FDA Warns 7 Companies Over Illegal Claims of Cardiovascular Benefits from Supplements

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The US Food and Drug Administration (FDA) has issued warnings to 7 companies for what they claim is the illegal sale and marketing of dietary supplements with claims to cure, treat, mitigate, or prevent cardiovascular disease or related conditions, such as stroke, atherosclerosis, or heart failure.

Announced in a statement on November 17, the FDA warnings cite the companies for being in violation Federal Food, Drug, and Cosmetic Act (FD&C Act) and urge 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.

“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, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, in the aforementioned statement. “We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”

The 7 companies who received warning letters from the FDA were:

Essential Elements

Calroy Health Sciences LLC

Iwi

BergaMet North America LLC

Healthy Trends Worldwide LLC

Chambers' Apothecary

Anabolic Laboratories, LLC

In their release, the FDA provided links to the letters administered to each of these companies, which were issued November 14, 2022, and signed by Ann M. Oxenham, director of the Office of Compliance in the Center for Food Safety and Applied Nutrition, that noted the specific products in question. As part of the warning letter, the FDA has requested the companies in violation of the FD&C Act provide responses within 15 working days stating how they will address the issues described in the warning letters or provide their reasoning and supporting information as to why they think the products are not in violation of the law. The FDA noted failure to correct violations promptly may result in legal action, including product seizure and/or injunction.

The warnings come less than a month after results of the SPORT trial, which were presented at AHA Scientific Sessions 2022, detailed the lack of benefit seen with various dietary supplements for reducing cholesterol compared against placebo therapy. In the aforementioned statement from the FDA, the administration advised consumers to talk to their health care provider or pharmacist before deciding to purchase or use any dietary supplement or drug.

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