Wicked Wizard E liquid Regulation profiles of e cigarettes in the United States: a critical review with qualitative synthesis
Regulation profiles of e cigarettes in the United States: a critical review with qualitative synthesis
Electronic cigarettes (e cigarettes) have been steadily increasing in popularity since their introduction to US markets in 2007. Debates surrounding the proper regulatory mechanisms needed to mitigate potential harms associated with their use have focused on youth access, their potential for nicotine addiction, and the renormalization of a smoking culture. The objective of this study was to describe the enacted and planned regulations addressing this novel public health concern in the US.
We searched LexisNexis Academic under Federal Regulations and Registers, as well as State Administrative Codes and Registers. This same database was also used to find information about planned regulations in secondary sources. The search was restricted to US documents produced between January 1 st , 2004, and July 14 th , 2014.
We found two planned regulations at the federal level, and 74 enacted and planned regulations in 44 states. We identified six state-based regulation types, including i) access, ii) usage, iii) marketing and advertisement, iv) packaging, v) taxation, and vi) licensure. These were further classified into 10 restriction subtypes: sales, sale to minors, use in indoor public places, use in limited venues, use by minors, licensure, marketing and advertising, packaging, and taxation. Most enacted restrictions aimed primarily to limit youth access, while few regulations enforced comprehensive restrictions on product use and availability.
Current regulations targeting e cigarettes in the US are varied in nature and scope. There is greater consensus surrounding youth protection (access by minors and/or use by minors, and/or use in limited venues), with little consensus on multi-level regulations, including comprehensive use bans in public spaces.
E cigarette regulation; Public health policy; United States
Electronic cigarettes (e cigarettes) are battery-powered devices that vaporize a flavored propylene glycol or glycerin solution, with or without nicotine, to simulate cigarette smoking. Since their introduction to North American markets in 2007, studies have shown increased awareness and use of e cigarettes, both among high school students and young adults. The e cigarette global industry is projected to reach US $10 billion by 2017 . Although e cigarettes have the potential to act as harm reduction devices due to the absence of combustion-related toxins and carcinogens produced by conventional cigarettes, the long-term health effects of vapor inhalation are unknown. Other public health concerns include e cigarettes’ potential for nicotine addiction in youth, the renormalization of a smoking culture, and accidental nicotine poisoning among children –. Despite these concerns, e cigarettes have largely evaded regulation given the ambiguity surrounding their classification as tobacco products, consumer products, or medical devices. Our objective was to conduct a critical review of current and planned legislation targeting e cigarettes at the US federal and state levels, in the aim of describing the different regulatory approaches that will inform the future availability of and access to e cigarettes.
This critical review was conducted following a pre-specified protocol and is reported according to the MOOSE (Meta-analysis Of Observational Studies in Epidemiology) guidelines , with the literature search described using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram . With guidance from a Law librarian, two specialized health librarians developed the search strategy and conducted the search in July 2014. The search was conducted in the subscription-based legal databases available in LexisNexis Academic, under Federal Regulations and Registers as well as State Administrative Codes and Registers, using the keywords “electronic cigarette*” OR “e cigarette*”. Secondary sources, including US Law reviews, journals, as well as newspaper articles, were also searched using LexisNexis Academic, using the keywords “electronic cigarette*” OR “e cigarette*”. The search was restricted to documents produced in the US between January 1 st , 2004, and July 14 th , 2014. In addition, six specialized websites were used to supplement and validate the search –.
We searched for regulations targeting e cigarettes at the US federal or state level, specifically enacted regulations and laws (hereafter collectively referred to as “regulations”), as well as future regulations proposed as of July 1 st , 2014. For the purposes of this review, an enacted regulation was considered an effective regulation or law (act, statute, code) or an enacted bill (signed into law), while a planned regulation was deemed a regulation or law draft presented to legislature for discussion, and mentioned in a bill or in proposed rules by a specific agency. Regulatory documents were included if they were i) issued at the US federal or state level and ii) explicitly targeted e cigarettes, electronic smoking devices, electronic nicotine delivery devices, or vapor products. Documents concerning municipal and county regulations were excluded. In addition, documents addressing only nicotine-containing or tobacco-derived products were excluded, unless they explicitly included e cigarettes as one of these products.
Data extraction and qualitative synthesis
Two reviewers performed data extraction and traditional data-near qualitative content analysis. For each included regulation, we extracted the following characteristics: i) level of regulation (federal or state); ii) status of regulation (enacted regulation; proposed regulation [bill] just signed into law; planned regulation); iii) year of introduction to legislature or of enactment; iv) description of regulation; and v) legal citation of act, statute, rule, or bill.
From regulation descriptions, similar groupings were identified using existing regulation typologies, –. Data were tabulated by level (federal, state) and by state for side-by-side comparison and compiled by regulation types. Regulation profiles were identified in an inductive interpretive manner by the first author and validated by the second author. Regulation profiles were defined as specific combinations of regulation types that illustrate the regulatory approach of a particular state.