GLP-1 Weight Loss Drug Enforcement in 2025: State Attorneys General Step into a Growing Regulatory Gap

The rapid rise of GLP-1 weight loss drugs such as semaglutide and tirzepatide has created two parallel markets. One market consists of FDA-approved products used under typical prescribing conditions. The other is a patchwork of compounded formulations, “research-grade” ingredients, internet-based peptide sellers and medspas using sourcing channels that were originally driven by national drug shortages. Now that FDA has resolved those shortages, many businesses have been slow to adapt. These delayed adjustments have created a predictable enforcement wave, led not by the FDA, but by state attorneys general.

For lawyers advising clinical research organizations, medspas, telemedicine companies and compounding pharmacies, the landscape has shifted. State regulators are using consumer protection law, unfair trade practice statutes and public health authority to intervene in GLP-1 distribution channels that operate outside the bounds of federal drug law. We outline the most significant developments, the theories supporting these enforcement actions and the implications for research sites and other clinical operators.

I. The Alabama Case: Research-Grade Materials Treated As a Consumer-Protection Issue

On Nov. 10, 2025, the Alabama Attorney General obtained a temporary restraining order against Aurora IV & Wellness, a weight-loss and infusion clinic operating in Cullman, Alabama. The state alleged that the clinic injected patients with research-grade semaglutide and tirzepatide while marketing the injections as pharmaceutical-grade GLP-1 weight-loss drugs. The materials purchased by the clinic were labeled “not for human use,” but were nevertheless administered to paying patients.

The restraining order froze the clinic’s assets and suspended clinical operations. What is notable for lawyers is the legal framing: Alabama did not treat the matter as a simple licensing violation. Instead, it positioned the conduct as a deceptive trade practice affecting consumer safety. This theory of liability places clinics and medspas within the scope of state consumer-protection law whenever their marketing claims diverge from the actual regulatory status of the products they administer.

The Alabama action also demonstrates a growing willingness among state attorneys general to intervene when the FDA has not yet taken action. Once shortages ended and compounding restrictions tightened, the enforcement vacuum created space for states to respond to patient complaints and adverse events arising from unapproved or low-quality GLP-1 sources.

II. Connecticut’s Warning Letter: “Fix It Now Before We Escalate”

The Alabama Attorney General’s actions are consistent with those of the Connecticut Attorney General. Earlier in the year, on May 21, 2025, the Connecticut Attorney General issued a statewide notice to weight-loss clinics and medspas. The letter emphasized several key points:

1. Bulk compounding of semaglutide and tirzepatide is no longer permitted because FDA removed these products from the national shortage list
2. Marketing terms such as “generic Ozempic,” “semaglutide pills” or “vitamin-enhanced GLP-1 injections” may violate state consumer-protection law when referring to non-approved formulations
3. Misleading advertising of unapproved GLP-1 products falls under the Connecticut Unfair Trade Practices Act (CUTPA)

Although the letter did not accuse any specific provider of wrongdoing, Connecticut placed clinics on formal notice that the GLP-1 market was under review and that enforcement would follow if risky practices continued. The letter also served as evidence that clinics had been warned, which strengthened the state’s position in any subsequent action.

For legitimate research sites operating under investigational new drug (IND) requirements, the letter has limited impact. These sites already rely on products designated for investigational use and follow strict informed-consent, institutional review board (IRB), pharmacy and storage requirements. Medspas and telehealth weight loss programs, however, often operate without these controls. Providers in those settings cannot label services as “research” or “clinical trials” unless they satisfy all formal elements of a regulated study.

III. Connecticut’s Enforcement Action Against Bootleg GLP-1 Sellers

Connecticut moved from warnings to enforcement later in 2025 by reaching a settlement with Triggered Brand, a “bootleg GLP-1 distributor.” Triggered Brand allegedly sold raw semaglutide and tirzepatide powders directly to consumers. The products were marketed as “research-grade,” yet the website provided instructions for dissolving, mixing and self-injecting the powder.

Without a prescription requirement, no sterility controls and inadequate assurance regarding potency or stability, consumers were effectively reconstituting injectable drugs at home without professional oversight. Connecticut required the seller to cease operations in the state and accept a significant monetary judgment.

The settlement is important for lawyers advising online sellers, compounding pharmacies and telemedicine programs. It shows that:

1. “Research-grade” disclaimers do not insulate companies from liability when marketing encourages human use
2. Direct-to-consumer peptide sales fall within state jurisdiction when they present health risks or misrepresent regulatory status
3. States are treating GLP-1 misconduct as a consumer protection and public health issue

IV. The Multi-State AG Letter: A National Response Forms

The most significant development is the formal multi-state letter sent to the FDA by more than 40 state attorneys general. The letter describes a national ecosystem of counterfeit, contaminated and research-grade GLP-1s entering the U.S. through unregulated channels. The attorneys general identified the following concerns including:

1. Counterfeit semaglutide imported from China, Turkey and India and repackaged as FDA-approved products
2. Online sellers promoting “research-only” peptides while providing instructions for human injection
3. Consumers mixing raw powders at home, leading to overdoses, contamination and serious adverse events
4. Compounding pharmacies operating around legal boundaries, including insanitary conditions and high-impurity formulations
5. Risks of hospitalization tied to dosing errors and adulterated ingredients

The attorneys general asked the FDA and the Department of Homeland Security to take joint action to intercept illegal imports and protect patient safety. The letter creates a clear national roadmap for enforcement and signals that state and federal regulators may soon coordinate efforts to curb GLP-1 misconduct.

V. Implications for Research Sites, Medspas, Telemedicine Programs and M&A Transactions

A. Research Sites

Research sites must ensure that no material labeled “research-grade” or “not for human consumption” is used outside an IND protocol. Even within a regulated study, GLP-1 materials should be sourced only from authorized suppliers, with appropriate storage, chain-of-custody records, temperature logs, informed consent language and IRB oversight.

Marketing materials for patient recruitment must match the regulatory status of the investigational product. Any inconsistency between public claims and investigational status may be interpreted as evidence of consumer deception or misbranding.

B. Medspas and Telemedicine Programs

These providers face heightened risk. Offering weight loss treatments using compounded or research-grade GLP-1s without meeting clinical trial requirements places them squarely within the theories used in Alabama and Connecticut:

• Deceptive trade practices
• Misleading advertising
• Unlawful compounding
• Misbranding
• Sale of unapproved drugs

Telemedicine providers working with outsourced compounding pharmacies or bulk peptide suppliers must perform rigorous vendor qualification and audit their supply chains.

C. Mergers and Acquisitions

GLP-1 exposure now requires dedicated due diligence. Buyers should consider requesting and reviewing the following to avoid successor liability:

• Vendor qualification files
• Sourcing records
• Compounding agreements
• Product labels and invoices
• Training records
• Storage and temperature logs
• All marketing materials referencing GLP-1 products
• Any history of state or federal regulator inquiries

Conclusion

The enforcement wave surrounding GLP-1 drugs reflects an emerging regulatory reality. As shortages resolved, many clinics, compounding pharmacies and online peptide sellers continued practices that had developed during a period of unusual market pressure. State attorneys general have stepped into the gap, using consumer-protection theories to police misrepresentations, dangerous sourcing practices and improper use of research-grade materials. The FDA is now being asked to join that response.

Lawyers advising research sites, medspas, online sellers, compounding pharmacies and telemedicine organizations should ensure their clients understand the new risks. Compliance failures are no longer theoretical. They carry immediate operational, financial and reputational consequences. Proper sourcing, accurate marketing and adherence to research standards are now essential. The GLP-1 market is changing quickly, and the legal response is evolving with it.