Just weeks after results from the SPORT trial showed no cholesterol benefit from common heart supplements, the FDA has issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease. The FDA is urging consumers not to use these or similar products because they have not been evaluated to be safe or effective for their intended use, and may in fact be harmful.
The warning letters were issued to:
- Iwi
- Essential Elements
- Calroy Health Sciences LLC
- BergaMet North America LLC
- Healthy Trends Worldwide LLC
- Chambers’ Apothecary
- Anabolic Laboratories, LLC.
Under the FD&C Act, products intended to diagnose, cure, treat, mitigate or prevent disease are subject to the regulatory requirements that apply to drugs, even if the products are labeled as dietary supplements. Calroy Health Sciences, for example, sells a one-month supply of a supplement that “strengthens the artery wall’s protective barrier” for $95.
The FDA explains that the unapproved products have not been evaluated for effectiveness, proper dosage, potential drug interactions, or whether they have dangerous side effects or other safety concerns. The warnings come less than a month after the SPORT trial was published, which detailed the lack of benefit seen with various dietary supplements for reducing cholesterol compared with placebo therapy.
The FDA has given the companies 15 working days to either address their concerns or justify why they think the products are not in violation of the law. Failure to correct violations “may result in legal action, including product seizure and/or injunction.”
The Takeaway
Over-the-counter heart supplements have played a big role in patients’ self-guided cardiology care for quite some time. Supplement companies have historically enjoyed looser FDA regulations, unlike drugs, which must be proven safe and effective before marketing. The FDA appears to now be cracking down on some of these companies, issuing seven warning letters that outline instances where the companies have illegally claimed to cure, treat, or prevent cardiovascular disease.
