FDA WARNING_LETTER - melanopharmacy.com - September 10, 2020

The FDA issued a Warning Letter to www.melanopharmacy.com for offering unapproved and misbranded opioid products, specifically "Tramadolo HCl" by Sandoz, 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 unapproved new drugs under sections 201(g) and 201(p) because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The specific tramadol product offered is not FDA-approved, despite approved versions existing, and lacks the required boxed warning for serious risks like addiction and respiratory depression.

Furthermore, the drugs are misbranded under section 502(f)(1) because they lack adequate directions for layperson use, as they are prescription drugs requiring professional supervision. Offering tramadol without a prescription also misbrands the drugs under section 503(b)(1) and violates section 301(k) by dispensing a prescription drug without a prescription.

The FDA emphasizes the significant public health risk posed by the easy availability of unapproved and misbranded opioids online. The company is required to immediately cease offering violative drugs for sale and respond within 15 working days