Any depression/anxiety supplements that states it is intended for use in the cure, mitigation, treatment, or prevention of disease may violate FDA guidelines if certain items, such as recommended dosage, are on the label.
Contact depression/anxiety supplements class action attorneys at Shamis & Gentile, P.A. by filling out a form on this page for a FREE case evaluation.
In February 2021, 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)
“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.”
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. Unlike drugs approved by the FDA, 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.’
In general, consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases. The FDA advises consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug. For example, some supplements might interact with medicines or other supplements. Also, if claims sound too good to be true, they probably are.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care professionals and consumers to report adverse reactions associated with FDA-regulated products to the FDA using MedWatch or the Safety Reporting Portal.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Have you purchased a supplement aimed at treating your depression or anxiety? Any depression/anxiety supplement that states it is intended for use in the cure, mitigation, treatment, or prevention of disease may violate FDA guidelines if certain items, such as recommended dosage, are on the label. Contact the depression supplements class action attorneys at Shamis & Gentile, P.A. by filling out the form on this page for a FREE consultation.