The U.S. Food and Drug Administration (FDA) must act to protect Americans from fake versions of GLP-1 weight loss and diabetes drugs such as Ozempic and Mounjaro and take “decisive action” against bad actors engaged in such trade, a letter from a bipartisan coalition of attorneys general from 38 U.S. states said.

“From inspections to enforcement actions, the FDA has several important tools at its disposal to help put an end to this unlawful and deceptive conduct. A federal response is necessary because many of the counterfeit drugs are shipped from outside of the country.”

Fake GLP-1 drugs have entered the U.S. supply chain from nations such as China, Turkey, and India, the attorneys general said.

“These counterfeits can contain contaminants, other unknown drugs, or dangerously high amounts of active ingredient(s). Scammers have also repackaged injectable insulin and falsely sold it as Ozempic,” they said.

Injecting counterfeit drugs “can lead to serious side effects for consumers, sometimes necessitating hospitalization,” the letter said, adding that most consumers cannot identify fake from legitimate variants.

The letter raised the issue of retailers illegally selling active ingredients of GLP-1 medications directly to consumers online without any prescriptions. These active ingredients come from unregulated sources and pose a risk of contamination, it said.

Consumers use the ingredients to formulate drugs without adequate knowledge of safely dissolving the active ingredients, drawing it into syringes, and then injecting the substance into the body, the attorneys general wrote.

“Some have contained bacteria, high impurity levels, different colors (pink, instead of colorless), or a completely different chemical structure than Lilly’s FDA-approved medicines,” the company said.

The letter called on the FDA to “work with federal partners like the Department of Homeland Security to intercept counterfeit GLP-1 drugs before they reach unsuspecting consumers.”

It asked the agency to send warning letters to sellers supplying active ingredients directly to people and “follow up with enforcement action if companies continue to act unlawfully.”

“FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said.

“Patients and prescribers may still see intermittent and limited localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.”

“FDA’s decision means that making or selling a knockoff compounded drug that is essentially a copy of Ozempic or Wegovy is illegal, under compounding laws, with rare exceptions,” it said.