The FDA is warning seven companies for allegedly illegally selling dietary supplements for heart disease. The FDA says that these corporations claim that their products cure, treat, mitigate, or prevent cardiovascular disease or related conditions, such as stroke, atherosclerosis, or heart failure. These products are considered unapproved new drugs and have not been evaluated by the FDA for safety and efficacy.
The warning letters were sent to these companies:
Essential Elements (Scale Media Inc.)
Healthy Trends Worldwide, LLC (Golden After 50)
The CDC states that cardiovascular disease is the leading cause of death in this country. In 2020, almost 700,000 Americans died from heart disease. Consumers who rely on these unapproved products instead of seeing a doctor may not receive appropriate treatment and could suffer harm.
The Federal Food, Drug, and Cosmetic Act states that products that are intended to diagnose, cure, treat, mitigate or prevent disease are considered drugs even if they are classified as dietary supplements. The products that the warned companies make have not been evaluated for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs or other substances, including over-the-counter products, or whether they may have dangerous side effects.
Responses from these companies must be sent to the FDA within 15 working days, indicating how they intend to address these issues, or providing reasoning and supporting information about why they think these dietary supplements for heart disease do not violate the law.
