FDA WARNING_LETTER - Mendez, Dr Antonio

The FDA issued a Warning Letter to uk-online-pharmacy.com and online-pharmacy-4u.com for offering unapproved and misbranded drugs for sale. The products, including "Acomplia," "Rimonabant," "Herbal Ambien," "Herbal Xanax," "Prozac," "Valium," and "Xanax," are considered drugs under 21 U.S.C. § 321(g). The firm violates the Federal Food, Drug, and Cosmetic Act by selling "Acomplia," "Rimonabant," "Herbal Ambien," and "Herbal Xanax" as unapproved new drugs, contrary to sections 301(d) and 505(a). Rimonabant was specifically rejected by FDA due to safety concerns. The letter highlights the inherent risks of unapproved drugs from unregulated sources. Additionally, the firm sells "Prozac," "Valium," and "Xanax" without requiring a prescription, rendering them misbranded under 21 U.S.C. § 353(b)(1) and violating sections 301(a), 301(b), and 301(k). Products are also misbranded under 21 U.S.C. § 352(a) due to false claims of FDA approval on the websites. Furthermore, "Herbal Ambien" and "Herbal Xanax" are misbranded under § 352(a) because their labeling falsely suggests they contain FDA-approved active ingredients or are manufactured by the approved sponsors. The FDA demands immediate cessation of marketing these violative products and a written response within 15 working days detailing corrective actions to prevent recurrence, warning of potential seizure or injunction for non-compliance.