FDA Guidelines a Perversion of Congressional Intent

July 12, 2011
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iStock_000006788919XSmallThe FDA is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. Let’s tell the FDA that supplements are not drugs and ask Congress for help!

Last week we told you about FDA’s draft guidance on New Dietary Ingredients, which allows FDA to arbitrarily deny the sale of any supplement created (or said to be created) in the past seventeen years!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 We expect them to say, “It’s only draft guidance!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 Just because the agency is calling it “draft guidance” doesn’t mean this thing doesn’t have teeth.

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

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

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 In fact, before this draft guidance was published, Sens.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

To quote DSHEA itself: “Congress finds that:

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

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

FDA: We Will Decide What Supplements Can Be Sold

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

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

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

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

DSHEA: Supplements Are Not Drugs or Food Additives

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

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

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

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

The 75-Day Waiting Period

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

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

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

The Question of Synthetics

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

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

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

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

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

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

TO SEND YOUR MESSAGE TO THE FDA AND CONGRESS

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.

48 Responses to “FDA Guidelines a Perversion of Congressional Intent”

  1. superb webpage and appreciated reading your content

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  2. Tony Long says:

    The FDA’s dream of eliminating supplements from the market and leaving the field to only FDA-approved drugs is closer to becoming a reality than most of us realize with the passing of the Food Safety Modernization Act (FSMA) which now subjects all dietary supplement companies in the U.S. to FDA licensing.

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  3. Ken B. says:

    Well, I just contacted my senators and representative, and posted a comment on the FDA’s “regulations gov” site. But I do agree, that the whole supplement industry needs challenge this. These days, politicians and lawmakers are not often fazed by popular dissent, but moreso by lawsuits and bad press.

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  4. brian says:

    It is great to put comments into congress and the FDA. But that will NOT be enough to stop the draft guidance from no longer be just a draft. The industry organizations and large comporations that produce supplements need to start legal action NOW to stop this before its too late.

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  5. John Bayne says:

    I may not have the right of say that an American citizen would have, but I believe my say has the value at least of a more objective onlooker, not to mention the fact tha whatever the FDA does in America seriously affects people all over the world, especially in an affluent country such as New Zealand.

    In order to earn my keep, so to speak, I will speak very objectively by saying that, there is no doubt about the fact that we are made up of around 100 trillion cells out of whichm, in addition to those cells which remain just as cells, we have the exceptions forming organs and connective tissue on what could be called the secondary level, which in turn make up, on the teriary level, the eleven systems of the human body, 1.skeletal, 2. muscular, 3. nervous, 4.cardio vascular, 5. digestive, 6. respirative, 7. reproductive, 8, integuminary, 9. endocrine, 10.Lymphaatic and 11. excretory; systems and all of three levels are integrated on the fourth and real life level called the human body.

    On the lowest level, the cellular, five things are vital in this order: 1. oxygen or death in minutes, 2. water, or death in around 48 hours, 3. nutrition, or death in months, 4. elimination, or death in arounmd 7 hours, an dfinally freedom from poisonous or toxic substances.

    On the fourth level, however, their are eight vital necessities, which, if provided adequately, will ensure good sound physical health, which eight things are known pneumonically as NEWSTART: nutrition, exercise, water, sunshine, temperance, air, rest and trust in God.

    It should be noted that although, there is no group which has 100% compliance with their beliefs, there is, at least, some in the naturapathic/homeopathic camp, who are responsible enough to live up to what they know and it is they, who prove by their lives, that their ideas are as much more sound and scientifically correct that the FDA’s, than their health and longevity exceeds that of the individuals who consitute the FDA, AMA, and all that is not only opposed to the natrual way, but actually kill, according to Nexus’s 10 year study of death by misadventure in the United States, around seven and a half million people over ten years or 750.000 per year, remembering that, these figures are only for deaths, as for injuries, they must be much higher numbers, also remembering that the AMA, the most prestigious representatives of the allopathic way, admist to around a third of those figures.

    Now, how come, the greatest public menace to society in America, killing more US citizens than any other cause per year, gets to be the legal authority over determining what is safe and what is not safe, remembering that their laws are both unfounded, unsound, scheming and unjust, effectively doing as good a job in preventing responsible people from having access to the natural products they need as if they were specifically formed for this very purpose, and all in the name of doing it for our own good.

    Regards

    John Bayne

    [email protected]

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  6. Barbara Williams says:

    I have already lost a form of Vitamin B which I really needed because of FDA. How many people have died from approved pharmaceuticals as opposed to natural supplements?

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  7. Dorothy M says:

    If the Food & DRUG Administration were doing its job, they would be investigating and/or controlling DRUGS in this nation. How many people have you heard of that have died of a vitamin/mineral overdose? Or have died because they were taking a vitamin that caused them to have a heart attack, caused cancer of the liver, or many other disastrous “reactions” to the vitamin……NONE!!!!

    How many have died of drug overdose, or reactions from a prescribed DRUG that was OK’d by the FDA (Food and DRUG Administration)?
    Next question, how much is the FDA being fed by big pharma to overlook dangerous ingredients, or downright lethal ingredients for the sake of making money?

    God help anyone who is working for either a drug company, pharmacy,, doctor or the FDA that is enabling products that are harmful or even lethal to go to market.

    What are they afraid of? That the vitamins will keep you too healthy and you will not “need” their products?

    While we’re at it…How much are they investigating large food packaging companies who might be adding harmful preservatives, or flavor enhancement, or dyes to make the food look more attractive?

    In my opinion, the FDA (Forcing Drug Advancement) has much, much more to keep them busy than trying to put vitamin/mineral companies out of business.

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  8. rachel says:

    Keep supplements (but make sure they contain the amounts and quantities they are stating), OUTLAW DRUGS…namaste’,rachel

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    • Nicholas Mekich says:

      If these guys would get out of bed with the drug companies and start regulating what really needs to be regulated and stop them from killing people with those poisons they allow to be shoved down our throats called prescription drugs and stop those legal drug junkies called doctors . When is the last time the drug companies came up with a drug that CURES a problem and not mask a condition to keep you as a returning customer. STOP THE DRUG LOBBY OUTLAW IT SEND SENATORS ON THEIR PAYROLL TO PRISON

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  9. Alan8 says:

    I see this attempt at unreasonably restrictive supplement laws as a corrupt ploy to eliminate competitors to expensive, unsafe prescription drugs produced by pharmaceutical corporations.

    The FDA works for THE PEOPLE – not the pharmaceutical corporations! The FDA’s responsibility is to insure people are protected from unsafe products – not to restrict safe products for arbitrary reasons.

    I would support legal action against the corrupt FDA officials who unreasonably restrict OUR RIGHT to safe supplements, in violation of the spirit and letter of the law.

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    • A. Werewulff says:

      @ Alan8… Don’t believe everything you think… just sayin’ *;-)

      The FDA, USDA and other alphabet soup government regulatory agencies, as well as, the (non)-government FED can only be reigned in by CONgressional oversight… At this time there are many that are bought and paid for long before they are elected to CONgress.

      WE THE PEOPLE that know better need to educate families, friends and neighbors to stop voting for psychopaths and sociopaths that lie, lie, lie, saying whatever they think we want to hear… Only then will we begin to see change we can believe in.

      “The key is to get to know people and trust them to be who they are. Instead, we trust people to be who we want them to be – and when they’re not, we cry.” ~Author unknown

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  10. Jesus says:

    this is ludicrous. these guys are not going to do anything against supplements and vitamins. far too many companies and normal citizens here and around the world depend on selling vitamins and supplements. this is exactly what Mr. McCain and the FDA guys tried to do in his so-called “warning speech” and the new bill. result? they lost!

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  11. Lila Languerand says:

    Hello:

    Leave our supplements alone. I do not want synthetics in our natural supplements.Supplements are not drugs, and I look at these supplements as getting what I need from them like what I get from fresh vegetables and fruits what is nutrients for my body.

    Senator Durkin needs to find another focus like why is arscenic being put in our chicken? Why aren’t our borders safe? Why don’t all republicans start cutting their pay checks, instead of balancing the budget by taking away from the poor and working class. Senator Durkin do something useful for this country instead of going after supplements. I would like to know what drug company is paying you to continue down this path??

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    • A. Werewulff says:

      @ Lila Languerand… I help you figure out your problem *;-)

      You must be confusing Jim Dirkin, Ill State Representative 82nd legislative district (R- Western Springs) with Sen. Dick Durbin (D-Ill.) Author of the legislation in question ‘FDA and Senator Durbin: Sneak Attack on Supplements’

      Rep. Jim Durkin is a republican in the Ill legislature AND Senator Dick Durbin is a Democrat from Ill in the US Senate and co-author of this HORRIBLE legislation with Senator Richard Blumenthal (Dem-CT)… S.1310: Dietary Supplement Labeling Act of 2011

      I can see why you may be confused, especially if you were directed from this StrokeDoctor site.. may be deliberately misleading.. then again, could be an honest mistake.

      http://strokedoctor.com/blog/new-bill-threatens-supplement-industry-you-can-help-get-it-defeated-2

      New bill threatens supplement industry! You can help get it defeated
      Posted July 11th, 2011 by admin with No Comments
      Recently Sen. Dick Durkin introduced bill that would give the FDA new regulatory muscle to control the supplement industry which could result in many products (especially new ones) not making the grade and, by virtue of this, disappearing from the marketplace. You can read all about this power move by clicking this link: http://www.anh-usa.org/fda-new-sneak-attack-on-supplements/.
      If after reading this article would like to sound off to the FDA about its attempt to strong-arm the supplement industry then just click this link and “have at it”:https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833
      Dr. Steenblock and his medical & web teams thank you for taking action!

      I’ll copy my comment back to the ANH website administrator and let them get the The StrokeDoctor misinformation squared away..

      In the meantime, everyone please do some research and catch up to speed so we can get this terrible piece of legislation defeated.

      “‘I do,’ Alice hastily replied; ‘at least – at least I mean what I say – that’s the same thing, you know.’ ‘Not the same thing a bit!’ said the Hatter. ‘You might just as well say that “I see what I eat“ is the same thing as “I eat what I see“!’” ~Lewis Carrol. Alice’s Adventures in Wonderland

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  12. Mary Paganis says:

    Please allow us, the consumer, to decide what we want to put in our bodies. The last thing we need is more “regulation”.

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  13. This stinks to high heaven and one of the smells coming off of this shady, crooked little deal smells like who? You guessed it, the Food Czar or you may like Der Food Fuhrer, Michael Taylor. He’s just the little goose stepper who could pull this counterfeit Catch 22 out of his you know where (rhymes with grass).

    I have commented on this creature before but it needs repeating so you know what you are dealing with. He is a former multiple employee of Monsanto, that is when he is not working for Monsanto within the FDA (where else).

    So Obama appointed him Der Food Fuhrer though he doesn’t know zip about food or nutrition. So what does Mikie know that got him this Obama appointment? Mikie knows how to pull off fraudulent, loop hole, word spins like this one in order to create the fascist ideal, the control of food, his track record is below.

    Here is Mikie playing Yoyo between Monsanto and the FDA:

    1976 staff attorney FDA, assistant to the Commissioner.

    1981 law firm representing Monsanto

    1991 returned to FDA as Deputy Commissioner for Policy

    1994 USDA, as Administrator of Food Safety & Inspection Service.

    1996 returned to Monsanto Vice President for Public Policy

    2009, senior advisor to FDA Commissioner

    2010 appointed to FDA, Deputy Commissioner for Foods

    The quote below fits perfectly the FDA proposed NDI guidance and the dangerous Durbin bill.

    “How smooth must be the language of the whites, when they can make right look like wrong, and wrong like right.”
    Black Hawk, Sauk (1767-1838) Ma-ka-tai-me-she-kia-kiak.

    Doc Blake

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  14. Osun Thyruss says:

    If the FDA devoted this much nit-picking scrutiny to every ingredient of processed “foods” and genetically modified goods, I’m sure we would all be healthier.
    Our drinking water is spiked with toxic smelting byproducts (lovingly called fluoride), and the FDA is worried about my vitamin D intake.
    And if we happen to one day learn that eating banana peels cured all forms of cancer, I’m certain the FDA would pull bananas from all the shelves, forcing us to enjoy canned, peeled bananas.

    I can’t help but wonder: How much influence/control does the pharmaceutical industry have over the FDA?

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  15. Julianne Daily says:

    I do not trust the fda. How many times did the release and had to recall gardisill and now they have released it again. How many people have their drugs killed? They don’t care about the people they only care about how much money they can make for big pharma and whoever else they work for. They also recall drugs that maybe helping people because it may not be doing exactly what it said but still is helping in that area.

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  16. Helen Coleman says:

    I think this is a good newsletter, and I appreciate you efforts. I’m not in a position to donate right now, but will qas soon as I can. Thanks

       0 likes

  17. Helen Coleman says:

    I previously sent a message to FDA. Please send that one to congress.

       0 likes

  18. Lunke Asbury says:

    What is this? Will you stop pandering to Big Pharma?

       0 likes

  19. Dan Smith says:

    We all know that the FDA is unfit to regulate the supplement industry because of its bias against supplements. We know the FDA will not abandon its goal of requiring all supplements to go through its drug approval process. As I understand it, the FDA benefits from these hefty drug approval fees. One approach to change this situation would be to require the FDA to turn-in all incoming fees to the general treasury to support needed social programs. Then the FDA would be required to work under a Congressional budget appropriation. This would give Congress more control over the FDA and make it more receptive to the will of the people. Also the FDA would not directly benefit by the number of drug approvals processed. If individuals within the FDA take bribes for approvals, this will become a criminal activity and people should go to jail. But the current situation is a round robin and something needs to be done to change the status quo.

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  20. alexander says:

    Please stop this.

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  21. Your ability to purchase new supplements is in genuine peril. Read and take two minutes to tell Congress to protect right to natural health.

       0 likes

  22. Carol Wright says:

    Herbs and supplements are not drugs and should not be treated as such. Don’t let Big Pharma convince you otherwise in order to sell us drugs to make a profit.

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  23. Judy says:

    This is how I rewrote the letter your suggested (shifted some paragraphs and starting on paragraph 5, added my own thoughts)

    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 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.

    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.

    The FDA’s track records, in general, are not in good shape. Dr. David Graham, senior drug safety researcher at the FDA, did an interview containing insights and disclosures about the corruption and crimes that take place every day inside the Food and Drug Administration. This is no outside critic, either: these are the words from a top FDA employee who has worked at the agency for two decades.

    Many people think the FDA is out there doing their own rigorous studies on the safety and efficacy of drugs and that’s not even the case. They rely on the information supplied to them by pharmaceutical companies. So who is behind the FDA?

    Michael Taylor, former Monsanto Vice President, is now the FDA Deputy Commissioner for Foods. Roger Beachy, former director of the Monsanto-funded Danforth Plant Science Center, is now the director of the USDA National Institute of Food and Agriculture. Islam Siddiqui, Vice President of the Monsanto and Dupont-funded pesticide-promoting lobbying group, CropLife, is now the Agriculture Negotiator for the US Trade Representative. Rajiv Shah former agricultural-development director for the pro-biotech Gates Foundation (a frequent Monsanto partner), served as Obama’s USDA Under-Secretary for Research Education and Economics and Chief Scientist and is now head of USAID. Elena Kagan, who, as President Obama’s Solicitor General, took Monsanto’s side against organic farmers in the Roundup Ready alfalfa case, is now on the Supreme Court. Ramona Romero, corporate counsel to DuPont, has been nominated by President Obama to serve as General Counsel for the USDA.

    Why would I trust these people to tell me and other consumers what is safe, healthy and supportive to health needs? There are special interests here…not a concern for vitality and health.

    In a response to a lawsuit filed by the Farm-to-Consumer Legal Defense Fund (FTCLDF), the FDA has articulated its belief that there is no such thing as a right to health or to purchase or consume any given food.

    A federal court has already found the FDA’s stance against vitamin health claims to be unconstitutional. Qualified health claims are a critical means toward communicating important health benefits of natural foods and dietary supplements otherwise forbidden by the FDA. Unfortunately, the FDA has consistently limited the information available to consumers about the real health benefits of food and supplements and routinely rejects all qualified health claims.

    The FDA uses tactics of extortion designed to shift money from health supplement companies to the pockets of top FDA contractors. At least three different companies have been targeted for extortion by U.S. Food and Drug Administration employees. (Look it up.)

    The FDA already refuses to “file” (turns down) most notifications of new supplements. If the new guidance is accepted, new supplements will be a rarity. It is all completely arbitrary.

    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. How absurd!

    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.

    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.

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  24. David Bauman says:

    Dear Sir:

    The FDA’s new proposed guidelines for natural diertary Ingredients is an end run around DSHEA 94. By strictly regulating new ingredients that have come on the market since 1994 they are putting a cumbersome and draconian set of rule tthat will drive thousand of dietary supplement manufacturers and distributors out of business. There intent is to try to treat dietary supplements like drugs. They want to expand their power and regulatory authority. They want to create a nutrition dictatorship. They should not be permitted to get away with this.
    Regards,
    Dave Bauman

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  25. Carole Dute says:

    The power grab by the FDA to lay a framework in which we will be forced to look to “big brother” for our basic needs is pretty transparent! It is obvious that our government agencies are increasingly in the pocket of those with “big pockets”. The FDA is supposed to be looking out for drug safety – they are doing a very poor job. An evening watching T.V. highlights just a few of the drug problems that should never have been foisted off on a trusting public. When they oversee the development of a product that may ease (I didn’t say “cure”) one problem while it makes six others, it’s apparent the FDA has work to do in its’ own back yard. Approving dozens of vaccines that can cripple the bodies and minds of our children, and leaving no legal recourse for parents – well, it looks like the FDA has plenty of work on its’ own turf!

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  26. KM Bradburn says:

    Supplements are not drugs. We each need to take responsibility for ourselves. Congress has no business in medicine or supplements unless you are protecting a lobby. We are a nation of individuals who pay you to do your jobs….not rule over us.

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  27. Keith O, Pratt says:

    I depend on suppliments for my good health. Any new restrictions on them can only cause ill effects to the health of many people.

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  28. I am a senior citizen who relies on vitamin supplements to help me stay out of a nursing home and be able to take care of myself. Vitamins are my lifeline. I can tolerate almost no prescription drugs because they are too strong and make me dizzy and nauseated…..what no older person needs.

    Vitamins have no side effects; all prescription drugs do and some are very dangerous. I have a friend who told ER personnel she couldn’t take a certain drug, but they gave it to her anyway. The resulting stroke made her a paraplegic.

    Pease do not support the Durbin bill. The FDA needs to spend their time reigning in prescription drugs that are dangerous to society.

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  29. Jenifer Parker says:

    suggestion?
    Give us a link to our congress/senate people ALSO with each ’send’ to the bad guys so we can hit both at once maybe?

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  30. GeorgeCarter says:

    I have no problem with providing some expert input into the FDA’s proposed rulemaking. Is there some way to determine how many supplements have been introduced since 1994 and what they are? NaturalNews, unfortunately, made fools of themselves by claiming all supplements would disappear which was just demonstrably false. It does our efforts no good if the rhetoric is just nonsense.

    That said, my hope as a USER of supplements, a person living with Hepatitis C and no medical insurance, is that they would be funded to take over consumerlabs work and, in a robust, fair and comprehensive fashion, test the identity, potency and purity of supplements and post these publicly to a website. Most companies would basically just be getting great advertising. And companies that make an error can correct. And those that really are just sleazy or second rate can happily go out of business (and that, I think, would be maybe 2-3% if that of supplement companies).

    What are you thoughts? And thanks for discussing some of the details which are important to address. I think that can be done in a smart, sharp and effective way.

       0 likes

    • A. Werewulff says:

      @ GeorgeCarter Mike Adams has toned down the satire in his articles; it has been pointed out by myself and others that his satire distracts from the truth, providing ammunition to the opposition. Don’t get stuck on that, there’s good information that isn’t tainted by distracting satire.

      ““The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.” ~World Health Organization Constitution
      .
      S 510 (now HR 3082) Food Safety Modernization Act, as adopted by the US Senate on Nov. 30, 2010.

      “There is No Right to Consume or Feed Children Any Particular Food; There is No Generalized Right to Bodily and Physical Health; There is No Fundamental Right to Freedom of Contract.” ~US Dept of Health & Human Services and US Food & Drug Administration, 2010

      http://foodfreedom.files.wordpress.com/2010/07/fda-no-right-to-food-health-contract.pdf .
      .
      “He has erected a multitude of New Offices, and sent hither swarms of Officers to harass our people, and eat out their substance.” ~Declaration of Independence

      If I had a world of my own, everything would be nonsense. Nothing would be what it is, because everything would be what it isn’t. And contrary wise, what is, it wouldn’t be. And what it wouldn’t be, it would. You see?” ~Lewis Carrol, Alice in Wonderland

      That said, check the supplement websites for shipping restrictions already in place for California… And Canada where there are restrictions on many more ingredients; they’ve been whittling away access for over 5 years. If not for DSHEA the FDA would like to do the same here… Check the websites..

      http://www.hc-sc.gc.ca/cps-spc/cosmet-person/indust/hot-list-critique/index-eng.php

      http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lnhpd-bdpsnh-eng.php

      The list of products that contain these ingredients is too long to post… check the website

      http://www.swansonvitamins.com/helpdesk/shipping-restrictions.html#

      California

      restricted ingredients they may contain:

      DHEA
      Pregnenolone
      Slippery Elm
      Xylitol
      Yohimbe

      Canada

      restricted ingredients they may contain:

      Aconitum species (napellum and others)
      Arnica (oral)
      Angelica
      Barberry (Berberis vulgaris)
      Bayberry
      Belladonna
      Black Cherry (Prunus serotina)
      Black Cohosh
      Blood Root
      Bryonia alba
      Camphor
      Celandine (Chelidonium majus)
      Colchicum chichum (Autumn crocus)
      Comfrey
      Cinchona officinalis
      Conium maculatum
      Cramp Bark (Virbunum opulus)
      Croton tiglium
      DHEA
      Dong Quai
      Gelsemium sempervirens
      Goldenseal (Hydrastis)
      Gotu Kola
      Hoodia
      Horse Chestnut
      Hydrastis canadensis
      Ignatia
      Juniper Berries
      L-Carnitine
      L-Tryptophan
      Lithium
      Lobelia
      Magnolia officinalis
      Melatonin
      Metabromine
      Peony
      Petroselinum sativum
      Phytolacca decandra
      Poison Oak (Rhus toxicodendron)
      Probiotics/Acidophilus
      Progesterone
      Ruta graveolens
      Sabadilla
      Sage oil
      Sanguinaria canadensis
      Slippery Elm
      Theobromine
      Thuja
      Uva Ursi
      Yohimbe
      Vitamin D >1000IU/Day
      Wintergreen

         0 likes

  31. Shell Lavender says:

    Don’t let big Pharma turn nature into their own personal cash cow.

       0 likes

  32. mona yoffie says:

    We, the Amereican people deserve the right to choose which supplements wi will use , we are free to research these and make our own dicisions..Kepp gov out of our cupboard.

       0 likes

  33. Gary says:

    The FDA, needs to be dismantled at once.They are the puppets for the big pharma crooks.

    Gary.

       0 likes

  34. Many people are turning to alternative medicine, ( Food supliments and herbs ), rather
    than taking drugs with all their sideeffects.
    Since food supliments and herbs are basically harmless and not a Drug, The FDA should
    steer clear and keep their nose out of it.
    This is supposed to be a FREE country where we can make our own choices.
    Lets keep it that way.
    The FDA shouldn’t be worried about pharmasuticle companies losing money .
    They should consider our freedom, ( or what’s left of it), and leave our food
    supliments and herbs out of it.
    They are NOT drugs !

       0 likes

  35. Gina says:

    It is obvious who Congress is working for…it’s time to FIRE CONGRESS 2012 – Google it.

       0 likes

    • GARY CARONE says:

      Congress has sold every American OUT to the BIG PHARMA CORPORATIONS AT THE EPENSE OF YOUR PERSONAL HEALTH, JUST REMEMBER THIS WHEN YOU VOTE NEXT ELECTION!!!!!

         0 likes

  36. DM Baptiste says:

    Please leave our supplements alone. Supplements are not drugs. With more people dying from prescription drug overdose than illegal drugs, perhaps they should be the focus?

       0 likes

    • A. Werewulff says:

      @ DM Baptiste… Please leave our supplements alone. Supplements are not drugs. With more people dying from legally prescribed prescription drugs overdose than illegal drugs, perhaps they should be the focus?

      Fixed *;-)

      I continue to hope that enough people wake up and vote the psychopaths and sociopaths out of CONgress… just sayin’.. *;-)

      “In my own country I am in a far-off land. I am strong yet have no force or power; I win yet remain a loser. At break of day I say goodnight. When I lie down I have a great fear of falling.” ~Francois Villon

         0 likes

  37. Kim Crowdis says:

    I have been taking supplements since I was 10 years old. I have never had any kind of negative reaction to them. I have taken a few prescription drugs here and there for something and have had a lot of negative reactions to them. Vitamins and minerals are NOT drugs.

       0 likes

  38. Gene Saxby says:

    We know where all of these proposed changes in how supplements comes from. The pharmacuticle
    companies want to be the only ones in charge of anything that you put in your mouth.
    When they get control we will find that only the rich can afford to buy supplements.

       0 likes

  39. Janet Geren says:

    I reported a side effect of an asthma medication and they did nothing even though others experience the same reactions! Why are they not taking these drugs that kill us off the market? It is none of anyones business, including the FDA or government what I choose to take for my health! I am sick of this meddling and anarchy that is starting to become the unacceptable norm here. No FDA!

       0 likes

    • Tom says:

      Why? Because the FDA and BigPharma are in collusion, that’s why.

         0 likes

      • Matt says:

        The FDA like many other agencies is out of control, and we the people need to get control back. How, I believe if each one of us makes a commitment to have our voices heard through our representative’s, we might be able to force the FDA to once again represent us, and not big Pharma/corporations. I wish everyone that reads this goes to a petition that was started at change.org, the name of the petition is (FDA vs People of the United States of America) and sign’s it. We have to get off this Road to tyranny that we are on and make a stand. I did, and I believe if we all get together change can happen, but we all need to participate.

           0 likes

  40. These new rules will unfairly limit access to vitamins and minerals that keep many of us healthy. The rules should de discarded.

       0 likes

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