products and services this year. It is the fastest growing retail segment in our economy. As the New York Times noted:

Surveys by the American Pet Products Manufacturers Association found that 77 percent of dog owners and 52 percent of cat owners gave their animals some sort of medication in 2006, both up at least 25 percentage points from 2004. Sales of drugs for pets recently surpassed those for farm animals. Eli Lilly created its “companion animal” division at the beginning of 2007 and over the next three years hopes to release several other drugs. Pfizer, whose companion animal revenues have grown 57 percent since 2003 to nearly $1 billion, hopes to develop medications for pain, cancer and behavioral issues.

The FDA has approved other drugs for dogs as well: Slentrol is the country’s first canine anti-obesity medication, and Anipryl treats cognitive dysfunction so that absentminded pets can remember the location of the supper bowl or doggie door.

There is also the burgeoning market of chemotherapy for dogs. But in our desperation to save our beloved companion animals’ lives, we may well forget how incredibly dangerous chemotherapy can be for humans; it often does more harm than good. It is surely no less toxic to animals.

When Medicare reduced reimbursements for oncologists in 2003, some physicians started giving their patients more expensive chemotherapy drugs. Keep in mind also that oncologists are not only permitted to prescribe specific chemotherapy drugs to their patients; they may then sell those same drugs to them—at a huge profit. Other doctors may not sell drugs, but oncologists can. Will chemo for dogs become a huge new profit center too—without making the dogs live longer or better in any way?

As Shirley Moore, director of Save a Dog of Sudbury, Massachusetts, told us, “I’m not surprised that the pet-loving population is not warned about Prozac. I just took a call from a woman last week whose dog was biting the kids and of course, the dog was on Prozac and she was told nothing about the side effects. She wanted to turn the dog over to the humane society, but I had to tell her that we can’t take dogs who are on Prozac because you can’t get them off of it. It’s designed to keep you coming back for more, just like all the other pharmaceuticals foisted on the pet owners.”

There is disagreement and dissent within the veterinary community over a number of such medications. The American Veterinary Medical Association’s annual convention in New Orleans, attended by more than 10,000 of the country’s leading vets, saw a heated debate about the doggie antidepressants Clomicalm and Reconcile, and Slentrol, the world’s first canine anti-obesity pill.

The veterinarian at Eli Lilly, the company that makes Reconcile, says, “Behavior modification by itself works. There’s not any question about that. But if you use behavior modification in conjunction with Reconcile, it works quicker and it works better.” Yet Eli Lilly’s own study showed that short-term side effects include lethargy, depression, and loss of appetite. Is that an example of “working better”?

It is easy to start antidepressant medications. But as with any highly addictive substance, it can be difficult to impossible to get off them.

Please write to the US Food and Drug Administration today in support of our Citizen Petition to put Black Box Warnings on all SSRI drugs—whether for humans or for dogs—that warn of the link between antidepressants and sudden violent behavior.

The Washington Times recently printed an opinion piece discussing the threat nutritional supplements are facing from the FDA and Sen. Durbin’s bill. The senator’s response makes one wonder if he has read his own bill. A follow-up to our Action Alert.

Durbin says he introduced the bill in response to “a product on the market now that is escaping regulation as an adulterated food by marketing itself as a ‘dietary supplement.’” This refers to the melatonin-laced brownies sold as Lazy Cakes we’ve been telling you about (melatonin is a natural hormone that puts us to sleep). But the FDA has in fact moved against Lazy Cakes and quite appropriately shut them down. The agency could have done this from the start. It always had the authority to do so, as Durbin surely knows. Why did it wait so long? Perhaps to support Durbin’s bill, or to avoid revealing how misleading the senator’s arguments are?

Note also that of the bill’s eight pages, only two sentences address food companies like the one that made Lazy Cakes. Almost all of the bill is aimed at nutritional supplements.

The senator’s credibility problem doesn’t stop there. He says that his bill is designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.” If that’s the case, he would be pleased to know that all those things are already against the law! That’s right: everything he mentioned is already prohibited under current law. Of course, the senator knows that perfectly well.

Since the purpose of this bill is clearly not the one stated, what is the purpose? It would seem to be an attempt to move us one step closer to a full FDA approval system for supplements. That, of course, would just make supplements insanely expensive, like drugs, if you could get them at all. If supplements are not yanked from the market, or turned into drugs, the high prices would kill demand and drive supplement companies out of business. The drug industry would be waiting, ready to pick up the pieces and make their current monopoly position even tighter. That’s why our Action Alert is so important—if you haven’t already done so, please take action now!

Under Durbin’s bill, the FDA would not be the sole evaluator of supplements. It would be assisted by the government’s Institute of Medicine. Perhaps this is supposed to satisfy critics of the FDA. But it doesn’t make the proposal any better. This is the same Institute of Medicine whose recent reevaluation of vitamin D doses has been ridiculed by scientists actually expert about vitamin D. Even conventional medical societies such as the American Association of Clinical Endocrinologists criticized the Institute’s work.

Here’s an example of the IOM’s logic. It recommended 600 IU of D for a pregnant woman. It then said that the moment the baby is born, it should have 400 IU while the mother continues to need 600 IU. On the face of it, this makes no sense at all. The IOM committee was also apparently about to restate the safe upper intake level of D well above the previous 2,000 IU per day. Then just before publication and for no apparent reason—certainly no reason based on science—it reversed course and pulled a meager 4,000 IU out of thin air as the new upper limit. Scientists such as John Cannell, MD, who have really studied D, suggest that 4,000 IU would be a more reasonable recommended daily allowance, not an upper limit.

Don’t forget that the FDA in 1972 tried to ban any supplement dose higher than 400 IU unless taken under a doctor’s prescription. What both the FDA and the Institute of Medicine have in common is that both agencies know very little about supplements but are nevertheless deeply biased against them. In the FDA’s case, this may be because of all the fees that the agency gets from drug companies. Or because many of the agency’s outside panelists are paid by drug companies. In the IOM’s case, many of its experts of course also receive fees from drug companies. Yet these are the people whom Senator Durbin wants to give completely arbitrary power over supplements!

For example, under the senator’s bill, the FDA could require warnings on supplement labels of any length that would say anything the government wants, no matter how unreasonable. It would create lists of “bad” ingredients or “bad” dosages based on completely arbitrary or nonexistent standards. Whatever the FDA says would go. And once an ingredient or supplement is singled out for this treatment, there is no process to challenge the determination, not even if new or contradictory evidence comes to light. This is really bad legislation.

Assuming that Sen. Durbin is sincere—and we assume he is, despite his misleading arguments—he should create a new federal agency to be in charge of supplements. That would at least begin to make possible sensible federal oversight of the supplement industry.

Michelle Minton, who works at the prestigious Competitive Enterprise Institute, got it exactly right in her July 28 article, “The Coming War on Vitamins.” Sen. Durbin’s Dietary Supplement Labeling Act (S. 1310) is part of a one-two punch aimed at eventually pulling supplements into the current and completely dysfunctional drug approval regime.

The second part of this one-two punch is the equally insidious proposed FDA New Dietary Ingredient (NDI) guidance, which applies to supplements created after 1994. Was it a coincidence that the bill and the proposed new standards rolled out at the same moment? Was the idea that if one was shot down, the other might get through? We don’t know. We do know that the American people need to know what is actually in the bill and the guidance, both of which are cloaked in obscure bureaucratic legalese intended to mask their true purposes.

It is past time for a return to honesty and openness in American politics. Sen. Durbin could start by abandoning the falsehood that his bill has anything to do with tainted brownies that have already been removed from the market.

If you have not already done so, please write to your senators and representatives immediately and ask them to oppose Sen. Durbin’s Dietary Supplement Labeling Act. Please take action now!

A reader asks an important question about the laws threatening integrative doctors. We lay it all out.

We recently received this question from David J. Getoff, CCN, CTN, FAAIM, vice president of the Price-Pottenger Nutrition Foundation:

I continually hear physicians say (at conferences) that it is illegal for them to treat patients with natural means (diet and supplements), and that in California and other states, it is illegal to treat cancer other than with chemo, surgery, and radiation.

I have been unable to locate the regulations which prohibit this and if I am going to mention this in my lectures, I need to be able to cite the actual legal regulations.

Can you help me?

David, we’ll be in touch with you privately over the specific laws you might wish to cite in your lectures. But for this newsletter (and for our other readers), here’s an overview of why natural health doctors and producers are under constant legal threat.

Whether for reasons of conviction or crony capitalism, the government is heavily biased in favor of conventional medicine and against integrative or natural medicine. So laws often trample doctors’ natural right and their patients’ right to choose the healthcare options they prefer. Recent legislation introduced by Sen. Durbin and the FDA’s disastrous NDI draft guidance offer even more evidence of that—as if we didn’t already have enough!

If you have not done so already, please follow these links to our urgent Action Alerts on the Durbin bill and the NDI draft guidance. Your access to supplements could depend on doing so.

Federal Law for Doctors

Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.

Despite this, the FDA has approached individual doctors and threatened them with legal action if they continue to prescribe or use anything other than an FDA-approved drug or a drug being investigated under FDA procedures. For example, doctors legally using bioidentical hormones made by a local compounding pharmacy in their practice have been been intimidated by FDA officials who send a letter or demand a visit. FDA employees may also demand to see the doctor’s books or patient records, none of which is proper. The doctor may also worry that the FDA is in contact with medical insurance companies or the state medical board.

How Medicare and Medicaid Have Criminalized Natural Medicine

The federal government has also gained more and more control over individual doctors by paying their bills through Medicare, Medicaid, the Veterans Administration, etc. Federal law makes fraudulent billing a felony that can land a doctor in jail. This sounds fair, until one realizes that the federal government may interpret a natural health treatment as a fraud simply because it is not conventional. In this way, medical care has become criminalized and any doctor who accepts a government payment may be facing a jail sentence.

This is further complicated by the fact that a doctor who contacts Medicare and asks if a treatment is acceptable under notoriously uncertain and unclear government rules may be given completely different answers by different Medicare employees. But whatever the answer given, that answer does not represent an acceptable legal defense. A doctor may therefore check with Medicare, proceed in good faith, and still be threatened with jail.

If You Want Easier Treatment from the Government, You’d Better Hire Their Friends

Doctors faced with jail may agree to consent decrees with the government that govern everything they do and require them to fill out unbelievably burdensome reports. In order to fill out these reports, they may also be required by current government employees to hire former government employees at very high fees to help them do this. This aspect of federal supervision has been likened to a racket, which it often is.

Doctors must also be careful not to talk among themselves about the low reimbursement rates they are receiving from government agencies or decide to drop out of Medicare together. This can result in a charge of price-fixing under the Antitrust Acts and also lead to draconian consent decrees or worse.

In 2010 we wrote about a case in which the US Department of Justice, together with the Idaho Attorney General, charged a group of Boise orthopedists with a criminal violation of the antitrust laws for discussing what to do about the very low fees offered by the State Workers Compensation Program. They were intimidated into signing a ten-year consent decree agreeing to accept the Idaho Industrial Commissions’ price controls. News accounts also suggest that the doctors were “persuaded” to hire a high priced lawyer who until recently worked for the same division of the Justice Department that was suing them.

Is it any wonder that doctors today increasingly live in fear—whether fear of lawyers, insurance companies, or the government—and many wonder why they ever chose this profession in the first place?

State Laws for Doctors—and Drugs

Few people realize that in Kentucky, doctors cannot discuss chelation therapy with their patients or else they are subject to revocation of their license. Indeed, almost all Kentucky physicians who use alternative therapies have been either forced out of state or forced to desist from using alternative therapies, especially chelation therapy, because it “departs from prevailing practice in the State of Kentucky.” In other states, pediatricians face the loss of their insurance reimbursements if they fail to vaccinate all their patients.

While federal law is supposed to regulate the marketing and advertising of non-conventional treatments in interstate commerce, state laws describe what may or may not be allowed within the states themselves. Many states have adopted the same language as the federal code, in whole or part, to govern intrastate commerce. For example, many states have nearly identical definitions for the adulteration and misbranding of drugs as the ones in the FD&C, definitions that have little or nothing to do with what the words “adulteration” or “misbranding” actually mean in plain English.

At least thirty states have passed laws pertaining specifically to cancer, and a few of them have provisions for regulating non-conventional cancer treatments. Cancer laws provide for a variety of activities, including organizing and providing resources to combat the disease, establishing registries and advisory boards, and assisting patients in paying for the treatment. Some laws specify that cancer can be treated by only certain categories of licensed health professionals. Others authorize that the state health agency must approve cancer treatments before they can be used within the state.

For example, the California Health and Safety Code specifically prohibits the sale, prescription, or administration of a drug, medicine, compound, or device to be used in the diagnosis, treatment, alleviation, or cure of cancer unless it has been approved by the FDA or by the California Department of Public Health.

State Medical Boards Largely Controlled by the AMA

The bias against complementary, alternative, or integrative medicine in state governments is strongly reinforced by professional organizations like the American Medical Association. The AMA, which represents only about 13% of US medical doctors (even the AMA claims only 26%, but up to half that number are residents and medical students, who get big discounts on membership and a free subscription to a journal when they join), also has a seeming stranglehold on the Federation of State Medical Boards, which in turn greatly influences the state medical boards themselves.

All of these forces in turn influence insurance reimbursement policies, in most cases denying any reimbursement for alternative treatments and therapies. But nonpayment is the least of an integrative doctor’s worries. Of greater concern is the likelihood that the insurance company will send a complaint to the state medical board, or encourage a patient to do so, in order to shut down a doctor and avoid any future payments along similar lines. For this reason, many integrative doctors refuse to accept third party insurance. Even that tactic doesn’t always work, because the patient may send the bill to the insurer anyway, and the insurer may retaliate even though the doctor is not seeking payment.

Happily, several states have enacted laws that specifically exempt certain unconventional treatments and medical practices from state regulation. New Jersey, for example, offered the following rationale for its provision legalizing the use of Laetrile in cancer treatment: “In a free society, people should be able to choose their own forms of treatment for disease as long as doing so does not expose them to harmful products. In other words, the safety of drugs needs to be assured by government but not necessarily the effectiveness of drugs.”

A number of states have laws requiring informed consent, to give patients more responsibility over the therapies they choose.

State Laws Create and Enforce Monopolies which Drive Up Costs

Who can treat you is also determined by state laws. All state legal codes include medical practice acts which define the practice of medicine; stipulate the requirements for licensing health care practitioners; describe the conditions that can lead to disciplinary action; and provide for a medical board that is in charge of oversight.

Much of what doctors do could be done by highly trained nurses and other personnel, but the AMA in particular lobbies the legislatures to stop this sensible cost-saving reform. If federal legislation to insure the uninsured succeeded, everyone knows that there would not be enough doctors to service the demand, and prices would explode without such reform.

“Standard of Care” Means Whatever the State Medical Board Says

Many states do not have licensing options for naturopaths, homeopaths, acupuncturists, etc.—and so the legality of how and what they can practice is uncertain and varies. But MDs must be licensed before they may legally practice medicine in the US. And when their procedures fall outside what is generally considered “standard” medical practice (even when it is a higher standard of care), physicians who offer non-conventional treatments may become vulnerable to investigations for medical incompetence, or unprofessional behavior, or alleged violations of state or federal laws; a guilty verdict may result in fines, injunctions, loss of license, or even jail sentences.

This vulnerability is frequently heightened when the topic is cancer. Since the medical standard of care for cancer is chemotherapy and radiation, deviating from this standard can often be tricky, and state medical board attacks on integrative practitioners are all too common, and state medical board misbehavior is not uncommon. You may recall our article about the Texas Medical Board’s attack on a leading researcher and clinician in the field of environmental medicine and chemical sensitivity. Happily, the doctor still has his medical license (after three years in court), but it was a long battle.

Then there’s the all-too-typical case of Mark Geier, MD, a critic of using Thimerosal (a form of mercury) in vaccines, especially for children. His criticisms and revelations became a major thorn in the side of vaccine companies. In April of this year, he received a letter telling him that a secret hearing had been held by the Maryland Board of Physicians, and they had decided that he was “a danger to the public.” Because of that his license was being immediately suspended. At a hearing in May, neither Dr. Geier nor his attorney were allowed to examine any of the state’s witnesses (the state refuses to release their names), nor would they be allowed to produce any witnesses or testimony of their own. In fact, at no time before either of the hearings would the Maryland Board of Physicians tell Dr. Geier precisely what he had been accused of. The case is ongoing.

A key resource outlining state law is ANH-USA’s free 80-page report, “Know Your State’s Medical Board: An Integrative Medical Practitioner’s Guide to Understanding the Legal and Regulatory Environments in the 50 States.” Download it today!

Being a natural health physician is the highest legal risk profession we know. Because of this, we all owe a great debt of thanks to those brave physicians who persevere because of their love for medicine and genuine desire to help people.

Part Two coming in a future issue. We’ll continue this discussion with an overview of federal law as it pertains to sellers of food, supplements, and medical devices. Stay tuned!

Federal and state teams arrest people at gunpoint, destroy food, and seize assets—all because they’re afraid of unpasteurized milk and cheese. Please don’t let them trample the Constitution this way—a new Action Alert!

On August 2, there was an armed raid on Rawesome Foods in Venice, California, conducted jointly by the Los Angeles County Sheriff’s Office, the FDA, the Department of Agriculture, and the Centers for Disease Control and Prevention. You may recall that we reported about a similar FDA raid on the same co-op last year.

Mike Adams, editor of NaturalNews.com, broke the story last week, and we thank him for his excellent and continuing coverage of this issue. He reports that armed teams were deployed with guns drawn, law enforcement ordered all co-op members out of the store, seized all the cash in the register, then handcuffed the co-op’s founder, James Stewart, and placed him in an unmarked car without reading him hist rights.

Then authorities seized $70,000 in raw organic food—raw milk, cheese, yogurt, and fresh produce—and poured an estimated 800 gallons of milk down the drain, though there was no evidence that any of the products were contaminated.

Two others were arrested as well: Sharon Palmer, owner of Healthy Family Farms, and Victoria Bloch, the LA County liaison for the Weston A. Price Foundation. They were charged with the production and sale of unpasteurized goat milk, goat cheese, and other products without the proper permit; and with “mislabeling cheese.” They were also charged with four counts of conspiracy to commit a crime.

Unpasteurized dairy products are legal in California, but the Los Angeles District Attorney says that applicable licenses and permits are required. This is a specious claim. As Mike Adams points out, Rawesome does not need a license because it is not a public store, but rather a private club or co-op whose members actually own a percentage of the cows, goats, and farms that produce the raw dairy. The state of California is trying to regulate it as a public grocery store, when it is instead a private buyers’ club. The facility is used only as a distribution point for the products that the members already own.

All three of those arrested have been released from jail after posting bail, but only on condition that they give up their First Amendment rights and refrain from talking to anyone about the case—specifically, from communicating in any way, verbally or nonverbally, about the government raids conducted against them.

The public has responded with outrage. A public protest was held in front of the LA County Courthouse; this, together with the global attention the raid has caused, may have been responsible for the swift reduction in James Stewart’s bail—from $123,000 down to $30,000.

Bye-bye, Constitutional Rights?

The raid places a spotlight on the constitutional right of bodily autonomy. Do we have the right to decide what we eat? As the Supreme Court observed more than a century ago, “No right is held more sacred, or is more carefully guarded, by the common law, than the right of every individual to the possession and control of his own person, free from all restraint or interference of others, unless by clear and unquestionable authority of law.” And Justice Cardozo wrote in 1914, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”

The FDA’s position is that people do not have the constitutional right to eat what they want. In response to a lawsuit by the Farm-to-Consumer Legal Defense (FCLD) Fund, the FDA made the following outrageous statements:

• “Plaintiffs’ assertion of a new ‘fundamental right’ to produce, obtain, and consume unpasteurized milk lacks any support in law.
• “There is no ‘deeply rooted’ historical tradition of unfettered access to foods of all kinds.”
• “Plaintiffs’ assertion of a ‘fundamental right to their own bodily and physical health, which includes what foods they do and do not choose to consume for themselves and their families,’ is similarly unavailing because plaintiffs do not have a fundamental right to obtain any food they wish.”

However, the US Constitution restricts the government from infringing on the rights of the people—so controlling what people eat, even through legislation, is an overreach of government power. In addition, it can be argued that health freedom—and the right to eat what we wish—is embedded in the ideas of privacy and personal autonomy protected by the 14th Amendment.

Government and Big Food

FDA justifies its actions from a food safety perspective. But virtually any food can contain harmful pathogens. In fact, you are 35,000 times more likely to get sick from other (FDA-protected) foods than you are from raw milk. Raw milk has been conclusively shown to be both safe and healthy.

The truth is, the FDA and other federal agencies are being motivated by the interests of Big Food—and in this case, the interests of the dairy industry. Once again, we see crony capitalism at work. The USDA has an entire marketing arm called Diary Management that actively pushes the sale of pasteurized cheese and milk.

This is merely the latest skirmish in the FDA’s long war against raw milk producers and small business owners. ANH-USA is working on a legislative approach that will buttress a right to health freedom, but for now, please read our new Action Alert. Congressman Ron Paul’s HR 1830 would authorize the interstate traffic of unpasteurized milk and milk products packaged for direct human consumption. Please contact your representative and senators today!

Want to let the drug industry take your favorite supplements off the market, patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now? A follow-up to our recent Action Alert.

As Big Pharma becomes more desperate to boost flagging profits, the industry will likely use this tactic to find new sources of revenue—and shame on the FDA for so blatantly aiding and abetting it!

This coming year, seven of the world’s twenty bestselling drugs will lose their patent protection and can be sold in generic forms. On this list are the top two money-makers ever created: cholesterol fighting (but overall health-threatening) Lipitor and blood thinning (but bone-destroying) Plavix. This wave of expiring drugs patents will have unprecedented and devastating effects on the industry bottom line. One drug recently made available in generic form—Protonix, a medication for severe heartburn (again, not a drug we would use, and especially dangerous when used with the blood-thinner mentioned above)—previously cost about $170 per month when it was still under patent; its generic version now costs $16. With seven of the top-selling drugs expected to see similarly drastic drops in prices, the drug industry is in a panic—especially considering the fact that there are no new “blockbuster” drugs in the pharmaceutical industry pipeline. Under these circumstances, why not try to turn some supplements into drugs?

Even before the draft FDA’s NDI (new supplement) guidelines, supplement manufacturers already faced a “race-to-the-market” threat from the drug companies. The Dietary Supplement Health & Education Act of 1994 (DSHEA) states that a company cannot market a New Dietary Ingredient—that is, a new supplement—if an IND (Investigational New Drug) application for that ingredient has already been filed and research on that ingredient is publically available (a study published in any scientific journal will do).

If the ingredient was already used in a supplement legally marketed before the IND (drug) application was filed, then the supplement company can continue to market it even after the drug filing. But what does “legally marketed” mean to the FDA? It can mean that the supplement was sold in quantity before 1994. Or it can mean that the supplement’s NDI (new supplement) filing has been accepted by the FDA. The problem is that the FDA rejects most NDI (new supplement) filings. And it takes a long time to review even the few it accepts, giving drug companies plenty of time to get a competing drug application in. In complete disregard of the clear intent of the law governing supplements, the FDA has stacked the deck against any new supplement and in favor of any new drug.

Bottom line: If a drug company files an IND (drug) application for a natural substance before a supplement manufacturer can meet the onerous NDI (supplement) notification standards and receive FDA approval, the supplement company can never again sell the substance in its natural form.

This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. And it could also happen to P5P— the ultimate form of natural B6 which all other forms of B6 must convert to before being used by our body. Without P5P we would all die, yet the FDA may turn it into a prescription drug. Please see our Action Alert on P5P.

According to the FDA’s draft guidance, there are 55,600 dietary supplements on the market but only about 700 NDI applications (new supplement applications) have been sent, and the FDA has rejected around 64% of them. Not all of the 55,600 supplements are new (NDIs), but since an NDI is defined as any substance created, modified from its original form, or newly marketed any time in the past seventeen years, we can assume that many of them are! Depending on how the term new supplement is defined in practice by the FDA, there are many thousands of natural substances that can easily be turned into prescription drugs.

At the present time, it is not even possible to know how many IND (drug) applications for natural ingredients have already been filed by drug companies. All this information is kept under wraps by the FDA and not made publicly available.

ANH-USA has read several of the FDA rejected NDI notifications (applications) for very commonly used and essential natural substances—ingredients which are now being investigated as drugs. We don’t want to name them for fear that it would put a target on their back, but the problem is very real.

Wait, there’s more.

Any “new” supplement is already at risk of being converted into a drug—and this risk is greatly increased by the new FDA NDI (new supplement) guidelines. But the new FDA guidelines don’t stop there. While they encourage drug companies to take natural substances, they forbid supplement companies from selling synthetic botanicals.

What does this mean? “Botanicals” refers to plants. For years drug companies have studied plants for medicinal uses. If they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance, a new molecule that can be patented and then taken through the FDA as a new drug.

Nothing unfamiliar about this. What is new in the draft FDA NDI (new supplement) guidelines is that synthetic versions of botanicals may never be sold as supplements, only as drugs. In effect, the FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, only synthetics can be patented, and only patented substances can be brought through the hugely expensive FDA approval process.

This is all blatant crony capitalism—a huge gift to the drug industry without any conceivable benefit to the public. There can be no reason for it other than to pad Big Pharma’s pockets—a guaranteed monopoly on synthetic botanicals for drug companies to patent, all of which will lead to larger drug company fees being paid to the FDA.

In saying that drug companies should not have a monopoly on synthetic products, we are not endorsing synthetic products per se. At ANH, we prefer natural products. For one thing, they are generally safer. Why? Because synthetics are new to our bodies; we have not evolved with them. The risk of unintended or unknown side effects is greater. One of the oldest drugs in the world, aspirin, is a synthetic derivative of white willow bark. The herbal form is less likely to cause internal bleeding.

Cholesterol-lowering drugs like Lipitor, Zocor, and Pravachol are synthetics based on the natural ingredient ivostatin found in red yeast rice. The FDA has repeatedly gone after companies that sell red yeast rice products containing ivostatin, on the grounds that this entirely natural substance has now become “an approved drug product” which can only be sold as a drug. Lipitor is the currently the best-selling drug ever made, with 2010 global profits at about $11.7 billion. It is also, unlike red yeast rice, an unrecognized but major health risk for millions of users, as we have pointed out in earlier articles.

Lovaza (omega-3-acid ethyl esters), is the only FDA-approved semi-synthetic omega-3 fish oil, though a second drug, Epanova, is in Phase III of its drug trials. To keep the FDA approval cost down, it is supposedly only approved for the treatment of very high triglycerides. But doctors prescribe it for many reasons, and it is the only fish oil that Medicare and Medicaid and the Veterans Administration is allowed to reimburse. This is wonderfully profitable monopoly for the drug company producing it. Lovaza costs $6.75 per day, over $200 per month. A high-potency natural fish oil supplement with the same EPA and DHA amounts may cost less than 50¢ per day, or $15 per month.

Given a choice between natural and synthetic, we vote for natural. But that doesn’t mean that drug companies should have a monopoly on synthetics. If the FDA has its way, everything we take apart from food would be synthetic, patentable, sold by a drug company, prescribed by a doctor, cost a fortune, and produce a mountain of fees for the FDA itself.

If you have not done so already, please send your message to Congress through our Action Alert on the FDA’s NDI guidance. While you’re at it, be sure to see our Action Alert on the closely related and equally dangerous Durbin bill and let your voice be heard! We cannot emphasize strongly enough how very important it is that we fight on these two issues—your access to natural supplements is at stake!

Nearly 20 million Americans experience dire health problems from eating foods that contain gluten. Congress told FDA to define the term “gluten-free” for food manufacturers by 2008. Why are they still “studying the matter”? A new Action Alert!

Celiac disease is an autoimmune condition in which dietary gluten, causes damage to the small intestine, which keeps nutrients from being properly absorbed. Even small amounts of gluten in foods such as wheat, rye, barley, and other products, can lead to serious health problems, ranging from gastrointestinal distress and infertility to an increased risk of osteoporosis and certain cancers, particularly colon cancer.

As we reported recently, gluten-related conditions greatly increase the risk for diabetes. A recent large study published in the Journal of the American Medical Association found that people with diagnosed, undiagnosed, and “latent” celiac disease or gluten sensitivity had a higher risk of death, mostly from heart disease and cancer.

More than 2.3 million people in the US have celiac disease, or about 1 in 133 people; some estimates place the total as high as 3 million Americans—and growing.

Many more Americans—as many as 30–40% of the US population, according to the research of a leading US laboratory working in the field—have gluten sensitivity (also called Non-Celiac Gluten Intolerance), which means that they, too, are sickened by the protein. It is also sometimes referred to as “silent” celiac disease, as the disease may remain latent for twenty years or more before becoming full-blown celiac disease if gluten consumption is continued.

In these people, gluten continues to cause irritation to the lining of the intestine, often giving rise to poor digestion and malabsorption (as enzyme production is compromised), abdominal pain, irritability, achiness, sluggishness or fatigue, apathy, headaches, skin problems, depression, “foggy mind,” other decrease in brain function, or tingling extremities.

Dr. Mark Hyman reports that a review paper in The New England Journal of Medicine listed 55 “diseases” that can be caused by eating gluten. These include osteoporosis, irritable bowel disease, inflammatory bowel disease, anemia, cancer, fatigue, canker sores, rheumatoid arthritis, lupus, multiple sclerosis, and almost all other autoimmune diseases. Gluten is also linked to many psychiatric and neurological diseases, including anxiety, depression, schizophrenia, dementia, migraines, epilepsy, and neuropathy (nerve damage). It has also been linked to autism.

Two important factors that may create gluten sensitivity are a diet containing too much gluten, and increased permeability of the small intestinal lining, also called leaky gut syndrome—which, as we reported last week, may develop because genetically engineered food genes are transferring to our own genes.

The incidence of celiac disease is rising sharply—and not just due to greater awareness: the rate has increased fourfold in the last 50 years. One possible culprit: agricultural changes to wheat that have boosted and changed the amount and quality of proteins present.

Celiac disease is being diagnosed in people as old as 70 who have eaten gluten safely all their lives—most likely the result of adults losing their immunological tolerance for gluten as they get older.

The treatment to this massive, preventable health problem—a problem aggravated by the fact that gluten is ubiquitous in the Western diet and is abundant in wheat, one of our most-consumed foods—is straightforward: a commitment to a gluten-free diet. Not a low-gluten diet, but a diet that is more-or-less completely free of gluten (i.e., containing gluten at less than 20 parts per million, or ppm).

The high numbers of celiac sufferers, and the rise in people with gluten sensitivity, has food manufacturers looking at a lucrative new niche. The gluten-free market is projected to reach $2.6 billion next year, up from $100 million in 2003, with products carrying a premium price. But there’s a problem: while some products labeled gluten-free contain no gluten, others might have a trace, and still others could contain a sizable amount.

In 2004, Congress gave the FDA until 2008 to establish a uniform definition for companies that want to label their products as gluten-free. But that deadline came and went three years ago.

The Washington Post reports that the FDA has spent years calling on experts to have open-forum debates and town hall meetings—all of whom have been saying the same things about the dangers of gluten and what “gluten-free” should mean. As Alessio Fasano, medical director of the Center for Celiac Research at the University of Maryland School of Medicine, said recently, “I really don’t understand why it’s lingering up in the air when it really should be a no-brainer.”

The FDA has said the issue is complicated, requiring analyses of various technical issues, including how well manufacturers and regulators can reliably test for the presence of gluten and whether oats are a source of gluten (not usually, but they can be—see Note below).

An FDA spokesperson recently told the Washington Post that “efforts are now underway” to publish another document in the Federal Register and reopen the matter to another round of public comments. The FDA will then “consider the comments,” the findings of a safety assessment and “other factors” to develop a final rule.

In other words, the agency is deliberately dragging its feet.

Even the House Appropriations Committee, which is considering FDA funding, noted the agency’s failure to meet its deadline: “Public Law 108–282 required a final rule…not later than August 2008….The Committee instructs FDA to issue a final rule before December 31, 2011.”

Three years of flouting the law, and all FDA gets is a slap on the wrist.

Canada, Brazil, and Australia have all set labeling standards for gluten-free items. In most cases, that standard is 20 parts per million: A food can be labeled gluten-free if it contains less than 0.0007 of an ounce of gluten for every 2.2 pounds of food. That level was chosen largely because it’s the minimum amount of gluten that can be reliably detected.

These countries have developed this standard after many years of discussion on the subject at the Codex Alimentarius Commission. Before 2008, the Codex standard for “gluten-free” foods was a whopping 200 ppm. The US government delegation, comprised of FDA staff, agreed to the international guideline level being lowered to 20 ppm. Now they seem to have cold feet. Is it that gluten is so widely distributed in processed foods that US food corporations would struggle to cope with the 20 ppm level?

Meanwhile in North Carolina two weeks ago, a man was sentenced to eleven years in prison after he was found guilty of buying regular breads and rolls and repackaging them as gluten-free under the name Great Specialty Products. Dozens of people became ill as a result.

On May 4, concerned citizens brought the world’s largest gluten-free cake—“symbolizing the big deal that clear, accurate, reliable labeling plays in the lives of people dependent on labeling for their health”—to Capitol Hill in protest of FDA’s inaction.

Please write to the FDA immediately and tell them to stop listening to Big Food interests, and define “gluten-free” to mean gluten-free.

Update: On August 3, one day after this article was published, the FDA reopened comment on gluten-free labeling. All messages sent through our Action Alert will be redirected so that you can make your voice heard during this comment period.

Note:

Gluten is a naturally occurring group of proteins in cereal grains which makes bread dough elastic and chewy and gives pasta its structure. Besides being found in grains, it is very common in more-or-less all processed foods, including foods many consumers would imagine were gluten-free, from processed meats to ready-made meals, soy sauce, blue cheese, brown rice syrup, and what ingredients labels call “flavor enhancer.” It may also be found in everyday products such as medicines, vitamins, and lip balms.

Oats are naturally gluten-free, but cross-contamination is a major problem. If oats are grown in a field that previously grew other gluten-containing grains, some of those grains will naturally grow in the oat field the next year, and they will contaminate next year’s oats. Cross-contamination can also occur if the farmer uses the same equipment to process all his grains, or the transport company bringing the oats to the processor has stored and transported other grains, or if the processor processes other gluten-containing grains. The same problem occurs with corn chips and corn tortillas—there is a high level of gluten cross-contamination. For these reasons, celiacs and those people eating gluten-free should purchase only certified gluten-free oats and corn products.

Prof. Markku Mäki, head of a gluten research at the Academy of Finland’s Research Program on Nutrition, Food, and Health, has been at the forefront of gluten research worldwide for over three decades. He estimates that around 75% of people with gluten intolerance remain undiagnosed owing to mild or atypical symptoms. However, he argues that continued exposure can lead to full-blown celiac disease later in life, explaining the fact that typically around twice as many of people over age 50 have celiac disease as compared with their younger counterparts. His group has also shown that while gluten intolerance may be inherited by many, it may also be triggered by environmental factors, including exposure to particular viruses. Gluten intolerance is the most common genetic disorder in North America and Europe, although it is found in populations all over the world.

To go back to where you were in the text, click here.

Despite a lack of independent safety testing, the government has seen fit to declare there will be no oversight of a genetically engineered grass. Is this the beginning of a GE avalanche?

Just before the July 4th weekend, the USDA released a statement saying that the agency has no authority to regulate genetically engineered (GE) Kentucky bluegrass. This leaves Kentucky bluegrass completely unregulated—and sets the precedent for a complete lack of oversight of GE crops in the future. This is extremely worrying: there are very few independent studies investigating the safety of genetically modified organisms (GMOs), and the ones that have been published show that GMOs can have very dangerous long term effects.

Oversight of GE crops is extremely lax, because there is no federal law specific to their regulation. The USDA only has two provisions that apply to GMOs—the regulation of plant pests, and the noxious weed provision.

The Plant Pest Act—a law established in the 1950s—gives the USDA power to restrict the introduction of organisms that might harm plants. In a bit of a stretch, the USDA has used this power to regulate GE crops. The reasoning is that GE crops qualify as “plant pests” because historically the DNA from natural plant pathogens/microbial material (bacteria, fungi, etc.) was used in the genetic engineering of various plants.

However, this is increasingly no longer the case. Kentucky bluegrass, for example, doesn’t use the DNA from plant pests at all. Accordingly, the makers of Kentucky Bluegrass, Scotts Miracle-Gro, claims the USDA has no authority over them since “Kentucky bluegrass itself is not a plant pest, and no plant pest components will be involved in the transformation.” And on July 1, the USDA agreed, sending the Scotts Miracle-Gro Company official confirmation on Kentucky bluegrass’s regulatory status.

In 2000 the Plant Pest Act was expanded to allow the USDA to also regulate noxious weeds, and became the Plant Protection Act. This is significant, because we believe this provision gives USDA the authority to regulate GE Kentucky bluegrass: any engineered crop that threatens to go rogue in the field and become a hard-to-control weed may be regulated. In this case, pollen is light enough to be carried for miles in the wind, causing gene transfer with non-GE crops; and bluegrass spread rapidly.

However, even though the USDA admitted that GE bluegrass could be considered a noxious weed, the agency declared it still would not “cause impact significant enough to warrant regulation at the federal level”—a position we find both absurd and unconscionable.

We have several major concerns:

• Kentucky bluegrass is widely grown, and is used in parks and home lawns. This means the genetically engineered variety will have wide exposure indeed.
• This decision paves the way for any number of GE crops in the future to avoid USDA regulation altogether.
• If it is determined that a GMO is out of the USDA’s jurisdiction, the courts cannot demand that the USDA conduct full environmental impact studies under the authority of the EPA. This means other safety nets will disappear as well.

Our biggest concern, however, is the potential impact on our health. Since the USDA jurisdiction covers only plant pests and noxious weeds, there are very few studies of actual long-term human health affects of GMOs. In fact, most safety studies on genetically engineered products have been conducted by GE companies themselves! Furthermore, it is difficult to get the actual raw data for independent testing because GE companies usually keep data proprietary and seriously block independent studies.

A documentary series of nine films on GMO by German filmmaker Bertram Verhaag reveals the undemocratic, global conspiracy to push GE interests over those of the consumer. When he learned that only 5% of scientists working in the area of GE are truly independent, Verhaag started work on his most recent film, Scientists Under Attack. It documents two scientists conducting independent research about GE against pressure from industry, the government, and the scientific community.

However, what we do know about the health effects of genetically engineered crops is frightening. In a letter to USDA Secretary Tom Vilsack, retired Purdue University professor Dr. Don Huber wrote that a newly discovered and widespread pathogen is damaging the health of plants, animals, and possibly human beings. Glyphosate (the active ingredient in in Roundup, the herbicide many crops are engineered to be resistant to) may be weakening its plant and animal hosts making it susceptible to this pathogen, which is similar to the way HIV works. The pathogen has been found in high concentrations of the Roundup Ready soybean meal and corn used in livestock feed. Lab tests confirmed presence in the organism of pigs, cattle, and other livestock that have experienced spontaneous abortions and infertility. Plants containing the pathogen are stricken with disease.

With the help of Greenpeace, biologists from two French universities obtained a court order to force Monsanto to hand over its findings from animal studies they had used in its assessment that three varieties of GE corn were safe. After analyzing Monsanto’s data themselves, they discovered “statistically significant” evidence that the crops could poison the liver and kidney (the body’s main detoxifying organs). They also found pesticide residues in GE crops and animal feeds that were high above safe levels—which could affect the endocrine system.

Even worse, they found that that Monsanto’s tests were purposely designed to obscure the results. The test involved only 80 rats and 320 control rats, instead of equal numbers of both. And the longest study was just 90 days long—which isn’t enough to show long-term effects. The results were published in the International Journal of Biological Sciences.

NaturalNews.com has called for a boycott of the Scotts Miracle-Gro Company and all its products. If you wish to participate, please visit the Natural News boycott page to learn more.

Monopoly utility companies across the country are installing radio frequency “smart meters” in your home. If you don’t want them, too bad: it’s take them or live without electricity. Meanwhile, RF is being investigated as a carcinogen.

Smart meters (including the SmartMeter, a trademark of SmartSynch, Inc.) are digital meters that have been increasingly in use since the 1980s. The new radio frequency (RF) smart meters include a small one-watt radio that allows two-way communication between the customer’s home and the utility company. A smart meter transmits non-ionizing radio waves, just like cell phones, baby monitors, microwaves, and Wi-Fi.

There are a number of health concerns with the smart meters. The California Council on Science and Technology, the FCC, and the FDA all claim this technology is safe. However, as early as 1972, there were already over 2,000 studies showing negative health effects from RF radiation.

Most of the research has centered on cell phones. There have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs (many men, after all, keep their cell phones in their pants pockets or attached at the hip).

In 2008, scientists from thirteen European countries reported that after a decade of cell phone use, the chance of getting a brain tumor—specifically on the side of the head where you use the phone—goes up as much as 40 percent for adults. An independent study in Sweden last year concluded that people who started using a cell phone before the age of 20 were five times as likely to develop a brain tumor. Another study reported a nearly 300 percent increased risk of acoustic neuroma, a tumor of the acoustic nerve.

Louis Slesin, who has a doctorate in environmental policy from MIT and in 1980 founded an investigative newsletter called Microwave News, suggests that much of the comfort of our modern lives depends on not caring, or refusing to recognize the dangers of microwave radiation. “We love our cell phones. Americans are not asking the questions, maybe because they don’t want the answers.”

Certainly the government does not seem to want any answers. Early on, it exempted cell phones from any FDA review, principally because the telecommunications industry asked it to do so.

As for smart meters, there have already been thousands of reports of negative short-term health effects where the meters are already in place. Complaints range from dizziness to heart palpitations, migraines to sleep disturbances, exhaustion to forgetfulness and confusion, nausea and vomiting to constant thirst, increased blood pressure to anxiety and an overall decrease in functionality. These reports, like drug or supplement adverse event reports mentioned in our other article in this issue, represent correlation rather than causation, as scientists say. But clearly more investigation is needed. One should also consider the cumulative effect of radiation exposure from the other wireless technologies coupled with this new wave of radiation.

The World Health Organization previously claimed RF technology posed no threat, but recently reversed its stance, classifying cell phones as “possibly carcinogenic.” President Obama’s Cancer Panel also recently issued a cautious recommendation of limiting exposure to RF wireless technology, calling cell phones a possible carcinogen. While both WHO and the Cancer Panel are careful to say that the technology was only “possibly” dangerous or carcinogenic, it is significant that such important bodies should—in the face of RF’s widespread use—say anything cautionary at all about it.

Radio frequency radiation is also currently under investigation as a carcinogen by the National Toxicology Program. Children are far more susceptible to the effects of microwave radiation than adults due to their thinner skulls and developing DNA. The science is at best inconclusive. If scientists worldwide cannot agree about the safety of these meters, surely that is reason to give pause before their mass deployment across the country.

There are other concerns as well. Smart meters are vulnerable to hacker attack. A sophisticated hacker might use the data to figure out when you’re away on vacation and your house is vulnerable to burglary. And if a hacker were to infect smart meters with malware, it could disrupt the electric grid and cause widespread power outages. According to CIA director Leon Panetta, hacking into the Smart Grid “brings down the financial system, brings down our government systems. You could paralyze this country. And I think it’s a real potential.”

Moreover, smart meters may suffer from problems with billing accuracy. Two major utilities in Texas have confirmed that some customers received inaccurate and sometimes inflated bills after turning to SmartMeters to measure their energy usage. And PG&E, which provides gas and electricity to two-thirds of California, also admitted to inaccuracies with the meters.

The Maryland utility company PEPCO has announced plans to install smart meters in Prince George’s County and Takoma Park beginning this summer. At present there is no opt-out option in Maryland for the smart meters.

Even if one were able to opt out, however, one could still be sickened by a neighbor’s device, at least in the confines of an apartment building. Of course, if you refuse to allow the smart meters, the company will threaten to turn off your power completely.

The extent of this issue depends where you live in the country. In many areas there is only one power company. In others, options may exist, but because there is only one infrastructure—one set of power lines—even if you purchase your power from an alternate company, the power still travels down the lines of the primary power company to your home and is metered by that power company. So if you purchase 5 kwh of power from a wind farm, the wind farm will pump 5 kwh into the power grid, which is operated by your vertically integrated power company (PEPCO, PG&E, etc.). Either way, there is a monopoly company that can shut off your power.

In Virginia, for example, the power company Dominion Resources Inc. plans to install smart meters to all their customers’ homes—and they have already installed half of the Smart Grid meters in Charlottesville. If you choose not to use the smart meters, you choose to have no grid power at all—and that is not a viable choice for most people.

This situation can be changed! Every state in the US has a public utilities commission (PUC). The exact powers and authorities given to a PUC vary from state to state, as each PUC was created by state legislation, but most PUCs are to some degree under the control of the state legislature, in the sense that their mission is to enforce state code as it relates to utilities. Legislation at the state level can be written to ban or, at the very least, allow customers to opt out of having a smart meter without losing their access to power altogether.

Maine residents have secured the right to opt-out of smart meters, but they must pay a penalty surcharge.

Many local jurisdictions in California have banned or issued moratoriums on smart meters, but the electric utility claims the bans are not legally enforceable and smart meter installation continues in much of the state. An opt-out plan for California will be voted on by the California PUC later this year. We will keep our eye on this and will issue an Action Alert at the proper time.

A plan to install smart meters throughout Maryland was killed last summer, but as we noted above, a new plan is now moving forward with installation in Prince George’s County and the incorporated city of Takoma Park (both of which border Washington, DC). And further north, Baltimore Gas and Electric will begin installing smart meters in all the homes, businesses, schools, and clinics in its jurisdiction beginning in October, 2011, and plans to have the Smart Grid “fully operational in mid-2014.” Maryland Residents Against Smart Meters (MRASM) has been organized to oppose the installation.

If you are a Maryland resident, please write to your legislators and the Maryland Public Service Commission today. Ask them to mandate an opt-out provision for the installation of smart meters.

The FDA is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. Let’s tell the FDA that supplements are not drugs and ask Congress for help!

Last week we told you about FDA’s draft guidance on New Dietary Ingredients, which allows FDA to arbitrarily deny the sale of any supplement created (or said to be created) in the past seventeen years! Already this has become an explosive issue, with media attention from numerous quarters. The FDA will no doubt call everything that is being said “an overreaction.” We expect them to say, “It’s only draft guidance! It’s not legally binding!” But don’t be fooled. Just because the agency is calling it “draft guidance” doesn’t mean this thing doesn’t have teeth.

If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by jail.

The FDA will also say that they have no intention of destroying the supplement market. This is true for now. The FDA knows they can’t just disapprove all supplements developed or modified since 1994, at least not all at once. But they can double or triple the price of supplements and they can gradually disapprove more and more of them over time until there is little left but drugs. Those of us opposing this new FDA guidance are not using scare tactics. The threat to supplements is real and urgent. This has to be stopped now, or over a long period of time supplements as we know them may disappear.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was landmark legislation. The NDI notification system that DSHEA outlined was supposed to be about notification, plain and simple, with only occasional response from the FDA. In fact, before this draft guidance was published, Sens. Tom Harkin and Orrin Hatch—the two principal authors of DSHEA seventeen years earlier—wrote to FDA Commissioner Margaret Hamburg, MD, to underscore their expectation that the guidance be consistent with the intentions of DSHEA. “In DSHEA,” they wrote, “Congress made clear that consumers should continue to have access to dietary supplements that meet the law’s definition [and] should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products.”

To quote DSHEA itself: “Congress finds that:

• the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
• dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;
• and legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

In nearly every provision of the draft guidance, the FDA simply disregards clear and compelling evidence of the law’s intent.

FDA: We Will Decide What Supplements Can Be Sold

By turning what was meant to be a pre-market notification system into a pre-approval system, the FDA becomes the ultimate arbiter of what dietary supplements will and will not be available.

The FDA does this by simply not “filing” (which means accepting) any NDI notifications they don’t like. It may be because the notification does not meet rigid FDA specifications. Or it may be for any reason, however arbitrary.

ANH-USA has gone through the NDI notifications publically available, and we can confirm that a large number of NDI notifications, we think a majority, have been rejected—and this was before the new guidance spelled everything out, complete with handy flowcharts. Now it will be even harder for an NDI to be accepted, greatly diminishing consumer access to dietary supplements. The FDA even wants human trials, even if a supplement already exists and has just been slightly modified.

If the FDA does not “file” (approve) the NDI notification, and a supplement manufacturer, distributor, or possibly health food store still markets the supplement, the FDA considers the supplement an adulterated product. This makes the manufacturer or distributor vulnerable to FDA enforcement—including seizure of their products, injunctions, fines, and jail.

DSHEA: Supplements Are Not Drugs or Food Additives

Built into the Federal Food, Drug, and Cosmetic Act (FD&C) are pre-approval food additive provisions. But under DSHEA, dietary ingredients were intentionally exempt from those food additive provisions, to ensure that the FDA would not ban new supplement dietary ingredients as illegal unapproved food additives.

Moreover, in the Congressional Record of August 13, 1994, the DSHEA authors explain the purpose of DSHEA is to “clarify that dietary supplements are not drugs or food additives” and that “regulations relating to food additives are not applicable to dietary supplements and their ingredients used for food additive purposes.” Since dietary supplements are also specifically not drugs, it is counter to congressional intent to push the approval standard in the NDI notification closer to the pharmaceutical standard.

According to DSHEA, all dietary ingredients on the market before 1994 are grandfathered in—that is, they are not considered new supplements (NDIs), and are therefore not subject to the NDI notification. But FDA interprets “chemical alteration” very broadly, and so the agency is demanding an NDI notification for every reformulation and every new combination of any dietary ingredient, even those marketed before 1994. This FDA interpretation essentially ensures that many—and eventually, most—dietary ingredients currently on the market will be considered an NDI, subject to notification, and therefore to disapproval.

This, too, is clearly counter to congressional intent. It sets up supplement manufacturers to fail, and will turn most of them into alleged criminals if they persist in selling supplements not specifically approved by the FDA. At the very least it will cause supplement costs to soar. Supplement costs are high enough already—too high for many Americans to buy them, no matter how much they benefit health and thus reduce costs over the long run.

The 75-Day Waiting Period

DSHEA says that a manufacturer or distributor has to submit a notification 75 days before it is introduced on the market. It makes no mention of any requirement for FDA to respond, because notification was assumed to be a routine event. FDA then takes that requirement and twists it to say that a supplement manufacturer must wait 75 days after FDA files (accepts) the notification before the product can be marketed. And depending on how much additional information the FDA requires, it can be a while before the FDA files or, as noted above, FDA may choose not to file the notification at all—ever. The product is then in limbo and can only be sold at great legal risk.

And who must submit the NDI notification? “Either the manufacturer or distributor of a dietary supplement that contains a NDI, or the manufacturer or distributor of the NDI.” But what, in FDA-speak, does “distributor” mean? Could it include health food stores? If so, this puts an absurd burden on mom and pop stores trying to offer healthy alternatives to the public—especially if no one else filed a NDI in the supply chain. It would certainly seem to apply to larger companies, like Whole Foods, who distribute supplements under their own label.

The FDA should limit the NDI notification requirement to ingredient or supplement manufacturers, not sellers. Putting that burden on sellers—making them file a notification if they learn that their supplier hasn’t done so—essentially turns them into FDA enforcers. We think that smacks of police state tactics. Make everybody turn everybody else in or be arrested yourself.

The Question of Synthetics

Synthetic vitamins and supplements still have to comply with the NDI notification process if they were not a dietary supplement ingredient before 1994. The FD&C Act repeatedly includes synthetic vitamins and minerals with natural ones in its definition, and NDI notifications for synthetic vitamins and minerals have been filed in the past.

However, the draft guidance makes clear that the FDA does not consider synthetic botanicals to be NDIs at all: “A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a ‘constituent’ of a botanical that qualifies as a dietary ingredient. Similarly, a synthetic version of a botanical extract is not an ‘extract’ of a botanical…because it was not actually extracted from the botanical.”

What does all this gobbledygook mean? Bear with us, because it is important. It means that while new formulations of both natural and synthetic minerals are required to make NDI “notifications,” synthetic molecules derived from plants are not included. Why? Because these molecules might easily be made into a new drug by a pharmaceutical company.

The FDA is saying that synthetic botanicals can never be sold as a supplement and must always be treated as drugs. No surprise, of course. The FDA, if it had the power, would treat everything as a drug and require the full drug approval process, no matter what it does for cost or availability.

Both the FDA proposed NDI guidance and the dangerous Durbin bill (see our new article on Durbin in this issue) seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on totally arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number of supplements and supplement potencies, raise prices substantially, injure our ability to take care of our health, raise healthcare costs, stifle supplement innovation, and cost millions of jobs in the supplement industry.

We are expanding our previous Action Alert to include Congress. They have the power to fix this, since it was they who passed DSHEA and set forth its guidelines. If you sent a message to the FDA alone before, don’t worry, we will see that your previous message gets to Congress too. Or you can send another one. If you haven’t yet sent a message, please be sure to do so. The future availability of supplements is at stake.

Sen. Durbin’s disingenuous “Dietary Supplement Labeling Act,” which we told you about last week, needs to be defeated. Please contact your senators!

The bill, S.1310, is finally available for viewing by the American public. It exploits the Lazy Cakes incident, where a rogue food company decided to put melatonin into brownies and allowed them to be sold to children. But that case was about the illegal actions of a food manufacturer, whereas this bill is simply another attempt to limit your access to dietary supplements.

The proposed law trusts the FDA and the Institute of Medicine (IOM) to decide what levels and combinations of dietary ingredients are considered safe and what aren’t. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s recent vitamin D report, these are hardly trustworthy sources of guidance!

If the bill is passed, neither the FDA nor the IOM will even be subject to any clear standards. They can just make it all up as they go along. Their judgments can be completely arbitrary.

The whole thrust of British and American constitutional history is telling the government it can’t just do anything it likes. There must be written standards and rules encoded in law. The government must follow those standards and rules like anyone else. It can’t just be arbitrary.

Durbin’s bill in other sections just reinvents the wheel, authorizing the FDA to do what it is already authorized to do, but with vague new language that could prove troublesome later. This isn’t needed. The FDA is fully empowered to enforce the many laws and regulations which already exist—provided by DSHEA, the Nutrition Labeling and Education Act, the Fair Packaging and Labeling Act, and Good Manufacturing Practices guidelines.

Sen. Durbin’s bill needs to be defeated. Period. That said, it’s a bill that modifies the procedures set forth by DSHEA, the Dietary Supplement Health and Education Act of 1994. And any bill that modifies the procedures set up by DSHEA should have at least two elements that are not in Durbin’s bill. It must:

• uphold the right to free speech about the science and health benefits of dietary supplements, and
• create a new agency under Health and Human Services dedicated to overseeing nutritional supplements.

FDA is supposed to be concerned with food and drugs; supplements are their own category, utterly different from either food or drugs, so they should not fall under the same agency’s administrative power. This is especially important since the FDA is so hostile to supplements and so beholden to drug companies.

Both the Durbin bill and the dangerous FDA’s proposed NDI guidance (see our new article on NDIs in this issue) seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on totally arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number of supplements and supplement potencies, raise prices substantially, injure our ability to take care of our health, raise healthcare costs, stifle supplement innovation, and cost millions of jobs in the supplement industry.

For now, though, the Dietary Supplement Labeling Act needs to be defeated. S.1310 has been referred to the Senate Health, Education, Labor, and Pensions Committee for further deliberation. If you have not done so already, please contact your senators and representative to voice your opposition to this bill. Please take a moment to send your message now.

The Texas Board of Chiropractic Examiners (TBCE) wants to greatly limit the scope of chiropractic practice in Texas. Why? A state-based Action Alert.

The TBCE has proposed a change in its rules that would prohibit chiropractic doctors from diagnosing or treating any condition not explicitly related to the biomechanics of the spine and musculoskeletal system. This would make a “definitive opinion or diagnosis that a patient suffers from a disease or condition unrelated to the biomechanics of the spine or musculoskeletal system” outside the scope of permitted practice.

In effect, many of the services chiropractic doctors currently perform in Texas would become illegal. They would no longer be able to diagnose or treat extremities or peripheral neuropathies (damage to the nerves and peripheral nervous system), and any discussion of diet or supplements would have to be directly related to the patient’s symptoms connected with the biomechanics of the spine. Chiropractors certainly won’t be able to offer an integrated approach to health if they are forced to focus so narrowly on the spine.

Why would the TBCE want to limit their own scope of practice? Nationally, chiropractors have had to defend the legitimacy of their practice against state medical boards and the traditional medical community—often waging lawsuits and introducing legislation on both the state and federal level. The American Chiropractic Association offers a two-part video on chiropractic history. The video outlines its struggles, in particular against efforts by the American Medical Association, to stop competition from chiropractors—a battle that went all the way to the Supreme Court.

In Texas there has been a longstanding turf war—in which profits figure prominently—between the Texas Medical Association (TMA) and the TBCE. The Texas Chiropractic Association has a timeline of the conflict, which began in the early 1900s.

Just last year, the TBCE was sued by the TMA (a suit recently joined by the Texas Medical Board), challenging three broad points in the TBCE’s existing rules. The lawsuit claims that only medical doctors can diagnose medical conditions. Chiropractic doctors would need an order or protocol from a medical doctor to perform a diagnosis. However, as the TBCE said in their defense, you cannot treat unless you first diagnose. And without a diagnosis, you also can’t decide if a condition is beyond your scope of treatment and needs to be referred to another professional.

Another point of contention is needle electromyography (EMG). In 1995, the Texas legislature prohibited chiropractors from performing surgical procedures or making incisions into any organ, body cavity, or tissue. The TBCE allows needle EMG, even though it involves inserting needles under the skin, because the procedure is used to assess the health of muscles and diagnose conditions such as carpal tunnel syndrome and Lou Gehrig’s disease.

The 1995 law also prohibited the chiropractic board from certifying chiropractors to perform spinal manipulation under anesthesia. However, the board took the stance that while the law prohibited it from certifying chiropractors to perform the procedure, it did not prohibit chiropractors from performing it.

Clearly, the TBCE’s decision to limit chiropractors’ scope of practice in Texas comes as a result of all the litigation and pressure applied by the Texas Medical Association (the preamble to the proposed rules specifically mentions the “recent litigation brought by the TMA”). The Texas Chiropractic Association has filed constitutional challenges protecting chiropractors’ scope of practice, but these cases are still tied up in the courts.

So, the way we see it, the Texas chiropractors, under assault again by conventional doctors, are trying to compromise. But in their effort to compromise, they are throwing out the baby with the bathwater. In particular, their ability to suggest supplements or offer integrative solutions not directly related to the spine will be gone. Moreover these new rules would be murky. It would be easy to attack a chiropractor for doing just about anything and force him or her to the wall with heavy legal expenses. This is one compromise which we don’t need.

What we do need is for the Texas chiropractors to show some backbone! They need to fight back at what is a clear attempt by conventional doctors to carve up the medical market and prevent competition.

If you are a Texas resident, please contact the TBCE immediately to protect chiropractors’ scope of practice in Texas and reject the changes in the proposed rules.

Just before the July 4 holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.

On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.

Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute “New Supplement” in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements—and if so, under what rules.

Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements. They had to do this because it was mandated by the recent Food Safety Modernization Act.

We have reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairly—one not hostile to supplements the way FDA is—they might be made to work. But in the hands of the FDA, which wants everything, supplements and drugs alike, to go through the vastly expensive new drug approval process, we fear the new rules will be used to forbid the development or sale of any new supplements—where “new” means anything after 1994, when DSHEA was passed.

Please note that many important supplements sold today were developed after 1994. Others the FDA will say were developed after 1994, even though they are just variants of what was “grandfathered” by DSHEA. For example, the FDA has already banned a critical form of vitamin B6, pyridoxamine, because that particular form of B6 couldn’t be shown to have been sold prior to 1994, even though B6 in general was certainly sold prior to 1994.

There are many other important new supplements that could be banned depending on how the NDI process is run. We won’t mention the names because to do so would be to put a target on their back. But we can assure you they are important and many of you are taking them.

The FDA already has the power to pull from the market any supplement, whether “grandfathered” or not, if they are unsafe, do not comply with Good Manufacturing Practices, etc. The oft-repeated claim that the supplements market is unregulated or “the Wild West” is patently false. But the FDA cannot pull a grandfathered supplement arbitrarily. They must show cause. What we don’t want is for the FDA to have the power to ban all new supplements arbitrarily. We fear that they will use this power to ban any supplement innovation unless the supplement is turned into a drug and brought through the drug approval process.

Since nobody can afford to pay for the new drug approval process if the substance is not patented, and supplements generally already exist in nature and cannot therefore be patented, to require full new drug approval is to ensure that there will be no new supplements. This should suit the drug industry very well and, based on past behavior, the FDA as well.

Our Concerns with the New Draft Guidance

The draft guidance clearly outlines the conditions under which an ingredient is considered an NDI (a new supplement) and when it is considered grandfathered. Further, it details the circumstances under which it is necessary to submit a notification for an NDI and when it is not. Not surprisingly, the FDA has applied a very narrow definition of grandfathered dietary ingredients, and so by extension a very broad definition of NDI.

Consequently, according to the draft guidance, almost all new supplements are NDIs, and thus are subject to NDI notification.

Please look carefully at this word “notification.” The term implies that the supplement company is just telling the FDA about the new product. But this is not the case. It is actually an approval process, and the FDA turns down most NDI applications.

Under the new rules, all ingredients/supplements in the food supply before 1994 that have been chemically altered in any way are considered NDIs and therefore subject to NDI notification. Moreover, the definition of “chemically altered” is extremely broad, describing multiple manufacturing processes that include:

• certain types of fermentation
• exposing ingredients to high temperature baking and cooking (if such treatment is not usually applied to the ingredient in conventional food)
• use of a botanical ingredient at a different life stage than previously used—for example, an extract of unripe apples instead of ripe apples

So if the ingredient is not absolutely identical to its pre-1994 counterpart, then it is considered an NDI and subject to NDI notification/approval.

Drug companies can exploit this process by trying to patent common dietary ingredients as drugs before supplement companies have an opportunity to submit their NDI notifications. Once a drug company investigates an ingredient for drug purposes and publishes their findings, the ingredient can no longer be used in supplements. This has happened before—it happened with the pyridoxamine form of vitamin B6 we mentioned above. In other words, what was once a supplement available to consumers at low cost will now be an expensive prescription-only drug, if it is available at all. (And it’s not only the drug that costs more: you’ll need to pay your doctor for an office visit just to get the prescription!)

The draft guidance also states that a synthetic copy of a supplement constituent, or an extract of an herb or other botanical, is not considered a dietary ingredient at all (much less an NDI). Isn’t this good—isn’t it better not to be an NDI? No. If the FDA says it is not an NDI, that means they are saying it can only be sold as a drug—period. This could knock out a number of important supplements currently sold.

The guidance discusses at length the evidence required for a notification (approval)—and the requirements are extensive, including a strong recommendation to include human studies. We sometimes forget that human studies, in addition to being very costly, do not always fit supplements.

In effect, it appears that the draft guidance pushes the scientific standard for NDI notifications closer and closer to the pharmaceutical  standard. As we have mentioned many times before, supplements are much safer than drugs, yet because of the big Catch-22 (supplements cannot usually be patented, and no non-patentable substance can be taken through a drug approval process which, on average, costs a billion dollars), it is very difficult for supplement manufactures to meet these standards. If they are met, it will push the price of supplements—already high—beyond consumers’ reach. The industry will die.

In these proposed rules, the FDA has effectively created a de facto pre-market approval system without any of the protections of such a system. The FDA has a very high bar that a supplement manufacturer must reach before they can file, but FDA reserves the right to reverse its decision about the safety of an ingredient at any time. It is important for the FDA to  recognize the NDI process was meant by Congress to be an actual notification system, not a pre-approval process run according to arbitrary rules set up by the FDA. Congress gave the FDA power to say no, but this was expected to be rare, while the FDA currently vetoes more often than not, often on trivial grounds.

In general, the draft guidance creates a process that is extremely burdensome and redundant—and is impossible for the FDA to realistically implement anyway.

The FDA even makes the NDI notification specific to the manufacturer, not the ingredient. So if two manufacturers are marketing the same ingredient, at the same quantity—they still each have to submit an NDI notification. They can’t hire a third party to do it for them as a group. This is arbitrary and punitive—there is no reason for this requirement at all.

The FDA also expects a different notification for the same ingredient for every different version of the supplement it is in. For example, the same ingredient at a higher concentration needs a separate notification/approval. Or the same ingredient in a different combination of ingredients requires yet another notification/approval.

The bottom line is that when new and unreasonable burdens are placed on supplement manufacturers, it immediately becomes a financial increase for consumers. And if the pressure becomes too great, the nutritional supplements on which you rely may simply become unavailable.

Please contact the FDA immediately and voice your strong opposition to the New Dietary Ingredient draft guidance!

This new bill pretends to be consumer-oriented but instead will give the FDA new powers it could easily misuse, restricting your access to supplements and raising the cost of buying them. An important new Action Alert for Congress!

Last week, Sen. Dick Durbin (D-IL) introduced S.1310. The Dietary Supplement Labeling Act would create new and burdensome regulations for supplement manufacturers—supposedly in an effort to protect supplement consumers. As we have said before, the FDA already has the power to protect consumers. In many cases, it does not choose to use these powers. Giving the agency even more power, especially murky powers that could easily be misused, will not make the situation better.

The bill has already been filed but the text is not yet available online as it should be. You can read an advance draft copy of the bill on our website.

As we reported just before the bill was introduced, the bill is disingenuous. It was purportedly created in response to the recent “Lazy Cakes” brownie controversy we told you about (the brownies contained melatonin). Lazy Cakes was unarguably a food product sold by a renegade food company. But this bill targets supplements and supplement manufacturers. Basically the bill exploits a hot-button food issue to try to pass more regulation for dietary supplements.

There is hardly any mention in this bill of food companies like the one that made the Lazy Cakes. In fact, the only reference comes at the very end of the bill, where it requires the FDA establish a definition for the term “conventional food.” But the FDA has already written draft guidance setting out the difference between dietary supplements and beverages and clarifies what “cannot be represented for use as a conventional food” means. The Agency has been sitting on this since 2009!

Durbin’s bill requires that the FDA, together with the government’s Institute of Medicine (IOM), compile a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. Dietary supplement manufacturers would have to put mandatory warnings on labels for any ingredient on this list. This sounds a lot better than it is for a number of reasons:

• Government-mandated warnings on labels could say anything the government wants them to say, no matter how unreasonable, and could be of any length, even if the packaging became prohibitively expensive. Essentially we don’t know what we are getting into here.
• The FDA is historically biased against supplements. The IOM is no better. Just look at the IOM’s recent report on vitamin D. This report willfully threw out most of the research on vitamin D and was altered at the last minute to reduce the upper limit of what is considered safe. Even conventional medical societies such as the American Association of Clinical Endocrinologists roundly condemned the report. Also because of some notorious conflicts of interest, the IOM is hardly the authority to determine what is safe and what isn’t.
• Creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope. It could be used as a hammer by the FDA to go after supplement companies. It could easily lead to European-style standards being applied here in the US. Remember those standards? If a beta carotene capsule contains more beta carotene than is in half a large carrot, it is banned.
• The safety of a new dietary ingredient (that is, new supplement) is already covered through the NDI notification process (see our article on NDIs in this issue). Why create new and confusing new legislation about the same thing?
• Under the Durbin bill, once an ingredient or supplement is on the list, there is no clear process to challenge the FDA and IOM determination, not even if new or contradictory evidence comes to light.
• Under existing law, all supplement facilities have to register with the FDA. Under this new bill, all facilities must also include a description of each dietary supplement product manufactured at that facility, a list of all ingredients in each dietary supplement, and a copy of the label and labeling for each product. Dietary supplements are already subject to many reporting and labeling requirements, so this bill’s requirements are just redundant.

Note that DSHEA—the Dietary Supplement Health and Education Act of 1994—already requires that all dietary supplement products show ingredient lists. Health claims already have to be pre-approved by the FDA according to the Nutrition Labeling and Education Act. Supplements must be manufactured under Good Manufacturing Practices to ensure the ingredients are safe and at the levels they claim them to be. Accurate disclosure of the contents in the dietary supplement package is already required under the Fair Packaging and Labeling Act. And almost all supplement manufacturers have a list of all their products and ingredients available to the public on their websites.

In other words, this bill creates extraneous red tape, paperwork, and burdensome labeling requirements when everything the bill mandates is already being accomplished under current law! All Sen. Durbin’s “Dietary Supplement Labeling Act” will do is make it more expensive to manufacture supplements and dampen innovation. The protections it provides consumers are very small, and if interpreted arbitrarily or unfairly, could be detrimental.

Furthermore, if the FDA is having trouble enforce existing legislation, it makes no sense to create new laws for the agency to enforce—especially since Congress is considering cutting their budget!

It would be easy for Congress to be taken in by this bill. Let’s insist on Congress looking at the facts of the case. Remember that Congress assumes that every message they receive reflects a far larger number of concerned voters. Please take a moment to send in your message now.

Senator Durbin’s bill, which will be introduced in Congress this week, is likely to be another example of burdensome and unnecessary legislation.

The staff of Sen. Dick Durbin (D-IL) has confirmed to ANH-USA that he plans to introduce new legislation this week—the Dietary Supplement Labeling Act—purportedly in response to the recent melatonin-filled “Lazy Cakes” brownie controversy we reported on recently.

The final bill is not yet available, but friends on Capitol Hill say the bill’s language is expected to include the following:

• Enhanced FDA registration requirements: Companies will have to list the names of their products, the ingredients in those products, and provide a label to FDA as part of their registration submission.
• Enhanced labeling requirements: FDA will require warning labels for certain products where the government decides there is risk of an adverse event (this to be determined through a risk review process with the Institute of Medicine), drug interactions (as with St. John’s Wort and antidepressants), or may be contraindicated for subpopulations like pregnant women. In addition, the precise weight or amount of the different dietary ingredients will have to be disclosed for products that are sold as proprietary blends, and product labels will have to include a batch number to help facilitate any possible recall.
• Supplements vs. conventional foods with food additives: FDA will need to publish guidance about the definition of “conventional food” so that legitimate dietary supplements can be differentiated from products like Lazy Cakes. This is intended to prevent a food producer from falsely labeling it a supplement.

As noted above, the final bill could differ from this. But this is what is expected to be in it.

It is worth noting that the stated impetus for the bill, the Lazy Cakes issue, is an example of where the FDA has simply failed to enforce current law. Melatonin in Lazy Cakes are unapproved food additives posing as a dietary supplement to evade the law. Before a substance may be added to a food, a Food Additive Petition must be submitted to the FDA and must include data demonstrating safety, unless the ingredient and the amount is Generally Recognized As Safe (GRAS)—which clearly isn’t the case for melatonin cakes! Just because FDA dropped the ball on Lazy Cakes doesn’t mean we need further potential regulations (which FDA may then either disregard or misuse).

Sen. Durbin also seems concerned with energy drinks that might be mistaken for dietary supplements. In this case, the FDA has been sitting on a draft guidance that clearly outlines the difference between beverages and dietary supplements since 2009. The FDA just needs to stop dithering and complete its work.

As for the enhanced registration requirements, current law already requires that all facilities must register with the FDA under the Bioterrorism Act. Under DSHEA, labeling must already bear a Supplement Facts table that includes the name and quantity of each dietary ingredient; in the case of proprietary blends, it must include the name of each ingredient and the quantity of the whole blend. To require the weight or amount of each ingredient in proprietary blends wouldn’t tell a consumer anything more although it could tell a competitor or a drug company something more. And disclosure of allergens is already required under the Food Allergen Labeling Act.

The FDA is already biased against dietary supplements. We strongly suspect this is because supplements do not go through drug approval processes costing close to $1 billion on average and therefore do not support the FDA’s own budget. We fear that further registration requirements and adverse events warnings could be a slippery slope to the European model—which has drastically reduced the number of supplements that may be sold, and is in the process of reducing potencies to ridiculously low levels. It wouldn’t surprise us if labels require so much warning information, determined by officials hostile to supplements, that it wouldn’t fit on a reasonably sized bottle.

Enhanced labeling requirements could be useful, depending on how this requirement is defined. We all want to know about the benefits and the risks of dietary supplements, and we need to know where potential drug interactions and real adverse events are a possibility. However, the number of adverse events from supplements is so small compared to those from conventional medicines, and the risks from most dietary supplements so insignificant, that we fear FDA will take this to an extreme, which could dissuade consumers from using supplements based on insignificant or false threats.

The best fix for this problem is to move supplements out of the drug agency and into their own agency under Health and Human Services. It doesn’t work for the supplement regulator (currently FDA) to be so beholden to drug companies, since drug companies are very afraid of supplement competition, despite the current government gag orders forbidding supplement makers from explaining their medical prevention and treatment uses.

We’ll be sure to keep you updated about this bill. Sen. Durbin is widely considered to be the senator most unfriendly to supplements, which puts us on our guard, but we will hope for the best.

When is organic not organic? When nanoparticles are involved. A new Action Alert.

Last year we reported on nanotechnology, the process of manipulating matter at the atomic and molecular level. As we said then, it has no place in organic food. Like genetic modification, it is the antithesis of the organic concept. Canada has already amended its national organic rules to ban nanotechnology in food production as a “Prohibited Substance or Method.”

The FDA has just released its draft guidance for regulated industries describing what to consider when determining whether a product uses nanotechnology or nanomaterials. The comment period is open for 60 days.

The FDA seems to be trying to avoid any offense to Big Food. The agency emphasizes that it is not providing a regulatory definition of nanotechnology—merely guidance to get more clarification on the issue of what counts as nanotechnology and what doesn’t. And of course, the guidance makes no mention of organic foods.

The FDA needs to state explicitly that nanotechnology has no place in organic food production. There is nothing complicated about that. Please contact the FDA today and make your views known!

A few weeks ago we issued an Action Alert to help pass an important bill to fight BPA in Delaware. Thanks to your activism, Delaware’s children will be healthier.

Bisphenol A (BPA) was created as a synthetic sex hormone. Today it is widely used in certain kinds of plastics and epoxy resins, including those commonly found in baby bottles and infant formula cans, and cash register receipts. But BPA is a known hormone disruptor. NIH is concerned that BPA exposure in children may lead to problems with brain development, behavior, early puberty, breast cancer, and prostate cancer. New research has also suggested that BPA may interfere with metabolism and lead to obesity, heart disease, and diabetes in humans.

Out of concern for children’s safety, Canada has banned the use of BPA in baby bottles and is restricting its use in infant formula cans, as has China and the European Union.

Delaware’s bill, SB 70, was created to protect the health of young children by prohibiting the chemical bisphenol-A in certain children’s products such as bottles, cups, and other containers used for food or beverages. The state Senate passed the bill on June 8, and the House passed it on June 22. Here’s the best part—the vote was unanimous in both chambers!

We applaud the progress in Delaware but still have a long road ahead. To that end, ANH-USA is filing a petition with OSHA, the Occupational Safety and Health Administration, to ban BPA in receipts. We are filing it as an adjunct to the petition we filed with the Consumer Product Safety Commission (CPSC), since CPSC keeps telling us that OSHA is the agency with jurisdiction. We disagree with their assessment, but we will follow strict procedure by filing with OSHA as well. CPSC says OSHA can do something about BPA, so let’s see if they really can!

Pending legislation in New York State wants to send investigative journalists to jail for photographing factory farms. A new State Action Alert.

According to the Humane Society, a recent investigation at New York’s largest dairy factory revealed shocking images of animal abuse, and the state’s agribusiness industry is now attempting to shield its inhumane practices from any further public scrutiny and debate.

S5172 aims to curtail free speech by prohibiting whistleblowing at factory farms, though the bill deceptively claims to be fighting “unlawful tampering with farm animals.” Of course, it’s all a matter of how terms are defined. According to the bill, “unlawful tampering” includes “unauthorized video, audio recording or photography done without the farm owner’s written consent”!

Rather than stop cruel treatment of animals, this bill will simply ensure that the public never learns about it. Rather than sending perpetrators of animal cruelty to jail, agribusiness wants to send those who expose the cruelty to jail.

Don’t let New York get away with the same censorship tactics other states have tried. If you are a New York resident, please contact your legislators immediately and ask them to oppose S5172!

And with that budget hit, the so-called “food safety” law can’t be implemented—and no money to approve Frankenfish! This is huge!

Last week the House of Representatives passed the agriculture funding bill for fiscal year 2012, and the bill included a gigantic cut in FDA’s budget. This is particularly significant because they were tasked with implementing most of the provisions of the Food Safety Modernization Act that Congress passed last year.

The Congressional Budget Office estimated that the cost of implementing the Food Safety act would be $1.4 billion over five years. The whopping $285 million budget cut makes it likely that many of the enforcement and oversight provisions of the act will not be implemented. FDA told an industry publication just before the vote that if the House funding cuts were approved, there will be a “significant delay in implementation of the new Food Safety Modernization Act (including the law’s nineteen priority areas, especially import oversight, training, and inspections).”

Before final passage of the agriculture funding bill, the House approved an amendment by Rep. Don Young (R-AK) to prohibit the FDA from spending money to approve an application for the controversial genetically engineered salmon.

Now the funding bill moves on to the Senate. ANH-USA will work hard to make sure the GE salmon amendment stays in place. If it passes in the Senate as well, FDA will not be allowed to use its funds in FY2012 to approve genetically engineered salmon. This is a big win!

A new bill would expand “eligible medical expenses” in the IRS code to include herbs, vitamins, minerals, homeopathic remedies, meal replacement products, and other dietary and nutritional supplements. A new Action Alert.

Sen. Orrin Hatch (R-UT) has introduced S.1098, the Retirement Health Investment Act of 2011. The House version of the bill, HR.2010, was introduced by Rep. Erik Paulsen (R-MN) and is already enjoying wide support with thirty cosponsors.

Last month we told you about two health savings programs that help pay for complementary and alternative medical (CAM) treatments not covered by regular insurance: Flexible Spending Arrangements (FSAs) and Health Savings Accounts (HSAs). “Eligible medical expenses” determine what can be covered by both HSAs and FSAs. Under current law the above are not considered “eligible medical expenses” and so HSAs cannot be used to cover them.

The bill as it stands is strong, and we support it—though hope to see the language tweaked to address that part of the healthcare reform act that threatens the very existence of HSAs. We met with Sen. Hatch’s staff earlier today to discuss the bill, and we were assured that the Senator understands the importance of maintaining access to healthcare plans used in conjunction with HSAs.  We will continue to work with Senator Hatch as the bill gains momentum.

You may recall that HSAs are savings accounts owned by the individual, and the funds contributed to them are not subject to federal income tax at the time of deposit. If the funds are not spent, they roll over and accumulate year to year. The law that created HSAs made eligibility dependent on whether one is covered under a high-deductible insurance plan. But section 1302 (e)2(A) of the healthcare reform act limits high-deductible or catastrophic healthcare insurance plans to persons under the age of 30.

This means that beginning in 2014, people over the age of 30 will not be able to purchase an HSA because they will not be eligible for catastrophic plans—making any changes to HSAs irrelevant to them.

Catastrophic plans are designed to give protection against emergencies. They have low monthly premiums in exchange for a higher deductible, making routine doctors visits, etc., more expensive. CAM patients use high-deductible plans to cover emergency services, and use HSAs for purchasing treatments not covered by traditional healthcare insurance. Without the preservation of both high-deductible healthcare plans and HSAs, CAM users will be forced to purchase expensive healthcare insurance with coverage they don’t want or use, while still having to spend money on alternative treatments not covered by insurance.

Therefore we fully support expanding HSAs and FSAs coverage to include supplements among the “eligible medical expenses.” However, the healthcare reform act needs to be amended to allow for catastrophic plans for people over 30 years of age.

Action Alert! Please contact your senators and representative immediately. Voice your support of S.1098 and HR.2010, and explain that coverage of herbs, vitamins, etc., is essential under HSAs and FSAs. Ask Congress to (a) co-sponsor the bills, and (b) include an amendment to the bills to repeal the portion of the healthcare reform act that limits eligibility for high-deductible and catastrophic insurance plans.

After thirty-three years of deliberation, the FDA tells consumers it’s OK to put toxic substances on their skin, and advises them to avoid natural sunlight!

The US Food and Drug Administration last week issued a final rule on the labeling of sunscreen products. The regulation says that sunscreen products which pass the FDA’s test for protection against both ultraviolent A (UVA) and ultraviolet B (UVB) rays may be labeled as “Broad Spectrum.” Both UVA and UVB radiation contribute to sunburn, skin cancer, and premature skin aging, but sunburn is primarily caused by UVB radiation. Only products that are labeled both as Broad Spectrum with SPF values of 15 or higher may state that they reduce the risk of skin cancer and early skin aging when used as directed.

However, as usual, the FDA is demonizing the sun and cautioning for limited sun exposure. Their press release states, “Most skin cancers are caused by sun exposure. FDA encourages consumers to protect themselves….Not only should consumers regularly apply and reapply sunscreens with Broad Spectrum and SPF 15 or higher, they should also limit sun exposure.”

But limiting your sun exposure can also limit your body’s vitamin D levels, since vitamin D is produced by your skin in response to exposure to natural sunlight. And as we have reported numerous times, vitamin D is essential to maintaining a strong immune system.

It is nearly impossible to get adequate amounts of vitamin D from your diet. Moreover, according to vitamin D expert Michael F. Holick, PhD, MD, professor of Medicine, Physiology, and Biophysics at Boston University School of Medicine, the further you live from the equator, the longer you need to be exposed to the sun (without sunscreen!) in order to generate vitamin D—and people with dark skin pigmentation who live far from the equator may need 20 to 30 times as much exposure to sunlight as fair-skinned people to generate the same amount of vitamin D. That’s why prostate cancer is epidemic among black men—it’s a simple but widespread sunlight deficiency.

Dr. Holick does advise caution so as not to get a sunburn, but says, “The population of the world has been brainwashed by the American Academy of Dermatology and the sunscreen industry for thirty years, with the unrelenting message that you should never be exposed to direct sunlight because it is going to cause serious skin cancer and death. People are really quite surprised by the new message that sensible sun exposure, in moderation, is very important for good health. We should appreciate the sun for its benefits, and not abuse it.”

But sunscreens make it easy to get too much sun, because they inhibit an enzyme in your skin that makes nitric acid. Nitric acid inflames the skin turning it red, so you know when to get out of the sun. By inhibiting this action you could actually stay out longer in the sun than you should.

FDA’s press release further stated that the agency is currently reexamining the safety information available for the active ingredients in most sunscreen products—though it “does not have any reason to believe these products are not safe for consumer use.” The agency also said that despite concerns that nanoparticles in sunscreen might be dangerous, “FDA testing has concluded that they do not penetrate the skin and are therefore safe.”

Given the highly absorptive properties of skin, we find FDA’s position to be the height of absurdity. In fact, during the media briefing, when FDA’s director of the Center for Drug Evaluation was asked whether the nanoparticles in spray on sunscreen was safe considering the added risk that they can be inhaled, she was was unable to answer the question. (That exchange is located at minute 37.51 in the webcast.)

The Environmental Working Group has criticized the FDA for still allowing toxic chemicals like retinyl palmitate and oxybenzone in sunscreen despite scientists’ concerns about their toxicity. Moreover, it has been demonstrably proven that the chemicals commonly used in sunscreens are indeed absorbed through the skin. As Dr. Tatiana Cannell of the Vitamin D Council puts it, “Sunscreens facilitate the skin’s absorption of pesticides. So if you want pesticides to be readily absorbed through your skin, circulate in your blood, go to your internal organs, and be excreted in your urine, wear sunscreens. Or you could take a swig of your Coppertone and chase it with a shot of Deepwoods Off.”

FDA finds higher levels of arsenic in chicken than previously thought; latest report says supplements are safe; and NIH abandons niacin study.

The Arsenic Deception

Last June, we reported that the chickens you buy at the grocery store are given feed which often includes arsenic, the deadly poison and known carcinogen, added to make them gain weight faster. The Center for Food Safety and the Institute for Agriculture and Trade Policy petitioned the FDA to ban arsenic in animal feed. Of course, the FDA listened to big chicken producers and the arsenic additive producer Pfizer, and no action was taken.

Now the FDA admits that some chicken meat may contain “small amounts” of arsenic. Previous studies have indicated that the arsenic was eliminated with chicken waste.

The FDA said in a press release that the inorganic arsenic “does not pose a health risk.” But Pfizer has decided voluntarily to suspend the sale of Roxarsone (the arsenic additive) in 30 days, and will “facilitate an orderly process for suspending use of the product” in the US. Sounds like a backroom deal with the FDA protecting Pfizer from liability while the company exits the arsenic feed business.

By the way, as we reported to you earlier, this is the company that pleaded guilty in 2009 to the largest healthcare fraud in US history and received the largest criminal penalty ever levied for illegal marketing of four of its drugs. But even that was only a slap on the wrist. If the US government prosecuted fully and won a conviction, by law Medicare could no longer buy from the company, so major drug companies are effectively exempt from serious criminal penalties.

Earlier this year, Rep. Louise Slaughter (D-NY) introduced the Preservation of Antibiotics for Medical Treatment Act, or PAMTA—essentially an anti-antibiotics in animal feed bill. And just yesterday, Sen. Diane Feinstein (D-CA) introduced a nearly identical bill in the Senate. S.1211 has three co-sponsors, including Sen. Susan Collins (R-ME). This is the first time such a bill has been introduced in the Senate; Congresswoman Slaughter introduced the bill in the House in the past few Congresses.

Supplements are Safe, Latest Report Confirms

The latest 200-page annual report of the American Association of Poison Control Centers, published in the journal Clinical Toxicology, shows no deaths whatsoever in 2009 from any dietary supplement, amino acid, herb, vitamin, or dietary mineral supplement.

As a press release from the Orthomolecular Medicine News Service puts it,

Over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 155,000,000 individual doses per day, for a total of nearly 57 billion doses annually. Since many persons take more than just one vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.

If nutritional supplements are allegedly so “dangerous,” as the FDA and news media so often claim, then where are the bodies?

We couldn’t have said it better ourselves. 2009 is just the latest of a long string of Poison Center reports showing the general safety of supplements, especially compared to drugs.

NIH Abandons Niacin Study

The National Institutes of Health has stopped a clinical trial on an extended-release form of niacin for cholesterol treatment eighteen months earlier than planned, claiming that niacin did not reduce the risk of cardiovascular events (that is, heart attacks) in patients taking statin drugs, though it did increase levels of HDL, the “good” cholesterol, and drop the levels of risky triglycerides.

Some might interpret the axing of the NIH’s niacin trial as an indication that niacin doesn’t work. Far from it. In fact, there isn’t a drug on the market that comes so close to offering the “Holy Grail” of simultaneously reducing both LDL (“bad”) cholesterol and triglycerides, while also raising HDL.

The problem with this trial is that cholesterol levels were already low because patients were taking a statin drug (Zocor) made by Merck. So the only real finding in the study was that the extended-release niacin drug Niaspan from Abbott Laboratories, while shown to increase HDL and lower triglycerides, didn’t have any effect on reducing heart attack rates. How different the results might have been if the patients hadn’t been on orthodox medicine’s standard offering of statins, the default choice for anyone with moderate to high cholesterol!

There are likely to be some drug companies that are worried about giving a simple, non-patentable vitamin (in this case niacin, or vitamin B3) too much positive publicity when they can’t make any money from it.

We wish we could say we are surprised. Registered dietitians are now being given formal education by the Coca-Cola Company on how safe its ingredients are.

The credentialing arm of the American Dietetic Association, the Commission on Dietetic Registration (CDR), has approved a program created by the The Coca-Cola Company Beverage Institute for Health and Wellness.This covers what it calls “urban myths” about the safety of food ingredients. Participating in this program will earn registered dietitians Continuing Professional Education unit credits.

“Children’s Dietary Recommendations: When Urban Myths, Opinions, Parental Perceptions & Evidence Collide,” tells dietitians that fluoride, sugar, artificial colors and nonnutritive sweeteners have been “carefully examined for their effects on children’s health, growth, and development.” The presenter, Dr. Ronald Kleinman, “explores prevalent misconceptions about these food ingredients” and suggests ways the dietitian can help quell unnecessary “concern among parents about their children’s health.”

At first glance, Dr. Kleinman should know what he is talking about. He is physician-in-chief at Massachusetts General Hospital for Children, chief of the Pediatric Gastrointestinal and Nutrition Unit, and Associate Professor of Pediatrics at Harvard Medical School. Couldn’t sound better, could it? But he has also received a great deal of money from industry sources—like artificial infant formula manufacturers Mead Johnson and Nestle Ltd. His study on optimal duration of breastfeeding was funded by Gerber Products. He also served as a paid expert witness for Gerber when they were sued for deceptive advertising. And he contributed to a brochure intended for children entitled “Variety’s Mountain” produced by the Sugar Association.

Now he’s being sponsored by the Coca-Cola Company and telling dietitians that the ingredients in Coke which everyone is alarmed about are safe. The dietitians, in turn, will be telling parents that their fears are unfounded, and Coke can sell more Coke to kids.

Program materials include gems like “[a] majority of studies so far have not found a link between sugar and behavior in children generally or children diagnosed with attention deficit hyperactivity disorder.” This is certainly news to us, since we have seen many studies that say the opposite. Apparently the dietitians are to teach us that any connection between artificial colors and neurotoxicity, or fears of the dangers of fluoride, are imaginary and come from hysterical (or at least unduly concerned) parents.

As we reported recently, sugar and artificial sweeteners are anything but safe. Fluoride poses a significant risk to the kidneys. And commonly used food dyes pose risks which include hyperactivity in children, cancer (in animal studies), and allergic reactions. Even the Center for Science in the Public Interest, an organization that supports nuking food, agrees with this. And the British government and European Union have taken actions that are virtually ending the use of dyes throughout Europe.

The ADA is sponsored by the soda and junk food industries—which we feel greatly tarnishes the organization’s credibility. And you may recall that the ADA has mounted a state-by-state campaign to make sure that its Commission is the only one which will be accepted as a credentialing body for both registered dietitians and nutritionists.

There are, of course, significant philosophical differences between nutritionists and dietitians—they represent two different fields of study and practice. By accepting only a single credentialing agency—one run by the dietitians, not nutritionists—state boards are establishing a “one-size-fits-all” standard which removes all competition, essentially handing the ADA a government mandated monopoly over nutritional therapy.

Unfortunately, the Nevada bill we told you about last month passed both the Assembly and the Senate and was signed by the governor on June 5th. While some amendments were made, the most troubling parts of the bill still remain: only registered dietitians can practice “dietetics,” which is defined by the law to include nutrition assessment, evaluation, diagnosis, counseling, intervention, monitoring and treatment—everything that a good nutritionist does and should do.

We also told you about an ADA bill in New York, S.3556. The state’s Senate Finance Committee met on June 13 and decided to pass the bill to the Rules Committee so that it could be considered on the Senate floor. They are trying to rush these bills through, because next week the Assembly is scheduled to finish its work for the year, unless the chair calls a special session in the fall. Please click on our New York Action Alert here.

The ADA’s power grab is a complete travesty. We will keep fighting it state by state until we restore competition in nutritional counseling and stop gagging PhD-trained nutritionists who don’t become dietitians.

Hint: It’s not about organic food.

When people began to die from E. coli poisoning in Europe, the first thing we heard was that organic cucumbers were to blame, or if not, that organic tomatoes or lettuce were. There wasn’t a shred of evidence for this, but the Internet began to fill up with people swearing off organic food!

Then the accusation shifted: it was German organic sprouts that were the culprit. Tests of the sprouts on the farm were negative. Well, so-called forensic evidence—in particular, the location of the infections—pointed toward the sprouts, so in the end they got the blame.

It could indeed be the sprouts. They are grown in a wet, warm environment, which would be conducive to bacterial overgrowth. But let’s be clear: no organic fertilizer (manure) was used, so that was not the source of contamination.

Since there was no manure, how could the sprouts have become infected? Did the workers not wash their hands? This isn’t likely to be it. Why? Because this was a new, mutant form of E. coli. Not only new and mutant—it was also resistant to antibiotics. A new, mutant, and resistant killer strain isn’t likely to come just from dirty hands.

Then where from? Most likely the seeds. And where would seeds pick up a new, mutant, and antibiotic-resistant strain? It could be from farms where antibiotics are overused—not an organic farm. Readers may recall last year’s Preservation of Antibiotics for Medical Treatment Act, introduced by Rep. Louise Slaughter (D–NY), the only microbiologist in Congress, which was supported by organizations like the Union of Concerned Scientists and the Center for Food Safety. The bill, HR 965, has been reintroduced in the current session of Congress and now has 59 co-sponsors. It would ban the nontherapeutic use of antimicrobials in animals, and would ban the use of even therapeutic antimicrobials unless it can be demonstrated that there is “a reasonable certainty of no harm to human health” due to the development of antibiotic drug resistance. We have a new Action Alert on this new bill.

The outbreak could also be related to the use of E. coli in creating new GMO strains: the E. coli bacterium is used by scientists to carry new genes into the organism. In the process, a new form of E. coli could have been created. If this happened (and of course, no one will ever know), it would be more than ironic to blame it on organic agriculture, which struggles to stay free from GMO contamination.

There is neither evidence nor reason to believe that organic agriculture produces a greater threat of E. coli contamination than conventional agriculture. This is especially true because contamination is associated with huge, industrial farms, and those farms are not generally organic.

If the first thing we heard about this outbreak was that it was an organic food problem, the second thing we heard was that it was time to start nuking our fresh produce. The FDA gave its blessing to irradiate raw spinach and lettuce three years ago, claiming that it was safe and had no effect on nutrients. This was in addition to prior approval by the FDA or USDA to nuke almonds, spices, imported produce and fruit, and especially meat—not surprisingly, much of the nuked meat ends up in children’s school lunch program. The Grocery Manufacturers Association wants more items approved for nuking, but also finds consumers reluctant to accept nuked products.

The consumer reaction is, of course, just common sense. The human race didn’t make it this far by eating irradiated food. To assume such food is safe and nutritious is just folly, no matter how convenient it might be for a beleaguered bureaucrat looking for some quick fix. There is a fix, but it isn’t in nuking. It lies in a totally different direction.

The massive Food Safety Act just passed by Congress requires the FDA to come up with new regulations to prevent E. coli and similar outbreaks. This is mostly a charade because no government agency has the slightest idea what to do about it other than nuke our food. As we at ANH-USA have noted before, the Food Safety Bill might have been written by the giant food industry, because it doesn’t do anything about industrial farming methods, the heart of the problem, and instead threatens the very existence of small farmers, including small organic farmers.

Is there a way to make food safer? Yes. Make CAFOs clean up their act and stop destroying small, independent agriculture. And support Rep. Slaughter’s bill to ban the nontherapeutic use of antibiotics in animals!

The world knows how dangerous BPA is. Even China, following the lead of Europe and Canada, has now banned BPA in baby bottles. In the absence of leadership from the federal government, many states have also started to take action.

The endocrine-disrupting chemical bisphenol-A (BPA) is a common ingredient in polycarbonate plastics; as we have reported numerous times, BPA has been linked with serious health problems, including cancer, birth defects, and heart disease. In China, the Ministry of Health, in conjunction with five other government bodies, has banned the manufacture of infant bottles that contain BPA as of June 1; the ban on all imports and sales of BPA-laced bottles begins September 1. China joins the European Union, which announced at the end of last year that it was banning the manufacture of BPA in baby bottles as of March 1 and importation and sales as of June 1, and Canada, which last October formally declared BPA to be a toxic substance.

In May we told you about SB 210, a bill before the Connecticut legislature to ban BPA in thermal cash register receipts and require the Chemical Innovations Institute to develop an annual list of chemicals of high toxic concern. On June 8, the bill passed in both the House and the Senate of Connecticut, and is on its way to be signed by the governor!

We had similar success in Maryland. HB4, a bill to prohibit more than 0.5 parts per billion of BPA in containers of infant formula, passed and was signed into law by the governor.

There are new bills in California, Delaware, and New York that seek to ban BPA in various products. If you are a citizen of these states, please contact your legislators immediately and ask them to support these important bills!

Click here for the California Action Alert

Click here for the Delaware Action Alert

Click here for the New York Action Alert

By contrast, the Federal government still doesn’t get the message. Last August, ANH-USA filed a Citizen Petition with the Consumer Products Safety Commission to have BPA banned from cash register receipts, the little-known but most common pathway of BPA into your body. We re-filed this past March, demanding that the agency fully consider our petition and assess it on the legal grounds and evidence that we presented to them, but the CPSC refused to consider our petition for a second time, citing OSHA as the appropriate venue.

However, CSPC let us know that the agency is in the process of working through an approach on BPA with the Environmental Protection Agency, to move toward alternatives to BPA that could be used in thermal paper for cash register receipts. EPA intends to post a “draft evaluation of ecological and human health hazards and environmental fate of BPA and alternate developers“ for public review and comment in September. We plan to wait and see the result before we consider litigation.

The CDC says 1 in 3 US adults will be diabetic by 2050. But the ADA—the supposed authority on diabetes—is providing seriously misguided information on how to manage and reverse the disease.

The Centers for Disease Control and Prevention estimates that there will be nearly 140 million diabetics in this country within the next 40 years. But the true number of diabetics will be much higher, because the conventional test for diabetes does not detect the disease until it’s in its advanced stages, and most doctors don’t perform more sensitive diagnostic tests necessary for early diagnosis. According to research done by Bill Faloon at the Life Extension Foundation, more than 75% of people over the age of 40 suffer some degree of pre-diabetes.

The good news is that diabetes and pre-diabetes can be controlled and even reversed, preventing kidney failure, limb amputation, and blindness. The risk of cardiovascular diseases could also be greatly reduced by better management of diabetes. And of course, the earlier it’s caught, the easier it is to get it under control.

The standard American diet tends to create insulin resistance, leaving higher levels of blood sugar to circulate in the system for longer and longer periods of time, wreaking havoc in the body and leading to organ damage. (Here is a brief animation showing how insulin regulates the amount of blood sugar is allowed in to our cells.)

While a poor diet and lack of exercise are the chief causes of most US cases of diabetes, anything that interferes with the complex mechanisms that the body uses to regulate blood sugar may also contribute —including heavy metal or mercury toxicity, prescription drug interactions, mineral deficiency (especially magnesium and chromium), Candida overgrowth, and low stomach acid, all of which are common.

A number of other factors may increase insulin resistance as well, including vitamin D deficiency, infections, celiac disease, gluten sensitivity, increased weight gain, stress, and puberty, as well as environmental contaminants like air pollutants, BPA, dioxin, PCBs, nitrates and nitrites, phthalates, and some pesticides.

In other words, it can happen to any of us—even if we think we’re following a sterling diet. Because so many of these causes can be “silent,” and because diabetes itself is generally “silent” until much damage has been done, everyone should be tested for diabetes.

Here’s where the American Diabetes Association (ADA) is completely dropping the ball. They want us to test. But their test recommendations are all wrong. To understand why, we need to provide a bit of background on the tests.

The main screening for diabetes is one’s fasting blood sugar levels, that is, glucose levels upon awakening, before breakfast. An optimally functioning metabolism will have fasting glucose levels of no more than 85 mg/dl, though the standard laboratory references call a reading of up to 99 “normal,” which is really too high. Also, blood sugar levels after meals should never spike more than 35 or 40 points above one’s fasting level, and should return to near-fasting level within two hours of eating.

The problem is, as one’s blood sugar starts to go awry, after-meal blood sugars can swing into the diabetic range at the two-hour mark. But because doctors typically only measure the fasting glucose, they don’t see this and miss the opportunity for early diagnosis and a higher likelihood of reversal. Blood sugars can swing this way for years before the fasting levels rise to the diabetic range, and at that point, the person usually has some diabetes-related complications.

A better test is a glucose tolerance test, where you are given a sugar drink and then have your glucose levels measured at one and two hours. Or you can purchase an inexpensive glucose meter at the drugstore and check your own levels two hours after meals, especially meals high in sugars or carbohydrates. It’s a quick and easy pinprick to the finger. Friends and families might even pitch in for a meter to share so everyone can test. (Each person uses a new, sterile lancet).

A third, more extensive test is the hemoglobin A1c test, which measures blood glucose average levels over the previous three-month period. This test is helpful for monitoring but is not the gold standard for diagnosis, because those with normal fasting blood sugar but raised after-meal blood sugars will fall through the cracks. Because their blood sugars fall back down to normal most of the time, the “average” can be normal even where one is in the early stages of diabetes.

So what does the ADA, the supposed authority on diabetes, tell us about testing? According to the ADA, one should strive for tight control of diabetes—as defined by the ADA, that is, “getting as close to a normal (nondiabetic) blood glucose level as you safely can. Ideally, this means levels between 70 and 130 mg/dl before meals, and less than 180 two hours after starting a meal.” The ADA doesn’t have any of it right!

The following chart makes it simple:

In a nutshell, the ADA’s standards, guidelines, and recommended diets are sure to turn a pre-diabetic into a full-blown diabetic, and a diabetic into one who is chronically ill with multiple complications.

Even worse, most of the studies on diabetes and related complications are using ADA guidelines. They assume that an HA1c under 7.0 is “tightly controlled,” which dramatically skews any findings they might produce. Most diabetes-related disease is actually the result of years of uncontrolled blood sugar. Most related organ damage such as retinopathy (damage to the retina that results in loss of vision), peripheral neuropathy (damage to nerves in the feet or hands), and kidney damage actually begins to occur when blood sugars exceed 140 for more than a couple hours per day. This is probably why the American Association of Clinical Endocrinologists recommends that people with diabetes keep their blood sugars below 140 as much as possible. Of course, the ADA still thinks up to 180 is acceptable.

Consumers are receiving false information in two critical ways: the unconscionable ADA misinformation, and conventional physicians telling them they are not diabetic and don’t need to worry, because their fasting glucose is “normal” based solely on fasting glucose tests—when in fact they may be in the beginning stages of diabetes and fully able to reverse it, which is the goal of truly preventive medicine. If diabetes were identified in the early stages, most of the related complications and the enormous expense of managing the chronic nature of the disease would be substantially diminished.

It is possible for many diabetics to keep their blood sugar levels close to a truly normal range with an integrative approach. Here are some natural approaches to controlling or even reversing diabetes (we strongly advise that any significant changes to your diet, supplement regime or lifestyle should be made in conjunction with support from your healthcare professional):

• Start with diet! A Paleolithic diet is best, loaded with leafy greens and other low-starch veggies, high-quality fats, and clean sources of protein. The ADA’s nutritional advice is not up to date. Be sure to look for a nutritional advisor who is independent. Organizations like the American Dietetic Association and the American Society for Nutrition receive major funding from corporate food interests, including junk food companies. In stark contrast, the American College of Nutrition is not similarly compromised.
  
• Botanicals. In a recent issue on diabetes in Dr. Jonathan Wright’s Nutrition and Healing newsletter, he notes that several studies have shown that berberine, an alkaloid found in the herb goldenseal, can lower blood glucose as effectively as the drug metformin at similar doses (500 mg 3x/day). Indian kino (Pterocarpus marsupium) gum resin is the only product ever found to regenerate beta cells that make insulin in the pancreas. This scientific finding validates its long use in Ayurvedic medicine for diabetes. Other herbs or food ingredients known to be of value for managing diabetes include cinnamon, bitter melon and the fruit Garcinia cambogia to enhance insulin sensitivity.
• Supplement wisely. According to Dr. Julian Whitaker, because the water-soluble antioxidants and other nutrients that protect against damage are lost in the excessive urination that accompanies diabetes, it’s no wonder so many people with diabetes end up developing kidney disease. All vitamin, mineral, and amino acid levels should be checked, monitored, and kept in normal range with supplements if necessary. He particularly recommends supplementing with magnesium and chromium, and alpha lipoic acid and acetyl-L-carnitine for peripheral neuropathy.
• Exercise at least 30 minutes every day. This will also control blood pressure more than drugs.
• Take care with prescription drugs. The FDA has launched a safety review of the diabetes drug Actos in light of new data suggesting that the drug may increase risk of bladder cancer. And a combination of two common drugs—one an antidepressant, the other used to lower blood cholesterol—may put people at risk of developing diabetes. This finding is especially important because so little is known about how drugs interact with each other, and so many people are prescribed multiple drugs together. Where possible, it’s always best to control diabetes without the use of prescription drugs.

A different kind of Action Alert

Diabetes does not have to be a degenerative disease, but early diagnosis and a strong resolve to manage and even reverse the disease are required. The ADA guidelines are a disincentive to doing so and give the green light to dangerously high glucose levels that result in huge and serious long-term health consequences.

So this week’s Action Alert is a personal request from ANH-USA executive director Gretchen DuBeau: Get to know how your body is processing the sugars and carbohydrates you consume! Have a “real” diabetes test—the oral glucose tolerance test (OGTT), which records your blood sugar levels at intervals after drinking a measured sugary liquid. The test is performed in a doctor’s office or in a lab. Alternatively, purchase a glucose meter and perform your own test two hours after a sugary or carb-heavy meal. Do not settle for a fasting glucose test.

We are asking all of our to activists pitch in and get tested for your own health’s sake, then use your voices to get others to also take responsibility for their health and in so doing create an important change in the world. We can reverse one of the most tragic (and most easily reversible) health conditions our country faces if we start now and spread the word!

Use the icons below to share this article with your friends, family and social networks!

We have updates on three big action items we’ve covered in these pages—two wins, one loss.

Monsanto Loses on Sugar Beets

As we reported last February, the USDA said it would once again allow the Monsanto’s genetically engineered sugarbeet to be planted, contrary to the ruling of a district court judge who had ordered that a full environmental impact statement (EIS) needed to be done first. An EIS of the type ordered by the judge is usually thousands of pages long and takes years to conduct. That would have kept the genetically modified sugarbeets out of the hands of farmers at least through 2012.

So we launched an Action Alert, and you and thousands of other activists fought back—and won! Two weeks ago, the US Court of Appeals issued a summary order that dismissed Monsanto’s case—and said that previous court rulings in favor of organic farmers and natural health advocates will stand, including the order requiring the USDA to complete a full EIS before deciding whether to again allow their future commercial use.

An attorney for the plaintiffs said, “Because of this case, there will be public disclosure and debate on the harmful impacts of these pesticide-promoting crops, as well as legal protections for farmers threatened by contamination.”

California GE Fish Labeling Bill, AB 88, Defeated in Committee

On May 13, we emailed an emergency Action Alert to California residents about Assembly Bill 88, which would have required labeling of genetically engineered fish.

As we had previously reported, the FDA is considering approval for the genetically engineered salmon, better known as the “Frankenfish.” If approved, it will be the first genetically engineered and untested animal to be eaten by humans in the US. So when the California legislature was considering a bill to label GE fish and give residents a conscious choice about the food they buy, we strongly supported the legislation.

The bill gained more traction than many other GE state bills. It was referred to the committee on health where it actually passed. From the health committee it was sent to the appropriations committee, but there, unfortunately, it failed to win passage on May 27.

Troubled Diet Pill Contrave Pulled from Development

We recently discussed the weight-loss drug Contrave, made by Orexigen. In February, the FDA declined to approve it for the time being, expressing concern about Contrave’s cardiovascular effects when used long-term in a population of overweight and obese subjects. Officials told the manufacturer it must conduct a study “of sufficient size and duration” to demonstrate that the risk of heart attacks, strokes, and other major cardiovascular events does not undermine the drug’s risk-benefit profile.

Our big concern about Contrave is that it includes an SSRI antidepressant, which most users wouldn’t even realize is there until they try to stop taking the drug and discover how incredibly addictive SSRIs are, as we noted in our recent article on them.

After the February announcement, Orexigen’s stock prices dropped 73 points; and in the four months since, prices have continued to bottom out. In response, the manufacturer said it will halt development of the drug in the US.

Bloomberg reports that the FDA is planning to ask an advisory committee to review general requirements for cardiovascular safety and diet pills, but that the meeting won’t be held until early next year. The agency told Orexigen that after that meeting, all products under development may be “measured by a different bar” for approval—which sounds to our ears like a promise that crony capitalism will be with us for some time to come.

GE organisms actually become part of the bacteria in our digestive tracts and reproduce continuously inside us. But the USDA now wants to to remove all controls from GE corn and cotton!

There are no human clinical trials of genetically engineered foods. The only published human feeding experiment revealed that genetic material inserted into GE soy transfers into the DNA of bacteria living inside our intestines and continues to function. Even after we stop eating GE foods, we may still have the GE proteins produced continuously inside us.

As the Institute for Responsible Technology has noted, the genetic engineering process creates massive collateral damage, causing mutations in hundreds or thousands of locations throughout the plant’s DNA. Natural genes can be deleted or permanently turned on or off, and hundreds may change their behavior. Even the inserted gene can be damaged or rearranged, and may create proteins that can trigger allergies or promote disease.

The idea of having genetically engineered genes permanently living inside our guts has staggering implications:

• If the antibiotic gene inserted into most GM crops were to transfer, it could create antibiotic-resistant diseases.
• Bt toxins (Bacillus thuringiensis) inserted into GM food crops to kill pests are reaching the bloodstreams of 93% of women and 80% of unborn babies because of the consumption of meat, milk, and eggs from livestock fed GE corn. This could turn bacteria in our intestines into pesticide factories.
• Animal studies show that DNA in food can travel into organs throughout the body, even into the fetus.

And we’ve seen cross-species transfer of DNA happen before. A significant percentage of human DNA is actually viral DNA that became part of us over 40 million years ago. There is concern that virally transmitted DNA may cause mutations and psychiatric disorders such as schizophrenia and mood disorders. GE organisms may exacerbate this phenomenon.

Genetically engineered food genes transferring to our own genes could lead to problems like leaky gut syndrome:

• Our small intestine, which is responsible for about 70% of our immune system, behaves like a selective sieve: it lets only nutrients and well-digested fats, proteins, and starches enter the bloodstream and keeps out large molecules, microbes, and toxins.
• Leaky gut syndrome happens when the intestinal lining becomes inflamed, and the microvilli on the lining become damaged; this prevents the microvilli from absorbing nutrients and producing necessary enzymes and secretions for healthy digestion and absorption.
• In between cells are desmosomes, which keep the cells together, forming a strong structure preventing large molecules from passing through. When an area becomes inflamed, the structure is weakened, allowing larger molecules to escape. The makes the immune system produce antibodies and cytokines to fight off molecules because they are perceived as antigens.

Allergies have already skyrocketed in the US, and with the introduction of GE soy in the UK, soy related allergies rose to 50%. Yet federal agencies turn a blind eye to the dangers of genetic engineering.

In 1989 there was a tragic outbreak of eosinophilia-myalgia syndrome (EMS), an incredibly painful disease. The outbreak was traced to consumption of l-tryptophan supplements produced by a Japanese company using genetically engineered bacteria. The bacteria are used to increase yields, but they increase impurities during the fermentation process—possibly leading to a level of contaminants that caused the EMS.

To this day, the government has refused to address the issue of purity standards for GE-manufactured products. Instead, federal agencies and biotech companies claimed that contaminants linked to the EMS tragedy were caused by changes in the company’s manufacturing process—despite the fact that the company was precisely following the purity standards enforced by government rules.

The EMS was rare and had a fast enough onset that the case histories of the patients could be linked to this supplement, and it was also acute enough that doctors took notice. There is a very clear causal link between EMS and these genetically engineered organisms.

The effects of other genetically modified products may not be as obvious so quickly, but can be even more devastating; as we have reported previously, GMOs are causing terrible genetic changes in mammal offspring. Scientists are seeing birth defects, high infant mortality rates, and sterility in hamsters, rats, and livestock fed GMO soy and corn, and some hamster pups even begin growing hair inside their mouths.

The late George Wald, Nobel Laureate in Medicine or Physiology in 1967 and Higgins Professor of Biology at Harvard University, was one of the first scientists to speak out about the potential dangers of genetic engineering:

Recombinant DNA technology [genetic engineering] faces our society with problems unprecedented, not only in the history of science, but of life on the Earth….Now whole new proteins will be transposed overnight into wholly new associations, with consequences no one can foretell, either for the host organism or their neighbors….For going ahead in this direction may not only be unwise but dangerous. Potentially, it could breed new animal and plant diseases, new sources of cancer, novel epidemics.[1]

The USDA has released two Environmental Assessment reports, one for Monsanto’s corn genetically engineered to be drought-tolerant, and the other for Syngenta Biotechnology’s cotton genetically engineered to be pest-resistant. USDA believes the cotton is “unlikely to pose a plant pest risk”; for the corn, the agency is considering either keeping the corn under regulation, or assigning it nonregulated status (banning it altogether is off the table). The comment period for both EAs is open until July 11.

Please take action today! Tell the USDA that the corn and cotton must not be deregulated—that without strict controls, GE crops will encroach on non-GE crops, contaminating them, including organic crops—which will, of course, render them non-organic.

The GE corn is especially dangerous because it is for human consumption. As noted above, GE genes from foods can affect the bacteria from our digestive system, and can lead to allergies, disease and even sterility.

GMOs are causing terrible genetic changes in mammal offspring. Scientists are seeing birth defects, high infant mortality rates, and sterility in hamsters, rats, and livestock fed GMO soy and corn, and some hamster pups even begin growing hair inside their mouths.

Please note that the comment period has now closed and this action alert is no longer available.

Melatonin-filled brownies called Lazy Cakes have come to the attention of Congress. Will the FDA use them as another excuse to over-regulate dietary supplements?

Two Massachusetts towns, Bedford and Fall River, are moving to ban the sale of “relaxation” brownies called Lazy Cakes after children who tried the cakes were rushed to the hospital, where it was extremely difficult to wake them up. The chocolate treats are filled with melatonin and are being sold in food markets and night clubs. In Arizona, a two-year-old boy given a few bites of a relative’s Lazy Cake was hospitalized after becoming withdrawn and falling deeply asleep.

The brownies contain nearly 8 milligrams of the supplemental sleep aid, so one piece has significantly more than the usual amount prescribed for adults—and who has only one brownie? Melatonin is a hormone produced naturally by the body. Standard doses in the Unites States (where it is available over the counter) and in Europe (where a prescription is typically required) range from 0.3 mg to 3 mg.

The Massachusetts towns want to ban their sales largely because of their appeal to children. Purple packaging features Lazy Larry, a cartoonish brownie with a big grin on its face.

Now Sen. Dick Durbin (D-IL) has written to the FDA, asking the agency to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin, and to clarify the difference between dietary supplements and food.

Existing laws already give the FDA all the tools they need to regulate supplements, and we already have regulations in place that explain the difference between dietary supplements and food and that regulate them accordingly. The FDA does not need more regulations. The drug-based paradigm is not a good paradigm for food and supplements!

Lazy Cakes are clearly not a dietary supplement because the law says that dietary supplements cannot be “represented for use as a conventional food or as a sole item of a meal or the diet.” Brownies are clearly represented as food and cannot be mistaken for something else.

Since Lazy Cakes are not dietary supplements the FDA must regulate them as food. Ingredients that are intentionally added to food—in this case, melatonin—are food additives. Food additives require pre-market approval based on data demonstrating safety submitted to FDA in a food additive petition.

A substance is exempt from pre-market approval if it is GRAS—that is, Generally Recognized as Safe by qualified experts under conditions of use. Since these Lazy Cakes contain significantly more than the usual amount prescribed for adults, the ingredient was not used in a way that is GRAS! Lazy Cakes, therefore, are already subject to FDA enforcement under existing law.

FDA might be trying a repeat performance of their actions after DSHEA was introduced. David Kessler, who was then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen.

With the way the agency has handled (or not handled) the Lazy Cakes situation, it would appear FDA is trying to allow bad food products to tarnish the dietary supplement industry—perhaps in the hope that Congress will repeal DSHEA. But the agency’s inaction is no excuse—there are already enough laws in place to make sure that dietary supplements and foods are safe.

Melatonin-laced cakes are clearly a terrible idea. Children should not take melatonin, especially during the day, and they shouldn’t eat chocolate at night. Melatonin does not belong in brownies!

Everyone should be justly concerned about companies that make misleading claims about their products. We should point out, however, that the worst offenders are Big Food companies who make confusing claims about their food products.

Call it the sledgehammer approach to medicine. Rather than catching or curing disease, aggressive cancer screenings and unnecessary biopsies are actually spreading deadly “superbugs” among patients.

Take prostate exams, for example. Millions of men each year are tested for prostate cancer—and an increasing number of them are getting sick from potentially lethal drug-resistant infections. Studies from three countries show that infectious complications from prostate biopsies have more than doubled in less than a decade. As much as five percent of prostate biopsies develop infections from the procedure—or about 50,000 Americans every year, and an equal number in Europe. Nine out of 10,000 men whose tests were negative for prostate cancer died within a month from sepsis and other complications, according to a recent study in the Journal of Urology.

The standard needle biopsy test for prostate cancer sends an ultrasound-guided needle a dozen times through the rectum to collect specimens from the prostate gland. But this also allows the needle to bring bacteria from the bowel into the prostate, bladder, and bloodstream. This is particularly dangerous if the bacteria happen to be “superbugs” which are resistant to antibiotics (please see our article on superbugs in this issue).

Part of the problem is the procedure itself. A 2004 study from the John Wayne Cancer Institute in California indicates that if you do have cancer, getting a needle biopsy may increase the chance that the cancer will spread by as much as 50 percent compared to patients who receive the more traditional excisional biopsies (or “lumpectomies”).

In response to this, it is argued that biopsies save lives too. A Swedish study is cited suggesting that younger men with early prostate cancer have better survival odds if they have surgery right away instead of waiting for treatment. But look more closely at the study. About 95 percent of the cancers in the Swedish study were found because they were causing symptoms. In the United States, however, most of the cancers are found after a PSA (prostate specific antigen) blood test raises a red flag, long before symptoms appear. And that’s the problem: an elevated PSA test almost invariably leads to a needle biopsy, even though false PSA positives are commonplace. A recent study concluded that after 20 years of follow-up with patients, the rate of death from prostate cancer did not differ significantly between men in the screening group and those in the control group.

Also keep in mind that some prostrate cancers are aggressive, while others grow very slowly and many may never cause problems. But the standard surgery and radiation treatment is the same for nearly all of them, and has been known to have nasty side effects like impotence, urinary incontinence, and bowel problems.

A European study on prostate cancer screening indicated that in a sample of 1,400 men, one man’s life would be saved from the early detection and treatment—while 48 others would undergo painful and dangerous treatments like surgery or radiation that would not improve their health because either the cancer was not life-threatening to begin with or because the cancer was too far gone.

Is this the only example of conventional “preventive” medicine run amok? Far from it.

Recent research suggests that the elderly get colonoscopies far too often—creating unnecessary risks to their health, and a waste of money, as Medicare is paying for it. In fact, the US Preventive Services Task Force recommends against routine colon cancer screening for most people 76 to 85—and says for those older than 85, screening risks outweigh the benefits. Complications for older patients include accidental perforation of the colon, bleeding, and complications from sedatives, any of which can lead to death. And most of these colonoscopies for the elderly are completely unnecessary to begin with—a study in the Archives of Internal Medicine says that only 27 percent of all study patients with frequent exams had any symptoms that might have raised suspicion of cancer.

There is big money in cancer screenings. Americans spend $4 billion on mammograms alone, and some of those tests cause false alarms that lead to unnecessary follow-up surgery on normal breasts—at a cost of as much as $70 billion over a decade. The radiation alone from too many mammograms can be a cause of cancer, although CAT scans, with their massive amount of radiation, may be an even bigger risk.

And this isn’t the only “preventive” medicine risk for women who are worried about breast cancer.

The Health Sciences Institute points out that the drug tamoxifen, which was identified as a carcinogen by the California EPA more than ten years ago, is frequently recommended if there is a risk of breast cancer. This synthetic hormone-like drug effectively prevents estrogen from binding to breast cancer cells, making it more effective than chemotherapy in treating estrogen-driven breast cancer tumors—the most common type of breast cancer tumor in postmenopausal women. But the potential dangers range from nausea and vomiting to deep-vein thrombosis and pulmonary embolism, not to mention cancer itself. Tamoxifen actually increases the risk of a rarer type of breast cancer that is aggressive and harder to treat.

What is really inexcusable is that animal studies suggest phytoestrogens from foods such as soy do as much or more than tamoxifen to prevent cancer without the side effect risks. But drug companies and the FDA couldn’t care less because these phytoestrogens can’t be patented and thus can’t be brought through the FDA approval process.

There are also other, much safer ways to reduce one’s risk of breast cancer: being as lean as possible without being underweight; exercising for at least 30 minutes a day; limiting alcohol consumption; and, for new mothers, breast-feeding their children for up to six months.

As we noted in March, more is not necessarily better when treating as well as trying to prevent cancer: after years of patient trials and clinical experience, even oncologists are grudgingly agreeing that more chemotherapy does not necessarily produce a better outcome. The side effects of additional aggressive chemo invariably outweigh the benefits. The same goes for radical, disfiguring surgeries like mastectomies with the removal of pectoral muscles and all area lymph glands: for many patients facing breast cancer at an early stage (estimated to be up to 40,000 per year) the removal of area lymph modes is now known to be unnecessary.

The book Death by Medicine by Gary Null et al. documents the fact that the number of people who die each day because of medical errors—physician mistakes, hospital-related illness, and reactions to FDA-approved medications—is the equivalent of six jumbo jets falling out of the sky. More Americans are dying each year at the hands of medicine than all American casualties in WWI and the Civil War combined. The book has recently become an award-winning documentary film.

Health policy expert John C. Goodman discusses the huge economic cost of adverse medical events—between $393 and $958 billion in 2006. He estimates that 6.1 million injuries and 187,000 deaths caused by the health care system: “This is equal to between $4,000 and $10,000 a year for every household in America. Roughly speaking, every time the healthcare system spends a dollar healing us, it causes up to 45 cents worth of harm.”

Drug-resistant bacteria—“superbugs”—are becoming a global crisis. But the government not only thwarts the development of new antibiotic drugs. It also willfully ignores powerful natural therapies and cures.

Last August, the UN’s World Health Organization issued a global alert on the dangers of drug-resistant bacteria: “Some bacteria have developed mechanisms which render them resistant to many of the antibiotics normally used for their treatment, so pose particular difficulties, as there may be few or no alternative options for therapy.” Germs resistant to one or more drugs kill 100,000 US hospital patients a year and cost the healthcare system more than $34 billion, according to the Infectious Disease Society of America. This could easily rise to the millions worldwide as major bacterial pandemics emerge.

And as we reported in February, the world is also facing wave after wave of antibiotic-resistant bacteria in our food—a consequence of farmers’ overuse of antibiotics for their animals, and doctors’ routine prescribing of antibiotics to treat sore throats and other non-bacterial illnesses.

At first glance, it would appear that the mainstream medical solution is to treat drug-resistant bacteria with more drugs. Optimer Pharmaceuticals, for example, is in the process of developing five new antibiotics over the next three years to treat drug-resistant germs. Other biotech companies are following suit. This will solve the problem—right?

Wrong. It is almost impossible to get a new antibiotic through the FDA these days. Partly because the new antibiotics can be genuinely dangerous. Partly because the FDA is dragging its feet out of fear of making a mistake. Forbes magazine recently reported that the prohibitive cost and bureaucracy of the FDA approval process is killing innovation and new treatments, noting that the agency’s “notoriety for making the approval of new drugs ever more expensive—with nothing to show in efficacy and safety—has been increasing over the years.”

After Ketek, a much-hyped antibiotic from Aventis, had to be restricted because the pill caused liver damage and Congressional hearings criticized FDA officials, standards were tightened at FDA; in 2008, only one new antibiotic made the cut. In effect, the agency seems to have decided to “let people die by depriving them of new medicines [rather] than to be excoriated” for approving medications with unintended side effects.”

According to Forbes, “The FDA recently attended a meeting on the antibiotics crisis. Since then, astonishingly, the agency has implied it only would ‘consider’ revamping its slow and deadly approval process. No wonder Pfizer has thrown in the antibiotics towel; more companies are sure to follow.”

Of course antibiotics are not the only way to control drug-resistant bacteria, just the only way that the government and the drug industry is interested in. There are highly effective natural solutions without the side effects—yet they are not being developed, or even fully researched.

Grapefruit seed extract, oregano (especially oil of oregano), topically applied manuka honey (especially good against MRSA) and colloidal silver are all very potent antibacterial agents. In the case of silver, of course it is important not to take too much—like the poor fellow who turned himself blue. But it’s easy to control the dose. Perhaps the medical authorities nonetheless feel that they are simply not competent to control silver’s use in a hospital setting?

Viruses may actually be another solution for out-of-control bacteria. It is not widely known that viruses kill half the bacteria in the ocean every day. For each deadly bacterium, there is a virus to kill it, including the bacteria that causes MRSA. This therapy was being developed in the past but largely disappeared after the discovery of antibiotics in the 1930s. More to the point, the FDA has not done anything about it because they have no way of approving it as a drug—there is simply no thinking outside the box, except when it comes to drugs pushed by Big Pharma, of course!

And of course, there is vitamin D, which is so effective in maintaining a robust immune system. An article that appeared in Nature Medicine says that new research is showing that active analogs of vitamin D can help fight a number of diseases, including cancer and chronic kidney failure. Physicians already prescribe one such drug—calcitriol, an active form of vitamin D first synthesized in the 1970s—to treat rickets, psoriasis and vitamin D deficiencies sometimes seen with kidney disease.

Against the backdrop of these successes, one will always find naysayers like Forbes’ contributor Steven Salzberg, who claims that “Pseudoscience is insinuating itself into our medical schools across the nation, going by the latest buzzword, ‘integrative medicine.’”

This is actually quite hypocritical. There is very little science behind much of what is done in conventional medicine. There is plenty of science behind using silver to kill bacteria. Why else would it be applied to clothing to keep it fresh (a real misuse) and many other commercial and industrial applications. Moreover, if silver could be patented, you could be sure that the drug companies and the FDA would be all over it.

Scientists have recently proposed using silver more widely to protect drinking water in areas where it is not safe. A study has confirmed that using filter paper impregnated with silver nanoparticles kill disease-causing bacteria as they pass through it. Very little silver escapes the portable filter, which could provide an efficient source of potable water to alleviate diseases—such as cholera and giardiasis—that are associated with drinking foul water. In this case, no one is calling the idea pseudoscience. But even the best science won’t get hospitals to start using silver as they obviously should be. Both the FDA and the medical societies involved should be ashamed of themselves. How many people must die before they change their minds?

Misleading claims vs. legitimate science—getting to the truth can be a minefield! Which is why the Free Speech about Science Act is so important.

The US Food and Drug Administration recently sent warning letters to manufacturers of a number of products—MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak—for making health claims about treating or preventing sexually transmitted diseases, including herpes.

According to the FDA press release, “While some of the companies market these products as dietary supplements, these products are all drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).”

On their websites, the supplement manufacturers make a wide variety of claims. Some of the claims are supported by varying degrees of science; some seem wildly overreaching. But all health- or disease-related claims are currently illegal. And that is precisely the problem: there is no mechanism in place for citing the legitimate science behind a food or supplement’s effectiveness. Many Americans are trying to take charge of their health, and they are desperate for information, so some supplement manufacturers are filling that void by violating current law and making health claims—which makes it even more difficult for consumers to judge a misleading claim from a scientifically valid one.

MedaVir’s website says that research about the product’s ingredients effectiveness has been published in national medical journals, though they don’t link to that research. The website also says MedaVir has been proven effective by an official FDA phase 2 double-blind clinical trial, as well as research at Proctor and Gamble’s laboratories for medical testing and the Cincinnati Children’s Hospital Infectious Diseases Division. Why would FDA warn a manufacturer over health claims when a FDA clinical trial has proven that the product is effective?

Here’s why. The sad truth is, whether the products are effective or not, or whether they have good science to back up their claims or not, is utterly irrelevant to the FDA. Dietary supplements cannot treat or prevent STDs like herpes—only FDA-approved, prescription-only medications can do that. That’s because, as you’ll note above in the FDA’s own words, any product that is offered as a treatment for disease is by definition a “drug product,” and without an NDA, said drug product cannot be sold.

Sadder still, natural substances can be powerful healers, but most of the public will never hear about them. As we have reported in previous newsletters, there are excellent natural treatments for diseases like herpes: vitamin C, selenium, lysine, and especially the powerhouse of the vitamin world, vitamin D. But the FDA says that making a health or disease claim for a supplement instantly and magically transforms it into a drug. It must therefore go through the FDA drug approval process or it cannot be sold. Alternatively, it can be sold, but you can’t tell anyone about its health benefits!

The difficulty, as we have noted many times, is that naturally occurring substances cannot be patented, and without patent protection, few manufacturers will pay the millions—and occasionally billions—of dollars to do the double-blind studies necessary to bring a new product through the FDA new drug approval process.

The long and short of it is this: the current health claim regulation system is broken, and the FDA is exploiting it.

This is why we so desperately need the Free Speech about Science Act of 2011 (FSAS). Passing this bill into law would make a food’s or product’s scientific studies and their implications more transparent and understandable to consumers.

Under FSAS, dietary supplement manufacturers will be able to make well-substantiated disease or health-related claims, based on legitimate scientific research. Because food and supplement manufacturers cannot legally make health claims, it becomes even harder for consumers to make informed and healthy decisions—and consumers are missing out on valuable information. FSAS creates a standard that would weed out junk science and misleading claims, and would provide health-conscious consumers with access to much-needed credible scientific information behind natural products.

We mentioned MedaVir earlier, but some of the other companies targeted by the FDA warning letter also cite scientific evidence to support their claims. The Herpaflor website, for example, cited science behind each of the product’s seventeen different ingredients (or did, before the FDA warning letter made them remove the citations, though we have a PDF of the page in question), supporting the claim that Herpaflor’s ingredients help prevent and treat herpes outbreaks as well as help alleviate some of the side effects such as pain and discomfort. They listed twenty reputable scientific sources for their claims, ranging from NIH studies, The Journal of Dermatology Treatment, The Journal of Medical Sciences Research, and The Journal of Antimicrobial Chemotherapy—though they also listed a number of sources that are not peer-reviewed, like BBC News and Answers.com.

ANH-USA does not, of course, support manufacturers’ misleading or fraudulent claims! We do support, however, the right of consumers to have access to credible, peer-reviewed scientific information about food and dietary supplements. It is difficult for consumers to differentiate what is credible information and what isn’t—because there is no standard in place for citing science for natural products. FSAS would help correct this.

The great irony here is that FDA and FTC absolutely allow egregiously misleading claims—with impunity—so long as they’re made by the major pharmaceutical manufacturers! For example, a full page ad for Astrazenica’s acid blocker drug Prilosec OTC in People magazine says in large type, ZERO HEARTBURN**. If you follow the asterisks down to the bottom of the page, it says in tiny type, “It’s possible while taking Prilosec OTC.” So the actual message is that zero heartburn is possible while taking this drug. Of course, zero heartburn is possible for any other product under the sun! Manufacturers of acid blockers are very careful to avoid saying that their product cures heartburn—because there is no evidence it does. There is abundant evidence, however, that it leads to more infection, pneumonia, bone problems, and a failure to absorb minerals. There is also evidence that it actually makes heartburn worse over time. Yet the FDA and FTC have no trouble with these claims.

Consumers have the right to access this information, and the FDA’s method of barring access to this information in untenable. There must be a system that allows consumers access to credible scientific data, through legislation like FSAS. If you have not already done so, please see our Action Alert and ask Congress to support the Free Speech about Science Act!

Drinking water that catches fire? Radioactive rainwater? You got the Senate to reintroduce the FRAC Act to close the Halliburton Loophole—now help it become law! Make the drilling companies accountable—an Action Alert.

In February, we reported on the terrible environmental and health hazards posed by a method of natural gas extraction employed in deep natural gas well drilling known as hydraulic fracturing, or “fracking.”

One of our biggest concerns was over what is commonly referred to as the Halliburton Loophole. In 1974, the Safe Drinking Water Act (SDWA) was passed by Congress to make sure we have clean drinking water which is free from both natural and man-made contaminates. But in 2005, the Bush Energy Bill exempted natural gas drilling from the SDWA as a favor to Halliburton, the world’s second largest oilfield services company. For each frack, 80 to 300 tons of chemicals may be used, though the Bush/Cheney Energy provision exempts companies from disclosing the chemicals used during hydraulic fracturing.

On March 15, S.587, the Fracturing Responsibility and Awareness of Chemicals (FRAC) Act, was introduced in the Senate. It would amend the SDWA to repeal the exemption for hydraulic fracturing.

This bill doesn’t come a moment too soon. In April there was an explosion and a leak of “thousands and thousands” of gallons of fracking fluid on to farmland and into streams in Bradford County, Pennsylvania. Nearby families were asked to evacuate the area as a precaution. Some did, some didn’t. “Our family’s been on this corner a long time and expect to stay and expect a good-faith effort from Chesapeake [Energy, the company doing the fracking] so that we can live here,” said Ted Tomlinson, a neighbor. His concern is for his drinking water well just several football fields away from the blown out gas well. “The biggest thing is the footprint on the environment. Well, obviously, this is a big footprint.”

And for the first time, a scientific study from Duke University has linked natural gas drilling with flammable water. The study determined a clear pattern of deep drinking water systems in some areas becoming so contaminated with methane that water faucets can actually be lit on fire.

The New York Times recently ran an exposé of the politics and the federal regulatory issues surrounding the natural gas industry. The article says that interviews with Environmental Protection Agency scientists, together with confidential documents obtained by the Times, show long and deep divisions within the agency over whether and how to increase regulation of oil and gas drillers, and over the enforcement of existing laws that some agency officials say are clearly being violated:

EPA scientists working on the agency’s national hydrofracking study have also emphasized that sewage treatment plants are not, technically speaking, treating the waste.

For example, when one agency scientist wrote in a draft plan for the national study that wastewater could be “discharged to surface water after treatment to remove contaminants,” another scientist corrected the statement in the margin.

Using the federal definition of treatment, the second scientist wrote, “we really don’t fully treat the waste.”

On a lighter note, you may enjoy the Fracking Song, created by the New York University Arthur L. Carter Journalism Institute’s Studio 20.

Please contact your senators today and ask them to pass the FRAC Act, and close the Halliburton Loophole!

The ADA is clever. It gets legislation passed under the radar, when no one is looking. And natural health nutritionists are getting a rotten deal.

As we reported a few weeks ago, the American Dietetic Association (ADA) has sponsored legislation in over 40 states. These bills usually lump dietitians and nutritionists into one licensing scheme, and require nutritionists to complete a dietitian program in order to practice nutritional therapy. Even if the nutritionist holds a Masters or a PhD in nutrition, the nutritionist is still required to complete registration through the ADA in order to keep practicing.

This is the organization that lists among its corporate sponsors soft drink giants Coca-Cola and PepsiCo, cereal manufacturers General Mills and Kellogg’s, candy maker Mars, and Unilever, the multinational corporation that owns many of the world’s consumer products brands in foods and beverages.

The ADA’s legislative manipulations are able to go undetected because it takes years for a bill to go through the regulatory phase and be implemented—so few people become aware of the full consequences of the law. Moreover, the ADA hasn’t yet “pulled the trigger” sending out cease-and-desist letters to nutritionists everywhere telling them they can no longer practice—but you can rest assured this will happen, as soon as the organization has its monopoly firmly established. In the meantime they go on to lobby for new legislation in other states.

Currently the ADA is pressing for bills in four states. They are have even organized a lobby day in New York state at the end of the month.

Take a look at what has been happening in North Carolina. It’s what will happen in all the states if the ADA monopoly grows.

There has been a dietetic monopoly law in NC since 1991. In 2003, Liz Lipski, PhD, CCN, CHN, a well-known and eminent nutritionist, applied for licensure. Just last month she was told by the North Carolina Board of Dietetics/Nutrition that she did not meet the minimum requirements for licensure.

As we have mentioned before, the “minimum requirements” fits the lower credentialing requirements of the dietitian model—so, for example, the NC dietitian board claimed that Liz did not meet the course requirement for organic chemistry, even though she has a doctoral level course in nutritional biochemistry—which is applied organic chemistry. Furthermore, Liz has a doctorate in clinical nutrition, has been board certified in holistic nutrition, and has been practicing for decades. But because she did not take the specific lower-level academic course as demanded by the ADA, she could no longer be licensed.

Liz has hired an attorney and is in the process of negotiating with the North Carolina Board of Dietetics/Nutrition. Her website has full details of her case, and if you can help with a donation toward her legal fees, it would be greatly appreciated.

Why does the the ADA, which claims to protect the consumer against poorly qualified nutritionists, reject nutritionists with advanced degrees from fully accredited institutions, like Liz Lipski? Could it be because they are more qualified than their own licensees?

We wanted to give you a follow-up on some of the bills the ADA we told you about previously. Remember, just because people are trying to get laws passed under the radar doesn’t mean we can’t stop them in their tracks!

Nevada AB 289: This bill is moving forward quickly. It has passed the Nevada House and is already in committee in its Senate. It is scheduled for a hearing tomorrow, May 11. This bad bill states that only ADA-licensed dietitians shall practice dietetics. “Dietetics” as defined in the bill encompasses a wide range of nutrition services including performing nutritional assessments and nutrition monitoring, counseling and evaluation, all of which fall under the scope of practice of any qualified and self-respecting nutritionist. Furthermore, the bill explicitly states that individuals cannot use the words “licensed nutritionist” or “LN” unless they complete the program for dietitians—which also requires completion of the ADA exam.

Nevada residents: If you have not done so already, please take action immediately, as the hearing will take place tomorrow!

There is also an online opinion poll on the Nevada legislative website. Nevada legislators use this opinion poll to get a sense of how their constituents feel about a certain bill. To let your legislator know how you feel about AB 289, fill this opinion poll by clicking here.

California AB 575: Victory! Due to a groundswell of opposition from our members, as well as the hard work of a coalition of activists, we were able to ensure that AB 575 was not heard in committee. We believe that AB 575 will not move anywhere this session but we are keeping eye open for the next session when it will almost certainly be reintroduced.

New York A.5666 and S.3556: As we noted in our previous article, this bill lumps dieticians and nutritionists together under one title, “Licensed Dietitian/Nutritionist” or “LDN,” and gives the ADA a majority membership on the new joint board—which means that the board will require that only the ADA exam be allowed, as they have done in other states. ADA-registered dietitians are planning a rally day on Friday, May 20, to lobby their legislators in support of this bill.

In response, we’re going to have an “online lobby day.” We’ll have a coordinated day of action tomorrow, on Wednesday, May 11—if you are a New York resident, please call your state representatives in opposition to the bill. Emails are great (and please continue to send them on our Action Alert page)—but real impact would be felt by calling representatives all on the same day.

New Jersey AB1987 and S809: No news here as yet. The Dietitian/Nutritionist Licensing Act lumps together “licensed dietitian/nutritionist,” and the terms are used interchangeably throughout the bill. Instead of noting and providing for the differences between the two, the bill creates a State Board of Dietitians/Nutritionists instead of a separate board for each. Furthermore, the Senate version of the bill requires the completion of a registered exam administered by the American Dietetic Association. If you are a New Jersey resident, please take action here.

Leading up to the 2012 election, ANH-USA will reach out to all candidates running for president and ask them real questions about natural health and where they stand on issues that are important to ANH-USA members. Our first interviewee asks, “Where is the profit in healthy people?”—a question that goes to the heart of many of our current health problems.

Gary Johnson, the former two-term governor of New Mexico, founded one of the largest construction companies in the southwest. During his time as governor, he pushed an anti-tax and anti-bureaucracy platform and vetoed more bills than the other 49 governors combined. He’s known as a fitness expert who has climbed Mount Everest and takes part in Ironman Triathlons. Gary Johnson announced his candidacy for president last month.

ANH-USA and its members believe that we don’t have a healthcare system in the US; we have a pharmaceutical-profit-driven “sick-care” system. How would you help change the paradigm and get the country on a real path to health and wellness?

I often point out that our current healthcare system is the least “free” of practically any component of our supposed free market system. Every step of the process, from what we eat and drink to the pharmaceuticals we are prescribed to the treatment options we face, is regulated in some fashion by bureaucracies—both government and corporate. In contrast, I am a firm believer that most people, if free to do so, will ultimately make the best decisions about their own well-being. Thus, my approach is to remove obstacles to free choice in a free market, thereby allowing the consumer to demand products and treatments that promote wellness, health and real preventative care. The system we have does just the opposite.

Why are so many natural and integrative health options not covered under insurance plans, even though they’re frequently less costly and more successful? What would you do to change that?

When government regulates, the inevitable result is policy that creates winners and losers. And whenever government creates winners and losers, those with the most clout and the loudest voices tend to prevail. In any industry as highly regulated as healthcare and insurance, that unfortunate tendency always filters down into the corporate cultures as well. I believe the institutional biases against natural health options are the direct result of a system that has picked winners and losers. Changing that requires a leveling of the playing field in which, again, consumers are picking the winners—not institutions.

There was a lot said on both sides of the healthcare reform debate last year, but if you ask natural health supporters, there was a third way that was completely left out of the debate. Why do you think natural health was left out of the debate? What can we do to make sure our side is heard?

Despite the rallies, bus tours and protests that occurred, let’s be honest. The process that resulted in the healthcare “reform” law was much less of a debate than it was a negotiation among massive vested interests. Those of us on the outside of that negotiation didn’t even have an opportunity to know what was in the so-called reform, and there was no room at the table for advocates of truly innovative or game-changing ideas. After all, where is the profit in healthy people?

At the end of the day, however, politicians’ self-preservation depends not on institutions, but on people who vote and make themselves heard. ANH-USA is on the right track toward mobilizing the millions of Americans who support natural health and wellness, and once the “system” is awakened to the fact that those millions of Americans are watching and voting, I suspect there will, indeed, be a seat at the table.

We asked our Facebook fans if they had a chance to ask a presidential hopeful a question, what would they ask. This question was the most popular: “Would you be willing to feed you and your family ONLY genetically modified food from now until you are out of office? If not, why should we be expected to eat it?”

I would absolutely not be willing to feed myself and my loved ones only genetically modified food, and I am equally opposed to expecting anyone else to do so. As an advocate of personal choice, I would also defend the right to choose to eat whatever kinds of food one wants—without those choices being limited by the government or the distorted, constrained marketplace it has created.

If our readers want to find out more about you, where can they go?

Our campaign is entirely about giving voice to the ideas of limited government intrusion in our lives, protecting individual freedom, and revolutionizing America with a large dose of common sense. ANH-USA members and supporters are an important part of that effort, and I encourage all to climb on board. Visit our website: www.garyjohnson2012.com.

A government agency doesn’t think your family is worth protecting from BPA in cash register receipts—that workers may be affected by it, but not consumers. Huh? Doesn’t the cashier put the receipt right into your hand? Tell them this is ridiculous with our new Action Alert!

Last August, ANH-USA filed a Citizen Petition with the Consumer Product Safety Commission (CPSC) to have the endocrine-disrupting chemical bisphenol-A (BPA) banned from thermal cash register receipts. Cash register receipts are the little-known but most common pathway for BPA into your body.

The CPSC responded by refusing to consider our petition, claiming that it did not meet their requirements based on some very flimsy reasoning: that the regulation of cash register receipts should be under the jurisdiction of worker safety (OSHA) and not consumer safety.

In early March we once again sent CPSC our petition, accompanied by a letter demanding that the agency fully consider our petition and assess it on the legal grounds and evidence that we presented to them. Their reasoning seemed especially absurd since both workers and consumers handle receipts. Anyone who handles the receipts is at risk, including consumers—so it’s not just OSHA’s territory.

CPSC has still not responded to our petition.

Meanwhile, the Connecticut legislature has introduced its own bill to ban BPA on thermal cash register receipts and require the Chemical Innovations Institute to develop an annual list of chemicals of high toxic concern.

Consumers are speaking out against BPA, and company shareholders are noticing. Twenty-six percent of Coca-Cola’s shareholders called for the company to publish a report to address consumer concerns about BPA in the epoxy linings of their cans. However, at Coke’s annual general meeting Wednesday, the CEO told shareholders that there was not enough evidence to stop using BPA in their cans. “If we had any sliver of doubt about the safety of our packaging, we would not continue to use (BPA),” he said. He used this phrase—“not a sliver of doubt”—despite the worldwide outcry against BPA , the government of Canada declaring BPA a toxic substance, and various bans in Europe.

Please contact the Consumer Product Safety Commission and ask them to reconsider our petition, and to stop giving us the runaround.

The Federal Trade Commission has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. Help us fight this new censorship of science all the way by taking action to support our Citizen Petition!

It’s imperative we protect access to good information about the benefits of a natural approach to maintaining health. But this will become much more difficult now that the FTC is requiring two random-controlled human trials for any health-related claim—even so-called structure/function claims, which are permitted under the Dietary Supplement Health and Education Act of 1994 (DSHEA) without such trials. Before it can adopt or enforce such new policies, the FTC is required by law to go through the rulemaking process, a process that becomes even more difficult for FTC whenever a new policy is controversial, such as health claims. Perhaps that is why FTC is ignoring that law and doing it anyway.

You will recall that the FTC would have been granted additional authority, enabling them to legally amend their regulations to require two such trials through what we called the Waxman amendment to the “Financial Reform” bill. Thanks to all of you, that amendment was defeated. But the FTC is just going ahead as if the amendment had passed and they had further gone through the necessary rulemaking process to amend their regulations.

In response, yesterday, April 25, the Alliance for Natural Health USA filed a Petition for Rulemaking before the Federal Trade Commission. ANH-USA is alleging the following:

• FTC lacks jurisdiction to enforce the Federal Food, Drug, and Cosmetic Act.
• The FTC’s two clinical trial requirement violates the First Amendment standard in Pearson v. Shalala.
• The FTC cannot violate the Constitution in consent orders.
• The FTC’s new policies chill protected speech.

Of particular concern is that the FTC’s new policies apply to the industry as a whole. The fear of enforcement under FTC’s new policies chills protected speech and reduces access to important health-related information for consumers. This petition, if denied, will lead to a litigation phase.

Once again ANH-USA and its co-plaintiffs, Durk Pearson and Sandy Shaw, are being represented by renowned constitutional law attorney Jonathan Emord, of Emord & Associates.

Further Background

Food and supplement producers are legally allowed to make structure/function claims. These are claims that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” However, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. The science doesn’t matter to the FDA. Nor does freedom of speech, which is why we so desperately need the Free Speech About Science Act of 2011.

Now the FTC is saying that even structure/function claims cannot be made unless two random-controlled human clinical trials, or RCTs, are performed! And that’s two RCTs for each product, not each ingredient. Even one RCT is tremendously expensive, so to require two for each product before any health claim is made is a nearly impossible undertaking.

Our petition essentially asks the FTC to stop this new requirement immediately.  They must follow the formal rulemaking requirement before any policies of this nature are formulated. The FTC should also keep in mind that only the FDA can legally regulate health claims. By usurping the FDA’s regulatory authority, the FTC opens itself up for Pearson v. Shalala to be applied. This landmark legal precedent says that the FDA cannot impose prior restraints on free speech. Our petition argues that if the FTC imposes FDA-specific regulations, then it must also abide by the Pearson precedent. Otherwise we have a blatant regulatory end-run around a federal court decision.

Moreover, we believe that the FTC is violating the First Amendment not only in silencing structure/function claims, but in the legal actions it has taken against companies advertising their products, including POM Wonderful, Iovate, Nestle, and Kellogg, all of which involve new regulatory action by the FTC.

The FTC denies making any new requirements across the board, though the FTC has indeed been making such requirements on a company-by-company basis via Consent Decrees. But Consent Decrees, or any other system of premarket approval or similar degree of censorship, would be an unconstitutional restraint of truthful speech.

The result of such aggressive tactics by the FTC is that companies, particularly smaller companies, are fearful of FTC reprisal and expensive investigations. This may lead them away from making any claims, including truthful and legally allowed structure/function claims. This in turn leaves consumers in the dark. Consumers have few means of finding credible information about natural foods and supplements—which is essential if one is to follow a natural approach to health.

We expect to have to go to court. But we’d rather not, so we’re asking you to contact the FTC and ask the agency to grant our petition. Take action now!

We have a number of new state-level Action Alerts on vaccine-related legislation for you—some bills expand your freedoms, some restrict them, and one even wants to vaccinate your food!

Most states offer philosophical or religious exemptions from compulsory vaccination. In some states, religious exceptions include personal religious beliefs, whereas other states require the individual to be a member of a religion whose written texts explicitly prohibit invasive medical procedures. Even in states with exemptions, there are generally only two options: be vaccinated on the schedule recommended by CDC, or else get no vaccines at all. These laws do not allow for modified vaccine schedules or selectively vaccinating for some, but not other diseases.

Vaccine laws, including exemptions, are in constant flux—and it is important to keep an eye on them. The National Vaccine Information Center keeps a current list of the bills pending in the states.

A number of state legislatures—Connecticut, Kansas, Maine, New Jersey, and New York, for example—have introduced new bills that would preserve a parent or guardian’s right to refuse immunization for their child on philosophical or religious grounds. Some bills are allowing such exemptions, but are making the requirements stricter. We have a number of state Action Alerts which need your attention below.

In New York, there is a bill that would prohibit the sale of eggs unless they come from a salmonella-vaccinated chicken—even organic and direct-to-consumer farmers’ market eggs. This bill failed last session of the NY assembly but was recently reintroduced.

The bill was offered by two assemblymen from Manhattan after the salmonella outbreak last year from an Iowa CAFO—a Concentrated Animal Feedlot Operation, factory farming at its most inhumane and its unhealthiest. New York has not had an outbreak of salmonella linked to eggs produced in the state since the 1980s. A voluntary egg quality assurance program, managed by the New York State Department of Agriculture and Markets, governs nearly 90 percent of the eggs produced in New York.

This New York bill would set a terrible precedent. If passed, it could lead to ordinary food laws being taken over by Big Pharma and vaccine manufacturers, and we would lose all choice about our food. This bill needs to be stopped right here, and deserves the full light of publicity. We have an Action Alert below for New York citizens.

Our article “Vaccine Mania,” also in this issue, has much background information on the immunization question and the various issues at stake. We hope you’ll find it informative.

Your help is needed. These Action Alerts will help you share your thoughts with your local lawmakers about a number of bills currently being considered in state legislatures. If you are a citizen of any of the states listed below, please contact your state lawmakers immediately!

Connecticut

HB5043: To allow the parent or guardian of a child attending a day care facility to decide whether the child will be given a flu vaccination. (Remember that most flu shots still contain mercury.)

Connecticut Action Alert

Georgia

HB11: Freedom from Compulsory Pandemic Act—relating to emergency management, to repeal the authority of the governor to issue mandatory vaccination orders.

Georgia Action Alert

Kansas

HB2094: Vaccinations are currently mandatory for all children in childcare facilities. This bill allows parents or guardians the right to decline vaccination for their child based on reasons of conscience or personal belief.

Kansas Action Alert

Maine

LD 694: Would require healthcare providers to disclose the ingredients of the immunizing agent to the parent or guardian of a child prior to immunization, and would allow the parent or guardian to refuse the immunization based on religious or philosophical beliefs.

SP 287 and its companion bill LD 941: Would prohibit mandatory immunizations of any person.

Maine Action Alert

New Jersey

SB2625 and its companion bill A3836: Current law provides exemptions from mandatory immunizations for students based on religious beliefs; this bill amends the law and adds to the exemption the qualifier “of bona fide religious tenets.” This is an attempt to greatly narrow down the previously broader interpretation of the religious exemption for students. It will be interesting to find out what New Jersey legislators consider bona fide religious tenets.

A3746 and its companion bill S2659: Would restore powers to Public Health Council—which has no accountability to public or legislature. Therefore it could mandate vaccinations without legislative oversight.

A2450: Provides for exemption to mandatory immunizations on the grounds of a sincerely held or moral objection to the immunization.

New Jersey Action Alert

New York

A5912: Bill to vaccinate all egg-laying hens in New York State against salmonella.

New York Action Alert 1

A699: Bill to require HPV vaccine for all children born after 1/1/96. This is neither a safe nor a necessary vaccine.

A608: Bill to require meningococcal vaccination for 7th graders and college students.

S1331: Bill to add philosophical exemption to vaccination.

New York Action Alert 2

Oregon

HB 2635: Bars immunization against hepatitis B for children under 10 years of age unless the parent or guardian of the child has received information on the side effects and negative reactions that may result from the vaccine, and the parent or guardian of the child has consented in writing to the vaccination.

Oregon Action Alert

Texas

SB1107 and its companion bill HB1557: Mandatory bacterial meningitis vaccination of all first-time college students. Currently mandated for first-time students living in on-campus housing only; these bills make it mandatory for all entering college students, regardless of where they live.

Texas Action Alert

The vaccination question is a hotly debated topic, even in the natural health community. It doesn’t help when vaccine companies have blatant conflicts of interest and the studies supporting their safety may be fraudulent!

What we all can agree upon is the need to keep crony capitalism out of it, to keep information clear, unambiguous, and uncensored, and to allow people to make informed choices for themselves and their families. As we noted last year, there is an increasing tendency for immunization mandates to become a financial joint venture of the vaccine manufacturer and the government. The government is providing much of the funding manufacturers need to build facilities. So the government, which is supposed to regulate vaccine makers, becomes a full financial and operating partner with the companies they’re regulating! The government then turns around and orders us to be vaccinated or be ineligible for school—or in some cases go to jail!

As it stands now, the government gives patent protection and FDA approvals to pharmaceutical companies and thus creates medical monopolies. The government also exempts vaccine makers from legal liability. But when in addition the government invests in the business itself and partners with private companies, then adds the threat of jail for consumer non-compliance, we have a completely out-of-control situation.

Many parents are concerned that some vaccines are unsafe because they may contain harmful ingredients like mercury or aluminum. Others believe the overloading of a young immune system with so many vaccines at once causes genetic changes. Some generally support vaccinations but wish there were more scientific clarity.

What is incontrovertible is that the vaccine industry is controlled and manipulated by Big Pharma. Drug companies are often able to fast-track vaccines through the FDA approval process without proper controls. And in the tight circle of scientists who work on vaccines, conflicts of interest are commonplace. Rep. Dan Burton (R–IN) says that the Centers for Disease Control and Prevention “routinely allows scientists with blatant conflicts of interest to serve on intellectual advisory committees that make recommendations on new vaccines,” even though they have “interests in the products and companies for which they are supposed to be providing unbiased oversight.”

This cozy relationship of government with the drug companies may be why the CDC is now recommending a cocktail of over ten different vaccines—adding up to more than 35 doses—for children under the age of 6.

One of the hot-button issues is the MMR vaccine—for measles, mumps, and rubella—and possible links of the vaccine to autism. The Journal of Immunotoxicology last month published an article by Helen Ratajczak, a former senior scientist at a pharmaceutical firm. Ratajczak did what nobody else apparently has bothered to do: she reviewed the body of published science since autism was first described in 1943. Not just one theory suggested by research—such as the role of MMR shots, or the mercury preservative thimerosal—but all of them.

Ratajczak’s article states, in part, that “Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis [brain damage] following vaccination.” The article goes on to discuss many potential vaccine-related culprits, including the increasing number of vaccines given in a short period of time—with the body’s immune system being thrown out of balance.

Ratajczak also looks at a factor that hasn’t been widely discussed: human DNA contained in vaccines. Ratajczak reports that about the same time vaccine makers took mercury (thimerosal) out of most vaccines—with the exception of flu shots, which still widely contain thimerosal—they began making some vaccines using human tissue. Ratajczak says human tissue is currently used in 23 vaccines, notes that the increase in autism incidences corresponds to the introduction of human DNA to the MMR vaccine, and suggests the two could be linked. Ratajczak also says an additional increased spike in autism occurred in 1995 when chicken pox vaccine was grown in human fetal tissue.

The problem is not simply that physicians (and the media, and the government) are ignorant of the published research—it’s also that some of the research simply cannot be trusted. For example, many articles in the mainstream media bend over backwards to assure the public that the MMR vaccine is safe, most often pointing to a “definitive study” in Denmark proving that the vaccine did not cause autism. But earlier this month, Poul Thorsen, who administered the CDC grant money for that study, was indicted for fraud and money laundering, falsely claiming that labs had performed work on the study which had not in fact been done. If some of the study’s conclusions were derived from work that was not actually performed, the entire study could be fraudulent.

Last month, former ANH-USA board president Sherri Tenpenny, MD, wrote a scathing article on fraudulent medical research the world over, especially in highly respected medical journals, concluding that “What doctors consider to be ‘usual and customary’ may turn out to be misleading, exaggerated and chillingly, flat-out wrong. Physicians would be well served to take medical publications under advisement rather than believing that just because it has been published, it is accurate and infallible, as gospel engraved in stone.”

As we noted in our Position Paper on Vaccinations, we believe that no one—children, pregnant women, adults, the military, seniors—should be forced to be vaccinated. We believe that in order for individuals to make up their minds about vaccination, they need accurate and impartial information. And we believe that informed choice is the best way to protect the right to decide about vaccination. The vaccine industry is a billion-dollar market, but it has meager proof of its products’ efficacy or safety. Consumers are entitled to know exactly what is going into their bodies—its benefits and risks—and how safe and how effective that substance is. Above all, we have a right to government regulation that is not completely tarnished by crony capitalist deals.

Last week we reported on the botched language in the new Leahy bill, and how it was on a fast track. Last Thursday, unfortunately, the Senate passed the bill. But there’s still time to get the House of Representatives to listen to us! Take action now to ensure the House doesn’t introduce and pass a similar bill!

The Senate’s Food Safety Accountability Act of 2011 contains language that is open to interpretation. While intended to protect the public from food manufacturers who would harm the public with their negligence, the vague language may also be used by the FDA to attack innocent natural health food and dietary supplement producers.

A bill must, of course, be passed in both the Senate and the House, and often their versions of the same basic bill may be quite different from one another. This bill has not yet been introduced in the House, so we need to seize the opportunity and contact our representatives to tell them what needs to be fixed in the bill’s language before it is introduced, or else oppose the bill altogether. The fact that it passed in the Senate so easily shows just how much education is needed on this issue on Capitol Hill.

A House version of the The Food Safety Accountability Act of 2011 must address the vagueness in the language and carve out certain exemptions in the definition of misbranding and adulteration—or better yet, define them anew instead of referring to the extremely broad Food, Drug and Cosmetic Act.

We would prefer, of course, that a similar bill is not introduced in the House at all, because we can’t be certain that even a much better House bill won’t be amended by the Senate during the conference process. Please contact your representative immediately and ask him or her to fight this bill’s introduction, or work to ensure that its language doesn’t target the wrong people!

For more on the substance of the Senate bill, please see this.

Take action now!

We took ’em to court—and we won! A federal court has found the FDA’s stance against vitamin health claims to be unconstitutional!

On April 13, the United States District Court for the District of Columbia held that the FDA’s denial of two health claims—which dealt with the ability of antioxidant vitamins to reduce the risk of cancer—was unconstitutional under the First Amendment.

ANH-USA, together with Durk Pearson and Sandy Shaw, sued the FDA for censoring antioxidant vitamin–cancer risk reduction claims after the agency denied multiple claims about the effectiveness of selenium and vitamins C and E in reducing cancer risk, and weakened and complicated other claims to the vanishing point. The plaintiffs were represented by Emord & Associates, a prominent constitutional law firm. You may recall that last October, Jonathan Emord successfully represented us against the FDA on the selenium claim. That win means that selenium supplements are now allowed to claim that “selenium may reduce the risk” of prostate, colon, bladder, or thyroid cancer.

“Qualified health claims” characterize the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. They are permitted in relation to foods and supplements—a precedent established by the landmark decision of Pearson v. Shalala. Qualified health claims are a critical means toward communicating important health benefits of natural foods and dietary supplements otherwise forbidden by the FDA. Unfortunately, the FDA has consistently limited the information available to consumers about the real health benefits of food and supplements and routinely rejects all qualified health claims. This should come as no surprise, given that the FDA has worked shoulder-to-shoulder with the European Commission for well over a decade agreeing on ridiculously onerous guidelines for scientific substantiation of health claims internationally in the Codex Alimentarius. These requirements have been carbon-copied into EU law and some time next year will ban thousands of claims that have informed European citizens for years. We must stop trans-Atlantic European regulatory creep at all costs, and our biggest defense remains our precious First Amendment.

Although the District Court for the District of Columbia upheld FDA censorship of six other claims, the court ruled that the FDA violated the First Amendment when it prohibited two vitamin health claims and stated that it would allow them in a form reworded by the agency:

Vitamin C / gastric cancer claim: “Vitamin C may reduce the risk of gastric cancer.”

• FDA had prohibited the claim, stating that it would only allow the following language to be used: “One weak study and one study with inconsistent results suggest that vitamin C supplements may reduce the risk of gastric cancer. Based on these studies, FDA concludes that it is highly uncertain that vitamin C supplements reduce the risk of gastric cancer.”

Vitamin E / bladder cancer claim: “Vitamin E may reduce the risk of bladder cancer.”

• FDA had prohibited the claim, stating that it would only allow the following language to be used: “One small study suggests that vitamin E supplements may reduce the risk of bladder cancer. However, two small studies showed no reduction of risk. Based on these studies, FDA concludes that it is highly unlikely that vitamin E supplements reduce the risk of bladder cancer.”

The court held FDA’s rewording of the two claims unconstitutional under the First Amendment. FDA “has replaced plaintiffs’ claims entirely,” explained the court, and the qualifying the claim so completely “effectively negates any relationship between cancer risk and vitamin intake. The FDA’s rewording . . . makes it difficult to tell what the original health claims are and appears to disavow the FDA’s own conclusions that those claims are supported by credible evidence.”

The court reaffirmed Pearson v. Shalala against the FDA’s objections, holding that “where the evidence supporting a claim is inconclusive, the First Amendment permits the claim to be made; the FDA cannot require a disclaimer that simply swallows the claim.” The FDA has been ordered to revise its claim qualifications consistent with the court’s decision.

In a separate case, ANH-USA sued the FDA over good manufacturing practices (GMPs), operating requirements for dietary supplement manufacturers. Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling “adulterated” products, with the same jail sentence. We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.

The judge in our GMP case, unfortunately, gave deference to FDA and its authority to regulate. This is another reason why the language in the Leahy bill is so troubling: it raises the penalty for “adulterating” a product to ten years in jail.

While we continue to make strides in the courtroom, the process is time-intensive, expensive, and—let’s face it—ridiculous. We should not have to sue the FDA to obtain the right to communicate every important piece of health-related information to consumers.

We need to pass the Free Speech about Science Act, which was introduced in Congress earlier this month. The Act would allow for the communication of legitimate scientific information to a health-conscious public more easily. If you haven’t already done so, please contact your senators and representatives and tell them how important this bill is!

The Integrative Medicine Consortium—a collaborating group of national physician organizations dedicated to making integrative medicine the standard of care—just held its first national medical conference. See photos below.

The IMC’s organizations have dedicated themselves to increasing awareness of the importance of the physical, mental, emotional, environmental, social, and spiritual aspects of health and wellness.

The name iMosaic stands for Integrative Medicine Offering Science-based Alternatives in Collaboration. The conference was put together by the American Academy of Environmental Medicine (AAEM), American College for Advancement in Medicine (ACAM), American Holistic Medical Association (AHMA), and the International College of Integrative Medicine (ICIM).

ANH-USA was joined by our European colleagues from the Alliance for Natural Health International. Gretchen DuBeau, our executive and legal director, and Dr. Robert Verkerk, executive and scientific director of ANH-Int’l, gave an important panel discussion on international threats to natural health and dietary supplements.

ANH-USA also hosted a very popular cocktail hour and awards ceremony at the iMosaic conference. We handed out Natural Health Advocate Awards to Dr. Gerald Natzke, Dr. Bill Manahan, Dr. Jeanne Drisko, and Dr. Robban Sica for their outstanding contributions to the natural health freedom movement. We are so very grateful for their efforts and look forward to working with all of them to protect access to natural health options.

ANH-USA Award Ceremony and Cocktail Hour
Natural Health Advocate Award Winner Gerald Natzke, MD, board certified allergist, past president of the American Academy of Environmental Medicine, Integrative Medicine Consortium  co-chair, and integrative practitioner in Michigan	Natural Health Advocate Award Winner Bill Manahan, MD, author, founding member of the American Board of Integrative and Holistic Medicine, and teacher and clinician at the University of Minnesota—actively working to transform America’s healthcare system
Natural Health Advocate Award Winner Jeanne Drisko, MD, director of the Program in Integrative Medicine at the University of Kansas Medical Center, member of Kansas Cancer Research Institute, who served on the Institute of Medicine Committee on Alternative and Complimentary Medicine, and former president of American College for the Advancement in Medicine	Natural Health Advocate Award Winner Robban Sica, MD, integrative practitioner in Connecticut for over 20 years, who sits on the board of directors on the American Board of Clinical Metal Toxicology, the International Board of Advanced Longevity Medicine, and is the president of the International College of Integrative Medicine
Darrell Rogers, ANH-USA communications director, moonlighting as the emcee for the night	Nandini Gopinadh, ANH-USA legislative and policy associate (L), growing our grassroots support by signing up new practitioner members
Guest signing up to become ANH-USA members	Rubbing shoulders with Gretchen DuBeau, ANH-USA executive and legal director
The attorneys defending integrative medical practitioners: Alan Dumoff, Richard Jaffe, and Jacques Simon	Darrell Rogers, ANH-USA communications director, with Robert Verkerk, executive and scientific director of ANH-International, Jeffrey Sternberg, and Richard Linchitz, MD, co-chair of the Integrative Medicine Consortium.
Alan Dumoff and Richard Jaffe trading legal tips	ANH-International colleagues Robert Verkerk, executive and scientific director (L) and Meleni Aldridge, executive coordinator (R), chatting with Paul Buffel
Ty Vincent, MD, Lisa Lundy, Trevor Cates, ND, Kenneth A. Bock, MD, and Richard Jaffe	Jacques Simon
Guests at the award ceremony and cocktail hour

Brek says:

I just want to say that I love you…what you at ANH are doing, what you are all about, the whole enchilada. I really mean it. When you people showed up, it was like an answer to a prayer. Finally, a truly commonsense and effective mechanism for citizens to respond to the looming bureaucratic overkill in Washington that has been threatening health freedom at every opportunity, especially in recent decades….Thank you for continuing to get this done right with eloquent and passionate advocacy for the truth and for facilitating an effective grassroots response! You are to be commended for a magnificent job and for having the integrity and foresight to understand how to do it!

Thank you, Brek—and thanks to and all of you. It is not hyperbole to say that you are our lifeblood. We do the work we do for—and through—you, and together we can move mountains, as Camille points out:

Camille says:

Between Big Pharma and Big Farma, us little peons trying to eat right and supplement the vitamins/minerals that are missing from our depleted soils don’t stand a chance unless we unite!

Amen to that!

Gina writes:

How would you suggest someone take action in their own state [to oppose genetically engineered foods]? I would love to know how these states were successful in establishing these bills! Would it be different than getting other bills established and passed?

These bills exist because activists just like you asked the very same questions. There are a number of different ways to have bills introduced in your state. The first thing to do is find out if there are GE food bills pending in your state, and determine if there are any folks already working on introducing them. You can do that a few different ways.

You can go to your state government’s legislative branch webpage and search for bills containing the phrases “genetically modified” or “genetically engineered.”

If your state does not have pending GE legislation and there’s no one working on the issue, take a look at existing bills around the country. Select a bill such as Labeling Genetically Engineered Food, and contact your local state representative and ask them if they be interested in introducing legislation relating to GE foods. If that door closes, open new ones! Ask your representative if they know of another member who would be interested, or perhaps contact the legislature’s environmental committee and seek feedback about GE food interests there.

If that fails, it’s time for people power! Collect signatures and send emails, and contact your representatives letting them know their constituents want them to act on the GE food issue. You can also start the ball rolling in local media, by asking your local news organizations to cover the story and bring attention to the dangers of genetically engineered foods.

Please keep us up to date on your efforts!

Increasingly, state governments are determining what treatments a child can and cannot have—regardless of parents’ wishes. Three shocking stories prove the point.

In April 2003, Barbara Jensen took her son Parker, then twelve years old, to an oral surgeon to have a small growth removed from his tongue. The growth was diagnosed as Ewing’s sarcoma, a rare and aggressive form of cancer. The medical center at the University of Utah recommended surgery and chemotherapy. The chemotherapy was very aggressive and ran the risk of making Parker sterile and stunting his growth. The parents refused treatment even though doctors said chemotherapy was imperative, and instead sought second and third opinions (they believed he had been misdiagnosed) and considered alternative therapies.

The doctor who provided the diagnosis went to the state Division of Child and Family Services (DCFS) and filed a medical neglect complaint against the Jensens in juvenile court, obtained a court order requiring chemotherapy, and a judge ordered the state of Utah to take custody of the boy.

The Jensens violated the order by moving to Idaho, whereupon they were charged with kidnaping and custodial interference. Parker’s father, Daren Jensen, was arrested, spent four nights in jail, and lost his job. Under political pressure the DCFS dismissed the petition, the criminal charges were downgraded to custodial interference, the parents were given one year of probation, and the record was finally expunged.

However, the deal that the Jensens struck also stipulated that they would take Parker to an oncologist of their choice in Idaho, and follow the doctor’s advice. On September 26, 2003, the Jensens announced that no cancer had been found, though a report later that week contradicted that information, claiming that chemo was being called for.

Parker never did have chemotherapy, the state eventually backed down under media scrutiny, and the 2004 and 2005 sessions of Utah’s state assembly were rife with “Parker Jensen laws” to protect the rights of parents.

In 2005, the Jensens sued University of Utah doctors and DCFS workers, arguing that Article 1 of the Utah Constitution includes “the fundamental right to make decisions regarding one’s family, including health matters.” The case was eventually heard by the Utah Supreme Court. Its March 29 ruling found that Parker Jensen and his parents have no legal claim against the state, its employees, or the doctors who turned him into DCFS.

Happily, Parker is alive and well at 20 years old. It is very possible he never had cancer. The conventional medical paradigm is quick to diagnose and prescribe aggressive, toxic treatments such as chemotherapy and surgery—despite the fact that it is not always effective and often dangerous. We shouldn’t penalize patients simply for looking for alternative treatments.

The police state is also a major force in Nevada. In March, Lincoln and Cecilia Rogers’s baby, Lilia, was born with mild jaundice. The hospital wanted to keep the child in the Neonatal ICU for treatment. The couple wanted to take the baby home and explore natural treatments, so they got a second opinion from a pediatrician at the hospital.

The pediatrician said they could take the baby home if they signed a medical release form. But a nurse called Child Protective Services and the police, because the parents did not agree to the hospital-recommended treatment: placing the child in isolation to undergo phototherapy, and being fed artificially with formula—despite the fact that the American Academy of Pediatrics recommends that jaundiced newborns continue to breastfeed regularly, as frequent feedings help remove bilirubin in the body. A police officer was sent to her room just hours after giving birth, and CPS told them “they were going to take the baby and put her in that incubator no matter what.”

About 65 parents, midwives, and birth professionals staged a protest outside the hospital on March 30. Baby Lilia is healthy and at home with her parents.

Not only were the parents not given the right to explore alternative options—like breastfeeding!—but the action is against Nevada’s Child Welfare Policy. It says that a child is not abused or neglected if a “parent or guardian, in good faith, selects and depends upon non-medical remedial treatment for such child, if such treatment is recognized and permitted under the laws of this State in lieu of medical treatment.…” Child protection laws are meant to protect against abuse and neglect—not as a proxy for forcing conventional treatments.

The police state exists in Europe, too. Two vegan parents in a small village 90 miles north of Paris called an ambulance because their 11-month-old child was dying. The ambulance arrived too late.

After learning that the couple were vegans, doctors ordered an autopsy, which revealed that the baby was deficient in vitamins A and B12, which experts say increases a child’s sensitivity to infection. The deficiency was assumed to be linked to the mother’s vegan diet.

As Mike Adams noted, “If the ambulance had shown up and found a dead baby in a family whose cupboards were stuffed full of junk food and fast food [it] would not have seemed suspicious at all….It is only the fact that the parents were vegans that the police were called.”

That couple is now on trial, charged with “neglect or food deprivation followed by death,” and are facing up to 30 years in prison.

As tragic as this story is, it should be noted that governments are quick to make examples of people who pursue alternative (in this case, vegan) lifestyles, yet turn a blind eye to the numerous health problems caused by artificial sweeteners and junk food, all backed by big business.

It should also be noted that it is entirely possible to have a healthy vegan lifestyle by carefully planning a diet rich in the necessary vitamins and supported with nutritional supplements. Of course, this may be easier said than done, with our health system not making access to this type of information very easy and with the European Union clamping down on traditional treatments and products.

We have news about intravenous vitamin C, the much-contested IOM vitamin D report, new lawsuits against Monsanto, and the outcry against KV Pharmaceutical.

Intravenous vitamin C

The FDA has responded to our campaign over intravenous vitamin C. The campaign was launched after they notified a pharmacy, McGuff Pharmaceuticals, that it will no longer be allowed to manufacture or distribute injectable vitamin C—despite its remarkable power to heal conditions that conventional medicine can’t touch.

After our initial article, we were heavily criticized by naysayers who claimed that FDA wasn’t going after IV C—that they were only going after McGuff for good manufacturing practices (GMP) violations. Our position was that despite the GMP violations, the FDA was also banning IV C, which FDA confirmed to us at that time. And now, a letter from the FDA further confirms it was indeed both—and states categorically that IV C is considered an “unapproved drug.”

Because of our grassroots activists—that is, you—the FDA came out of the shadows and provided official confirmation on a policy that they usually determine behind closed doors. According to statutory language in the Food, Drug, and Cosmetic Act, the oral form of vitamin C is a dietary supplement, but the same vitamin C in its intravenous solution form is a drug. This is especially vexing, since vitamin C, being a natural substance, cannot be patented, which means no one will make bundles of money from it, which means no one will pay the billions of dollars to go through the drug approval process required by the FDA.

ANH-USA has met with Congressional leaders on this issue, and we are working to convene meetings with National Cancer Institute, a division of the NIH, to conduct the studies necessary to approve intravenous vitamin C.

The flawed vitamin D report produces even more flawed statistics

According to new data released by the CDC, only 8% of Americans are vitamin D deficient. This is not surprising, since they are using the levels deemed “sufficient” by the Institute of Medicine in their flawed report from last November—which, as we pointed out last November, flies in the face of overwhelming scientific evidence.

Part of the reason IOM recommended such low levels is because they based their findings solely on the bare minimum amount required to prevent bone disease, ignoring all the other benefits of vitamin D, and failing to look at levels necessary for optimal health—bone and otherwise. And now they are on the defensive, thanks to public outcry generated in no small part by our grassroots activists (that’s you, remember?). Previously they would have just kept quiet, but after so much furor and bad press, they were forced to publicly defend their position in the New England Journal of Medicine.

US organic farmers sue Monsanto

On behalf of 22 agricultural organizations, 12 seed businesses, and 26 farms, the Public Patent Foundation (PubPat), filed suit against Monsanto’s patents on genetically modified seeds. Organic farmers are asking to be protected against any lawsuits Monsanto might file against them in case their crops are accidentally contaminated by Monsanto’s genetically modified plants. They fear Monsanto will sue them for patent infringement if Monsanto’s transgenic seed should land on their property through windblown cross-pollination.

As PubPat’s executive director put it, “It seems quite perverse that an organic farmer contaminated by transgenic seed could be accused of patent infringement, but Monsanto has made such accusations before and is notorious for having sued hundreds of farmers for patent infringement, so we had to act to protect the interests of our clients.”

As we’ve reported previously, cross-pollination is inevitable without careful controls—which Monsanto has fought against. The company has also fought against action at the state level, which is why we are asking you to support your state’s bills on genetically engineered foods.

Now that the US Department of Agriculture has given farmers the go-ahead to resume planting Monsanto’s Roundup Ready sugarbeets (even though the USDA has not as yet completed the court-ordered environmental impact statement), the board of directors of American Crystal Sugar Company has decided to use the RR sugarbeet seed—despite the fact that we still don’t know the extent of the threat posed by the seed, nor its fuzzy legal status. This is one more example of big business in league together—to the detriment of our health.

KV Pharmaceutical faces the backlash

We now have official confirmation from the FDA that, as we reported last week, the agency will not prevent compounding pharmacies from continuing to provide 17P—which is exactly what you (our grassroots activists) asked them for.

In addition, KV Pharmaceutical has just lowered the list price on their high-risk pregnancy drug Makena to $690 per injection—nearly 55% less than the $1,500 they had originally decided to sell it for. However, this is still a far cry from the $10 per treatment which 17P sells for!

KV Pharmaceutical also plans to offer supplemental rebates, which will result in “a substantially reduced cost per injection” for state Medicaid agencies, and will expand its patient assistance program by removing income caps to qualify for financial assistance. They claim that 85 percent of patients will pay $20 or less per injection. (Only a 100% increase in the price of 17P rather than the previous 14,900%!)

The Washington Post reports that several members of Congress plan to investigate the drug’s pricing. “While I am glad the company is taking a hard look at their prices, the proposed price reduction doesn’t go far enough to protect public health,” Rep. Louise M. Slaughter (D-N.Y.) said.

You may recall our report that the March of Dimes, which received funding from KV Pharmaceutical and supported the company’s New Drug Application, sent a letter to KV expressing their serious concern about the price of Makena.” Apparently the public pressure has grown too great, and March of Dimes has now severed ties with KV entirely, asking that KV “immediately cease and desist the use, distribution or publication of or reference to the March of Dimes name and/or logo on any and all materials or communications in connection with KV Pharmaceuticals, Ther-Rx and Makena.”

We’ve also learned that, KV Pharmaceutical’s stock is down, and in its recent quarterly SEC filing, the company noted their “tough road ahead.”

Now that’s what grassroots activism is all about!

The North Carolina Senate is likely voting on a bill this evening which will make the unlicensed and unregistered practice of “medicine or surgery” a felony. The problem is that “medicine or surgery” is unnecessarily vague, and may include some alternative health practices. Please take action immediately!

The bill, S.31 (“To Clarify the Penalty for Unauthorized Practice of Medicine”), would increase penalties for unlicensed medicine or surgery from a misdemeanor to a felony. We looked into North Carolina law to find out more about who would and would not be affected by this bill if it is passed into law.

NC Code § 90-18 (c) states that “The following shall not constitute practicing medicine or surgery” (and therefore would not be affected by this proposed bill). They include, among a number of other practices:

• Domestic or family remedies
• Licensed midwifery
• Licensed chiropractic
• Dietetics or nutritionist practice
• Licensed acupuncture

While these specific exceptions are very good, our concern is that the North Carolina code’s definition of “medicine or surgery” is too broad, especially if the penalty will be increased to a felony. We strongly urge the North Carolina General Assembly to postpone the vote on this bill until they hold additional conversations or hearings clearly identifying who exactly would and would not be affected by this bill if it is passed into law. Would homeopaths be included, for example? What about herbalists?

If you are  a citizen of North Carolina, please contact your senators and representative immediately and ask them to postpone the vote. The vote is scheduled for Tuesday evening!

The Free Speech about Science Act of 2011 is about to be introduced in Congress. This is an exciting and hugely important bill that you’ll want to support with zeal.

Current FDA regulations prohibit dietary supplement manufacturers and food producers from referring to any scientific studies on the health benefits of a food or natural substance. FDA says that such a reference changes the regulatory category of said food and—as absurd as it sounds—actually makes it an unapproved drug. In the FDA’s view, even providing a link on a website to a study converts a healthy fruit or nut into an unapproved new drug—a bizarre result that effectively censors scientific information and greatly restricts consumer access to scientific research.

As more and more Americans take charge of their personal health, they need accurate, reliable information more than ever. We fervently believe that consumers have a right to access that information, particularly the scientific studies that discuss a food’s health benefits.

The Free Speech about Science (FSAS) Act, which our sources on Capitol Hill tell us could be introduced at any moment, would change FDA regulations so that legitimate, peer-reviewed scientific studies can be referenced without changing the food’s regulatory category to an unapproved drug. This will protect access to scientific information, and will protect your right to know about the healthy benefits of food and food supplements. The bill amends the appropriate sections of current law to allow the flow of legitimate scientific and educational information while still giving FDA and FTC the right to take action against misleading information and against false and unsubstantiated claims.

As we note in our FSAS White Paper, research suggests that changes in diet could reduce both heart disease and cancer by as much as 90%. This is not just a question of eating more fruits and vegetables, although that alone might increase lifespan by an estimated average of 14 years. It is also about specific nutrients. In many cases, there is strong scientific evidence that a specific nutrient may be used to prevent, moderate, reverse, or in therapeutic doses cure disease. Unfortunately the American people do not hear about this research. Food producers would like to tell them about it. But FDA rules prevent it.

Take cherries. Research from Harvard published in the Annals of Internal Medicine suggested that cherries could reduce heart attack risk. A large number of other studies published in prestigious journals have indicated that cherries could do that and also reduce pain and cancer. But the FDA says that cherry producers, sellers, and food manufacturers may not talk about this research: In 2006, the FDA demanded that 29 companies cease making claims about the health benefits of cherries, and draconian requirements were imposed on the growers.

FSAS was originally introduced last year in the House by Rep. Jason Chaffetz (R-UT3). But that bill died in committee at the end of the previous Congress with no action being taken on it. This year we have a new committee chairman and prospects are much better.

The government should not be gatekeeper of scientific information. And the last time we looked, the First Amendment prohibits the making of any law infringing on the freedom of speech. When the information being censored is true, scientifically sound, and will only make people healthier, it is particularly galling. Our White Paper says it best:

The FDA’s own mission statement says that the Agency “is responsible for…helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” Given this mission, it is perverse to allow pharmaceutical companies to spend so many billions on consumer advertising but not to allow food producers to tell the public about legitimate and revolutionary food research. This is all the more true given our heritage of free speech and free science, the opportunity to save or prolong million of American lives, and the need to use every resource at our command to rein in surging and economically destructive healthcare costs.

As soon the Free Speech about Science Act of 2011 is introduced, we will be issuing an Action Alert and asking you to contact your congressional representative immediately and ask him or her to co-sponsor and support this extremely important bill. We’ll be emailing our newsletter subscribers the moment it happens. If you’re not already a subscriber, just click here to sign up. It’s free, and you’ll be among the first to hear the news.

According to The Washington Post, last Friday the FDA—just days after you started contacting them in protest over their pregnancy drug Makena—has reversed their stance. Keep up the pressure!