Chemical Composition of JUUL Pods Collected From Students in California High Schools
Authors: Michael A Tynan
Wenhao Chen
Lauren Tanz
Mays Shamout
Kristy Marynak
Amy Heinzerling
Liza Valentín-Blasini
Brian A King
Paul Melstrom
José J Pérez
Israel T Agaku
Ping Wang
Flavia Wong
Catherine Hess
Lisa P Oakley
Rebecca J Williams
Kazukiyo Kumagai
Chunxia Wang
Carolyn Herzig
Clifford H Watson
Maeh Al-Shawaf
Corey M Peak
Sarah Planche
Journal: Journal of Adolescent Health (2021)
Discipline: CLINICAL MEDICINE
Keywords: Adolescent; Curriculum; Electronic nicotine Delivery Systems; Nicotine; Schools
Affiliations: Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia; Epidemic Intelligence Service, Division of Scientific Education and Professional Development, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, Atlanta, Georgia. Electronic address: ., Indoor Air Quality Program, California Department of Public Health, Richmond, California., Tobacco and Volatiles Branch, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, Georgia., Epidemic Intelligence Service, Division of Scientific Education and Professional Development, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, Atlanta, Georgia., California Tobacco Control Program, California Department of Public Health, Sacramento, California., California Tobacco Control Program, California Department of Public Health, Sacramento, California; Institute for Population Health Improvement, University of California Davis Health System, Sacramento, California., Tobacco-Use Prevention Education Office, California Department of Education, Sacramento, California., Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, Georgia.

Abstract:  Purpose: To examine the chemical composition of JUUL pods collected from a convenience sample of 16 high schools in California to identify possible consumer modification or counterfeit use. Methods: Using Gas Chromatography-Mass Spectrometry, we quantitatively analyzed the nicotine, propylene glycol (PG), and vegetable glycerin (VG) in JUUL pods (n = 26) collected from California high schools and compared results to commercial 3% (n = 15) and 5% (n = 24) JUUL pods purchased online. Results: Most of the collected JUUL pods (24/26 pods) had a nicotine concentration (43.3 mg/ml, 95% PI: 21.5-65.1) outside the prediction intervals (PI) of the 3% (33.5 mg/ml, 95% PI: 31.8-35.2) and 5% (55.0 mg/ml, 95% PI: 51.5-58.3) commercial JUUL pods. Most (73%) collected JUUL pods had VG concentrations (583.5 mg/ml, PI: 428.9-738.1) lower than the 3% (722.2 mg/ml, PI: 643.0-801.4) and 5% (710.5 mg/ml, PI: 653.1-767.8) commercial JUUL pods. Conclusions: Used JUUL products collected from high school students or found on school grounds were not chemically consistent with the manufacturer's stated formulations. 

Retracted: No

PubPeer comments:
 Chemical Composition of JUUL Pods Collected from Students in California High Schools. Mays Shamout, et al. (2021) Journal of Adolescent Health In their recent publication, u201cChemical Composition of JUUL Pods Collected From Students in California High Schools,u201d Shamout et al., raise important points in their analyses of pre-filled cartridges for ENDS products (or pods) collected at high schools and initially identified as JUUL products. In this short report, Shamout examined 26 discarded JUUL or JUUL-like pods collected from 16 California high schools to evaluate differences in nicotine, propylene glycol, and vegetable glycerin compared to commercially available JUULpods purchased from juul.com (Juul Labsu2019 21+ owned-and-operated e-commerce platform). JUULpods are pre-filled, tamper-resistant, and not intended to be refilled or modified by the user. A clear strength of the study is that investigators purchased comparison JUULpods from juul.com to use as controls in their analysis. The authors conclude that the vast majority of u201cused JUUL products collected from high school students or found on school grounds were not chemically consistent with the manufactureru2019s stated formulations.u201d Conversely, the authors found that JUULpods purchased from juul.com had nicotine concentrations consistent with labelling, and that quantitative values and measurement variances of the commercial JUUL products were in u201cexcellentu201d agreement with previously and independently analyzed JUULpods purchased from Atlanta stores. The authors conclude these results indicate students may have obtained illicit counterfeit JUUL products or unauthorized JUUL-compatible products, potentially modified the e-liquids, or that changes occurred as a result of chemical degradation. The study results highlight important public-health concerns about the potential prevalence of illicit counterfeit and compatible products in the market, including their impact on underage use. Illicit ENDS products undermine tobacco-control efforts by regulators, law enforcement, and responsible commercial parties to prevent underage use. It is well established that illicit products facilitate underage access given how they are often sold through non-traditional retail channels, such as social sourcing and online with little to no age-verification. Moreover, counterfeit and other illicit ENDS vapor products may present additional health and safety risks to consumers given that they often are produced in unsanitary conditions without manufacturing and quality controls and lack ingredient testing and product characterization. An emerging market of illicit ENDS products developed in recent years, particularly unauthorized JUUL-compatible products distributed by hundreds of manufacturers, including Eonsmoke and Ziip Labs, two of the most prominent brands. In November 2018, in response to the troubling rise of underage vaping, Juul Labs suspended the distribution of non-tobacco and non-menthol based flavored JUUL products to all of our retail store partners. Following this decision, we saw dramatic growth in the illicit market for unauthorized so-called compatible products, consistent with the time period covered in this study, and continuing well into 2019. Industry has a critical role not only to proactively enforce against illicit products trading on their brand and in violation of intellectual-property rights, but also to support law-enforcement authorities across levels of government to combat illicit trade. Juul Labs remains committed to using our global enforcement program to aggressively disrupt the illicit trade of vapor products and to create a more responsible marketplace for current adult users. We have pursued multiple patent infringement actions with the United States International Trade Commission (ITC) against dozens of illicit manufacturers of unauthorized compatible products and have successfully removed over 40 compatible brands from the marketplace, including Eonsmoke and Ziip Labs, the largest manufacturers and distributors of unauthorized JUUL-compatible products. We recently filed a third ITC action seeking a General Exclusion Order that would bar the importation and later sale of any infringing, unauthorized pod-based product that is intended to be compatible with the JUUL System, including nicotine, non-nicotine, and empty pods. A win will help rid the market of compatible products that can be modified by the user, such as empty and refillable pods, which can also be used with non-nicotine substances such as THC, or other unauthorized materials. In addition, our Brand Enforcement team collaborates with customs and law enforcement in the United States and abroad to provide training, share intelligence, and support their investigations against illicit products. We also have executed a series of enforcement campaigns in China -- the primary source of counterfeit JUUL products -- that have resulted in the shut-down of several illicit operations, seizure of hundreds of thousands of counterfeit products intended for the U.S. market, and jail sentences for illicit offenders. Juul Labs also supports FDAu2019s active enforcement against illicit ENDS products that jeopardize the category and its harm-reduction potential for adult smokers. FDA has taken strong action to remove illegally marketed compatible products from the market, notably through several enforcement actions against Eonsmoke specifically. For example, in October 2019 FDA issued a warning letter to Eonsmoke ordering them to remove 96 products from the market because they lacked premarket authorization. This included 48 different unauthorized JUUL-compatible products under the Eonsmoke and 4X brand names. In May 2020, FDA published Import Alert 98-06 which added over 80 Eonsmoke products to the u201cred listu201d for CBP to detain at U.S. ports-of-entry and mailing facilities. In August 2020, FDA issued another warning letter to Eonsmoke ordering them to remove additional unauthorized JUUL-compatible products from the market because they violated FDA laws and regulations. As a result of these actions, what was once an emerging market of unauthorized JUUL-compatible products has now been largely dismantled. While the researchers called it u201cless likely,u201d it is also possible that some of the samples collected for this study were authentic JUULpods which chemically degraded due to non-standard storage and collection conditions. Quality conditions, chemistry and related degradation are matters subject to review by FDA, and we have submitted relevant data as part of our PMTA submission. Our data repeatedly demonstrates the chemical stability and integrity of JUUL products when stored in known and controlled storage conditions. One would expect that analysis of opened and partially used pods would result in disparate concentrations of chemical constituents compared to unopened pods stored under uniform conditions. Unfortunately, limitations in the methodology do not allow for a definitive answer to this question. We thank the authors for their valuable contributions to the knowledge base regarding underage ENDS use, including the potential prevalence of illicit counterfeit and compatible products. We will continue to use our own resources and partner with key stakeholders to address the illicit trade of all ENDS products and ensure a more responsible marketplace. Lindsay Andrews VP, Scientific Engagement Juul Labs ,