Swisschems
FDA issued a warning letter to Swisschems (New York, NY) on December 10, 2024, after reviewing their website and social media accounts and finding that they were selling unapproved Semaglutide and Retatrutide products in the United States. Despite labeling the products as 'research chemicals only,' FDA determined the marketing claims established intended human drug use, making them unapproved new drugs in violation of FD&C Act sections 505(a) and 301(d). FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure and injunction.
Flagged claims (4)
Retatrutide (LY-3437943) is a promising anti-obesity agent. It is designed to be a triple hormone receptor agonist, meaning it activates three important receptors in the body: GLP-1 (glucagon-like peptide-1), GIP (glucose-dependent insulinotropic polypeptide), and GCGR (glucagon receptor). These receptors play crucial roles in regulating glucose levels and metabolic functions in the body.
Peer-Reviewed Studies . . . Once-weekly semaglutide in adults with overweight or obesity. . .. Semaglutide and cardiovascular outcomes in patients with type 2 diabetes.
Peer-Reviewed Studies . . . Triple-Hormone-Receptor Agonist Retatrutide for Obesity – A Phase 2 Trial . . . Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA
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Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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