Loading…
Distributor RFR, LLC was cited for distributing "SANGTER Natural Male Energy Supplement," an unapproved new drug that violated the Federal Food, Drug, and Cosmetic Act by being marketed as a dietary supplement without FDA approval. FDA laboratory analysis confirmed the product contained an undeclared active pharmaceutical ingredient—sildenafil (the active ingredient in prescription Viagra)—which cannot legally be included in dietary supplements since it was not marketed as a food or supplement before its drug approval in 1998. The product was also deemed misbranded and sold in violation of multiple sections of the FD&C Act. The violations were identified during an FDA inspection of the company's Doral, Florida facility in June 2022 and review of the product's labeling and website.