Newman Clinic, PLLC dba Newman Clinic

Warning LetterOpen

United StatesIssued Feb 20, 2026Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateFeb 20, 2026

Product TypeDrugs

StatusOpen

Letter Details

Firm: Newman Clinic, PLLC dba Newman Clinic
Location: United States
FEI Number: N/A
Country: United States
Issue Date: February 20, 2026
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Newman Clinic was cited for marketing compounded semaglutide and tirzepatide products with false or misleading claims and labeling that violated the Federal Food, Drug, and Cosmetic Act. The clinic's website falsely represented that Newman Clinic was the compounder of these drugs when it was not, and made unsubstantiated claims equating the compounded products to FDA-approved drugs like Ozempic®, Wegovy®, Mounjaro®, and Zepbound®, implying FDA approval that did not exist. These violations rendered the products misbranded under sections 502(a) and 502(bb) of the FDCA and constituted introduction of misbranded drugs into interstate commerce.

Newman Clinic, PLLC dba Newman Clinic FDA Warning Letter, February 20, 2026