"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.”
Under the FD&C Act, 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 drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters announced today 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.
In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug. For example, some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also 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.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
