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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

GIPR is expressed in adipose tissue, bone, and the central nervous system, particularly in brain regions involved in reward processing and energy homeostasis

Report severe or persistent GI symptoms to your provider

Supporting this view was the fact that compared with non-diabetic patients, the levels of white blood cells, creatinine and triglycerides in diabetic patients with HFpEF were higher [35]