11.17.22
The U.S. Food and Drug Administration (FDA) issued a batch of warning letters to seven companies that it said have made claims related to cardiovascular disease in violation of the Federal Food, Drug, and Cosmetic (FD&C) Act.
Cardiovascular disease killed an estimated 697,000 people in the U.S. in 2020, according to the CDC, which equates to roughly one in five deaths.
FDA urged consumers not to use any of the products for their intended use, and charged the companies with making respective claims related to atherosclerosis, stroke, and heart failure.
Claims that a dietary supplement can cure, treat, mitigate, or prevent diseases are unlawful to make.
Warning letters were issued to Essential Elements, Calroy Health Sciences LLC, Iwi, BergaMet North America LLC, Healthy Trends Worldwide LLC, Chambers’ Apothecary, and Anabolic Laboratories, LLC. Each company has 15 days upon receipt of each letter to notify the agency of the steps they will take to address the charges made against them.
“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,” said Cara Welch, PhD, 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.”
FDA said in a statement that any product which makes disease-related claims is subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. The agency is concerned that consumers who rely on unapproved products making disease-related claims instead of discussing symptoms with a healthcare professional may not receive appropriate treatment and may potentially suffer harm.
Cardiovascular disease killed an estimated 697,000 people in the U.S. in 2020, according to the CDC, which equates to roughly one in five deaths.
FDA urged consumers not to use any of the products for their intended use, and charged the companies with making respective claims related to atherosclerosis, stroke, and heart failure.
Claims that a dietary supplement can cure, treat, mitigate, or prevent diseases are unlawful to make.
Warning letters were issued to Essential Elements, Calroy Health Sciences LLC, Iwi, BergaMet North America LLC, Healthy Trends Worldwide LLC, Chambers’ Apothecary, and Anabolic Laboratories, LLC. Each company has 15 days upon receipt of each letter to notify the agency of the steps they will take to address the charges made against them.
“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,” said Cara Welch, PhD, 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.”
FDA said in a statement that any product which makes disease-related claims is subject to the requirements that apply to drugs, even if they are labeled as dietary supplements. The agency is concerned that consumers who rely on unapproved products making disease-related claims instead of discussing symptoms with a healthcare professional may not receive appropriate treatment and may potentially suffer harm.
