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Posted February 22, 2021

FDA Warns Sellers of Depression and Anxiety Supplements for Drug Claims

On February 18, 2021, the FDA issued warning letters to three companies following reviews of the companies' websites, which found statements made about the companies' depression and/or anxiety products to be drug claims. These products include Dr. Garber's Depression Relief from Dr. Garber's Natural Solutions, Inositol 100% Pure Free Form from FDC Nutrition Inc., and Natural Anxiety & Depression Relief from Wholesome Wellness.

More information about each warning is below (use the links to read the full warning letter):

  • Dr. Garber's Natural Solutions (Dr. Garber's Depression Relief) was promoted with statements such as "Benefit: For the relief of temporary depression or occasional feelings of sadness and melancholy."

  • FDC Nutrition Inc. (Inositol 100% Pure Free Form) was promoted with statements such as "Reduce Anxiety by Affecting Serotonin" and "Aid Blood Sugar Control by Improving Insulin Sensitivity. Improve Fertility in Women With PCOS. Reduce Symptoms of Depression."

  • Wholesome Wellness (Natural Anxiety & Depression Relief) was promoted with statements about its ingredients such as "Rhodiola Root... reducing... depression, and anxiety," "St. John's Wort... alleviating (and protecting against) diseases," "Ashwagandha Root... to reduce the symptoms of... anxiety disorders... effective herbal... anxiety, and depression remedy," and "Ginkgo Leaf:... Chinese herbalists prepare the herb in formulas... and mixed in different decoctions to cure diseases."

See ConsumerLab's Reviews of Rhodiola Rosea Supplements, St. John's Wort Supplements, Ashwagandha Supplements, and Ginkgo Biloba Supplements for tests of related products.

Also see the CL Answer What are the best supplements for depression and anxiety? for more information.

In addition, the products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.

See related warnings:

Seller of BioCBD+ Products Warned for COVID-19 and Drug Claims

Seller of Aloe Products Warned for Claiming to Treat Joint Stiffness

FDA Warns Seller of Reishi Mushroom Supplements

FDA Warns Seller of Ginger, Echinacea, and More

Seller of Omega-3 Warned for Making Claims to Treat Focus, Mood