FDA Breaks Promise on Proposed New Supplement Rules

May 1, 2012
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Vitamin-Herbal-SupplementsFDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.

The specific provision that FDA has decided to enforce is the one that says synthetic botanicals will no longer be considered New Dietary Ingredients and must never be sold as supplements, only as drugs. Last Friday, FDA issued a press release and sent warning letters to ten companies who sell supplements containing DMAA (dimethylamylamine), which is advertised to increase energy, concentration, and metabolism. The manufacturer says DMAA is derived from the Asian geranium—specifically, geranium oil.

In their warning letters, FDA said the supplements are technically classed as “adulterated” for two reasons: (1) DMAA has not gone through the NDI notification process, and (2) it is a synthetically produced botanical which, by definition, is not an NDI.

However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new distinction comes exclusively from the NDI draft guidance, which is one reason we called it a perversion of congressional intent.

For years drug companies have studied plants for medicinal uses. As we noted recently, if they find a useful plant, the next step is to try to create a synthetic analog of the natural plant substance—a new molecule that can be patented and then taken through the FDA as a new drug. With this provision in the NDI draft guidance, FDA is giving drug companies a monopoly on synthetics, knowing full well that, in general, natural products cannot be patented while synthetics can, and only patented substances can afford to be brought through the hugely expensive FDA approval process.

The worst part is that FDA is now treating the guidance as if it has been finalized—something they promised not to do. In February, FDA held a meeting with the Natural Products Association (NPA), and explicitly told the group that until FDA finishes reviewing comments and releases final guidance, it would enforce only DSHEA and not the draft guidance. Now they’ve gone back on their word.

In addition, we would point out that FDA has still not addressed the many formal comments that were submitted on the synthetic botanicals question. We, and many others, said that FDA’s claim that synthetic constituents of botanicals are not NDIs while synthetic constituents of any other substance are NDIs is a completely arbitrary distinction. Taking action when they haven’t reviewed any of the thousands of pages in public comments makes a complete sham of the formal comment period. Moreover, FDA shouldn’t be enforcing a guidance when it is still in the draft stages anyway—that’s the point of it being a draft.

Worse, by going outside the bounds of DSHEA, the NDI guidance is basically creating new law, which the FDA is not allowed to do. Instead of issuing proper regulations and going through the formal rulemaking process (as is required when creating a new law), the FDA sidestepped everything by issuing a guidance. Technically, a guidance is not legally binding—which makes lawsuits difficult—but as feared, the FDA is enforcing the guidance as if it were.

DMAA is not without some controversy. Last year, two soldiers died after having heart attacks during fitness exercises, and both happened to be taking supplements that contained DMAA, though as of this writing, DMAA has not been conclusively linked to the deaths. A spokesperson for the manufacturer said that “there have been over one billion doses of DMAA-containing products taken without a single corroborated serious” health problem among people who used the products as directed. Just to be safe, the US Army is investigating, and the Defense Department has removed all products containing DMAA from stores on military bases until the safety review is complete.

If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is a New Dietary Ingredient, then by all means it should go through the NDI notification process as outlined by DSHEA. But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical—that is not a requirement of DSHEA. That requirement comes only from FDA, and it is not supported by law.

Here’s the crux of the matter: If FDA fully enforces this guidance as drafted, we will likely lose up to 29,000 nutritional supplements  from the market, at an economic loss of between $5.6 billion and $10.5 billion; the nutritional supplement market could shrink by between 28% and 52.5%, producing an annual loss for the industry of between $7.84 billion to $14.7 billion; and between 55,720 and 104,475 jobs in the supplement industry could be lost.

Let’s be clear: this is not about DMAA. This is the FDA setting in motion its draft guidance, which threatens our access to more than half of the supplements we all need to stay and get healthy.

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169 Responses to “FDA Breaks Promise on Proposed New Supplement Rules”

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  2. barry parks says:

    screw fda eat what u want.they r bought & sold they fool no one..buy organic buy supplements u have right 2 put what u want into your body.FDA can KMA!!! u r the resistance question authority its a democracy.november we throw them all out of office.send them a message!!!


  3. blue heron says:

    Y’all need to take under consideration that annual combined profits of Big Pharma are about 2x (double) those of all other major US industrial groups combined, making it so powerful that it may take a major public revolt to change the workings of the FDA, insurance companies in their pockets, and other govt. agencies that seem to listen only to Big Pharma and their myriad lobbyists.

    My suggestion is to educate your friends, family, and relatives, and keep talking to anyone who will listen about the false promises the FDA is making, and their numerous illusions that they are following any mandate to keep our food safe. Strip the veil at the local level and perhaps sooner than later, enough Americans will wake up to the damage done every day by this conspiracy of thieves and deceptions: Big Pharma, Big Ag and Big Insurance.


  4. Steve says:

    It is common knowledge that the FDA is a rogue organization answering only to Big Pharma. The cited companies should send a link to this article back to the FDA informing them that they will take any necessary corrective measures when such regulations become law. I realize this may result in a SWAT raid, but a stand has to be made at some point to nullify the FDA.

    Meanwhile, for those supplement manufacturers who wish to continue supplying customers with quality products but want to avoid threats by the FDA, here is a method:

    A central database should be established to hold nutritional supplement product data for all manufacturers that wish to participate. The database would be hosted on a website by a third party, not any supplement manufacturer. By virtue of free speech, that site would allow consumers to find supplements with full truthful descriptions about the products; if it cures cancer then that may be stated. No FDA mandated labels apply here! There would be a link to the manufacturer’s website where the purchase may be completed. Since this third party site does not sell anything, any verbiage may be used to describe products; the FDA is powerless to regulate the site because no commerce is involved.

    Now, here is the tricky part. We know that the FDA is planning to do everything it can to effectively ban supplements by classifying them as “New Dietary Ingredients”. So the way around that is to stop selling supplements, and start selling decorations! Yes, simply sell the same nutritional supplement products, but package and label them as decorations that the consumer may wish to enjoy by looking at them. The FDA does not regulate the ornament industry, so they would be powerless to interfere. For example, if a company wanted to sell some tree bark as a nutritional product to make a tea with medicinal properties, the FDA has jurisdiction. But if that same company is selling that same tree bark as a decoration, the FDA has no jurisdiction.

    The central database on the third party website would match up generic product codes for “decorations” to the truthful nutritional info. There would also be a feature to print proper labels for the products so that the consumer could accurately keep track of the items they order, even across multiple vendors. Manufacturers could register on the site and obtain new “decoration” product codes and enter the corresponding nutritional product info.

    This is a rather convoluted…


    • Steve says:

      … This is a rather convoluted method to ensure we have access to nutritional products without censorship and banning by the pharmaceutical industry, but it would certainly be effective and quick to implement. The site and database would be a sort of “open source” of information for nutritional products. The consumer could query on various ailments or desired outcomes and scan results filtered by cost, vendor, testimonials, etc. Let’s just quit playing the FDA’s games!


  5. chris says:

    i dont really care either way they will come out with something else for us to take but my problem with it what that . 1 it is a synthetic suppossidly and 2 i know several people that have had a false positive or this coming up as amphetamines and ruined there career . im millitary they are cracking down on us for pissing hot. studies done by a civilian lead resurcher show that 93% of hot urinalysis had dmaa in it that to much for me no thanx


  6. L.P. says:

    The FDA (Food & Death Administration) and the Obama Regime have a lot in common. BOTH break laws and BOTH have been given WAY too much power. BOTH NEED to go….permanently!!
    The FDA’s arrogance is UN-Conscionable. Corruption runs deep in the United States Government and in ALL entities within that government, but particularly the FDA. DISMANTLE ASAP!!!!


    • john639 says:

      The FDA was just as corrupt under Bush as it is under Obama. The FDA is simply run by corporations.


  7. HS Incubar says:

    How much longer before we replace industry shills in the FDA, USDA, EPA, etc with people who are not beholden to the corporatocracy?


  8. Ron says:

    Bring on the lawsuit. Every company that uses DMAA should pull out their quality control specs on this product. Then SUE the FDA for breaking the laws set for them to function under.


    • Elena Marcus says:

      One solution I see is to make people suspicious of all synthetic drugs to the point that they would not touch them and would break the trust between them and the unscrupulous drug-pushing physicians.. Less consumers and less sales will make it expensive for the Pharma to make new drugs. The ANH should spread the word on the adverse effects of drugs, including the physicians’ denials of them, and setup awareness opportunities for more attorneys to get on the wagon of fighting the Pharma, in the way they did with Fosomax and Vioxx.
      The ANH should spearhead a SSRI mass lawsuit – the adverse effects such as movement disorders (Parkinsonism and swollowing difficulties) are well established, accepted consequences by the medical communities, but the patients are being held in the dark by physicians (and given other noxious drugs to fix the symptoms — temporarily).


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