CRITICALGLP-1 / Weight LossFDA Warning Letter · February 20, 2026

Newman Clinic, PLLC dba Newman Clinic

Atlas ID: 2026-02-fda-newman-clinic-pllc-dba-newman-clinic-p8qm59

FDA issued a warning letter to Newman Clinic, PLLC (operated by Donna Newman, DMSc, PA-C) on February 20, 2026, after reviewing the clinic's website in December 2025 and finding false or misleading claims related to compounded semaglutide and tirzepatide products. The clinic's website falsely implied Newman Clinic was the compounder of these drugs by displaying its name on product labels, and made claims suggesting the compounded products were FDA-approved by stating they contained the 'Same Ingredient as Ozempic® and Wegovy®' and 'Same Ingredient as Mounjaro® and Zepbound®.' FDA found these representations misbranded the products under FDCA sections 502(a) and 502(bb), and demanded a written corrective response within 15 working days, warning that failure to comply could result in seizure or injunction.

Flagged claims (2)

Same Ingredient as Mounjaro® and Zepbound®

FDA trademark misuse · implied-fda-approval-compounded-drug

Same Ingredient as Ozempic® and Wegovy®

FDA trademark misuse · implied-fda-approval-compounded-drug

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

Does your site contain similar claims?

The free site audit scans your whole site against every entry in this Atlas. Most glp-1 / weight loss sites match 3-6 patterns.

Run my free site audit

Worried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.

Check specific copy in the Claim Checker