FDA WARNING_LETTER - Bonagens - January 12, 2021

The FDA reviewed Bonagens Inc.'s website, bonagensinc.com, in July 2020 and determined that products such as "Anti-Aging Supports," "Cholesterol & Diabetes Control," "Gout Control," "Hypertension Control," "Liver Supports," "Lungs Supports," "Vita-V for Men," and "Weight Lost" are marketed with claims establishing them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. These claims indicate the products are intended for the cure, mitigation, treatment, or prevention of disease.

Specific examples of drug claims include "alleviate the effects of menopausal syndrome" for "Anti-Aging Supports," "significant decrease in fasting blood glucose" for "Cholesterol & Diabetes Control," and "reduce the uric acid" for "Gout Control."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act [21 U.S.C. 331(