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FDA will evaluate claims and other information on a dietary supplement’s website to establish the product’s “intended use.” In general, a dietary supplement is allowed to make claims about having an effect on the “structure” or a “function” of the human body. If FDA finds that the product is intended for use in the cure, mitigation, treatment, or prevention of disease, it will be deemed a “drug” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). FDA routinely takes enforcement action against such unapproved new drugs.
In a February 18, 2021 Constituent Update, FDA announced that it had issued warning letters to 10 companies for illegally selling dietary supplements, containing a variety of ingredients, that all claim on their websites, as well as their Amazon product pages in some cases, to cure, treat, mitigate, or prevent depression and other mental health disorders as follows:
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FDA warns 10 companies for selling unlawful dietary supplements that claim to treat mental health problems
Today, the U.S. Food and Drug Administration announced warning letters to 10 companies for 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; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber’s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc.
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
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FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders
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SILVER SPRING, Md., Feb. 19, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration announced warning letters to 10 companies for 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; Lifted Naturals; Mountain Peak Nutritionals; SANA Group LLC.; Wholesome Wellness; Dr. Garber s Natural Solutions; ProHealth Inc.; Blossom Nature LLC; FDC Nutrition Inc.; and Silver Star Brands, Inc.
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