The US Food and Drug Administration(FDA) has issued warnings to seven companies for illegally selling dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The companies claimed the supplements cured, treated, mitigated or prevented cardiovascular diseases or related conditions, such as atherosclerosis, stroke or heart failure.
The FDA has urged consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful, the FDA said in a press release. The warning letters were issued to Anabolic Laboratories, Calroy Health Sciences, Essential Elements, Bergamet North America, Healthy Trends Worldwide and Chambers’ Apothecary.
“Given that cardiovascular disease is the leading cause of death in the US, 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,” said Cara Welch, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Under the 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 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 advises consumers to talk to their doctor, pharmacist or other healthcare providers before deciding to purchase or use any dietary supplement or drug. Some supplements might interact with medicines or other supplements. Healthcare providers will work with patients to determine which treatment is the best option for their condition.