November 17, 2022
The U.S. Food and Drug Administration (FDA) issued 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). The products cited in these letters are unapproved new drugs and have not been evaluated by the FDA to be safe and effective for their intended use.
According to the Centers for Disease Control and Prevention, cardiovascular disease is the leading cause of death in the United States. In 202o, nearly 700,000 Americans died from cardiovascular disease, accounting for 1 in every 5 deaths.
Consumers who rely on unapproved products claiming to cure, treat, mitigate, or prevent cardiovascular disease or related conditions instead of discussing their symptoms with a health care professional may not receive appropriate treatment and could potentially suffer harm.
Warning letters were sent to the following companies:
- Essential Elements (Scale Media Inc.)
- Calroy Health Sciences, LLC
- BergaMet North America, LLC
- Healthy Trends Worldwide, LLC (Golden After 50)
- Chambers' Apothecary
- Anabolic Laboratories, LLC
Under the Federal Food, Drug, and Cosmetic 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 the warning letters announced today 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.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues, or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to correct violations promptly may result in legal action, including product seizure and/or injunction.
For More Information
- Dietary Supplements
- Press Release: FDA Warns Seven Companies for Selling Dietary Supplements with Claims to Treat Cardiovascular Disease