In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them.  This is a confusing area for the public. On March 6, 2023, the FDA announced (here) a Directory of Ingredients Used in Products Marketed as Dietary Supplements to assist consumers to “look up ingredients used in products marketed as dietary supplements and quickly find what the FDA has said about that ingredient and whether the agency has taken any action with regard to the ingredient.”

In the announcement of the list, the Agency cautions that not all ingredients used in dietary supplements may be listed and all actions taken by the Agency may not be currently available, especially if the action had been taken a long time ago. This new resource will have links to current actions FDA has taken to assist consumers to make informed decisions about the ingredients that are included in dietary supplements.  FDA also notes that the list will be updated frequently in the future.

The FDA advises that “[A]s the agency is instituting the Ingredient Directory, we are also retiring the FDA Dietary Supplement Ingredient Advisory List, which was a rapid-response tool meant to quickly alert the public when the agency identified ingredients that did not appear to be lawfully marketed in dietary supplements. Anyone who signed up for the Dietary Supplement Ingredient Advisory listserv will automatically receive updates to the Ingredient Directory as they become available.”

The link to the list can be found here.  There is also a link to the submitted 75-day premarket notifications that are required to be filed with the FDA prior to the marketing of a new dietary ingredient (here).

These lists together form some powerful and useful tools for the FDA and industry, as well as helping the consumer keep up with this dynamic segment of the market.