The U.S. Food and Drug Administration (FDA) has warned seven companies for illegally selling dietary supplements that claim to be able to “cure, treat, mitigate or prevent” cardiovascular disease or other related conditions such as atherosclerosis, stroke and heart failure.
Essential Elements, Calroy Health Sciences, Iwi, BergaMet North America, Healthy Trends Worldwide, Chambers’ Apothecary and Anabolic Laboratories all received warnings letters from the agency.
The FDA has said consumers should not use the supplements distributed by these companies because they have not been properly evaluated and “may be harmful.” According to the Federal Food, Drug and Cosmetic Act, any products marketed as being able cure, treat, mitigate or prevent a disease are subject to the same regulations and requirements as any other pharmaceutical drugs sold in the United States. These companies, however, have been selling products that make such claims without gaining any of the necessary regulatory approvals.
“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,” Cara Welch, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, said in a prepared statement. “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 healthcare providers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”
Each of the seven companies was asked to respond within 15 working days with either a plan to address the issue or a detailed explanation of their reasoning for selling the products. The FDA threatened them with legal action if these issues are not properly handled.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.