Dietary supplement industry bands together to challenge NDI reporting requirements

WASHINGTON — Five trade associations representing the dietary supplement industry on Tuesday collectively called for an overhaul of the Food and Drug Administration's draft guidance regarding new dietary ingredient reporting requirements.



"The [NDI] draft guidance issued by FDA in July, if implemented and enforced by FDA, would burden industry, placing unreasonable requirements on business, especially smaller firms, and create unreasonable barriers of entry for newer market entrants, without any related benefits for consumers," the trade associations stated. While the groups submitted separate comments to reflect their own membership priorities, the five associations stressed that FDA should focus on the common themes in their respective submissions. “We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes [the Dietary Supplement Health and Education Act]."



Common key issues include:

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  Requiring submission of a notification for virtually every product that contains an NDI from every manufacturer;

  
  


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  A shift in the burden of proof that an ingredient is not an NDI from the FDA to individual companies;

  
  


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  FDA’s claim that there are no authoritative lists of “grandfathered” ingredients that can be used to establish that a dietary ingredient is an Old Dietary Ingredient, which dismisses the relevance of “grandfathered” lists submitted by the trade associations in 1996-1998 for establishing that dietary ingredients are pre-DSHEA ingredients;

  
  


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  Redefining the meaning of the term ‘‘chemically altered’’ in such a way that significantly expands the category of ingredients that would constitute an NDI;

  
  


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  Stating that human synthesized constituents of botanical ingredients are different from those synthesized by the plant; and

  
  


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  Imposing a level of data necessary to demonstrate the safety of an NDI similar to what is required for food additives, a standard already rejected by Congress and the courts.

  
  

The trade associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance.

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