FDA issues warning letters to seven companies for violating the FD&C Act

21 Nov 2022 --- The US Food and Drug Administration (FDA) has issued warning letters to seven companies violating the Federal Food, Drug and Cosmetics Act (FD&C Act). The companies are said to have been selling illegal dietary supplements claiming to cure, mitigate, treat and prevent cardiovascular diseases.

The warnings were issued to seven US-based companies; Anabolic Laboratories, Calroy Health Sciences, Essential Elements, Bergamet North America, Healthy Trends Worldwide and Chambers’ Apothecary.

The companies have 15 working days to respond to the warnings issued and are expected to explain how the issues will be addressed and provide information on how their products do not violate the FD&C Act.

If the companies fail to do so, it may result in legal action, product injunctions and seizures.

Supplements are not drugs
The FDA explains that supplements claiming to treat, cure and prevent diseases are subject to the same requirements applying to drugs, although listed as dietary supplements. 

“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,” says Cara Welch, director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. If the companies fail to respond to the letters, it may result in legal action, product injunctions and seizures.

“Dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease and related conditions could harm consumers who use these products instead of seeking safe and effective FDA-approved treatments from qualified health care providers.”

Unsafe supplements
The agency explains that, unlike approved drugs, the FDA has not evaluated whether the unapproved products subject to the warning letters announced today are adequate 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.”

Recently, the FDA’s action of issuing warning letters was criticized by the Council for Responsible Nutrition (CRN) as being ineffective.

“Unfortunately, the agency is not doing its job when one can find the same rogue ingredients in the same bad products six years after warning letters have been issued,” Megan Olsen, senior vice president and general counsel at CRN, said earlier this year.

The agency has previously said that it lacks the authority to regulate the market fully and urged congress to grant authority to do so. Additionally, the CRN has said that the FDA tends to focus on potential hazards when it comes to dietary supplements rather than the health benefits they may bring.

The agency urges the public not to consume these and similar supplements, as they have not been deemed safe 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,” Welch adds.

Edited by Beatrice Wihlander