genericpharmacyusa.com – FDA Warning Letter, Sep 10, 2020

On August 31, 2020, the FDA issued a Warning Letter to www.genericpharmacyusa.com for offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The website introduces into interstate commerce opioids that are misbranded and unapproved new drugs, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, the website offers "OL-TRAM" (Tramadol), manufactured by "Janssen Pharmaceuticals." This product is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act because no approved applications are in effect for it. FDA-approved tramadol carries a boxed warning due to risks like addiction, abuse, respiratory depression, and neonatal opioid withdrawal syndrome, which are not adequately addressed by the unapproved version.

Furthermore, the drug is misbranded under section 502(f)(1) of the FD&C Act because it lacks adequate directions for use by a layperson, as it is a prescription drug requiring professional supervision. The website's sale of this product constitutes the introduction of a misbranded drug into interstate commerce, violating section 301(a).

The FDA demands immediate cessation of offering violative drugs to U.S. consumers