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: - “Clinically studied ingredients.” - “Clinically studied to help patients….” - “Proven to lose weight effectively” Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Passage 2Your website claims that the compounded drug products it offers are sourced from “FDA approved pharmacies.” Compounding facilities, including pharmacies and outsourcing facilities, are not “FDA-approved” or “FDA-licensed” entities. The FD&C Act does not establish an "FDA-approved" or "FDA-licensed” designation for pharmacies or outsourcing facilities.***2*** Therefore, representing a compounding pharmacy or outsourcing facility as “FDA-approved” or “FDA-licensed” is false and misleading, as these terms imply a formal authorization that FDA does not grant to such entities or their compounded products.