The U.S. Food and Drug Administration (FDA) has issued warning letters to supplement companies that have illegally sold dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease. The Nov. 17 announcement included a warning from the FDA urging consumers not to use products that have not been evaluated by the FDA.
The agency issued letters to Essential Elements, doing business as Scale Media Inc.; Calroy Health Sciences LLC, iwi; BergaMet North America LLC; Healthy Trends Worldwide LLC, doing business as Golden After 50; Chambers’ Apothecary; and Anabolic Laboratories LLC. According to the FDA, these organizations have improperly sold dietary supplements and/or have been selling illegal drugs.
Dietary supplements are generally exempt from any pre-market examination by the FDA. However, if a dietary supplement is sold with the promise to cure, mitigate, prevent or treat a disease or health condition, then it is no longer classified as a supplement by the FDA. According to the agency’s announcement, the seven companies were claiming that their dietary supplements could be used like drugs to treat a number of conditions, including:
- Cardiovascular disease
- Heart failure
These claims violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The reason that the FDA mandates that all products intended to cure, prevent or treat medical conditions pass agency review is to assess whether the products are effective for their intended use, what the proper dosages might be, how they could interact with other FDA-approved drugs, how they could interact with other substances or whether they have dangerous side effects. The FDA considers the supplements to have unknown safety or effectiveness and consider them potentially harmful.
Dr. Cara Welch, Ph.D., director of the Office of Dietary Supplement Programs, stated, “Given that cardiovascular disease is the leading cause of death in the U.S., it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it. Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could potentially harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers.”
If the situation is not resolved, the companies will risk injunction or product seizure. Potential steps to resolve this situation may include removing the claims from their products, explaining why the company is not actually in violation of the law, or applying for approval as a drug.