FDA Issues Flurry of Warning Letters Regarding Adulterated Dietary Supplements

On Monday May 9, 2022, FDA issued an “update”  announcing that it had sent 11 Warning Letters to companies that distributed dietary supplements alleged to be adulterated because one or more ingredients in the companies’ products contained an illegal dietary ingredient. (Two days later, one of the Warning Letters was withdrawn because of a clerical error.)

The main ingredients at issue are 5-alpha-hydroxy-laxogenin, higenamine, higenamine-HCl, hardenine,  hardenine HCl, and octopamine.   According to FDA, higenamine HCl and hordenine HCl do not qualify as dietary ingredients and, because they are neither approved as food additives nor generally recognized as safe for use, they are unapproved food additives.  Although FDA acknowledges that the other ingredients at issue, higenamine, hordenine, 5-alpha-hydroxy- laxogenin, and octopamine are dietary ingredients (because they are present in botanical products), the agency asserts that they are new dietary ingredients subject to the requirement for pre-market, new dietary ingredient (NDI) notification.  FDA has not received NDI notifications for any of these four ingredients.    Moreover, even if NDI notifications had been submitted for the dietary supplements containing these new dietary ingredients, the products would still be adulterated because (according to FDA) there is no history of use or other evidence that these ingredients will reasonably be expected to be safe when used as dietary ingredients.

Several of these substances have been on FDA’s Dietary Supplement Ingredient Advisory List (“Advisory List”) for several years.  After issuing and announcing the Warning Letters, FDA removed those substances from the Advisory List.  The Advisory List dates from 2019 and, according to FDA’s constituent update was intended “to quickly alert the public when the FDA identifies ingredients that do not appear to be lawfully included in products marketed as dietary supplements.”  FDA includes ingredients in the Advisory List based on a preliminary evaluation by the agency. Because FDA now has completed its evaluation of the substances in the Warning Letters and is not “aware of any evidence that would call into question its current conclusion[s] about these ingredients,” they no longer meet the criteria for inclusion in the Advisory List.

As readers of our blog may know, a Warning Letter is an advisory action.  Companies are generally given 15 working days to respond.  The recipient of a letter may present FDA with any evidence bearing on the legal status and safety of an ingredient.

Whether the flurry of Warning Letters foreshadows an increase in FDA action related to dietary supplements with ingredients on the Advisory List remains to be seen.