i- Today, FDA unveiled its Information on Select Dietary Supplement Ingredients and Other Substances (the “Directory”), which is an updated version of the prior Dietary Supplement Ingredient Directory, which was released in 2023 and replaced the Dietary Supplement Ingredient Advisory List.
- The Directory is intended to allow the public to quickly look up FDA commentary and/or actions on certain ingredients that have been used in products marketed as dietary supplements. The revised Directory adds categories classifying the type of agency action/communication (e.g., safety issue, absence of new dietary ingredient notification), records the date that each ingredient is added to the directory, and streamlines the introductory text on the webpage.
- The Directory represents FDA’s continued efforts to ensure that dietary supplements contain ingredients with an appropriate regulatory status and which are safe. In a 2022 draft guidance intended to encourage manufacturers and distributors of new dietary ingredients and dietary supplements containing new dietary ingredients to submit new dietary ingredient notifications (NDINs), FDA noted that it is likely that thousands of dietary supplements containing new dietary ingredients are unlawfully marketed without a NDIN.
- A NDIN is required where a dietary ingredient has been used in dietary supplements for the first time after October 15, 1994 (i.e., a “new dietary ingredient”) and such ingredient has not been present in the food supply.
FDA Launches New Directory of Ingredients Used in Dietary Supplements
Wednesday, February 21, 2024
Current Legal Analysis
More from Keller and Heckman LLP
Upcoming Legal Education Events
May
22
2024
May
17
2024
