The Evolution of the Electronic Cigarette
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The Evolution of the
Electronic Cigarette
by Azim Chowdhury
Background ate an estimated $100 million annually in sales2, caused the
The electronic cigarette or “e-cigarette”—a rechargeable U.S. Food and Drug Administration (FDA) to take notice and,
battery-powered device designed to resemble a conventional in September 2008, add “Electronic Cigarettes and Electronic
tobacco cigarette—was originally developed and patented Cigarette Components” to Import Alert 66-41, halting the
in 2003 by RUYAN Group (Holdings) Ltd. (Ruyan), a com- importation of certain e-cigarette shipments from China.
pany based in Beijing, China. Ruyan first began selling its FDA declared e-cigarettes to be unapproved drug-device
e-cigarettes in May 2004, and by 2009 saw its annual revenues combination products that could not be sold in the United
skyrocket to $54 million USD.1 By 2007, thanks to the Internet, States without FDA pre-market approval.
the novel “tobacco-free” product started getting noticed by The e-cigarette is designed to resemble and mimic conven-
consumers in the United States, and its popularity has contin- tional cigarettes by providing inhaled doses of tobacco-derived
vaporized nicotine solution. When a user puffs through the
ued to swell with its growing presence in shopping mall kiosks
mouthpiece, a sensor detects the air flow and activates a heat-
and convenience stores around the country. The growing
ing element (i.e., the atomizer) which vaporizes the solution
popularity and market share of e-cigarettes, which now gener-
stored in a removable cartridge in the device. The vapor pro-
vides a flavor and physical sensation similar to that of inhaled
Azim Chowdhury is an Associate with tobacco smoke, although there is no tobacco, combustion or
the law firm of Keller and Heckman
smoke present.
LLP in Washington, D.C.
In response to FDA’s import ban, in April 2009, two of the
largest U.S. distributors of e-cigarettes, Smoking Everywhere,
Inc. (Smoking Everywhere) and Sottera, Inc. d/b/a NJOY
(Sottera) filed suit against FDA in the U.S. District Court for
30 Update May/June 2011 www.fdli.orgTobacco Regulation
the District of Columbia, seeking to quality problems related to e-cigarette drug-delivery devices and not tobacco
enjoin FDA from denying entry of their use to its MedWatch Adverse Event products. FDA maintained that the
products into the country, as well as from Reporting program;8 to date, FDA has Supreme Court’s decision in Brown
regulating their products as drug-deliv- not publicized any adverse events related only applied to “traditional” cigarettes
ery devices.3 The Plaintiffs argued that to e-cigarettes. and smokeless tobacco products, not to
their products should instead be treated The Plaintiffs in Sottera argued that novel nicotine-delivery systems. Sottera
and regulated in the same manner as because their products contain liquid countered, in pertinent part, that if ac-
conventional tobacco cigarettes. nicotine that is derived from tobacco, cepted, FDA’s position—that any product
In June 2009, shortly after the law suit their e-cigarettes fall within FDA’s to- affecting the structure/function of the
was filed, the Family Smoking Preven- bacco product jurisdiction rather than its body is automatically a drug under the
tion Tobacco Control Act (the Tobacco drug-device jurisdiction. The Plaintiff’s FDCA, even without express therapeutic
Act) was enacted, giving FDA authority position was initially vindicated when claims— “would dramatically expand
to regulate the manufacture, distribu- the District Court agreed, and held that FDA’s jurisdiction and produce absurd
tion, advertising, promotion, sale and use because the nicotine was derived from results that Congress never intended.”13
of tobacco products. A “tobacco product” tobacco, the tobacco-free e-cigarettes fell On September 9, 2010, just prior to
is defined in the Tobacco Act as “any within the meaning of “tobacco product” the oral arguments before the Court of
product made or derived from tobacco in the Tobacco Act, and were therefore Appeals, FDA sent Warning Letters to
that is intended for human consump- exempt from FDA regulation as drug- five e-cigarettes distributors.14 The letters
tion.”4 The new tobacco legislation filled device combination products.9 More spe- alleged that each of the companies made
the regulatory vacuum with respect to cifically, Judge Richard J. Leon held that unauthorized statements on their web-
tobacco products created by the Supreme because the Plaintiff’s e-cigarettes were sites, labels and advertising materials that
Court’s decision in FDA v. Brown & Wil- not marketed to prevent, mitigate or treat demonstrate that their products were
liamson Tobacco Corp., which held that the withdrawal symptoms of nicotine intended to affect the structure/function
of the body, as well as to mitigate, treat or
Congress had not yet given FDA author- addiction, and did not affect the struc-
prevent disease. More specifically, FDA
ity to regulate “customarily marketed” ture and function of the body any more
charged that claims suggesting that e-cig-
tobacco products (i.e., tobacco products than conventional cigarettes, the product
arettes could help smokers quit can only
marketed for recreational use only and did not fit the definition of a drug in the
be made after approval of a new drug
without manufacturer claims of thera- Food, Drug and Cosmetic Act (FDCA).10
application. Because the five e-cigarette
peutic benefit).5 Accordingly, the District Court granted
companies were allegedly making such
Subsequently, on July 22, 2009, FDA the Plaintiff’s motion to enjoin FDA from
claims without going through FDA’s pre-
issued a warning against the use of e- continuing to implement the import ban
market approval process, their products
cigarettes.6 The agency announced that and from treating e-cigarettes as drugs
were unapproved drugs. FDA also sent
its Division of Pharmaceutical Analysis absent claims of therapeutic benefit.11
a letter to the Electronic Cigarettes As-
analyzed the liquid nicotine from Smok- Rather than exercise its author-
sociation, an organization established to
ing Everywhere and Sottera’s e-cigarettes ity under the Tobacco Act to establish
promote industry-wide standards and a
and detected diethylene glycol, a regulations covering e-cigarettes as
code of conduct for e-cigarette technolo-
toxic chemical used in antifreeze, in one tobacco products,12 FDA continued to
gies, affirming that e-cigarette compa-
sample, as well as carcinogens, including advocate that e-cigarettes are drug-
nies must comply with FDA’s pre-market
tobacco specific nitrosamines, in several delivery devices. It appealed the District
drug approval process before marketing
other samples.7 Conspicuously missing Court’s decision and filed an emergency
their products.
from FDA’s analysis, however, was any motion with the U.S. Court of Appeals
mention of what toxins and carcinogens for the District of Columbia Circuit to U.S. Court of
are typically found in traditional tobacco stay the District Court’s decision. On Appeals Decision
cigarettes. FDA also requested that appeal, FDA argued that although Sot- FDA’s continued efforts to character-
healthcare professionals and consumers tera did not make express therapeutic ize e-cigarettes as drug-delivery devices
report serious adverse events or product claims, its e-cigarettes are nevertheless would soon take another blow, however.
FDLI May/June 2011 Update 31Tobacco Regulation
On December 7, 2010, the appellate has authority to regulate customarily Agency charged with interpreting the
court’s three-judge panel in Sottera marketed tobacco products under the new law, should be entitled to deference
unanimously ruled in favor of Sottera, Tobacco Act, and tobacco products mar- (i.e., Chevron deference).30 The Judge
the remaining plaintiff,15 and upheld the keted for therapeutic purposes under its stated, however, that because there was
District Court’s decision.16 The Court drug-device jurisdiction.22 The majority, no final agency action from FDA inter-
held that FDA lacks the authority to however, concluded its opinion with the preting the new law, there was no way
regulate e-cigarettes as drugs or devices, following caveat: “Of course, in the event to award such deference to the Agency’s
because (1) e-cigarettes fall within mean- that Congress prefers that FDA regulate e- position.31 He concluded with the fol-
ing of “tobacco product,” as defined in cigarettes under the FDCA’s drug-device lowing: “What the result would be were
the Tobacco Act, given that the nicotine provisions, it can always so decree.”23 the FDA to offer a contrary statutory
used in the Plaintiff’s product is derived interpretation in the form of a regulation,
Concurring Opinion I leave for the day the agency decides to
from tobacco plants and (2) Sottera’s e-
Judge Merrick B. Garland concurred take that step.”32
cigarettes were not marketed with claims
with the majority, but not entirely for On December 20, 2010, FDA, refusing
of therapeutic benefit, but rather, only for
the same reasons. Like the majority, to accept what appeared to be inevitable,
“smoking pleasure.”17 In other words, like
Judge Garland agreed that based on filed a Petition for a Rehearing and a Re-
traditional cigarettes, Sottera’s product
the plain language of the Tobacco Act, hearing En Banc, as well as a motion to
did not fall within FDA’s drug-device au-
Sottera’s e-cigarettes fall within mean- reinstate the stay of the District Court’s
thority because they were not marketed
ing of “tobacco product” because the decision to grant Sottera’s preliminary
with any drug claims.18
liquid nicotine used in those products injunction, arguing that the panel’s deci-
The Court’s majority (Judges Stephen
is derived from tobacco plants.24 There- sion was based on a “fundamental mis-
F. Williams and Brett M. Kavanaugh)
fore, e-cigarettes should be regulated as understanding” of the Brown decision.
made clear that they did not agree with
tobacco products and not drug-delivery FDA contended that the panel’s ruling
FDA’s interpretation of the meaning
devices.25 However, Judge Garland did would erode incentives for companies to
of the term “tobacco product” in the
not agree that the holding in Brown develop nicotine replacement therapies,
Supreme Court’s decision in Brown.19 extended to the e-cigarette situation.26 and would “exacerbate the problem of
FDA argued that in the Brown decision, Rather, he stated that the Supreme nicotine addiction and undercut an im-
the Supreme Court was only referring Court’s decision was only meant to portant tobacco control measure.” 33 On
to traditional cigarettes and smokeless apply to products that actually contain January 24, 2011, the Court of Appeals
tobacco when it used the phrase “tobacco tobacco - which e-cigarettes do not.27 unanimously denied the FDA’s en banc
products,” and, therefore, the Supreme According to Judge Garland, the reason rehearing request and left in place the
Court’s ruling that FDA did not have au- the Supreme Court in Brown held that injunction preventing FDA from barring
thority to regulate “customarily market- FDA did not have jurisdiction to regulate e-cigarette imports and from regulating
ed” tobacco products had no bearing on customarily marketed tobacco cigarettes the products as drug-devices.
the present e-cigarette situation.20 Rather, as drug-devices was because such prod- The ruling underscored the panel’s
Judges Williams and Kavanaugh sided ucts allegedly could not be used safely for original decision and forced FDA to
with Sottera and held that the Brown any therapeutic purpose, and would thus consider the extent to which it should
decision did not just apply to only those have to be banned by FDA if the Agency regulate e-cigarettes under the Tobacco
tobacco products for which Congress had drug-device authority over them.28 Act, or appeal to the Supreme Court.
had passed specific regulatory statues However, this premise does not hold true
(i.e., traditional cigarettes and smokeless for e-cigarettes or other tobacco-free Regulation of E-Cigarettes
tobacco) but to all tobacco products as products that deliver pure nicotine; these under the Tobacco Act
customarily marketed.21 Accordingly, types of products could have therapeutic Although e-cigarettes meet the
the Court’s majority held that based on benefits and would not necessarily have tobacco product definition in the To-
Brown, as well as Congress’ decision to to be banned.29 Finally, Judge Garland bacco Act, the new legislation does not
fill the regulatory vacuum by passing the acknowledged FDA’s argument that its automatically include the new products.
Tobacco Act, it was clear that FDA now interpretation of the Tobacco Act, as the Section 901 of the Tobacco Act provides
32 Update May/June 2011 www.fdli.orgTobacco Regulation
that the law “shall apply to cigarettes, e-cigarettes to minors. Strong majorities company to provide free e-cigarette
cigarette tobacco, roll-your-own tobacco, also prefer that FDA regulate e-cigarettes samples to passengers.41
and smokeless tobacco and to any other like other nicotine-containing products Supporting the pro e-cigarette effort
tobacco products that the Secretary [of and believe there should be marketing are two studies recently published by
Health and Human Services] by regula- restrictions on social networking sites researchers from the Boston University
tion deems to be to be subject” to the law popular among youth. School of Public Health and the Johns
(author’s emphasis). On April 5, 2011 Hopkins Bloomberg School of Medicine
– the last day FDA could petition the States Move to Regulate suggesting that the possible banning of
Supreme Court for a Writ of Certiorari E-Cigarettes e-cigarettes could actually further en-
to review the appellate court’s decision While FDA was pursuing its litigation danger the public health.42 The studies—
– FDA published a letter to stakeholders position, many state legislatures took apparently the first unbiased investiga-
on its website conceding defeat in the the initiative with regard to the tions into the use of e-cigarettes—found
e-cigarette litigation and announcing regulation of e-cigarettes. In January, smokers who used e-cigarettes had a 31
that it planned to regulate e-cigarettes New York lawmakers advanced a bill percent quit rate; traditional nicotine re-
as tobacco products. FDA must now go that would make the state the first placement therapies such as the nicotine
through a rule-making procedure and to ban e-cigarettes. In Colorado, patch and gum have only a 12-18 percent
promulgate a regulation on e-cigarettes. Democratic legislators introduced a quit rate.43 The studies did not examine
Specifically, the Tobacco Act requires the bill to expand the definition of tobacco the potential health risks or benefits of
Secretary to publish a notice of proposed products prohibited for sale to minors the actual e-cigarettes but measured only
rulemaking in the Federal Register, pro- to include “any device that is designed the quit rates for smokers compared to
vide a comment period of not less than to deliver inhaled, ingested or physi- available smoking cessation products.
60 days, and then: (A) if the Secretary cally applied doses of nicotine.” The bill The studies also claim that the proposed
determines that the standard would be further defines a tobacco product as “any bans could result in former smokers
appropriate for the protection of the cartridge that is designed to deliver in- who have switched to using e-cigarettes
public health, promulgate a regulation haled doses of any substance containing reverting back to tobacco cigarettes—
establishing a tobacco product standard any amount of nicotine.”36 In Spokane, which, as most would agree, would be far
and publish in the Federal Register find- Washington the City Council voted worse for their health.
ings on the matters referred to in subsec- unanimously to ban people under the
tion (c); or (B) publish a notice terminat- age of 18 from purchasing e-cigarettes.37 Conclusion
ing the proceeding for the development The U.S. Department of Transporta- The evolution of the e-cigarette from
of the standard together with the reasons tion (DOT) has even announced that it a potential drug-delivery device to a
for such termination.34 intends to impose a ban on e-cigarettes FDA-regulated tobacco product is nearly
on airplanes.38 complete. Although e-cigarettes will not
Public Perception of Although the list of those attempt- require FDA’s pre-market approval to be
E-Cigarettes ing to ban or impose restrictions on sold, FDA will be able to use its authority
FDA’s decision to regulate e-cigarettes e-cigarettes continues to grow, so does under the Tobacco Act to ensure that ap-
as tobacco products is in line with the the grass roots movement supporting propriate age and marketing restrictions
public’s desire that these products be the product. Supporters of e-cigarettes are in place, and also require e-cigarette
regulated. The University of Michigan’s have claimed victories in Illinois, where manufacturers and distributors to dis-
C.S. Mott Children’s Hospital recently advocacy efforts resulted in postpone- close all ingredients, additives and any
released results of a poll that found that ment of voting on a bill to ban sales of potentially harmful constituents used in
U.S. adults favor restrictions, safety test- e-cigarette,39 as well as in Virginia, where their products. The e-cigarette industry
ing and age restrictions for e-cigarettes.35 the Attorney General determined that should also welcome regulation as a way
Ninety-one percent of adults surveyed e-cigarettes were not included in the state to legitimize their business, and recog-
thought manufacturers should be re- smoking ban.40 Last year, before the DOT nize that regulation may ultimately help
quired to test e-cigarettes for safety and recently announced its position, a charter prove the e-cigarette to be a safer alterna-
85 percent favor prohibiting the sale of airline even partnered with an e-cigarette tive to traditional tobacco products. FDLI
FDLI May/June 2011 Update 33Tobacco Regulation
1 Jonathan K Noel, Vaughan W Rees and Gregory 33 Petition for Rehearing and Rehearing En Banc (Dec.
N Connolly, Electronic cigarettes: a new ‘tobacco’ 20, 2010); available at http://www.fdalawyersblog.
industry?, Tobacco Control Journal; available at com/FDA%20e-cigarett%20rehearing%20petition.
http://media.khi.org/news/documents/2010/10/29/ pdf.
ecigarettes-a_new_tobacco_industry.PDF (last 34 See Tobacco Act, Section 907(d).
updated Oct. 15, 2010). 35 National Poll on Children’s Health (Sep. 13, 2010),
2 Alicia Gallegos, FDA regulation of e-cigarettes available at http://www.med.umich.edu/mott/npch/
rebuffed again, American Medical News (Feb. 14, pdf/091310report.pdf.
2011); available at http://www.ama-assn.org/amed- 36 Ken Green, Bill seeks to ban sale of e-cigs to minors
news/2011/02/14/gvsb0214.htm. in Denver, state, Examiner.com (Feb. 23, 2011, 11:00
3 See Sottera, Inc. v. FDA, 680 F.Supp.2d 62 (D.C. Cir. AM), http://www.examiner.com/top-news-in-
Dec. 7, 2010). denver/bill-seeks-to-ban-sale-of-e-cigs-to-minors-
4 See the Tobacco Act § 1019(1), 21 U.S.C. § 321(rr)(1). denver-state#ixzz1FyoQowCf.
5 529 U.S. 120 (2000). 37 KREM.com, E-cigarette dealers support banning
6 Transcript for FDA’s Media Briefing on Electronic product to minors, NWCN.com (Feb. 8, 2011,
Cigarettes (Jul. 22, 2009, 1:30 PM); available at http:// 10:27 PM), http://www.nwcn.com/news/washing-
www.fda.gov/downloads/NewsEvents/Newsroom/ ton/115621224.html.
MediaTranscripts/UCM173405.pdf. 38 Roger Yu, Federal regulators to formally ban e-
7 Evaluation of e-cigarettes, Final Report on FDA cigarette use on planes, USA Today (Feb. 11, 2011);
Analyses (May 4, 2009); available at http://www. available at http://travel.usatoday.com/flights/
fda.gov/downloads/Drugs/ScienceResearch/ post/2011/02/federal-regulators-to-formally-ban-e-
UCM173250.pdf. cigarette-use-on-planes/142656/1.
8 MedWatch Online Voluntary Reporting Form; 39 Consumer Advocates for Smoke-Free Alternatives
available at https://www.accessdata.fda.gov/scripts/ Association (CASAA) Newsletter (May 11, 2010),
medwatch/medwatch-online.htm (last updated Jun. available at http://www.casaa.org/news/article.
12, 2009). asp?articleID=98&l=a&;p=.
9 See Sottera, Inc. v. FDA, 680 F.Supp.2d at 62. 40 CASAA Newsletter (Jun. 10, 2010); avail-
10 Section 321(g)(1) of the FDCA defines “drug,” in able at http://www.casaa.org/news/article.
pertinent part, as “articles intended for use in the asp?articleID=99&l=a&;p=.
diagnosis, cure, mitigation, treatment, or prevention 41 Charisse Jones, Charter airline gives out free Blu Cigs
of disease in man or other animals” and “articles electronic cigarettes, USA Today (Nov. 1, 2010); avail-
(other than food) intended to affect the structure or able at http://travel.usatoday.com/flights/2010-11-02-
any function of the body of man or other animals.” airlinesmoking02_ST_N.htm.
See 21 U.S.C. § 321(g)(1)(B) and (C). 42 Zachary Cahn and Michael Siegel, Electronic ciga-
11 Sottera, 680 F.Supp.2d at 63. rettes as a harm reduction strategy for tobacco control:
12 As discussed in the author’s November/December A step forward or a repeat of past mistakes?, Journal of
2010 Update Article (Update 2010, Issue 6), Elec- Public Health Policy (2010); available at http://www.
tronic Cigarettes: The Saga Continues. hsph.harvard.edu/centers-institutes/population-
13 Sottera Appellate Brief at 1 (Statement of the development/files/article.jphp.pdf.
Case); available at http://reason.com/assets/ 43 Ryan Moore, New study suggests e-cigarette ban could
db/12786080313937.pdf. be bad for public health, Examiner.com (Feb. 10, 2011,
14 FDA Warning Letters, sent to Gamucci America 6:16 PM), http://www.examiner.com/technology-
(Smokey Bayou, Inc.), E-Cig Technology, Inc., in-cincinnati/new-study-suggests-e-cigarette-ban-
E-CigaretteDirect, LLC, Johnson Creek Enterprises, could-be-bad-for-public-health.
LLC and Ruyan America, Inc.; available at http://
www.fda.gov/NewsEvents/PublicHealthFocus/
ucm172906.htm.
15 Plaintiff Smoking Everywhere, Inc. withdrew its
initial complaint and was not a party to the appeal.
16 Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010).
17 Id. at 897.
18 Id. at 898-99.
19 Id. at 895.
20 Id.
21 Id.
22 Id. at 898.
23 Id. at 899.
24 Id.
25 Id. at 904.
26 Id. at 901.
27 Id.
28 Id. at 900-01.
29 Id. at 901.
30 Id. at 902-03.
31 Id. at 903.
32 Id. at 904.
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