FDA Warns Dietary Supplement Companies Not to Make Unverified Claims About Depression Treatments

In a press release published Friday, the Food and Drug Administration (FDA) announced that it had sent advisory letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders. The letters were reportedly issued to Enlifta LLC, Lifted Naturals, Mountain Peak Nutritionals, SANA Group LLC., Wholesome Wellness, Dr. Garber’s Natural Solutions, ProHealth Inc., Blossom Nature LLC, FDC Nutrition Inc., and Silver Star Brands, Inc.

The FDA explained that drugs which claim to treat disease are subject to additional requirements, even if they are labeled as dietary supplements, pursuant to the Federal Food, Drug, and Cosmetic Act. In this case, the companies made claims that were ostensibly problematic because the agency did not evaluate whether the associated products “are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.”

For example, in its letter to Silver Star Brands, the FDA cited inappropriate claims that the company’s MindSoothe Drops product, “[r]elieves feelings of depression” and “[r]egulates disturbed sleep patterns.” Reportedly, Silver Star Brands’ website also contains impermissible personal testimonials recommending or describing the use of products for treatment of depression.

Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition commented on the matter. In a statement he said, “[d]ietary supplements that claim to cure, treat, mitigate or prevent depression and other mental health disorders are unapproved new drugs that could potentially harm consumers who use these products instead of seeking proven treatments from qualified health care providers. This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues.”

The FDA requested responses from the companies within 15 days explaining how they will address its concerns or stating why they believe the products are not in violation of the law. According to the agency, failure to timely correct violations could result in legal action, including product seizure and/or injunction.