FDA Flexes Enforcement Muscle

In Multi-Company Warning Letters Issued to Dietary Supplement Companies. FDA Issues Seven Warning Letters to Dietary Supplements Claiming to Treat Cardiovascular Disease.

FDA sent a strong reminder of its enforcement authority last week by simultaneously issuing seven warning letters to dietary supplement companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease, atherosclerosis, stroke or heart failure. In a November 17 news release, the FDA advised consumers to stop using the products or similar products given that the products have not undergone FDA evaluation for safety and efficacy and may be harmful.

The warning letters were issued to Essential Elements (Scale Media Inc.), Calroy Health Sciences LLC, Iwi, BergaMet North America LLC, Healthy Trends Worldwide LLC, Chamber’s Apothecary and Anabolic Laboratories LLC.

Dr. Cara Welch, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition stated that “given that cardiovascular disease is the leading case of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers.”

Under FDA regulations, products that are intended to diagnose, cure, treat, mitigate or prevent disease are drugs, even if labeled as dietary supplements, are treated and subject to the requirements that apply to drugs. The agency stated that in contrast to FDA approved drugs, FDA did not evaluate whether the unapproved products subject to the warning letters “are effective for their intended use, what the proper dosage may be, how the products could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.”

FDA has been simultaneously issuing multi-company warning letters to have the message hit home: that industry should ensure compliance with FDA dietary supplement regulations, and that FDA continues to keep watch and enforce dietary supplement activities.