On February 19, 2021, the U.S. Food and Drug Administration announced warning letters to 10 companies (listed below) for illegally 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 (FD&C Act).
“Dietary 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,” said Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “The agency is committed to taking action to protect the public from unlawful dietary supplements.”
In its press release, the FDA made several key points regarding the FD&C Act and dietary supplements.
- Disease Claims Are Not Permissible: “Products intended to cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.” Unlike FDA-approved drugs, “the agency has not evaluated whether the unapproved products subject to the warning letters … 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.”
- Beware of Medication Interactions: “Consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases” and “advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug.” The FDA goes on to say that “some supplements might interact with medicines or other supplements” and cautions consumers to beware of “claims … too good to be true.”
- Report Adverse Reactions to FDA: Consumers who believe “a product might have caused a reaction or an illness … should immediately stop using the product and contact their health care provider.” FDA “encourages health care professionals and consumers to report adverse reactions associated with FDA-regulated products to the FDA using MedWatch or the Safety Reporting Portal.”
Warning letters were issued to the following companies: 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.
Attorneys at Finkelstein, Blankinship, Frei-Pearson & Garber, LLP have successfully recovered millions of dollars on behalf of victims of false advertising and harmful and defective products. We are currently investigating this matter. If you have purchased dietary supplements from one of the listed manufacturers, please contact us to discover your legal options.