FDA tightens controls on compounded GLP-1 weight-loss injections amid surge in fraud and safety concerns

Regulators increase scrutiny over the import, labelling, and safety of compounded GLP-1 weight-loss drugs, warning of counterfeit products and dangerous ingredients in circulation across the US and globally.

Federal regulators have moved to tighten control over the ingredients used in compounded GLP-1 weight-loss injections, as the Food and Drug Administration warns that the risks to patients go well beyond the border. In new guidance, the agency said some products have arrived warm, some have been labelled with pharmacies that did not make them, and some have carried ingredients that should not legally be used in compounding at all.

The FDA’s new green-list import alert is aimed at active pharmaceutical ingredients for drugs such as semaglutide and tirzepatide. According to the agency, the system is designed to keep suspect imports out of the United States while still allowing ingredients from manufacturers that appear to meet FDA standards. The alert does not ban lawful compounding, but it does add a screening layer for supplies with quality concerns.

One of the agency’s sharpest warnings involves fraudulent labelling. The FDA said some compounded semaglutide and tirzepatide products have been sold under the names of pharmacies that either do not exist or had no role in making the medicine. That can leave patients with a false sense of security when they check the vial or packaging. The agency also said it has seen counterfeit Ozempic in the supply chain and online products marked for research use or not for human consumption that were nonetheless sold with dosing instructions.

The FDA is also flagging ingredients that should not be part of compounded GLP-1 products. Retatrutide and cagrilintide are not ingredients in any FDA-approved drug and have not been found safe or effective for any condition, the agency said. It has already issued warning letters to telehealth companies, ingredient distributors and outsourcing facilities over retatrutide. The agency separately warned that some products marketed as semaglutide may actually contain semaglutide sodium or semaglutide acetate, salt forms that are not the same as the ingredient in approved drugs and for which the FDA says there is no lawful basis for compounding.

For patients who already have these products at home, the FDA says storage and dosing remain major concerns. Injectable GLP-1 medicines should be refrigerated, and the agency says products that arrive warm or inadequately packed should not be used. It also advises discarding multiple-dose vials 28 days after first use, even if medicine remains, and using a fresh needle and syringe each time. The FDA has received reports of dosing errors serious enough to require hospital treatment, along with complaints of nausea, vomiting, diarrhoea, abdominal pain and constipation after patients were given doses beyond approved labelling.

The scale of the problem is also significant. As of May 31, the FDA said it had received 990 adverse event reports tied to compounded semaglutide and more than 730 linked to compounded tirzepatide, though it believes those figures understate the true total because many state-licensed pharmacies are not required to report. The agency says compounded medicines should generally be used only when a patient cannot meet their needs with an FDA-approved product. It is urging patients, clinicians and compounders to report quality problems through MedWatch and to be alert for red flags such as claims that a compounded drug is identical to an approved medicine, spelling mistakes on labels, missing instructions, damaged packaging and suspiciously low prices.