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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

Additionally, stopping Ozempic without medical supervision means missing the opportunity to implement alternative treatments or lifestyle modifications that could maintain the benefits achieved during treatment

By extending beyond weight loss, semaglutide treatment potentially enhances vital health benchmarks, significantly aiding in preventing diseases such as heart conditions, stroke, and type 2 diabetes, providing a comprehensive approach to bettering long-term health

Adverse events observed with tirzepatide The adverse events observed in the clinical study program with tirzepatide are similar to those associated with therapy with GLP-1RA

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