The Next Safety Gap
- carbesman
- Sep 17
- 4 min read
Updated: 4 minutes ago
How Compounded GLP-1s Expose the Limits of Oversight
Paul Schrimpf, Christine Arbesman
Weight-loss drugs are among the hottest products in medicine. GLP-1 receptor agonists such as Ozempic and Wegovy are so popular that demand has routinely exceeded supply. Into that gap, a booming market for compounded versions has emerged. One that authors from The Journal of the American Medical Association (JAMA) and JAMA Health Forum warn is largely unregulated, inconsistently manufactured, and increasingly risky.
Demand Outpaces Supply
A 2024 JAMA analysis reported that U.S. prescriptions for GLP-1 receptor agonists rose more than 300% in just two years. The surge came not only from patients with diabetes but also from millions seeking weight loss. The FDA has even placed branded GLP-1s on its official drug shortage list, which has opened the door for compounding pharmacies to step in. As Dr. Joshua Sharfstein of Johns Hopkins wrote in JAMA Health Forum: “The unprecedented demand for GLP-1 receptor agonists has expanded the market for compounded products, many of which lack rigorous evidence of safety or efficacy.”
Compounding: Legal but Loophole-Heavy
Compounding pharmacies play an important role, tailoring medications for patients with allergies or unique dosing needs. But as JAMA has emphasized, compounded drugs are not FDA-approved. They bypass the trials, quality checks, and labeling requirements that protect patients using branded medications.
The FDA has cautioned against certain compounded versions. In a 2024 alert, the agency warned that salt forms such as semaglutide sodium or acetate “have not been shown to be safe and effective.” Patients often can’t distinguish those versions from FDA-approved Ozempic or Wegovy. As Dr. Aaron Kesselheim of Harvard Medical School noted in a JAMA editorial: “The boundary between legitimate compounding and commercial manufacturing becomes blurred, leaving patients vulnerable to under-regulated products.”
Marketing Outruns Regulation
Another major gap lies in how these products are marketed. JAMA Health Forum reports that some telehealth startups and aesthetic clinics aggressively promote compounded GLP-1s directly to consumers, often with minimal physician oversight. These ads promise rapid weight loss with few risks. Yet FDA adverse event reports cited by JAMA already describe dozens of severe side effects — from nausea and vomiting to dehydration and, in rare cases, hospitalization.
As Dr. Rita Redberg, editor of JAMA Internal Medicine, observed in an editorial on similar markets: “We’ve seen this story before. Products get marketed well ahead of the science, and patients are left to absorb the consequences.”
The Bigger Pattern: Regulation Trails Innovation
The rise of compounded GLP-1s reflects a broader pattern JAMA has tracked for decades: regulation lags behind fast-moving markets. The same dynamic has played out before. Dietary supplements marketed for weight loss or performance often contained undeclared prescription drugs. Stem-cell therapies were promoted for arthritis, autism, and spinal cord injuries despite repeated FDA warnings. And compounded bioidentical hormones became a multimillion-dollar industry even as their quality and safety remained inconsistent.
As Dr. Caleb Alexander of Johns Hopkins noted in a 2023 JAMA commentary, “Entrepreneurship tends to outpace regulation, especially when products tap into powerful hopes like reversing aging, restoring mobility, or losing weight.” GLP-1s are simply the latest and most visible chapter of this ongoing story.
This is why, at first glance, the issue may seem confined to a niche market of weight-loss seekers and opportunistic pharmacies. Yet JAMA’s coverage shows the stakes are much broader. Patient safety is a primary concern, since compounded versions vary in dose and purity, making adverse events less predictable. Providers face their own risks, as many may not realize whether their patients are taking FDA-approved drugs or compounded alternatives. The system itself absorbs the costs when complications lead to ER visits or hospitalizations, straining both insurers and taxpayers. And at the population level, public perception is at risk: if patients are harmed by compounded versions, trust in the entire GLP-1 class may erode — even for rigorously tested, FDA-approved medications.
What Oversight Could Look Like
Experts writing in JAMA and JAMA Health Forum suggest several remedies. Clear labeling could help patients and providers distinguish compounded versions from FDA-approved products. Limits on compounding once branded shortages resolve would prevent gray-market products from becoming permanent fixtures. Regulators could tighten enforcement of marketing claims, particularly from telehealth companies whose ads often outpace science. And stronger adverse event monitoring could track risks in real time, preventing harm from spreading unnoticed.
As Dr. Sharfstein summarized in JAMA Health Forum, “Without timely action, compounded GLP-1s risk becoming the next case study in how regulatory gaps compromise public health.”
The GLP-1 story is bigger than weight loss. It’s a test of whether the health system can keep pace with surging demand, aggressive marketing, and markets that form overnight. As JAMA’s reporting reminds us, the danger isn’t limited to one drug class. It lies in the recurring cycle where regulation arrives too late, leaving patients to pay the price first.
Acknowledgements & Citations
This report draws insights and direct quotes from:
Sharfstein J. Compounded GLP-1 Products and the Demand for Oversight. JAMA Health Forum. 2025.
Kesselheim A. Blurred Boundaries Between Compounding and Manufacturing. JAMA. 2024.
Redberg R. Marketing Ahead of Evidence. JAMA Internal Medicine. 2024.
Alexander C. Entrepreneurship Outpaces Regulation. JAMA. 2023.
FDA. Compounded Semaglutide Safety Alert. 2024.