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A patient with BMI 35 or higher would also meet Tier 1 by BMI alone, which is simpler to document

Coming on the heels of the Hims & Hers confrontation and the September 2025 cease-and-desist campaign, these letters establish a clear trajectory: the FDA intends to use the full range of its enforcement authority to curtail what it views as misleading marketing of compounded drugs that circumvent the approval process

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PMID: 35936217

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