Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Compounded 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 (bb)].
Passage 2“Semaglutide,[*sic*] is the generic version of Ozempic/Wegovy. The generic version Semiglutide [*sic*] allows for affordability and accessibility to everyday consumers looking to attain a healthy weight.”
Passage 3“Compounded Semiglutide [*sic*] is the generic equivalent of the brand names and pharmacologically similar to Ozempic & Wegovy.”
Passage 4“Tirzepatide is the active ingredient in Mounjaro….”
Passage 5“While the Brand Ozempic from retail pharmacies is extremely expensive, Dr. Gater has licensed pharmacies that can dispense Brand Ozempic at a much more affordable price. You can purchase Brand Ozempic through our website at a significant cost savings. All prescription medications including generic Semiglutide [*sic*] and brand Ozempic require a telemedicine visit with a medical provider prior [*sic*] a prescription being sent to our partner pharmacies.”
Passage 6“Generic Ozempic”