The demand for GLP-1 medications, commonly used for weight loss and diabetes management, is soaring. As a result, an increasing number of Americans are turning away from pharmacies and opting for unregulated sellers in an effort to evade high costs, insurance challenges, and ongoing medication shortages.
The U.S. Food and Drug Administration (FDA) has issued warnings regarding these so-called “gray-market” GLP-1 drugs, such as semaglutide and tirzepatide. Since these products are not assessed for safety, quality, or efficacy, they fall outside the legal drug supply chain. As noted by the FDA, unapproved medications might be counterfeit, contaminated, or poorly compounded.
Some of these GLP-1 products are marketed online as “compounded semaglutide” or labeled for “research-use only” and are shipped directly to consumers with minimal oversight. A recent study in the JAMA Health Forum cautioned that some of these compounded products might use unverified versions of semaglutide, differing from those approved by the FDA.
Additionally, a report published this month in The Medicine Maker highlighted how unregulated GLP-1 drugs could erode patient confidence and complicate global drug safety monitoring.
Frank Dumont, M.D., the medical director at Virta Health in Colorado, discussed the alarming trend of gray-market GLP-1s, attributing it to a rising desperation to secure access to these medications without going through standard medical channels. Dumont explained, “Gray-market medications are versions of prescription medications that are obtained outside of the usual prescription process. The usual safety precautions have been bypassed, in one way or another, and this increases the medical risk of using such a product.”
The need for strict regulation of prescription drugs stems from the rigorous processes of FDA approval, including manufacturing and dispensing norms. “Without the usual controls, there are a lot of unknowns, and this translates into more risk for you,” Dumont cautioned.
While licensed healthcare providers are closely monitored, those operating outside legal avenues lack supervision regarding quality and safety. Dumont noted, “They are flying beneath the radar.” The ease of accessing these substances online has heightened the risk, making it too simple for consumers seeking medications like GLP-1 to stumble upon questionable sources.
The financial burden of GLP-1 medications, which can exceed $1,000 a month if not covered by insurance, drives many to seek cheaper alternatives. Dumont observed, “Some are trying to find less expensive versions.” This cost pressure, coupled with social media enthusiasm, is fueling the surge in unregulated usage.
Moreover, Dumont indicated that misinformation around “DIY” or compounded semaglutide complicates consumer understanding, making it challenging to distinguish genuine medical information from misleading statements. He remarked, “It has become increasingly easy to make statements and promises without any accountability. And the further an entity is away from the legitimate prescription pathways, the less likely they are to be called out for making questionable or false claims.”
Regulatory responses have emerged in light of these risks. In April 2025, both the FDA and Novo Nordisk, the manufacturer of Ozempic and Wegovy, uncovered counterfeit Ozempic units in the U.S. supply chain, leading the FDA to seize these units for investigation. Dumont offered a cautionary note: “If the promises or the price sound too good to be true, they probably are.”
The FDA has received hundreds of reports detailing adverse events associated with compounded semaglutide and tirzepatide. These reports indicate serious complications, including overdosing, severe nausea, dehydration, and more. In response, federal and state officials are intensifying enforcement efforts, with attorneys general from 38 states urging the FDA to take action against counterfeit distributors, as highlighted by the National Association of Attorneys General.
Legal experts have warned that licensed pharmacies might face penalties if they inadvertently handle adulterated or misbranded products, creating further complications within the industry. For consumers concerned about counterfeit drugs, Dumont’s advice is clear: adhere to legitimate medical channels. “Stick with the FDA-approved versions of prescription medications rather than substitutes or compounded versions,” he advised. When it comes to online purchasing, he advised skepticism: “If the promises or the price sound too good to be true, they probably are.”
