GeroNova Research Inc. – FDA Warning Letter, Oct 31, 2021

The FDA issued a Warning Letter to GeroNova Research Inc. on November 18, 2021, following a review of their Amazon.com store and social media (Facebook, Twitter) in September-October 2021. The FDA determined that GeroNova Research Inc. sells products—CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg—with claims establishing them as unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The violations stem from numerous claims on their websites and social media promoting the products for the diagnosis, cure, mitigation, treatment, or prevention of diseases, including mitochondrial dysfunction, aging, autism, cardiomyopathy, dislipidemia, renal disease, depressive symptoms, Parkinson's disease, insulin resistance, endothelial dysfunction, diabetes, obesity, nonalcoholic steatosis, and neurological disorders. These claims render the products "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)], requiring prior FDA approval, which they lack.

Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they