Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Doctors frequently recommend Compounded Tirzepatide or Compounded Semaglutide, both of which are GLP-1 agonists with the same active ingredient as the brand name medications.” • “GLP-1 Injections contain GLP-1, which mimics a naturally occurring hormone in the body. This is the same active ingredient
Passage 2Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and
Passage 3The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)].