FDA WARNING_LETTER - SPHERE Inc.

The FDA issued a Warning Letter to SPHERE Inc. on September 21, 2011, addressing the internet marketing of unapproved and misbranded drugs through numerous websites. The FDA determined that the company's websites offered products for sale in violation of multiple sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including 301(a), 301(d), 303(e), 502(f), 503(b), and 505(a). Key violations included the introduction into interstate commerce of unapproved new drugs, such as "Viagra Professional," "Cialis Super Active," Acomplia, and Melanotan, for which no FDA-approved applications exist. The firm also unlawfully distributed human growth hormone (HGH) without a physician's order, a violation punishable by significant prison time and fines. Furthermore, SPHERE Inc. offered prescription drugs, including controlled substances, without requiring a valid prescription, leading to misbranding under section 503(b)(1). The labeling for many products failed to bear adequate directions for use, resulting in misbranding under section 502(f)(1). Specifically, misbranded Accutane (isotretinoin) was sold, bypassing critical safety controls like the iPLEDGE program, which places patients at risk. The FDA emphasized the inherent risks of unapproved and misbranded drugs from unregulated sources, citing concerns about safety, efficacy, quality, contamination, counterfeiting, and inconsistent active ingredients. SPHERE Inc. was instructed to immediately cease marketing all violative drug products and to respond in writing within 15 working days, detailing corrective actions and recurrence prevention measures. Failure to comply could result in regulatory actions such as seizure and injunction.