iIn a March 6, 2023 constituent update, the U.S. Food and Drug Administration (“FDA”) announced the launch of its new Dietary Supplement Ingredient Directory (the “Directory”), which the agency describes as “a one stop shop of ingredient information that was previously found on different FDA webpages.” According to the FDA, the Directory is “intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.” With the release of the Directory, the FDA is now retiring the “FDA Dietary Supplement Advisory Ingredient List.”
As of the date of this post, the Directory includes the following 27 ingredients:
|
5-Alpha-Hydroxy-Laxogenin |
DMHA |
N-acetyl-L-cysteine |
|
Acacia rigidula |
Ephedrine alkaloids |
Octopamine |
|
Biotin |
Higenamine |
Phenibut |
|
BMPEA |
Higenamine HCl |
Picamilon |
|
Cannabidiol |
Hordenine |
Pure and Highly Concentrated Caffeine |
|
Cesium chloride |
Hordenine HCl |
Pyridoxamine |
|
Comfrey |
Kava |
Red yeast rice |
|
DMAA |
Kratom |
Tianeptine |
|
DMBA |
Methylsynephrin |
Vinpocetine |
The FDA cautions that these are “commonly used names for each ingredient” and that “synonyms or other known names for an ingredient” may not be listed.
Interestingly, the FDA acknowledges that the Directory is not intended to be “a comprehensive list of all ingredients used in products marketed as dietary supplements[.]” Rather, it appears that the FDA intends to highlight ingredients that the FDA has either addressed in a warning letter or otherwise questioned the use of in dietary supplements. Indeed, the Directory is, in large part, populated with links to FDA safety communications and warning letters. It is yet to be seen how plaintiffs’ class action lawyers might attempt to use the Directory; however, the FDA has not stated that the Directory has any particular legal effect. In fact, the FDA acknowledges that the Directory “may not include all actions the agency has taken with respect to a particular ingredient.” Nevertheless, manufacturers, retailers, and companies marketing dietary supplements should assess whether any of their current or anticipated products contain the ingredients listed on the Directory, and, if so, determine the impact of any FDA-issued guidance concerning such ingredient(s). EBG will continue to monitor additions and other updates to the Directory.
