FDA WARNING_LETTER - USApeptide.com - March 11, 2025

On February 26, 2025, the FDA issued a Warning Letter to www.usapeptide.com for unlawfully selling unapproved and misbranded semaglutide and tirzepatide drug products to U.S. consumers over the internet. The FDA observed that the website introduces these products into interstate commerce, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

Despite disclaimers like "research use only," the website's claims for products like "Semaglutide (GLP-1 Analogue) 5mg/10mg" and "5mg/10mg Tirzepatide (Mounjaro)" indicate intended human use for conditions such as weight loss and type 2 diabetes. These products are considered unapproved new drugs under sections 201(g) and 201(p) of the FD&C Act, as no FDA-approved applications are in effect for them. The FDA emphasizes that approved versions of semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) are prescription-only and carry boxed warnings for serious risks like thyroid C-cell tumors.

Furthermore, the products are misbranded under section 502(