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Nature 526, 719722

Only a healthcare professional can determine if it is appropriate based on health needs and medical history

Indeed, CDER Acting Director Michael Davis reinforced the policy point publicly on X, emphasizing that compounded GLP1 products are not FDAapproved and have not undergone the rigorous review for safety, efficacy, and manufacturing quality that is required for drugs approved through the new drug application (NDA) or abbreviated new drug application (ANDA) pathways.[3] This is now the third major set of warning letters in less than a year with the majority aimed at telehealth marketing of compounded GLP-1 products: September 2025: roughly 80 warning letters and 40 untitled letters March 2026: 30 warning letters June 2026: 25 warning letters The Claims FDA Is Targeting As in earlier rounds, the June 2026 letters appear highly standardized and focus on consumerfacing promotion of compounded GLP-1 products

It affects: How you get new patients How you screen and evaluate them How you document care How you order, stock, and track meds How you communicate with patients Patient Leads and Advertising The FDAs 2026 warning letters targeted clinics and telehealth companies for using phrases like same active ingredient as Ozempic, generic Zepbound, or from the same family as Mounjaro. If you've got anything like that on your website or in your ads, take it down

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