FDA warns 10 companies for illegally selling dietary supplements claiming to treat depression and other mental health disorders
Tue, 02/23/2021 – 02:00
FDA has issued warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, violating the Federal Food, Drug, and Cosmetic Act. The warning letters were 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. “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 FDA’s Center for Food Safety and Applied Nutrition. The agency has requested responses from the companies within 15 working days indicating how they will resolve the issues, or providing their reasoning and supporting information as to why they believe their products are not in violation of the law. Failure to correct the violations promptly could result in legal action, including product seizure and/or injunction. FDA recommends that consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug.