Enforcement Tracker

Enforcement Tracker

FDA, DOJ, and state enforcement actions against gray-market GLP-1 vendors. Updated as actions occur.

85+
FDA warning letters sent to GLP-1 vendors and compounders
FDA, Sept 2025 + March 2026
2
Shortage list removals eliminating legal basis for compounding
FDA 2024-2025
3+
Federal indictments and guilty pleas
DOJ press releases
1
Major vendor shutdown (Peptide Sciences)
March 2026
Timeline

Key enforcement milestones

April 2026
Dr. Watkins indicted; Gram Peptides warning letter
Federal indictment for prescribing and distributing unapproved GLP-1 compounds. Separately, FDA issued warning letter to Gram Peptides for marketing unapproved semaglutide products.
March 2026
Peptide Sciences shuts down
The vendor long considered the “gold standard” by the research chemical community ceased operations without public explanation. Community speculation centers on pending federal action.
March 2026
30 telehealth warning letters
FDA issued warning letters to approximately 30 telehealth companies continuing to prescribe compounded semaglutide and tirzepatide after shortage resolution. Letters demanded immediate cessation of marketing and distribution.
February 21, 2025
Semaglutide removed from FDA shortage list
FDA determined that semaglutide (Wegovy/Ozempic) supply was sufficient to meet demand. This eliminated the Section 503A exemption that had allowed compounding pharmacies to legally produce semaglutide. All compounded semaglutide became legally unapproved.
October 2024
Tirzepatide removed from shortage list
FDA resolved the tirzepatide (Zepbound/Mounjaro) shortage, removing the legal basis for compounding. Compounders given transition period; many continued production in defiance of FDA guidance.
September 16, 2025
55+ FDA warning letters
FDA issued its largest single batch of warning letters targeting companies selling compounded and unapproved GLP-1 receptor agonists. Letters cited marketing of unapproved new drugs, misleading claims, and failure to register as drug manufacturers.

This page is updated with each new enforcement action

We monitor FDA warning letters, DOJ press releases, CBP seizure reports, and state attorney general actions. When a new enforcement action targets a gray-market GLP-1 vendor, compounder, or telehealth prescriber, it is added to this timeline. Bookmark this page or check back regularly for updates.

What these actions mean

An FDA warning letter is not a criminal charge — it is a formal notice that a company is violating federal law and must correct course or face further action. Warning letters become public record. DOJ indictments and guilty pleas represent criminal prosecution. CBP seizures indicate interception of illegal drug imports at the border. Each action narrows the supply of gray-market peptides and increases the legal risk for buyers.