As demand for GLP-1 medications continues to skyrocket for weight loss and diabetes, more Americans are skipping pharmacies and turning to unregulated sellers as a way to avoid high prices, insurance barriers and recurring shortages.
The U.S. Food and Drug Administration has warned that so-called "gray-market" GLP-1s (such as semaglutide or tirzepatide) are not evaluated for safety, quality or efficacy.
As they fall outside the legal drug supply chain, these unapproved drugs may be counterfeit, contaminated or improperly compounded, the agency states.
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Some are marketed online as "compounded semaglutide" or "research-use only," shipped directly to consumers with little oversight.
Recent research published in JAMA Health Forum also warned that some compounded products use unverified chemical forms of semaglutide that differ from FDA-approved versions.
Another report this month in The Medicine Maker, a pharmaceutical industry publication, noted that unregulated GLP-1s "could undermine patient confidence" and complicate global drug-safety monitoring.
Fox News Digital spoke with Frank Dumont, M.D., medical director at Virta Health in Colorado, who said the rise of gray-market GLP-1s reflects growing desperation to access these medications outside regulated medical channels.
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"Gray-market medications are versions of prescription medications that are obtained outside of the usual prescription process," Dumont said.
"The usual safety precautions have been bypassed, in one way or another, and this increases the medical risk of using such a product."
Dumont noted that there's a good reason that prescription drugs are tightly regulated, from the FDA approval process to how they are manufactured and prescribed.
"Without the usual controls, there are a lot of unknowns, and this translates into more risk for you," he warned.
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While licensed doctors and pharmacies are closely monitored, Dumont noted that "those who are operating outside of licensure are not being monitored for quality and safety. They are flying beneath the radar."
Online access has made it "all too easy for an individual looking for a medication such as a GLP-1 to intentionally or unintentionally find questionable sources," he added.
The surge in unregulated GLP-1 use is driven by cost, supply issues and social media hype, according to Dumont.
"Some are trying to find less expensive versions, considering they can cost over $1,000 per month out of pocket if not covered by a prescription plan," he said.
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Dumont also warned that misinformation about "DIY" or compounded semaglutide has made it harder for consumers to separate real science from false claims.
"It has become increasingly easy to make statements and promises without any accountability," he said. "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."
In April 2025, the FDA and Novo Nordisk (maker of Ozempic and Wegovy) announced that counterfeit Ozempic units had been circulating in the U.S. supply chain. The FDA reportedly seized the units for investigation.
Regulators have received hundreds of reports of adverse events tied to compounded semaglutide and tirzepatide, including overdosing, severe nausea, dehydration and other complications, per the health agency.
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Federal and state regulators are ramping up enforcement, with attorneys general from 38 states urging the FDA to crack down on counterfeit distributors, according to a report from the National Association of Attorneys General.
Legal experts have warned that even licensed pharmacies could face penalties if they inadvertently handle adulterated or misbranded products.
For consumers worried about counterfeit products, Dumont’s advice is simple: Stay within the legitimate medical system.
"Stick with the FDA-approved versions of prescription medications rather than substitutes or compounded versions," he advised.
"When it comes to the internet, be skeptical. If the promises or the price sound too good to be true, they probably are."
In a statement provided to Fox News Digital, Eli Lilly (manufacturer of Zepbound and Mounjaro) provided the below statement.
"All mass compounded and ‘research use only’ tirzepatide is unlawful and threatens patient safety. Bad actors continue selling illicit tirzepatide made with substandard foreign ingredients, despite the FDA warning that it puts Americans at ‘heightened risk,’ and we continue to find critical safety and effectiveness issues in tirzepatide knockoffs, including bacterial contamination, high endotoxin levels and other impurities."
"No one should ever be exposed to those risks, and we urge FDA and other regulators to stop this unlawful activity before more people get hurt."
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