FDA WARNING_LETTER - Eugene Lefter

The FDA reviewed wellknowndrugs.com and found it offers products in violation of the Federal Food, Drug, and Cosmetic Act. Products like "Acomplia (Generic)," "Valium (Brand)," and "Xanax (Generic)" are deemed drugs under section 201(g) of the Act.

Violations include marketing unapproved new drugs, specifically "Acomplia (Generic)," which was rejected for FDA approval due to safety concerns like neurological and psychiatric side effects. This violates sections 301(d) and 505(a) of the Act, requiring FDA-approved applications for new drugs.

Additionally, products like "Valium (Brand)" and "Xanax (Generic)" are misbranded under section 503(b)(1) because they are sold without requiring a prescription from a licensed practitioner, despite some being controlled substances with abuse potential. The website also falsely claims products are FDA-approved, violating section 502(a) regarding false and misleading labeling.

The FDA emphasizes the inherent risk of buying unapproved prescription drugs from unregulated sources, citing potential contamination, counterfeiting, and inconsistent active ingredients. The firm must immediately cease marketing violative products. Failure to correct these violations within 15 working days may result in regulatory action, including seizure or injunction. A written response detailing corrective actions and prevention measures is required within 15 working days.