Med Light Ltd – FDA Warning Letter

The FDA issued a Warning Letter after reviewing multiple websites (e.g., refill-rxmeds.com, brand-meds.com) operated by the firm, which were found to be offering violative drug products for sale. The products, including "Acomplia (Brand/Generic)," "Rimonabant," "Viagra (Brand)," "Cialis (Brand)," and "Prozac (Generic)," are considered drugs under section 201(g) of the Act. The firm is in violation for marketing unapproved new drugs, specifically "Acomplia" and "Rimonabant," without FDA-approved applications, contravening sections 301(d) and 505(a) of the Act. Rimonabant was previously rejected by the FDA due to significant safety concerns, including neurological and psychiatric side effects. Unapproved drugs from unregulated sources lack safety and effectiveness assurances. Additionally, the firm markets misbranded drugs. Products like "Viagra," "Cialis," and "Prozac" are sold without requiring a prescription from a licensed practitioner, violating section 503(b)(1) and other provisions. Furthermore, the websites falsely claim products are FDA-approved, making the labeling false and misleading under section 502(a). The introduction of these misbranded products into interstate commerce violates section 301(a). The FDA requires the firm to immediately cease marketing these violative products and respond in writing within 15 working days detailing corrective actions and recurrence prevention. Failure to comply may lead to regulatory actions such as seizure or injunction.