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.
According to FDA that the companies selling the supplement claimed to cure, treat, mitigate, or prevent depression and other mental health disorders.
The agency added that the sale of these dietary supplements, which are unapproved new drugs, could potentially harm consumers who use these products instead of seeking proven treatments from qualified health care providers.
This warning from the FDA comes at a time when consumers were even more susceptible to depression and mental health issues amidst the ongoing COVID-19 pandemic.
Under the FD&C Act, products intended to cure, treat, mitigate, or prevent disease are drugs and are required to be approved by the FDA, even if they are labeled as dietary supplements.
The agency said it has not evaluated whether these unapproved products are effective for their intended use, the proper dosage and if these products interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.
The FDA urged consumers to talk to their doctor, pharmacist, or other health care professional before deciding to purchase or use any dietary supplement or drug.
The FDA said consumers should be cautious of products marketed and sold online with unproven claims to prevent, treat, mitigate or cure diseases.
The agency warned consumers to immediately stop using the product and contact their health care provider if they think such a product might have caused a reaction or illness.
The FDA has sought responses from these ten companies within 15 working days on how they will address these issues or as to why they think the products are not in violation of the law.
Failing this, the company may be subjected to law enforcement action such as product seizure or injunction. (dpa/NAN)