With obesity afflicting over 44% of U.S. adults, Americans are sick, facing a chronic disease epidemic unlike anything we’ve ever seen before. Fortunately, we now have a powerful tool to address this crisis: GLP-1 medications, which have shown unprecedented success in helping patients lose weight and manage related chronic conditions. GLP-1s are key to making America healthy again – but unapproved, untested copycats with foreign ingredients put us at risk.
During a recent shortage of FDA-approved GLP-1s such as Ozempic and Wegovy, which use the active pharmaceutical ingredient (API) semaglutide, a troubling workaround emerged: compounded versions of these medications produced by unregulated pharmacies like the popular HIMS and HERS. These compounders push alternatives to branded GLP-1s to American consumers with catchy ads and promises of “affordable” and “doctor-trusted” weight loss treatments – but at what cost?
The semaglutide shortage is over, but the illegal, unsafe, and venal exploitation of the American public by drug compounders continues. During a House Energy and Commerce Committee hearing this week, we will hear about the dangers of foreign ingredients – a majority of which come from China – in our pharmaceuticals. Committee members need to look no further than GLP-1 scammers masquerading as pharmaceutical companies.
Recently the FDA reclassified the semaglutide shortage as "resolved." That means compounding of semaglutide is no longer permitted under current regulations.
Over and done with? Hardly. Several companies are still hawking compounded GLP-1s under the guise of “personalization.” When a consumer takes a five-question survey to receive a prescription, that shouldn’t count as personalized medicine.
Compounding pharmacies aren’t pharmaceutical companies. The safety and effectiveness of their drugs aren’t tested by the FDA and their manufacturing facilities aren’t inspected. Most source ingredients from sketchy factories in China. These “compounding cowboys” don’t report adverse events to the FDA, and the agency has “received reports that in some cases, compounders may be using salt forms of semaglutide, including semaglutide sodium and semaglutide acetate.”
The salt forms are different active ingredients than the approved drugs, which contain the base form of semaglutide. The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded.” Buyer beware isn’t acceptable, and no one should be playing around with unapproved, untested, unregulated drugs.
The quality issues are real. Less than a quarter of Chinese facilities marketing semaglutide were inspected by the FDA. And the three Chinese firms responsible for 20% of the imported semaglutide volume haven’t been inspected as of September 2024. A recent investigation found that one popular supplier was using active ingredients made for animals – not humans.
As of March 2025, the FDA has received 925 adverse event reports related to compounded semaglutide products, many of which involve life-threatening and even deadly consequences, with at least 18 deaths associated with compounded ingredients like semaglutide. This isn’t surprising since, according to the Kaiser Family Foundation,1 in 4 U.S. adults taking GLP-1 drugs source them without a primary physician.
Why hasn’t there been more aggressive regulatory action? Currently, the FDA can only target false or misleading posts by influencers or telehealth companies when they have an established financial relationship with the legitimate manufacturer of the drug and, in the age of social media and aggressive pharmaceutical compounding, that loophole has become an ever-expanding wormhole of dangerous behavior. The Hims & Hers Super Bowl ad and subsequent ads in major newspapers like the New York Times for these illegal products is only the most recent, brazen, and illegal manifestation of greed trumping public health.
The good news is that the agency has proposed a new rule that addresses what drugs should not be permitted for compounding. Per “Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding,” those criteria are: “the formulation complexity, drug delivery mechanism complexity, dosage form complexity, complexity of achieving or assessing bioavailability, compounding process complexity, and complexity of physicochemical or analytical testing of the drug product or category of drug products.” GLP-1 medicines would meet all these enhanced standards. It’s a start, but cowboy compounders, fighting for their lives, are filing lawsuits and amping up aggressive public relations programs.
The ballooning regulatory end-run to slimness also has serious systemic implications – such as slowing research into new and important uses for GLP-1 medicines. There’s mounting evidence that these medicines may potentially treat other serious conditions, but to really dig into the scientific opportunities, the legitimate manufacturers of FDA-approved semaglutide products will have to invest hundreds of millions into research and development. That’s the good news. The bad news is that if the compounding snake oil salesmen hawking their knock-off products from China continue their dangerous exponential growth, legitimate manufacturers may be dissuaded from undertaking these additional high-risk research programs.
Legitimate GLP-1s have already started to revolutionize health care in America – but we can’t let cowboy compounders get in the way. The FDA and Department of Justice must act swiftly and decisively to stop the flow of illicit GLP-1s into the country. At the same time, the FDA must issue clear guidance to health care providers and pharmacies on the serious risks of compounded versions and the critical need to rely on FDA-approved sources. As the Energy and Commerce Committee takes up this issue, lawmakers must make it clear: illegal compounding is a public health crisis – and it demands an aggressive federal response.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.
