FDA issues warning letters to seven US companies

The US Food and Drug Administration (FDA) has issued warning letters to seven companies after the regulator said they illegally sold dietary supplements which violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The seven companies claimed that the supplements could cure, treat, mitigate or prevent cardiovascular disease or related conditions such as atherosclerosis, stroke or heart failure.

The warning letters were issued 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.

“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,” said Cara Welch, PhD, Director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition.

“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.”

The Federal Food, Drug & Cosmetic Act (FD&C Act)

The FD&C Act gives the FDA the authority to regulate foods, drugs, medical devices, cosmetics, and tobacco products.

The FDA has said that, under the 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 labelled as dietary supplements.

Unlike drugs approved by the FDA, the agency has not evaluated whether the unapproved products subject to the warning letters 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.

For this reason, the FDA is advising consumers to talk to their doctor, pharmacist, or other healthcare provider before deciding to purchase or use any dietary supplement or drug. This is because some supplements might interact with medicines or other supplements.

The FDA is urging consumers not to use these or similar products as they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.

“We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk,” said Welch.

The FDA is also encouraging health care providers and consumers to report any adverse reactions associated with FDA-regulated products.