Lilly escalates fight over weight-loss shots sold on black market

Eli Lilly and Co. is stepping up its fight against a booming black market for retatrutide, an experimental drug that the company is counting on to expand its crucial weight-loss franchise.

For almost two years, the Indianapolis company has been warning consumers not to take knockoff versions of the shot that are being sold online and at wellness clinics and medical spas. The drug hasn’t been approved by regulators anywhere in the world.

Now, Lilly is upping the pressure. The drug company said Wednesday that it planned to file lawsuits against U.S. businesses that sell retatrutide products illegally, and it’s asking regulators to do more to rein in the illicit market. Businesses that enable and facilitate the sales – including credit card companies, shipping firms and social media sites – also have a role to play in protecting consumers, Lilly said, calling it an “urgent public health crisis.”

Max Denning, an associate vice president at Lilly who oversees global patient safety for its cardiometabolic health division, said tracking knockoff retatrutide is like a game of “whack-a-mole.” The drugs are frequently made by unregulated foreign manufacturers, according to Lilly.

“It’s a huge problem, a global problem,” Denning said in an interview. “It’s not something we can tackle alone.”

The U.S. Food and Drug Administration has said it’s illegal for pharmacies to compound retatrutide. Since 2024, the FDA has sent warning letters to at least 16 companies claiming to sell retatrutide. As of Aug. 11, however, many of them are still selling knockoff versions of the drug, according to a Bloomberg analysis. The FDA didn’t immediately respond to a request for comment outside normal business hours.

Behind the scenes, Lilly has been working for years to disrupt the global retatrutide trade. The company has referred more than 200 entities to the FDA, the U.S. Department of Justice, state attorneys general, law enforcement and professional licensing boards. Lilly says it has reported more than 14,000 websites, advertisements, social media posts and product listings in over 100 countries, but some companies continue to amplify misleading content to vulnerable consumers.

Lilly and rival Novo Nordisk A/S have been fighting a similar battle against copycat versions of their bestselling weight-loss drugs Zepbound and Wegovy. But retatrutide has taken that fight to a whole new level.

Lilly shares were little changed in trading before U.S. exchanges opened on Wednesday. Novo fell as much as 3.3% in Copenhagen, with most of the loss coming before Lilly’s announcement.

The hype about retatrutide has been building for years, ever since Lilly revealed results from a mid-stage study that suggested the drug might be more powerful than any weight-loss drug currently on the market. Since then, people all over the world have been clamoring to get their hands on black-market versions, buying them from overseas sellers who market them as “research-use only” to avoid scrutiny. On social media, the drug is called “reta” or “r3ta,” sometimes even “ratatouille,” as people increasingly find workarounds to avoid some of the restrictions that companies like TikTok have put in place on content related to weight loss.

If approved by regulators, retatrutide is expected to generate more than $5.4 billion in annual sales for Lilly by 2030. But the black market could pose a major risk. Any safety concerns that emerge with knockoff versions could threaten the drug’s reputation, even though Lilly has been running its own large-scale clinical trial program on the medication. The company plans to seek approval from the FDA early next year.

Lilly said there’s been some “encouraging” actions taken by federal and state authorities, including a large Customs and Border Protection seizure in Cincinnati last year. Federal prosecutors have also been targeting illegal sellers, and last month a judge sentenced the owner of a popular peptide company that sold retatrutide to nearly six years in prison.

Denning said Lilly is also engaging with law enforcement in the UK, Brazil, New Zealand, Saudi Arabia and Hong Kong. The company is urging regulators and law enforcement agencies to prioritize enforcement actions and “to coordinate across borders to dismantle the criminal networks” involved in selling retatrutide, he said.