The U.S. Food and Drug Administration said it has sent warning letters to 10 companies who are claiming their dietary supplements can treat depression and other mental health disorders.
The FDA said the companies are “illegally selling dietary supplements that 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 - Enlifta Mood Elevator and Enlifta Anxiety
- Lifted Naturals - Mood Boosting Probiotic
- Mountain Peak Nutritionals - Mood Support
- SANA Group LLC - Sleep Sana Sleep Drops and Sleep Shots
- Wholesome Wellness - Natural Anxiety & Depression Relief
- Dr. Garber’s Natural Solutions - Dr. Garber’s Depression Relief
- ProHealth Inc. - Full Spectrum St. John’s Wort Extract
- Blossom Nature LLC - St. John’s Wort
- FDC Nutrition Inc. - Inositol 100% Pure Free Form
- Silver Star Brands, Inc. - MindSoothe Drops and MindSoothe Capsules
“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.”
According to the FDA, “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.”
While the FDA evaluates drugs, 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 said consumers “should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases.”
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February 22, 2021 at 07:23PM
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