NDI Draft Guidance Comments

Trade associations united in calls for ‘substantial overhaul’ of NDI draft guidance

By Stephen Daniells

- Last updated on GMT

Related tags Dietary supplement

Trade associations united in calls for ‘substantial overhaul’ of NDI draft guidance
The five main trade associations for the dietary supplements industry are united in their calls for a ‘timely’ and ‘substantial overhaul’ of the draft guidance, according to a joint statement.

Despite filing comments independently, 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 to provide a united voice for the industry.

“We are all committed to seeing a substantial overhaul of the draft guidance and are united in our common belief that the document is overreaching and contravenes DSHEA,”​ the five associations announced jointly.

No limbo

In addition to a ‘substantial overhaul’, the trade associations urged the agency for a timely response to the comments submitted by stakeholders.

Only last week, Duffy MacKay, ND, VP of scientific and regulatory affairs for the CRN told NutraIngredients-USA.com: “The FDA is not obligated to respond within a certain timeframe or necessarily publish a final guidance.

“But we absolutely don’t want this to just sit around as a draft for years. That would be the worst outcome. Some people want it to be withdrawn, others want substantial revisions. But doing nothing would be detrimental; it would be unfair to leave the industry in limbo.”

United we stand…

Now that the comments are in, the five trade associations have called for FDA to 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”.

The common key issues 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). The trade associations submitted ‘grandfathered’ lists in 1996-1998 to establish 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.

Related topics Regulation NDI draft guidance

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