Key Takeaways
- The FDA has launched a new "Dietary Supplement Ingredient Directory" that allows users to search for information on ingredients in dietary supplements and quickly find links to agency actions and communications.
- The directory currently includes 27 ingredients that have been marketed as dietary supplements, with the majority of information linked to these ingredients being FDA safety communications and Warning Letters.
- Manufacturers and firms marketing dietary supplements should review the directory before launching new products and periodically monitor it to identify new ingredients the FDA has signaled concern over. This can help them assess regulatory and litigation risk over the dietary supplement product life cycle.
On March 6, the FDA announced the launch of its new “Dietary Supplement Ingredient Directory.” According to the FDA, the directory is “a one-stop shop of ingredient information that was previously found on different FDA webpages.” It will allow users to search for information on ingredients in dietary supplements and quickly find links to agency actions and communications. Concurrently, FDA is retiring the existing “FDA Dietary Supplement Ingredient Advisory List.”
At the time of publication, the directory is currently a list of 27 ingredients that have been marketed as dietary supplements. The majority of the information linked to these 27 ingredients is FDA safety communications and Warning Letters.
Manufacturers and firms marketing dietary supplements in addition to foods or nutraceuticals should review the Dietary Supplement Ingredient Directory before launching new products and periodically monitor the directory to identify new ingredients the FDA has signaled concern over. This directory will aid manufacturers and firms marketing dietary supplements in assessing regulatory and litigation risk over the dietary supplement product life cycle.
It is safe to assume that if the FTC is investigating advertising claims for any products containing ingredients listed in the new directory, the directory is going to be one of the first places the FTC focuses its attention.
For a deeper dive on health claim substantiation, join us for our upcoming webinar “The Federal Trade Commission’s New Health Product Compliance Guidance” on March 23.
Authored by: Winston S. Kirton; Lee H. Rosebush; Francis Palumbo; Marc N. Wagner; Laura E. Macherelli