Nicotine and Cigarettes Across Policy Environments

Co-PIs: Drs. Richard O'Connor and Maciej Goniewicz

https://www.roswellpark.org/shared-resources/nicotine-tobacco-product-assessment

Most of the focus of tobacco control research over the last two decades has been on patterns and determinants of use, with an implicit assumption that variation among products was of minimal importance.

This history is informed by the negative experience with so-called low tar cigarettes, which did little to reduce, and may have negatively impacted, disease rates. However, the emergence of novel nicotine-delivering devices makes this assumption of product equivalence increasingly untenable. Product characteristics affect both their safety and acute toxicity, and the experiences of use, which is central to understanding patterns of use. Ensuring product safety and minimising delivery of toxins should be something that is dealt with early in the life cycle of a product where pre-existing standards do not exist. In this emerging market, regulation is evolving, so understanding the implications of allowing product innovation without overarching guidelines is important. Delivery of toxic or otherwise dangerous substances is a function of the engineering of the product and how it is used. Product engineering also affects patterns of use. It determines, along with the way the consumer uses them and their expectations, the experiences of use. Some forms of potentially harmful usage patterns are naturally inhibited because they produce noxious experiences and marketers are incentivised to correct such problems or train users to prevent them happening, as they tend to inhibit post-trial use and adoption. Challenges arise with components and use patterns that are sufficiently toxic to do harms that are undetectable or otherwise do not inhibit use, and particularly any toxic components that are correlated with positive experiences of use (the core of the smoked tobacco problem). Thus, understanding what toxic substances are delivered, under what conditions, and whether this may be related to experiences of use is critical for informing the kind of regulation needed.

Longer-term consequences for harm and implications for use require studying how the products are actually used and how those use behaviours change over time. The population-based studies of Project 1 cover the broader detail of types of product, duration, and quantity of use, but there is a large gap in understanding the functions of those products; i.e., what they do and what exposures they achieve with each episode of use, and the extent to which this might vary and thus average out over time. Project 2 is designed to answer a broad set of questions about the evolution of the nicotine delivery marketplace in countries with differing policy frameworks towards vaporised nicotine products (VNPs). The project is intended to complement Project 1’s approach to following the natural history of product users. Specifically, the proposed research revolves around three major questions: 1) How does the policy environment in a country affect the mix of product types and brands (both VNPs such as e-cigarette and conventional cigarette) used most commonly? 2) Does regulation of VNP as a medicine versus recreational product affect VNP contents, labelling accuracy, nicotine emission and delivery, and unit variability? 3) Do product characteristics and/or brand preferences shift as VNP use changes with time? Surveillance of product characteristics during the project period will allow the investigative team to elucidate the potential roles of consumer preference, regulation, and larger market dynamics (e.g., mergers and acquisitions) in changes to product performance and brand share.

Specific Aims will include:

Aim 1: Tracking of leading VNP and cigarette products in US, England, and Canada.

1. Assess preferences from International Tobacco Control (ITC) survey data (Project 1), supplemented with market sources
2. Repository of VNP by subtype, purchased biannually, selected from Project 1
3. Repository of top 10 leading cigarette brands purchased biannually, selected from Project 1

Aim 2: Characterising the design and contents of products.

1. Packaging – labelling, usability, child resistance, environmental (e.g., recycling)
2. Design and engineering
   1. VNP: Battery voltage, liquid volume (including tank capacity), heating element
   2. Cigarettes: Ventilation, paper porosity, tobacco weight
3. Contents
   1. VNP: nicotine & minor alkaloids, nitrosamines, flavorants
   2. Cigarettes: nicotine & minor alkaloids, nitrosamines, menthol and other flavorants

Aim 3: Characterising product emissions under a range of conditions (performance).

1. Nicotine
2. Toxicants, including volatile organic compounds (VOC)