NPA Has Supplemental Comments for NDI Draft Guidance

September 14, 2012

NDA is concerned with draft guidance relating to synthetic ingredients, chemically altered ingredients, and duplicate NDI filings.

Natural products industry leaders have been vocal about changes they want to see in FDA’s draft guidance for enforcement of New Dietary Ingredient (NDI) notifications. As they await FDA’s new (and hopefully clarified) draft guidance, the Natural Products Association (NPA; Washington, DC) decided to offer a few more suggestions for the agency.

NPA filed new comments for FDA last week, including three major points about synthetic ingredients, chemically altered ingredients, and duplicate NDI filings. Here are those points from senior vice president of scientific and regulatory affairs Cara Welch, PhD:

 

…the draft guidance should make clear that a synthetic copy of a constituent or extract of a botanical can be a dietary ingredient. Legislation previously passed by Congress mandates that synthetic and natural ingredients for vitamins cannot be differentiated since our bodies treat the synthetic version the same way as the natural version.

…the draft guidance should provide criteria for identifying a “chemically altered” ingredient. NPA believes that a better approach would be to provide objective, analytically based criteria for the industry.

…the draft guidance should eliminate the need for unnecessary duplicate filings of the same NDI. The FDA should revise the draft to expressly permit filing of an NDI master file, and acknowledge that an NDI notification may incorporate by reference any information already submitted to the FDA.

 

Interested parties can download a full copy of NPA’s detailed comments here.