Journal of Legal Medicine

ISSN: 0194-7648 (Print) 1521-057X (Online) Journal homepage: http://www.tandfonline.com/loi/ulgm20

Treading Lightly: Why The FDA Should Use Its

New Authority To Regulate Electronic Cigarettes
Sparingly
Andrew P. Ray
To cite this article: Andrew P. Ray (2015) Treading Lightly: Why The FDA Should Use Its New
Authority To Regulate Electronic Cigarettes Sparingly, Journal of Legal Medicine, 36:2, 215-231,
DOI: 10.1080/01947648.2015.1121076
To link to this article: http://dx.doi.org/10.1080/01947648.2015.1121076

Published online: 29 Apr 2016.

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Date: 10 October 2016, At: 18:23

Journal of Legal Medicine, 36:215231

C 2015 American College of Legal Medicine
Copyright 
0194-7648 print / 1521-057X online
DOI: 10.1080/01947648.2015.1121076

TREADING LIGHTLY: WHY THE FDA SHOULD

USE ITS NEW AUTHORITY TO REGULATE
ELECTRONIC CIGARETTES SPARINGLY
Andrew P. Ray*

[Electronic Cigarettes (ECs)] are probably the most effective tool right
now in curbing the most preventable form of death we have in our society.1
Phil Daman, President of the Smoke-Free Alternatives Trade
Association.2

INTRODUCTION
I got tired of being like that little kid in Peanuts who had the cloud of
smoke following him all the time.3 Craig Lashley decided he was tired of the
smell, cost, and adverse health effects of traditional cigarettes (TCs).4 Since
he discovered ECs over a year ago, Craig has not smoked a single TC.5
Now that hes switched to ECs, Craig is able to participate in the smoking experience without actually smoking a TC.6 ECs allow users to inhale

*Mr.

Ray is a third-year J.D. candidate with a specialization in health law and policy (2016) at Southern
Illinois University School of Law. The author would like to thank Prof. Jennifer A. Brobst for her
assistance with this commentary, as well as the JLM staff for their edits. The author would also like to
thank his wife, Eliza, and daughter, Mary Margaret, for their unwavering support throughout the drafting
process. Address correspondence to Mr. Ray at Southern Illinois University School of Law, Law Journal
Office, Lesar Law Building, Carbondale, IL 62901, or via email at andrewpray@siu.edu
1
See Ruth Marcus, The E-cigarette Quandary: Helping Smokers Quit While Enticing New Addicts: The E-cigarette Dilemma, THE WASHINGTON POST, http://www.washingtonpost.com/opinions/
ruth-marcus-the-e-cigarette-quandary-helping-smokers-quit-while-enticing-new-addictsthe-e
-cigarette-dilemma/2014/09/05/95ccd876-3538-11e4-a723-fa3895a25d02 story.html (Sept. 5, 2014).
2
Id.
3
See Jen Christensen, E-cigarettes: Healthy Tool or Gateway Device?, CNN, http://www.cnn.com/2013/
09/12/health/e-cigarettes-debate/ (Feb. 6, 2014).
4
Id.
5
Id.
6
Id.

215

216

RAY

and exhale flavored nicotine vapor7 and achieve a buzz that is similar to
smoking TCs simply by holding and puffing a device that looks, feels, and
tastes like a TC.8 Because ECs contain nicotine, though, EC users can become
addicted much like TC users can.9
I. OVERVIEW OF ELECTRONIC CIGARETTES AND HOW THEY
WORK
The concept of the EC dates back to 1963, when Thomas Schelling, a
Nobel Prizewinning economist, developed a battery operated, smokeless,
non-tobacco cigarette.10 In the 2000s, ECs quickly pervaded the United States
and international marketplace as a seemingly safer, more convenient way to
get a nicotine fix.11
Unlike traditional TCs, which require burning tobacco and the inhalation
of its smoke, ECs are not smoked.12 Instead, ECs consist of an e-liquid that
usually contains nicotine derived from tobacco leaves and other ingredients
that create flavoring.13 EC users purchase the e-liquid to fill their ECs.14 The
heat from the EC produces a water-based vapor15 that the user inhales into the
lungs through the mouth.16 Inhaling the vapor is colloquially referred to as
vaping.17
Studies suggest that ECs contain fewer harmful substances than TCs,
but additional scientific investigation is needed.18 Of note, clinical trials show
7

See Caroline Franck, Talia Budlovsky, Sarah B. Windle, Kristian B. Filion, & Mark J. Eisenberg, ECs
in North America: History, Use, & Implications for Smoking Cessation, (2014) 129 CIRCULATION 1945,
http://circ.ahajournals.org.proxy.lib.siu.edu/content/129/19/1945 (last visited Oct. 11, 2015).
8
See Megan McArdle, Thank You for E-Smoking (2014) BLOOMBERG BUS. WK. MAG., 56.
9
Brian A. King, Suhana Alam, Gabbi Promoff, Rene Arrazola, & Shanta Dube, Awareness and Ever-Use
of Electronic Cigarettes Among U.S. Adults, 20102011 (2013) 15 NICOTINE TOBACCO RES. 9, 1626.
10
McArdle, supra note 8.
11
See A. R. Buchhalter, M. C. Acosta, S. E. Evans, A. B. Breland, & T. Eissenberg, Tobacco Abstinence
Symptom Suppression: The Role Played by the Smoking-related Stimuli that are Delivered by Denicotinized Cigarettes, (2005) 100 ADDICTION 550559, http://onlinelibrary.wiley.com/enhanced/doi/10.
1111/j.1360-0443.2005.01030.x/ (Mar. 22, 2005).
12
Id.
13
McArdle, supra note 8.
14
Peter Hajek, Jean-Francois Etter, Neal Benowitz, Thomas Eissenberg, & Hayden McRobbie, Electronic Cigarettes: Review of Use, Content, Safety, Effects on Smokers and Potential for Harm and Benefit (2014) 109 ADDICTION 1801, 1803, http://onlinelibrary.wiley.com/store/10.1111/add.12659/asset/
add12659.pdf?v=1&t=i2fcpzee&s=cdd529ffc766e237cbfddfa2be2ac6472afc9e6f
15
See Nick Dantonio, Comment, Vape Away: Why a Minimalist Regulatory Structure Is the Best Option
for FDA E-cigarette Regulation (2014) 48 U. RICH. L. REV. 1319, 1363.
16
See SURGEON GENERALS REPORT: THE HEALTH CONSEQUENCES OF SMOKING, ch. 7, The Impact of Smoking
on Disease and the Benefits of Smoking Reduction, 860-61, U.S. DEPT OF HEALTH & HUMAN SERVS.
(2004), http://www.cdc.gov/tobacco/data statistics/sgr/2004/pdfs/chapter7.pdf.
17
Id.
18
See Konstantinos E. Farsalinos, Dimitris Tsiapras, Stamatis Kyrzopoulos, Maria Savvopoulou, & Vassilis Voudris, Acute Effects of Using an Electronic Nicotine-Delivery Device (EC) on Myocardial

REGULATING ELECTRONIC CIGARETTES

217

that the [ECs] may help smokers quit smoking or reduce harm by smoking
fewer [TCs], without any remarkable adverse events or risks for the user or
for the bystander.19
EC sales are thriving: 3.5 million Americans now use ECs on a regular
basis,20 with EC use tripling from 20092010.21 EC sales are growing at a pace
of 20% per year while TC sales are falling at a rate of 4% per year.22 EC sales
are projected to surpass TC sales by volume starting in 2023.23
In response to the rapid growth in popularity of ECs, the Food and
Drug Administration (FDA) issued a statement in 2009, and the World Health
Organization (WHO) issued a public statement in 2014, expressing concern
about the health effects of ECs, citing the presence of known carcinogens.24
The FDA announced plans to regulate ECs as tobacco products in April 2011
but has yet to implement any regulations to that effect.25 Adding to the pressure
on the FDA, six U.S. senators wrote a letter to the FDA, dated October 9,

Function: Comparison with the Effects of Regular Cigarettes (2014) 14 BMC CARDIOVASC. DISORD. 78
(This study provides the first clinical evidence that electronic cigarettes have less acute adverse effects
on myocardial function when compared to tobacco cigarettes . . . more studies are urgently needed.);
See also Carolyn Pennington, Smoking out the Facts in the E-cigarette Debate, UCONN TODAY MAG
(2014) http://today.uconn.edu/blog/2014/09/smoking-out-the-facts-in-the-e-cigarette-debate (Sept.
29, 2014); Denis Getsios, Jen Marton, Nikhil Revankar, Alexandra J. Ward, Richard J. Willke,
Dale Rublee, K. Jack Ishak, & James G. Xenakis, Smoking Cessation Treatment & Outcomes
Patterns Simulation: A New Framework for Evaluating the Potential Health & Economic Impact of Smoking Cessation Interventions, (2013) 31 PHARMOECONOMICS 9, 767-780, available at
http://www.ncbi.nlm.nih.gov/pubmed/23821436 (Last visited Oct. 2, 2014). After this study was completed, the authors performed studies using funds provided to the institution by e-cigarette companies.
19
See Daniela Saitta, Giancarlo Antonio Ferro, & Riccardo Polosa, Achieving Appropriate Regulations for ECs, (2014) 5(2) THER. AD. CHRON. DIS. 50-61, http://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3926346/# ffn sectitle (Mar. 2014).
20
See Jordan Paradise, Comment, No Sisyphean Task: How the FDA Can Regulate ECs (2013) 13 YALE
J. HEALTH POLY L. ETHICS 326, 352.
21
See Jordan Paradise, Comment, ECs: Smoke-Free Laws, Sale Restrictions, & the Public Health (2014)
104 AM. J. PUB. HEALTH 17.
22
Marcus, supra note 1.
23
See Chris Bickers, U.S. Tobacco Growers Target the EC Market (2014) 41
SOUTHEAST
FARM
PRESS
18,
http://pdc-connection.ebscohost.com/c/articles/95498466/
u-s-tobacco-growers-target-electronic-cigarette-market.
24
See FOOD & DRUG ADMIN., Electronic Cigarettes, Jul. 22, 2009, http://www.fda.gov/Safety/MedWatch/
SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173327.htm (discussing preliminary
findings by the FDA that electronic cigarettes contain known carcinogens, including diethylene glycol); WORLD HEALTH ORG., Backgrounder on WHO Report on Regulation of E-cigarettes and Similar
Products, Aug. 28, 2014, http://www.who.int/nmh/events/2014/backgrounder-e-cigarettes/en/ (recommending restrictions such as a ban on fruit flavorings of ECs, advertising of ECs, and indoor use of
ECs).
25
See Stakeholder Letter: Regulation of E-cigarettes and Other Tobacco Products, Food & Drug
Admin., http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm, Apr. 25, 2011 (discussing the steps the FDA plans to take to ensure that appropriate regulatory mechanisms govern all tobacco products and all other products made or derived from tobacco after the Sottera decision); see also Timeline of ECs Milestones, THE ASSOCIATED PRESS, Apr. 24, 2014, http:
//bigstory.ap.org/article/timeline-electronic-cigarettes-milestones.

218

RAY

2014, urging the FDA to be more proactive and transparent in its regulation of
ECs.26
In the absence of federal rules on the subject, state and municipal legislatures as well as public health agencies throughout the United States have
promulgated regulations for ECs, including setting minimum age limits on
the sale of ECs and placing restrictions on where ECs may be consumed.27
The United States is at a crossroads: should public health agencies, like
the FDA, preemptively promulgate restrictive regulations of the electronic
cigarette market based on fear of the unknown, or should these agencies use
the ECs untapped potential benefit to lead current and future TC users away
from more hazardous TCs?
Section II of this commentary contrasts the adverse health effects caused
by TC use against the health effects of EC use and the economic costs of these
effects. Section III examines the current regulatory environment of ECs at
the federal, state, and municipal levels. Section IV discusses why the current
regulatory scheme of ECs is inadequate; how it does not provide the necessary
public protections; and how it does not allow for utilization of the potential
benefit of ECs. Section V discusses the solution: a balanced approach to the
regulation the EC market.
II. COMPARATIVE ADVERSE HEALTH EFFECTS AND
ECONOMIC COSTS OF TRADITIONAL CIGARETTE AND
ELECTRONIC CIGARETTE USE
TC smoking, according to the Surgeon General, remains the leading
cause of premature disease and death in the United States.28 Although TC
use is declining,29 19% of Americans currently smoke TCs.30
The use of TCs directly causes over 480,000 preventable deaths in the
United States each year.31 The costs associated with the use of TCs are substantial. They include cancers of the mouth, throat, and lungs; cardiovascular

26

See Letter from Sens. Barbara Boxer, Richard Durbin, Richard Blumenthal, Jack Reed, Sherrod Brown,
& Edward Markey for FDA Commissioner Margaret Hamburg (Oct. 9, 2014), available at http:
//www.boxer.senate.gov/en/press/related/2014 1009 FDA-Ecigarette-Warning-Letter.pdf.
27
See HAW.REV.STAT.709-908; COLO. REV. STAT. 18-13-121 (2014); MD. HEALTH-GEN. CODE ANN. 24305 (2013); MISS. CODE ANN. 97-32-51 (2013); S.C.CODEANN.16-17-500; TENN. CODE ANN. 39-171502 (2013); WASH.REV.CODE26.28.080.
28
See The Health Consequences of Smoking50 Years of Progress. A Report of the Surgeon General,
U.S. DEPT OF HEALTH & HUMAN SERVS. (2014), Printed with corrections, January 2014, http://www.
surgeongeneral.gov/library/reports/50-years-of-progress/full-report.pdf (hereinafter Surgeon General,
50 Years).
29
Getsios et al., supra note 18.
30
Id.
31
Franck et al., supra note 7.

REGULATING ELECTRONIC CIGARETTES

219

diseases; and the loss of both productivity and quality of life.32 Direct health
care costs associated with TC smoking have topped $133 billion per year in
the United States alone.33 In addition, TC use directly causes $156 billion in
lost productivity.34
Fewer than 25% of TC smokers who attempt to quit remain smoke-free 8
to 10 months after quitting.35 Unassisted quitting methods, informally known
as quitting cold turkey, are common.36 Quitters, however, who use a quitting
aid, known as nicotine replacement therapy (NRT), experience higher rates
of success.37 Many quitters relapse, nonetheless, after ceasing use of NRTs.38
ECs offer an advantage to TC quitters over traditional NRTs by allowing
users to gradually reduce the amount of nicotine they consume over time (by
purchasing ECs with reduced nicotine amounts over time) while still allowing
them to participate in the smoking experience.
The FDA, WHO, and many other health industry authorities are cautious
about ECs in general and much more so about using ECs as an NRT or smoking
cessation aid.39 Liquid nicotine is dangerous because it is lethal to human
beings, even in very small amounts.40 The amount of nicotine in a single EC can
exceed the amount of nicotine found in an entire pack of TCs.41 Although most
TCs are designed to be used over the course of multiple smoking sessions, the
fact that so much pure nicotine is concentrated in an EC raises safety concerns,
including the risk of poisoning.42 Calls to poison control centers throughout
the United States involving ECs increased 41.7% from February 2010 through
February 2014.43 Over 94% of calls involved accidental ingestion of liquid

32

See Margarethe Wacker, Rolf Holle, Joachim Heinrich, Karl-Heinz Ladwig, Annette Peters, Reiner
Leidl, & Petra Menn, The Association of Smoking Status with Healthcare Utilisation, Productivity Loss
& Resulting Costs: Results from the Population-Based KORA F4 Study (2013) 13 BMC HEALTH SERV.
RES., 278, http://www.biomedcentral.com/1472-6963/13/278.
33
Surgeon General, 50 Years, supra note 28.
34
Id.
35
Getsios et al., supra note 18, relying on Hyland A, Borland R, Li Q, et al. Individual-level predictors
of cessation behaviours among participants in the International Tobacco Control (ITC) Four Country
Survey. Tob Control. 2006;15 Suppl. 3:iii8394.
36
Id.
37
Id., at 768
38
Id.
39
See Food and Drug Admin., FDA Warns of Health Risks Posed by E-cigarettes, FDA CONSUMER UPDATES,
1, http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM173430.pdf (Jul. 2009).
40
See New York Times Editorial Board, Lethal Liquid Nicotine, NEW YORK TIMES, Mar. 24, 2014,
http://www.nytimes.com/2014/03/25/opinion/lethal-liquid-nicotine.html? r = 0
41
Paradise, supra note 21.
42
See Centers for Disease Control, Notes from the Field: Calls to Poison Centers for Exposures to
ECsUnited States, September 2010February 2014, MORB. MORTAL. WKLY. REP., Apr. 4, 2014, 63(13)
292293, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6313a4.htm
43
Id.

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RAY

nicotine by children.44 Thus, ECs pose a significant health risk to children if

they are not packaged or contained properly.45
Additionally, nicotine is a highly addictive drug.46 Some argue that many
teens who start using ECs may be condemned to struggling with a lifelong
addiction to nicotine.47 There is also concern that EC use may lead young
people to use TCs in the future: this is known as the gateway effect.48 According
to a Centers for Disease Control study, teenage users of ECs indicated that
they are more likely to smoke TCs in the future than their counterparts who do
not use ECs.49 One health study, however, suggests that the opposite is true.50
This study found that most EC users between ages 13 and 18 began using TCs
and then switched over to ECs.51
Further, the FDA cautions that not enough research has been conducted
to know the full extent of health effects caused by ECs.52 Due to a lack of
in-depth study and research, it is not known with medical certainty whether
EC vapor is safer than TC smoke, even though EC vapor contains far fewer
toxic chemicals than TC smoke.53
In addition, ECs have the potential to revive the smoking culture in
the United States, a culture that has taken decades to dismantle.54 More than
250,000 youths who had never smoked a TC had used an EC in 2013.55 A
revival of the smoking culture, which was prevalent in decades past, could
result in an increase in nicotine-dependent youth.56
Contrarily, a recent study published in Toxicology and Applied Pharmacology found that [ECs] are not safer than [TCs].57 In addition, vaping an
44

Id.
Id.
46
See E-cigarette Use More Than Doubles Among U.S. Middle & High School Students from 2011-2012,
Ctr. for Disease Control, http://www.cdc.gov/media/releases/2013/p0905-ecigarette-use.html (Sept. 5,
2013); See also Roy Prussel, Electronic Cigarettes: Do We Know the Benefits vs. the Risks?, 56 Brit.
Colum. Med. J. 398, (2014) (discussing the importance of keeping ECs out of the reach of vulnerable
persons, including children).
47
Id.
48
See GATEWAY DRUG, Merriam-Webster.com, http://www.merriam-webster.com/dictionary/gateway%
20drug (last visited Oct. 7, 2015).
49
Pennington, supra note 18.
50
See Farsalinos et al., supra note 18.
51
Id.
52
FDA Warns of Health Risks Posed by E-cigarettes, supra note 39.
53
Pennington, supra note 18.
54
See Lawrence O. Gostin & Aliza Y. Glasner, E-cigarettes, Vaping, & Youth (2014) 312 JAMA 596,
http://jama.jamanetwork.com/article.aspx?articleid = 1886077.
55
See More Than a Quarter-Million Youth Who Had Never Smoked a Cigarette Used E-cigarettes
in 2013, CTRS. FOR DISEASE CONTROL MEDIA RELATIONS, http://www.cdc.gov/media/releases/2014/
p0825-e-cigarettes.html (Last visited Oct. 7, 2015).
56
Franck et al., supra note 7.
57
See Sara Marini, Girgio Buonanno, Luca Stabile, & Giorgio Ficco, Short-term Effects of Electronic
& Tobacco Cigarettes on Exhaled Nitric Oxide (2014) 278 TOXICOLOGY & APPLIED PHARMACOLOGY 9,
http://www.sciencedirect.com/science/article/pii/S004100814001367.
45

REGULATING ELECTRONIC CIGARETTES

221

e-cigarette for 10 minutes causes a significant increase in airway resistance in

the cardiovascular system.58 However, the conductors of this study cautioned
that [t]he authors, . . . point out that on the basis of the current literature
no definitive results can be provided to clearly evidence the main parameter
affecting lung function during e-cigarette vaping.59
A. Studies Showing That Electronic Cigarettes Pose a Negligible Health
Risk
Studies concluding that health risks associated with ECs are substantially
lower than the risks of TCs are becoming more abundant.60 In [ECs], such
chemicals may be formed from the heating process during liquid evaporation;
however, the levels found were lower compared to tobacco cigarettes by orders
of magnitude.61
EC vapor, however, is probably much less harmful than TC smoke.62 It
is not harmless.63 Concentrations of toxins in EC vapor are below 1/20th of
those found in TCs.64 Further, another study found that [n]o adverse effects
on [heart] function were observed after using electronic cigarette[s] with
nicotine-containing liquid . . .65
Further, and perhaps most important, the use of ECs may help TC
smokers quit or reduce the number of TCs smoked.66 Because ECs mimic the
smoking experience of TCs, they may be more effective in helping people
quit smoking than other NRTs like nicotine gum or nicotine patches.67
Noting the potential that ECs have to reduce the overall number of
TCs smoked, a recent BBC article warned the WHO and the FDA not to
unnecessarily overregulate or stigmatize ECs.68 The article cites a University
of London study that claims that up to 6,000 lives could be saved for every
million EC users by helping traditional smokers quit or reduce their TC use.69
This study found trivial amounts of toxins present in secondhand EC vapor,
suggesting that banning them in public places would be overkill.70
58

Id.
Id.
60
See Farsalinos et al., supra note 18; see also Adam Miller, E-cigarette Debate Divides Regulators
& Consumers (2014) 186 CANADIAN MED. ASSN J. E481-E482, http://www.cmaj.ca/content/186/13/
E481.full?sid = baeb9705-fa49-4098-8bc9-7a7f9268d958.
61
Id.
62
Miller, supra note 60.
63
Id.
64
See Nick Triggle, E-cigarette Criticisms Alarmist Say Researchers, BBC (Sept. 4, 2014) http:
//www.bbc.com/news/health-29061169.
65
Farsalinos et al., supra note 18.
66
Id.
67
Pennington, supra note 18.
68
Triggle, supra note 64.
69
Id.
70
Id.
59

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RAY

Allowing the use of ECs in public places may give TC users an incentive
to switch to ECs because TCs may not be smoked in many public places.71
An adequate understanding of the health effects of EC use is hazy
at best.72 Thus, it is understandable that many interested parties advocate
utilizing the precautionary principle, in which the public takes precaution in
regulating public health concerns that are not yet fully understood, like ECs.73
An article entitled E-Cigs and Minors: Kid Taste, Adult Problem, argues EC
regulation is an area precisely where the precautionary principle should be
applied.74
ECs have tremendous potential to reduce the number of current and
future TC users through harm reduction.75 The notion of harm reduction is
simple and is explained by Zachary Cahna and Michael Siege in their scholarly
article on harm reduction: Harm reduction is a framework for public health
policy that focuses on reducing the harmful consequences of [use of a harmful
substance] without necessarily reducing or eliminating the use itself.76
The fact that EC use can suppress a traditional smokers craving for a
cigarette is significant because this shows the potential of ECs to be more
effective than current smoking cessation methods such as nicotine gum or
Chantix, which do not provide smokers with this smoking experience.77 According to a study conducted in cooperation with the National Institute for
Health Innovation, ECs are at least as effective as approved NRTs like nicotine
patches in helping TC users quit smoking.78
Facilitating a switch from traditional cigarettes to ECs could save billions
in health care expenditures and lost productivity, while preventing millions
of premature deaths in the United States. ECs can be used to help reduce
the exposure of TC smokers to the harmful effects of cigarettes. Although
ECs are not harmless, they are much less harmful than TCs.79 Focusing on
steering new and existing TC smokers toward using ECs will help reduce
71

See Mike Esterl, E-cigarettes Encounter Rising Heat, WALL STREET JOURNAL, Dec. 18, 2013, http:
//online.wsj.com/articles/SB10001424052702304866904579266070565485270
72
Marini et al., supra note 57; Pennington, supra note 18.
73
Saitta et al., supra note 19.
74
See Sasika Subramaniam, E-cigs & Minors: Kid Taste, Adult Problem? THE NETWORK FOR PUBLIC HEALTH
LAW (Mar. 15, 2013 10:24 AM), http://www.networkforphl.org/the network blog/2013/03/15/166/.
75
See Zachary Cahna & Michael Siege, ECs as a Harm Reduction Strategy for Tobacco Control: A Step
Forward or a Repeat of Past Mistakes? (2012) 32 J. PUB. HEALTH POLY, 16-31; Saitta et al., supra note
19.
76
Id.
77
Id.
78
See Christopher Bullen, Colin Howe, Murray Laugesen, Hayden McRobbie, Varsha Parag, Jonathan
Williman, & Natalie Walker, Electronic Cigarettes for Smoking Cessation: A Randomized Controlled Trial, 382 LANCET, 162937, Sept. 7, 2014, http://www.thelancet.com/journals/lancet/article/
PIIS0140-6736(13)61842-5/abstract
79
See Farsalinos et al., supra note 18.

REGULATING ELECTRONIC CIGARETTES

223

exposure to TCs. The potential of ECs to assist in harm reduction should

be considered by legislatures and public health regulators when formulating
regulations pertaining to ECs.
III. THE CURRENT FEDERAL, STATE, AND MUNICIPAL
REGULATORY ENVIRONMENT FOR ECS
The regulatory environment of ECs is analogous to the wild wild west,
according to the director of the FDAs Center for Tobacco Products, Mitch
Zeller.80 Due to a lack of regulations or guidance from federal health agencies
or Congress regarding ECs, municipal and state government agencies have
promulgated rules and regulations that limit or restrict access to ECs.81
The FDA may only regulate certain tobacco products under the Food,
Drug, and Cosmetic Act (FDCA).82 Currently, the FDA has the authority to
regulate cigarette tobacco, roll-your-own tobacco, and smokeless tobacco such
as snuff, dip, and chewing tobacco.83 ECs, however, are not considered tobacco
products under the FDCA, and the FDA has no authority to regulate ECs
unless they are marketed and sold for therapeutic purposes.84 The MerriamWebster Dictionary defines therapeutic as of or relating to the treatment
of disease, and courts have interpreted the word therapeutic as such.85 The
Supreme Court ruled in Brown that [t]he inescapable conclusion is that there
is no room for tobacco products within the FDCAs regulatory scheme. If
they cannot be used safely for any therapeutic purpose, and yet they cannot
be banned, they simply do not fit.86 Currently, the FDA approves no ECs
marketed for therapeutic use in the United States.87
80

See Judy Woodruff, Appeal Growing Among Kids, FDA Cracks Down on Wild West of Ecigarettes, PBS (Apr. 24, 2014, 6:18 PM), http://www.pbs.org/newshour/bb/appeal-growing-amongkids-fda-cracks-wild-west-e-cigarettes/.
81
See generally IDAHO CODE ANN. 39-5705 (2012); WIS. STAT. ANN. 134.66 (West 2012).
82
See generally 21 U.S.C.A. 387a (West 2014).
83
Id.
84
See Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 122 (2000);
DEPT OF HEALTH & HUMAN SERVS., FOOD & DRUG ADMIN., Innovative Products and Treatments to
Achieve Abstinence from Tobacco Use, Reductions in Consumption of Tobacco, and Reductions in
the Harm Associated with Continued Tobacco Use, Report to Congress, available at http://www.
fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM348930.pdf. Currently,
only cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products are subject
to FDAs tobacco authorities under Chapter IX of the FD&C Act.
85
Therapeutic, Merriam-Webster.com, http://www.merriam-webster.com/dictionary/therapeutic (last
visited Oct. 10, 2015); Food & Drug Admin. v. Brown, 529 U.S. at 122; see also Smoking Everywhere, Inc. v. U.S. Food & Drug Admin., 680 F. Supp. 2d 62 (D.D.C. 2010) affd sub nom. Sottera,
Inc. v. Food & Drug Admin., 627 F.3d 891 (D.C. Cir. 2010); see also Natl Nutritional Foods Assn. v.
Mathews, 557 F.2d 325 (2d Cir. 1977).
86
Food & Drug Admin. v. Brown, 529 U.S. at 122.
87
See Electronic Cigarettes, DEPT. OF HEALTH & HUMAN SERVS., http://betobaccofree.hhs.gov/
about-tobacco/Electronic-Cigarettes/ (last visited Oct. 10, 2015).

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The Supreme Court also determined in Brown that if a device is marketed

as a drug, device, or drugdevice combination under the FDCA, then the FDA
may only move to restrict or otherwise impede the sale, manufacture, or
distribution of a drug, device, or drugdevice combination after weighing the
products risks against its benefits pursuant to 21 U.S.C. 360c(a)(2).88
In 2010, the D.C. Circuit Court of Appeals considered Smoking Everywhere, Inc. v. FDA, in which an EC importer sued the FDA after the FDA seized
one of the EC importers imports of ECs from an overseas manufacturer.89
This is the first instance by the FDA to regulate the importation of ECs.90 The
FDA asserted that it had the authority to do this under the FDCA because
the ECs were not approved for human consumption by the FDA.91 The EC
manufacturers, who were the plaintiffs in Smoking Everywhere, asserted that
their ECs were tobacco products, and not drugs, drug devices, or drugdevice
combinations, and were thus outside the regulatory authority of the FDA.92
An injunction was granted for the EC manufacturers, and against the FDA,
by the Circuit Court for the District of Columbia, which ruled that the FDA
does not have the statutory authority to impose regulations on ECs under the
FDCA because the FDA only has the authority to regulate drugs, devices, or
drugdevice combinations under the FDCA, and ECs are not drugs, devices,
or drugdevice combinations.93 The D.C. District Court chastised the FDAs
overreaching, urging that the FDA should take a conservative approach to
regulating ECs, stating that
[t]his case appears to be yet another example of FDAs aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically,
notwithstanding that Congress has now taken the unprecedented step of granting
FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its
tenacious drive to maximize its regulatory power has resulted in its advocacy of an
interpretation of the relevant law that I find, at first blush, to be unreasonable and
unacceptable.94

Additionally, the court in Smoking Everywhere determined that the ECs

were not drugdevice combinations because the ECs were not customarily
marketed for the purpose of treating nicotine withdrawal.95
88

Food & Drug Admin. v. Brown, 529 U.S., at 140; see also 21 U.S.C. 360c(a)(2).
Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62.
90
Id.
91
Id.
92
Id.
93
See id. 21 U.S.C.A. 321(g)(1) (West); see also id.; F. Hardin, Comment, Blowing Electronic Smoke:
ECs, Regulation, & Protecting the Public Health (2011) 2011 U. ILL. J.L. TECH. POLY. 433, 443; Duff
Wilson, Judge Orders F.D.A. to Stop Blocking Imports of E-cigarettes from China, N.Y. TIMES (Jan. 14,
2010), http://www.nytimes.com/2010/01/15/business/15smoke.html.
94
Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62. The D.C. Circuit Court denied a rehearing on
this matter on Jan. 24, 2011, affirming the D.C. District Courts ruling on the matter.
95
Id.
89

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In response to the decision of the DC Circuit Court, the FDA proposed

a rule, entitled Deeming Tobacco Products to Be Subject to the Federal Food,
Drug, & Cosmetic Act, as Amended by the Family Smoking Prevention &
Tobacco Control Act, which would allow the FDA to regulate ECs under the
Family Smoking Prevention and Tobacco Control Act (TCA) by deeming ECs
to be tobacco products.96 This would bring ECs under the regulatory authority
of the FDA.97 At the time of publishing of this commentary, the proposed
rule is still pending; however, the FDA has sent multiple warning letters to
EC manufacturers warning them against deceptive advertising practices.98
The TCA, enacted in 2009, expanded the FDAs authority to regulate tobacco
products: [t]obacco products, . . . shall be regulated by the Secretary [of the
FDA] under this chapter.99 The TCA broadened the FDAs regulatory power
regarding tobacco products beyond the FDCA and allowed the FDA to create
rules to reduce access of minors to tobacco products.100 In 2009, the FDA
used this grant of authority to place larger, more prominent warning labels
on tobacco products, to ban the sale of tobacco from vending machines, and
to give the FDA broader authority to inspect, audit, and observe tobacco
companies.101
The director of the FDAs Center for Tobacco Products, Mitch Zeller,
predicts that the regulatory environment of ECs will become more uniform
and efficient after the FDAs proposed rule is enacted.102
[The FDA] will be the gatekeeper standing between the companies, their product
developers, their marketers and consumers. And we will be the ones to make the
decisions on whether health claims can be made. We will be the ones to make
decisions reviewing evidence on whether new products can come to market.103
96

See Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, as Amended
by the Family Smoking Prevention & Tobacco Control Act; Regulations on the Sale & Distribution of
Tobacco Products & Required Warning Statements for Tobacco Products, 79 FED. REG. 80 (Apr. 24,
2014) (to be codified at 21 C.F.R. Pts. 1100, 1140, & 1143).
97
Id.
98
See FOOD AND DRUG ADMIN., Warning letter, Apr. 2, 2015, http://www.fda.gov/ICECI/
EnforcementActions/WarningLetters/ucm441302.htm; FOOD AND DRUG ADMIN., Warning letter,
Apr. 2, 2015, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm441314.htm; FOOD
AND DRUG ADMIN., Warning letter, Apr. 2, 2015, http://www.fda.gov/ICECI/EnforcementActions/
WarningLetters/ucm441310.htm; See also Laurie Tarkan, How New Rules Could Kill the Vaping
Boom, FORTUNE, Sep. 29, 2015; http://fortune.com/2015/09/29/vaping-fda-rules/; see also FDA supra
note 96.
99
See PUBLIC LAW 111-31 Sec. 901, modifying 21 USC 387a. Tobacco products, including modified risk
tobacco products for which an order has been issued in accordance with section 911, shall be regulated
by the Secretary [of the FDA] under this chapter.
100
See FOOD & DRUG ADMIN., Overview of the Family Smoking Prevention and Tobacco Control
Act, http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
UCM336940.pdf (last visited Oct. 10, 2015).
101
See generally PUB. L. 111-31 907, PUB. L. 111-31 906,
102
Woodruff, supra note 80.
103
Id.

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Under the proposed rule, the FDA would impose uniform and consistent
restrictions at the federal level, such as a minimum age requirement, placing
warning labels on packaging, overseeing the purity of ingredients of ECs,
and banning the use of flavoring in ECs.104 Further, the FDA would require
approval of new EC products before they could be sold,105 would ban the
distribution of free samples of ECs,106 and would ban the sale of ECs from
vending machines.107 These new regulations would preempt less stringent state
and municipal regulations pertaining to ECs.108
Although the period for public comment has ended, the FDA rule has
not taken effect, and the FDA has not released a timeline disclosing when
the FDA plans to have a proposed final rule and when that is expected to
take effect.109 An optimistic date by which the FDA should have issued a final
deeming rule was one year from the date of the rules comment deadline,
which would be April 25, 2015.110 This date has long since passed. It is likely,
however, that the FDA will take significantly longer than one year to issue a
final deeming rule, and as of the date of publication of this commentary, the
rule has not become effective despite over 18 months having passed since the
original comment deadline.111
In the absence of federal oversight on the manufacture, sale, or use of
ECs, it is left to states and municipalities to fill this regulatory gap by enacting
regulations to protect the public from the known risks of ECs, including use
by minors and ingestion of liquid nicotine by children.112 A Tobacco Control
study briefly summarizes the status of statewide EC regulations in effect:
Thirty-four states laws address e-cigarettes either explicitly or as part of language
applying to tobacco-derived or nicotine-containing products. Laws explicitly addressing e-cigarettes primarily focus on youth access (22 states) or smoke-free air
(12 states); . . . Similarly, tobacco-derived or nicotine-containing products are primarily regulated through youth access restrictions (6 states), smoke-free air laws (5
states), or excise taxation (2 states).113
104

Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, supra note 96.
Id.
106
Id.
107
Id.
108
Id.
109
See Tim Devaney, E-cig Rules Draw More than 70,000 Comments, THE HILL, Aug. 8, 2014,
http://thehill.com/regulation/214631-e-cig-rules-draw-more-than-70000-comments. See also Issue
Snapshot on Deeming: Regulating Additional Tobacco Products, Food and Drug Admin., Jan. 2015,
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM397724.pdf
110
Id.
111
Id; see also Laurie Tarkan, supra note 98; http://fortune.com/2015/09/29/vaping-fda-rules/; see also
FDA supra note 96.
112
See C.K.Gourdet, J.F.Chriqui, & F.J.Chaloupka, A Baseline Understanding of State Laws Governing Ecigarettes (2014) 23 TOBACCO CONTROL 3, 37, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078672/
(50 state survey data current as of Nov. 15, 2013).
113
Id.
105

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227

Many states have instituted their own regulations of ECs, including a

ban on sales to persons under the age of 18, levying a special tax on ECs,
as well as a ban on using ECs in public places such as libraries, city halls,
and museums.114 These states include Utah, North Dakota, Arkansas, and
California.115 Other states, including Nevada and Kentucky, allow EC use in
public places as an incentive for the public to use ECs rather than TCs.116
In New Hampshire, neither ECs nor liquid nicotine may be sold to persons under the age of 18.117 Other states that have enacted legislation banning
the sale of ECs to minors include California,118 Colorado,119 Idaho,120 Illinois,121
Maryland,122 Minnesota,123 New Jersey,124 New Hampshire,125 Tennessee,126
Utah,127 and Wisconsin.128
In 10 states, however, there are no laws prohibiting the sale of ECs to
minors.129 Many municipalities in these states, however, have enacted restrictions on EC sale to minors.130 States in which a bill has been rejected by the
state legislature that would have banned the sale of ECs to minors include
Arizona131 and Vermont.132
114

Dantonio, supra note 15.

States and Municipalities with Laws Regulating Use of Electronic Cigarettes, The American Nonsmokers Rights Foundation, Oct. 2, 2015, https://cats.informa.com/PTS/proof/external/
prepareCorrectionsFrames.do?nopopup=true&manuscriptId=1121076&t=MANUSCRIPT
116
See generally Demographics of Tobacco Use, ORAL CANCER FOUND., http://www.oralcancerfoundation.
org/tobacco/demographics.php (last visited Oct. 11, 2015) (finding that smoking prevalence among
adults in Nevada is 31.5% and in Kentucky is 29.7%).
117
See generally 2009 N.H. Rev. Stat. Ann. 126-K:3
118
See generally CAL. HEALTH & SAFETY CODE 119405 (2011).
119
See generally COLO. REV. STAT. ANN. 8-13-121 (2011).
120
See generally IDAHO CODE ANN. 39-5705 (2012).
121
See generally 720 ILL. COMP. STAT. 678/7 (2014).
122
See generally MD. CODE ANN., Health Gen. 24-305(2012).
123
See generally MINN. STAT. 609.6855 (2010) purchaser must be 19.
124
See generally N.J. STAT. ANN. 2C:33-13.1 (2010).
125
See generally N.H. REV. STAT. ANN. 126-K:4 (2010).
126
See generally TENN. CODE ANN. 39-17-1504 (West 2012).
127
See generally UTAH CODE ANN. 76-10-104 (2010).
128
See generally WIS. STAT. ANN. 134.66 (West 2012)
129
Marcus, supra note 1.
130
See LeAnn Eckroth, Bismarck Bans E-cigarette Sales to Minors, THE BISMARCK TRIBUNE, Feb. 11, 2014,
http://bismarcktribune.com/news/local/govt-and-politics/bismarck-bans-e-cigarette-sales-to-minors/
article cc176c66-938a-11e3-b224-0019bb2963f4.html (discussing city of Bismarck, North Dakotas,
adopting of an ordinance that bans the sale of electronic cigarettes to minors); see also Maria Roque &
Laura Rice, How Central Texas Cities Regulate (or Dont Regulate) E-cigarettes, KUT.org, Jun. 6, 2014,
http://kut.org/post/how-central-texas-cities-regulate-or-dont-regulate-e-cigarettes (discussing city of
Kyle, Texass, adopting of an ordinance that bans the sale of electronic cigarettes to minors); see also
James Day, Corvallis Limits Sales, Use of Electronic Cigarettes, CORVALLIS GAZETTE-TIMES, Dec. 30,
2013,
http://www.gazettetimes.com/news/local/corvallis-limits-sales-use-of-electronic-cigarettes/
article 31baae2e-71bd-11e3-99a7-001a4bcf887a.html (discussing city of Corvallis, Oregons,
adopting of an ordinance that bans the sale of electronic cigarettes to minors).
131
See generally 2012 ARIZ. LAWS SB 1280, http://www.azleg.gov/legtext/50leg/2r/bills/sb1280h.pdf.
132
See generally 2014 VERM. LAWS H. 747, 14-0108, http://www.leg.state.vt.us/database/status/summary.
cfm?Bill = H.0747 & Session = 2012.
115

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For example, the city of New York passed legislation that took effect in
early 2014 that bans the use of ECs in all places where smoking is prohibited,
such as in public parks and inside public buildings.133 This legislation amended
existing antismoking laws to include ECs.134 Further, the legislation imposed
stricter age restrictions than most other states and municipalities: the sale of
ECs is restricted to those 21 and older.135
IV. THE CURRENT REGULATORY SCHEME OF ECS IS
INEFFECTIVE AND INCONSISTENT
A. Dangers of Overregulation of ECs
The FDAs public stigmatizing of ECs, without conclusive evidence that
they are harmful, will lead Americans to disregard the benefit that ECs can
provide the public. Public stigmatizing of ECs sours the public image of ECs
and hinders a national discussion about how ECs may be utilized to decrease
TC use in the United States.
Bringing ECs within the jurisdiction of the TCA would allow the FDA
to ban free samples of ECs.136 Giving out free samples allows current TC users
to see for themselves that ECs provide a smoking experience similar to TCs.
If TC users are provided free samples of ECs and can see that ECs allow them
to puff, inhale, and receive a buzz, all without lighting up a more harmful TC,
then users will be more inclined to switch to ECs.
Further, a ban on the sale of ECs from vending machines would decrease access of the public to ECs in places like nightclubs and bars, where
social cigarette use is common.137 Access to ECs in vending machines has
the potential to keep social smokers away from TCs by providing them with
the smoking experience without the use of a harmful TC. Banning the sale of
ECs by vending machine would decrease access of key demographics (social
smokers) to ECs.
The FDA should be cautious when it uses its new regulatory authority to
promulgate regulations of ECs. New regulations should only serve to protect
the public from known harms and should not seek to unnecessarily reduce
access to ECs based on an abundance of caution or for fear that there could be
adverse health consequences that are unknown. Future regulations should be
rooted solely concrete science and not in speculation or needless precaution.
133

See generally City of New York Smoke Free Air Act of 2002 amendments, http://www.nyc.gov/html/
doh/html/environmental/smoke-free-act.shtml
134
Id.
135
Id.
136
Deeming Tobacco Products to Be Subject to the Federal Food, Drug, & Cosmetic Act, supra note 96.
137
Ray Hainer, Social Smokers Arent Hooked on Nicotine, Just Smoking, CNN, Apr. 24, 2010, http:
//www.cnn.com/2010/HEALTH/04/24/social.smokers/.

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229

Uniform age restrictions, regulations on the purity of ingredients in

ECs, mandatory childproof packaging and design of ECs, as well as warning
labels on EC packaging are beneficial rules the FDA could implement that
would protect the public from known, tangible harms and would not otherwise
needlessly restrict access to ECs.
V. A MORE BALANCED METHOD OF REGULATING THE EC
MARKET
An appropriate and effective regulation of the EC market would balance
the interests of safety and consumer protection and the benefits that ECs can
provide in terms of lives and resources saved.
The FDA should not implement restrictive regulation on ECs until conclusive evidence is presented that would justify that regulation. For example,
a ban on ECs in public places should not be promulgated by the FDA until sufficient evidence is produced that ECs are significantly harmful to bystanders.
Persons over age 18 should have unrestricted access to ECs at any place
TCs are sold, with valid government identification. It is imperative that ECs
are widely available not only in places where TCs are available for purchase
but also in vending machines. Further, it is crucial to set uniform laws at the
federal level so that EC safety, quality, packaging, and labeling standards apply
uniformly to all states and municipalities within the United States because the
current regulatory scheme is inadequate in some states and municipalities and
too restrictive in others.
Many antitobacco advocates have called for intense, restrictive regulations on ECs, relying on the reasoning that the health effects of ECs have not
been adequately studied.138 Though it is of utmost importance to protect the
public from adverse health effects when possible, regulations promulgated
due to overprecaution tend to preclude the benefits of the regulated product.
Though the FDA should not ignore adverse health effects of ECs, it
should likewise not ignore the benefits that ECs could provide the American
public. A balanced approach to the regulation of ECs will allow tapping into
the benefits of ECs while ensuring the safety of users.
A. Financial Incentives to Switch to Electronic Cigarettes
Historically, one of the most effective incentives to reduce or eliminate
TC consumption has been to increase the cost of TCs.139 TC use declines
3%5% for every 10% increase in price.140 Congress should impose a reduced

138

Saitta et al., supra note 19.

Surgeon General, 50 Years, supra note 28.
140
Id.
139

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RAY

sales tax level on ECs, while gradually increasing the sales tax and excise tax
level on TCs.
An increase or decrease in the federal excise tax on tobacco products
directly correlates with fluctuation in the price paid for the tobacco product by
the consumer.141 Further, changes in the price of tobacco products will create a
more powerful incentive for lower income persons, who are more likely to be
enrolled in government health programs like Medicaid, to make the switch.142
Reducing the number of TC smokers who utilize public aid programs like
Medicaid will amount to a substantial decrease in public spending on medical
costs related to tobacco-related preventable disease.
Financial incentives have the potential to persuade TC users to switch
to ECs, which will result in reduced spending on health care and saved lives.
B. The FDA Should Treat Electronic Cigarettes as a NRT
Upon further study, the FDA should consider allowing physicians to
recommend ECs as a smoking cessation aid, like Chantix or Nicorette, to
persons attempting to quit smoking TCs. In this case, the physician could
prescribe ECs with gradually lower concentrations of nicotine. The FDA
should recognize ECs as a NRT or as a smoking cessation device.
C. Protection of the Public from Known Risks
The FDA should restrict the sale of ECs to those aged 18 years and
older. The age at which persons may purchase TCs is 18 in all but four
states.143 Requiring an age of 21 would steer seekers of ECs between the ages
of 18 and 21 toward TCs, which are much more harmful. Although many
states already do this,144 a federal rule would set an age requirement in the 10
states that have no minimum purchase age for ECs.
The FDA should require tamper-proof packaging and child safety features on every EC and on the packaging of every EC, similar to the requirements that became effective in Illinois in January 2015.145 This Illinois law
requires [e]lectronic cigarette liquids sold and marketed for the refilling of
e-cigarettes may be sold only in special packaging. The Department of Public
141

N. Jamison, M. Tynan, A. MacNeil, & R. Merritt, Federal and State Cigarette Excise TaxesUnited
States, 19952009, OFFICE ON SMOKING & HEALTH, NATL CTR. FOR CHRONIC DISEASE PREVENTION &
HEALTH PROMOTION, CDC (May 22, 2009), http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5819a2.
htm.
142
Id.
143
See New Jersey May Become First State to Raise Smoking Age to 21, FOX NEWS (Aug.
7, 2014), http://www.foxnews.com/politics/2014/08/07/new-jersey-may-become-first-state-to-raisesmoking-age-to-21/.
144
See generally Alternative Nicotine ProductsElectronic Cigarettes, NATL CONFERENCE OF STATE LEGISLATURES, Oct. 9, 2015, http://www.ncsl.org/research/health/alternative-nicotine-products-e-cigarettes.
aspx.
145
See generally 430 ILL. COMP. STAT. 40/10 (2014).

REGULATING ELECTRONIC CIGARETTES

231

Health shall adopt rules establishing the standards for special packaging to be
used for e-cigarette liquids.146 This would reduce the risk posed by the liquid
nicotine found inside most commercially available ECs.
The FDA should not ban flavored ECs or flavored liquid nicotine, because these provide an incentive to smoke ECs over TCs, which are only
available with no flavor or with menthol. The flavoring of ECs adds an incentive to the use of ECs over TCs, particularly in young people.
The FDA should discontinue its negative publicity campaign against
ECs and acknowledge the potential benefits that ECs can provide. The FDAs
broad, general stigmatizing of EC use interferes with the harm reduction
strategy.
If ECs can reduce TC consumption, the United States will see a decline
in health care expenditures and a decline in preventable deaths.
CONCLUSION
Despite the FDAs attempt to regulate the EC market, studies are beginning to emerge that ECs can provide benefits to its users by steering new and
existing TC smokers away from TCs.147
U.S. public health agencies, including the FDA under its new authority,
should balance their approach to ECs. Any regulation promulgated should
take into account both known and researched risks associated with EC use
and not out of fear that there may be unknown risks. Overregulation would
stigmatize and decrease availability of ECs for people who could benefit from
them.
The FDA, under its new authority pursuant to the Deeming Tobacco
Products to Be Subject to the Federal Food, Drug, and Cosmetic Act Rule,
should carefully implement minimally restrictive regulations that protect consumers from known risks regarding ECs. Most important, the FDA should
continue to study the risks and potential benefits that ECs can provide and
implement regulations based on a careful consideration of both the harms and
the benefits of ECs.

146
147

Id.
Farsalinos et al., supra note 18.