FDA Intention to Develop A New Standard for Tobacco Products- Reduced Health Risk!
The Food and Drug Administration (FDA) has recently announced its intention to “explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine” (CTP, 2017). More research that is optimally designed to compare and isolate the health effects of certain product characteristics from one another is needed. Overall, studies typically show that product characteristic variation and patterns of use can meaningfully alter the effects of e-cigarette use on important outcomes.
Based on the findings of a published report, e-cigarettes cannot be simply categorized as either beneficial or harmful to health. The net public health outcome depends on the balance between adverse outcomes (increased youth initiation of combustible tobacco cigarettes, low or even decreased cessation rates in adults, and a high-risk profile) and positive outcomes (very low youth initiation, high cessation rates in adults, and a low-risk profile). In some circumstances, adverse effects of e-cigarettes clearly warrant concern, such as the use of e-cigarettes among non-smoking adolescents and young adults, devices that are prone to explosion, and the presence of constituents in e-cigarette liquids that are of major health concern (e.g., diacetyl and some other flavorings). In other circumstances, namely regular combustible tobacco cigarette smokers who use e-cigarettes to successfully quit smoking, e-cigarettes may represent an opportunity to reduce smoking-related illness. For these reasons, e-cigarette regulation that merely considers whether to be restrictive or permissive to the marketing, manufacture and sales of all e-cigarettes for all populations is unlikely to maximize benefits and minimize the risks. A number of federal regulatory tools exist to maximize the benefits and minimize the harms of e-cigarettes. One of those is the adoption of product standards, which require that product characteristics related to e-cigarette devices (e.g., electrical power, heating element, customizability), e-liquid constituents (e.g., nicotine concentration, flavoring additives, solvents such as propylene glycol and glycerol), and packaging meets certain criteria to ensure maximal benefit to the population as a whole.
To provide data to inform regulatory strategies that maximize benefits and minimize the risks of e-cigarettes, research is needed to identify product characteristics with an unfavorable health profile across key outcomes. Evidence is needed that isolates the effects of certain product characteristics on (1) toxicity and long-term health risks; (2) appeal and uptake of e-cigarettes among youth and young adult non-smokers as well as the risk of transition to smoking; (3) appeal, uptake, and efficacy as a smoking cessation aid among regular combustible tobacco cigarette smokers; and (4) appeal, uptake, and effects on maintaining abstinence or precipitating relapse among former combustible tobacco cigarette smokers. Some product characteristics may pose much greater health risks with little potential benefit and be viable candidates for restrictive product standards. For example, if evidence were to identify certain flavor additives that increased toxicity and appeal to youth, but did not enhance appeal or efficacy as a smoking cessation aid, the development of product standards to prohibit the use of such additives would likely have net improvement on the health of the population.
The effects of e-cigarette use on smoking cessation may carry a considerable influence on the overall population health burden over the next 30 years. Consequently, data examining the influence of product-characteristic variation on combustible tobacco cigarette cessation are of particular value. Other nascent issues that intersect with e-cigarettes are likely to have a major impact on population health and warrant attention but have yet to receive significant scientific study. E-cigarettes can be placed within a broader class of “non-combustible” tobacco products that, like e-cigarettes, generate inhalable aerosols and may lack certain toxicants found in tobacco smoke (HHS, 2014; TAG, 2008). For example, heat-not-burn tobacco products (e.g., devices that aerosolize tobacco leaf mixtures without combustion) share many similarities to e-cigarettes, including the use of propylene glycol and an electric heating element. Phillip Morris’s heat-not-burn product iQOS, which electronically aerosolizes tobacco leaves soaked in the same solvents present in e-liquid, has sold more than 3 million units and is currently available in more than 20 markets, but not in the United States (Reuters, 2017). In May 2017, Phillip Morris submitted modified-risk tobacco product (MRTP) applications to FDA for iQOS products and, if approved, would permit marketing with claims of reduced health risk.
It is important for regulatory science to translate the same methodologies and research questions directed toward e-cigarettes addressed in that published report to heat-not-burn products. Furthermore, patterns of poly-tobacco product use and transitions in use among e-cigarettes, heat-not-burn tobacco products, and combustible tobacco products will also necessitate study.