⚖️ Peptide Industry Legal Shifts: Past 30 Days
In the past 30 days, the research peptide industry has seen a wave of legal developments—including lawsuits, government enforcement, and several new regulations affecting production, sales, and clinical use. 🏭 Manufacturer Lawsuits & FDA Enforcement - Eli Lilly filed multiple lawsuits against telehealth companies and compounding pharmacies in California federal court, alleging they were selling compounded GLP-1 drugs (like tirzepatide) without FDA approval following the end of the FDA’s shortage designation in 2025. - The FDA has stepped up enforcement, sending warning letters to peptide sellers who market unapproved peptides (notably semaglutide and tirzepatide) for human use under “research only” labels, threatening seizures, injunctions, and criminal referrals. - Enforcement is now targeting manufacturers and supply chains, focusing on GMP, sterility, and traceability—especially for “research use only” (RUO) operations. 🌐 State Crackdowns on Grey Market Peptides - Ohio state medical and pharmacy boards suspended several medical spa licenses for administering non-FDA-approved peptides, highlighting a national trend of state-level crackdowns. - Providers using “grey market” peptides face heightened risk, from license suspensions to civil or criminal charges, if they use unapproved compounds in patient care. ⚖️ Mass Torts & Major Lawsuits - Multidistrict litigation against Novo Nordisk for Ozempic and other GLP-1 drugs has surged, with nearly 2,000 active cases alleging defective drug claims and harmful side effects in the past 30 days. 📜 Regulatory Guidance & Compounding Law - As of January 2025, new FDA rules limit bulk substance use by compounding pharmacies. Only peptides on the FDA Bulks List—or those meeting strict FDA criteria—may be compounded. - FDA enforcement is focusing heavily on marketing claims. Peptides labeled RUO cannot be legally compounded or sold for human use, even with disclaimers. Providing syringes or injection instructions alongside RUO peptides has also triggered warning letters.