Americans are turning to risky, unregulated sellers for their GLP-1 weight-loss drugs

As demand for GLP-1 drugs continues to skyrocket for weight loss and diabetes, more Americans are avoiding pharmacies and turning to unregulated sellers in order to avoid high prices, insurance barriers and recurring shortages.

The US 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 effectiveness.

Because they are not part of the legal drug supply chain, these unapproved drugs may be counterfeit, contaminated or improperly compounded, the agency says.

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Some are marketed online as “compound semaglutide” or “for research use only,” shipped directly to consumers with little oversight.

Recent research published in the JAMA Health Forum also warned that some compounded products use unverified chemical forms of semaglutide that differ from FDA-approved versions.

As demand for GLP-1 increases, some Americans are turning to unregulated online sellers, sparking warnings from doctors and regulators. (iStock)

Another report this month in The Medicine Maker, a pharmaceutical industry publication, noted that unregulated GLP-1 “could undermine patient confidence” and complicate global drug safety monitoring.

Fox News Digital spoke with Dr. Frank Dumont, medical director of Virta Health in Colorado, who said the rise of GLP-1s on the gray market reflects the growing desperation to access these drugs outside of regulated medical channels.

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“Grey market drugs are versions of prescription drugs that are obtained outside of the usual prescription process,” Dumont said.

“The usual safety precautions have been circumvented, in one way or another, increasing the medical risk associated with the use of such a product.”

The FDA has issued warnings about counterfeit GLP-1 drugs and compounds found in the U.S. supply chain. (iStock)

Dumont noted that there’s a good reason why prescription drugs are closely regulated, from the FDA approval process to how they are manufactured and prescribed.

“Without the usual controls, there are a lot of unknowns, and that translates into more risk for you,” he warned.

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While licensed doctors and pharmacies are closely monitored, Dumont noted that “those operating without a license are not monitored for quality and safety.” They go unnoticed.”

Online access has made it “too easy for someone searching for a drug such as a GLP-1 to intentionally or unintentionally find questionable sources,” he added.

Patients lured by cheaper, unregulated versions of GLP-1 drugs face unknown medical risks, doctors warn. (iStock)

The increase in unregulated use of GLP-1 is driven by costs, supply issues and social media hype, according to Dumont.

“Some are trying to find cheaper versions, considering they can cost more than $1,000 a month 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 distinguish 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 strays from legitimate prescribing avenues, the less likely it is to be called out for making questionable or false statements.”

Regulatory action

In April 2025, the FDA and Novo Nordisk, the maker of Ozempic and Wegovy, announced that counterfeit Ozempic units were circulating in the U.S. supply chain. The FDA reportedly seized the units for investigation.

“If the promises or price seem too good to be true, they probably are.”

Regulators have received hundreds of reports of adverse events related to the semaglutide and tirzepatide compounds, including overdose, severe nausea, dehydration and other complications, according to the health agency.

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Federal and state regulators are stepping up enforcement, with attorneys general in 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 mislabeled products.

Doctor warns that misinformation and unlicensed sellers have turned the GLP-1 market into the ‘Wild West.’ (iStock)

For consumers worried about counterfeit products, Dumont’s advice is simple: stay within the legitimate medical system.

“Stick to FDA-approved versions of prescription drugs rather than substitutes or compounded versions,” he advised.

“When it comes to the Internet, be skeptical. If the promises or the price seem too good to be true, they probably are.”

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In a statement provided to Fox News Digital, Eli Lilly, the maker of Zepbound and Mounjaro, provided the statement below.

“Any mass-compounded and ‘research-only’ tirzepatide is illegal and threatens patient safety. Bad actors continue to sell illicit tirzepatide made with substandard foreign ingredients despite the FDA’s warning that doing so puts Americans at “increased risk,” and we continue to find critical safety and effectiveness issues in counterfeit tirzepatide, including bacterial contamination, high levels of endotoxins, and other impurities.

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“No one should ever be exposed to these risks, and we urge the FDA and other regulators to stop this illegal activity before more people are harmed.”