BergaMet North America LLC – FDA Warning Letter, Nov 17, 2022

The FDA issued a Warning Letter to Mr. Jay Decker of Bergamet North America regarding their "Cholesterol Command" product. The FDA reviewed the company's websites (bergametna.com, facebook.com/BergametNorthAmerica.com) and Walmart.com product listing in October 2022.

The FDA determined that claims made on these platforms establish "Cholesterol Command" as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because it is intended for the cure, mitigation, treatment, or prevention of disease. Examples of drug claims include statements on product pages, "What is Bergamot" pages, Walmart product listings, and personal testimonials endorsed by the company.

As a result, "Cholesterol Command" is considered a "new drug" under section 201(p) of the Act, as it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is misbranded under section 502(f)(1) of the Act because it fails to bear adequate directions for its intended use. Since the product is intended for diseases not amenable to self-diagnosis or treatment, adequate directions for layperson use cannot be provided. The introduction or