On November 17, the agency sent warning letters to Essential Elements, Calroy Health Sciences, Iwi, BergaMet North America, Healthy Trends Worldwide, Chambers’ Apothecary, and Anabolic Laboratories.
FDA sent warning letters to seven dietary supplement companies the agency said made claims their products treat cardiovascular disease. On November 17, the agency sent warning letters to Essential Elements (Scale Media Inc.), Calroy Health Sciences LLC, Iwi, BergaMet North America LLC, Healthy Trends Worldwide LLC (Golden After 50), Chambers' Apothecary, and Anabolic Laboratories LLC. Products marketed as dietary supplements are prohibited from making claims to treat, prevent, or cure diseases.
FDA stated in yesterday’s press release: “Today, the U.S. Food and Drug Administration issued warning letters to seven companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent cardiovascular disease or related conditions, such as atherosclerosis, stroke, or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging 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.”
Product claims FDA said companies made included: “helps reduce LDL levels,” “helps you to keep cholesterol levels under control,” “clinically shown to decrease cholesterol,” “protect your heart by lowering bad cholesterol,” “anti-inflammatory,” “clinically shown to reduce inflammation,” “help improve blood vessel function,” “may lower cholesterol,” “may lower blood pressure,” and “may improve health of blood vessels in those with…heart disease.” The companies were flagged not just for claims made on product packaging but also claims on their websites, retailer pages, social media, YouTube, and in customer testimonials.
In the FDA press release, Cara Welch, PhD, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition, 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. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk.”