Online Generic Medicine/www.onlinegenericmedicine.com

On September 23, 2026, FDA's Center for Drug Evaluation and Research (CDER) issued Warning Letter MARCS-CMS 737806 to Online Generic Medicine, operator of www.onlinegenericmedicine.com, following website reviews conducted on August 26, 2026, and September 2, 2026. FDA determined that the site introduces into interstate commerce unapproved new drugs and misbranded drug products in violation of sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 331(a), 331(d), 331(k), 352(f)(1), 353(b)(1), and 355(a). The specific product identified is "Semanat Injection (Semaglutide)," an injectable semaglutide product marketed on the site with the claim that it is "a potent glucagon-like peptide-1 (GLP-1) receptor agonist" intended to manage blood sugar in type 2 diabetes and support weight management. No approved application under FD&C Act section 505 is in effect for this product. FDA notes that while approved semaglutide products exist in the U.S. market (OZEMPIC and WEGOVY, both prescription-only), the product offered by the respondent is not among them and bears none of the required regulatory approvals, including the mandatory boxed warning addressing the risk of thyroid C-cell tumors that accompanies all FDA-approved semaglutide injections. FDA cited misbranding on two independent grounds. First, the labeling fails to bear adequate directions for use under section 502(f)(1) of the FD&C Act and 21 CFR 201.5, because the drug is a prescription product intended for conditions not amenable to layperson self-diagnosis or treatment, and because the product lacks an approved application that would otherwise exempt it under 21 CFR 201.115(a). Second, the site dispenses the prescription drug without requiring a valid prescription from a licensed practitioner, violating section 503(b)(1) of the FD&C Act and constituting misbranding while held for sale under section 301(k). FDA warned that failure to adequately address the violations could result in seizure, injunction, or other regulatory or legal action without further notice. The respondent was directed to submit a written corrective-action response to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov within 15 business days, referencing MARCS-CMS 737806, and to include specific remediation steps, recurrence-prevention measures, and supporting documentation.