The term "e-cigarettes" refers to a wide range of products that share the same basic design and generally consist of three main parts: a power source (typically a battery), a heating element containing a wick (to deliver liquid to the heating element), and a cartridge or tank containing liquid solution. Cartridges and liquid are often sold separately from e- cigarette devices containing the battery and heating element. Liquid typically contains nicotine, a solvent (e.g., propylene glycol, glycerin, or both), and flavorings. E-cigarettes heat liquids to deliver aerosol that usually contains nicotine and other chemical substances to the user by inhalation. E-cigarettes come in two main forms: Closed systems that include disposable e-cigarettes or require users to buy e-cigarette components, including the cartridge with liquid, from the same manufacturer or brand. Open systems that enable users to purchase the heating element, battery, tank, and liquid separately and from different manufacturers or brands. Industry experts we interviewed estimated that the size of the U.S. e- cigarette market in 2014 was about $2.5 billion. Although there are no definitive data on the relative proportions of imported and domestically manufactured e-cigarettes, industry experts we interviewed told us that the majority of e-cigarettes sold in the United States are imported from China. The U.S. e-cigarette market has developed rapidly in the last decade. U.S. Customs and Border Protection issued a customs ruling for the classification of e-cigarette imports to the United States as early as 2006. USPTO issued a registration for a trademark applied to e-cigarettes as early as May 2008 and had recorded more than 1,600 U.S. trademark registrations for e-cigarette devices, parts, liquid, and services as of March 2015. Hundreds of e-cigarette companies participate in the U.S. e- cigarette market. Large tobacco companies began entering the U.S. e- cigarette market in 2012 and now manufacture some of the leading closed system e-cigarette brands, according to industry experts we interviewed. Some industry experts we spoke with predict that the U.S. e- cigarette market will continue to grow, although factors such as the extent of federal and state regulation create uncertainty about the rate of growth. E-cigarettes are sold in multiple types of outlets, including traditional retail stores, such as convenience stores and grocery stores, as well as at "vape stores" and over the Internet. According to industry experts, closed system e-cigarette products are mainly sold in traditional retail outlets, while open system e-cigarette products are often sold online and at vape stores. Private companies collect point-of-sale data on the quantities and prices of e-cigarettes sold at traditional retail stores, according to documentation from these companies; however, these data do not cover online sales or "vape store" sales. Financial analysts from one firm estimate that 40 to 60 percent of e-cigarettes are sold online or at vape stores. In 2014, CDC reported a statistically significant increase in the percentage of U.S. adults who had used e-cigarettes in the preceding 30 days, from 1 percent in 2010 to 2.6 percent in 2013. Past-month e- cigarette use was especially prominent among current adult cigarette smokers and grew in this population, at a statistically significant level, from 4.9 percent in 2010 and 2011 to 9.4 percent in 2012 and 2013. Past- month e-cigarette use by former adult cigarette smokers also rose, from 1 percent to 1.3 percent during the same period, although the increase was not statistically significant. The National Youth Tobacco Survey by CDC and FDA showed a statistically significant increase in high school students' past-month e- cigarette use, from 1.5 percent in 2011 to 13.4 percent in 2014. In addition, the survey found that in 2014, high school students' past-month e-cigarette use surpassed their use of cigarettes and other tobacco products at a statistically significant level (see fig. 2). The survey further found a statistically significant increase in past-month e-cigarette use among middle school students. In April 2014, FDA issued a proposed rule to deem e-cigarettes and other products meeting the Tobacco Control Act's definition of "tobacco product" to be subject to the agency's regulation. FDA received more than 135,000 comments about the proposed deeming rule during the public comment period, which ended in August 2014. FDA announced its intent to issue the final rule in June 2015 in the spring 2015 semiannual regulatory agenda. The final rule had not been issued as of August 2015. The Tobacco Control Act aimed to, among other things, promote cessation to decrease health risks and social costs associated with tobacco-related diseases. According to the act, FDA can, by regulation, require restrictions on the sale, distribution, advertising, and promotion of a tobacco product if the agency determines that the proposed regulation is appropriate for the protection of public health, based on a consideration of the risks and benefits to the population as a whole, including users and nonusers of tobacco products. In the act, Congress recognized that virtually all new users of tobacco products are under the age of 18. In the proposed deeming rule, FDA stated that it was researching the effect of e-cigarette use on public health. FDA noted that e-cigarettes could have a positive net impact if using them resulted in minimal initiation by children and adolescents and in significant numbers of smokers' quitting. The FDA also noted that e-cigarette use could have a negative net impact if it resulted in significant initiation by young people, minimal quitting, or significant dual use of combustible products, such as cigarettes, and noncombustible products, such as e-cigarettes. The IRC, which defines tobacco products subject to FET and sets rates of tax, does not specifically define or list a tax rate for e-cigarettes. However, two states--Minnesota and North Carolina--have imposed an excise tax on e-cigarettes or vapor products containing nicotine. The Minnesota Department of Revenue issued a notice in 2012 stating its position that e-cigarettes are subject to the tobacco products tax; the current tax rate is 95 percent of the wholesale price of the nicotine- containing liquid or, if the liquid cannot be sold separately, of the complete e-cigarette. North Carolina has taxed vapor products at 5 cents per milliliter of nicotine-containing liquid or other material since June 2015. In addition, at least 18 states and the District of Columbia have proposed legislation to tax e-cigarettes, vapor products, nicotine vapor products, or e-cigarette cartridges since 2013. For example, a bill in Maine proposed to include e-cigarettes in its definition of cigarettes and to apply the same tax rate to cigarettes and e-cigarettes, and a bill in Montana proposed a tax on vapor products, such as e-cigarettes, that would be partially based on the weight in milligrams of the nicotine present in the product. As of January 2015, three countries--Italy, Portugal, and South Korea-- imposed national-level taxes on e-cigarettes that contain nicotine, and each of these countries applies its tax to nicotine-containing e-cigarette liquid, according to an industry expert. In addition, according to research by the Law Library of Congress, Serbia recently enacted legislation to introduce an excise tax on e-cigarette liquid, which went into effect in August 2015. Our analysis of Treasury data on cigarette FET revenue found no current evidence that e-cigarette use has affected the historical decreasing trend in FET collections over the past 6 years. We used a time series regression to determine the change in cigarette FET revenue from April 2009, when the last increase in FET on cigarettes and other tobacco products became effective, through December 2014. Variables in the model control for (1) historical decreases in cigarette FET revenue over the last 6 years; (2) quantities of cigars, pipe tobacco, and roll-your-own tobacco removed from domestic factories or released from customs custody for distribution in the United States; and (3) monthly seasonality effect. Our model tests for the inclusion of e-cigarettes at different points in time and tests for any significant changes from the historical trend. We found no significant evidence that e-cigarettes have decreased the collection of FET revenue from cigarettes at a rate greater than the 6-year historical trend. Specifically, we found that, when other variables in the model are held constant, the 6-year historical trend of cigarette FET revenue decreased at a rate between $4.4 million and $5.5 million per month (see fig. 3). However, we found no significant evidence of a decrease in FET revenue from cigarettes at a rate greater than the 6-year historical trend during the time frame when e-cigarettes have been on the U.S. market. We estimate that cigarette FET revenue would need to decrease by an additional $2 million to $3 million per month to signal a significant effect from e-cigarettes. Several factors may explain why our analysis did not detect an effect of e- cigarette use on cigarette FET revenue. First, the e-cigarette market-- estimated at $2.5 billion in sales in 2014--is relatively small compared with the cigarette market, which had $80 billion in sales in the same year. As a result, without a substantial increase in the e-cigarette market, any effect on the cigarette market would be too minor to significantly affect cigarette FET revenue. Second, comprehensive and reliable data on e- cigarette sales and prices--which would enable us to corroborate the size of the e-cigarette market and accurately identify when it became significant--are not available. Third, comprehensive and reliable data about the extent to which e-cigarettes are used as substitutes for cigarettes are also not available. Without such data and information, estimating the effect of e-cigarette use on cigarette FET revenue will be difficult, even if the e-cigarette market continues to grow. How consumers' use of e-cigarettes relates to their use of cigarettes-- whether e-cigarettes are substitutes, complements, or unrelated--may determine any effect of e-cigarette use on cigarette FET revenue. The relationship between the use of e-cigarettes and cigarettes is currently unknown, according to public health officials. Table 1 describes these three possible relationships and summarizes their potential revenue effects. The most recent data from the National Youth Tobacco Survey by CDC and FDA showing high school students' increasing use of e-cigarettes and decreasing use of cigarettes (see fig. 2), suggest that cigarette FET revenue could decline further if these trends continue. If the percentage of high school students using cigarettes continues to decline, and if other factors such as current levels of regulation remain constant, the number of cigarette smokers could dwindle further in the coming years as the current cohort of high school students ages. A continued decline in cigarette smoking among high school students--which could be due, in part, to increased use of e-cigarettes--would reduce cigarette FET revenue at a greater rate than the average historical trend. FDA and CDC are undertaking efforts that, over time, may enable them to better understand e-cigarettes' relationship to cigarettes and other tobacco products, according to agency officials. For example, FDA and CDC are refining survey instruments that they use to measure adults' and youths' use of e-cigarettes, cigarettes, and other tobacco products, such as the National Health Interview Survey and the National Youth Tobacco Survey. In addition, FDA, in collaboration with the National Institutes of Health, is funding a longitudinal cohort study, the Population Assessment of Tobacco and Health, which asks detailed questions about adults' and youths' use of e-cigarettes, cigarettes, and other tobacco products. FDA officials said that they expect to receive the data from the first year of the study in the summer of 2015. Further, according to FDA and CDC officials, other national surveys, state-level surveys, results of National Institutes of Health and other studies currently under way, and, if available, e-cigarette quantity data could help researchers analyze trends and observe statistical relationships. Treasury and FDA do not collect data on quantities of e-cigarettes on the U.S. market, and we did not identify any other federal agencies that do so. However, Treasury collects data on quantities of domestically manufactured tobacco products that are subject to FET to ensure that the proper FET amount is paid. FDA collects data on quantities of tobacco products that it regulates under its tobacco product authorities to calculate user fees that fund FDA's tobacco regulation activities. Treasury and FDA collect data on quantities for different sets of tobacco products because their authorities to regulate tobacco products stem from different statutes: Treasury's authorities stem from the IRC. The IRC defines "tobacco products" as cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, and pipe tobacco and sets FET rates for these products. The IRC defines each of these products as containing or consisting of tobacco. FDA's tobacco product authorities stem from the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. The Tobacco Control Act defines "tobacco product," in part, as any product made or derived from tobacco. The act granted FDA immediate authority over cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The act also gave FDA authority to deem by regulation any other product meeting the Tobacco Control Act's definition of tobacco product to be subject to FDA's tobacco product authorities. Under this authority, in April 2014 FDA proposed to deem additional products, including e-cigarettes, to be subject to its tobacco product regulation. Treasury collects data on quantities of cigarettes and other federally taxed tobacco products from domestic manufacturers of these products, but does not collect such data for e-cigarettes, because the IRC does not define or list a tax rate for e-cigarettes. According to Treasury officials, on the basis of definitions of the tobacco products enumerated in the IRC, Treasury's ability to tax e-cigarettes--and collect data for them--depends on whether e-cigarettes contain tobacco. Treasury officials said that for e- cigarettes that do not contain tobacco, Treasury could not assert federal taxation and any related data collection by regulation; instead, such authority would require an act of Congress. As of August 2015, Treasury had not collected any FET or data associated with e-cigarettes, according to Treasury officials. FDA does not collect data on quantities of e-cigarettes sold on the U.S. market. FDA's preliminary economic impact analysis accompanying the proposed deeming rule states that when the deemed products become subject to FDA's tobacco product authorities, the agency can begin collecting data to determine the number of regulated entities and to monitor the number and type of unique products sold to the public. At present, FDA collects data on quantities of four tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) that it regulates under its tobacco product authorities to apply the legally mandated method for allocating user fees among the domestic manufacturers and importers of those products. In July 2014, FDA stated that if additional products are deemed subject to its tobacco regulation, the agency would conduct a new rulemaking to make appropriate changes to the user fee regulation. FDA also stated that it recognized that the issue of whether it had authority to assess user fees on some deemed products was controversial and that it intended to solicit public comment to further explore issues related to user fee assessments on tobacco products that may be deemed subject to FDA's tobacco product authorities. According to FDA officials, if e-cigarettes become subject to user fees, FDA would likely need data on quantities of e- cigarettes sold on the U.S. market, comparable to data that the agency collects for the four products currently subject to user fees. Table 2 summarizes information about Treasury's and FDA's collection of data on quantities of cigarettes, other tobacco products, and e-cigarettes. The Department of Labor's Bureau of Labor Statistics (BLS) began collecting limited e-cigarette price information in September 2014 as part of its ongoing data collection for the Consumer Price Index. The Consumer Price Index provides monthly data on changes in the prices paid by urban consumers for a representative "basket" of goods and services. The index is divided into more than 200 categories representing the goods and services that an urban consumer might typically buy. BLS collects e-cigarette price information, under the category "tobacco products other than cigarettes," for disposable e-cigarettes, starter kits, liquid refills, and e-cigarette replacement cartridges. These items may or may not contain nicotine and may have any flavor. According to BLS officials, the number of observations on e-cigarette prices is too small to calculate a reliable national average price or reliable state-level prices. According to the officials, U.S. consumers' e-cigarette expenditures, while increasing, represent a small share of total expenditures in the representative basket of goods and services. Additionally, BLS officials explained that the Consumer Price Index sample for "tobacco products other than cigarettes" is refreshed over a 4- year cycle; the length of time it takes to fully replace samples causes Consumer Price Index sample shares (the percentage of the sample composed of the prices of a given product) to lag real-world percentages for items for which consumers' expenditures are changing rapidly. The Consumer Price Index sample included 10 e-cigarette price observations as of June 2015 and, according to the BLS officials, will increase to 14 e- cigarette price observations by October 2015. BLS would require more resources in order to collect substantially more data on e-cigarettes, according to BLS officials. Our analysis shows no current effect of the growing e-cigarette market on FET revenue from cigarettes. Given the limited information about the e- cigarette market, it is difficult to accurately estimate this market's size or analyze its potential effect on FET revenue from cigarettes and other tobacco products. The increased regulation of tobacco products at the federal and state level, among other things, has contributed to a decline in cigarette use and FET revenue. Recent CDC studies show that e- cigarette use has significantly increased among high school students, while cigarette use has significantly declined. As the regulation of e- cigarettes unfolds and the market develops, e-cigarette use patterns may change. Federal agencies' efforts to develop a better understanding of the relationship between e-cigarette and cigarette use will help analysts and government officials develop a more complete understanding of the e-cigarette market and its effect on cigarette FET revenue. We provided a draft of this report to DOL, HHS, and Treasury. We also provided relevant portions to U.S. Customs and Border Protection and USPTO. We received technical comments from DOL, HHS, and Treasury and incorporated the comments as appropriate. We are sending copies of this report to the appropriate congressional committees; the Secretaries of Health and Human Services, Labor, and the Treasury; and other interested parties. In addition, the report is available at no charge on the GAO website at http://www.gao.gov. If you or your staff have any questions about this report, please contact me at (202) 512-3149 or gootnickd@gao.gov. Contact points for our Offices of Congressional Relations and Public Affairs may be found on the last page of this report. GAO staff who made key contributions to this report are listed in appendix III. This report examines the extent to which (1) use of electronic cigarettes (also known as e-cigarettes) affects federal excise tax (FET) revenue from cigarettes and (2) data on quantities and prices of e-cigarettes on the U.S. market are available from federal agencies. To address these objectives, we reviewed documents and interviewed officials from the Department of the Treasury's (Treasury) Alcohol and Tobacco Tax and Trade Bureau and Treasury's Office of Tax Analysis, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), the U.S. Bureau of Labor Statistics (BLS), and the U.S. Patent and Trademark Office (USPTO) to obtain information and views about e-cigarette and tobacco sales and revenue trends and regulation. We determined the reliability of USPTO e-cigarette trademark registration data by interviewing cognizant USPTO officials. We also interviewed industry experts, including e-cigarette industry members, tobacco industry members, financial analysts, researchers, and representatives of public health organizations. We interviewed organizations and companies that represent a range of perspectives. We spoke with industry associations that represent small and midsized e- cigarette companies; we also spoke with representatives of leading companies that produce e-cigarettes, as measured by dollar share from available data, including an independent e-cigarette company and tobacco companies. The views expressed by these representatives are not generalizable and do not represent the views of the entire e-cigarette industry. We also attended an e-cigarette industry conference as well as three FDA public workshops featuring current research on e-cigarette product science and implications of e-cigarette use for individual health and population health. To determine whether e-cigarette use affects cigarette FET revenue, we examined cigarette FET revenue from April 2009 through December 2014. For this analysis, we used monthly data obtained from Treasury on FET revenue from cigarettes removed from domestic factories or released from customs custody for distribution in the United States. In addition, using these removals data and testimonial evidence, we constructed a multivariate model that estimates the effect of e-cigarette use on cigarette FET revenue. In particular, we regressed cigarette FET revenue on a number of variables, including other tobacco products, a trend, presence of e-cigarettes on the market, and seasonality. We assessed the reliability of the data by checking the data for inconsistency errors and for completeness. We determined that the cigarette removals data were sufficiently reliable for the purposes of this report. See appendix II for more explanation of our analysis. To examine the extent to which data on quantities and prices for e- cigarettes on the U.S. market are available from federal agencies, we interviewed cognizant officials from Treasury, FDA, CDC, BLS, and the Congressional Budget Office, as well as industry experts. To describe Treasury's collection of data on quantities of federally taxed tobacco products, we reviewed documents and interviewed officials from Treasury's Alcohol and Tobacco Tax and Trade Bureau. To describe FDA's collection of data on quantities of tobacco products regulated by the agency, we examined FDA's regulatory actions, including its April 2014 proposed rule to deem additional products, including e-cigarettes, to be subject to the agency's tobacco product authorities, and the July 2014 final user fee rule, and we interviewed cognizant FDA officials. To describe BLS's collection of data on e-cigarette prices, we reviewed documents and interviewed BLS officials. We conducted this performance audit from September 2014 to September 2015 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. We constructed a multivariate model to estimate the effect of electronic cigarette (e-cigarette) use on federal excise tax (FET) revenue from traditional cigarettes. The model uses monthly data obtained from the Department of the Treasury's (Treasury) Alcohol and Tobacco Tax and Trade Bureau and controls for a 6-year historical trend in cigarette FET revenue, from April 2009 through December 2014; the presence of other tobacco products (cigars, roll-your-own tobacco, and pipe tobacco); and seasonality effects. The model also includes a time variable that tests for the presence of e-cigarettes. We used five different dates during the period January 2012 to October 2013 for the time variable, and we estimated regressions for each date. In particular, the model uses the following equation: and imported cigarettes collected in period t; CCCCCC_rrrrrrtt=+ccCCCCccrrcctt+rr_ppCCpprrtt+ttrrrrtttttt+rrccCCCC_ccsspprrtt CCCCCC_rrrrrrtt= the amount of FET revenue, in nominal dollars, from domestic where = an intercept; ccCCCCccrrcctt = the sum of small and large cigar removals in number of sticks rr_ppCCpprrtt = the sum of roll-your-own and pipe tobacco removals in in period t; ttrrrrtttttt = a monthly trend that controls for the historical changes in pounds in period t; rrccCCCC_ccsspprrtt = a dummy variable that equals one for each month on or cigarette revenue at period t; after the date that indicates the presence of e-cigarettes in the market (because there is no clear indicator of this presence, we selected five different dates to indicate the beginning of this presence); monthly seasonality, with June as the reference month; and mmtttthss_CCttttCCccccttrrcctt = a set of eleven dummy variables controlling for utt = an error term assumed to be heteroskedastic and possibly autocorrelated. David Gootnick, (202) 512-3149 or gootnickd@gao.gov. In addition to the contact named above, Christine Broderick (Assistant Director), Christina Werth, Sada Aksartova, Pedro Almoguera, Grace Lui, and Srinidhi Vijaykumar made key contributions to this report. In addition, Tina Cheng and Reid Lowe provided technical assistance.

Summary:
While use of traditional cigarettes in the United States continues to decline, use of e-cigarettes is increasing. Treasury collects FET on cigarettes and other tobacco products manufactured in the United States. The Internal Revenue Code of 1986, as amended, does not specifically define or list a tax rate for e-cigarettes. The decline in cigarette use has led to a decline in cigarette FET revenue, from $15.3 billion in fiscal year 2010 to $13.2 billion in fiscal year 2014. FDA currently regulates four tobacco products. In April 2014, FDA proposed to deem additional tobacco products, including e-cigarettes, subject to its tobacco product authorities. GAO was asked to examine issues related to the U.S. e-cigarette market. This report examines the extent to which (1) e-cigarette use affects cigarette FET revenue, and (2) data on quantities and prices of e-cigarettes on the U.S. market are available from federal agencies. GAO conducted a regression analysis to assess the effect of e-cigarette use on cigarette FET revenue from April 2009 through December 2014, using Treasury data on FET revenue from cigarettes. GAO also reviewed agency documents and interviewed agency officials and industry experts. GAO's analysis found no evidence that use of electronic cigarettes (e-cigarettes) has affected federal excise tax (FET) revenue from traditional cigarettes, which has been declining over time (see figure). Possible reasons for the lack of a detectable effect include the small size of the e-cigarette market (estimated at $2.5 billion in 2014) relative to the cigarette market ($80 billion in the same year); lack of comprehensive and reliable data on e-cigarette quantities and prices; and lack of comprehensive and reliable information about the extent to which e-cigarettes substitute for cigarettes. If users consume e-cigarettes instead of cigarettes, cigarette FET revenue would decline as fewer cigarettes are consumed. Data from a recent survey by the Centers for Disease Control and Prevention showing high school students' increasing use of e-cigarettes and decreasing use of cigarettes suggest that these students may substitute e-cigarettes for cigarettes to some extent. If the percentage of high school students using cigarettes continues to decline, cigarette FET revenue could also decrease at a greater rate than the average historic trend observed since April 2009, when FET on cigarettes and other tobacco products was last increased. Comprehensive data on e-cigarette quantities and prices are not available from federal agencies. The Department of the Treasury (Treasury) and Food and Drug Administration (FDA) do not collect data on e-cigarette quantities comparable to data that they collect for cigarettes and some other tobacco products. According to FDA officials, if e-cigarettes are deemed subject to FDA's tobacco product authorities as a result of a rule proposed in April 2014, the agency could start collecting some data on the types of e-cigarettes on the U.S. market but will not collect data on the quantities of e-cigarettes sold. The Bureau of Labor Statistics began collecting data on e-cigarette prices in September 2014 as part of its data collection for the Consumer Price Index, but these data are limited. GAO is not making recommendations in this report.