FDA’s New Sneak Attack on Supplements

109

iStock_000016803962XSmall

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On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA).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Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements.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!


TO SEND YOUR MESSAGE TO THE FDA

Click THIS LINK to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.

We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not the FDA, Congress etc.

Share.
  • debora tyler

    I wish the FDA would get it right!!!!!!!
    the fact that over 1700 drugs were black boxed. ( the last 2 years) and that psychiatric drugs do not work, and cause kidney , liver disease of heart attacks. diabetes on the rise thank you coke.
    and the drug companies have paid over 20 billion dollars on fines for mis representation of their pharmaceuticals. and it is found that we are one of the most obese of the developed nations, not under developed , thanks to HFC and aspertame.
    that GMO crops kill lab rats and mice
    fire the remaining FDA and hire real scientists , if you can find them. since we are running 48th worldwide in scienc and math, OMG

  • Loren Mortensen

    We dont need your help we can think for ourselfs

  • http://www.drtchiro.com William M. Thomas, D.C.

    I will keep posting articles like this on my website, http://www.drtchiro.com. I also tweet and facebook your action alerts. Thanks for the work you are doing.

  • Patricia King

    Those of us who care about the quality of the food and supplements we ingest must not only be very vocal to agencies such as the FDA, we must also be very vocal directly to President Obama who has the responsibility for appointing people to head up these agencies. When I look at the decisions being made by the Department of Agriculture and the FDA I am not happy with the choices he has made to date. I have communicated my discontent to President Obama and I hope all of you will join me in the effort to persuade him to appoint people who are more attuned to the people and less attuned to the desires of agri-business and pharmaceutical manufacturers.

    • jackie

      this is what I added to the top of ‘the letter’… 😉
      ‘First.. Why would the American people trust the FDA about anything? sadly their own record speaks for themselves.. Drug Corps have got richer and people have got sicker…So, the fact they have launched an all out war on ‘natural food and medicine’ because it is not safe??? is laughable and dangerous… I would appreciate it if you took the time to read the whole letter..
      A few things…’

    • Linda N

      Done! Thanks for the tip.

  • jill warga

    The government has no problem approving drugs that kill and maim us, but they want to take away our freedom to buy supplements? They have no problem telling us we can’t smoke anywhere–they want us to take deadly drugs to quit like Chantix. They have no problem genetically modifying our foods; yet they don’t want the food to be labelled GMO. The government wants to tax soda–instead they want you to buy drinks laden with deadly nutrasweet. The government rewards big business and financial crooks, yet it’s us who has to pay more for health insurance, home and auto insurance, bank and credit card fees, mortgages. No one is helping the PEOPLE of America. I think it’s time they butt out of our lives and let us live as we choose. DON’T MESS WITH MY NATURAL SUPPLEMENTS!

    • Gina Coker

      You have hit all the problems right on the button! This administration, like all the others, is toothless in the face of big business. If I was getting rich screwing the people who voted for me, as opposed to being on sale (like a whore) to the highest bidder, I would do everything I could to lie, beg, borrow, and steal. The government and big business are the ones who sent our jobs out of the country, beginning with Clinton and NAFTA; under the first Bush they robbed the S&Ls; under the second Bush, the banks robbed the people with the fake mortgages; and they caused a worldwide recession. Instead of bailing them out, someone should have gone to jail! Because they don’t want to pay us decent wages, give us health coverage, they shipped our jobs out. Now, they want to bust up the unions who had to be created in the first place because this is how they were treating us in the 1900s. People better wake up. We’ll all be in the poor house, or under the ground, or filled with cancer, because all they care about is amassing more money and don’t care who they kill to do so.

  • Pamela Powers

    this is what I added to the letter:

    If this a democracy, and I’m beginning to wonder, it is our right to choose our health regiment in the manner we see best. I had endocarditis twice, and I would have had open heart surgery to replace 2-3 valves, probably would have died, or been at the mercy of the pharmaceutical industry for the rest of my life, paying out my meager savings, put on welfare and die with dementia in an old folks home, stripped of my money, stripped of my health, stripped of my dignity.

    It is imperative that you stop interferring in our choices for health care, and let us choose our methods. With supplements and without pharmaceuticals I am nigh healthy. I refuse to be put in a position of taking those damnable prescription pills with all their side effects. Those are the pills you should be taking off the market , not messing with our supplements. How can you think you are doing something good, when you let these hellaciouos prescriptions continue on the market???

    I’ve never smoked, so this is like cigarettes vs marijuana. You can’t deny marijuana when you know cigarettes kill but you still let them on the market. In the same way you can’t make it harder for supplement makers when you allow these horrible prescriptions on the market.

  • http://HTML Jeane Jaime

    Thank you for keeping the public updated on the FBA’s actions.

    Since the Food Supplements have made people healthier, many do not take any prescription drugs and the Pharmaceutical Companies are losing money. Many people have died from the wrong drugs. Everyone’s system is different and what affects one person a certain way may not apply to the next individual. Gender differences would naturally apply also. I do not believe enough research has been done on these very important issues.

    Natural food supplements very seldom cause any reactions on people, especially if they follow the instructions. I am a healthy active 88 year old lady who takes many health food supplements. If the Drug companies get involved and change or try to stop health food supplements and thus raise the cost much higher for these supplements, it would be an unnecessary tragedy for us Seniors or anyone who else who uses food supplements.
    As far as I know no deaths have occurred from taking food supplements whereas the pharmaceutical companies cannot make this claim.

    We must do all we can to stop the New Dietary Ingredient (NDI) laws enacted to stop the Natural food supplements in any way.
    Thank you. Keep up the vigilance on the FDA.

  • Wallace Shaunfield

    When will congress realize that the FDA really is a loby for the drug companies and are only interested in the profits of the drug companies and in filling their own pockets? Health of the American public is the last thing on their list of priorities.

    • Melinda

      What makes you think they don’t? Sadly, I believe they do know but it is the all mighty dollar running the show, Campaign contrabutions are very motivating you know…

  • Susan

    Our rights are rapidly disintigrating. When we will be forced to choose between big pharma and all of it’s misgivings, and nothing else, because our natural meds/supplements will be gone; then, there is no more choice for us.

    “That whenever any Form of Government becomes destructive of these ends, it is the Right of the People to alter or to abolish it, and to institute new Government, laying its foundation on such principles and organizing its powers in such form, as to them shall seem most likely to effect their Safety” [health] “and Happiness.”

    Our for fathers did not know to add health in there, so I did. Fed up!

  • RIchard Vultaggio

    We do not need natural supplements regulated and/or not allowed for purchase in the USA. Big business & drug companies want this passed as they did in Europe(which is hard to understand why the people could not stop it as they have been leaders in natural healing & environmental issues, obviously big pharma, big business and possibly govt’s took over). This is unfair and unjust to limit ones access to Natural Supplements and Natural products. No one but God or whoever you believe to be the Creator, has a say in who is able to use or purchase natural products or ingredients.

    Richard Vultaggio

  • Kevin

    I am outraged! As a person who has been using natural medicine for almost half of my life, it is unconscionable to think that a bunch of bureaucrats in Washington, D.C. It could dictate to everyone else, what vitamins they can take. I have personally been helped by supplements and by natural doctors. I know what they can do for myself, and for other people. It always amazes me that they approve drugs, which we know has had some terrible effects on people’s life’s, and yet they go after these vitamins which we know, “have had very little problems” Their only crime. They have helped many people. In my case, they stopped my seizures. I know this does not always work in every case, especially with seizures. Every seizure is different, and it can be very dangerous, but it does work in some cases. It’s time to send our Representatives and Senators a message:
    Stop ruling by fiat, and start representing the people, as you were sent there to do.

  • nancy

    Leave our supplements alone. The drugs are too darn expensive and the supplements are all we have.

  • http://n/a Sherry

    I prefer my supplements to dangerous prescriptions with terrible side effects. My family doctor even recomends use of certain natural supplements. It seems to me the pharmasutical companies want the polticians to step in and stop the use of supplements so they can make more money selling the dangerous medications, all while the politicians get their pockets lined in the process. The citizens are not being well represented when the medical community rules the politicans. We need to put a stop to this practise in America.

  • http://n/a Sue Moxley

    Can any of you folks tell me why two of the three most important issues of a nation or in the life of an individual are controlled by two entities that cannot be touched. The Federal Reserve has the final and absolute say insofar as money is concerned, and it answers to noone. The FDA has the final and absolute say insofar as our food supply, drugs, medical treatments (such as stem cell therapy), vitamins and other nutrients are concerned.
    Why are these entities untouchable? The rest of our government has checks and balances, and although they often fall short in the integretity department, at least they can be chastised on election day.
    The third most important issue of our nation and in our individual lives is freedom, and the Federal Reserve and FDA, through the control of our bodies and our finances ,do a very good job of stripping us of that.

  • Harmony Salvatore

    I will use what I decide is safe!

  • Sarajane Hall

    Retaining the freedom to take the supplements I chose and that are not adulterated or disappeared by nonsensical actions that seem to me largely political (e.g., Big Pharma’s desire to control all health related matters) is a passion of mine. I urge you to organize rallies, marches, and online protests to combat the evil, greedy forces that don’t give a rap about my or anyone’s health, but instead care only about their bottom lines and their “reputations” as guardians of health food safety. Let’s band together and educate the public about the true state of food safety, and at the same time fight for ctizens’ right to design their own supplement programs in conjunction with the work of knowledgeable health professionals.

  • Dorothy & Richard Chamberlin

    Compared to drugs, supplements generally are very safe and you do not see thousands dying every year from them as you do with drugs. Please remove some of these very dangerous drugs from the market and leave our supplements alone. Our health depends on these products as we avoid drugs best we can. Thank you.

  • geminga

    The new world order better known as the rich and powerful feel that the planet is too crowded. Therefore what do you do?Take away healthy food with your massive agra profits.Take away supplements from the public who has no health care . In the meantime as folks get sick with no way to protect themselves,their supplements gone,will get increasingly more dangerous pharma drugs if they can afford them. Those who cannot afford medical care will just die needlessly. Many of my friends think I am a conspiracy theorist. Wait untill the long arm of the rich and powerful grabs them personally. I prefer to call thse rich folks better known as elite, as evil doers.They don’t care who they kill. Don’t believe me…..see the documentary”Burzynski the Movie”. You will never see the FDA or your so called government in the same way again.
    Call every congressment in your district and let them know you want the clear evil intentions of the FDA reined in now. Tell them you want the hostility toward supplements stopped and the power of Pharma in our public agency haulted.

  • alexander

    Please don’t hinder the Supplement market. Due to the pitiful lack of nutrition in factory farmed, processed and restaurant foods, we need to have these supplements in our diets or we are destined to chronic, nutrition-based diseases like candida, crones, diabetes, cancer, tuberculosis and others .

  • Mary

    I’ve been taking various vitamins most of my adult life. I think it should be continued as it was, since it has not caused anyone ill effects when you follow dose amounts. I usually do some research on my own regards some health issues, such as menapause, and found what I needed in vitamins to make the transition smooth. Several doctors tried to put me on hormone treatments even though I said I had no complaints. I then told them my regimen about two certain vitamins and the daily dose. Both of them knew what I was talking about, as they put down their pens after hearing me out. Most doctors are told by pharmaceutical companies to push their product, no matter what. I feel a natural solution should be the first choice then procede to other alternatives if that doesn’t work. Medicines only cover up the problem, it never resolves the cause of the disease.

  • Michele B. Ford

    Well little by little the American public is losing more control over our lives in regards to our health and well being. All for a dollar.

  • George Halas

    Properly prescribed prescription drugs kill 110 thousand people a year in the USA. That is twice the number of our soldiers that were killed in Vietnam over 15 years.
    JAMA’s own report – Compare that with deaths from supplements yearly.

    Hey FDA you’re parking up the wrong tree. Of course you won’t dare report any abuses of your future employers (Big Pharma) will you.

    How do you people (FDA) sleep at night.

  • Kathleen Nicholson

    I really appreciate the e-mails that I receive from the Alliance for Natural Health. You have kept me abreast of what is happening in Congress and Washington. Without your e-mails, I would not know what they are doing and how it affects my freedoms and rights to purchase what I feel I need for my personal health. Please keep up your good work please keep helping me to know when and how I can be of help in these efforts.

  • http://evolvedesign.biz Stephen Perkins

    Please keep up the EXCELLENT and DILIGENT whistle-blowing. I know we have made a difference in other similar matters. ANH carries a very important torch. I salute you!!!

    Stephen M. Perkins
    Certified Natural & Holistic Health Practitioner

  • Kelley Harper

    The FDA has overstepped their bounds, They should but out!!!!!!

  • http://don'thaveone joan downey

    none at this time

  • Randy Alexander

    The FDA needs to but out. Look what a good job they have for the drug companies and they work for them not us. They need to be fired and put in jail for all of the bad drugs they have approved and that have killed so many people with their approval. Supplements are not drugs they are the missing part of the bad food we have to eat that the FDA already approves! I guess they do it for population control. I don’t know how they sleep at night.

  • http://none Dalon Jones

    I keep hearing that the FDA is under funded and understaffed and that’s why regulations regarding the polluting of our planet can’t be kept up with. Yet, the FDA can allow the poison makers control our health and take away natural options to increase the cost of healhcare without improving the potential for accessing better healthcare. What is your purpose and/or intent? Will robbing us of healthcare options improve your health? If so, who the hell are you?

    • LK

      I think you may be confusing the FDA, which is the powerful Food and Drug czars, with the EPA, which has, as you suggest, been rendered toothless.

  • Ben Martinez

    Please reevaluate your policy of blocking all supplements for sale. I take a group of them and have found that they have been of much help to me. Thank you.

  • Laura B

    Keep your hands away from MY health and supplements.

  • Tim Moore

    The FDA has not shown the evidence of their actions being fair .

  • David Forde

    Go get them

  • Kristen Zehner

    I cannot understand HOW Congress (mostly the GOP fascists) has the time to fiddle-faddle with these issues when it is doing absolutely nothing about jobs or the economy, let alone the debt ceiling. WHY has the deficit become the big topic of concern with the GOP when nobody cared a whim while the GOP was creating that same deficit that they all voted to approve?? NUT JOBS.

    • don

      ABATE the FDA,TSA,HLS,CIA,NSA,fedreserve industrial military complex these organizations has rotted our very core of our principals of american and world freedoms nothing but parasites

    • Kelly Fuc

      Wow Kristen. Take it down a notch, and back off the GOP. Obama’s been nothing but a failure. I’m sure you haven’t noticed…spending MORE MONEY which has done jack to unemployment, and giving us Obama-care which is nothing but a big disaster nobody wanted. Besides, it’s the D-E-M-O-C-R-A-T-S that routinely get big money from BIG PHARMA lining their pockets during election years. Hilary Clinton and Obama are at the top of the list.

      And Last time I checked, the majority of Conservatives are for LIMITED GOVERNMENT and personal freedom. Ron Paul even supports the production of Raw Milk. So if you’re for all the things this website stands for, you’re really in the wrong party. Wake up and smell the coffee: Obama’s going to be OUTTA THERE in 2013.

    • http://kidsvites.com Daniel

      And the Democrats are sleeping around too >>> (NaturalNews) A new bill introduced by Sen. Dick Durbin (D-Ill.), S. 1310, the “Dietary Supplement Labeling Act of 2011,” threatens to undermine the dietary supplement industry by giving the US Food and Drug Administration (FDA) more power over it, despite…

  • http://sweattshop-graphic-artist.blogspot.com/ Dennis Sweatt

    The FDA is guided by big pharma. This is the last straw for people feel that it is their right to take care of themselves. This will be a fight the FDA doesn’t want.

  • Abdi

    The fda is now hitler many people need vitamin b6

  • JB

    FDA regulations that poison our food and drugs and try to take away our supplements reveal an agenda for population control and mass murder. Such govt. institutions are controlled by the same foreign financial powers who control our money supply, have us in debt and tank the economy at will. We’re living in a dark Orwellian age of evil. Not by mistake or accident but all by top 1% design.

  • Michelle Friesenhahn

    It’s absolutely repugnant that the FDA could have the power to nix all vitamin supplements, while allowing Big Pharma to push synthetic drugs that eventually prove to be deadly. This issue will bring all people of different political persuasions, even radical opposing radical perspectives, together.

  • Diane Kavanagh

    Natural supplements should only be banned if there are complaints from users and thy are serious enough to warrant investigation. Pharmaceutical drugs which are approved by the FDA have killed and maimed hundreds of thousands of people. The FDA could be usefl if it randomly tested supplement bvrands for having the listed amount of ingredients in the product.

  • Kelly Smith

    Power and Money: That’s what it is all about! They could care less about the health of the consumer.

  • Alan8

    Let’s not mince words here: THIS IS A SYMPTOM OF THE BIPARTISAN FASCIST ATTACK ON CITIZENS.

    Fascism is the corrupt alliance of government and corporations against the people. This is being done to increase the profits of the health-related corporations that contribute to Republicans and Democrats.

    We have to stop playing the two corporate-funded parties’ rigged game. The Green Party doesn’t accept corporate money and represents CITIZENS’ interests. 5% of the vote will get the Green Party matching Federal funds, and send a strong message to the corporate parties that selling us out to corporate interests will lose them votes.

    VOTE GREEN!

  • jb

    The answer to this new, obscene FDA tyranny is simple.
    DISBAND THE FDA!
    It is past time.

  • Bill Z

    Make no mistake, this is an egregious abuse of power. Remember what Jefferson said, it is the responsibility of the people to resist tyranny. Requiring NDI notifications under DSHEA, in the guise of compliance of the Food Safety Modernization act is a tyrannical attempt by the FDA to bend to the will of those interests that would like to eliminate supplements. This should make people angry as it is a misuse of the law. The fact that this was proposed on July 1, the day before a holiday weekend in the US, glaringly spotlights the fact that the FDA knows this will be controversial and was desperately trying to avoid media attention. This needs to be brought into the light of day and widely debated, fairly and responsibly. I think if this is done there is a good chance cooler heads will prevail and such an outrageous and ridiculous proposal will fade into the trashbin of history as just another failed idea of those who would put profit motives ahead of human health and the freedom to choose what supplements citizens can consume.

  • KB

    I called three supplement companies that I have done business with to let them know what the FDA is attempting (again) and whether or not they actually knew of this, and their various representatives responded with:

    1. “Oh, I’m sure they’re aware.” (i.e., when pushed for an answer, had no clear idea, made excuses, and did not really appear to care because the topic was outside her scripted replies)
    2. “I will definitely let my supervisors know” (i.e., this person was actually concerned as he took time to read the article I was referring to).
    3. “We’re not going to worry about that now. I’m sure this is way in the future. This has happened before.” (i.e., felt that this just would not happen to HER company and didn’t really care because they “are totally compliant with the FDA”).

    What apathy. Guess which company I will continue doing business with (you guessed it, Bachelor #2)

  • http://http//www.painreliefnetwork.org/forums Ian MacLeo

    It seems like at least twice a month I have to fight this same battle over again. Handing our ability to choose healthy foods, herbal remedies and correctly made supplements of our own choosing is, for once, a clear case of a threat to National Security, and is treasonous on its face! Most of the drugs the FDA approves are vetted on the basis of how of the FDA’s budget the makers paid for, not of effective or safe they are! They’re forced to recall an unconscionable percentage of new medications very quickly – unconscionable because all too often thousands of patients (and in the cases of SSRIs and gabapentin, innocent bystanders) DIE! Healthy foods, herbal medical treatments and supplements are constantly under threat by the FDA at the behest of big Pharma. How about if we push for a more realistic charge for once, and have those involved up on charges of treason? We could add attempted mass murder by poisoning, suppression of life-saving treatments for cancer, with many of them actual cures as well!

    We are under attack in so many ways from so many different directions, some well-hidden, some blatant, that it’s getting impossible to keep track of them all, much less to catch them. I am disabled with massive nerve damage (and have been so for 28 YEARS!), the sole correct treatment for my own condition is legal, scheduled, very safe and well-understood – and doctors dare not prescribe those medications because the government refuses to recognize the science behind the Medical Standard of Care the rest of the civilized world (so-called) uses so as to allow those with otherwise untreatable chronic pain to have near-freedom from pain, and often it even cures the condition! Without treatment we are crippled, unable to work, we lose everything from jobs to spouses and children, homes, and our own self-image. The DEA attacks our doctors as thought they had been caught standing in schoolyards selling drugs to first graders, and with 800 or so of them in prison we are left with no treatment at all. Doctors refuse to see us; clinics ‘aren’t taking new patients.” Emergency Rooms mock us and the doctors there take workshops on how to browbeat us and pressure us into walking out with not so much as an exam, much less even temporary treatment so we can sleep for an hour or two – if we’re lucky. The advice we get amounts to “Then die. You’re worthless anyway.” Henry Kissinger’s name for us was, “Useless eaters.” Seems to me that the parasites who’ve been destroying the economy and every supposed regulatory agency we (used to) have in this country would fit that better than people like me. We worked hard before we got hurt, and would again if we could find decent food, medicine that doesn’t make us worse when it doesn’t kill us, and a few honest Federal Judges and Prosecutors. If they still exist.

    Ian

  • C Williams

    Go ahead and be done with it. Just ban all foods. That will solve all of our problems.

  • Penny

    Sir: What in the world are u thinking….If you were sick and you knew that the supplements would help you get better or cured… What do you think you would do… THINK…God had made some men and women to help others.. not to be rich, but to HELP….THINK……..THINK

  • Brenda Rogers

    FDA is a sick, sad, sorry bunch of killers who are in bed with the money-mad drug and chemical companies and they should be discontinued altogether. They’re not even slightly interested in what’s good for the people but are only after preserving their own greedy selves and their jobs and their control-freak self serving. How about the recent attacks on Vitamin C injectible form AFTER some near miraculous incidents of people being healed from near death states by using large HARMLESS doses. They just can’t stand the competition. They’re more for kill, steal and destroy than for healing that would leave people alone to enjoy peace, love, joy and good health.

  • Brenda Rogers

    The whole FDA system appears to be a sick, sad, sorry bunch of killers who are in bed with the money-mad drug and chemical companies and they should be the ones taking the heat. They’re not even slightly interested in what’s good for the people but are only after preserving their own greedy selves, their jobs and their control-freak self serving ways. How about the recent attacks on Vitamin C injectible form after there were some practically miraculous incidents of people being healed from near death states by using large amounts in harmless doses. They just can’t stand the competition. They appear to be more interested in killing, stealing and destroying than for healing that would leave people alone to enjoy peace, love, joy and really good health that can only be built with good, wholesome, organic foods – not with chemicals and drugs.

  • Traute Klein

    Americans are asleep and will wake up when it is too late. Canadians have been fighting this war for years. The Canadian federal government has drafted legislation which is far more stringent than what the FDA is proposing. If that legislation passes, an inspector can come into my garden and destroy all the medicinal herbs which I am growing. If I continue to advise people about natural remedies, something I have done free of charge all my life, I can be sent to jail. Here is how we are fighting the government: http://nhppa.org

  • jim

    Wake up people. Most of you sound ignorant of the true motives of the elite. They want you dead. They poison your water with FLUORIDE, your food with GMOs, your air with CHEMTRAILS, vaccinate you with MERCURY AND OTHER POISONS, are trying their best to destroy your food and natural health alternatives, and now they do not want you growing your own food or finding your own supplement alternatives. Find the famous quotes on de-population and eugenics. They want to reduce population to a billion or less. Easier to control you then.

  • http://cyberesolutions Wendy Rice

    I am with nearly every other American, regardless of politics, race, gender, religion…
    We are not being represented. You know what has happened in this country in other times when we came together as a nation over a common cause. Come on, we can not stand by and let this agency…(any agency) Federal or not take away our human rights. They can not tell us what to eat/drink/feed our children. How can the people within any agency like (FDA for one) these abide by these crazy “regulations”? I would doubt they want their lives dictated to them. All the money is not worth it…All the power is not worth it.

    • Vincent

      Also, do not forget to contact your congressmen regarding this issue.

    • ah

      The processing of all these redundant and unnecessary notifications will require more staff and consequently more budget for the FDA, which creates more burden on all taxpayers. I would approve a budget increase for the FDA to spend more money on field inspections of factory farms and slaughterhouses and to require more stringent reviews of pesticide uses in industrial agriculture, but not on processing redundant documentation for botanicals and other ingredients that have already proved their worth throughout human history. The real threat to our health and the safety of our food supply is coming from the excessive use of antibiotics in livestock operations, and the cumulative levels of pesticides on crops and in grain-fed livestock–and consequently in us. Everybody has to eat; not everybody takes a nutritional supplement. The FDA’s priorities seem upside down to me.

      In addition, there is a disturbing double standard in use here. Why is it that genetically modified ingredients in food are not labeled–in fact, labeling them is not allowed–but the FDA proposes to apply such scrutiny to “chemically altered” traditional medicinal ingredients in nutritional supplements? There is substantial evidence that GMO foods contain significant risks to the health of consumers and that they are widely used in the food supply–think of the GMO corn in high fructose corn syrup–without appropriate disclosure. Consequently, consumers can not make an informed choice about ingesting them, as they do when taking “chemically altered” supplements.

      • JB

        I couldn’t agree more!

        • http://pikalainavippi.org/ Elina

          Totally agree! The use of antibiotics, etc. in our food is the real threat.

    • EddieW

      My Congressman ignores me, but answers…always with why this is such a good idea!!! of course he’s a Dem!!, but I keep track of everything he does, and will give it to one who runs against him!!

  • L.P.

    The FDA (Food and Death Administration MUST be dismantled. Any entity given this much power and we are in George Orwell’s “1984”….which seems to be coming to fruition with the Obama Regime currently in power, but not for long….. hopefully.

    “If you want a vision of the future, imagine a boot stamping on a human face-forever.”
    (George Orwell)

  • mary elsa taylor

    The politics of the Pharmaceutical industry are plain and it is time the citizens of this country start understanding that their own health is in the balance; that they are pawns in this game of greed.
    I am not ignorant regarding health and the benefits of supplements….herbal, vitamin and homeopathy. Many of these substances are those that benefited our ancestors who, contrary to
    popular opinion maintained good health and well being. Give me a physician to mend my broken bones and thank God for the medical community when it is truly needed…..but to take away
    our right to heal our bodies for the numerous conditions that the medical community seems to FAIL at, is downright “life in a dictatorship”…..and the dictators are Corporate Greed, putting profit above
    health, wellbeing and Life itself.

  • Aaron Raimey

    I have family members and friends who need natural supplements and if this law is passed they’re in serious risk of fatal health issues. i agree with alot of the comments made earIier. How is it in a country founded on freedom can change to taking them away without any notice or giving the nation a say on the issue. My questions to the Fda are as follows; Don’t you have familes? Do any of them take natural supplements? Do you know that by doing this you are hurting our economy more than helpling it? I Hope that awareness to issues like this one with help people open their minds instead of thinkin about their bank accounts.

  • KS

    Class Action Suit or die. Supplement Companies unite

  • J Buckhart

    If the FDA does this, what’s next? Are they going to prohibit the sale of cullinary herbs and spices – such as cinnamon, thyme, sage, cheyenne pepper, garlic, etc. that can be used for health purposes as well. Are they going to take away the right to grow our own gardens?
    Will we be required to get a permit to have fruit trees or grape vines in our yards so we can have some good wholesome fruit? Maybe they will come and check our foods we are allowed to grow and make sure we are using the approved poisons to kill bugs and worms. Are they going to destroy all heirloom seeds so nothing will be available but GM seeds? Think about it. There’s no end of what they can do to keep us sick and die younger.

    • DABIGRAGU

      As a matter of fact, YES they are, that is their intention. Look up CODEX. This is why they rushed through and passed (“We to pass it to know what is in it”-Nancy Pelosi) the heal-care bill. If people will unite, party politics aside, we can and will move mountains!!
      Let your “representatives” know we will not stand for their tyrannical behavior any longer. Enough is enough.

  • Kelli

    Yet they allow thousands of dangerous and useless drugs to be handed out like candy?
    Let me choose my own healthcare. Supplements can save lives and prevent disease.

  • Candy

    People must open their eyes and see that the government is looking for ways to control everything you do. Make sure you vote for people that believe in LESS government control. There are those that think they know better what is best for you and love having the control to do so. I do not want to be told what I can eat. Every time this is a LOSS of FREEDOM to make your own decisions.

  • John

    We need to work smarter, not harder. While I think sending emails to politicians and bureaucrats may have some limited benefit, it seems we should look to Big Pharma’s tactics, and focus our efforts on lobbying those in government whom we know to be sympathetic to our cause. That gives our efforts more leverage. In contrast, when I email my congressional delegation, I generally get a form letter containing assurances that they will ‘carefully examine the issues, and keep my views in mind.’ That gives me lots of confidence – NOT.

  • Scott

    For God’s sake people, step up and make this country what it’s supposed to be, free.
    The FDA should be charged with murder and many other charges of illegal activity.
    I guess they will create another black market of natural products.

    Please, everyone, don’t believe the media or government propaganda, find your own answers.
    There is just too much deception and too much wrong; healthcare, fed reserve, FDA, insurance, taxes, drug tests, cops tasering, on and on and on. Let’s stop it all now.

    Vote Ron Paul.

    • http://www.mylifevantage.com/158444 Beth Moell

      For God sakes we need to dismantle the FDA and it needs to be done now. The so called cancer treatment “radiation and chemo killed my sister. When is this madness going to end. We need to walk for health and not cancer. I wish I could get hold of everyone who signed this so we could start a new moment “walk for health”
      If you read this and want to be apart of something so big it changes they way we approach disease please email me. [email protected]
      God Bless Beth

    • Tiffany

      Everything everyone is saying here is true and right, however, do you all really believe that anything we say or do to the government is going to change their mind about killing us all off, until there is only 5 million population left? The world is over populated and our economy in bondage…the government’s way of solving the problem (rather than controlling “their” expenses) is to kill us. It’s the new world order. I hate to sound so negative, but it’s true. If they don’t care about our freedom or health, what makes you think they care about our opinions? No one “good” has the power to change anything. They all work together, from the police to the president…all one motive “steal, kill, and destroy.”

      • RG

        This is preposterous. Think about what would happen if the government ‘killed off’ a large section of its population. The economy would crumble and their tax revenue would plummet. Thinking that they would do this is insanity. What could possibly be the reason? Who benefits? How exactly do they benefit? Craziness.

        Please think before you speak. One of the pretenses for this bill is stems from foolish people who look before they leap and are being taken advantage of or hurt. This is unfortunate as it hurts those that are willing to educate themselves.

        • John

          RG- Its not preposterous that the government would try to kill off a large portion of the population. The UN very openly states their intention cull our numbers down to one billion people in UN Agenda 21, a a 40 Chapter document that you can read here http://www.un.org/esa/dsd/agenda21/ Codex is part of this agenda, and so is any national legislation or regulatory move such as this which would block consumer access to dietary supplements or to healthy organic food. All the entitlement programs are bankrupt, the government would much prefer you die before reaching age 65. The European Union is the blueprint for what the ruling elite are trying to do globally. To get some badly needed perspective, please read Dr.Rath’s book The Nazi Roots of the Brussels EU, especially read Chapter 5 which documents how the level of societal control is being exponentially ramped up to strip people of the last vestiges of privacy. This whole book can be read for free on the web. The EU was originally conceived by the Nazi High Command in the waning hours of WW2 when it became apparent the Nazis would lose the war. They devised a long range scheme to get the control over Europe that had eluded them militarily. They figured out a way to isolate England. Germany and France politically dominate the EU Parliament which is a truly farcical entity since the unelected European Commission actually makes the laws which the Parliament merely rubberstamps. They’re banning access to supplements in the EU very rapidly and the US is trying to play “catch up” ball. An effort is underway to destroy America so we will be forced into the Council on Foreign Relations planned North American Union collectivist dictatorship. The FDA already has generated one harmonized set of Food and Drug regs for Canada, the US and Mexico via their Trilateral Cooperation Charter. Canada is in a process of harmonizing their laws with the EU via their CETA Trade Agreement. The end goal of the ruling eilte is a global totalitarian state modeled after the EU and they’re moving rapidly in that direction. This effort to ban our access to supplements is just part of a much larger ruling elite effort to engage in population control and societal control. Do some reading on UN Agenda 21 and about ICLEI, the NGO organization pushing it. A growing number of US Counties and Cities have been quitting ICLEI upon becoming aware of this population control agenda. Google “Carroll County Maryland, and ICLEI” and see how this county removed itself from ICLEI and why. Take the time to study this website and a lot will become clear to you: http://www.green-agenda.com/

  • Betsy

    It just makes me sick to know that ex-Monsanto executives/lawyers are in the FDA…….because it’s the FOOD that’s making us sick….

  • Tanya

    Please do not allow this to go into effect. Doctors recommend supplements fo patients also.

  • Wendy

    Seems like they want to make sure the GMOfood & Chemtrails will kill us faster.

  • TD

    The industry is full of garbage products and needs to be more or less shut down. Most nutritional supplements are snake oil.

    Everything NEEDS to be proven to be effective if it is being marketed for doing something, otherwise what is to prevent people from selling fraudulent products? Nothing.

    And this is EXACTLY what the food supplement industry is doing right now. They are taking money for selling useless products to people.

    They obviously are going to oppose any effort at regulating them, because right now they are stealing from stupid people.

    • dez

      Even the worst or poorest supplement does far more good than any Pharmaceutical drug. At least it will not kill us or destroy our health. If a supplement is not working we soon know it and drop it. Can you say the same for a expensive FDA, Doctor approved drug.

      • Megatron

        Tell that to the people who took too much ‘so pure’ colloidal silver and ended up with blue skin and silver compounds in their eyes, or took the actually effective Kava for their anxiety, but overdosed and damaged their livers thanks to toxicity, or bitter orange for weight loss, which contains compounds so similar to ephedrine that it has the same effect on the human body and may cause heart damage and death. Stop making the connection of Natural = Good and Unnatural = Bad! Arsenic is natural! That doesn’t mean I’m going to take it as a supplement!

    • Megatron

      I agree. Many supplements out there are unproven to do anything, and many have known interactions with prescription and over the counter drugs, and even with other supplements. Supplements that are ground herbs or oils don’t take the potency of individual plants, which can vary -greatly-, and thus the dosage per pill labelled on the bottle is inaccurate. These pills NEED to be looked at more closely, people have been injured and even killed thanks to reactions and interactions.

  • Ron Payne

    I can’t believe this , I have Hep-C & Cirrosis of the the liver . I have taken Big-Pharma’s treatments twice and nearly died from the side effects, plus the hep-c came back. Today I’m holding the disease at bay with nutural herbs . It’s the only reason I’m alive . I have a right to take natural herbs grown from the earth ‘ just like having a right to eat real food . GOD put all plants here for a reason . Who could I contact in order to stop these greedy bastards , surely there must be a lawyer or group of people who are willing to do whatever it takes to stop this. I’ll check back here later if anyone can help …. Thanks Ron Payne

  • Dora Anne Gramly

    I am sad.
    It was not one woman that took prayer out of our schools.
    It was a lot of people that sat back and did nothing but complain as they thought it wold not happen.
    Without our natural health supplements many of us will die as we chose not to go to doctors and hospitals to let the medical professionals use us for test rats and kill us.
    How long will it be before the government police come into our homes and yards to find herbs growing and haul us off to jail for growing drugs
    How can I help to stop this horrible wrong? What can we do together to stop this shameful leap in control from our government?
    Dora Anne

  • http://www.edenessence.miessence.com Constance Bratt

    We have WAY TOO MUCH government intervention!! No matter how many officials we elect that seem to represent us, there are way too many that are corrupted by selfish interests. Let’s vote those greedy buggers out of office and elect some honest, non-corruptible people. Some have been in way too long and we are becoming like post-war Germany! I’m truly ashamed of our government…
    It is not for the people, by the people!

  • Anthony

    The American People need to stop being so intimidated by their government and call this power-grab what it is. The bottom line is…I don’t need the government’s permission, despite what they think. However, I am but one person. If 10 MILLION Americans got up and said…”Hey FDA! I won’t do what you tell me!!” Then what??

  • http://www.voltahealth.com RR

    Thank you for the work you are doing. This not only affects people of the United States, this affects all the countries that import their supplements and bulk ingredients from the USA, such as my country Canada. Canadians, get on board, your health freedom is equally at risk. The FDA and Health Canada are pretty good friends, as they have all been infiltrated by big pharma exec’s.

  • http://www.pathway-health.com Phil

    Hi To all our brothers and sisters in the USA, The Land of the Free!.
    Well it won’t be for much longer. Equally, we have the same problems in Europe coming soon.
    This surely must be the tipping point. Your “leaders” have led you into illegal wars costing millions of lives, they have allowed the banks to enrich themselves, they are spraying crap into your skies daily, they have hidden from you the natural cures for diseases such as Cancer and Heart Disease, they are lying to you about global warming in order to rob you of the little wealth you may have left, they are monitoring your activities, your e-mails, your phone calls, your websites, they have trained a police force not to serve you but to control you and protect the corrupt politicians, the poison your ware with a carcinogen (fluoride) and still you drink it, give it to your children and say nothing, they control the media who lie to you and cover up the truth (and still you purchase the newspapers), they give you football and mind numbing TV programmes (and still you keep watching), they teach your children nothing other than the political correctness and obedience to Government, they allow the CIA, FBI to act as criminals to kill as they wish. YOU, hide your head in the sand fearful to know the truth (911, USS Liberty, Oklahoma, Waco and all the countless others), they destroy your manufacturing base. AND YOU ALL SIT THERE (JUST LIKE US). WHERE ARE YOUR BALLS? STOP COOPERATING, STOP PAYING TAXES, STOP BUYING NEWSPAPERS, STOP TAKING DEADLY MEDICINES, SWITH OF THE TV AND OPEN YOUR EYES!
    GOOD LUCK EVERYONE-WE ARE ALL GOING TO NEED IT

    • O’Ross

      Phil, you nailed it.

  • BlogShag

    What really makes me sick is all the people that keep voting Deomocratic or Republican. They don’t seem to get it. This nonsense will never stop if you keep voting for people that are backed by huge corproations

  • http://www.hawksandassociates.com Jade Hawks

    I was appalled when I read this article as I figured the grassroots movement of 1993-4 had put a stop to the FDA’s nonsense in trying to take control of vitamins and supplements! It was clear then that they were in bed with the big drug companies who didn’t want people to have a less expensive option for healthcare than having to buy prescriptions doled out by doctors! Well, we stopped them 17 years ago WITHOUT the amazing communication system we have now with computers and social networks, so in the immortal words of Barney Fife: it’s once more time to ‘NIP IT IN THE BUD!”

  • Mike Lowry

    A lobby group is 100% necessary. Best way to get your voice heard is to get professionals to lobby in Washington for you. There also has to be a constitutionality approach to this. Dietary Supplements provide citizens with alternatives to maintain or obtain health and wellness. Maybe there is a right to life approach someone with a greater legal capacity can approach. Maybe introducing the ability to apply the residing state’s sales tax to supplement purchases. Also, approaching ‘Dr. Oz’ as the front-person for this campaign could also help. Every single angle or approach must be considered, the FDA is pulling out all of the stops, and so must we as citizens. We must protect our right to maintain and improve our health.

  • http://engageamerica.com Jesse_EngAmer

    The nanny state school principal is at it again.

    Did you know that according to the FDA we have no actual right to choose what we eat. In an excerpt from the briefing to the supreme court case: Farm-To-Consumer Legal Defense Fund vs. the United States Department of Health and Human Services the FDA implicitly stated the American public’s “claim to a fundamental privacy interest in obtaining ‘foods of their own choice’ for themselves and their families is without merit.” In other words, we don’t actually have the right to choose what we eat. Furthermore, the American public has no generalized right to bodily or physical health.

    Furthermore, the FDA doesn’t even have the funding to keep contaminated food off our plates and dangerous drugs out of systems. The FDA admitted in their report Pathway to Global Product Safety and Quality it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority and every foreign food facility as well. The plan calls for the FDA to inspect 600 foreign food facilities in the first year and double their inspections each subsequent year. By year 9 that would 153,600 facilities or just under 420 facilities a day.

    There’s no way the FDA has the resources to handle additional, unnecessary regulation. Its about time the FDA stopped waging its war on everything consumable, especially vitamins and supplements that have been proven safe and effective time and time again and focused their misguided efforts where it really matters.

    • O’Ross

      Jesse, very interesting. Evidently, we don’t have the right to survive. So much for the Constitution. Here’s something to chew on. According to Dr. Rath, Codex traces back to the 3 companies resulting from the dissolution of I. G. Farben, post WWII. I. G. were the makers of Zyclon B, the gas that went into the ovens of camps like Auschwitz.

      • http://engageamerica.com Jesse_EngAmer

        Wow. I had no idea. I should be more shocked than I am unfortunately. Thanks for the info, something definitely to look into. It certainly explains the attack on an individual’s right to choose what he or she consumes.

  • Carole Starr

    I’ve not read ALL the comments and links and words here yet – but I AGREE with Blog Shag, Jade Hawks and Mike Lowry (and prob all others). I spent 11 years in pharmaceutical sales (about 8 years too long) and learned a great deal – 17 years in nutrition sales and 43 years studying natural nutrition and healing. Kevin Trudeaus book “Natural Cures They Don’t want you to know about” is a good read (albeit in the American way he’ll try to sell you some items – that’s ok – he still speaks the truth). 27 years ago, as a drug rep – I heard a cardiologist at a major meeting espouse the merits of CoQ enzyme 10 (and have been taking it ever since) then I heard a major drug company was trying to make it into a drug (so they could control and profit) it is INDEED the PHARMACEUTICAL industry/big corporations that are controlling America/our politicians/our freedoms in this particular issue.

    The Dr. Oz suggested is RIGHT ON. HE/his network has the clout – HURRY big business will buy and gag him soon – THAT”S what happens!!

    Now – all that being said – we do need some quality controls – In nutrition sales I had a meeting with an internationally recognized expert on fish oils (a critical care surgeon with a passion about nutrition and has written text book chapters on the subject). His lab had tested multiple brands of fish oil capsules looking at the levels of Omega’ 3’s …..some had NONE, so consumers waste their money completely.

    We also do not want false and undocumented claims leading people’s health and money down the wrong trail –

    Lastly – this link said it was sending me to a petition to sign, but I could not find it (yet)

  • http://www.facebook.com/groups/136038876480703/?ap=1 Liz Sookarry

    We, as a third-generation family-owned health food store, are worried sick this will ruin our business. We have always prided ourselves on the fact that we have never made anyone ill, and in fact have helped to heal thousands of people over 35 years. We have started our own in-store campaign, getting our customers to send letters and sign our petition. We have also started a Facebook Group, and would appreciate any and all support from across the nation! We are positive we can fight this and win, we have always survived in the past, but the American people have to come together to save this industry. At the moment, nobody seems to know anything about it, except what we tell them!! Please spread the word, tell everybody you know, even those you DON’T know, that the government chosen to represent them has sorely let America down with this Bill.

    http://www.facebook.com/groups/136038876480703/?ap=1

  • Justin J

    Its clear to me that we need to unite on a massive front. We need to organize and take down this through a massive campaign and grassroots movement, we need to attack this from every angle. The main thing is unite every organization together. Every supplement company, every health care store, every person who takes supplements, every watch dog group. We need to fire bomb congress with emails and letters protest in the streets. Protest in front of the FDA. Spread the word far and wide.

  • Shannon

    I am very concerned with this new proposal. Here is the letter that I sent to all representative and the FDA. Feel free to take from it to form your own. I covered the “basics” as suggested here, but also included a bit on the economy (loss af at least $61 billion and millions of jobs), and research into vitamin supplement related deaths (which is ZERO over the last 27 years). Contrast that to Viagra (which will not fall under these proposed regulations) which in one study alone involved looking at 1,473 major adverse medical events involving the use of Viagra. There were 522 deaths, most involving cardiovascular causes developing within 4-5 hours of taking a 50 mg dose of Viagra. The majority of deaths occurred in patients who were less than 65 years of age and had no reported cardiac risk factors. This was only 2 years after it was approved by the FDA.

    Before I could send this letter, my 8 year-old daughter asked me what I was doing. I explained that I was writting to our representatives because I was worried about a new rule that would prevent us from having the vitamins we like.

    Her response was “Why do they want us to be sick?”

    I am greatly concerned about the FDA’s draft guidance on New Dietary Ingredient notifications for dietary supplements. It turns what was meant to be a simple notification system into a scheme where FDA can approve — or deny — any supplement created in the past seventeen years, making the FDA the ultimate arbiter of what dietary supplements will and will not be available.

    The agency’s interpretation of “new dietary ingredient” is far too broad. Under the new rules, all ingredients 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” includes certain types of fermentation and exposure of ingredients to high temperature baking and cooking, and using a botanical ingredient at a different life stage than previously used — for example, an extract of unripe apples instead of ripe apples.

    The guidance states that a synthetic copy of a constituent or extract of an herb or other botanical is not considered a dietary ingredient. This arbitrary distinction will make many dietary ingredients on the market illegal — particularly as this standard does not apply to non-botanicals.

    Most importantly, the guidance makes the NDI notification process burdensome and repetitive. It requires 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 Dietary Supplement Health and Education Act of 1994 states 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.” It says that Congress finds that “dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.” And it says that “legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”

    The guidance may also have far-reaching consequences. For example, if Sen. Durbin’s dangerous Dietary Supplement Labeling Act goes forward, with the list of “safe” supplements and doses which FDA and IOM would draw up under the bill — such as vitamin D in amounts greater than 4000 IU — it would mean that more therapeutic doses or supplement preparations could never meet the new NDI hurdle. This could have a profoundly negative impact on this nation’s health (Please see research done at the bottom of this email. There have been ZERO deaths attributed to vitamin supplements including intentional and accidental misuse of vitamins over the last 27 years as reported by the American Association of Poison Control Centers).

    This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its NDI draft guidelines to reflect DSHEA’s (and Congress’s) stated values and goals.

    A secondary concern I have is related to the effect on our economy. The Natural Products Foundation conservatively says that dietary supplements contribute $61 billion to the U.S. economy and supports 450,000 jobs. The FDA’s new regulations, however, impact not just dietary supplements but also superfoods and functional foods which are part of an even larger market. In all, millions of jobs will be impacted by the FDA’s proposed new regulations. How does this come to millions of jobs? Add up all the jobs related to the importing, manufacturing and transportation of nutritional supplements and superfoods. Include all the jobs related to marketing, advertising, promoting, distributing and publicizing these supplements. Then include all the jobs of workers in health food stores, fulfillment centers and supplement formulators. On top of that, you have all the jobs which are supported by successful nutritional supplement companies, including accounting, legal, graphic design and technology jobs. So $61 billion and 450,000 jobs is a CONSERVATIVE ESTIMATE.

    In closing, I would encourage you at the first sign of your next cold or flu, to begin taking at least 8g (8000 mg) of vitamin C as ascorbic acid every twenty minutes for 3 to 4 hours until bowel tolerance, and then smaller dosages of 2-4 g every 4-6 hours for ten days to prevent recurrence. If you have trouble with 8g, you might try lowering to 2g every 20-30 minutes for the first two to three hours. I can guarantee that you will not only prevent the common virus from getting worse but if you continue to do this regime you will never have a cold again.

    “Why do they want us to be sick?” Why indeed?

    Research done on safety regarding vitamin supplements
    Over a twenty-seven year period, vitamin supplements have been alleged to have caused the deaths of a total of eleven people in the United States. A new analysis of US poison control center annual report data indicates that there have, in fact, been no deaths whatsoever from vitamins . . . none at all, in the 27 years that such reports have been available. Download any Annual Report of the American Association of Poison Control Centers from 1983-2009 free of charge at http://www.aapcc.org/dnn/NPDSPoisonData/NPDSAnnualReports.aspx The “Vitamin” category is usually near the very end of the report.

  • http://www.elenagreco.com Elena Greco

    I signed your petition; it was sent to my senator (Schumer). His response was that it “protects” consumers. I wrote him back:

    “There is already legislation in place to “protect” consumers from risks, so there is no need for more legislation. This is a prelude to an attempt by the major drug companies, who are only interested in profit, to crush the supplement industry, which is a competitor. Please read the fine print in this bill and do not fall for their propaganda. Our health is at stake.

    I realize that serious issues are on the table, and that this might seem minor in comparison, but that is exactly what the drug companies and the FDA (I consider them partners, as the FDA is virtually controlled by the drug companies now) are hoping for – that no one will notice what they are actually trying to accomplish with this bill. How could it hurt anyone to label supplements more carefully? Please understand that that is NOT what this bill is about. They are trying to make it impossible for consumers to purchase supplements that protect our health and ensure our longevity by pursuing a lengthy campaign that accomplishes these things in very small increments in the hope that no one notices until it’s too late. Please support our health and the rights of your constituents to purchase any supplements they deem necessary for their personal health by voting against this bill.

    Thank you for your attention to this bill and our ability to access nutrients and supplements that ensure health and longevity.”

    Lawmakers are just accepting this bill without realizing what it actually does — or they are in the pockets of Big Pharma. Not sure which is scarier….

  • Matthew Smola

    Big pharmaceutical lobbyists are on their way to getting this Durbin bill passed. I believe the only way to get the attention of any of our lawmakers is to tell them directly that you will not vote for them again and campaign against them if they vote yes on this bill. We all need to start taking personal responsibility stand up against this tyranny. We also need to push our will on to our politicians that are looking out for their best interest, which always seems to have something to do with money! If it’s for family, friends, or any other interests our politicians may have.

  • http://www.marketplace1.net David Laverty

    I just heard about these proposed new regulations while shopping at Vitamin Cottage, a great Colorado-based company that provides vitamins and supplements at very reasonable prices. This over-reach by the FDA is alarming. Millions of Americans are benefiting from the long list of health benefits from COQ10, Resveratrol, Fish Oils, and many other items. Consumers receive great health outcomes at retail prices of less than $10.

    Countless studies indicate extensive safety with these products and no measurable side-effects. Nearly any drug on the market has considerably more safety concerns along with distinct side-effects. It appears that these regulations are an attempt to use government influence to benefit corporate pharmaceutical companies to lock-in profit streams in the name of consumer protection. How about if we let the free market work? Of course, when there is evidence, a badly performing supplement should be removed from the market. However, in this circumstance, medical professionals, consumers, health organizations, and nearly anyone can read the studies for the themselves to determine whether they are interested in consuming safe, nature-oriented supplements.

    Who knows, perhaps in the future, people will be buying fish oil on the black market? Go ahead and try to regulate these supplements, the power of the Internet will be become painfully apparent.

  • http://www.a8211604.com a8211604

    I’ve said that least 8211604 times. SKC was here…

  • Suzanne Wells

    Oh Susie!!!! I am so glad you are still here!!!! When my daughter (Isabella) went to the store and saw you had closed I was terribly disappointed. I truly hoped to begin therapy and perhaps even an apprenticeship with you. Boy I could tell you a few things about the FDA and every other government program that is going to end human life as we know it things continue. May sound crazy, but I’m hoping to ascend this winter solstice. I’ll be more than happy to support this cause however. Many blessings and much success!

  • http://www.islate.org/ Supplements

    It seems that the only supplements that the government go after are the ones that actually work.

  • johnathan

    All a waste of time look at the general food market basically the cause of 90% of Americas diseases and all “unknown” or should I say unlisted ingredients have been identified and past as safe and or healthy soo who gives a rats ass about some b vitamin really wow such a pointless job let’s give um a hand FDA has our backs god I feel safe thanks