Rx-promotion – FDA Warning Letter

The FDA issued a Warning Letter after reviewing numerous websites operated by the recipient, determining that they offer unapproved and misbranded new drugs for sale, violating sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA). Specifically, products like "Viagra Professional," "Cialis Super Active," and "Acomplia" are considered new drugs under FFDCA section 201(p) because they lack FDA approval and are not generally recognized as safe and effective for their labeled uses. The introduction of these unapproved drugs into interstate commerce violates sections 505(a) and 301(d). Furthermore, the websites offer prescription drugs, including controlled substances, without requiring a valid prescription, rendering them misbranded under FFDCA section 503(b)(1). Their labeling also fails to bear adequate directions for use for conditions not amenable to self-diagnosis, causing misbranding under section 502(f)(1). This applies specifically to Accutane (isotretinoin), a dangerous prescription drug requiring strict safety controls like the iPLEDGE program, which are bypassed by online sales. The introduction of these misbranded products into interstate commerce violates FFDCA section 301. The FDA emphasizes the inherent risks of unapproved and misbranded drugs, which lack safety and effectiveness assurances. The firm is required to immediately cease marketing these violative products and respond within 15 working days with corrective actions to prevent recurrence, or face potential regulatory actions like seizure or injunction.