FDA WARNING_LETTER - Live Good Inc. - September 09, 2021

The FDA issued a Warning Letter to Berry Gen regarding their "Berry Gen Sugar Control" product, sold on their website, social media, and Amazon storefront. The FDA reviewed these platforms in August 2021 and determined that claims made for the product establish it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), as it is intended for the cure, mitigation, treatment, or prevention of disease.

Examples of drug claims include statements like "treatment… that helps reduce blood sugar levels, control glucose, improve conditions for diabetic people," "Helps control diabetes," and "regulates blood sugar and insulin levels." These claims were found on the product description page, Facebook, Instagram, and Amazon product listings.

The FDA states that "Berry Gen Sugar Control" is a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its intended 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 deemed misbranded under section 502(f)(1) of the Act because it lacks adequate directions for use by a layperson, as it is intended for diseases not amenable to self-diagnosis or treatment without professional supervision. This misbranding violates section 3