By: Caitlin Koppenhaver
FDA’s “Green List” for GLP-1 Ingredients
On September 5, 2025, the U.S. Food and Drug Administration (FDA) announced a new “green list” import alert for active pharmaceutical ingredients (APIs) used in GLP-1 medications such as semaglutide and tirzepatide. The green list will include GLP-1 APIs from facilities the agency has inspected or evaluated that appear to be in compliance with the FDA’s rigorous standards, standards applicable to all APIs manufactured in the U.S. APIs from other sources are subject to detention without physical examination. The policy reflects FDA’s heightened concern over compounded GLP-1 products sourced from unverified suppliers, which is not to be confused with compounding pharmacies who are already committed to supply chain transparency, safety and quality for specific patient needs. The agency has warned that some products involve unapproved chemical forms or inconsistent potency, with adverse events including hospitalizations already reported. For compounding pharmacies, distributors, and providers, the expectation is now clear that sourcing must be transparent, quality must be documented, and regulatory compliance must be demonstrable.
Crackdown on Deceptive Drug Advertising
Just four days later, on September 9, 2025, FDA announced a parallel initiative: a nationwide crackdown on deceptive drug advertising. Thousands of warning letters and nearly one hundred cease-and-desist notices are being issued to companies whose promotional materials emphasize benefits while minimizing or omitting risks. The agency is also moving to close the long-standing 1997 “adequate provision” loophole in broadcast advertising, which permitted companies to reference safety information indirectly rather than disclose it directly in the advertisement. Going forward, FDA expects risks to be presented clearly and prominently alongside benefits.
Further, enforcement extends beyond preventing false or exaggerated claims. Omitting material facts such as contraindications, warnings, or key limitations can render an otherwise accurate statement misleading under the Federal Food, Drug, and Cosmetic Act. Digital and social media advertising are particular priorities, with FDA deploying AI-powered monitoring tools to review influencer content and other online promotions.
Broader Enforcement Trends
These back-to-back actions reflect a significant broadening of FDA’s enforcement posture. Historically, the agency’s most visible interventions in this space centered on Research Use Only (RUO) peptide platforms, particularly where websites implied human use. That focus has now expanded to include global supply chain practices for high-demand therapies and mainstream pharmaceutical advertising. Enforcement is no longer narrow or reactive. FDA is proactively targeting both manufacturing integrity and the accuracy of consumer-facing communications.
The Bottom Line and What This Means for Industry Stakeholders
For companies across the healthcare and life sciences sectors, the implications are immediate: sourcing arrangements for GLP-1 APIs must be confirmed against FDA’s new green list to avoid shipment detention, and all promotional materials, including digital and influencer campaigns, should be reviewed to confirm that risks are presented as clearly as benefits and that no omissions make statements misleading. In this heightened enforcement environment, businesses that proactively strengthen compliance, documentation, and transparency will be best positioned to withstand scrutiny and maintain long-term credibility as the enforcement landscape continues to evolve.
