fda compounding semaglutide warning letters november 2025 issued 25 to telehealth companies for false and misleading claims about compounded GLP-1 products. Unlike FDA-approved drugs, these products have not been proven to be safe, effective, or of Last month, the FDA issued

DISCLAIMER: For in-vitro laboratory research and peptide reconstitution purposes only

The FDA's Category 2 designation means the substance may present significant safety risks when used in compounding and is prohibited in compounded medications pending further evaluation

Thus, the mode of action of a given GLP-1RA may be highly dependent on its individual pharmacokinetic properties

While a direct causal link was not publicly established, this episode is a sobering reminder that early tolerability data in small studies do not guarantee safety at scale or over time

Borensztein at any time for check-ins, questions, and encouragement

And we are going to discuss assessment and testing in great detail in Part 2