The FDA warned 10 companies selling dietary supplements

The US Food and Drug Administration (FDA) warned companies selling dietary supplements, in violation of the Drug and Cosmetic Act (FD&C Act), to treat depression and other mental health disorders. These 10 companies include 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.

These supplements are marketed to treat depression and mental health disorders. However, they are products not approved as drugs and may potentially harm consumers. People may have become more prone to depression during the pandemic (see a cancer patient’s psychological adversaries during the coronavirus pandemic). Steven Tave, director of the Office of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition, said they were taking action to protect people from illegal supplements.

Under the FD&C Act, products intended to cure, treat or alleviate disease are classified as drugs even if labeled as dietary supplements. They are therefore subject to the requirements applicable to drugs. Unlike FDA-approved drugs, these products have not been evaluated for appropriate dosage, suitability for their intended use, interactions with other drugs or side effects.

Consumers should generally be cautious about products sold to prevent, alleviate or cure diseases. The FDA recommends seeking advice from a doctor, pharmacist or another healthcare professional before using any dietary supplement or drug. Some supplements may interact with medicines or other supplements. Claims that sound too good to be true probably are. If a consumer thinks a product may be causing a reaction or illness, they should stop it immediately and contact their doctor.

The FDA asked the companies to submit explanations of why they believed they had not violated the law. Failure to correct violations promptly may result in legal action, such as seizure of products.

As an agency within the US Department of Health and Human Services, the FDA protects public health by ensuring the safety and efficacy of human and veterinary drugs, vaccines, other biological products and medical devices. It is also responsible for regulating food, cosmetics, dietary supplements, electronic radiation-emitting products and tobacco products.