FDA WARNING_LETTER - Medstore.biz

The FDA issued a Warning Letter to Medstore.biz for offering unapproved and misbranded opioid products, specifically "Ultram" (tramadol) manufactured by Ranbaxy and Cadila, for sale to U.S. consumers. This violates sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The products are deemed "new drugs" under section 201(p) because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The FDA-approved versions of tramadol carry a "black box warning" due to risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the drugs are "misbranded" under section 502(f)(1) because they lack adequate directions for layperson use, as they are prescription-only drugs requiring professional supervision. Medstore.biz's sale of tramadol without a prescription also misbrands the drug under section 503(b)(1) and violates section 301(k).

The FDA emphasizes the inherent risk of unapproved drugs, which may be contaminated, counterfeit, or have inconsistent active ingredients. Medstore.biz is required to immediately cease offering violative drugs and respond in writing within 10 working days, detailing