Counterfeit e-cigarettes, or fake vapes as they are better known, are becoming incredibly common. In 2021, U.S. Customs and Border Protection officers at Chicago O’Hare International Mail Branch intercepted a massive shipment of over 77,000 counterfeit Rick and Morty vape pens 1“CBP Officers in Chicago Capture $1.5 Million in Counterfeit Vaping Pens,” U.S. Customs and Border Protection, Mar. 11, 2021. [Online]. Available: CBP, which is equivalent to $1.5 million. This shipment, which originated from the home of vape manufacturing, Shenzhen, China, is just one of many similar shipments that are flooding into America.
The Food and Drug Administration (FDA) has proven itself to be an ineffective barrier against these types of counterfeit products. The current strategy to eliminate fake vapes centers around Premarket Tobacco Product Applications (PMTAs), which manufacturers have to submit before they can legally sell vape products.
Despite denying tens of thousands of applications 2“FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health,” U.S. Food and Drug Administration, Aug. 26, 2021. [Online]. Available: FDA, the FDA is still struggling to gain a foothold on the problem of counterfeit products. It banned ‘kid-friendly’ vapes 3“FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint,” U.S. Food and Drug Administration, Jan. 2, 2020. [Online]. Available: FDA in 2020 but, as the mail clerks at Chicago O’Hare International Mail Branch know, this ban did little to deter counterfeit manufacturers.
One brand has developed an ingenious solution to the problem. Juul is one of the best-known vape brands, so it is no surprise that it is a frequent target of counterfeit manufacturers. The legal representatives at Juul are constantly issuing new lawsuits against knock-off brands. Just a few months ago, Juul was awarded $2 million in a trademark infringement lawsuit 4R. Love, “JUUL Awarded $2M After Counterfeit Products Infringed Trademarks,” Bloomberg Law. [Online]. Available: Bloomberg Law against a Chinese company operating and selling counterfeit Juul products in California.
Still not satisfied with the state of the fake vape landscape, Juul is now seeking approval from the FDA to release Juul2 in America 5JUUL Labs, “Next Generation Platform PMTA,” JUUL Labs. [Online]. Available: JUUL Labs. This vape pen has a unique, built-in Pod ID Chip. Users pair their devices to a mobile and web-based app to verify their age and see a breakdown of the flavor, strength, and approximate e-liquid level inside their Juul.
Once users have downloaded the app, they can choose from one of two options. They can either upload their government ID and a real-time selfie or input their personal information and give a third-party app permission to verify their identity. Once that is complete, Juul can verify that only age-appropriate people are using their products.
Juul2 was first launched in the UK as the Juul2 system, where it became a massive success. Chief Product Officer Kirk Phelps said that the new model aims to ‘eliminate combustible cigarettes and combat underage use.’ Of course, there are a few other positive outcomes.
The decision to create a watertight age verification feature may have been influenced by the millions of dollars that Juul has paid to California, New York, and other states. This titan brand reached a $462 million settlement 6“Juul Reaches $462 Million Settlement With New York, California and Others,” The New York Times, Apr. 12, 2023. [Online]. Available: The New York Times to atone for its early teen-centric marketing campaigns, which involved Juul handing out freebies at trendy, adolescent-targeted events like Nocturnal Wonderland in San Bernardino.
Whatever the reason, we are glad to see big vape brands taking a proactive approach to protecting the public from counterfeit vapes. If the Juul2 system gains approval and success in America, it might encourage other brands to implement similar systems.
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Yet Another Study Linking Vaping to Disease is Retracted
Research on vaping is sparse, so each new paper is held in high regard. This is true of the paper published by the peer-reviewed journal Gastroenterology Research. The paper, ‘Association of Smoking and E-Cigarettes in Chronic Liver Disease: An NHANES Study’ 7R. C. Chakinala, S. Dawoodi, S. P. Fabara, M. Asad, A. Khayyat, S. Chandramohan, A. Aslam, N. Unachukwu, B. Nasyrlaeva, R. Jaiswal, S. B. Chowdary, P. Malik, and R. Rabbani, “Association of Smoking and E-Cigarette in Chronic Liver Disease: An NHANES Study,” Gastroenterology Res, vol. 15, no. 3, pp. 113–119, Jun. 2022. [Online]. Available: PubMed Central, was first published in June 2022. It concluded that e-cigarette users have ‘higher odds of having liver disease compared to non-smokers.’
Soon after the paper was published, the editor received a letter that questioned the validity of the paper. The letter to the editor has not been made public, but we know that the journal was concerned about the ‘methodology, source data processing […] and reliability of conclusions’ in the paper.
Researchers who conducted the study based their findings on the National Health and Nutrition Examination Survey (NHANES), a survey that is designed to assess the health of children and adults in the United States.
Ray Niaura, an epidemiology professor at New York University’s School of Public Health, highlighted the insubstantial focus on vaping in the survey. ‘The only survey question on vaping was a broad one,’ 8S. Nautiyal, “Experts want Gastroenterology Research to publish letter that led to study paper retraction,” PharmaBiz, Mumbai, Jul. 29, 2023. [Online]. Available: PharmaBiz Niaura says. Researchers compared the answers to ‘Have you ever used an e-cigarette?’ to answers about combustible cigarettes.
Researchers asked participants whether they had smoked ‘at least 100 cigarettes’ in their lifetime. As Niaura points out, this is a ‘weak variable’, but it is especially alarming that researchers tried to base their conclusions on it. The researchers also failed to consider the timing of the development of lung cancer, another vital metric for any sound conclusions.
The journal officially retracted the paper on June 11th, 2023, an entire year after its publication. This is not the first time that misinformation about vaping has been published.
Riccardo Polosa, Founder of the CoEHAR, and Konstantinos Farsalinos, a research fellow at the Onassis Cardiac Surgery Center in Athens, recently published ‘A tale of flawed e-cigarette research undetected by defective peer review process’ 9R. Polosa and K. Farsalinos, “A tale of flawed e-cigarette research undetected by defective peer review process,” Intern Emerg Med, vol. 18, no. 4, pp. 973–975, Jun. 2023. [Online]. Available: PubMed doi: 10.1007/s11739-022-03163-x. in the journal of the Italian Society of Internal Medicine. The researchers emphasize that many studies ‘fail to include the information on the age of initiation of e-cigarette and combustible cigarette use’ and that this failure stops them from forming any evidence-based opinions.
Another group of researchers who operate under CoEHAR pointed out similar flaws in 24 of the most well-known vaping studies. The resulting review, titled ‘Analysis of common methodological flaws in the highest cites e-cigarette epidemiology research’10C. Hajat, E. Stein, A. Selya, R. Polosa, and CoEHAR study group, “Analysis of common methodological flaws in the highest cited e-cigarette epidemiology research,” Intern Emerg Med, vol. 17, no. 3, pp. 887–909, Apr. 2022. [Online]. Available: PubMed doi: 10.1007/s11739-022-02967-1., found that many studies ‘lacked a clear hypothesis statement’ and that ‘the methods were not tailored to address the question of interest.’ Yet more problems arose, with the most eye-catching being the ‘failure to control for confounding factors.’
A lack of robust methodology seems to be the leading cause of flawed research, but why? The answer may lie in the relatively short time that vape devices have been around, compounded by frenzied anti-vape arguments and campaigns. The rush to find evidence one way or the other might have led researchers to rely on insufficient or unsuitable data sources, as is evident in the NHANES Study.
