FDA WARNING_LETTER - www.buynetmeds.com
On June 12, 2025, the FDA issued a Warning Letter to www.buynetmeds.com (India) 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 Federal Food, Drug, and Cosmetic Act (FD&C Act).
The website was found to be introducing unapproved and misbranded opioid drug products (specifically tapentadol, sold under various brand names like Asmanol, Aspadol, Etadol, etc.) and semaglutide drug products, including injectable versions (marketed as Rybelsus and Fitaro). These products are considered "new drugs" under section 201(p) of the FD&C Act because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a).
Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for layperson use, as they are prescription drugs requiring professional supervision. The website also offers these prescription drugs without requiring a prescription, violating sections 503(b)(1) and 301(
- Company
- www.buynetmeds.com
- Product Type
- Drugs
ID · 9df3ecca-6eb6-4cfe-bad6-7f9ae82cab1a
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