Levity Inc. dba Levity

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 offers compounded drug products, including semaglutide and liraglutide drug products.***1*** As described below, your website’s false or misleading claims concerning compounded semaglutide and liraglutide 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 semaglutide and liraglutide products displayed on your website identify “Levity” on the pictured label, suggesting Levity is the compounder of those drugs when in fact it is not.***2*** Accordingly, the representations on your website that Levity 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(

Passage 3

Additionally, the following claims concerning compounded semaglutide and liraglutide products appear on your website: - “The same ingredient as Ozempic® + Wegovy®” - “The power of Saxenda®” Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have 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) a