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Is the DMAA crackdown an enforcement of the NDI draft guidance?

1 commentBy Elaine Watson , 02-May-2012
Last updated on 02-May-2012 at 20:56 GMT2012-05-02T20:56:04Z

In warning letters sent as part of its recent crackdown on DMAA , the FDA says “synthetically produced DMAA is not a dietary ingredient and, therefore, is not eligible to be used as an active ingredient in a dietary supplement”.

This, claim many industry commentators, is the first example of the agency enforcing its controversial 2011 draft guidance on new dietary ingredients (NDIs), which states that synthetically produced botanical constituents are not dietary ingredients.

FDA warning letter wording is open to interpretation

The FDA, however, has not stated explicitly that it is enforcing its new draft guidance by cracking down on DMAA.

Its warning letters do not refer to the stance on synthetic botanicals outlined in the guidance and do not state that DMAA supplements are misbranded because DMAA is a synthetic version of geranium extract.

Indeed, the wording above could simply mean the FDA doesn’t believe DMAA is a synthetic copy of a botanical, but is instead a novel substance/drug that does not meet the legal definition of a dietary ingredient enshrined in the Dietary Supplements Health & Education Act (DSHEA).

And if this is the case, there is no future for DMAA in supplements, whether firms can prove it is safe or not.

Is there any wiggle room?

However, if the FDA acknowledges DMAA could be a synthetic copy of geranium extract - but argues (as per the NDI guidance) that synthetic botanical constituents are not dietary ingredients - there could be some wiggle room for the firms affected, as guidance is not law.

(Providing these firms can come up with rock solid evidence that DMAA is in geranium, that is.)

ANH-USA: If DMAA is proven to be unsafe it should be removed

If they can, the NDI draft guidance will take center stage in the debate, predicts consumer health advocacy group the Alliance for Natural Health (ANH) USA.

And this could put the FDA on shaky legal ground, it claims, as the agency would be challenging the regulatory status of DMAA by citing a document “still in the draft stages” that has been widely criticized for directly contradicting the legislation it is designed to clarify.

The claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements: DSHEA,” it argues. “This new distinction comes exclusively from the NDI draft guidance.

“If DMAA is proven to be unsafe, it should be removed, plain and simple. If it is an NDI, then by all means it should go through the NDI notification process.

“But let’s just stop this nonsense about it being illegal because it’s a synthetic botanical. That is not a requirement of DSHEA."

FDA is treating the guidance as if it has been finalized

It adds: “The FDA is now treating the guidance as if it has been finalized… [But it has] still not addressed the many formal comments that were submitted on the synthetic botanicals question.

“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.”

Click here to read about the latest wave of class action lawsuits on DMAA.

Click here to see GNC's reaction to the FDA crackdown and background on DMAA.

Click here to see AHPA’s reaction.

Click here to get reaction from the CRN, NPA, ABC and analytical testing experts plus a list of the products and firms targeted.

Click here to see the NutraIngredients-USA DMAA timeline.


1 comment (Comments are now closed)

Factually incorrrect

Guidance documents are not legally enforceable. Ready literally any guidance document ever put out by FDA. I'm not sure what ANH's argument is here, but it's sure not grounded on much.

Guidance documents only represent FDA's "current thinking on a matter and clearly states that it does not establish legally enforceable requirements."

- AG

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Posted by Alexander
02 May 2012 | 20h332012-05-02T20:33:58Z

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