FDA's September 2026 warning letter to Empower Pharmacy finds its compounded tirzepatide and semaglutide products are essentially copies of approved GLP-1 drugs and flags prescriber statements repeated verbatim across many records. Former DOJ prosecutors explain the seizure, injunction, criminal, and kickback exposure for compounders, telehealth platforms, prescribers, med spas, and executives.

FDA announced 30 warning letters to telehealth companies over compounded semaglutide and tirzepatide marketing on March 3, 2026, then issued 25 more on June 8. One day later, DOJ unsealed a counterfeit Ozempic indictment. Former DOJ Fraud Section prosecutors explain how warning letters become criminal evidence, why False Claims Act and Anti-Kickback cases against compounders and telehealth prescribers are the next phase, and where the defense begins.