Misleading Statements Common in Online Ads for Compounded GLP-1s

Online advertising of glucagon-like peptide-1 (GLP-1) receptor agonists aimed at consumers who want to purchase compounded versions of the sought-after drugs are often misleading or inaccurate and should be subjected to greater regulatory oversight, an analysis suggests.

Of 79 websites offering compounded versions of semaglutide, tirzepatide, or liraglutide—most with no prescription requirement—37.6% stated or implied that the version they were selling was approved by the US Food and Drug Administration. While compounding pharmacies have been allowed by the FDA to sell copies of branded GLP-1 drugs during shortages, they are not approved by the agency, nor are they “generic” versions of the drugs from any regulatory perspective.

Last month, the FDA clarified its policy for compounders after removing tirzepatide from its shortage list.

“It’s incredibly concerning that some patients might be starting a GLP-1 knowing mostly the benefits and maybe not knowing all, if any, of the risks associated with a compound of GLP-1,” lead researcher Ashwin K. Chetty, BS (Yale University School of Medicine, New Haven, CT), told TCTMD. “Discontinuing a GLP-1 can lead to weight regain, weight cycling, and that has its own adverse effects. Ultimately, for some patients in this landscape of not enough information, more harm could be done than good.”

Ultimately, for some patients in this landscape of not enough information, more harm could be done than good. Ashwin K. Chetty

In their research letter published Friday in JAMA Health Forum, Chetty and colleagues say they analyzed websites appearing in Google’s sponsored results to look at how compound GLP-1 suppliers are functioning within FDA and federal requirements that prescription advertisements, including for compounded medications, be truthful, not misleading, and accurate.

About 14% of the websites did not explicitly state that what they were selling was a compounded version and 9% falsely said the medications were generic. The prices for a typical 1-month supply ranged from $189-$294 for semaglutide and $223-$274 for liraglutide to $275-$399 for tirzepatide. Approximately 40% of the websites selling compound GLP-1s used a telehealth visit and 25% advertised virtual contact but the method was unspecified. Only 6.3% required an in-person visit to obtain the medication and 2.5% required a prior prescription.

Writing in a related viewpoint article in the same issue of the journal, T. Joseph Mattingly II, PharmD, PhD (University of Utah College of Pharmacy, Salt Lake City), and Rena M. Conti, PhD (Boston University, MA), say compound pharmacies fall into a “regulatory gray zone,” where their advertising is not illegal but also is not consistent with the Drug Quality and Security Act (DQSA). The DQSA was passed to support patient access to safe and effective drugs from traditional compounding pharmacies—often used to individualize prescriptions in the case of a patient allergy to a certain ingredient, for example—and outsourcing facilities that function as compounders.

“Congress’s intent in passing DQSA was to extend long-standing protections from unsafe, substandard, or fraudulent products to compounded pharmacy practices,” Mattingly and Conti write. “They were not intended to create a window of time where opportunistic vendors exploit a shortage to gain market share and drive new demand through aggressive marketing tactics. The advertisements are just a snapshot of the online marketing for GLP-1 RA–focused weight-loss programs.”

Concerns About Counterfeit Products and More

In addition to concerns that patients are being influenced by misleading advertisements and not getting adequate education about what they are purchasing, Mattingly and Conti say counterfeit versions of the products are entering into the US supply chain.

“Nearly half of online pharmacies offering semaglutide may be operating illegally, operating nondelivery scams, or providing products that do not meet quality standards,” they add.

Beyond online claims, there’s reason to be concerned about brick-and-mortal suppliers of compounded GLP-1 drugs, as a study published last year by researchers led by Michael DiStefano, PhD (University of Colorado Anschutz Medical Campus, Aurora), showed.

Rather than look at online-only providers, DiStefano and colleagues analyzed clinics, medical spas, and mobile or telehealth services with physical locations that advertise online to consumers in Colorado. They found instances of deceptive advertising and references to compound drugs as generic in line with what Chetty et al found, but they also noted currently unapproved retatrutide being offered for sale as well as an unspecified GLP-1 product and oral GLP-1 products.

More than 8% of the businesses were selling products compounded with B vitamins and one had added levocarnitine, mannitol, glycine, and BPC 157, a peptide that the FDA classifies as a bulk drug substance, which may pose risk for immunogenicity or peptide impurities.

With the added compounds not being part of the advertising, DiStefano said, it’s impossible to know if patients are being told about them at the time of consultation or not.

What Needs to Be Done

Chetty and colleagues say the FDA could implement change by requiring websites selling GLP-1s to explicitly disclose and define compounding, including lack of FDA approval; instituting unique naming conventions for compounded medications; and being given greater authority to act against misleading compounded medication advertising.

“Guidance on what is appropriate advertising would go a long way to improving the information landscape for compounded drugs,” Chetty added.

The resolution of the shortage in the US is likely to help somewhat, but Mattingly and Conti say it will not prevent questionable marketing practices of online providers or resolve the problem of illegal weight loss products offered for sale.

They recommend requiring advertisements for compounded GLP-1 drugs to meet the same standards expected of existing direct-to-consumer ads of prescription medications as well as aggressive prosecution of bad actors who illegally traffic counterfeit or adulterated GLP-1 products. Finally, they suggest the formation of an independent task force outside of the FDA that would be charged with the final determination for adding or removing a drug from the shortages list.

Compounding is a legitimate, longstanding practice, and many compounders are doing a very good job [in terms of] patient intake and patient monitoring and information. Michael DiStefano

DiStefano said it’s clear that FDA needs more resources to get a handle on the problem and suggested that the Federal Trade Commission could potentially get more involved in prescription drug advertising, as could the licensing boards that oversee medical spas that dispense GLP-1s.

“Compounding is a legitimate, longstanding practice, and many compounders are doing a very good job [in terms of] patient intake and patient monitoring and information,” he said. “There are people who can certainly benefit from these drugs but can't afford them because they don't have insurance access, and there are patients with diabetes who need them and who during a shortage might benefit from people without diabetes getting these drugs from a compounder. But, it’s important to have the proper monitoring in place.”

Chetty said it’s important for physicians to have compounded GLP-1s on their radar and be aware that their patients may be buying these products.

“When healthcare providers are advising patients, it would be great if they were able to look at particular pieces of information or have a resource of compounding pharmacies that are consistently reputable and follow standard practices,” he said. “It's really important that patients talk to their healthcare provider about compounded GLP 1s and let them know that they are on one . . . and for physicians to encourage their patients to share this information with them so they are better prepared to help them.”