The FDA Already Drew Line On China-Linked Experimental Drug. Now It Has To Enforce It

In July, a 41-year-old woman went into cardiac arrest after taking retatrutide that a health care worker said came from an “unreliable source.” A second report followed in September. A 49-year-old patient had died of cardiac arrest after severe dehydration and malnutrition, having bought the drug online on a nurse’s recommendation. Both deaths were reported to the Food and Drug Administration (FDA), and CBS News obtained the records through a public records request.

Adverse event reports can’t establish a cause of death. Regulators are supposed to chase them anyway, and these two point to a product that should never have been on the market.

Retatrutide is Eli Lilly’s experimental weight-loss drug, still in clinical trials. Its early results were dramatic enough to create a market long before any approval. No country has cleared it for human use. The FDA says the drug “has not been found safe and effective for any condition,” and federal law bars pharmacies from compounding it.

I take a GLP-1 myself, so I understand the demand. According to Gallup, 11% of American adults now use one of these medications to lose weight, nearly four times the share in 2024. I’ve seen what they can do for a person’s health. I’ve also seen the bills. Brand-name prescriptions are expensive and coverage is spotty; Gallup found that more than half of people who switched to cheaper compounded versions did it for cost or insurance reasons. Against that backdrop, a six-month supply of retatrutide for $150 looks tempting. Still, when it comes to cost, nothing beats safety. My prescription comes from a pharmacy, and I can trust what’s in it. Someone ordering vials from a website has no idea.

Much of that cheap supply starts in China. Reporters have traced Chinese factories that advertise retatrutide to Americans on social media and ship it by mail for Bitcoin. Last month in the Washington Examiner, Jennifer Nunez warned that the drug is turning up on TikTok and in medical spas, and that teenagers are getting their hands on it. The vials usually say “research use only.” They also arrive with dosing instructions, which tells you who the seller expects to use them.

Regulators have noticed the trick. The FDA has warned companies whose products were falsely labeled “for research purposes” yet sold to consumers for human use. A buyer has no way to check the dose or how the stuff was made.

We have watched this play out before. In 2016 and 2017, Chinese-sourced fentanyl made up 97% of the high-purity fentanyl the Drug Enforcement Administration (DEA) seized from shipments bound for the United States. Beijing eventually banned the drug itself. Its chemical suppliers adapted by selling precursors to Mexican cartels, and U.S. intelligence still lists China as a primary source of them. By the time pressure from Washington produced real cooperation, synthetic opioids were killing close to 78,000 Americans a year.

Retatrutide is a different drug with a different risk. The supply chain looks familiar, though, and so does Beijing’s habit of tolerating a profitable export until the United States makes it costly. We shouldn’t wait for the death toll to climb this time.

On paper, the rules are settled. In practice, nobody is enforcing them at the scale the problem demands. Companies that get warning letters tend to reopen under new names. An overseas vendor shipping small packages knows most will clear customs, and an influencer can send thousands of young followers to an online storefront in an afternoon.

Washington has the authority to change that. The FDA and Customs and Border Protection should make retatrutide a detention priority, beginning with parcels from China, and the administration ought to press Beijing to control peptide exports the way it pushed on fentanyl chemicals. Warning letters need teeth. When a company ignores one, the FDA and the Justice Department should seek seizures and injunctions. Repeat offenders belong in court under the Federal Food, Drug, and Cosmetic Act. A “research use only” label stapled to human dosing instructions is evidence of intent, and prosecutors can treat it that way. The FDA also needs to work with social media platforms to take down accounts targeting minors, and with state licensing boards to discipline nurses and other professionals who steer patients toward these products.

And the agencies owe the public a scorecard: how many shipments were stopped, how many warning letters led to enforcement and whether illegal sales are falling. Most of that data is already in their hands.

Congress doesn’t need to pass anything new. The FDA drew its line on retatrutide months ago, and two reported deaths suggest the line isn’t holding. Enforcement has to catch up with the black market before the next report lands.

Leif Larson is a messaging consultant and media strategist for multiple political candidates and issue campaigns across the country.

The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller News Foundation.

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