FDA WARNING_LETTER - Nuturna International LLC - September 09, 2021

The FDA issued a Warning Letter to Nuturna International regarding its "Diabetic Support Formula" product, sold on its website 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.

Evidence of intended use includes personal testimonials on both the website and Amazon product page, citing improved A1C levels, lowered sugar levels, and blood sugar readings within a normal range. The Amazon page also features claims like "Support for Lower Blood Sugar Levels" and references a clinical trial suggesting the product reduces infection incidence in type 2 diabetics.

The FDA states that "Diabetic Support Formula" is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) of the Act. New drugs require prior FDA approval, which this product lacks, violating sections 301(d) and 505(a). Furthermore, the product is deemed misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it addresses conditions requiring supervision by a licensed practitioner. Introducing or delivering this misbranded drug into interstate commerce violates section 301(a).