Gray-Market Weight-Loss Drugs Pose Significant Health Risks as Unregulated Sales Skyrocket

As demand for GLP-1 medications for weight loss and diabetes care continues to rise, more Americans are turning to unregulated sellers to bypass high prices, insurance restrictions, and recurring shortages. The U.S. Food and Drug Administration has raised alarms about the dangers of so-called ‘gray-market’ GLP-1 drugs, such as semaglutide and tirzepatide, warning that these unapproved products may be counterfeit, contaminated, or improperly compounded. Dr. Frank Dumont, a medical director at Virta Health, highlights the increasing medical risks associated with using gray-market drugs that skip the usual safety protocols. With online access making questionable sources easy to find, and misinformation making it harder for consumers to recognize legitimate options, experts like Dumont stress the importance of staying within the regulated medical system and avoiding unverified versions of prescription medications. The situation is further complicated by the rise of counterfeit Ozempic units, as reported by the FDA and Novo Nordisk in April 2025, leading to calls for stricter enforcement from federal and state regulators. Companies like Eli Lilly have also issued statements warning of the threats posed by illicit tirzepatide products and urging regulators to address these risks to protect public health.