Unregulated 'Gray‑Market' GLP‑1 Weight‑Loss Drugs Flood U.S., FDA Warns
As demand for GLP‑1 medicines (semaglutide, tirzepatide) surges in the United States, consumers are increasingly buying unapproved 'gray‑market' versions online. The FDA has issued warnings—including a joint April 2025 notice with Novo Nordisk about counterfeit Ozempic units—about counterfeit, contaminated or improperly compounded products. Recent research in JAMA Health Forum and industry reporting (The Medicine Maker) find some compounded versions use unverified chemical forms, raising safety and surveillance concerns and prompting doctors and regulators to warn patients to avoid unregulated suppliers.
Health
Regulatory
📌 Key Facts
- FDA and Novo Nordisk issued a joint notice in April 2025 about counterfeit Ozempic units entering the U.S. supply chain.
- A recent JAMA Health Forum study found some compounded semaglutide products use unverified chemical forms that differ from FDA‑approved versions.
- Gray‑market GLP‑1s are marketed online (as 'compounded semaglutide' or 'research‑use only'), shipped directly to consumers, and bypass regulated prescribing and pharmacy oversight, increasing risk of counterfeit, contamination, dosing errors and lack of post‑market safety monitoring.