P osition P aper
Annals of Internal Medicine
Electronic Nicotine Delivery Systems: Executive Summary of a Policy Position Paper From the American College of Physicians Ryan A. Crowley, BSJ, for the Health Public Policy Committee of the American College of Physicians*
Electronic nicotine delivery systems (ENDS), which include elec tronic cigarettes, or e-cigarettes, are growing in popularity, but their safety and efficacy as a smoking cessation aid are not well understood. Some argue that they have the potential to reduce tobacco-related morbidity and mortality and could be a useful tool for reducing tobacco-related harm. Others express concern that the health effects of ENDS use are unknown, that they may appeal to young people, and that they may encourage dual use of ENDS and traditional tobacco products. Although ENDS are a new and unregulated product, the U.S. Food and Drug Admin istration has proposed regulations that would deem ENDS to be
lectronic nicotine delivery systems (ENDS), which include electronic cigarettes, or e-cigarettes, are battery-pow ered mechanisms that usually contain liq uid nicotine. When heated, the liquid is vaporized into an aerosol and inhaled or drawn in by the user. ENDS have been available in the United States since 2007 (1), and th e ir availability and popularity have increased dra matically. ENDS use m ore than d o u b le d am ong adults from 2010 to 2013 (2), am ounting to a nearly $2 billion industry. Global sales are expected to grow to more than $50 b illion by 2030 (3). Proliferation o f ENDS has been facilitated by an unregulated market, where stan dards fo r consum er protection and com pany oversight are largely nonexistent. Product m arketing is also unfet tered. Federal law prohibits the airing o f com bustible cigarette com m ercials on television, but that ban does not extend to ENDS. As a result, ENDS com panies have spent billions to m arket th e ir products on television, often pitched by celebrity spokespeople. Despite th e ir popularity, the evidence regarding th e ir safety and efficacy as a sm oking cessation to o l is lim ited (4). Some cite the devices' potential as a sm ok ing cessation aid, the user's ability to circum vent clean in d o o r air laws, and possible low er toxicity com pared with com bustible cigarettes as reasons to su pp ort greater availability to a du lt users. O thers express con cern a bo ut the lack o f substantial data on the health effects o f ENDS, th e ir appeal to young people, their potential to underm ine sm oking cessation if used in ad d ition to traditional cigarettes (that is, dual use), and th e ir lack o f regulation as reasons why availability should be restricted. A t press tim e, the federal govern m ent does not regulate ENDS, although many states and local governm ents have taken action to p ro h ib it sales to youths and restrict in d o o r use. In 2008, the U.S. Food and Drug A dm inistration (FDA) attem pted to reg
E
subject to the Family Smoking Prevention and Tobacco Control Act, which regulates cigarettes and other tobacco products. In this position paper, the American College of Physicians offers policy recommendations on ENDS regulation and oversight, tax ation, flavorings, promotion and marketing, indoor and public use, and research. This paper is not intended to offer clinical guidance or serve as an exhaustive literature review of existing ENDS-related evidence but to help direct the College, policy makers, and regulators on how to address these products. Ann Intern Med. 2015;162:583-584. doi:10.7326/M14-2481 www.annals.org For author affiliation, see end of text.
ulate ENDS as drug delivery devices but was sued by ENDS manufacturers, who argued that the products were not being marketed as such (5). In A pril 2014, the FDA released a proposed rule deem ing electronic cig arettes (and o the r tobacco products) as subject to the Tobacco C ontrol Act. W hile this is a prom ising step to ward increased oversight o f ENDS, many tobacco con tro l proponents have advocated expanding regulation and accelerating im plem entation (6). In its 2010 paper, "Tobacco C ontrol and Preven tion," the Am erican C ollege o f Physicians (ACP) called fo r regulation and oversight o f ENDS, noting that the products may expose users and bystanders to toxic constituents (7). The C ollege developed this position paper to provide updated policy and regulatory g u id ance to policym akers to address the g row ing ENDS market. This paper does not intend to provide specific clinical guidance regarding ENDS, but instead offers recom m endations on p ro du ct regulation, flavorings, taxation, m arketing and prom otion, in d o o r air laws, and additional research. W hile the long-term public health consequences o f ENDS are unknown, the C ollege be lieves th a t efforts should be made to oversee these novel products to p ro tect th e health o f ENDS users and nonusers and strongly p ro h ib it youth access. Further, robust research is needed to better understand the p o tential benefits and harms associated with ENDS. This Executive Summary provides a synopsis o f the full p o sition paper, which is available in the Appendix (avail able at w w w.annals.org).
M
etho ds
This policy paper was drafted by the ACP's Health and Public Policy C om m ittee, which is charged with d e ve loping and assisting with im plem entation o f ACP pol-
* This paper, written by Ryan A. Crowley, BSJ, was developed for the Health and Public Policy Committee of the American College of Physicians. Individuals who served on the Health and Public Policy Committee from initiation of the project until its approval are Thomas G. Tape, MD (Chair); Douglas M. DeLong, MD (Vice Chair); Sue S. Bornstein, MD; James F. Bush, MD; Gregory A. Hood, MD; Gregory C. Kane, MD; Robert M. Lohr, MD; Kenneth E. Olive, MD; Shakaib U. Rehman, MD; Micah Beachy, DO; Tracey Henry MD, MPH, MS; and Ashley Minaei. Approved by the ACP Board of Regents on 16 November 2014.
© 2015 American College of Physicians 583
P osition P aper icy on issues affecting the health care o f the U.S. p ublic and the practice o f internal m edicine and its subspeciaities. The authors reviewed available studies, re ports, and surveys on ENDS culled from such sources as PubMed; G oogle Scholar; and relevant news arti cles, policy docum ents, and W eb sites. Search term s used included "electronic cigarettes," "e-cigarettes," "ecigs," and "electronic nicotine delivery systems." Rec om m endations were based on reviewed literature as well as in p u t from the C ollege's Board o f Governors, Board o f Regents, Council o f Early Career Physicians, Council o f R esident/Fellow Members, Council o f Stu dent M em bers, and Council o f Subspecialty Societies. The policy paper and related recom m endations were reviewed and approved by the Health and Public Policy C om m ittee in O cto b er 2014 and the C ollege's Board o f Regents in N ovem ber 2014. Financial su pp ort fo r the deve lo pm e nt o f this position paper comes exclusively from the ACP operating budget.
Electronic Nicotine Delivery Systems An appropriate federal agency, such as the A gency for Healthcare Research and Quality, N ational Institutes o f Health, o r Centers fo r Disease C ontrol and Prevention, should commission an evidence review to evaluate the current research and data related to benefits and harms o f ENDS that can be utilized as a basis fo r a clinical guideline. From the Am erican C o lle ge of Physicians, W ashington, DC. Disclaimer: The authors o f this article are responsible fo r its contents, in clud in g any clinical o r treatm e nt recom m endations. Acknowledgment: The authors thank Jorge Fuentes, MD, fo r his con tribu tions to this article. Financial Support: Financial su p p o rt fo r the d e ve lo p m e n t o f this g u id e lin e comes exclusively from the ACP op era ting budget.
R ecommendations The fo llo w in g statements represent the official p o l icy positions and recom m endations o f the ACP. The rationale fo r each is p rovided in the full position paper (see Appendix). 7. The Am erican College o f Physicians recom mends that the Food and Drug Adm inistration extend its regulatory authority g ranted through the Family Sm oking Prevention and Tobacco C ontrol A ct to cover electronic nicotine delivery systems (ENDS). 2. The Am erican C ollege o f Physicians recom m ends that characterizing flavors should be banned from all tobacco products, including ENDS. 3. The Am erican C ollege o f Physicians reiterates its su pp ort fo r taxing tobacco products, including ENDS devices and nicotine liquids, to discourage use am ong children and adolescents. Local governm ents should be p e rm itte d to establish h ig he r tax rates fo r ENDS and related products than state levels. 4. The Am erican C ollege o f Physicians supports legislative or regulatory efforts to restrict prom otion, ad vertising, and m arketing fo r ENDS products in the same m anner as fo r com bustible cigarettes, including a p ro hibition on television advertising. Youth tobacco p re vention efforts, such as antism oking m edia campaigns and school-based interventions, should include infor m ation a bo ut the p ote n tia l risks o f ENDS use. 5. The Am erican C ollege o f Physicians recom mends that federal, state, and local regulators should take action to extend in d o o r and p u b lic place clean air laws that p ro h ib it sm oking in p u b lic places, places o f em ploym ent, com m ercial aircraft, and other areas to ENDS products. 6. The Am erican C ollege o f Physicians recom m ends that the federal g overnm ent should authorize and appropriate funding to rigorously research the health effects o f ENDS use, chem ical content, and tox icity; effects o f ENDS vapor exposure; dual-use rates; and effects o f ENDS-derived nicotine on human health.
584 Annals of Internal Medicine ■ Vol. 162 No. 8 • 21 April 2015
Disclosures: Disclosures can be view ed at w w w .acponline .o rq /a u th o rs/icm je /C o n flictO fln te re stF o rm s.d o ? m sN u m = M 1 4 -2481. Requests for Single Reprints: Ryan A. Crowley, BSJ, Am erican C ollege o f Physicians, 25 Massachusetts Avenue NW, Suite 700, W ashington, DC 20001; e-mail, RCrowley@mail .acponline.org. A u th o r con tribu tions are available at w w w .annals.org.
R eferences 1. Gourdet CK, Chriqui JF, Chaloupka FJ. A baseline understanding of state laws governing e-cigarettes. Tob Control. 2014;23 Suppl 3:iii37-40. [PMID: 24935897] doi: 10.1136/tobaccocontrol-2013 -051459. 2. Centers for Disease Control and Prevention. Key findings: trends in awareness and use of electronic cigarettes among U.S. adults, 2010-2013. 19 September 2014. Accessed a twww.cdc.gov/tobacco /basic_information/e-dgarettes/adult-trends/index.htm on 31 De cember 2014. 3. Pringle S. Big Tobacco starts coughing on e-cigarettes. The Deal. Pipeline. 4 June 2014. Accessed at www.thedeal.com/content /industrials/big-tobacco-starts-coughing-on-e-cigarettes.php on 31 December 2014. 4. Callahan-Lyon P. Electronic cigarettes: human health effects. Tob Control. 2014;23 Suppl 2:ii36-40. [PMID: 24732161] doi:10.1136 /tobaccocontrol-2013-051470 5. Belluz J. Why the US hasn't banned vaping-and a map of coun tries that have. Vox. 11 July 2014. Accessed at www.vox.com/2014/7 /11/5888609/why-US-FDA-havent-banned-e-cigarettes on 31 De cember 2014. 6. Campaign for Tobacco-Free Kids. Leading health groups urge FDA to finalize rule regulating all tobacco products by April 2015 and reject exemption for some cigars. 8 August 2014. Accessed at www.tobaccofreekids.org/press_releases/post/2014_08_08_fda on 25 September 2014. 7. American College of Physicians. Tobacco control and prevention. Philadelphia: American College of Physicians; 2010. Accessed at www.acponline.org/newsroom/control_tobacco.pdf on 2 March 2015.
www.annals.org
Copyright © American College of Physicians 2015.
Annals of Internal Medicine
Electronic Nicotine Delivery Systems: Executive Summary of a Policy Position Paper From the American College of Physicians Ryan A. Crowley, BSJ, for the Health Public Policy Committee of the American College of Physicians*
Electronic nicotine delivery systems (ENDS), which include elec tronic cigarettes, or e-cigarettes, are growing in popularity, but their safety and efficacy as a smoking cessation aid are not well understood. Some argue that they have the potential to reduce tobacco-related morbidity and mortality and could be a useful tool for reducing tobacco-related harm. Others express concern that the health effects of ENDS use are unknown, that they may appeal to young people, and that they may encourage dual use of ENDS and traditional tobacco products. Although ENDS are a new and unregulated product, the U.S. Food and Drug Admin istration has proposed regulations that would deem ENDS to be
lectronic nicotine delivery systems (ENDS), which include electronic cigarettes, or e-cigarettes, are battery-pow ered mechanisms that usually contain liq uid nicotine. When heated, the liquid is vaporized into an aerosol and inhaled or drawn in by the user. ENDS have been available in the United States since 2007 (1), and th e ir availability and popularity have increased dra matically. ENDS use m ore than d o u b le d am ong adults from 2010 to 2013 (2), am ounting to a nearly $2 billion industry. Global sales are expected to grow to more than $50 b illion by 2030 (3). Proliferation o f ENDS has been facilitated by an unregulated market, where stan dards fo r consum er protection and com pany oversight are largely nonexistent. Product m arketing is also unfet tered. Federal law prohibits the airing o f com bustible cigarette com m ercials on television, but that ban does not extend to ENDS. As a result, ENDS com panies have spent billions to m arket th e ir products on television, often pitched by celebrity spokespeople. Despite th e ir popularity, the evidence regarding th e ir safety and efficacy as a sm oking cessation to o l is lim ited (4). Some cite the devices' potential as a sm ok ing cessation aid, the user's ability to circum vent clean in d o o r air laws, and possible low er toxicity com pared with com bustible cigarettes as reasons to su pp ort greater availability to a du lt users. O thers express con cern a bo ut the lack o f substantial data on the health effects o f ENDS, th e ir appeal to young people, their potential to underm ine sm oking cessation if used in ad d ition to traditional cigarettes (that is, dual use), and th e ir lack o f regulation as reasons why availability should be restricted. A t press tim e, the federal govern m ent does not regulate ENDS, although many states and local governm ents have taken action to p ro h ib it sales to youths and restrict in d o o r use. In 2008, the U.S. Food and Drug A dm inistration (FDA) attem pted to reg
E
subject to the Family Smoking Prevention and Tobacco Control Act, which regulates cigarettes and other tobacco products. In this position paper, the American College of Physicians offers policy recommendations on ENDS regulation and oversight, tax ation, flavorings, promotion and marketing, indoor and public use, and research. This paper is not intended to offer clinical guidance or serve as an exhaustive literature review of existing ENDS-related evidence but to help direct the College, policy makers, and regulators on how to address these products. Ann Intern Med. 2015;162:583-584. doi:10.7326/M14-2481 www.annals.org For author affiliation, see end of text.
ulate ENDS as drug delivery devices but was sued by ENDS manufacturers, who argued that the products were not being marketed as such (5). In A pril 2014, the FDA released a proposed rule deem ing electronic cig arettes (and o the r tobacco products) as subject to the Tobacco C ontrol Act. W hile this is a prom ising step to ward increased oversight o f ENDS, many tobacco con tro l proponents have advocated expanding regulation and accelerating im plem entation (6). In its 2010 paper, "Tobacco C ontrol and Preven tion," the Am erican C ollege o f Physicians (ACP) called fo r regulation and oversight o f ENDS, noting that the products may expose users and bystanders to toxic constituents (7). The C ollege developed this position paper to provide updated policy and regulatory g u id ance to policym akers to address the g row ing ENDS market. This paper does not intend to provide specific clinical guidance regarding ENDS, but instead offers recom m endations on p ro du ct regulation, flavorings, taxation, m arketing and prom otion, in d o o r air laws, and additional research. W hile the long-term public health consequences o f ENDS are unknown, the C ollege be lieves th a t efforts should be made to oversee these novel products to p ro tect th e health o f ENDS users and nonusers and strongly p ro h ib it youth access. Further, robust research is needed to better understand the p o tential benefits and harms associated with ENDS. This Executive Summary provides a synopsis o f the full p o sition paper, which is available in the Appendix (avail able at w w w.annals.org).
M
etho ds
This policy paper was drafted by the ACP's Health and Public Policy C om m ittee, which is charged with d e ve loping and assisting with im plem entation o f ACP pol-
* This paper, written by Ryan A. Crowley, BSJ, was developed for the Health and Public Policy Committee of the American College of Physicians. Individuals who served on the Health and Public Policy Committee from initiation of the project until its approval are Thomas G. Tape, MD (Chair); Douglas M. DeLong, MD (Vice Chair); Sue S. Bornstein, MD; James F. Bush, MD; Gregory A. Hood, MD; Gregory C. Kane, MD; Robert M. Lohr, MD; Kenneth E. Olive, MD; Shakaib U. Rehman, MD; Micah Beachy, DO; Tracey Henry MD, MPH, MS; and Ashley Minaei. Approved by the ACP Board of Regents on 16 November 2014.
© 2015 American College of Physicians 583
P osition P aper icy on issues affecting the health care o f the U.S. p ublic and the practice o f internal m edicine and its subspeciaities. The authors reviewed available studies, re ports, and surveys on ENDS culled from such sources as PubMed; G oogle Scholar; and relevant news arti cles, policy docum ents, and W eb sites. Search term s used included "electronic cigarettes," "e-cigarettes," "ecigs," and "electronic nicotine delivery systems." Rec om m endations were based on reviewed literature as well as in p u t from the C ollege's Board o f Governors, Board o f Regents, Council o f Early Career Physicians, Council o f R esident/Fellow Members, Council o f Stu dent M em bers, and Council o f Subspecialty Societies. The policy paper and related recom m endations were reviewed and approved by the Health and Public Policy C om m ittee in O cto b er 2014 and the C ollege's Board o f Regents in N ovem ber 2014. Financial su pp ort fo r the deve lo pm e nt o f this position paper comes exclusively from the ACP operating budget.
Electronic Nicotine Delivery Systems An appropriate federal agency, such as the A gency for Healthcare Research and Quality, N ational Institutes o f Health, o r Centers fo r Disease C ontrol and Prevention, should commission an evidence review to evaluate the current research and data related to benefits and harms o f ENDS that can be utilized as a basis fo r a clinical guideline. From the Am erican C o lle ge of Physicians, W ashington, DC. Disclaimer: The authors o f this article are responsible fo r its contents, in clud in g any clinical o r treatm e nt recom m endations. Acknowledgment: The authors thank Jorge Fuentes, MD, fo r his con tribu tions to this article. Financial Support: Financial su p p o rt fo r the d e ve lo p m e n t o f this g u id e lin e comes exclusively from the ACP op era ting budget.
R ecommendations The fo llo w in g statements represent the official p o l icy positions and recom m endations o f the ACP. The rationale fo r each is p rovided in the full position paper (see Appendix). 7. The Am erican College o f Physicians recom mends that the Food and Drug Adm inistration extend its regulatory authority g ranted through the Family Sm oking Prevention and Tobacco C ontrol A ct to cover electronic nicotine delivery systems (ENDS). 2. The Am erican C ollege o f Physicians recom m ends that characterizing flavors should be banned from all tobacco products, including ENDS. 3. The Am erican C ollege o f Physicians reiterates its su pp ort fo r taxing tobacco products, including ENDS devices and nicotine liquids, to discourage use am ong children and adolescents. Local governm ents should be p e rm itte d to establish h ig he r tax rates fo r ENDS and related products than state levels. 4. The Am erican C ollege o f Physicians supports legislative or regulatory efforts to restrict prom otion, ad vertising, and m arketing fo r ENDS products in the same m anner as fo r com bustible cigarettes, including a p ro hibition on television advertising. Youth tobacco p re vention efforts, such as antism oking m edia campaigns and school-based interventions, should include infor m ation a bo ut the p ote n tia l risks o f ENDS use. 5. The Am erican C ollege o f Physicians recom mends that federal, state, and local regulators should take action to extend in d o o r and p u b lic place clean air laws that p ro h ib it sm oking in p u b lic places, places o f em ploym ent, com m ercial aircraft, and other areas to ENDS products. 6. The Am erican C ollege o f Physicians recom m ends that the federal g overnm ent should authorize and appropriate funding to rigorously research the health effects o f ENDS use, chem ical content, and tox icity; effects o f ENDS vapor exposure; dual-use rates; and effects o f ENDS-derived nicotine on human health.
584 Annals of Internal Medicine ■ Vol. 162 No. 8 • 21 April 2015
Disclosures: Disclosures can be view ed at w w w .acponline .o rq /a u th o rs/icm je /C o n flictO fln te re stF o rm s.d o ? m sN u m = M 1 4 -2481. Requests for Single Reprints: Ryan A. Crowley, BSJ, Am erican C ollege o f Physicians, 25 Massachusetts Avenue NW, Suite 700, W ashington, DC 20001; e-mail, RCrowley@mail .acponline.org. A u th o r con tribu tions are available at w w w .annals.org.
R eferences 1. Gourdet CK, Chriqui JF, Chaloupka FJ. A baseline understanding of state laws governing e-cigarettes. Tob Control. 2014;23 Suppl 3:iii37-40. [PMID: 24935897] doi: 10.1136/tobaccocontrol-2013 -051459. 2. Centers for Disease Control and Prevention. Key findings: trends in awareness and use of electronic cigarettes among U.S. adults, 2010-2013. 19 September 2014. Accessed a twww.cdc.gov/tobacco /basic_information/e-dgarettes/adult-trends/index.htm on 31 De cember 2014. 3. Pringle S. Big Tobacco starts coughing on e-cigarettes. The Deal. Pipeline. 4 June 2014. Accessed at www.thedeal.com/content /industrials/big-tobacco-starts-coughing-on-e-cigarettes.php on 31 December 2014. 4. Callahan-Lyon P. Electronic cigarettes: human health effects. Tob Control. 2014;23 Suppl 2:ii36-40. [PMID: 24732161] doi:10.1136 /tobaccocontrol-2013-051470 5. Belluz J. Why the US hasn't banned vaping-and a map of coun tries that have. Vox. 11 July 2014. Accessed at www.vox.com/2014/7 /11/5888609/why-US-FDA-havent-banned-e-cigarettes on 31 De cember 2014. 6. Campaign for Tobacco-Free Kids. Leading health groups urge FDA to finalize rule regulating all tobacco products by April 2015 and reject exemption for some cigars. 8 August 2014. Accessed at www.tobaccofreekids.org/press_releases/post/2014_08_08_fda on 25 September 2014. 7. American College of Physicians. Tobacco control and prevention. Philadelphia: American College of Physicians; 2010. Accessed at www.acponline.org/newsroom/control_tobacco.pdf on 2 March 2015.
www.annals.org
Copyright © American College of Physicians 2015.
