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Supplement Perspectives

NDI Draft Guidance: A Relatively Painless Recap

NDI regulations

Lets review the facts.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) governs the sale of dietary supplements in the United States. Following the enactment of DSHEA, there were a few parts that required clarification: what the FDA actually considers to be a dietary ingredient; the use of synthetics; whether each ingredient or each product requires a separate NDI notification, and uncertainty regarding the standard applied to the FDAs NDI reviews.

Thats just to name a few. 

Additionally, the FDA has failed to process New Dietary Ingredients (NDI) submissions within the 75-day period required by DSHEA. As a result, the FDA issued Draft Guidance for Industry; New Dietary Ingredient (NDI) Notifications and Related Issues (NDI Guidance) in July 2011, which was met with industry backlash. 

Critics felt that the NDI Guidance did not reflect the intentions of DSHEA. For instance, the synthetic issue addressed in the NDI Guidance is a matter of great concern to the industry. The NDI Guidance states that a synthetic identical copy of a natural constituent cannot be a dietary ingredient. Question 2 of the NDI Guidance declares, A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a constituent of the botanical that qualifies as a dietary ingredientSimilarly, a synthetic version of a botanical extract is not an extract of a botanical . . . because it was not actually extracted from the botanical. 

The agency takes this position without regard for whether the synthetic substance is chemically identical to and behaves in the body in exactly the same way as what is found in nature. For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated. Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C and various amino acids. Thus, virtually all of the vitamin C on the market today would violate DSHEA.

The NDI Guidance not only ignores the realities of the marketplace today, but also does not consider that it is often more desirable to use a synthetic to avoid contaminants. 

As a result of the criticism, the FDA agreed to rework the draft in June 2012. However, to date, no reworked guidance has been released. In July 2013, Reps. Frank Pallone (D-NJ) and Brett Guthrie (R-KY), joined by 27 other House members, sent a letter to FDA Commissioner Margaret Hamburg urging the agency to expedite its efforts to release the draft guidance for NDI notifications. 

In the interim, the industry has received very negative nationwide press, specifically USA Today: Drivens Craze and Gapsaris Detonate were tested and allegedly found to contain a methamphetamine analogue; the FDA announced that it is recalling USPLabs OxyElite following an outbreak of liver illnesses, including one death, and USPLabs destroyed $8 million worth of OxyElite Pro and Jack3d as it contained DMAA.

The New York Times published a piece on the two deaths allegedly linked to use of DMAA containing Jack3d and the wrongful death lawsuit against USPLabs and GNC filed as a result of one of those deaths.   

Will this recent negative publicity sway the guidance in the wrong direction? Lets hope not.

TAGS: Regulatory
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