In September, U.S. regulation of the GLP-1 supply chain tightened markedly, with state-level pressure and federal enforcement advancing in tandem.
20 States Jointly Call for Tightening Green List Access
On September 18, led by Alabama, attorneys general from 20 states jointly sent a letter to the U.S. Department of State and the National Security Council, pointing out traceability loopholes in the FDA's GLP-1 Green List mechanism. Established in September 2025, the mechanism is intended to streamline customs clearance for compliant APIs and includes only overseas manufacturing facilities that have been inspected or evaluated on site by the FDA. The attorneys general said, "Some foreign companies exploit traceability weaknesses by repackaging products, falsifying batch information, and other means to funnel unapproved semaglutide and tirzepatide APIs into the U.S. market, where they are made into compounded weight-loss drugs and reach consumers." The joint letter calls on the federal government to tighten, or even suspend, new GLP-1 company admissions to the Green List and to strengthen traceability verification of imported APIs.
FDA Penalizes Leading Compounding Pharmacy
On September 18, the FDA issued a warning letter to Houston-based Empower Pharmacy, which was made public on September 22. Empower is one of the largest suppliers of compounded GLP-1 drugs in the United States. During an on-site inspection in November 2025, the FDA found three core violations.
The FDA determined that Empower had long produced compounded semaglutide and tirzepatide injections in large quantities, creating the illusion of "personalized customization" merely by adding trace amounts of vitamins or excipients, while in essence copying approved originator drugs. Some prescriptions lacked documentation of the prescriber's determination of a "significant difference"; in some prescriptions, that determination appeared in identical wording repeated across a large number of records. Problems also existed in aseptic production. The FDA inspection report stated that its sterile products were prepared, packaged, or stored under "insanitary conditions." The remediation documents submitted by Empower contained "omissions and discrepancies" and failed to meet FDA requirements. The company has failed FDA inspections nine times in the past decade and has received one informal letter and four formal warning letters.
Semaglutide and tirzepatide originator drugs are no longer in shortage, and large-scale compounding has lost its legal basis for exemption.
Shengnuo Biotech Placed on Import Alert 66-40
On September 19, Chengdu Shengnuo Pharmaceutical was placed on the FDA's Import Alert 66-40 list. From August 20 to 27, the FDA conducted an on-site inspection of the plant and issued a Form FDA 483 observation form listing eight observations involving identification of critical quality attributes, contamination control capability, detection and result-acceptance capability, and quality system governance.
Shengnuo Pharmaceutical has not yet received a warning letter, but the import alert has already taken effect. For a facility placed on the alert, all products will be automatically detained by Customs until released by the FDA, equivalent to a suspension of exports to the United States. Shengnuo Biotech has committed to fully stopping sales and shipments of peptide APIs to the United States until the alert is lifted.
In the first half of 2026, Shengnuo Biotech's U.S. sales revenue was RMB 167 million, accounting for 32.83% of its operating revenue for the same period. For the full year 2025, the U.S. revenue share was 20.19%, an increase of more than 12 percentage points within six months.
This time, the FDA did not issue a warning letter in advance; it blocked the export channel based solely on systemic deficiencies found during an on-site inspection. The path to lifting the ban remains unclear. The company must complete remediation and obtain FDA confirmation, or pass a new FDA on-site inspection, before the ban can be lifted.
Some Chinese Companies Have Entered the Compliance Channel
Chinese Peptide Company's semaglutide API has completed FDA DMF registration and entered the FDA Import Alert 66-80 Green List, becoming one of the few Chinese suppliers approved to be exempt from import detention. Its tirzepatide API completed FDA DMF registration in May 2026. Hybio Pharmaceutical's Pingshan Branch passed a routine FDA cGMP supervisory inspection in June 2026. Its peptide formulation production base, API production base, and R&D laboratory have all obtained FDA on-site inspection reports; the API production base had previously passed inspection with zero deficiencies.
Export Risk Alert
In this round of inspections, the FDA has adjusted its enforcement pathway: deficiencies found during on-site inspections can directly trigger an import ban, with no warning letter required as a prerequisite. Companies no longer enjoy a remediation buffer period; one failed on-site inspection may lead to closure of their export channel to the United States. The higher a company's revenue share from the United States, the greater the impact of this risk. Diversifying markets in advance and ensuring that in-house production capacity passes inspections are currently controllable response directions.
