The US Food and Drug Administration (FDA) sent warning letters to 10 companies that are illegally selling dietary supplements that “claim to cure, treat, mitigate, or prevent depression and other mental health disorders,” according to a news release.
Dietary supplements that claim to treat mental illnesses may harm consumers who opt to use supplements as a replacement for evidence-based treatments from qualified healthcare providers, stated Steven Tare, the FDA’s Director of the Office of Dietary Supplement Programs in the Center for Food Safety and Applied Nutrition.
“This is especially concerning during the ongoing pandemic, when consumers are even more susceptible to depression and mental health issues,” he said in the press release. “The [FDA] is committed to taking action to protect the public from unlawful dietary supplements.
The 10 companies — 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 — are in violation of the Food, Drug, and Cosmetic Act (FD&C Act), under which products that are “intended to cure, treat, mitigate, or prevent disease” must meet the requirements that apply to drugs, regardless of whether or not the product is labeled as a dietary supplement.
The companies have until March 10, 2021, to present evidence to the FDA that they have taken specific steps to remedy the issue. If they fail to promptly address each of the violations cited in their warning letters, the FDA may take legal action.
The FDA has not evaluated the safety and efficacy of any of the products that prompted the warning letters, and urges consumers to discuss any dietary supplements or drugs with a healthcare professional before deciding to purchase or use a product. Clinicians should discuss with patients whether or not a supplement is right for them, and if it will interact with any medicines or supplements patients are already taking.
If a product’s claims sound too good to be true, they probably are, the FDA said. The supplements sold by these 10 companies are not proven treatments for mental illnesses, including depression, and patients should not take supplements without first speaking with their provider.
FDA warns 10 companies for illegally selling dietary supplements claiming to treat depression and other mental health disorders. News Release. US Food and Drug Administration; February 19, 2021. Accessed February 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-warns-10-companies-illegally-selling-dietary-supplements-claiming-treat-depression-and-other