Online Generic Medicine/www.onlinegenericmedicine.com
FDA issued a warning letter to Online Generic Medicine (www.onlinegenericmedicine.com) for selling unapproved and misbranded injectable semaglutide products — specifically 'Semanat Injection (Semaglutide)' — to U.S. consumers without an approved NDA and without requiring a prescription. The site's marketing claimed the product is a GLP-1 receptor agonist designed to manage blood sugar and support weight management, triggering violations of FD&C Act sections 301(a), 301(d), 301(k), 502(f)(1), 503(b)(1), and 505(a). FDA demanded cessation of sales to U.S. consumers and a written corrective-action response within 15 business days, warning that failure to comply could result in seizure and injunction.
Flagged claims (1)
Semanat Injection, [sic] is a potent glucagon-like peptide-1 (GLP-1) receptor agonist wich [sic] is designed to help manage blood sugar levels in type 2 diabetes and support weight management.
Required actions (3)
FDA requests that www.onlinegenericmedicine.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers.
Send your written response to [email protected] within 15 business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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