As demand for GLP-1 drug It continues to skyrocket Weight loss Diabetes, more Americans are skipping pharmacies and turning to unregulated sellers as a way to avoid high prices, insurance barriers and repeated shortages.
The US Food and Drug Administration warns that the so-called “gray market” GLP-1 (such as semaglutide and tilzepatide) have not been evaluated for safety, quality or efficacy.
If they fall outside the legal drug supply chain, these unapproved drugs could be counterfeited, contaminated or improperly combined, the agency said.
Why Microdosing Ozempics are as common as taking multivitamins
Some are sold online as “compound semaglutide” or “research use only” and are shipped directly to consumers with little monitoring.
A recent study published in the Jama Health Forum warned that some composite products use unverified chemical forms of semaglutide, which are different from the FDA-approved version.
Another report this month from the drug manufacturer, a pharmaceutical industry publication, said that unregulated GLP-1 “may undermine patient confidence,” complicating global drug safety monitoring.
Fox News Digital spoke with Frank Dumont (Maryland), medical director at Virta Health in Colorado.
“Next Ozempic” aims to provide 30% weight loss with fewer side effects
“Grey Market drugs are the version of prescription drugs obtained outside of the usual prescription process,” Dumont said.
“Normal safety precautions have been bypassed in some way, and this Medical risks Use such products. ”
Dumont pointed out that there is a good reason for this. Prescription drugs From the FDA approval process to the methods of manufacturing and formulating them, there are strict regulations.
“Without normal control there is a lot of unknowns, which leads to more risks for you,” he warned.
Can GLP-1 weight loss drugs like Ozempic be “all medicines”?
meanwhile Authorized doctor And pharmacies are being monitored closely, Dumont said, “People operating without their licenses don’t monitor quality and safety. They’re flying under the radar.”
Online access “has allowed individuals looking for drugs such as GLP-1 to find suspicious sources, intentionally or unintentionally,” he added.
The surge in unregulated GLP-1 use is driven by costs. Supply issues Social media hype, according to Dumont.
“Some people are trying to find a cheaper version given that it could cost more than $1,000 a month if not covered by their prescription plan,” he said.
Click here to sign up for our health newsletter
Dumont also warned that misinformation about “DIY” or compounded semaglutide made it difficult for consumers to isolate True science From false claims.
“It’s become increasingly easier to make statements and commitments without accountability,” he said. “And the more the entity is away from the legitimate prescribing route, the less likely it is to be called to make a suspicious or false claim.”
In April 2025, the FDA and Novo Nordisk (manufactured by Ozempic and Wegovy) announced that counterfeit Ozempic units are distributed in the US supply chain. The FDA reportedly seized the unit for investigation.
Regulators have received hundreds of reports of adverse events linked to complex semaglutide and tilzepatide. Serious nauseaaccording to the health agency.
Federal and state regulators are tightening enforcement, with attorney generals in 38 states urging the FDA to crack down on them. Fake Distributoraccording to a report by the National Association of Attorney Generals.
Legal experts warn that even licensed pharmacies can face penalties if they inadvertently deal with real estate or wrong branded products.
For consumers worried about counterfeit products, Dumont’s advice is simple. Stay within a legal health system.
“I’ll stick to the FDA-approved version of prescription drugs, not the alternative or combined version,” he advised.
“I’m skeptical about the internet. If it seems too good for promises and prices to be true, then that’s probably true.”
Fox News Digital reached out to Novo Nordisk and Eli Lilly for comment.
