As for demand GLP-1 therapeutics As weight loss and diabetes cases continue to soar, more Americans are bypassing pharmacies and turning to unregulated distributors as a way to avoid high prices, insurance barriers and repeated shortages.
The U.S. Food and Drug Administration has warned that so-called “gray market” GLP-1 (such as semaglutide and tirzepatide) has not been evaluated for safety, quality, or efficacy.
Because these unapproved drugs are outside the legal drug supply chain, they may be counterfeit, contaminated or improperly formulated, the agency said.
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Some are sold online as “combined semaglutide” or “research use only” and shipped directly to consumers with little oversight.
A recent study published in JAMA Health Forum warned that some combination products use an untested chemical form of semaglutide that is different from the FDA-approved version.
Another report, published this month in the pharmaceutical industry publication The Medicine Maker, said unregulated GLP-1 could “undermine patient confidence” and complicate global pharmacovigilance.
Fox News Digital spoke with Dr. Frank Dumont, medical director of Virta Health in Colorado. He said the rise in gray market GLP-1 reflects a growing desire to obtain these drugs outside of regulated medical channels.
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“Gray market drugs are versions of prescription drugs that are obtained outside the normal prescription process,” Dumont said.
“Normal safety measures have somehow been circumvented and this increases the risk. medical risks About using such products. ”
Dumont pointed out that there’s a good reason for that. prescription drugs Everything from the FDA approval process to manufacturing and formulation methods are highly regulated.
“Without regular controls, there are a lot of unknowns, which increases the risk,” he warned.
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meanwhile licensed doctor “Dispensaries operating off-license are not monitored for quality or safety. They fly under the radar,” Dumont said.
Thanks to online access, “people looking for drugs such as GLP-1 can find questionable sources very easily, whether intentionally or unintentionally,” he added.
The surge in unregulated GLP-1 use is driven by cost; supply issues There’s also the hype on social media, Dumont said.
“Some people are trying to find a cheaper version, considering it can cost more than $1,000 a month out of pocket if it’s not covered by a prescription plan,” he said.
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Dumont also warned that “do-it-yourself” and misinformation about compounded semaglutide is making it difficult for consumers to isolate. real science From false claims.
“It’s becoming easier and easier to make statements and promises without accountability,” he said. “And the further a company moves from legitimate prescription channels, the less likely it is to be accused of making dubious or false claims.”
In April 2025, the FDA and Novo Nordisk, the manufacturer of Ozempic and Wegovy, announced that counterfeit Ozempic products were circulating in the U.S. supply chain. The FDA reportedly seized the devices for investigation.
Regulatory agencies have received hundreds of reports of adverse events related to combined semaglutide and tirzepatide, including overdoses. severe nauseaDehydration and other complications, according to the health agency.
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Federal and state regulators are cracking down, and 38 state attorneys general have asked the FDA to crack down. seller of counterfeit goodsaccording to a report by the National Association of Attorneys General.
Legal experts have warned that even licensed pharmacies could face penalties if they inadvertently sell adulterated or misbranded products.
Dumont’s advice for consumers concerned about counterfeit products is simple. “Staying within the legitimate medical system.”
“Continue using FDA-approved prescription medications rather than substitutes or compounded products,” he advised.
“When it comes to the Internet, be skeptical. If the promises and prices sound too good to be true, they probably are.”
Eli Lilly, the maker of Zepbound and Mounjaro, provided the following statement in a statement provided to Fox News Digital.
“High-volume compounded ‘research use only’ tirzepatide is illegal and poses a threat to patient safety. Despite FDA warnings that it puts Americans at ‘increased risk,’ unscrupulous vendors continue to sell illegal tirzepatide made with substandard foreign ingredients, and we continue to find significant safety and efficacy issues with counterfeit tirzepatide containing bacterial contamination, high levels of endotoxin, and other impurities.”
“No one should be exposed to such risks, and we urge the FDA and other regulators to stop this illegal practice before more people are harmed.”
