FDA WARNING_LETTER - Secure Medical Inc

The FDA issued a Warning Letter after reviewing the websites viamedic.com, accessrx.com, and AmeriMedixRx.com, determining that they offer unapproved and misbranded new drugs for sale, specifically "Tamiflu 75mg Gel Tablet," in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The "Tamiflu 75mg Gel Tablet" is considered an unapproved new drug, violating section 505(a) and prohibited under section 301(d) of the FD&C Act. Furthermore, the drugs are misbranded in multiple ways: they are offered for sale without requiring a prescription, violating section 503(b)(1); their labeling is false or misleading, violating section 502(a), by implying FDA approval; and the labeling fails to bear adequate directions for use, violating section 502(f)(1), as the conditions are not amenable to self-diagnosis. The FDA emphasized the inherent risks of unapproved and misbranded drugs from unregulated sources. The firm is required to immediately cease marketing these violative drug products and notify the FDA within 15 working days of corrective actions taken or planned to prevent recurrence. Failure to comply may result in regulatory actions, including seizure and/or injunction.