20 groups and health care professionals say warning letters are not enough, call for seizures, injunctions, and a crackdown on distributors of illegal retatrutide
(Washington, D.C.) September 29, 2026 – Americans for Safe and Effective Medicines (ASEM), along with 19 patient advocacy groups, physicians, and health care professionals has sent a letter urging Acting U.S. Food and Drug Administrator (FDA) Commissioner Kyle Diamantas to take decisive action against the illegal distribution of retatrutide – an investigational obesity drug that has not yet been approved by the FDA.
In the letter to the agency, the physicians and advocacy groups warn that illegal retatrutide is being aggressively marketed and distributed through online black markets, wellness clinics, and medical spas to consumers who have no way of verifying what is in the product, where it came from, or if it is even safe. While early clinical trials have generated significant interest in retatrutide, the drug is still currently undergoing Phase 3 clinical trials – making any sale to the general public illegal.
“Illegal sellers have built a sprawling black market for retatrutide and dressed it up with sophisticated marketing and clinical-sounding language to convince consumers that these products are legitimate,” said Fred H. Mills, Jr., PharmD, Chief Policy Officer of Americans for Safe and Effective Medicines. “Every vial sold through this market puts another patient in harm’s way and undermines the FDA approval process Americans rely on. We urge the agency to take meaningful action with its state and federal partners to shut down the illegal retatrutide market for good.”
ASEM, along with the undersigned physician and advocacy groups, are asking FDA to:
- Coordinate a cross-government response. Work with the Department of Justice, and state boards of pharmacy to carry out seizures and injunctions that stop illegal retatrutide at the border and dismantle the domestic distribution channels already operating within the country.
- Cut off online sellers. Partner with the Federal Trade Commission and other federal agencies to shut down illegal online sellers, compel social media platforms and payment processors to remove illegal ads, and pursue enforcement action against shipping carriers and any other business facilitating illegal trade.
ASEM and the signatories stand ready to work with the agency and other federal and state regulators to protect consumers from this illegal market, strengthen the integrity of the U.S drug supply chain, and ensure that the FDA’s authority is enforced with the urgency that this crisis demands.
You can read the full letter here.
A full list of signatories is below:
- Americans for Safe and Effective Medicines
- Alliance for Aging Research
- Alliance for Safe Biologic Medicines
- ASOP Global
- Caroline Apovian, MD, FACP, FTOS, DABOM, Mass General Brigham
- Collaboration for Evidence-Based Medicines
- Color of Gastrointestinal Illnesses
- Fatima Cody Stanford, MD, MPH, MPA
- HealthyWomen
- Jacinda A. Grant, MD, Mass General Brigham and Harvard Medical School
- John Buse, MD, PhD, DMExperts, LLC
- Lindsay Miamen, RDN, CSOWM, Brigham and Women’s Hospital
- Lisa Larkin, MD, FACP, IF, MSCP, HERmedicine
- National Consumers League
- Olayemi Olubowale, MD, Massachusetts General Hospital Weight Center
- Paul Copeland, MD, DABOM, Massachusetts General Hospital Weight Center
- Shannon Burke, MS, RD, LDN
- Shivani Moktar Reddy, MD, Mass General Brigham
- StopAfib.org
- The Mended Hearts, Inc.