Stem Cells, Cell Therapies and Bioengineering in Lung Biology and Diseases 2023.

Repair and regeneration of a diseased lung using stem cells or bioengineered tissues is an exciting therapeutic approach for a variety of lung diseases and critical illnesses. Over the past decade increasing evidence from preclinical models suggests that cells, which are not normally resident in the lung can be utilized to modulate immune responses after injury, but there have been challenges in translating these promising findings to the clinic. In parallel, there has been a surge in bioengineering studies investigating the use of artificial and acellular lung matrices as scaffolds for three-dimensional lung or airway regeneration, with some recent attempts of transplantation in large animal models. The combination of these studies with those involving stem cells, induced pluripotent stem cell derivatives, and/or cell therapies is a promising and rapidly developing research area. These studies have been further paralleled by significant increases in our understanding of the molecular and cellular events by which endogenous lung stem and/or progenitor cells arise during lung development and participate in normal and pathologic remodeling after lung injury. For the 2023 Stem Cells, Cell Therapies, and Bioengineering in Lung Biology and Diseases Conference, scientific symposia were chosen to reflect the most cutting-edge advances in these fields. Sessions focused on the integration of "-omics" technologies with function, the influence of immune cells on regeneration, and the role of the extracellular matrix in regeneration. The necessity for basic science studies to enhance fundamental understanding of lung regeneration and to design innovative translational studies was reinforced throughout the conference.

Effects of "Tobacco Free" Language in Warning Labels on Perceptions of Electronic Cigarettes and Nicotine Pouches among Young Adult Men: A Randomized Trial.

Background: Manufacturers of Puff Bar electronic cigarettes (e-cigarettes) and Fre nicotine pouches claim that their products contain synthetic nicotine. The packages for Puff Bar and Fre have modified versions of the warning labels required by the Food and Drug Administration (FDA) for tobacco products, which specify that Puff Bar and Fre products contain "tobacco free" or "non-tobacco" nicotine, respectively. We evaluated whether exposure to these "tobacco free" warning labels was associated with differing perceptions about the products. Method: N = 239 young adult men who were enrolled in a cohort study completed a short online experiment. Participants were randomly assigned to view either packages of Puff Bar and Fre nicotine pouches with the standard FDA warning or packages with the standard FDA warning + the tobacco free descriptor. We compared harm and addictiveness perceptions and products' perceived substitutability for cigarettes and smokeless tobacco (SLT) by exposure to a "tobacco free" warning. Results: Viewing a Puff Bar package with a "tobacco free" warning label was associated with increased perceived substitutability of the product for cigarettes and smokeless tobacco (p's<.05). Viewing a Fre package with a "non-tobacco" warning label was associated with thinking the product was less harmful than SLT (p<.01). Conclusions: "Tobacco free" descriptors in warning labels for e-cigarettes and nicotine pouches affect young adults' perceptions of the products. To date, it is unclear whether the FDA will continue to permit "tobacco free" descriptors in warning labels. As e-cigarettes and nicotine pouches are increasingly marketed with "tobacco free" language, urgent action is needed.

Switching stories: user testimonials on juul.com continue to contradict JUUL's switch ≠ cessation narrative.

BACKGROUND: In January 2019, electronic nicotine delivery systems (ENDS) market leader Juul Labs (JUUL) launched an advertising campaign encouraging adult smokers to 'make the switch' from combustible cigarettes to JUUL. Our primary aim was to describe consumer perceptions of JUUL as communicated by members of JUUL's online social community via testimonials promoted on JUUL's website. METHODS: User testimonials that were displayed on the JUUL website in December 2019 and January 2020 were collected and coded by three reviewers. A total of 220 testimonials were coded for primary and secondary themes (eight codes within four broader themes). RESULTS: Testimonial writers were, on average, 43.0 years old (range 28 to 74) and reported using JUUL for an average of 21.8 months (range 9 to 59 months). The most prominent theme, present in nearly half of the testimonials, was a description of how to use JUUL, with a mention of JUUL's benefits and tips on how to use the product. Nearly four in 10 statements encouraged smokers to give JUUL a try or noted that JUUL is a better product compared with cigarettes. About one in 10 statements focused on switching from smoking cigarettes to using JUUL. CONCLUSION: This study presents a foundation for understanding how adult users describe JUUL, including their experiences using JUUL to 'switch' or stop smoking. Currently, the effectiveness of ENDS for smoking cessation is not supported by substantial evidence; however, if cessation is defined as 'quitting combustible tobacco products', then regulators should be aware that switch and cessation messages may not be distinct.

Anticipating Industry Arguments: The US Food and Drug Administration's Authority to Reduce Nicotine Levels in Cigarettes.

The US Food and Drug Administration has announced that it is considering lowering nicotine levels in cigarettes to "minimally addictive or nonaddictive levels." This could be a transformative public health measure, but the tobacco industry is likely to challenge such an action in court. This article reviews some of the key legal arguments that industry is likely to advance and considers possible responses. As we demonstrate, there are strong arguments that the US Food and Drug Administration has the authority to implement a policy to reduce nicotine in cigarettes to nonaddictive levels.

Closing the Regulatory Gap for Synthetic Nicotine Products.

In July 2017 the U.S. Food and Drug Administration (FDA) announced a new "comprehensive plan for tobacco and nicotine regulation." This plan is focused on making cigarettes less addictive while facilitating the development of alternative, and less-harmful, nicotine-containing products. This approach holds promise, and the public health stakes could not be higher-smoking is the leading cause of preventable death in the United States, resulting in roughly 480,000 deaths per year. But a new consumer product is emerging that could upset the FDA's plans for a well-balanced regulatory scheme: synthetic nicotine. These products currently fall into a regulatory gap because they fall outside the Federal Food, Drug, and Cosmetic Act's (FDCA) definition of a tobacco product. If this gap remains in place, it is likely that more companies will exploit it in order to evade regulation, undoing the potential benefits of the FDA's plan for tobacco and nicotine regulation. This Article argues that the FDA can, and should, address this problem by regulating synthetic nicotine products as drugs. After reviewing the science of nicotine addiction and the FDA's past and present regulatory schemes for nicotine, it explains how the FDA could establish that synthetic nicotine products satisfy the FDCA's definition of a drug. It concludes with a discussion of the policy benefits of categorizing synthetic nicotine products as drugs.