Supplements for Depression? FDA Says Not So Fast

FDA warns 10 companies for selling supplements that claim to treat depression

(RxWiki News) The US Food and Drug Administration (FDA) has issued warning letters to 10 companies accused of illegally selling dietary supplements.

According to the FDA, these companies were claiming that the supplements could prevent, treat or cure mental health disorders like depression.

This is a violation of the Federal Food, Drug, and Cosmetic Act. Under this law, any product that claims to treat or prevent a disease is subject to FDA review. This review is meant to test the products for safety and effectiveness, as well as look for side effects and potential drug interactions.

"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," said Steven Tave, Director of the FDA's Office of Dietary Supplement Programs, in a press release. "This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues."

The following companies received warning letters from the FDA regarding this issue:

  • 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.
  • Silver Star Brands, Inc.

The FDA has asked these companies to respond to the warning letters within 15 working days. The responses must detail the companies' reasoning for marketing products with unproven health claims and how they plan to address this issue. The FDA said it may take legal action if the companies fail to properly respond.

Generally, consumers should be cautious of any product sold online that claims to treat, cure or prevent a disease, the FDA said. If you are facing any kind of mental health issue, reach out to a qualified mental health care provider.

If anything you take appears to cause an adverse reaction, stop taking the product and call your health care provider. Speak with your doctor or pharmacist before taking any new supplement or medication.

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Review Date: 
March 4, 2021