QUEBEC CITY—The New Dietary Ingredient (NDI) Draft Guidance, in its current form, would establish an unlawful premarket regulatory process, according to Atrium Innovations Inc. in its comments submitted to FDA. Atrium Innovations, which manufactures dietary supplements, said the Draft Guidance is contrary to both the letter and Congressional intent of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
"We question why, after 17 years, FDA has promulgated such stringent guidelines, as we do not believe that a consumer safety crisis exists to merit such action by the Agency," the company wrote in its comments. "This Draft Guidance’s unnecessarily burdensome and costly requirements will have the additional consequence of stifling innovation in our industry, as well as limiting consumer access to currently available, traditionally used, safe and effective supplements."
Like the trade organizations, Atrium Innovations calls for FDA to withdraw the Draft Guidance and to work closely with the industry to develop a new one.
The company called out specific areas of concern, such as:
Products vs. ingredient notification—Atrium Innovations said it believes the Draft Guidance's position that NDI notifications (NDINs) are required for each new product—rather than for each new ingredient—violates DHSEA and FDA's historical regulatory policy. Atrium Innovations added that once an NDI is deemed safe by FDA (i.e., not rejected), no new submissions for other products that use that ingredient should be required.
"Chemically altered"—The Draft Guidance gives a list of processes that would not render an ingredient "chemically altered," and thus not requiring na NDIN, but said anything else would cause a chemical change necessitating a NDIN. Atrium Innovations said this list is unnecessarily limited and any process used in food manufacturing should be OK for dietary ingredients, long as the result is identical to a previously marketed product. "The Draft Guidance would have the industry turn the clock back to 1994 and disregard all innovation since or, at the very least, require expensive and complicated NDI submissions based on improvements in safety stability, or environmental impact," the company wrote.
Probiotics—Probiotics are a lawful and viable category of dietary ingredients, Atrium Innovations asserted, and FDA should confirm fermentation advancements designed to improve culture yield and stability do not create an NDI.
Synthetic botanicals—Atrium Innovations said the Draft Guidance said a synthetic botanical copy is not an ingredient, despite the fact that nothing in DSHEA permits or provides for it. Atrium Innovations said this opinion has no basis in law and runs against FDA's policy that allows for synthetic vitamins, minerals and other ingredients.
Atrium Innovations concluded its comments by saying the Draft Guidance, as written, would stifle innovation and create a market that lacks product differentiation, thereby limiting consumer access and choice, which is contrary to the spirit of DSHEA.
