FDA WARNING_LETTER - www.buyprosoma.com - June 10, 2025

On June 10, 2025, the FDA issued a Warning Letter to www.buyprosoma.com for unlawfully selling unapproved and misbranded drugs to U.S. consumers via the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website was found to be introducing unapproved and misbranded opioids (e.g., Tapentadol, Tramadol, Hydrocodone, Oxycodone) and benzodiazepines (e.g., Alprazolam, Clonazepam, Diazepam, Lorazepam) into interstate commerce. These drugs are considered "new drugs" under section 201(p) of the FD&C Act because they lack FDA approval for safety and effectiveness. Their sale without prior FDA approval violates sections 301(d) and 505(a).

Furthermore, these prescription drugs are misbranded under section 502(f)(1) because their labeling lacks adequate directions for layperson use, and they are not exempt from this requirement. The website also offers these prescription drugs without requiring a prescription, violating section 503(b)(1) and causing misbranding under section 301(k).

The FDA emphasized the significant public health risks associated with