FDA WARNING_LETTER - www.buynetmeds.com - July 01, 2025
Discuss this record with AI
On June 12, 2025, the FDA issued a Warning Letter to www.buynetmeds.com for unlawfully selling unapproved and misbranded drugs to U.S. consumers over 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 opioid drug products, specifically various formulations of tapentadol (e.g., Asmanol, Aspadol, Tapaday), and unapproved and misbranded semaglutide drug products, including injectable versions (e.g., Rybelsus, Fitaro). These products are considered "new drugs" under section 201(p) of the FD&C Act and lack FDA approval, violating sections 301(d) and 505(a).
Furthermore, these drugs are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use, as they are prescription drugs requiring professional supervision. The website also offers these prescription drugs without requiring a prescription, violating section 301(k) and misbranding them under section 503(b)(1).
The FDA emphasized the inherent risks of purchasing unapproved drugs,
ID · 9d5810b0-0bab-426a-a1b7-481966b15153
Full citation text and observation details available on the Dashboard.