CRITICALPharmacy / CompoundingFDA Warning Letter · February 20, 2026

NewSelf Limited dba NewSelf

Atlas ID: 2026-02-fda-newself-limited-dba-newself-wcp8s8

FDA issued a warning letter to NewSelf Limited dba NewSelf on February 20, 2026, concerning its website marketing of compounded semaglutide and tirzepatide products. The agency found the website made false or misleading claims by displaying the 'NewSelf' label on drug products it does not compound, and by using language implying FDA approval for compounded drugs that have not been approved. These representations render the products misbranded under FDCA sections 502(a) and 502(bb), and their interstate commerce introduction violates section 301(a). NewSelf was given 15 working days to respond with corrective steps, and was warned that failure to act may result in seizure or injunction.

Flagged claims (4)

Same active ingredient as Mounjaro® & Zepbound®

FDA trademark misuse · fda-approved-misuse

Same active ingredient as Ozempic® & Wegovy®

FDA trademark misuse · fda-approved-misuse

What is the FDA-approved use of Zepbound?

FDA trademark misuse · fda-approved-implied-equivalence

What is the FDA-approved use of Wegovy?

FDA trademark misuse · fda-approved-implied-equivalence

Required actions (3)

Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)'s Office of Compliance describing the specific steps you have taken to address any violations.

Response required · 15 days

Addressing the basis for other website claims that could be construed as false or misleading or demonstrating that such claims have been modified or removed in light of FDCA §§ 502(a) and 502(bb)) [21 U.S.C. §§ 352(a) and (bb)].

Claim removal

Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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