Zeuss LLC dba Zeuss

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website’s false or misleading claims concerning compounded tirzepatide products under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], result in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].

Passage 2

The compounded tirzepatide products displayed on your website identify “Zeuss” on the pictured label, suggesting Zeuss is the compounder of those drugs when in fact it is not.***2*** Accordingly, the representations on your website that Zeuss is the compounder of these drug products are false or misleading, and the products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].