FDA WARNING_LETTER - Petroff, Andrey

The FDA issued a Warning Letter after reviewing websites including shrinkrapthemovie.com and walona.com, which offer products like "Ativan (Generic)," "Viagra (Brand)," "Xanax (Brand)," "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Herbal Xanax," "Herbal Ambien," and "Herbal Viagra." The FDA determined these products are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) and are being sold in violation of the Act.

Violations include marketing unapproved new drugs, specifically "Acomplia (Generic)," "Acomplia (Brand)," "Rimonabant," "Herbal Xanax," "Herbal Ambien," and "Herbal Viagra." Rimonabant (Acomplia) was previously rejected by the FDA due to safety concerns. "Herbal Xanax," "Herbal Ambien," and "Herbal Viagra" are considered new drugs under section 201(p) of the Act. The sale of these products without FDA-approved applications violates sections 301(d) and 505(a) of the Act.

Additionally, products like "Ativan (Generic)," "Viagra (Brand)," and "Xanax (Brand)" are misbranded under section 503(b)(1) of the