Dietary supplements that came on the market after October 15, 1994 must have a new dietary ingredient notification (NDI) to the FDA, according to an extensive new guidance document issued on August 11.
This includes manufacturing processes on supplements prior to this date that change the identity of the ingredient such as a different chemical structure or composition, use of extraction or use of a different starting material, such as a different part of a botanical.
If you manufacture or sell product in this category and did not submit a notification with the proper information to the FDA at least 75 days before marketing, your product may be deemed adulterated and an unapproved drug or an otherwise dangerous substance and falsely labeled as a dietary supplement.
The FDA estimates there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year. However, the agency has received fewer than 1,000 NDI notifications since 1994 when the Dietary Supplement Health and Education Act (DSHEA) was passed.
The FDA's 102-page guidance provides insight on how to go about establishing the identity of the new dietary supplement in your NDI. Such material includes, but not exclusively, the manufacturing process, specifications not only for the new ingredient, but all of the components of the product, the quantity of the ingredient, dosage recommended and either present or historical safety data on the ingredient.
The guidance categorizes dietary ingredients and provides sources of information for each category to establish the safety of the ingredient. This guidance is in draft and is still open for comment, but this period does not exempt the requirement for an NDI if warranted per DSHEA.
Enforcement in the dietary supplement industry has become a high priority. Last year the FDA created the Office of Dietary Supplement Programs to assist in identifying dangerous supplements. The Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers.
If you are in the industry, it is imperative to read this newly released guidance. The last guidance in this area was released in 2011. This guidance is more comprehensive and should be carefully followed.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
