The FDA has warned 10 companies for selling dietary supplements with false claims, sending them warning letters. These supplements “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).” 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.
Steven Tave, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, said in a statement, “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.”
These companies have 15 working days to respond to the letters, stating how they will address these issues. They can also providing supporting information as to why they think their products do not violate the law.
Under the FD&C Act, any products that are intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to requirements that apply to drugs, even if they are labeled as dietary supplements. The agency has not evaluated whether or not these products are “effective for their intended use,” what the proper dosage might be, how they may interact with other substance or actual FDA-approved drugs, or whether they may have safety concerns or dangerous side effects.
All consumers need to be careful of any product that is marketed or sold online with unproved claims that it prevents, treats, or cures diseases. Consumers should always talk to their doctor or pharmacist before using any dietary supplement or drug. If claims are too good to be true, they probably are.
If anyone thinks they may be having problems because of a supplement, they should call their doctor. Any adverse reactions that may be caused by a product should be reported to the FDA using their MedWatch program.
