FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells

Hogan Lovells

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders in violation of the Federal Food, Drug, and Cosmetic Act. We expect the action signals that FDA labeling enforcement on health-related claims is on the rise under the new Administration and that we should anticipate similar market sweeps in the future.

FDA Warning Letters

Specific claims varied among the warning letters, but generally included claims related to “reduces anxiety,” “relief of temporary depression or occasional feelings of sadness and melancholy,” and “mood support,” within the context of other claims about depression. 

Notably, none of the dietary supplements targeted by the market sweep  contain cannabidiol (CBD), which has been an enforcement focus for FDA in the past.  Nor do any of the products or claims refer to COVID-19.  Since the beginning of the COVID-19 pandemic, FDA has conducted other market sweeps of dietary supplements that claim to treat or mitigate symptoms of COVID-19.  The claims at issue here are separate from, but still related to the COVID-19 claims.  Specifically, in the press release, the Director of the Office of Dietary Supplement Programs in CFSAN, Steven Tave, explained that the dietary supplements “could potentially harm consumers who use these products instead of seeking proven treatments from qualified health care providers,” which is “especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues.”

The warning letters could suggest an uptick in labeling enforcement on health-related claims and that FDA may conduct other market sweeps in the future.  We also expect that that the Federal Trade Commission (FTC) to take a more active role on enforcement matters under the new Administration.  Like FDA, the FTC has been predominantly bringing enforcement actions related to COVID-19.  We believe FTC may shift its attention toward areas that have been dormant in the last Administration, such as health-related claims and environmental claims (e.g., “recyclable”). 

Next steps   

We will continue to monitor FDA and FTC enforcement actions.  

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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