jueves, 8 de septiembre de 2016

FDA Law Blog: FDA Tries New Approach to Removing Marketed Dietary Ingredients; Prepares About-Face on Dietary Ingredient Status of Vinpocetine

FDA Law Blog: FDA Tries New Approach to Removing Marketed Dietary Ingredients; Prepares About-Face on Dietary Ingredient Status of Vinpocetine

Posted: 07 Sep 2016 01:02 PM PDT
By Wes Siegner –

After 20 years of marketing vinpocetine, and accepting without objection the filing of 5 new dietary ingredient notifications (NDINs), FDA has “tentatively concluded” that vinpocetine is an illegal dietary ingredient for two reasons: 1) it does not fit within the statutory list of dietary ingredient types in FDC Act § 201(ff)(1)(A)-(F); and 2) it is excluded from legal dietary ingredient status as a result of drug studies in the mid 1980s pursuant to FDC Act § 201(ff)(3). From any perspective, this is an important development for the dietary supplement industry.

Coming on the heels of several rounds of warning letters over the past 18 months to remove BMPEApicamilon, and oxilofrinefrom the market, as well as FDA’s attempted rewrite of the draft NDI guidance (see our previous post here), FDA’s approach to vinpocetine reflects an as yet uncharted path for ingredient removal – notice to industry and a request for comments on an FDA “tentative conclusion.” It is not clear what initiated FDA’s action -- FDA may have received information from a drug company wishing to pursue marketing of vinpocetine in the U.S.  What is clear is that, without a strong response, FDA intends to remove vipocetine from the dietary supplement market.

FDA’s first reason for its tentative conclusion of illegality is based on FDA’s narrow reading of the list of types of dietary ingredients in FDC Act § 201(ff)(1)(A)-(F) asexclusive, rather than inclusive. This theory has been presented in warning letters as well as FDA’s first draft of the NDI guidance in July 2011.  As this firm and others have stated in comments (see our previous post here), FDA has interpreted the list of types to exclude synthetic copies of botanical ingredients, and more important from a limiting standpoint, to exclude any ingredient that is not already marketed as an ingredient in food.  This turns on its head the flexibility Congress intended to provide to dietary supplement marketing through the Dietary Supplement Health and Education Act of 1994 (DSHEA), effectively precluding the marketing of any truly “new” dietary ingredients.

FDA’s second basis rests on the statutory prohibition of the marketing of ingredients first studied as drug ingredients “where substantial clinical investigations have been instituted and for which the existence of such investigations has been made public” (FDC Act § 201(ff)(3)). This theory will require further research to determine whether the facts as FDA presents them trigger the so-called “exclusionary clause.”  All we can ask now is, if these facts are so clear and so easily known, then how have they escaped FDA’s and industry’s notice for 20 years?

Recall that DSHEA passed with unanimous consent in both houses of Congress as a result of FDA’s having exceeded its statutory authority to limit the dietary supplement market through the rules for conventional food ingredients in ways that the courts, Congress and consumers found unacceptable. FDA’s move on vinpocetine should help wake industry up to the danger that FDA’s new (but not much revised) NDI draft guidance presents. If FDA’s narrow construction of DSHEA as illustrated in the 2011 and 2016 drafts of the NDI guidance and the vinpocetine notice prevails, FDA will succeed in relegating many dietary ingredients in dietary supplements to a more limited market than for conventional foods.

Vinpocetine is but a symptom of a bigger struggle, but a symptom that nonetheless deserves the best defense that the industry can offer.

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