In an Alert published on August 12, I provided an update on new FDA guidance regarding dietary supplements:
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.
To read my full discussion of the guidance document, please visit the Fox Rothschild website.
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.
