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On June 23, 2022, the US Food and Drug Administration (FDA) denied Juul Labs marketing approval for all JUUL products that are marketed in the USA. JUUL is an electronic nicotine-delivery system (ENDS) that has higher nicotine content than many other devices and has therefore become a public health target for health-care professionals and others who are concerned about people becoming addicted to nicotine and the use of ENDS as a gateway to smoking. A day after the FDA announcement, the FDA issued a temporary stay of the order after an application by the company through the US Court of Appeals. This was followed by an administrative stay on July 5, 2022, as the FDA “determined that there were scientific issues unique to the JUUL application that warrant additional review.” The stay was met with dismay within the health-care community and calls into question the FDA’s commitment to tackling the vaping epidemic. A few weeks later, a key FDA tobacco scientist left to join Philip Morris, a major tobacco manufacturer that also sells e-cigarettes, heated tobacco, and oral nicotine products.
It is unsurprising that Juul Labs was quick to oppose the FDA decision, given the known effectiveness of denying marketing approval for tobacco-based products, such as traditional cigarettes, in reducing smoking prevalence. The initial marketing denial order issued by the FDA referred to the JUUL device and four types of pod: 3% and 5% nicotine Virginia tobacco-flavoured pods, and 3% and 5% nicotine menthol-flavoured pods. The menthol flavour, together with many sweet flavours such as gummy bear, vanilla, and custard—all flavours commonly used by ENDS manufacturers—have been criticised as being especially attractive to adolescents and young adults. Furthermore, the US Centers for Disease Control and Prevention (CDC) indicates on their website that approximately two-thirds of JUUL users aged 15–24 years do not know that the devices contain nicotine, which can affect adolescent brain development, with harms continuing into early adulthood. Those who use e-cigarettes are also more likely to start smoking traditional cigarettes than are non-ENDS users.
Other detrimental health effects of ENDS, including cardiopulmonary effects, are known or suspected, despite contrary claims by industry. In 2019, e-cigarette, or vaping, product use associated lung injury (EVALI) was noted in e-cigarette users, with close to 3000 cases reported in the USA by Feb 18, 2020, and 68 deaths. Many cases were thought to be associated with tetrahydrocannabinol (THC)-containing products and vitamin E acetate. More recently, Hariri and colleagues reported in NEJM Evidence a series of four patients with chronic lung disease associated with e-cigarette use. The patients had between a 3-year and an 8-year history of use and reported chest pain and breathlessness. Using imaging techniques, including high-resolution chest CT, the authors observed small airway-centred fibrosis, including constrictive bronchiolitis, and speculated that, given the timing of symptoms, this pattern was most likely due to e-cigarette use. Interestingly, in patients who stopped vaping, there was a partial reversal of disease.
COVID-19 has already left large populations with post-acute lung sequelae, and in a Personal View published in The Lancet Respiratory Medicine on the links between tobacco product use and risks of SARS-CoV-2 infection and COVID-19, Neal Benowitz and colleagues note a five-times increased likelihood of COVID-19 in adolescent and young adult users of e-cigarettes. This figure rose to a nearly seven-times likelihood in those who were also using traditional cigarettes. Clear evidence for the role of cigarette smoking in increasing COVID-19 severity and poor outcomes is also presented by Benowitz and colleagues. As discussed by Jonathan Grigg in a linked Comment, the nicotine hypothesis that proposes a protective effect of nicotine against SARS-CoV-2 infection is based on weak and conflicting evidence, and has been misused by those with vested interests in the sale of tobacco products. He emphasises that ENDS should not be used to reduce COVID-19 risk and, in line with respiratory society recommendations, should not be used for smoking cessation.
The latest CDC statistics show that e-cigarette use in young people is already at alarming levels: in 2021, 11·3% of high school students (about one in nine) used e-cigarettes; the figure was 2·8% (one in 35) for middle school students. There is an urgent need for the FDA, and other health agencies, to act more decisively to prevent a future wave of vaping-associated disease.
Créditos: Comité científico Covid