Newman Clinic: What the FDA Letter Means for What You Pay

This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.newmanclinic.com, in December 2025, and has observed that your website offers compounded drug products, including semaglutide and tirzepatide drug products. As described below, your website’s false or misleading claims concerning compounded semaglutide and 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)].

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   “The compounded semaglutide and tirzepatide products displayed on your website identify “Newman Clinic” on the pictured label, suggesting Newman Clinic is the compounder of those drugs when in fact it is not. Accordingly, the representations on your website that Newman Clinic 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)].”

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   “Additionally, the following claims concerning compounded semaglutide and tirzepatide products appear on your website: “Same Ingredient as Ozempic® and Wegovy®” “Same Ingredient as Mounjaro® and Zepbound®””

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   “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) and (bb)].”

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   Letter issued

   February 2026

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   15-working-day response window

   FDA gives the company 15 working days to respond in writing.

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   Close-out, if issued

   FDA may post one once it is satisfied the cited issues have been corrected.

www.newmanclinic.com returned a live site on 2026-08-09 titled "Weight Loss, Hormone Therapy, & Concierge Medicine I Newman Clinic", listing semaglutide, tirzepatide and phentermine under weight-loss medications, stating service in AZ, CA, HI, OH and TX, and running a grand-opening referral promotion — an operating practice.

Two things here are worth a reader's attention, and the first is how little the claim had to say. "Same Ingredient as Ozempic® and Wegovy®" is five words with no verb, no promise and no mention of approval — and FDA still held that it implies the compounded product has been evaluated for safety and effectiveness. That is a useful calibration when comparing pages: a claim does not have to be a sentence, or overstated, or even complete to carry the implication FDA objects to. The registered trademark symbols do part of the work, borrowing the weight of the brands they belong to. The second is that this letter went to a named clinician at her own practice, not to a marketing company. It is a reminder that these findings are about published copy rather than about clinical judgement, and that a small telehealth practice run by an identifiable provider is subject to the same standard as a venture-funded platform. Nothing in the letter concerns the safety of the medication or the quality of care — it concerns whose name was on the vial and what two short lines of website copy told a reader.

As of August 2026, FDA’s public tracking for this letter does not show a logged company response. Companies are not required to make a response public, and FDA does not always update this field promptly — this is not evidence Newman Clinic failed to respond.