Americans for Safe and Effective Medicines (ASEM), a national advocacy organization dedicated to protecting patients from illegal mass compounding, counterfeit products, and misleading marketing, applauds the attorneys general of 20 states for calling attention to vulnerabilities in the supply chain for compounded GLP-1 drugs.
As the attorneys general explain, recent allegations involving a Chinese supplier of semaglutide, tirzepatide, and retatrutide active pharmaceutical ingredient demonstrate the danger of relying on trusted-supplier designations without continuing oversight. When unapproved ingredients can be repackaged, relabeled, or shipped without adequate inspection, patient safety is placed at unacceptable risk and potential harm.
This letter rightly recognizes that protecting America’s drug supply extends beyond routine regulatory compliance and requires stronger federal-state coordination. ASEM supports the attorneys general’s call for:
- Greater transparency regarding the identity, ownership, regulatory history, and manufacturing practices of foreign suppliers whose active pharmaceutical ingredients enter the U.S. drug supply.
- Real-time information sharing among federal regulators, customs officials, law-enforcement agencies, intelligence partners, and state attorneys general so emerging risks can be identified and addressed before unsafe ingredients reach patients.
- Effective border controls that use risk-based screening, documentation verification, product testing, and targeted inspections to prevent unapproved, adulterated, or falsely labeled ingredients from entering the country.
- Regular foreign-facility inspections to verify compliance with U.S. quality standards, confirm manufacturing and testing records, and ensure that trusted suppliers continue to meet safety requirements.
- Decisive enforcement against suppliers that conceal the true origin or chain of custody of ingredients, circumvent import safeguards, alter manufacturing records, mislabel products, or otherwise place American patients at risk.
“Americans should not have to wonder whether a medicine contains an unapproved, adulterated, or falsely labeled ingredient,” said ASEM Chief Policy Officer Fred Mills, PharmD. “Protecting patients must remain the government’s highest priority, and meaningful enforcement is essential to restoring trust and keeping unsafe products out of American homes and clinics.”
States whose attorney general signed the letter include: Alabama, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Montana, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, Tennessee, Utah, and West Virginia.