NDA is concerned with draft guidance relating to synthetic ingredients, chemically altered ingredients, and duplicate NDI filings.
Natural products industry leaders have been vocal about changes they want to see in FDA’s draft guidance for enforcement of New Dietary Ingredient (NDI) notifications. As they await FDA’s new (and hopefully clarified) draft guidance, the Natural Products Association (NPA; Washington, DC) decided to offer a few more suggestions for the agency.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…the draft guidance should make clear that a synthetic copy of a constituent or extract of a botanical can be a dietary ingredient.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…the draft guidance should provide criteria for identifying a “chemically altered” ingredient.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…the draft guidance should eliminate the need for unnecessary duplicate filings of the same NDI.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.
The Nutritional Outlook Podcast Episode 29: 2024 Ingredients to Watch
January 31st 2024Nutritional Outlook interviews Scott Dicker, market insights director from market researcher SPINS, about ingredients and product categories nutraceutical and nutrition product manufacturers should watch in 2024.
Judge denies CRN’s motion for preliminary injunction but its lawsuit against NY state will proceed
April 23rd 2024The judge in CRN's lawsuit against NY state's law banning the sale of weight management and muscle building supplements to minors has denied its motion for a preliminary injunction, but determined that CRN has standing to sue on behalf of its members.
Arla Foods to acquired whey nutrition business from Volac International
April 22nd 2024Arla Foods Ingredients has reached an agreement to acquire Volac’s Whey Nutrition business through a purchase of shares in Volac Whey Nutrition Holdings Limited and its subsidiary, Volac Whey Nutrition Limited and Volac Renewable Energy Limited.