On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health.
The dietary supplements named in the warning letters were found to be in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA specifically referenced claims related to “lowering cholesterol”, “blood pressure”, and reducing “major adverse cardiovascular events”, amongst others, within the warning letters. These claims were considered to be “illegal” under the FD&C Act because dietary supplements cannot claim to be used to “diagnose, treat, cure, or prevent” any disease, including heart disease and related conditions. Under the FD&C Act, the only claims allowed for dietary supplements are health claims, structure/function claims or nutrient claims.
The manufacturers were given 15 days to correct violations or face enforcement action up to and including “product seizure and/or injunction”.
The warning letters can be accessed here.
If you are the manufacturer or distributor of a supplement marketed for the promotion of cardiovascular health and are concerned that the claims on your labels may not be compliant with the FDA, please reach out to dicentra today.