California DEFEATED!

Colorado

Hawaii

Indiana - DEFEATED!

New Jersey

New York

Virginia - DELAYED UNTIL 2013

West Virginia

Our Action Alert is simple: Ask your senator or representative to make a one-minute floor speech opposing the FDA’s plan to sweep many supplements off the shelf and make the ones that survive much more expensive. Please help!

Madam Speaker, I rise today to express my concern over another example of rampant government regulation.

For seventeen years, the Food and Drug Administration has sought to ignore congressional intent and create a vast new regulatory regime for dietary supplements. Millions of Americans, including many of my constituents and my family, rely on dietary supplements as part of their everyday health maintenance routine. Moreover, they play an important role in ensuring that people take individual responsibility for preventative health care. We all can agree that the FDA should not limit Americans’ access to dietary supplements....

Last week, the comment period on the FDA’s draft guidance closed. Now that they’ve heard from the public, and now that I’m sure they’ve heard from countless Americans who share my concern, I urge them to go back to the drawing board and ensure that they do not limit Americans’ access to dietary supplements.

If you are a resident of Illinois, please take action here:

If you are a resident of Iowa, please take action here:

If you are a resident of Utah, please take action here:

If you are a resident of any other state, please take action here:

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

1. Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)
2. The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

Congress wants to limit your access to research—even though your tax dollars paid for it. If this bill passes, you’ll learn only what mainstream medicine wishes you to know. Action Alert!

But that’s just the problem: consumers, integrative doctors, and small businesses might not have the funds to access all these scientific journals—which means your access to the science behind natural products will be limited to what mainstream medicine may wish you to know.

• First, help us gain co-sponsors for the Free Speech about Science Act (FSAS). This landmark legislation enables the natural health products community to share peer-reviewed scientific findings about natural health products with the public. The problem, of course, is that if it becomes more difficult for supplement companies and consumers to access the scientific studies themselves, the entire point of FSAS is effectively undermined.
• The second step is to ask Congress to defeat this new Research Works Act. Please send your message today and explain why limiting access to the results of important studies—which your tax dollars have already paid for—is such a terrible idea. Take action immediately!

Statins are taken by one in four Americans over the age of 45, even though diet can fix high cholesterol quicker and more safely. Here’s new evidence of the drugs’ dangers.

• Weaken the immune system and make it difficult to fight off bacterial infections, and increase the production of cytokines, which trigger and sustain inflammation.
• Make some patients unable to concentrate or remember words, and is linked to muscle and neurological problems, including Lou Gehrig’s Disease.
• Have documented side effects which include nerve damage, muscle damage, liver enzyme derangement, and in some cases even kidney failure, not to mention, tendon problems, anemia, acidosis, cataracts, and sexual dysfunction.

The Food and Drug Administration This agency has significant authority to regulate the dietary supplement industry, including (but not limited to) the authority to:

• Stop a company from selling any dietary supplement that is unsanitary or unsafe.
• Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling
• Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury"

• Challenge and stop advertising that is not sufficiently substantiated
• Negotiate a consent order for a company to change or fix its promotional marketing or advertising practices
• Seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders

The law gives the Food and Drug Administration  (FDA) authority to require nutrition labeling of most foods regulated by the Agency; and to require that all nutrient content claims and health claims meet FDA regulations

Creates a structure for regulation of dietary supplements by making dietary supplements a new category of regulation within the framework of food and apart from drugs, that included labeling requirements, safety provisions, good manufacturing practices, also created the Office of Dietary Supplements at NIH.

Requires registration of facilities with FDA and record-keeping regulations extend to those that transport, distribute, receive, or import foods and dietary supplements.

Requires a manufacturer, packer, or distributor whose name appears on the label of a dietary supplement—known as the “responsible person”—to report a serious adverse event to FDA within 15 days of receipt of the information

Prohibits the addition of drugs or biologics to food and to authorize the creation of a “reportable food registry” to collect information about articles of food that may pose serious health risks.

FDA also regulates dietary supplements under FSMA, a comprehensive food safety statute enacted in 2011.  Nearly all the provisions of the FSMA apply to dietary supplements. ]]> http://www.anh-usa.org/dietary-supplement-regulation-facts/feed/ 5 http://www.anh-usa.org/new-regulations-threaten-insurance-for-cam-patients/ http://www.anh-usa.org/new-regulations-threaten-insurance-for-cam-patients/#commentshttp://www.anh-usa.org/new_site/images/default_thumb.jpg Tue, 10 Jan 2012 20:00:31 +0000 ANH-USA http://www.anh-usa.org/?p=8313 There are many questions about how the healthcare act will actually work, but complex regs just released seem likely to doom the very programs that help us pay for our integrative medical treatments. New Action Alert! An important provision of President Obama’s Patient Protection and Affordable Care Act (PPACA) requires insurance companies to use at least 80% of premium dollars (85% for large employer plans) on healthcare expenses and quality improvement, rather than on sales, overhead, and profits. If they don’t, the insurance companies will be required to provide a rebate to their customers starting in 2012. This requirement is called the Medical Loss Ratio, or MLR. The government estimates that up to 9 million Americans could be eligible for rebates starting in 2012, worth up to $1.4 billion—which is intended to put pressure on the insurance companies to keep their administrative and sales costs as low as possible. The Department of Health and Human Services (HHS) recently issued its final standards on how to rebate money from insurance carriers that fail to reach the MLR standards. In essence, the new rules of how MLR is computed discriminate against health plans with higher deductibles. Particularly hard hit will be the Health Savings Accounts (HSAs) that help so many of us pay for complementary and alternative medical (CAM) treatments not covered by regular insurance. A bit of background: The advantage of HSAs for those of us relying on integrative medicine is that we control how the HSA money is used. We don’t need insurance company approval. So we can use that money to pay an integrative doctor whose services would not be reimbursable under a conventional insurance policy. We can then add to the HSA a high-deductible (low-cost) conventional medical policy to cover us in case we need those services—for example, if we are injured in an auto accident. If high-deductible plans are eliminated, then our only option is to combine an HSA with a much more expensive conventional policy. That will make integrative care completely unaffordable for many. It will also lead to less demand for HSAs. Before long, they would probably disappear. If HSAs disappear, direct consumer control over healthcare would suffer yet another blow. As many analysts have suggested, the fact that consumers do not directly buy medical services explains much of what is wrong with medicine today. With this background, let’s now return to the new regulations and see why they are a threat to high deductible medical policies and thus to HSAs. The problem is that under the new regulation, any payment for a healthcare service that an individual or family makes, either directly or through an HSA—that is, any payment that’s part of the deductible—doesn’t count toward the requirement that your medical insurer must spend 80 to 85% of all insurance premiums on medical treatments. Only payments for healthcare services that are made by insurers count, not payments by individuals or through HSAs. As with many government regulations, the implications of this may not be readily apparent. Here’s a helpful illustration:

• Let’s say I pay $5,000 for in premium insurance policy which has no deductible. I have $4,000 in medical expenses, which the health plan pays. Because the insurer’s payment comes to 80% of my premium, my health plan is in compliance.
• However, let’s say I pay $4,000 in premium for a policy with a $1,000 deductible, and I still have $4,000 in medical expenses. I pay the first $1,000 directly to meet my deductible, and the health plan pays the remaining $3,000. That’s only 75% of my $4,000 premium, so the plan is not in compliance with the new MLR regulations, and the insurance company would have to give me a rebate, even though I spent $5,000 out of pocket and received $4,000 in medical care in both scenarios.

In light of this research, Dr. Wright suggested that ANH-USA launch a new campaign to encourage not only our readers but everyone to donate blood regularly. This is a great idea. Let’s all do it. We’ll live longer, and we may save someone else’s life!

Donate blood! Help yourself, and help another!]]> http://www.anh-usa.org/reduce-your-heart-risk/feed/ 17 http://www.anh-usa.org/american-dietetic-association-monopoly/ http://www.anh-usa.org/american-dietetic-association-monopoly/#commentshttp://www.anh-usa.org/new_site/images/default_thumb.jpg Tue, 03 Jan 2012 22:56:22 +0000 ANH-USA http://www.anh-usa.org/?p=7795 New bills have been introduced in a number of states that will give the ADA a monopoly over the practice of nutritional therapy—these are the people in charge of the wonderful hospital food. Please take action in your state to stop this power grab and ensure consumer choice!The American Dietetic Association (ADA) has sponsored legislation in over 40 states. These bills 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 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.In some states, individuals are even prohibited from using the words “nutritionist” and “nutritional care.” Such legislation impedes an individual’s right to access highly qualified nutritional therapists of their choice, and prohibits hundreds of qualified practitioners from providing nutritional therapy.Nutritionists and dietitians differ in important ways. In general, nutritionists are health practitioners with comprehensive knowledge of how nutrition impacts the whole body focusing on medical nutrition therapy, metabolism and biochemistry, and work primarily in private practice settings conducting one-on-one nutrition counseling. Nutritionists practice an integrative approach to medicine and concentrate on prevention and treatment of chronic disease. Dietitians, in general, are experts in what passes for nutrition science today, much of it often woefully out of date, with training focusing on institutional diets and food service management—developing diets for hospital patients, school food service programs, and nursing homes. Dietitians can provide individualized counseling on diet and disease and there can be an overlap in the type of work each profession practices.CaliforniaRead our bill analysis HERE The California Legislature is currently considering a bill that would create a new Dieticians Bureau and create and an advisory committee made up of dietitians. Under this bill nutritionists are forced to become licensed as dietitians in order to practice, regardless of whether they already have a Masters degree or a PHd. This bill would effectively eliminate an entire profession and removes all competition in the field of nutrition services. California residents please take action now!New JerseyNJ Assembly bill AB1987 and the senate version in the NJ Senate, S809, is the Dietitian/Nutritionist Licensing Act. This bill 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.This is not the first time we’ve worked in New Jersey on this issue—we were able to kill two different bills last session.New Jersey residents please take action now!New YorkA.5666 and its identical companion bill in the NY Senate, S.3556, provides for the licensure of dietitians and nutritionists. This proposed bill lumps dieticians and nutritionists together under one title, “Licensed Dietitian/Nutritionist” or “LDN” rather than providing separate licensing for each.The bill creates a joint board, appointing four members of the ADA and three representing nutritional associations. It does not identify the required exam—but it directs the board to do so. We have run into this problem in other states, where the board, heavy with ADA reps, refuses any but the ADA exam. Note further that this is a title provision, meaning that they aren’t preventing the practice of nutrition (subject to these requirements), but they are limiting the title by which one may advertise! And their certification requirements are standard-issue ADA: a BA, 900 hours supervision, etc.New York currently recognizes credentialing agencies beyond the ADA—in particular the Certification Board for Nutrition Specialists (CBNS), which is specifically designed for nutritionists. This would change once the ADA-majority board takes its first vote. Any new legislation must keep nutritionists separate from dieticians (who will immediately take control of the licensing process), and must ensure the same protections.New York residents please take action now! ]]> http://www.anh-usa.org/american-dietetic-association-monopoly/feed/ 70 http://www.anh-usa.org/a-look-back/ http://www.anh-usa.org/a-look-back/#commentshttp://www.anh-usa.org/new_site/images/default_thumb.jpg Tue, 03 Jan 2012 22:14:58 +0000 ANH-USA http://www.anh-usa.org/?p=8303 Warning: strpos() [function.strpos]: Offset not contained in string. in /usr/local/www/wp-includes/feed-rss2.php on line 58
...]]> And the future looks bright thanks to all your support.In the early 1990s, a small group of practitioners, MDs, and DOs who used nutritional and other complementary therapies in their practices met to share their concerns. Medical freedom was being threatened by the FDA, by powerful allopathic medical organizations like the AMA, by insurance companies, and by state medical boards around the country. Good doctors were losing their licenses or being driven into bankruptcy simply because they used an unconventional, holistic approach to preventing disease and optimizing health.Advancements in medicine were being stymied because good practitioners were afraid of censure. Americans had no access to some of the most cutting-edge medical therapies and technologies available in other countries, while medical costs were spiraling out of control, spurred on by the explosion in pharmaceutical, surgical, and chemotherapy treatments, many of them based on doubtful science and not even effective, despite their high cost.In 1992, this small group began advocating for holistic health practitioners and consumers on Capitol Hill, in state legislatures, in the courts, and with the media. We called ourselves the American Preventive Medical Association (APMA) to reflect our belief that truly preventive medicine focuses on maintaining optimal health with healthy food, key nutraceuticals and dietary supplements, exercise, and complementary medical therapies.It was a critical time: a coalition of health and industry organizations were mobilizing the largest national grassroots effort ever seen in our country. Working with a broad coalition of allies, we were able to persuade Congress to pass the Dietary Supplement Health Education Act (DSHEA) of 1994—a major reform of the food and drug laws regulating supplements. It specifically prohibited the FDA from classifying supplements as new drugs or food additives, and permitted, for the first time, limited health claims on supplement labels, so long as no specific disease was mentioned. It also stated that the federal government should not take any actions to impose unreasonable regulatory barriers to limit or slow the flow of safe products and accurate information to consumers.By 2004, the tide seemed to be turning against us with the FDA’s growing power and increased hostility to any approach to health that didn’t bow down before allopathic medicine and FDA-approved drugs. At that time, we changed our name to the American Association for Health Freedom, and channeled our energies into pushing back and saying No to the powers that threatened natural health. We organized a grassroots “Reform the FDA” campaign, and lobbied for the passage of an Access to Medical Treatment Act that would have guaranteed all citizens the right to the medical treatments they desired, as provided by a qualified medical professional.About the same time, we met the folks at the Alliance for Natural Health, a UK-based organization that seemed to agree with us on just about everything. Their work in Europe since 2002 paralleled the work we were doing in the United States, and we benefited from sharing information and ideas with each other. In December of 2009, the two organizations decided to take our relationship to the next level by becoming the Alliance for Natural Health Europe and the Alliance for Natural Health USA, within one parent organization, the Alliance for Natural Health International.This year marks our twentieth anniversary, and you have a great deal to be proud of—for we couldn’t have done the smallest bit of it without your support and grassroots activism. Thanks to you, ANH is changing the way medicine is done, and on an even deeper level, even helping to shift consciousness toward a better understanding of how our connection to nature is intimately connected to our health. Most critically, in our country ANH-USA has played an important role in passing significant legislation that directly benefits the natural health approach while blocking legislation that threatens it. We have also filed lawsuits to accomplish the same aims.

• To date, we have filed nine precedent-setting lawsuits against the FDA, which have established qualified health claims for saw palmetto, Omega 3 fatty acids, fiber, vitamin E, vitamin B, and selenium. Our first suit was the landmark case of Pearson v. Shalala—and because we won, there is now widespread public knowledge about the importance of consuming enough folate during pregnancy to prevent neural tube defects. Prior to this legal victory, supplement manufacturers were not permitted to let consumers know about this important nutrient relationship, and many consumers were in the dark.
• We also sued the FDA (and won!) for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels.
• We also succeeded in having the Health Insurance Accountability and Portability Act (HIPAA) state explicitly that the practice of alternative medicine is not fraud—a critical protection for alternative health care practitioners.
• We led the effort to establish the National Center for Complementary and Alternative Medicine (NCCAM) in 1998. It’s part of the National Institutes of Health (NIH), undertakes research, does training, and disseminates data to the public and professionals. NCCAM still isn’t where we want it to be, but we hope to get it there.
• We worked with Reps. Chaffetz and Polis to introduce the Free Speech about Science Act in the House of Representatives, which will permit supplement companies to cite peer-reviewed scientific research in support of product health benefits.
• We organized an emergency response to a major threat to dietary supplements in Congress: Sen. McCain's Dietary Supplement Safety Act. ANH-USA activists sent more than 200,000 messages to Congress opposing the bill, and we took out a full-page ad in Roll Call, the Capitol Hill newspaper, which highlighted misleading remarks from Sen. McCain on the Senate floor. In just three weeks, Sen. McCain took the almost unheard-of step of withdrawing support for his own bill, which subsequently died without a vote.
• Our activists, still mobilized and eager to act, were then able to defeat a sneak amendment to the Wall Street Finance Reform bill from Congressman Waxman that would have greatly expanded the FTC’s power to target supplement companies.
• Not much later, you sent more than 60,000 messages to Congress opposing Sen. Leahy's Food Safety Accountability Act, which would have established ten-year prison terms for violating FDA regulations, leading Leahy's office to reach out to ANH-USA to develop compromise language requiring proof of actual harm for prosecution. When the bill failed to become law, we worked together to ensure the ten-year prison term language did not make it into the Senate's Food Safety Modernization Act.
• It was not long before the FDA and Sen. Durbin made their coordinated attacks on dietary supplements. The response to our call for activists to oppose the FDA's new draft guidance has been nothing short of inspiring (read our exciting news on that subject in this issue!).

Will it be enough to rein in FDA’s outrageous power grab?

• The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
• This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
• The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
• This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!

Two powerful new bills will help control GMOs. Spread the word with our Action Alert!

Rep. Dennis Kucinich has introduced two bills that would mandate labeling and provide stricter safety protections for GE products. HR 3553, the Genetically Engineered Food Right to Know Act, already has twelve co-sponsors (and bipartisan support). The bill requires labeling of all genetically engineered organisms—including fish, which is especially important since GM salmon approval seems imminent. For animals and animal products, the bill would also require disclosure if the animal has been fed GMO.

• Prohibits open-air cultivation of genetically engineered pharmaceutical and industrial crops, to prevent cross-pollination and contamination;
• Prohibits the use of common human food or animal feed as the host plant for a genetically engineered pharmaceutical or industrial chemical; and
• Establishes a tracking system to regulate the growing, handling, transportation, and disposal of GE pharmaceutical and industrial crops and their by-products.

Please take a moment and write to your representative, your senators, and President Obama, and ask them to fight genetically modified organisms by supporting these bills from Rep. Kucinich. Please take action today!

Please contact the National Organics Program immediately and ask them to reject the NOSB’s recommendation on DHA and ARA. GMO and synthetic chemical solvents have no place in organic food, much less baby food, and should be banned immediately, not allowed to remain while the rulemaking process lumbers on. Please take action today!

• The NDI guidance is a departure from the FDA’s previous standards for NDI notifications. It alters and broadens the meaning of what qualifies as an NDI, and creates new—and very expensive—requirements to comply with the NDI notification process (creating what we would call a de facto pre-approval system), counter to what is outlined in Dietary Supplement Health and Education Act (DSHEA).
• Not fulfilling the NDI notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the NDI guidance.
• Supplements that are considered illegal can be confiscated, and under the Food Safety Modernization Act, as we noted lasted week, can now be subject to administrative detention as well.

• Between 22,240 and 41,700 nutritional supplements would likely be removed from the market, at an economic loss of between $5.6 billion and $10.5 billion;
• The nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and
• Between 55,720 and 104,475 jobs in the supplement industry could be lost.

Even worse, since this is presented as guidance and not formal rulemaking, the FDA is very likely to enforce the provisions in the draft guidance as though they were final—with limited legal recourse for affected parties!

• FDA will be forced to have a formal comment period, and to review and consider all comments before they issue a final rule. This includes a rulemaking record that shows the data and analysis behind a proposed rule, and sometimes even public hearings.
• If the result is not to the liking of interested parties, “Each agency shall give an interested person the right to petition for the issuance, amendment, or repeal of a rule.” This means, that unlike a guidance, it is possible to challenge a rule in court. It is very likely that FDA conveniently issued a guidance, instead of going through the rulemaking process, to avoid this very outcome.

There is a surprising reason why the government won’t go after drug companies for serious crimes.

This means that when a company becomes too deeply enmeshed in the government’s business, these companies simply become too big to prosecute!

Listen:

• A recent study shows that the statin drug simvastatin, which the government is advocating we take to lower cholesterol levels, actually weakens our immune system and makes it difficult to fight off bacterial infections.
• Italian scientists found that the drug, sold under the names Zocor and Simvacor, hinders the ability of the body’s immune cells to kill pathogens, and increases the production of cytokines, which trigger and sustain inflammation.
• The Wall Street Journal noted that statins like Lipitor make some patients, most of them women, unable to concentrate or remember words.
• Duane Graveline, MD, former NASA astronaut and scientist, demonstrated the link between statin drugs and muscle and neurological problems, including memory loss and Lou Gehrig’s Disease, in his book Statin Drug Side Effects.
• Other documented side effects include nerve damage, muscle damage (just what kids need, when their muscles are growing most rapidly!), liver enzyme derangement, and in some cases even kidney failure.
• Dr. Joseph Mercola notes a number of other side effects of statins, which he calls “some of the most dangerous drugs on the market”: blood glucose elevation, tendon problems, anemia, acidosis, cataracts, and sexual dysfunction.

They no longer need evidence that a product is harmful. Just a suspicion that there’s an error in the paperwork.

There are only a few days left to make your voice heard on this absurd NDI guidance. If you have not done so already, please send the FDA your comments today!

Their latest move targets supplements while giving drugs and vaccines a free pass. New Action Alert!

• Supplements: 1,080 adverse events, of which 672 were considered serious;
• Vaccines: 26,517 adverse events, of which 3,923 were considered serious; and
• Prescription drugs and “therapeutic biologics”: 526,527 adverse events, of which 275,421 “had serious outcomes.”

“Vitamin D Warning!” says MSNBC. “High Vitamin D Levels Linked to Serious Heart Condition” says Fox. What could be behind these terrifying headlines?

• Under 30 ng/ml of vitamin D is clearly deficient;
• 30–100 ng/ml is the safety range;
• Over 100 ng/ml, and your risk starts to grow.

The pioneering cancer doctor is a target once again. But you can help stop the attack.

Stanislaw Burzynski, MD, PhD, is a biochemist practicing in Texas who developed (using his own money) a nontoxic gene-targeted cancer therapy called antineoplastons. It has been shown to effectively help cure some of the most “incurable” forms of terminal cancer.

Dr. Burzynski had tried to get the FDA to review and approve antineoplastons since 1977, to no avail. To make sure he would not get into trouble for using the experimental therapy in his practice, his legal team confirmed that he was acting within the law and could use antineoplastons in his own practice “to meet the immediate needs of patients.” But in the 1980s the Texas Medical Board (TMB) charged him with breaking a law that didn’t actually exist and tried to revoke his medical license. Numerous investigations later—including an appearance before the Texas Supreme Court—found no violation of any law or standard of care. The TMB came up empty-handed.

We have reported on the TMB’s pattern of harassment against integrative doctors a number of times, discussing serious allegations from the Association of American Physicians and Surgeons, the serious attacks on Dr. Bill Rea’s work in environmental medicine and chemical sensitivity, and on Texas Governor Rick Perry’s involvement in appointing board members who actively harass integrative physicians.

As Dr. Joseph Mercola reported in June of this year, the FDA, the pharmaceutical industry, and the National Cancer Institute all knew how promising Dr. Burzynski’s therapy was proving to be. Standard cancer treatment is based on very expensive machines and very expensive toxic drugs. There is an enormous amount of money to be made in this paradigm, and Dr. Burzynski’s work single-handedly threatened to overturn much of it. On the other hand, this treatment showed such promise that they wanted to get their hands on it themselves.

So first they tried to copy his invention using a single non-patented ingredient, and when that failed, they tried to steal his patents out from under him. However, they knew they couldn't use the stolen patents so long as he had the ability to defend his rights. So the government spent over $60 million to prosecute him on 75 counts of violating federal law, hoping to tuck him away in jail for the rest of his life.

For the next ten years, Dr. Burzynski was engaged in a lengthy and convoluted legal battle with the FDA. After two trials, he was found not guilty on all counts, and his antineoplastons medication is currently undergoing the FDA approval process. His fight was chronicled in a stunning documentary film, Burzynski: The Movie. More info on the documentary can be found at the film’s website, while the movie itself can be viewed online for a limited time.

Now the Texas Medical Board is back. The TMB is making yet another attempt to revoke Dr. Burzynski’s medical license which, if successful, would result in the closure of his clinic, the abandonment of all his patients, and would squelch any possibility of antineoplastons gaining FDA-approval.

Using the death of two of his terminally ill patients as a pretext, the TMB is charging Dr. Burzynski with the off-label use of FDA-approved drugs. It must be stressed, however, that Dr. Burzynski uses the drugs off-label in order to tailor the medication specifically to an individual’s genetic profile, rather than using a one-size-fits-all approach. Dr. Burzynski takes blood and tissue samples from his patients to form their molecular profile. From that he chooses from wide variety of existing FDA-approved drugs to tailor his gene-targeted therapy to his patient’s genetic profile specifically.

Multi-agent targeted gene therapies are the way of future. The American Society of Clinical Oncology has stated that they want to focus on “targeted therapies and personalized diagnosis and treatment” over the next decade. Dr. Burzynski is the only one who is using such a treatment on patients today.

The TMB’s complaint concerns a patient who had triple-negative breast cancer, had already undergone conventional cancer treatment without success, and initially felt better after Dr. Burzynski’s treatment and was able to return to work. The board is charging Dr. Burzynski over the side effects of his treatment, though they do not seem concerned with the horrible side effects she experienced with the conventional cancer treatments.

The complaint also concerns a patient with estensioneruoblastoma, a cancer so rare that any medication use would have been “off-label” since there is no recognized treatment for this disease at all. The patient lived for five more years and the tumor decreased in size by 40%, but the TMB complaint is charging that the disease actually progressed during his treatment.

The off-label use of FDA-approved drugs is not uncommon, and it is legal. According to the American Cancer Society, a study showed that 8 out of 10 cancer doctors surveyed had used drugs off-label. And half of the chemotherapy drugs used are for conditions not listed on the FDA-approved drug label.

Please take 20 minutes to watch this brand-new video on the upcoming court case, and share it with friends. Not only does it outline the charges involved in this case, but it also gives you a glimpse at a new side of Dr. Burzynski’s treatment. You’ll be shocked at how flimsy the TMB’s case is—and how doggedly persistent the board is in harassing Dr. Burzynski and others like him.

The Texas Medical Board v. Stanislaw Burzynski trial will begin on April 11, 2012. Please write to Gov. Rick Perry, who appointed a number of members of the TMB, including its heads, as well as the House Committee on Public Health and the Senate Committee on Health and Human Services, which oversee the TMB. This is about our right as citizens to choose our own cancer treatment—and not allow decades of important gene-targeted cancer research be flushed down the drain in the name of protecting the profits of an industry that doesn’t want Burzynski to survive. Please take action today!

• Allegation: The ADA receives payments from Coca-Cola, Hershey, the National Dairy Council, Mars, PepsiCo, and others. Is this a lie? No: ADA lists them as corporate sponsors.
• Allegation: The credentialing arm of the ADA, the Commission on Dietetic Registration, offers continuing professional courses sponsored by Coca-Cola. Is this a lie? No: The Beverage Institute for Health & Wellness, which created the “Urban Myths” program, is an arm of the Coca-Cola Company.
• Allegation: The ADA allowed the junk food company–sponsored “Smart Choices” food labeling program (now considered a failure and an embarrassment) to be introduced at their Food & Nutrition Conference & Expo. Is this a lie? No: The New York Times reported on just how absurd the program was.
• Allegation: The ADA is under investigation by Congress. Is this a lie? No: Sen. Charles Grassley asked the ADA and other health advocacy groups for a listing of their payments from the pharmaceutical, medical device, and insurance industries. The senator’s investigation into the ADA’s financial transparency is ongoing.
• Allegation: The ADA receives about $1 million a year in payments from pharmaceutical companies. Is this a lie? No: Because of Sen. Grassley’s investigation, the ADA disclosed its payments from the pharmaceutical, medical device, and insurance industries.
• Allegation: The ADA allows pharmaceutical companies to market their controversial products at ADA events. Is this a lie? No: At the 2007 ADA Food & Nutrition Conference & Expo, GlaxoSmithKline was allowed to promote their first over-the-counter diet pill, Alli, even though the drug’s weight loss effectiveness is minimal and side effects such as hard-to-control bowel movements and anal discharge are common. The FDA has since issued warnings to Alli, noting the possibly of severe liver damage, and consumer groups are asking the FDA to remove Alli from the market.
• Allegation: The ADA is trying to gain a monopoly over nutritional therapy practice in the US. Is this a lie? No: The ADA has sponsored legislation in over 40 states that lumps dietitians and nutritionists into one licensing bill and requires nutritionists to complete its own dietitian program in order to practice nutritional therapy. Even if the nutritionist holds a Masters or a PhD in Nutrition, he or she is still required to complete registration through ADA just to continue to practice. In some states, these well-qualified individuals are even prohibited from using the words “nutritionist” and “nutritional care.”

Please join our efforts by signing our petition at ReallyEatRight.org. Tell the ADA leadership to return the payments they receive from junk food and pharmaceutical companies, and end their attempts stop attempts to monopolize nutritional therapy through underhanded statewide legislative efforts! (If you’re a Registered Dietitian, nutrition student, or ADA member, please sign this one instead!)

• FDA can still claim, without basis, that a grandfathered ingredient is “chemically altered”—and that would require a new NDI notification.
• FDA would not be stopped from moving its standard for NDI “notifications” closer to the food additive or pharmaceutical drug standard. This will continue to crush future innovation.
• FDA expects a different notification for the same ingredient for every different version of the supplement it is in. Contrary to Congress’s original intention—that each new dietary ingredient would provide notification—FDA seeks to apply their guidance to each supplement that contains an NDI. This means that a new magnesium formulation found in twenty different supplements would have to go through the expensive and burdensome process twenty times—once for each supplement.  Additionally, the same ingredient at a higher concentration would need a separate notification/approval.
• Worst of all, there is always the risk that this bill will give Congress the illusion that the NDI issue is being adequately addressed.

You may have heard that the USDA awarded a hefty research grant to AquaBounty, the “Frankenfish” creator. But there is more to the story….

Grocery customers in California and elsewhere are chopping its onions that produce fewer tears, stir-frying its broccoli that decreases cholesterol, and biting into tiny orange tomatoes that last longer on the shelf. Soon, people will be thumping melons bred to be a single serving and shucking sweet corn genetically modified to enable farmers to spray the fields with the company's weed killer, Roundup. To do this, it’s marrying conventional breeding methods with its vast technological resources to bring about changes in fruits and vegetables in months or years, rather than in decades.

Registered Dietitians are tired of their organization being financed by the junk food industry and Big Pharma. Now they’re starting to speak out.

• Lifestyle and nutrition is essential in preventing many chronic diseases such as type 2 diabetes, heart disease, and cancer—which currently place a huge burden on US healthcare. In the US, approximately ten percent of healthcare dollars are for diabetes treatment directly. Indirect costs are much higher and include increased work absenteeism, reduced productivity, and lost productive capacity due to early mortality.
• Instead of taking important preventive measures, healthcare is focused on treating the disease with drugs.
• Sen. Charles Grassley (R-IA) has asked the ADA and other health advocacy groups for a listing of their payments from the pharmaceutical, medical device, and insurance industries. The senator’s investigation is ongoing.
• The ADA receives about $1 million a year in payments from pharmaceutical companies. Because of Sen. Grassley’s investigation, the ADA disclosed their payments from the pharmaceutical, medical device, and insurance industries.
• The ADA receives payments from Coca-Cola, Hershey, the National Dairy Council, Mars, PepsiCo, and others. The ADA won’t say exactly how much they receive from these companies and industry associations.
• The credentialing arm of the ADA, the Commission on Dietetic Registration, offers continuing professional education courses sponsored by Coca-Cola.
• The ADA allowed the junk food company–sponsored “Smart Choices” food labeling program (now widely considered a failure and an embarrassment) to be introduced at their Food & Nutrition Conference & Expo. One of the biggest critics was Food Safety News (a very mainstream website, not particularly natural-health-friendly), whose reporter said, “The corporate takeover by Big Food was worse than I even imagined.”
• The ADA allows pharmaceutical companies to market their controversial products at ADA events. At the 2007 ADA Food & Nutrition Conference & Expo, GlaxoSmithKline was allowed to promote their first over-the-counter diet pill, Alli, even though the drug’s weight loss effectiveness is minimal and there are side effects such as hard-to-control bowel movements and anal discharge. The FDA has since issued warnings for Alli, noting the possibly of severe liver damage, and consumer groups are asking the FDA to remove Alli from the market.

I'm slightly concerned by your article posted recently, called “BREAKING NEWS! CDC Has Just Recommended Routine HPV Vaccinations for Boys!” Your article is extremely misleading almost to the point of shoddy journalism....

From your article: “A whopping 1,498 of those events (8%) were considered ‘serious’—such as blood clots, the neurological disorder Guillain-Barre Syndrome, and 68 reports of death.”

From the CDC website you use as a source, the number of deaths was in fact 71 but only 34 of those deaths were reported with all the information necessary. The author completely ignored the most relevant last sentence of that section: “In the 34 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.” It is irresponsible and misleading of your author to be neglecting this point by using the statistic and citing death as a side effect when it is obviously not. While vaccines can pose a risk to people with obvious health complications (family history or allergies, etc.) it is inappropriate to be cherry picking statistics on a site that tries to promote healthy living.

Since he’s having trouble getting his own bill passed, he’s trying a different approach to get the same results. New Action Alert!

• increased supplement labeling regulations—one of the Durbin bill’s main goals;
• a clear delineation to be made between food and supplements—a first step toward treating supplements as drugs—this is also in the Durbin bill, and it’s the particular clause we feared he would slip into the appropriations bill; and
• an increase in AER requirements: currently only severe adverse events must be reported, but this would force AERs to be filed even for the most minor events.

In the meantime, if you haven’t yet sent a message to Congress about the Durbin bill, please do it now! But just as important, the appropriations bill is scheduled to be voted on by next Monday, October 31, at which time Sen. Durbin will try to add his amendment. Please write your senators today and stop this language dead in its tracks!

In our free market society, consumers should be able to purchase dietary supplements and companies should be able to sell these products so long as the labeling and advertising are truthful, non-misleading, and there exists a reasonable scientific basis for product claims.

Unfortunately, not everyone in our federal government shares these views. For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors.

As you know, [DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.

Time is running out—the comment period ends on December 2! Help us protect your access to supplements. We need everyone reading this to send their message to Congress and FDA right now to make sure the FDA and Waxman don’t win! Take action today!

• Coca-Cola, which sponsors Komen grants, lines its soda cans with BPA. The company doesn’t deny it, either—but simply says “it’s not enough to hurt anyone.” In fact, research suggests that even tiny amounts of BPA will hurt you.
• General Mills uses BPA in its canned foods (bowing to consumer pressure on its Muir Glen canned tomatoes but keeping them in other canned foods), and Georgia-Pacific manufactures epoxy resins that contain BPA. Both are Komen corporate sponsors.

We are asking you to walk, run, hike, bike ride, or do some other physical activity—on Sunday, December 4. The event will support integrative medicine research and continued access to important alternative treatments for breast cancer. We’re asking our readers to organize some favorite physical activity, then get their friends to sponsor them through peer-to-peer fundraising .

Worry?—no. Supplements have a remarkable record of safety. Give it careful thought—yes. Here are some things to consider.

• American Association of Environmental Medicine
• American Association of Naturopathic Physicians
• American College for the Advancement of Medicine
• International College of Integrative Medicine

• Is this the right form of the supplement?
• Is it natural or synthetic?
• Are there co-factors that must be taken with it?
• Do I trust the company selling it?
• Am I taking the right amount?

"This study is a classic example of scientific reductionism being used to fulfill a particular need. In this case, it’s supplement bashing, a well-known preoccupation of Big Pharma — and an approach that appears to be central to the protection of Big Pharma’s profit margins."

• Saturated fatty acids constitute at least 50% of cell membranes, giving cells their necessary stiffness and integrity.
• For calcium to be effectively incorporated into the skeletal structure, at least 50% of the dietary fats should be saturated.
• Saturated fats lower Lp(a), a substance in the blood that indicates proneness to heart disease, and protect the liver from alcohol and other toxins such as Tylenol.
• They enhance the immune system, and have important antimicrobial properties.
• Healthful omega-3 fatty acids are better retained in the tissues when the diet is rich in saturated fats.
• The heart is most directly nourished by saturated fats; in fact, the body creates reserves of highly saturated fats around the heart muscle, so the heart can draw on it in times of stress.

Think about this: Even though one of the triggers of delirium is hospital-prescribed drugs (sedatives), the solution they’re considering is to prescribe even more dangerous and potentially damaging drugs (antipsychotics).

• Plaintiffs [Loiselle, Karp, and the Zinnikers] do not have a fundamental right to own and use a dairy cow or a dairy herd;
• Plaintiffs do not have a fundamental right to consume the milk from their own cow;
• Plaintiffs do not have a fundamental right to board their cow at the farm of a farmer; [and]
• Plaintiffs do not have a fundamental right to produce and consume the foods of their choice.

• 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.

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

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.

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!

• 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.

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

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?

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.

“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.”

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!”

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

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

• 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.

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

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!]]> http://www.anh-usa.org/public-servants-should-listen-to-the-public/feed/ 21 http://www.anh-usa.org/competition-talking-science-take-em-to-court/ http://www.anh-usa.org/competition-talking-science-take-em-to-court/#commentshttp://www.anh-usa.org/new_site/images/default_thumb.jpg Tue, 23 Aug 2011 20:20:45 +0000 ANH-USA http://www.anh-usa.org/?p=8028 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

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

All Other States

]]> http://www.anh-usa.org/competition-talking-science-take-em-to-court/feed/ 118 http://www.anh-usa.org/anh-usa-files-analysis-with-fda-new-supplement-guidance/ http://www.anh-usa.org/anh-usa-files-analysis-with-fda-new-supplement-guidance/#commentshttp://www.anh-usa.org/new_site/images/default_thumb.jpg Tue, 23 Aug 2011 19:59:25 +0000 ANH-USA http://www.anh-usa.org/?p=8030 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!

• 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.

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

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.

• 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.

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.

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?

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

How Medicare and Medicaid Have Criminalized Natural Medicine

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

State Laws for Doctors—and Drugs

State Medical Boards Largely Controlled by the AMA

State Laws Create and Enforce Monopolies which Drive Up Costs

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

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!

• “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.”

• 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.

• It suggests that McCain backed off his own bill because he was concerned about the damage to his campaign from a highly motivated industry. But industry didn’t “rally consumers”—opposition came from the groundswell of self-motivated grassroots opposition opposing the bill, with more than 200,000 messages from our activists alone.

• It implicitly criticizes current legislation for not requiring supplements to be subject to the FDA drug approval process. But as regular Pulse readers know, this completely ignores the fact that manufacturers of natural, non-patentable substances cannot afford the billion-dollar costs associated with FDA drug approval, because without patent protection they would never make back their money.

• The article claims, “Just in the last two years, 2,292 serious illnesses, including 33 that were fatal, were reported by consumers of supposedly harmless nutritional supplements, federal records show.” We contacted the New York Times and asked where this data came from, since we have not seen it elsewhere. They told us that an unnamed source within the FDA had given them these figures by phone. No such figures are available on the FDA website. Moreover, in its reporting of adverse events, the FDA does not presently break out supplements from drugs—perhaps because the agency does not want to highlight that almost all the adverse events are coming from pharmaceuticals that have gone through the FDA drug approval process.A federal agency that does publish annual statistics on supplement adverse events and deaths is the national Poison Control Center. Its 2009 Annual Report, which is the latest available data, records only a single death concurrent with supplement use—an “unknown dietary supplement or homeopathic agent”—with no deaths reported before 2009. (By way of comparison, the same report attributed 122 deaths to acetaminophen—an over-the-counter pain reliever sold under the brand name Tylenol.) It is notable that this one death was concurrent with an “unknown dietary supplement or homeopathic agent.” So there was an alleged supplement or homeopathic agent, but they don’t know what it was! Furthermore, for anyone who understands homeopathy, the notion that a homeopathic agent caused death is ludicrous. It is also completely inconsistent with the conventional medical view that homeopathy is just sugar pills that do nothing other than create a placebo effect. Conventional medicine can’t have it both ways: homeopathy can’t be both a killer and a harmless placebo.

• It states that under legislation Hatch “pushed through Congress,” nutritional supplement companies could introduce products without FDA approval, and make general health claims without proving their effectiveness or safety.” But it is already illegal to make disease claims under DSHEA, and there are strict protocols for other claims.

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!

• 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.”

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.

• 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.

• 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

• 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.