Thedonrx.net – FDA Warning Letter, Apr 2, 2019

On March 27, 2019, the FDA issued a Warning Letter to Thedonrx.net for unlawfully selling unapproved and misbranded opioids to U.S. consumers over the internet. The FDA determined that the website violates sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation is the sale of unapproved new drugs, specifically "Contramal 100 mg/2 ml" (tramadol). This product is considered a new drug under section 201(p) of the FD&C Act because it lacks FDA approval for safety and effectiveness. The FDA emphasizes the significant risks associated with unapproved opioids, including abuse, dependency, and potential for contamination or incorrect active ingredients, especially amid the U.S. opioid epidemic.

Additionally, the product is deemed misbranded under section 502(f)(1) of the FD&C Act because it lacks adequate directions for use by a layperson. As a prescription drug, tramadol requires supervision by a licensed practitioner due to its potential for harmful effects, making self-diagnosis and treatment unsafe.

The FDA demands immediate cessation of all violative drug sales to U.S. consumers. Thedonrx.net must respond in writing within 15 working days, detailing corrective actions