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. 2024 Nov 7:26:e65440.
doi: 10.2196/65440.

Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study

Amir Reza Ashraf  1 , Tim Ken Mackey  2 , Róbert György Vida  1 , Győző Kulcsár  3 , János Schmidt  4 , Orsolya Balázs  1 , Bálint Márk Domián  1 , Jiawei Li  5 , Ibolya Csákó  6 , András Fittler  1
Affiliations

Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study

Amir Reza Ashraf et al. J Med Internet Res. .

Abstract

Background: Over the past 4 decades, obesity has escalated into a global epidemic, with its worldwide prevalence nearly tripling. Pharmacological treatments have evolved with the recent development of glucagon-like peptide 1 agonists, such as semaglutide. However, off-label use of drugs such as Ozempic for cosmetic weight loss has surged in popularity, raising concerns about potential misuse and the emergence of substandard and falsified products in the unregulated supply chain.

Objective: This study aims to conduct a multifactor investigation of product quality and patient safety risks associated with the unregulated online sale of semaglutide by examining product availability and vendor characteristics and assessing product quality through test purchases.

Methods: We used a complex risk and quality assessment methodology combining online market surveillance, search engine results page analysis, website content assessment, domain traffic analytics, conducting targeted product test purchases, visual quality inspection of product packaging, microbiological sterility and endotoxin contamination evaluation, and quantitative sample analysis using liquid chromatography coupled with mass spectrometry.

Results: We collected and evaluated 1080 links from search engine results pages and identified 317 (29.35%) links belonging to online pharmacies, of which 183 (57.7%) led to legal pharmacies and 134 (42.3%) directed users to 59 unique illegal online pharmacy websites. Web traffic data for the period between July and September 2023 revealed that the top 30 domains directly or indirectly affiliated with illegal online pharmacies accumulated over 4.7 million visits. Test purchases were completed from 6 illegal online pharmacies with the highest number of links offering semaglutide products for sale without prescription at the lowest price range. Three injection vial purchases were delivered; none of the 3 Ozempic prefilled injection pens were received due to nondelivery e-commerce scams. All purchased vials were considered probable substandard and falsified products, as visual inspection indicated noncompliance in more than half (59%-63%) of the evaluated criteria. The semaglutide content of samples substantially exceeded labeled amounts by 28.56%-38.69%, although no peptide-like impurities were identified. The lyophilized peptide samples were devoid of viable microorganisms at the time of testing; however, endotoxin was detected in all samples with levels ranging between 2.1645 EU/mg and 8.9511 EU/mg. Furthermore, the measured semaglutide purity was significantly low, ranging between 7.7% and 14.37% and deviating from the 99% claimed on product labels by manufacturers.

Conclusions: Glucagon-like peptide 1 agonist drugs promoted for weight loss, similar to erectile dysfunction medications more than 2 decades ago, are becoming the new blockbuster lifestyle medications for the illegal online pharmacy market. Protecting the pharmaceutical supply chain from substandard and falsified weight loss products and raising awareness regarding online medication safety must be a public health priority for regulators and technology platforms alike.

Keywords: Ozempic; Wegovy; counterfeit; medication safety; nondelivery schemes; online pharmacies; patient safety; search engines; semaglutide; substandard and falsified medical products.

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Conflict of interest statement

Conflicts of Interest: TKM and JL are employees of the startup company S-3 Research LLC. TKM is also a cofounder and co-owner of the company. S-3 Research is a small business that was originally created through a National Institute on Drug Abuse startup business award and has been subsequently funded through government contracts with federal agencies to develop research tools and services for data science in public health, including social listening, data mining, and machine learning approaches. TKM has also received funding from the World Health Organization (WHO) to attend a round table of subject matter experts for the WHO Member State Mechanism for Substandard and Falsified Medical Products Working Group on Informal Markets. TKM is also the editor-in-chief of JMIR Infodemiology. The authors report no other conflicts of interest associated with this manuscript.

Figures

Figure 1
Figure 1
Summary of study methodology, including online market availability, website monitoring, packaging analysis, and complex product quality control testing. EU: European Union; FIP: International Pharmaceutical Federation.
Figure 2
Figure 2
Screenshot of SemaSpace demonstrating common characteristics of illegal online pharmacies: off-label use promotion, no prescription requirements, unverified before-and-after photos to suggest efficacy, and misleading marketing strategies, such as risk-free trial and money-back guarantees. Personal identifiers have been blurred.
Figure 3
Figure 3
Screenshots of legitimate GLS Group on the left, and fraudulent GLSCourierServices website on the right. The legitimate website features authentic corporate branding, while the fraudulent website, which imitates the official GLS site, provides misleading information intended to deceive consumers. Note that GLS Group has since updated its logo, removing the yellow arrow [38].
Figure 4
Figure 4
Injection vials containing lyophilized semaglutide peptide purchased from illegal internet pharmacies. USChemLabs and BiotechPeptides included purity information and warnings on the labels, while SemaSpace labeling did not. SemaSpace provided a complete injection kit with the semaglutide vials, BiotechPeptides provided bacteriostatic water with the semaglutide vials, while USChemLabs supplied semaglutide vials only.
See this image and copyright information in PMC

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