In May, I wrote about the emergence of a bootleg market for retatrutide, Eli Lilly’s experimental obesity drug. The problem was already hard to miss. Websites and wellness businesses were selling products they called retatrutide even though the medicine remained in clinical trials, had not been approved by the Food and Drug Administration and had no legitimate commercial supply chain.
Less than three months later, Eli Lilly has filed six lawsuits against businesses it says are illegally selling versions of the drug. The defendants include peptide vendors, a compounding pharmacy and a medical spa. Some allegedly use the familiar “research use only” disclaimer even as they market their products in ways that suggest the research subject is the customer.
Lilly is certainly entitled to protect its intellectual property, but that is not what makes these lawsuits interesting. What should get Washington’s attention is that a pharmaceutical company is being forced to police a black market for a medicine that isn’t yet a medicine. Protecting Americans from unapproved and potentially dangerous drugs is supposed to be the government’s job.
Retatrutide is still in Phase 3 clinical development, and Lilly expects to seek FDA approval next year. The promising results reported so far have generated enormous interest, which is hardly surprising. They have also generated an enormous opportunity for people willing to sell consumers something carrying the retatrutide name without waiting for either the science or the FDA.
This isn't a handful of guys selling peptides from the digital equivalent of a car trunk. Lilly says it has reported more than 200 individuals and businesses to federal and state authorities and identified more than 14,000 websites, advertisements, social-media posts and product listings offering purported retatrutide in more than 100 countries. At some point, a collection of bad actors becomes a market. We have passed that point.
And it is a market that depends on ordinary commercial infrastructure. The material must be manufactured and imported, the advertising has to reach consumers, payments have to be processed, and packages have to be delivered. The remarkable thing about today's pharmaceutical black market is how easily an illegal injectable drug can be made to look like an ordinary online purchase.
That is why six Lilly lawsuits, however justified, aren't much of an enforcement strategy. A drug company can go after businesses misusing its trademarks, investigate counterfeit products and warn consumers. It cannot substitute for the FDA, Justice Department, Customs and Border Protection and state authorities charged with protecting the drug supply.
The underlying issue isn't particularly complicated. Retatrutide is not an approved drug and cannot lawfully be compounded. Calling a vial “research use only” or “not for human consumption” doesn't change what is going on when the seller understands perfectly well that the customer plans to inject it. A disclaimer isn't a regulatory loophole simply because someone prints it on a label.
More important, nobody really knows what is in many of these vials. An FDA-approved medicine comes with enforceable standards for identity, strength and manufacturing quality. A vial bought from an online peptide seller sourcing material from an unregulated manufacturer comes with none of those assurances. The label may say retatrutide. That doesn't make it retatrutide.
That creates another problem. If someone injects one of these products and ends up in the hospital, the resulting story may be that retatrutide caused the injury. But was it retatrutide? Was the dose correct? Was the product contaminated? Was something else in the vial? Without knowing the provenance of the product, blaming the investigational medicine is scientifically meaningless. The damage, however, to the patient and potentially to public confidence is quite real.
This is why the impatience with FDA approval that fuels some of this market is so misguided. The regulatory process can be slow and imperfect, but clinical trials and FDA review exist to answer questions about safety, efficacy, manufacturing quality and appropriate use before millions of people start taking a medicine. Replacing that process with an Internet vendor, a credit card and a FedEx envelope isn't healthcare innovation.
Nor is the broader illicit GLP-1 trade some theoretical concern. Customs and Border Protection intercepted more than 690 shipments containing more than 31,000 units of illicit GLP-1 drugs during fiscal 2025. In July alone, seizures exceeded 1,400 shipments and nearly 90,000 vials. Those are not numbers that call for another sternly worded warning letter.
Regulators and law enforcement need to treat the business as a supply chain rather than a game of whack-a-mole with websites. Follow the product back to the manufacturers and importers and follow the money through the businesses selling it. The government doesn't need Lilly to explain that an international market in unapproved injectable medicines deserves more than episodic attention.
None of this is an indictment of legitimate pharmacy compounding. Compounding has an important role when individual patients have medical needs that commercially available FDA-approved products cannot meet. But there is a world of difference between that practice and creating a parallel commercial market for an investigational drug that has never been approved. Responsible compounders should be among the first to insist on the distinction.
When I called this a new bootlegger economy in May, the analogy was deliberate. Prohibition-era consumers bought liquor outside the regulated marketplace and often had little idea where it came from or what was actually in the bottle. Today's customer may be buying a peptide rather than gin, and the transaction may happen on a smartphone rather than in a speakeasy, but the economics haven't changed much. Demand is strong, profits are attractive and provenance is murky.
Lilly's lawsuits may put a few sellers out of business, and good for Lilly if they do. But six lawsuits aren't going to dismantle a market that already spans thousands of online listings and scores of countries. If a pharmaceutical company has to become the principal cop on the beat, the actual cops aren't doing enough.
Retatrutide may eventually become an important new treatment for obesity and related diseases. If and when FDA approves it, patients should be able to know that the medicine they receive is the medicine FDA reviewed. Until then, a vial claiming to contain retatrutide isn't an early-access version of the future. It is an unapproved drug of uncertain provenance being sold ahead of the science, ahead of the regulator and, increasingly, in plain sight.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.
