Overview

As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and compounded GLP-1 drugs, such as those containing semaglutide or tirzepatide. Recent public statements, lawsuits, and enforcement actions underscore the urgent need for vigilance among healthcare providers, pharmacies, platforms, clinics, med spas, and consumers.

State Attorneys General Raise Concerns Regarding Counterfeit and Compounded GLP-1s 

In February 2025, 38 states attorneys general (“38 State AGs”) signed a letter addressed to then-Acting Commissioner of the Federal Food & Drug Administration (“FDA”) Sara Brenner, asking FDA to take action against the high-volume of counterfeit GLP-1 drugs entering the U.S. drug supply chain from China, Turkey, India, and other foreign countries. According to the 38 State AGs, these products may have contained unknown contaminants, incorrect dosages, or even repackaged insulin falsely labeled as GLP-1 drugs. In addition, online retailers were illegally selling the active ingredients of GLP-1 drugs directly to consumers, without a prescription. These ingredients were labeled “for research purposes only” or “not for human consumption” and, like the counterfeit versions, came from unregulated and undisclosed sources in foreign countries. 

The letter also took issue with compounding pharmacies, noting that while such pharmacies are a necessary part of the drug supply chain, some have “cut corners in pursuit of a quick profit” and noted that insanitary conditions at such pharmacies can lead to public health issues. The 38 State AGs asked FDA to step up enforcement actions against companies behaving unlawfully, including by initiating investigations and inspections, and sending warning letters where appropriate. 

This letter was echoed by letters from several other state attorneys general, including:

• Illinois – State Attorney General Kwame Raoul warned residents about the dangers of purchasing unapproved or compounded GLP-1 weight loss drugs from unlicensed sellers, emphasizing the risks associated with misleading advertising by med spas and online retailers. AG Raoul urged consumers to obtain prescriptions from trusted healthcare providers and have those prescriptions filled only at licensed pharmacies.
• South Carolina – State Attorney General Alan Wilson cautioned consumers against buying unapproved or compounded weight loss medications containing tirzepatide or semaglutide, highlighting the prevalence of misleading marketing, untested product forms (such as drops, lozenges, and patches), and the risks of counterfeit drugs. AG Wilson encouraged reporting of deceptive sales practices regarding unapproved or compounded weight loss medications.
• Tennessee – The Tennessee State Attorney General’s Office warned consumers about scams involving GLP-1 weight loss drugs, including those sold without prescriptions, by compounding pharmacies, or through unregulated channels such as social media. The AG’s Office provided a detailed list of red flags to help consumers identify potentially dangerous and counterfeit products.
• Connecticut – State Attorney General William Tong announced enforcement actions against online distributors selling unapproved “research-grade” GLP-1 weight loss drugs without prescriptions and warned weight loss clinics against marketing and selling compounded GLP-1 drugs not approved by FDA, citing health risks, dosing errors, and deceptive marketing practices.
• Ohio – State Attorney General Dave Yost sent warning letters to 14 med spas for making false or misleading claims about compounded versions of semaglutide and tirzepatide, stating that the compounded drugs were not FDA approved, are not the same as brand name or generic weight loss drugs, and that misleading advertising was prohibited.
• Pennsylvania – State Attorney General Dave Sunday warned consumers about the dangers of counterfeit GLP-1 weight loss drugs, which were increasingly entering the market due to high demand. AG Sunday emphasized the particular risks of counterfeit drugs with foreign contents, urged consumers to obtain GLP-1 weight loss drugs only from reliable pharmacies, and called on FDA to intensify enforcement against counterfeit sellers.
• Mississippi – State Attorney General Lynn Fitch urged consumers to only purchase GLP-1 weight loss drugs from licensed and regulated sources, warning of the dangers posed by unapproved and compounded tirzepatide and semaglutide products, especially those in untested forms like sublingual drops and nasal sprays. 

Federal Trade Commission (“FTC”) Targets Online Seller of GLP-1s

The FTC is also ramping up enforcement efforts. On July 14, 2025, FTC announced a settlement with a telehealth company, NextMed, and its founders following allegations of deceptive and unfair practices related to NextMed’s telehealth weight loss programs offering GLP-1 drugs such as Ozempic and Wegovy. As noted in the Complaint, NextMed allegedly advertised prices for its weight-loss membership program that suggested that the GLP-1 medications, lab tests, and medical consultations were included, but they were not. Consumers were allegedly enrolled in undisclosed one-year contracts with recurring 28-day billing and early termination fees. 

NextMed also used paid actors and fake before/after photos as testimonials, manipulated reviews on third-party sites, and promised average weight loss of 53 pounds or 23 percent body weight without any supporting data. Consumers frequently faced obstacles when cancelling memberships. The company allegedly delayed refunds and had a high chargeback rate, leading to payment processor issues. NextMed is further alleged to have instituted recurring charges to consumers without prior written authorization, violating the Electronic Fund Transfer Act and Regulation E. 

NextMed and its founders agreed to settle with FTC for $150,000, which will be used to provide refunds to consumers. They further agreed to refrain from engaging in the conduct giving rise to FTC’s Complaint. As part of the settlement, FTC will publish the proposed settlement package in the Federal Register and allow for thirty (30) days of public comment. Thereafter, FTC will decide whether to make the proposed consent order final. 

Congress Asks Federal FDA to Act 

Finally, on July 25, 2025, a bipartisan group of more than 80 congressional representatives sent a letter to FDA Commissioner Martin Makary raising concerns regarding an alleged surge in illegal and counterfeit anti-obesity medication (“AOMs”), which include semaglutide and tirzepatide, entering the United States from foreign entities. The letter indicated that these counterfeit products are often smuggled in from unregistered foreign suppliers, primarily in China, and pose a risk to consumers.

The representatives asked FDA to increase enforcement efforts over illegal imports of AOMs by issuing warning letters, initiating civil enforcement actions, and monitoring non-compliant online retailers and compounders selling unapproved AOMs. They were careful to distinguish between “legitimate compounded drugs prepared in state-licensed pharmacies and counterfeit or compounded drugs made from illicit ingredients obtained from illegitimate sources.” They also asked FDA to work with U.S. Customs and Border Patrol (“CBP”) to issue an import alert and step up border enforcement to prevent Chinese entities from shipping counterfeit weight-loss drugs into the United States.

Congressional representatives asked for a response and update to FDA’s efforts by July 30, 2025. 

What This Means for Healthcare Providers and Businesses

The heightened scrutiny from state and federal regulators signals a new era of enforcement and oversight for all entities involved in the distribution, compounding, and administration of GLP-1 drugs. Providers, platforms, clinics, pharmacies, and med spas must ensure strict compliance with all applicable laws and regulations, maintain rigorous quality controls, and educate patients about the risks of unapproved or counterfeit products.