E-Cigarette Science and Its Relevance for Regulatory Actions and Policy

E-Cigarette Science and Its Relevance for Regulatory Actions and Policy Nicotine & Tobacco Research, 2018, 1–1 doi:10.1093/ntr/nty091 Editorial Editorial In this issue of the journal, a collection of papers on e-cigarettes is Scientific inferences are further challenged by rapidly evolving presented. The topics run the gamut from surveillance to their pur- product technology, entry of new products into the marketplace, ported effects on tobacco use behaviors, health, and exposures to consumer-driven selection of products governed by poorly under- toxic compounds. The steep rise in the popularity of research on stood factors, variability in how products are used, etc. The objects e-cigarettes and related devices parallels their rise in attention and of inference are, truly, moving targets. concern by tobacco control advocates, regulators, and policy makers. Temporal aspects of the transition process (eg, from combust- Currently, for regulatory purposes in the United States, e-cig- ible to vapor products) are poorly understood. Product transitions arettes reside in the class of consumer recreational as opposed to (e.g., successful switching) are multidetermined, not stable, and medicinal products. The FDA has issued a final rule to this effect: therefore not easily captured by research. Consumer selection pro- “…this final rule will help to avoid consumer confusion about which cesses not under the researcher’s control are myriad and include, products made or derived from tobacco are intended for a medical for example, product appeal, convenience and ease of use, flavors, use (i.e., as a drug/device) versus for a recreational use. Specifically, price, ease of access and purchase, device characteristics, perceived FDA wishes to avoid situations where products intended to be sold harm reduction, personal lifestyle statement, social processes, as tobacco products are marketed with the same claims as products cleanliness and hygiene, not to mention policy and regulatory sold as drugs or devices.” (https://www.fda.gov/TobaccoProducts/ environment effects including taxes, sales restrictions, information Labeling/RulesRegulationsGuidance/ucm462957.htm). available to the public, and information campaigns by govern- The distinction between recreational and medical products ments and NGOs. All of these and perhaps many more currently that contain nicotine is important insofar as it restricts which FDA unidentified factors can, to some extent, be isolated and studied, Centers exert regulatory authority over recreational (Center for and this may be worthwhile, but no study can ever fully capture Tobacco Products—CTP) and medicinal nicotine (Center for Drug the phenomena of interest, nor should they ever claim to be able to Evaluation and Research—CDER) products. This poses a dilemma do so. Effects (strength of association) are also likely to be small, for researchers who are interested in understanding the use of these so implications for regulation and policy will need to be thought- products and their effects “in the wild,” as they would normally be fully considered. used, as compared to determining whether they confer a therapeutic The diversity in products and how they are used also poses benefit in terms of smoking cessation. For now, all therapeutic (ces- another dilemma for researchers: whether to assume that all sation) studies must be overseen by the CDER, while consumer use/ of these products are sufficiently similar such that they can be recreational studies fall under the purview of the CTP. Adding to lumped together as a class of products and contrasted with other the confusion, harm reduction effects studies (eg, reduced exposures classes of products such as cigarettes or, a bit less specifically, and/or modified risks) fall under the purview of the CTP, although combustible tobacco products. Such lumping may mask hetero- researchers can pursue funding for such studies from other sources, geneity of effects and lead to erroneous conclusions. The FDA’s including the National Institutes of Health, philanthropic founda- regulatory policy currently requires that each product be evalu- tions, and companies that manufacture these products. ated separately. If researchers choose to study how e-cigarettes are used by con- Nevertheless, there is room for optimism. Greater understanding sumers, they invariably are confronted by choices for study designs. will be achieved, albeit slowly, assembled piece by piece into a fair if Clinical trials, in the usual sense, are disallowed, but experiments hazy representation of reality that should guide rational, regulatory are not. But, if researchers are to understand how these products are decision making. Researchers in great numbers appear to be rising actually used by consumers, they must navigate between the Scylla to the challenge with great enthusiasm. Enthusiasm, however, must of experimental overcontrol and the Charybdis of noninterfering be tempered by caution, reason, and humility. observation. Highly structured experimental studies cannot easily be generalized to larger populations, whereas representative population Ray Niaura PhD studies, that may be good for surveillance purposes, cannot easily or College of Global Public Health, New York University, 715 adequately answer causal questions of interest. Broadway, New York, NY 10012, USA. E-mail: niaura@nyu.edu © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. 1 For permissions, please e-mail: journals.permissions@oup.com. Downloaded from https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/nty091/4996940 by Ed 'DeepDyve' Gillespie user on 08 June 2018 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Nicotine and Tobacco Research Oxford University Press

E-Cigarette Science and Its Relevance for Regulatory Actions and Policy

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.
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1462-2203
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1469-994X
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10.1093/ntr/nty091
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Abstract

Nicotine & Tobacco Research, 2018, 1–1 doi:10.1093/ntr/nty091 Editorial Editorial In this issue of the journal, a collection of papers on e-cigarettes is Scientific inferences are further challenged by rapidly evolving presented. The topics run the gamut from surveillance to their pur- product technology, entry of new products into the marketplace, ported effects on tobacco use behaviors, health, and exposures to consumer-driven selection of products governed by poorly under- toxic compounds. The steep rise in the popularity of research on stood factors, variability in how products are used, etc. The objects e-cigarettes and related devices parallels their rise in attention and of inference are, truly, moving targets. concern by tobacco control advocates, regulators, and policy makers. Temporal aspects of the transition process (eg, from combust- Currently, for regulatory purposes in the United States, e-cig- ible to vapor products) are poorly understood. Product transitions arettes reside in the class of consumer recreational as opposed to (e.g., successful switching) are multidetermined, not stable, and medicinal products. The FDA has issued a final rule to this effect: therefore not easily captured by research. Consumer selection pro- “…this final rule will help to avoid consumer confusion about which cesses not under the researcher’s control are myriad and include, products made or derived from tobacco are intended for a medical for example, product appeal, convenience and ease of use, flavors, use (i.e., as a drug/device) versus for a recreational use. Specifically, price, ease of access and purchase, device characteristics, perceived FDA wishes to avoid situations where products intended to be sold harm reduction, personal lifestyle statement, social processes, as tobacco products are marketed with the same claims as products cleanliness and hygiene, not to mention policy and regulatory sold as drugs or devices.” (https://www.fda.gov/TobaccoProducts/ environment effects including taxes, sales restrictions, information Labeling/RulesRegulationsGuidance/ucm462957.htm). available to the public, and information campaigns by govern- The distinction between recreational and medical products ments and NGOs. All of these and perhaps many more currently that contain nicotine is important insofar as it restricts which FDA unidentified factors can, to some extent, be isolated and studied, Centers exert regulatory authority over recreational (Center for and this may be worthwhile, but no study can ever fully capture Tobacco Products—CTP) and medicinal nicotine (Center for Drug the phenomena of interest, nor should they ever claim to be able to Evaluation and Research—CDER) products. This poses a dilemma do so. Effects (strength of association) are also likely to be small, for researchers who are interested in understanding the use of these so implications for regulation and policy will need to be thought- products and their effects “in the wild,” as they would normally be fully considered. used, as compared to determining whether they confer a therapeutic The diversity in products and how they are used also poses benefit in terms of smoking cessation. For now, all therapeutic (ces- another dilemma for researchers: whether to assume that all sation) studies must be overseen by the CDER, while consumer use/ of these products are sufficiently similar such that they can be recreational studies fall under the purview of the CTP. Adding to lumped together as a class of products and contrasted with other the confusion, harm reduction effects studies (eg, reduced exposures classes of products such as cigarettes or, a bit less specifically, and/or modified risks) fall under the purview of the CTP, although combustible tobacco products. Such lumping may mask hetero- researchers can pursue funding for such studies from other sources, geneity of effects and lead to erroneous conclusions. The FDA’s including the National Institutes of Health, philanthropic founda- regulatory policy currently requires that each product be evalu- tions, and companies that manufacture these products. ated separately. If researchers choose to study how e-cigarettes are used by con- Nevertheless, there is room for optimism. Greater understanding sumers, they invariably are confronted by choices for study designs. will be achieved, albeit slowly, assembled piece by piece into a fair if Clinical trials, in the usual sense, are disallowed, but experiments hazy representation of reality that should guide rational, regulatory are not. But, if researchers are to understand how these products are decision making. Researchers in great numbers appear to be rising actually used by consumers, they must navigate between the Scylla to the challenge with great enthusiasm. Enthusiasm, however, must of experimental overcontrol and the Charybdis of noninterfering be tempered by caution, reason, and humility. observation. Highly structured experimental studies cannot easily be generalized to larger populations, whereas representative population Ray Niaura PhD studies, that may be good for surveillance purposes, cannot easily or College of Global Public Health, New York University, 715 adequately answer causal questions of interest. Broadway, New York, NY 10012, USA. E-mail: niaura@nyu.edu © The Author(s) 2018. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. 1 For permissions, please e-mail: journals.permissions@oup.com. Downloaded from https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/nty091/4996940 by Ed 'DeepDyve' Gillespie user on 08 June 2018

Journal

Nicotine and Tobacco ResearchOxford University Press

Published: May 16, 2018

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