FDA Sends Warning Letters to Companies for Illegally Selling Dietary Supplements Through False Claims

(UNDATED) – The U.S. Food and Drug Administration (FDA) Friday posted warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders. The dietary supplements discussed in these letters are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.

Consumers who rely on dietary supplements in lieu of discussing their symptoms with a health care professional could potentially suffer harm and may not receive appropriate therapies that have been determined to be safe and effective to treat depression and other mental health disorders.

Warning letters were sent to the following companies:

“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.”

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.

Under the Federal Food, Drug, and Cosmetic 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.

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.

For more information, see the FDA press release.

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