Claiming FDA’s New Dietary Ingredient (NDI) notifications guidance undermines both the letter of the law and the intent of the Dietary Supplement Health & Education Act (DSHEA) of 1994, the dietary supplement industry’s trade associations—the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA)—have joined together to call for revisions.

The associations said the draft guidance issued by FDA in July 2011, if implemented and enforced, would burden industry, placing unreasonable requirements on business—especially smaller firms—and create unreasonable barriers of entry to newer market entrants without any related benefits for consumers.

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, rather than look for points of disparity as indicating any substantive differences of opinion among the groups. “We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes DSHEA,” the five associations announced jointly.

Common key issues identified in the draft guidance by the trade groups representing the dietary supplement industry, if implemented and enforced by FDA, include:

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

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

• 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 (ODI), which dismisses the relevance of “grandfathered” lists submitted by the trade associations in 1996-1998 for establishing that dietary ingredients are pre-DSHEA ingredients;

• Misinterpreting the meaning of the term ‘‘chemically altered,’’ which significantly expands the category of ingredients that would constitute an NDI;

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

• 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 called on FDA to consider the comments it has received and to issue guidance that addresses these concerns. The associations also urged for a timely response from the agency to provide industry with clarity and direction as the industry attempts to comply with the requirements of the law; the associations also offered to work with FDA to achieve that goal.