Bypassing Prescribers and Pharmacists: Online Purchasing of Semaglutide and Tirzepatide “For Research Purposes”

Figure 2 summarizes what we learned about these companies using a legal loophole to sell their semaglutide or tirzepatide products to consumers. Most of the websites sold both semaglutide and tirzepatide, and none required a prescription. Thirty-eight sites sold the products “for research purposes,” but only 4 sites asked the purchaser to check a box stating that they were a researcher. No site required the purchaser to verify they were researchers, the product was being shipped to an actual research facility, or to identify the research project they were conducting. No proof of age was required to purchase these products. Thirty-seven sites specified that the product was “not for human consumption,” although 17 sites provided us with targeted advertising on social media platforms once we performed these internet searches. Figure 3 provides representative screenshot excerpts from 1 website and 2 Facebook targeted ads. Many targeted ads on social media had consumer testimonials in the comments section stating or suggesting non-research human use of the products, which the companies did not refute.

When consumers purchase these vials containing lyophilized semaglutide or tirzepatide powder, they are effectively on their own. Only 3 sites included the diluent needed to dissolve the active pharmaceutical ingredients; the other required consumers to find the correct diluent and purchase it separately. Only 3 sites told consumers how to dose the products, the rest leaving them to figure that out independently. None of the sites showed consumers how to reconstitute products, draw them up, or properly inject them into the body. None of the sites provided the expiration date of products dissolved in sterile water for injection and/or bacteriostatic water. Only 7 sites provided clinical trial information on effectiveness or adverse events. When sites provided consumer information, they used another legal loophole, specifying that this information was for “educational purposes” only. The average costs of 5 mg of semaglutide and tirzepatide products are $181 and $203, respectively, although a wide range of doses is sold at variable prices from site to site.

While our assessment was focused on semaglutide and tirzepatide, we also identified 11 sites selling retatrutide products as well. Retatrutide is an experimental weight loss active pharmaceutical ingredient without proof of acceptable efficacy and safety in humans, showing just how far the sellers are willing to take this charade.

Patients can have inconsistent effects if the amount of active ingredient varies from vial to vial, either from poor manufacturing or degradation during storage. Some sites offered additional discounts if larger quantities were purchased up front, but those products then need to be appropriately stored in consumers’ homes. Administering too high of a dose due to poor quality control during vial filling, improper dissolution of the powder, or inaccurate filling of the syringe can lead patients to experience significant nausea and vomiting.^1,2 Heavy metal contamination in poorly manufactured products can pose significant health risks when used chronically.¹⁰ Microbial contamination due to poor manufacturing, improper storage, or the selection of an incorrect expiration date can lead to skin and skin structure infections. For example, using sterile water for injection as the diluent will have a beyond use date of only a day after reconstitution in a nonsterile environment.¹¹ These products could be intentionally adulterated with other synthetic chemicals such as other weight loss ingredients or contamination from improper cleaning of equipment when companies manufacture products with different active ingredients. Finally, improper injection techniques or injecting non-dissolved drugs can lead to infections, bleeding, tissue damage, or inconsistent effects.¹² Sharing syringes or needles is associated with the risk of hepatitis B and C as well as HIV,^1,2 but sites do not provide those warnings to consumers purchasing the products. Consumers must locate and purchase their own syringes and needles.

The issues of product sterility and the accuracy of the included dose are not just theoretical. In a recent assessment, lyophilized peptide samples for semaglutide products were purchased from US Chem Labs, Semaspace, and Biotech Peptides.¹³ Sterility was assessed at an ISO 14644-1-certified microbiology laboratory and the active ingredient quantified by high-performance liquid chromatography and mass spectrophotometry. One sample had elevated presence of endotoxin (8.95 EU/mg), indicating possible contamination. Product purity levels ranged from 7% to 14%, which is different than the promised ~99% purity. The measured semaglutide content was 29% to 39% higher than promised on the label, which could lead to excessive dosing and accentuated adverse events. Equally important is that 3 other products were purchased from weightcrunchshop.com, puremedsonline.com, and genius-pharmacy.com but never arrived. The purchaser was asked to pay additional fees ranging from $650 to $1200 to clear customs, which was said to be fraudulent by custom agencies.¹³

Bypassing prescribers and pharmacists to access these products comes with substantial patient risks. People who are underweight with eating disorders would be denied a prescription for semaglutide or tirzepatide products from licensed prescribers but can still purchase these “peptide” products without a prescription. Teenage women might be especially susceptible because a lack of sufficient calories can prevent menstruation and a lack of proper nutrients can cause deficiencies.¹⁴ In addition, the FDA approved semaglutide and tirzepatide^1,2 based on clinical trials in patients with elevated body weights who often had comorbid conditions. It is unknown whether the balance of benefits to risks is still positive in a younger, thinner, and healthier population. Semaglutide and tirzepatide can cause hypersensitivity reactions, increase the risk of developing pancreatitis and diabetic retinitis, and acute kidney injury.^1,2 Younger patients could potentially have more years of exposure over a lifetime, and the long-term safety of these products is not well known. The phentermine-fenfluramine combination (Phen-Fen) was not known to cause heart valve damage for many years after commercial use.¹⁵ Patients on other blood glucose-modifying drugs can have an accentuated risk of hypoglycemia by starting semaglutide or tirzepatide,^1,2 but pharmacists are not able to detect drug interactions for undisclosed products. Accessing active pharmaceutical ingredients that are not FDA-approved, such as retatrutide, is especially risky, given the lack of adequate safety and efficacy data.

We were able to readily find 40 sites selling these “peptides” to consumers, but the FDA has not warned most of them to date. In October 2023, the FDA published a warning letter for US Chem Labs.¹⁶ The letter cited several violations, including misbranding, selling unapproved drug products, and falsely marketing products as “research chemicals only,” when other areas of the website show they are intended for human use. As of June 2024, US Chem Labs was still selling GLP-1 products despite the FDA warning letter stating that action must be taken within 15 days. This lack of follow-through to force compliance with FDA requirements has also been observed in the dietary supplement industry. In 2018,¹⁷ the FDA identified experimental synthetic stimulants (β-methylphenethylamine, methylsynephrine, and octodrine) in dietary supplement products for increasing energy and weight loss and issued 31 warning letters. By January 2022,¹⁸ 9 products were still available for consumers. Fifty-six percent of the 9 products still contained at least 1 FDA-prohibited stimulant, and 1 contained 3 prohibited ingredients. Unfortunately, when the FDA finds clear violations of its regulations and its imposed warnings are not immediately complied with voluntarily, it cannot force rapid compliance.

Even if the FDA eventually forces US Chem Labs to stop selling unapproved drug products, whether they can stop sellers who are savvier with their advertising is unclear. There are already sites that are steering conversations out of the comments section and behind invitation only, password-protected chat platforms (Figure 3d). Improved regulations should close this loophole and explicitly hold companies selling drugs for research purposes to a higher standard in verifying the purchasing entity’s identity as a researcher and the legitimacy of the research institution with legal penalties for malfeasance. Researchers or research institutions found diverting drugs purchased for research purposes to consumers should face similar penalties.

However, more regulations will only be effective if coupled with reasonable FDA oversight. The FDA is well funded for functions like approving new drugs, devices, and diagnostic tests that are paid for, in part, by manufacturer user fees.¹⁹ The user fees are negotiated between the industry and the FDA, with underlying taxpayer funding for these services maintained and unable to move to other purposes. Taxpayers are solely expected to fund all other FDA functions from food safety to counterfeit products and dietary supplements. This part of the FDA is withering on the vine and has neither the workforce nor the funding to adequately protect the public. Legislative support for the FDA is key to protecting human health.

Health professional organizations and patient safety advocate groups should jointly advocate for sensible tightening of regulations surrounding the sale of research products to consumers. They also need to advocate for a more in-depth assessment of the FDA to determine the minimum funding levels to truly meet its charges and then support legislative action to secure those funds. There are many competing priorities for health professional organizations time, but few that matter as much to our patients’ health. Health professionals need to be the agitators to get these organizations to put product safety and the defense of our legitimate drug supply on their radar.

In the meantime, prescribers and pharmacists need to proactively ask about products that patients might buy outside of the traditional legitimate supply chain. We need to warn patients that accessing non-FDA-approved products carries real health risks. We need to explain why these risks exist and that it is difficult for patients to ensure they are getting a quality product and that they are using them properly. To amplify this messaging outside of the hospital, clinic, or pharmacy counter, we need to develop messaging that resonates with media outlets to disseminate it broadly. Finally, we need to advocate for a health care system that does not leave so many without access to legitimate drug treatments and pushes people to look for alternatives that circumvent their prescribers and pharmacists.