Multifactor Quality and Safety Analysis of Semaglutide Products Sold by Online Sellers Without a Prescription: Market Surveillance, Content Analysis, and Product Purchase Evaluation Study.
This market surveillance study investigated the quality and safety risks of semaglutide products sold without a prescription through illegal online pharmacies. Researchers analyzed 1,080 links from search engine results pages, identifying 59 unique illegal online pharmacy websites. Web traffic data showed the top 30 affiliated domains accumulated over 4.7 million visits in a three-month period. Test purchases were attempted from six illegal vendors; three injection vials were delivered (three prefilled pens were never delivered, representing e-commerce scams). Visual inspection of the vials revealed noncompliance in 59–63% of evaluated packaging criteria, flagging them as probable substandard or falsified products. Laboratory analysis using liquid chromatography–mass spectrometry found semaglutide content exceeded labeled amounts by 28.56–38.69%, while measured purity was critically low (7.7–14.37%), far below the 99% claimed on labels. Endotoxin contamination was detected in all samples (2.16–8.95 EU/mg), posing a serious injection safety risk. No viable microorganisms were detected at the time of testing. The study's limitations include a small number of purchased samples and a single geographic/time window of surveillance. The authors conclude that unregulated online semaglutide markets present significant public health risks analogous to earlier waves of illicit erectile dysfunction drug sales.
Why this grade: The study involves human-relevant product safety data from test purchases and laboratory analysis, but it is a non-randomized market surveillance study with only three delivered product samples, limiting generalizability.
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.
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