On November 17, 2022, the U.S. Food and Drug Administration (FDA) sent warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure).
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.
Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to these warning letters are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns. Thus, the products cited in these letters are unapproved new drugs.
The FDA has requested responses from the companies within 15 working days stating how they will address the issues described in the warning letters or providing their reasoning and supporting information as to why they think the products are not in violation of the law.
Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.