FDA warns overseas websites selling injectable semaglutide to U.S. consumers without prescriptions

FDA's Internet Pharmacy Task Force sent warning letters to the operators of onlinegenericmedicine.com, dated September 23, 2026, and cheapmedicineshop.com, dated September 24, after reviewing the websites. Each offered an injectable semaglutide product, marketed as Semanat Injection and Semanext Injection respectively, for which no approved application exists. FDA cites the products as unapproved new drugs under section 505(a), introduced into interstate commerce in violation of section 301(a) and 301(d).

The letters also find the products misbranded under section 502(f)(1) because a prescription drug for conditions that cannot be self diagnosed cannot carry adequate directions for lay use, and note that offering the product without requiring a prescription violates section 503(b)(1). FDA points to the boxed warning on approved semaglutide for thyroid C cell tumor risk as part of why an unapproved version matters, asks each site to cease offering unapproved and misbranded drugs to U.S. consumers, and requires a written response within fifteen business days. Warning letters state FDA's allegations, not findings.

• Overseas websites offering branded or generic named semaglutide to U.S. consumers without a prescription.
• Licensed online pharmacies competing with those sellers on price, and patients comparing them.

The recipients are overseas websites, not licensed pharmacies. The relevance to a licensed pharmacy is the channel it competes with and the standard FDA applies to any site offering a prescription injectable to U.S. consumers.

1. Make sure every prescription product on your site is behind a prescription requirement that a visitor can see before ordering.
2. If you dispense semaglutide, state on the product page whether it is the approved product or a compounded preparation, and never describe a compounded one with an invented brand name.
3. Report sites offering injectable semaglutide without a prescription to FDA rather than price matching them.

Website and Digital Presence. The Website and Digital Presence domain covers what a pharmacy's public pages offer and claim, including whether prescription products are gated behind a prescription.

• Warning letter to Online Generic Medicine (www.onlinegenericmedicine.com), MARCS-CMS 737806
  PrimaryFDA Center for Drug Evaluation and ResearchMARCS-CMS 737806Retrieved Oct 6, 2026

  Letter dated September 23, 2026: Semanat Injection; sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), 505(a); the no prescription finding; response instructions.

• Warning letter to Cheap Medicine Shop (www.cheapmedicineshop.com), MARCS-CMS 737810
  PrimaryFDA Center for Drug Evaluation and ResearchMARCS-CMS 737810Retrieved Oct 6, 2026

  Letter dated September 24, 2026: Semanext Injection; the same statutory sections; response to the Internet Pharmacy Task Force within 15 business days.