Challenges for rulemaking and insurance guidelines from conventional definitions of tobacco and nicotine products

The growth of e-cigarettes (or electronic nicotine delivery systems) and related smoking or vapor devices has created a distinction between tobacco products and nicotine products that challenges conventional definitions and categories in regulation, public policy, and insurance. Traditional characterizations of smoking are no longer sufficient for tobacco control and related rulemaking by federal and state agencies. As regulatory policies gradually advance to cover the full spectrum of nicotine-containing products, there are potential hazards for consumers, insurers, and regulators who will rely on proper classification and understanding of these products. I conduct several case studies where insurers and regulatory bodies encounter such issues when creating regulations or guidelines. I review existing Federal Register rules and the definitions used by various state and local agencies and examine the effects of when these nicotine products are treated in the same way or not . For instance, ACA marketplace health plans do not provide guidelines about whether e-cigarette use qualifies as tobacco use, yet enrollees may be subject to significantly larger premiums if they are tobacco users. On the other end of the range of categorization is the FDA, which is establishing a regulatory framework that encompasses all nicotine and tobacco products subject to FDA regulation. To the extent public policies, regulations, and insurance standards treat these products in an equivalent manner, other actors (consumers, insurers, and regulators) may respond to this equivalence in both intended and unintended ways. If some of these products are determined to be effective at tobacco harm reduction, then their potential benefits may not be captured by those most likely to realize them. And if indeed their negative health effects outweigh any positive ones, then these definitions should be better aligned. Poor understanding of these products, confusion about their health consequences, and inaccurate beliefs about their substitutability pose significant problems for the public and policy-makers.