Guidance to Employers on Integrating E-Cigarettes/Electronic Nicotine Delivery Systems Into Tobacco Worksite Policy

ACOEM GUIDELINES

Laurie P.Whitsel, PhD, Neal Benowitz, MD, Aruni Bhatnagar, PhD, FAHA, Chris Bullen, MBChB, PhD, Fred Goldstein, Lena Matthias-Gray, BS, Jessica Grossmeier, PhD, MPH, John Harris, MEd, Fikry Isaac, MD, MPH, Ron Loeppke, MD, MPH, Marc Manley, MD, MPH, Karen Moseley, Ted Niemiec, MD, Vince O’Brien, LaVaughn Palma-Davis, MA, Nico Pronk, PhD, Jim Pshock, Gregg M. Stave, MD, JD, MPH, and Paul Terry, PhD

this purpose. Moreover, even though many In recent years, new products have entered the DESCRIPTION OF smokers report that using e-cigarettes as- marketplace that complicate decisions about to- E-CIGARETTES sists in quitting smoking,5,6 and two small bacco control policies and prevention in the work- Electronic cigarettes (e-cigarettes) are clinical trials found that e-cigarettes pro- place. These products, called electronic cigarettes a general category of products that most of- mote long-term smoking cessation,6 there (e-cigarettes) or electronic nicotine delivery sys- ten use battery power to heat a solution of is not sufficient scientific evidence to sug- tems, most often deliver nicotine as an aerosol for tobacco-derived nicotine in propylene gly- gest that they are effective and their rela- inhalation, without combustion of tobacco. This col and/or glycerol that is aerosolized for tive efficacy in comparison with other FDA- new mode of nicotine delivery raises several ques- 1 inhalation. Some e-cigarettes or e-cigarette approved nicotine replacement therapy needs tions about the safety of the product for the user, liquids, however, contain only the carrier further elucidation.7 the effects of secondhand exposure, how the pub- but no nicotine. Collectively, these devices lic use of these products should be handled within are referred to as electronic nicotine deliv- E-CIGARETTES IN THE tobacco-free and smoke-free air policies, and how ery systems, a category that also includes their use affects tobacco cessation programs, well- devices referred to as personal vaporizers, MARKETPLACE ness incentives, and other initiatives to prevent and The first e-cigarette design was vape pens, and e-hookah. Although there is 8 control tobacco use. In this article, we provide a significant difference in design features of patented in 1965, and the first product was background on e-cigarettes and then outline key introduced to the US marketplace in 2003 these devices, their key components include 1 policy recommendations for employers on how the a battery (often rechargeable), a heating el- from China. Since then, the design of the use of these new devices should be managed within ement (atomizer), and the reservoir or car- devices has undergone considerable evolu- worksite tobacco prevention programs and control tridge for storing the liquid for aerosolization. tion and currently the marketplace has been policies. Some of these devices are designed to appear flooded with a plethora of brands selling de- similar to cigarettes (so-called cigalikes), al- vices with many different design features. A though newer models are much larger and 2014 survey of Web sites identified at least 466 brands available in 7764 different fla- From the American Heart Association (Dr Whitsel), have a unique tank-like device (tankomiz- Washington, DC; University of California (Dr vors, with two types of propellants, offering ers) that can hold several milliliters of e- 2 Benowitz), San Francisco; The University of liquid.2 Newer e-cigarettes also have pro- an average of four to five nicotine strengths. Louisville (Dr Bhatnagar), Louisville, Ky; Uni- 2 grammable features to control heating tem- These products are sold on-line and in retail versity of Auckland (Dr Bullen), Auckland, stores.9 In the United States, they are avail- New Zealand; Population Health Alliance perature, which influences the extent of nico- (Mr Goldstein), Washington, DC; University of tine delivery.1 Some e-cigarettes are dispens- able in more than 30% of retail stores, most Michigan (Ms Matthias-Gray and Ms Palma- able and others have replaceable cartridges. often in those specializing in tobacco prod- Davis), Ann Arbor; Health Enhancement Re- Although many cigalikes are fully closed and ucts, but increasingly in convenience stores search Organization (Dr Grossmeier), Edina, and other outlets.9 An audit of a nationally Minn; Performance pH (Mr Harris), Holland, are disposable, the tankomizers and other Ohio; Johnson & Johnson (Dr Isaac); US Pre- electronic nicotine delivery systems come representative sample of US retailers found ventive Medicine/American College of Occupa- with cartridges or refillable tanks containing that e-cigarettes were more likely to be sold tional and Environmental Medicine (Dr Loeppke), variable concentrations of nicotine in propy- in neighborhoods with higher median house- Elk Grove Village, Ill; American College of hold income and a lower percentage of minor- Preventive Medicine (Dr Manley), Washington, lene glycol and/or glycerol (vegetable glyc- 9 DC; Health Enhancement Research Organiza- erin) and a wide range of optional flavor- ity residents. The sales of e-cigarettes in the tion, Population Health Alliance (Ms Moseley), ing agents including tobacco and menthol United States have increased steadily since Edina, Minn; ArcelorMittal/American College and fruit and candy.3 When users puff on these products were first introduced in the of Occupational and Environmental Medicine market, and are predicted to reach at least (Dr Niemiec), Elk Grove Village, Ill; Inter- the e-cigarette or, in some models, activate a active Health (Mr O’Brien); HealthPartners/ switch, the liquid is heated and the resulting $10 billion by 2017 on the basis of current Harvard University (Dr Pronk); Bravo Well- aerosol is available to be inhaled. market trends, as well as the fact that adver- ness (Mr Pshock), Cleveland, Ohio; Preven- E-cigarettes are not currently regu- tising expenditures across all media outlets tion Partners/American College of Occupational have surpassed $82 million in 2013.10 and Environmental Medicine/Duke University lated by the US Food and Drug Adminis- (Dr Stave), Durham, NC; and StayWell Health tration (FDA). In 2014, the FDA initiated Management (Dr Terry), Saint Paul, Minn. a process that could lead to regulation of CONSTITUENTS, The authors declare no conflicts of interest. TOXICOLOGY, AND HEALTH Address correspondence to: Laurie P. Whitsel, PhD, e-cigarettes under authority granted by the Policy Research, American Heart Association, Family Smoking Prevention and Tobacco EFFECTS OF E-CIGARETTES 1150 Connecticut Avenue, Suite 300, Washington, Control Act (FSPTCA).4 Although the FDA The major difference between e- DC 20036. has approved several nicotine replacement cigarettes and conventional cigarettes is that Copyright C 2015 by American College of Occupa- tional and Environmental Medicine products for tobacco cessation, e-cigarettes e-cigarettes do not generate a nicotine aerosol DOI: 10.1097/JOM.0000000000000420 have not been approved by the FDA for by combustion. Smoking conventional r 334 JOEM Volume 57, Number 3, March 2015

Copyright © 2015 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. r JOEM Volume 57, Number 3, March 2015Guidance to Employers on Integrating E-Cigarettes/Electronic Nicotine Delivery Systems

cigarettes involves the combustion of to- the FDA as a solubilizing agent for different cardiopulmonary toxicity and mortality.31 bacco, which generates more than 5000 dis- types of medications.23 It is also used to gen- Nevertheless, unlike ambient air particles, tinct chemicals dispersed in both the partic- erate theater fog and in the aviation industry. e-cigarette particles do not contain carbon ulate and gas phase of the smoke.11 These Prolonged exposure to propylene glycol can and are generated as an aerosol from super- include reactive and toxic carbonyls such cause eye and respiratory irritation. There- saturated propane-1,2-diol vapor. There is no as acrolein, acetaldehyde, butyraldehyde, fore, frequent exposure to propylene glycol evidence available to indicate whether their formaldehyde, propionaldehyde, and butadi- could be of concern, especially when the ex- toxicity is similar to that of ambient air parti- ene, metals such as cadmium, lead, arsenic, posure involves susceptible individuals, such cles or particles generated in tobacco smoke. and nickel, as well as carbon disulfide, hy- as those with asthma or chronic obstructive There have been few direct evalua- drogen cyanide, benzene, nitrosamines, and lung disease. In addition to propylene glycol tions of the health effects and toxicity of polycyclic aromatic hydrocarbons (PAHs). and glycerol, ethylene glycol has also been e-cigarettes on humans or animals. Acute Cigarette smoke also contains high levels detected in some e-cigarette aerosol.24 Ethy- exposure in individuals using e-cigarettes of carbon monoxide (CO), which increases lene glycol is used in antifreeze and other in- has been found to increase dynamic air resis- the levels of carboxyhemoglobin and re- dustrial formulations and it is a strong irritant tance and to significantly decrease exhaled duces oxygen delivery from red blood cells with moderate toxicity that affects the central nitric oxide,32 indicating that e-cigarette con- in smokers. The particulate phase of main- nervous system and cardiovascular tissues. stituents may be pulmonary irritants. Never- stream smoke contains more than 5 × 1025 Hence, its use as a humectant in conventional theless, unlike conventional cigarettes, using particles per cubic cm12 that range in particle tobacco products is currently prohibited.24 e-cigarettes has not been associated with a de- size from 0.1 to 1 μm. Recurrent exposure to Ingestion of a high amount of ethylene glycol crease in forced expiratory volume (FEV) or this complex mixture of chemicals has been can be fatal.25 an increase in inflammatory responses.33 The shown to result in the development of cancer, Because nicotine in most e-cigarette use of e-cigarettes has been associated with as well as cardiovascular and respiratory dis- liquids is derived from tobacco, it con- an acute increase in heart rate and blood pres- eases, including an increased risk and sever- tains trace levels of tobacco alkaloids sure. Nevertheless, the changes in diastolic ity of respiratory tract infections.13 such as nornicotine, anabasine, and function and increased coronary vascular Although there is little direct evidence anatabine as well as tobacco-specific ni- resistance seen with smoking conventional linking individual chemicals to specific tox- trosamines including N-nitrosonornicotine cigarettes have not been observed.34 In icological effects of tobacco smoke, expo- and 4-(methylnitrosamine)-1-(3-pyridyl)- randomized controlled studies, no serious sure to tobacco smoke constituents such 1-butanone (NNK).26 In most samples adverse health effects have been reported as carbonyls, benzene, butadiene, metals, of e-cigarette liquids, the levels of mi- in individuals using e-cigarettes for the tobacco-specific nitrosamines, and PAHs has nor tobacco alkaloids such as nornicotine, 6-month duration of the research protocol.34 been associated with various adverse health anatabine, and anabasine are between 1% and Studies with longer follow-up have not been effects.14 Biomarkers of exposure to tobacco- 2% of nicotine. These alkaloids have actions performed. Asthmatic smokers switching specific nitrosamine and PAHs have been in- similar to nicotine but are generally less toxic from conventional cigarettes to e-cigarettes dependently associated with the development and less potent, and their presence in trace have reported improvements in FEV1 and of lung cancer in smokers.15 levels is not currently believed to signifi- scores on an asthma control questionnaire, Results from animal studies sug- cantly impact e-cigarette toxicity.27 The main with most of the improvement likely related gest that exposure to aldehydes such as e-cigarette constituents of concern, however, to quitting smoking or a decrease in the acrolein results in endothelial dysfunction,16 are volatile organic compounds and particu- number of cigarettes smoked per day.35 dyslipidemia,17 increased thrombosis,18 and late matter. In conventional cigarettes, these Several anecdotal incidences, such as an increased formation of atherosclerotic constituents are generated by combustion, increase in atrial fibrillation,36 have also been lesions.19 Recent hazard index approaches and even though heating and vaporization of reported. Some flavorings in e-cigarettes developed from weighted exposure to indi- e-cigarette liquids do not involve combus- contain diacetyl, a compound that is known vidual mainstream smoke constituents sug- tion, high levels of organic compounds such to cause bronchiolitis obliterans, a condition gest that much of the derived theoretical as formaldehyde have been detected in some that may result in respiratory failure and re- noncancer index is dominated by the reac- e-cigarette aerosols with higher levels seen quire lung transplantation.37 Further studies tive aldehyde acrolein whereas the theoreti- with higher vaporization temperatures.28 will be required to establish the biological cal cancer index is dominated by genotoxic Nonaerosolized samples of e-cigarette liq- plausibility of these effects and to ascertain carcinogens of the mainstream vapor phase uids contain only trace levels of aldehydes; their prevalence in e-cigarette users. such as 1,3-butadiene, isoprene, formalde- however, 10- to 20-fold higher concen- In summary, even though the specific hyde, acetaldehyde, and acrylonitrile.20 trations of aldehydes are generated upon toxicity of e-cigarette constituents remains The levels of most of the chemi- heating.24 Aldehyde generation is further unclear, because their emissions contain cals with significant cancer and noncancer accelerated by increased air flow, and there- high levels of aldehydes and particulate risk are much lower in e-cigarette liquid fore the release of aldehydes is significantly matter (PM) with an aerodynamic diameter than in conventional cigarettes.21 Neverthe- increased as the liquid level in the cartridge of less than 2.5 μm, there is concern that less, the levels of these chemicals gener- is decreased and replaced by air. Therefore, the frequent use of e-cigarettes could have ated in e-cigarette aerosol are variable and in some conditions (eg, after 10 to 100 adverse health effects. Further research and depend upon the specific device, the bat- puffs), the levels of aldehydes generated in monitoring are required to assess both the tery voltage, and puff duration because they e-cigarettes are comparable to or even higher short- and long-term toxicity of direct and affect the temperature at which the liq- than those in conventional cigarettes.24 secondhand exposure to e-cigarettes. uid will be heated. In addition to nicotine, Similarly, aerosol generated by e-cigarettes e-cigarettes contain glycerol and propylene contains particulates at a number, concentra- Adult Awareness and Use of glycol also called propane-1,2-diol. Propy- tion, and size similar to those of conventional E-Cigarettes lene glycol, a key component of e-cigarette cigarettes.29,30 Extensive studies have shown Awareness and use of e-cigarettes liquids because of its ability to create a fine that exposure to ambient air particles of have increased significantly since researchers aerosol, when heated, is generally consid- the size distribution similar to those in started monitoring US trends about 5 years ered nontoxic22 and has been approved by e-cigarettes is associated with significant ago, particularly among young adults. A 2011

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US consumer survey found that 6.2% of comparatively cheaper than cigarette smok- or potentially carcinogenic elements such as American adults have tried e-cigarettes at ing. Both these factors make e-cigarettes par- cadmium, arsenic, and thallium, has been least once, a significant increase over 2010 ticularly attractive to youth. detected.49 In one study, the use of nicotine- levels.38 A review of studies indicates that In addition to the impact of youth containing e-cigarettes in a ventilated room the use of e-cigarettes has increased from less using e-cigarettes themselves, the use of for 2 hours did not result in an increase in than 1% in 2009 to 6% in 2011, with people e-cigarettes by adults poses additional health formaldehyde, benzene, or acrolein levels.48 trying them most often being current or for- hazards to children. Through December 31, The presence of nicotine in exhaled e- mer smokers.38–40 A recent study indicated 2014, the American Association of Poison cigarette vapor could potentially expose in- that ever use of e-cigarettes doubled by 18- Control Centers had received calls reporting dividuals in the vicinity to significant levels to 34-year-olds from 2011 to 2012.41 2,724 e-cigarette device and liquid nicotine of nicotine. In a human exposure study in Awareness of e-cigarettes varies exposures.45 Slightly more than half of these which 15 individuals participated in a pas- within the demographic profile of users. Men reported exposures have occurred in children sive e-cigarette use session, exposure to e- aged 45 to 54 years, with some college ed- younger than 6 years and some children cigarette vapor for 1 hour increased serum co- ucation, earning more than $60,000 annu- and toddlers have required emergency tinine levels similarly to those observed with ally tend to be most aware of e-cigarettes.38 department visits with nausea and vomiting secondhand exposure to combustible tobacco Ever-users tend to be female and aged 18 being the most significant symptoms. A smoke,33 suggesting that significant second- to 24 years, have a high school level of toddler in upstate New York died from hand exposure to e-cigarette emissions could education, and earn $25,000 to $39,999 ingesting nicotine liquid,46 renewing calls to lead to significant passive absorption of nico- annually.38 These groups are more alike in require child-proof packaging and adequate tine. Although the effects of exposure to sec- their racial/ethnic background (more fre- warning labels to prevent these tragedies. ondhand nicotine have not been studied di- quently white, non-Hispanic), have Mid- rectly, these findings also suggest that there western residential status, and are current WORKPLACE EXPOSURE is the potential for significant involuntary ex- cigarette smokers.38 There is extensive, rigorous, and con- posure in a bystander as a result of being near vincing evidence that secondhand exposure someone who is using an e-cigarette. Youth Awareness and Use of to cigarette smoke increases the risk of ad- Passive exposure to particulates gen- E-cigarettes verse health effects on others.13 Exposure erated in exhaled e-cigarette aerosols could From an employer’s perspective, to secondhand smoke has been linked to also potentially have adverse health con- young people represent the workforce of the 600,000 premature deaths every year around sequences. E-cigarette aerosols have been future. The current use of e-cigarettes among the world, mostly from cardiovascular dis- found to contain fine and ultrafine particles. young people could increase the likelihood ease, asthma, lung cancer, and respiratory These particles show a bimodal distribution of smoking in adolescence and adulthood.42 tract infections.47 Implementation of smok- with peaks at 30 and 100 nm. In comparison, Because experimentation with e-cigarettes ing bans in public places has led to an im- the particle size distribution of the conven- might lead to later or concurrent use of con- provement in air quality and a significant tional cigarette shows a single mode with a ventional cigarettes, it is important to pre- decrease in the rate of acute cardiovascular maximum at 100 nm.50 Although in some vent young people from obtaining and using events.14 studies the number concentration of particles e-cigarettes. Whether secondhand exposure to generated from e-cigarettes has been found to Data obtained from the US National e-cigarettes has similar consequences re- be similar to that of conventional cigarettes, it Youth Tobacco Survey42 show an increase in mains unclear as only limited research has is important to note that e-cigarette-derived ever use (at least one time in the last 30 days) been completed on the secondhand effects of particles do not contain carbonaceous ma- of e-cigarettes among never-smoking young e-cigarettes. Unlike conventional cigarettes, terial. They are also likely to be vastly dif- people from 79,000 in 2011 to 263,000 in e-cigarettes do not produce a side stream ferent in their chemical properties from the 2013, a 3-fold increase. More than a quar- vapor or smoke that is generated from particles emitted by combustible cigarettes or ter of a million youth who had never smoked product smoldering. The emissions from those present in the ambient air, which have a conventional cigarette used e-cigarettes in e-cigarettes derive only from exhalation and been linked to a variety of untoward health 2013. The researchers noted that e-cigarette contain e-cigarette constituents transformed effects.31 Environmental e-cigarette particles use was associated with increased intentions after interaction with the human lung as well are exhaled after inhalation, and therefore it to smoke cigarettes. Compared with those as other breath constituents of the user. is likely that their size distribution and other who had never used e-cigarettes, young in- The limited evaluation of exhaled properties are altered in the human lung, dividuals who had never smoked conven- aerosol from e-cigarette users has shown which leads to the exhalation of smaller par- tional cigarettes but who used e-cigarettes great variability due to different styles of ticles with altered toxicological properties.50 were almost twice as likely to have the in- use, the e-cigarette types and products used, Further studies are required to address these tention to smoke conventional cigarettes. Al- the characteristics of the indoor environ- issues. most 45% of nonsmoking youth who had ment (closed or open) and the measurement ever used e-cigarettes indicated that they in- methods used. Nevertheless, they show sig- APPROACHES USED BY tend to smoke conventional cigarettes within nificant dispersion of propylene glycol and the next year, compared with about 20% of nicotine into the environment. In one study, DIFFERENT COUNTRIES IN those who had never used e-cigarettes, in- measurements of the environment in which CREATING E-CIGARETTE dicating that using e-cigarettes is correlated e-cigarette aerosol was exhaled showed sig- POLICIES with the intention to smoke conventional nificant levels of nicotine, propylene glycol in E-cigarettes have fallen between ex- cigarettes. The need for stringent regulations the gas phase, as well as high concentrations isting regulatory gaps. Because of their nov- 3 48 to prevent e-cigarette marketing and promo- of PM2.5 (mean 197 μg/m ). elty and the lack of conclusive evidence on tion to youths has been emphasized by the Some studies have found that the ex- their health effects, safety, and cessation effi- World Health Organization43 and the Ameri- haled e-cigarette vapor also contains volatile cacy, it has been unclear whether e-cigarettes can Heart Association,44 especially given that organic carbons as well as PAHs and alu- should be regulated as tobacco products, ther- the products come in attractive flavors and are minum. No increase in the levels of CO, apeutic goods, medical devices, or consumer

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“lifestyle” products. As a result, the develop- to e-cigarettes. In the absence of federal For those organizations that continue ment of an effective regulatory policy is likely regulations, more than half of US states to host designated cigarette smoking areas, to be a complex undertaking. Ultimately, the and municipalities have proceeded to enact we strongly recommend that they join the chosen regulatory route will depend on many their own e-cigarette regulations.53 Most growing number of organizations with en- factors, including the flexibility of the current commonly, these laws prohibit sales to tirely tobacco-free buildings as well as those regulatory framework, whether the products minors, while some laws prohibit e-cigarette businesses who now support tobacco-free have significant health effects and toxicity, use in areas where smoking is banned. grounds. Nevertheless, if an organization is and whether therapeutic claims are success- not yet ready to move to an entirely tobacco- fully made by the manufacturers (eg, the use HOW US EMPLOYERS SHOULD free policy, we recommend that the organiza- of e-cigarettes as a cessation aid). ADDRESS E-CIGARETTES tion create a separate designated e-cigarette Currently, the regulation of e- area from the tobacco smoking area, given cigarettes varies widely around the world, Policy Recommendations the significance of the evidence concerning fromanabsenceofanyregulation(eg,in The following sections outline key the dangers of secondhand tobacco smoke Turkey) to absolute bans on use, sales, and recommendations for employers as they de- detailed earlier. Also, it might be difficult for marketing (eg, in Singapore and Canada). velop policies regulating the use of e- e-cigarette users to quit as recurrent expo- Many countries make a distinction between cigarettes in the workplace (Table 1). These sure to tobacco smoke may tempt them to nicotine and non-nicotine products, whereby recommendations do not constitute legal ad- start smoking again. refills or cartridges without nicotine are per- vice. Employers should consult with their at- mitted (as long as they do not make ther- torneys to ensure compliance with applica- E-Cigarettes and Tobacco apeutic claims) but those with nicotine re- ble local, state, and federal laws. Employers Cessation Benefits in quire a license. Most countries that regulate should review applicable state and local laws Employer-Based Health Insurance e-cigarettes allow the importation of devices regulating e-cigarette use that might already and liquids for personal use but ban impor- exist in their cities or states. It is also rec- Recommendation tation for sale. Few countries have yet deter- ommended that employers at least consider Employers should offer comprehen- mined whether or not e-cigarettes should be e-cigarettes that contain nicotine to be to- sive tobacco cessation services within their subject to regulatory controls when used in bacco products and develop policies consis- employee health care plans and wellness pro- smoke-free areas, such as workplaces. tent with this perspective.44 grams and e-cigarette users should be eligible In the United Kingdom, e-cigarettes for these programs. are regulated as a medicine and a product Tobacco-Free Policies that is currently undergoing review by the Explanation medicines regulator. Other restrictions, in- Recommendation To address e-cigarette use, employ- cluding the age of individuals permitted to Employers should include e-cigarettes ers should examine their companies’ tobacco purchase, and use where smoking is cur- in their tobacco-free policies and should cessation insurance benefits. Currently, fed- rently banned, are under consideration.51 In ban e-cigarette use in their smoke-free work eral law requires companies with nongrand- the European Union, e-cigarettes have been areas. fathered health plans to provide coverage for 61 categorized as tobacco products. E-cigarettes tobacco cessation as a preventive service. were included in the recent European Union Explanation Nevertheless, policies to date are silent on Tobacco Products Directive that proposed Tobacco-free and clean indoor air poli- whether e-cigarette users should be included banning devices, refills over 20-mg nicotine cies continue to become more prevalent in under these benefits. The US Preventive Ser- strength, advertising, and international sales US workplaces. More than 24 states have vices Task Force has concluded that tobacco over the Internet.52 banned smoking in the workplace, but a ma- cessation services are effective, and that In August 2014, the World Health Or- jority of these have not included e-cigarettes these services should include both counseling 62 ganization recommended that governments in their laws.54 This is particularly significant, and FDA-approved pharmacotherapy. The ban e-cigarette use indoors, prohibit sales to as e-cigarettes are becoming more popular Community Preventive Services Task Force people younger than 18 years, ban the use of and distributors continue to market them as provides several recommendations specific vending machine sales, and restrict manufac- a way to circumvent smoke-free laws, claim- to the workplace setting. Smoke-free poli- turers from claiming e-cigarettes aid smoking that they contain “no tobacco smoke, only cies to reduce secondhand smoke expo- ing cessation until they provide evidence to vapor.”3,55 sure and tobacco use are recommended support such claims.43 At a distance, e-cigarette use can be on the basis of strong evidence of effec- The recommendations in this policy difficult to distinguish from conventional tiveness. In addition, the Community Pre- paper apply to the United States, where e- cigarette use and therefore can create con- ventive Services Task Force recommends cigarettes are not currently regulated by the fusion in smoke-free areas.56 The inability worksite-based incentives and competitions FDA. After an unsuccessful attempt to reg- of employers to distinguish between conven- when combined with additional interventions ulate e-cigarettes as drug delivery devices, tional and e-cigarettes may make it difficult to to support individual cessation efforts based the FDA now intends to regulate e-cigarettes monitor employee cigarette use and to imple- on strong evidence of effectiveness in reduc- 63 as “tobacco products,” not as drugs or deliv- ment and enforce tobacco-free policies.44,57 ing tobacco use among workers. The US ery devices unless marketed for therapeutic A lack of enforcement of e-cigarettes in Department of Labor recently provided guid- purposes. This was the result of a clarifica- tobacco-free areas may turn back decades ance to employers to help define adequate tion of the FDA’s authority under the 2009 of work to create social norms around coverage as follows: FSPTCA.53 Among the regulations proposed clean indoor air in public places.44,58–60 The Departments will consider a are disclosure of ingredients, proof of safety, Decreasing the visibility of cigarettes in group health plan or health insurance and regulation of the design features of the the work environment and in the media issuer to be in compliance with the re- devices. has been a major factor in denormalizing quirement to cover tobacco use coun- The FSPTCA does not propose smoking behavior. Therefore, reintroduction seling and interventions, if, for exam- overriding the ability of states or local of smoking-like activities could erode these ple, the plan or issuer covers without authorities to make laws and policies related important public health gains. cost-sharing:

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TABLE 1. Summary Recommendations for US Employers to Address E-Cigarettesa

Recommendation Explanation/Rationale

Designate e-cigarettes that contain nicotine to be tobacco products This would be consistent with the way e-cigarettes have been treated under federal law.77 Review applicable state and local laws regulating e-cigarette use Company policy must be consistent with federal, state, and local laws. that might already exist Although federal law is consistent, state and local laws vary. Employers should include e-cigarettes in their tobacco-free policies The inability to distinguish between conventional and e-cigarettes makes it and ban e-cigarette use in their smoke-free work areas difficult to monitor and enforce compliance if e-cigarettes are not treated the same way as conventional cigarettes in smoke-free areas. Failing to eliminate the use of e-cigarettes in smoke-free areas could turn back decades of work to create social norms around clean indoor air in public places. Decreasing the visibility of cigarettes in the work environment and in the media has been a major factor in denormalizing smoking behavior; reintroduction of smoking-like activities could reverse important public health gains. We recommend that organizations be entirely tobacco free in their buildings, but for those organizations that continue to host designated smoking areas, they should create a separate designated e-cigarette use area. Employers should offer comprehensive tobacco cessation services Many e-cigarette users also use other forms of tobacco and thus can be within their employee health care plans and wellness programs, helped by cessation support. and e-cigarette users should be eligible for these programs. Nicotine addiction is not a recognized disability under federal or most state laws, so employers are not obligated to allow e-cigarettes in the workplace to accommodate employees who are trying to quit smoking. The US Preventive Services Task Force has concluded that tobacco cessation services are effective and should include both counseling and FDA-approved pharmacotherapy. The Community Preventive Services Task Force recommends incentives and competitions along with other interventions to support cessation efforts based on strong evidence of effectiveness. The US Department of Labor recently provided guidance to employers to help define adequate tobacco cessation coverage. Employers should screen for both tobacco and e-cigarette use to Screening can be performed by personal attestation or with biological tailor their wellness programs and worksite policies optimally. testing of nicotine metabolites in the saliva, blood, or urine. Biological testing has several limitations. Employers who choose biological testing should have protocols in place to determine how to interpret positive findings, respond to false positives, and administer an appeals process. If employers have concerns about the veracity of personal attestations, they may require a statement from the personal physician of the employee and/or a written voucher with legal sanctions for inaccurate reporting. Employers should target tobacco use instead of nicotine use if they The ACA wellness regulations categorize “tobacco use” as a elect to administer health contingent incentives. An incentive “health-contingent outcomes-based” category with which employers policy consistent with Affordable Care Act (ACA) regulation may associate financial rewards or penalties, as long as they comply with cannot require success at cessation under a health contingent all of the requirements associated with such programs. incentive design but may offer employees who use tobacco In addition to other requirements, the regulations limit the amount of the “reasonable alternatives” that most commonly include reward or penalty for tobacco use to 50% of the total premium for an completion of a cessation program. employee’s category (single, family, etc). Although verification of tobacco use in the form of a blood or urine test for nicotine/cotinine is permitted, the fact that a positive result indicates only the presence of nicotine rather than tobacco, may pose a risk to employers who seek to tie the health-contingent incentive to the test. Determining tobacco use, electronic cigarette use, or use of a nicotine replacement therapy (NRT) will typically require an employee’s personal attestation or affidavit or a note from his or her personal physician. In a health-contingent incentive, a positive nicotine test would prevent an individual from earning an incentive (or avoiding a penalty) unless they meet the reasonable alternative standard and/or have provided a physician statement indicating that stopping the use of tobacco/nicotine or completing a cessation program is medically inadvisable or unreasonably difficult due to a medical condition or due to the use of an NRT. (continues)

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TABLE 1. (Continued)

Recommendation Explanation/Rationale

Health care plans sold through the regional exchanges should Regional exchanges may play a greater role as some employers shift their include comprehensive tobacco cessation services that also employees to the exchanges for health care coverage. address e-cigarettes in their coverage. Employers should be deliberate about the tobacco cessation beneﬁts they want to see offered in the exchanges for their employees and should decide which exchanges provide the best option for their employees’ health and well-being. Joint labor-management actions should be taken to address Labor organizations are important, valuable, and culturally relevant e-cigarettes within tobacco control policies and programming at partners in addressing e-cigarettes at the workplace. the workplace as part of the bargaining process. Most unionized workers support their union in bargaining for restrictions on workplace smoking and for the availability of cessation programs. There are many supportive actions labor organizations can take to help reduce worker exposure to nicotine and tobacco-related products. Where employers extend their health promotion programs to It is especially important to reach children and adolescents where families, they should raise awareness and include education education may prevent initiation of a nicotine habit. around e-cigarettes and cessation therapy. Family members often drive more of the medical cost than employees. Employers should publicize their tobacco policies (including Employers can help the community and the ﬁeld gain a better e-cigarettes) to demonstrate best-practice, comprehensive efforts understanding of best practices. that are a model in the community. Employers can help inform further research around effective policy for e-cigarettes and other emerging tobacco products.

aThis does not constitute legal advice. Employers should consult with their attorney(s) to comply with applicable local, state, and federal law.

1. Screening for tobacco use; and, cessation among tobacco users are likely to dicate that a falsified statement may be sub- 2. For those who use tobacco prod- benefit e-cigarette users as well. ject to disciplinary action. Alternatively, or ucts, at least two tobacco cessa- As described in the introductory additionally, biological testing can be con- tion attempts per year. For this pur- paragraphs of this article, both e-cigarette sidered. Biological testing for tobacco use pose, covering a cessation attempt retailers and many e-cigarette users have typically involves the measurement of coti- includes coverage for: claimed that e-cigarettes can play a role in nine, the major metabolite of nicotine, usu- • Four tobacco cessation counsel- smoking cessation. Absent definitive scien- ally in the urine, blood, or saliva. Employ- ing sessions of at least 10 minutes tific evidence supporting such claims, we do ers who choose to measure cotinine should each (including telephone coun- not recommend the use of e-cigarettes as a be aware that the test has several limitations seling, group counseling and part of smoking cessation programs. These and the results have to be interpreted with individual counseling) without recommendations may change if, and when, caution. The cutoff level for a positive test prior authorization; and rigorous studies demonstrate the safety should be set high enough to avoid classi- • All FDA-approved tobacco ces- and efficacy of e-cigarettes in promoting fying people exposed only to environmental sation medications (including cessation, and they are approved by the FDA tobacco smoke as smokers. Tobacco prod- both prescription and over-the- as a cessation aid. Related to this, because uct users can produce a negative cotinine test counter medications) for a 90- e-cigarettes are not approved by the FDA as if they abstain from using the product for day treatment regimen when pre- cessation aids, we do not recommend that more than 4 days.66 It is also important to scribed by a health care provider e-cigarettes be offered as a covered benefit note that cotinine measurement in the blood, without prior authorization.64 for tobacco users. Moreover, because nico- urine, or saliva cannot distinguish between tine addiction is not a recognized disability a cigarette smoker, an e-cigarette user, or In addition, it is important for employers to under federal or most state laws, employers someone who is using other tobacco prod- understand that tobacco cessation interven- are not obligated to allow e-cigarettes in the ucts or FDA-approved nicotine replacement tions are more likely to be successful when workplace to accommodate an employee therapy because all of these products contain offered in a supportive work environment. who is trying to quit smoking.65 nicotine, which upon metabolism generates Such an environment may include a policy cotinine.44 that prohibits tobacco use on the property, in- Screening for E-Cigarettes Other biomarkers that have been centives (financial and otherwise) to encour- considered for assessing tobacco use are age cessation, and regular communications Recommendation anabasine and anatabine. Testing for an- from company leadership about the benefits Employers should screen for abasine can distinguish between the use of and importance of cessation. e-cigarette use in their health screen- nicotine replacement therapy (NRT) from Although the aforementioned federal ings and in their health insurance plan tobacco products.64 Measurable but low guidelines do not address coverage of e- design and wellness programs to be able to levels of anabasine and anatabine have been cigarette users, we recommend that employ- tailor their wellness programs and worksite detected in a majority of e-cigarettes tested ers include them in their cessation program policies optimally. by the FDA, so anabasine/anatabine analysis efforts. Many e-cigarette users also use other might be able to distinguish between users forms of tobacco, such as cigarettes. We rec- Explanation of NRT and e-cigarettes.65 Nevertheless, ommend that any user of e-cigarettes, in- There are different ways to screen for whether e-cigarette use can be detected by dulging in sole or dual use, has access to nicotine and tobacco use, including personal anabasine/anatabine testing will depend on and coverage by the company’s tobacco ces- attestation and biomarker testing. Most em- various factors, including the concentration sation program. The programs that support ployers use personal attestation and some in- of these minor alkaloids in the specific

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product and the time since last use. Tests sonable alternatives” the most common being A positive nicotine test, whether due are under development to better differentiate the completion of a cessation program. to tobacco use, nicotine replacement ther- between e-cigarettes and cigarettes. apy such as gum or a patch, or the use of Clearly, a robust detection method Explanation e-cigarettes, would prevent an individual would help distinguish between the uses of The ACA wellness regulations69 cate- from earning any incentive unless they met different products containing nicotine, but it gorize “tobacco use” as a “health-contingent” the reasonable alternative standard by com- is prudent to recognize the limitation of cur- category with which employers may asso- pleting a qualified cessation program, and/or rent assays. Employers who choose to pursue ciate financial rewards or penalties (in the have provided a physician statement, indicat- biological testing should have protocols in form of premium differentials or health ben- ing that stopping the use of tobacco/nicotine place to determine how to interpret positive efit adjustments such as deductibles or co- or completing the cessation program was findings, respond to false positives, and ad- pays), as long as they comply with all of medically inadvisable or unreasonably dif- minister an appeals process. As mentioned the requirements associated with such in- ficult because of a medical issue or that the previously, any testing must be in compli- centive designs. Previous guidance has out- positive cotinine test result was due to the ance with federal and state laws. South Car- lined how employers might consider design- use of an NRT. The physician may join in a olina, for example, prohibits mandatory nico- ing their health contingent programs.70 request for a different cessation method or tine and tobacco testing by employers.67 In addition to requirements such as the indicate that a waiver of the requirement is A National Business Group on Health incentive being part of a comprehensive well- appropriate. survey in 2012 indicated that 16% of mem- ness program that has a reasonable chance of Employers should be aware that bers responding to the survey were using co- improving the health of the individual, the fi- the Equal Employment Opportunity Com- tinine testing.68 With the provisions in the Af- nal regulations limit the amount of the reward mission has filed several lawsuits against fordable Care Act (ACA) that allow differen- or penalty to 50% of the total employee-only employers using health contingent incentive tial premiums based on health outcomes, the premium (or 50% of the category in which the designs, indicating that they believe ACA number of employers testing tobacco product employee is enrolled if other family mem- wellness provisions do not satisfy the use by their employees is likely to rise. Nev- bers are also part of the incentive design). nondiscrimination tenets of the Americans ertheless, before testing, employers should The total of all rewards may not exceed the with Disabilities Act. Further guidance from consider the nature of the relationship they 50% threshold, and outside of tobacco use, the agency should be forthcoming to help wish to have with their employees and the the total of all categories may not exceed employers factor in other federal laws as culture of their workplaces. Mandating bio- 30%. Although verification of tobacco use they design financial incentives. logical testing for tobacco and nicotine use in the form of a blood or urine test for nico- Finally, note that the ACA regulations has the potential to result in a loss of trust tine/cotinine (or other metabolite of nicotine) for small groups (businesses with 50 employ- between employers and workers. In addition, is permitted, the fact that a positive result in- ees or fewer) define tobacco use (for purposes cost-effectiveness considerations factor into dicates only the presence of nicotine rather of underwriting and rating variables) as “the decision making concerning screening for to- than tobacco may pose a risk to employers use of tobacco on average of four or more bacco use, given that large populations with who seek to tie more than 30% of premium times per week within no longer than the a low percentage of tobacco users may find to the test. Determining true “tobacco use” past six months.” Furthermore, tobacco use it undesirable to request invasive tests from will typically require an employee’s personal must be defined in terms of when a tobacco the majority to validate the veracity of a mi- attestation through a questionnaire or an af- product was last used. Tobacco includes all nority. A simple attestation can be sufficient fidavit, or a note from his or her personal tobacco products; however, religious or cer- for qualifying the vast majority of nonsmok- physician. If the use is solely determined by emonial uses of tobacco (eg, by American ers for insurance policy differentials. If an the presence of nicotine in a laboratory test, Indians and Alaska Natives) are specifically organization remains concerned that a mi- employers are advised that it may be from exempt under the final rule. Note that the final nority are inappropriately qualifying for in- NRT rather than tobacco use for purposes of wellness regulations did not adopt this defi- surance differentials, an attestation accompa- determining the maximum reward or penalty. nition, so employers in small groups should nied by a note from the employee’s physician Employers are, however, permitted to require be aware that definitions used for application and/or a written voucher with legal sanctions verification that the NRT is being used in con- and underwriting reasons may differ from for inaccurate reporting could be considered. junction with a qualified cessation program.69 those used for insurance-based incentives. Some employers have conducted outbound The ACA wellness provisions related recorded phone calls with scripted messag- to the use of incentives specifically state that Additional Considerations for ing about the importance of truthful attesta- recommendations of an individual’s personal Employers tion as a way to reduce inaccurate employee physician must be accommodated with re- self-reported nonsmoking. spect to “reasonable alternatives” related to Regional Health Care Exchanges rewards or penalties for tobacco or nicotine The new health insurance exchanges Addressing E-Cigarettes Within status.69 For some employers who implement may play a greater role in population health ACA Sanctioned Health tobacco/nicotine incentive programs, a stan- management as some employers shift their Contingent, Outcomes-Based dard policy is to offer a reward for those peo- employees to the exchanges for health care Incentive Programs ple who are tobacco and nicotine/cotinine coverage. Health care plans sold through the free, or who are enrolled in, or have re- exchanges should include comprehensive Recommendation cently completed a qualified tobacco ces- tobacco cessation services that also address Employers should target tobacco use sation program. Note that the regulations e-cigarettes within their coverage. Further instead of nicotine use if they elect to admin- specifically acknowledge that tobacco ces- analysis will determine whether there are ister health contingent incentives in coordina- sation “sometimes requires a cycle of failure differences between private and public health tion with their wellness programs. An incen- and renewed effort.”69 Therefore, incentives exchanges in the content of their wellness tive policy consistent with ACA regulations eligibility cannot be contingent on success, offerings and how they are positioned for cannot require success at cessation under a but rather relate only to the completion of a beneficiaries. Employers should advocate health contingent incentive design. Rather, it cessation program or some other reasonable for the tobacco cessation benefits they may offer employees who use tobacco “rea- alternative. want to see offered in the exchanges and

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should decide which exchanges provide the gain a better understanding of best practices, policies, programming, and cessation ser- most effective programs in support of their thereby helping inform further research vices. This guidance is developed from employees’ health and well-being. around effective policy for e-cigarettes and expert consensus and may evolve as new other emerging tobacco products. research emerges and we gain a greater un- Collaboration With Labor derstanding of the long-term health impact of Organizations HOSPITAL SYSTEMS AS e-cigarettes and their effect on social norms Labor organizations are important, EMPLOYERS AND and nicotine addiction. The organizations and valuable, and culturally relevant partners researchers involved in writing this statement in addressing e-cigarettes at the workplace. COMMUNITY INFLUENCERS will continue to monitor the impact of these This is especially true considering that most Hospitals, by virtue of their mis- products on personal health, public health, unionized workers support their union in sion, “lead the way and serve as role mod- employee health and safety, workplace bargaining for restrictions on workplace els for healthy living and fitness for their culture, access to comprehensive cessation 74 smoking and for the availability of ces- communities.” In a 2010 survey of hospi- services, and the inclusion of e-cigarettes in sation programs.71,72 As such, joint labor- tals conducted by the American Hospital As- laws, regulations, and organizational policy. management actions to address tobacco and sociation, 76% of respondents indicated that e-cigarettes at the workplace are important they had a tobacco-free campus and 79% of- as policy development, adoption, and im- fered smoking cessation programs for their REFERENCES 74 plementation are all part of the bargaining employees. 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