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
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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Over a 26-year period, most new dietary ingredient notifications were met with objections from FDA, government data shows.
Since the mid-1990s, FDA has objected to most new dietary ingredient notifications (NDINs) for one reason or another. This past fiscal year was no different.
In FY20, filed 27 objection letters to NDINs and acknowledged 16 notifications without objection, reflecting an acknowledgement rate of 37.2%, FDA data shows.
Steven Tave, director of FDA’s Office of Dietary Supplement Programs, reminded industry during a 2019 public meeting that “an effective NDI notification process represents FDA s only opportunity to evaluate the safety of a new dietary ingredient before it becomes available to consumers.”