Tennessee and other states are urging the Food and Drug Administration (FDA) to take action against those who sell “counterfeit, unapproved and contaminated weight loss drugs.”
A press release from Attorney General Jonathan Skrmetti said he has led a “38-state and territory bipartisan coalition” that is asking the agency to regulate the sale of drugs with weight loss side effects. These drugs include Ozempic, Wegovy, Mounjaro and Zepbound.
The FDA has addressed concerns for these “unapproved” drugs. They noted that these are “options for weight loss” but noted that illegitimate versions “do not undergo the FDA’s review for safety” among other testing.
A letter from the coalition to the FDA noted that while the states have a role in “protecting their own customers,” they need the agency to regulate counterfeits that originate outside of the United States.
“With its broad jurisdiction and resources the FDA is uniquely positioned to lead the campaign against dangerous adulterations of GLP-1 medications in the U.S. drug supply,” the letter said. “We urge the FDA to exercise its statutory authority through investigations, inspections, and enforcement actions to safeguard consumers.”
Skrmetti noted that while many rely on these drugs for health reasons, there are people taking advantage of this need. The Attorney General said high demand and “tight supply” have created a lucrative market for counterfeits. He added that not only have these bogus products not been tested but pose a threat to the country’s “national security” and they have “infiltrated the U.S. supply chain.”
“These counterfeit or copycat drugs can be contaminated through shady supply chains running from China, Turkey, and other overseas suppliers, or they can contain entirely different drugs manufactured and packaged to look like GLP-1 drugs,” Skrmetti said in a statement. “We are asking the FDA to lead efforts to safeguard our American supply chain and to work with other federal and state agencies to stop bad actors from producing counterfeit drugs.”
In a consumer protection warning against these items — known as GLP-1 drugs — Skrmetti mentioned that online marketing and social media have helped their spread. While these sellers advertise these products for a “fraction of the price” they could be offering an “ineffective alternative.”
“Online health/wellness companies might try to bypass prescription requirements by offering to sell the active ingredient of GLP-1 drugs (semaglutide or tirzepatide) and marketing them as ‘not for human consumption’ or for ‘research purposes only,’” the warning said. The websites, however, will often provide consumers with tips on how to use the active ingredients to make their own versions of GLP-1 drugs at home.
The letter to the FDA said that the fake items only offer “active ingredients,” which creates additional issues for consumers. Users are then required to supplement the medication themselves, without the proper knowledge on how to administer injections.
“Patient error in self-dosing has contributed to the dramatic increase in reports of semaglutide overdoses in the U.S. Consumers may also expose themselves to danger by improperly storing active ingredients or using non-sterile equipment,” the letter said.
