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What stands out: Enforcement focus on mass-marketing, not patient-specific compounding Clear limits on advertising claims, including prohibitions on calling compounded products generic, the same as, or clinically proven Reinforcement of FD&C Act authorities, including misbranding provisions and Section 503A requirements Shift as shortages resolve, removing the legal basis for broad compounding of GLP-1 drugs Expanded compliance tools, including warning letters, seizure, and injunction where violations persist Bottom line: This signals a firmer FDA posture as the GLP-1 market matures, reinforcing long-standing distinctions between FDA-approved drugs and unapproved compounded preparations, particularly when promoted directly to consumers at scale
Compounded drugs may be improperly stored (since injectable GLP-1 medications require refrigeration), and some may be fraudulent (missing high-quality active ingredients)
When natural levels fall too low, cellular protection weakens, potentially contributing to health problems
The Bottom Line Melanotan 2 dosing is not one-size-fits-all
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