JURI 5622 Health Law Seminar Ryan Moxom

Smoke Without Fire: The Folly of Regulating E-cigarettes as Tobacco Products

I. Introduction

  “ATLANTA—Several eyewitnesses confirmed Tuesday that a man seen smoking a high-tech E-cigarette device must, in all likelihood, be some sort of futuristic bounty hunter in the midst of a covert time-stream-altering mission of critical importance..

“Judging by his cool, calm demeanor and the fact that he was inhaling what looked like e-fumes from some kind of shiny black mecha-cigarette, I’m just going to assume this guy has journeyed here from hundreds of years in the future to apprehend a dangerous digi-convict of some kind,” said data management analyst Paul Rankin,” 

Patrons at Brady’s Bar and Grill on Courtland Street say they first spotted the presumed futuristic mercenary in a corner booth smoking the cutting-edge nicotine delivery system. Sources then surmised that the criminal hunter from the distant future had likely been deployed to the bar to capture a defector from Quadrant 4.”

The above account is only somewhat unbelievable.1 While Atlanta is likely centuries

away from its first time travelling bounty hunter visit, the recent surge in popularity of electronic

cigarettes, or E-cigarette, products has produced many similar encounters between “vapers” and

curious onlookers across America. At first glance E-cigarettes are almost indistinguishable from

regular cigarettes; designed to mimic the look and feel of traditional cigarettes, emit a traditional

cigarette like vapor, and some models even feature light up tips used to simulate the glow of a lit

cigarette.

The differences between E-cigarettes and their traditional brethren are what informs

much of the debate presently occurring at the local, state, and federal level. Today’s E-cigarettes

are engineered to vaporize a nicotine solution, not a mixture of nicotine and other carcinogenic

chemicals like traditional cigarettes, that which can be discreetly and odor freely odorlessly

inhaled by a user. Without the dangerous mix of tobacco, nicotine, and dozens of other

chemicals, E-cigarettes are being billed by some as both a healthier alternative to smoking and an

efficient way to stop smoking altogether. The absence of health concerns that go along with

traditional cigarette smoking, such as substantial second hand smoke exposure, smell, irritation,

and associated types of cancers are reasons pointed to bywhy many that think E-cigarettes should

not be subject to the same set of regulatory schemes as traditional cigarettes.

But a large number of the claims made by E-cigarette makers and supporters have not yet

been backed by enough scientific research to fully prove or disprove them one way or another –

in other the available science is still out as to a widely accepted conclusion regarding the effects

and efficacy of E-cigarettes. Advocates for increased regulation of E-cigarettes, concerned with

potential health risks both to vapers and those around them, often cite the lack of conclusive long

term research as a reason to err on the side of caution with E-cigarettes. In addition to the

perceived potentiality of harmful effects from E-cigarette vapor itself, some believe that the E-

cigarette might lead to an increase in youth smoking through a normalization of smoking

behavior.

This paper will examine new E-cigarette technology and the public health impacts of

both electronic and traditional smoking. Current federal regulations regarding E-cigarettes will

be analyzed also. This paper will conclude byby suggesting that the FDA should not let the

benefits of this new technology be buried under a regulatory scheme that treats E-cigarette

like traditional tobacco cigarettes.

II. Background

1. New Technologies for Nicotine Delivery

Methods to separate nicotine from the tobacco in cigarettes are not new. In the mid-

1980s clinical studies involving nicotine patches showed that nicotine could be delivered to the

body without any burning, chewing, or ingestion of tobacco.2 Patches, gums and nicotine

inhalers are used to supply users with varying amounts of nicotine they would normally get from

smoking tobacco in an effort to curb smoking desirescravings, also known as nicotine

replacement therapy (NRT).

E-cigarettes are designed to deliver nicotine to a user in the form of a vapor, without the

combustion of tobacco.3 Most E-cigarettes feature a battery-operated heating element, a

replaceable cartridge containing nicotine or other chemicals, and an atomizer that, when heated,

converts the contents of the cartridge into a vapor.4 The vapor is then inhaled by the user, similar

to the induction of tobacco smoke in traditional cigarettes . E-cigarettes are sometimes designed

to mimic the look and feel of traditional cigarettes, while some models others opt for amore

“futuristic” look that can include multi-color light up tips and metallic casings. They are also

sometimes designed to look like everyday items such as pens and USB memory sticks, for

people who wish to use the product without drawing the attention of onlookers.5 The solution

contained inside E-cigarette cartridges usually consists of a liquid mixture of nicotine, water,

and propylene glycol, and glycerol. 

2. The Public Health Cost of Traditional Cigarette Smoking

With both sides of the E-cigarette debate claiming personal and public health concerns as

reasons for and against regulation it is important to establish what the effects of traditional

cigarette smoking are. Tobacco smoking is the leading preventable cause of death in the world;

440,000 of the nearly 5.5 million global tobacco deaths occur in the United States each year.67

For comparison, smoking tobacco causes more deaths than HIV, illegal drugs, alcohol, vehicle

accidents, and firearm incidents combined each year.8 It is estimated that by 2030 tobacco use

will be the cause of more than 8 million deaths worldwide each yearannually.9

The tobacco found in traditional cigarettes contains thousands of different chemical

ingredients.10 The FDA considers ninety three chemical or chemical compounds found in

cigarette smoke as Harmful and potentially harmful constituents (HPHCs), chemicals that cause,

or could cause, harm to smookers or non-smokers.11 Cancer, oOne of the most harmful health

effects caused by smoking,, cancer, can be attributed to the dozens of known or probable

carcinogenic chemical compounds found in cigarette smoke.12 The list of cancers attributed to

cigarette smoking is lengthy: lung, urinary bladder, esophagus, kidney, larynx, oral, and

pancreatic cancer are just some of the types of cancer caused by smoking highlighted by the

Surgeon General.13

Cigarette smoking has negative health effects on those who inhale the smoke

secondhand as well.14 In the year 2005 alone exposure to secondhand smoke was estimated to

kill more than 3,000 adult nonsmokers from lung cancer, 46,000 from coronary heart disease,

and an estimated 430 newborns from sudden infant death syndrome.15 Approximately 60 percent

of non-smokers in the United States exhibit biological evidence of exposure to secondhand

smoke.16 For every one person who dies from a smoking-related disease twenty more people

suffer from at least one serious illness from smoking.17 The home and workplace are the places

where people are most often exposed to secondhand smoke, while those with lower incomes are

at risk of an increased exposure to secondhand smoke.18

3. Public Health evaluation of E-cigarettes

The delivery of nicotine using E-cigarettes is a relatively new development compared to

the combustion method of burning tobacco that is hundreds, if not thousands of years old.19

Touted as a healthier alternative to traditional cigarettes, E-cigarettes do not contain nearly the

same amount of chemical compounds found in traditional cigarettes and avoid the harm caused

by tobacco’s release of carbon monoxide when burned.20 Despite the advantages of E-cigarette

smoking there is very little in the way of long term studies that might definitely answer the

question of E-cigarette smoking’s health safety.

A typical E-cigarette contains a solution of a liquid mixture of nicotine, water, propylene

glycol, and glycerol. Water, it comes as no surprise, is the most uncontroverted of the

ingredients in E-cigarettes. Nicotine, a stimulant approved by the FDA for use in Nicotine

Replacement Therapy patches and lozenges, is found in tobacco leaves and is an ingredient

common to both traditional cigarettes and E-cigarettes. Nicotine’s most harmful health impact is

not the absorption of the chemical itself, which has been compared to caffeine by some, but it’s

addictive traits that cause smokers to want to light up more often.21

The FDA first studied the health effects of E-cigarettes in 2009, analyzing two different

E-cigarette products on the market at the time.22 The FDA found diethylene glycol, a chemical

used in antifreeze is toxic to humans, in one of eighteen cartridges test, and in half the samples

carcinogens, including nitrosamines, were founddiscovered.23 The analysis also found

discrepancies between the labelled existence of nicotine, nicotine level variations amongst

identical cartridge types, and one sample contained twice the nicotine amount of an FDA

approved NRT inhaler.24

The FDA’s alarm was soundedwarning was released at approximately the same time that

E-cigarettes were seeing the start of their full scale rollout to the US market. A later piece of

research puts some of the FDA’s findings into perspective, if not outright doubt, in regards to the

levels of nitrosamines found.25 The study, which analyzed the results of numerous tobacco

related studies, found maximum nitrosamine levels in the E-cigarettes tested were almost

identical to that of the NicoDerm CQ NRT patch, 8.18 nanograms to 8.00 respectively.26 In

comparison, maximum cigarette nitrosamine levels were observed at anywhere from 3365-

6260ng in various traditional cigarettes. This study puts maximum nitrosamine levels found in

the E-cigarettes tested at roughly .1% of that found in traditional cigarettes. These results are

further supported by a comprehensive review of chemical data obtained in numerous E-cigarette

studies that concluded that levels of nitrosamines and other contaminants found in E-cigarettes

are not concentrated enough to be of concern.27

4. E-cigarettes as a gateway = to to … what?

E-cigarettes are not marketed as smoking cessation aids (discussed in section III), but that

does not stop many from claiming the product can be used as an effective method to transition

from traditional cigarettes to electronic/no cigarettes. On the other hand, many public health

officials see the E-cigarette as a dangerous gateway device that will lead to increased teen

smoking as their popularity grows. Both of these views are supported by research that, like the

chemical analysis of E-cigarettes, does not provide a definitive answer one way or the other.

A recent study in New Zealand compared the cessation outcomes of three groups:

nicotine E-cigarette users, nicotine patch users, and placebo E-cigarette users.28 The results,

while less of a cessation than the authors predicted, showed that the nicotine E-cigarette group

had the highest percentage of abstinence (7.3%) compared to the nicotine patch (5.8%) or

placebo E-cigarette (4.1%).29 Another study conducted in Italy of some 300 cigarette smokers

concluded that E-cigarettes are effective and safe smoking cessation devices, but some have

questioned the efficacy of studies such as these due to the similarity between placebo E-cigarette

and nicotine E-cigarette results.30 These critics might point to the Hawthorne effect might alsoto

explain the improvements of both nicotine and placebo E-cigarette users, as the process of

observation sometimes results in improvements regardless of method tested.

The available data on E-cigarettes relationship to teen smoking is even less conclusive.

In September of this year, forty 40 state’s Attorney Generals cosigned a letter to the FDA that

cited an CDC study showing the percentage of middle and high school students who had ever

tried an E-cigarette rose to 6.8% in 2012 from 3.3% in 2011.3132 Ever E-cigarette use amongst

high schoolers alone more than doubled from 4.7% in 2011 to 10.0% in 2012.33 Much like the

FDA’s 2009 report results, some E-cigarette proponents take issue with the conclusion reached

from the CDC’s teen smoking survey. According to a group of doctors and academics these

statistics are misleading because of the survey’s use of “current use” to describe any

experimentation with E-cigarettes within 30 days preceding the survey.34 One public health

professor’s analysis of the CDC’s data led him to conclude that just 7.2% of high schoolers who

used E-cigarettes in 2012 were not prior cigarette smokers, with only 0.5% of nonsmoking high

schoolers having reported trying e-cigs within the 30 day period.35 A recent survey of 1300

college aged students found that only 43 reported E-cigarettes as their first nicotine products and

only one went on to smoke traditional cigarettes, supporting the notion that E-cigarettes are not

the gateway products to traditional cigarettes feared by the FDA.36

III. Federal Regulation of E-cigarettes – Starts and Stops

1. The FDA's Attempt to Regulate Traditional Tobacco

Congress gave the FDA the authority to regulate products as drugs, devices, or drug-

device combination products under the FDCA.37 The Federal Food, Drug, and Cosmetic Act

defines “drugs” as products used to treat or prevent diseases while defining “devices” as products

which affect the structure or any function of the body.38 The determination of whether a product

is a drug or a device hinges on whether the manufacturer intends the product to be used for

functions that meet the drug/device/combination definitions.39

In 1996 The FDA concluded that cigarettes and smokeless tobacco products were drug-

device combinations which would subject them to regulation under the FDCA.40 Tobacco

companies challenged the FDA's determination, and in FDA v. Brown & Williamson Tobacco

Corp., the Supreme Court held that Congress did not intend to give the FDA authority to regulate

tobacco products. The Court looked at the tobacco legislation Congress had passed as evidence

of Congress's intent that tobacco remain on the market.

2. The Family Smoking Prevention and Tobacco Control Act

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act

which granted the FDA authority to regulate tobacco products. The TCA defines “tobacco

product” as “any product made or derived from tobacco that is intended for human

consumption,” and states that tobacco products shall not be considered a drug, device, or

combination product under the FDCA.

The TCA grants the FDA the general power to “require restrictions on the sale and

distribution of a tobacco product, including restrictions on access to, and the advertising and

promotion of the tobacco product if the Secretary determines that such regulation would be

appropriate for the protection of the public health.” The FDA's powers to regulate tobacco under

the TCA must follow two limitations: the agency cannot ban traditional tobacco and cannot

require that nicotine be eliminated from tobacco products.

3. The FDA oversteps its regulatory bounds again - Sottera

In April 2009, before the passage of the TCA, the FDA began detaining shipments of E-

cigarettes entering the country under its authority to regulate drug-device combinations under the

FDCA.41 E-cigarette manufacturers challenged the FDA's decision to classify E-cigarettes as

drugs or devices under the FDCA. The D.C. Circuit ultimately upheld the lower courts grant of

an injunction, holding that the TCA together with the Williamson decision require E-cigarettes be

regulated under the TCA as tobacco products.42 The Court held that as a matter of interpretation

E-cigarettes fall under the TCA's definition of tobacco products because nicotine is a product of

tobacco, the act broadly defines tobacco products as “any product made or derived

from tobacco,”.43 The Court also held that the E-cigarettes in question did not fall under FDCA’s

regulation as no therapeutic claims were made in marketing the product that could subject them

to FDCA regulation.44

The FDA chose not to appeal the D.C. Circuit Court’s ruling. Today, E-cigarettes

marketed for non-therapeutic purposes are regulated as tobacco products under the TCA. The

TCA states that “The Secretary may by regulation require restrictions on the sale and distribution

of a tobacco product, including restrictions on the access to, and the advertising and promotion

of, the tobacco product, if the Secretary determines that such regulation would be appropriate for

the protection of the public health.”45 In addition to this general grant of oversight the TCA has

several enumerated regulatory devices the FDA may use to accomplish its goals such as allowing

the FDA to regulate tobacco advertising and marketing to the fullest extent possible, the

elimination of flavoring additives designed to appeal to youths (except menthol)46, and the

requirement of premarket approval for new tobacco products (subject to public health analysis).47

VI. E-cigarettes Should Be Regulated More Flexibly ThanNot Be Regulated As Traditional

Cigarettes

“The core responsibility of the FDA is to protect consumers by applying the best possible

science to its regulatory activities—from pre-market review of efficacy and safety to

post-market, product surveillance to review of product quality.”48

Regulating E-cigarettes identical to traditional ones would be a mistake the FDA cannot

afford to make. The FDA must consider two guiding principles when determining whether

tobacco regulations are in the interest of public health (ignoring the fact that E-cigarettes contain

no tobacco): (A) the increased or decreased likelihood that existing users of tobacco products

will stop using such products; and (B) the increased or decreased likelihood that those who do

not use tobacco products will start using such products.49

Smoking an E-cigarette, lacking tobacco and the thousands of known harmful

ingredients, is assuredly safer than lighting up a traditional one. The available studies tend to

show a lack of toxic, carcinogenic chemical compounds in the vapor E-cigarette smokers inhale,

and the few potentially harmful ones contained in e-cig vapor are found at exponentially smaller

levels than traditional cigarettes. Studies also show that E-cigarettes can produce smoking

cessation results, even if they limited in their efficacy.

As E-cigarettes become more and more popular the rationale relied upon by those who

seek to impose burdensome tobacco like regulations upon the industry becomes weaker and

weaker. The public health analysis of E-cigarettes does not occur in a vacuum – the

aforementioned statistics regarding the enormous health costs, both in lives and serious illness,

that traditional cigarettes impose on smokers cannot should not be ignored but rather must be

weighed against whatever negative effects are to be associated with E-cigarettes.

Appropriate E-cigarette regulation should must be flexible enough to encourage further

E-cigarette innovation yet still provide protections against youth access and toxic ingredients;

regulations that would require pre-market approval, television advertisement bans, point of sale

restrictions (behind counter), or the elimination of allowable flavorings are likely to have chilling

effects on the adoption of E-cigarettes as an alternative to traditional smoking. Regulations

which seek to associate E-cigarettes with traditional ones in part because of the emotional

response to both as “smoking” risks stigmatizing the safer E-cigarette.

In the three years since the Sottera decision the FDA has failed to propose, or adopt, any

regulations of E-cigarettes. In April of 2011 the FDA announced it would be taking steps to

extend its regulatory powers over the E-cigarette industry.50 The FDA had been preparing to

release its proposed regulations for public comment in October of 2013, but the government

shutdown forced a delay in the release of the proposed regulations which are now expected to

arrive in the near future.

The lack of federal guidance on E-cigarettes has created a Wild West type landscape for

state and local regulation of the products.51 Several states, New Jersey being the first, have

enacted E-cigarette bans, restricting their use in public places such as bars and restaurants.52

Some states, like Ohio and Pennsylvania, currently lack legislation regarding E-cigarettes and

their sale to minors is not yet prohibited.5354 The FDA should utilize state level responses to E-

cigarettes as its own laboratory of sorts, further monitoring the emerging science showing E-

cigarettes not to be as harmful as traditional ones.

1 The Onion – America’s Finest News Source - http://www.theonion.com/articles/man-smoking-ecigarette-must-be-futuristic-bounty-h,34531/2 Rose, J. E.; Herskovic, J. E.; Trilling, Y.; Jarvik, M. E. (1985). "Transdermal nicotine reduces cigarette craving and nicotine preference". Clinical pharmacology and therapeutics 38 (4): 450–4563 E-cigarettes: Questions and Answers, Food and Drug Admin. (2010), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm225210.htm.4 Id.5 Id.6  WHO Report on the global tobacco epidemic, 2008 (foreword and summary) (PDF). World Health Organization. 2008. p. 8.7 http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/8 CDC - Fact Sheet - Health Effects of Cigarette Smoking - Smoking & Tobacco Use, http://www.cdc.gov/tobacco/data_statistics/fact_sheets/health_effects/effects_cig_smoking/..9 Id.10 Id.11 Harmful and Potentially Harmful Constituents (HPHCs), http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/HPHCs/default.htm.12 “[T]here is broad scientific agreement that several of the major classes of chemicals in the combustion emissions of burned tobacco are toxic and carcinogenic.” How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. http://www.ncbi.nlm.nih.gov/books/NBK53014/13 The health consequences of smoking: a report of the Surgeon General. [Atlanta, Ga.]: Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; Washington, D.C14 Also known as environmental tobacco smoke, is a mixture of the smoke given off by the burning end of tobacco products and smoke exhaled by smokers.15  "The Health Consequences of Involuntary Exposure to Tobacco Smoke: A Report of the Surgeon General". Surgeon General of the United States. 2006-06-27.16 Id.17 Id.18 Id.19 Tobacco: A Cultural History of How an Exotic Plant Seduced Civilization. By Iain Gately20 Andrea R. Vansickel et al., A Clinical Laboratory Model for Evaluating the Acute Effects of Electronic “Cigarettes”: Nicotine Delivery Profile and Cardiovascular and Subjective Effects, 19 Cancer, Epidemiology, Biomarkers & Prevention OF1, OF8 (2010).21 Nicotine and tobacco: MedlinePlus Medical Encyclopedia, http://www.nlm.nih.gov/medlineplus/ency/article/000953.htm.22 Safety Alerts for Human Medical Products > E-cigarettes, http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm173327.htm.23 Public Health Focus > Summary of Results: Laboratory Analysis of E-cigarettes Conducted By FDA, http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm173146.24 Id.25 Journal of Public Health Policy (2011) 32, 16–31. doi:10.1057/jphp.2010.41; published online 9 December 2010. E-cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Zachary Cahna and Michael Siegelb.26 Id., Table 2. Maximum tobacco-specific nitrosamine levels in various cigarettes and nicotine-delivery products (ng/g, except for nicotine gum and patch that are ng/patch or ng/gum piece)27 Peering through the mist: What does the chemistry of contaminants in e-cigarettes tell us about health risks? Igor Burstyn, PhD.

28 Lancet. 2013 Nov 16;382(9905):1629-37. doi: 10.1016/S0140-6736(13)61842-5. Epub 2013 Sep 9. E-cigarettes for smoking cessation: a randomised controlled trial.29 Id.30 EffiCiency and Safety of an e-cigarette (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design StudyPasquale Caponnetto,Davide Campagna,Fabio Cibella,Jaymin B. Morjaria,Massimo Caruso,Cristina Russo, Riccardo Polosa31 http://www.ncdoj.gov/getdoc/bf9ecec0-bbae-4ca8-8082-c59f6059db13/E-cigarette-Final-Letter.aspx.32 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm?s_cid=mm6235a6_w33 Id.34 http://ecigarettereviewed.com/wp-content/uploads/2013/12/Electronic-Cigarette-Regulation-Letter-to-the-FDA.pdf.35 The Rest of the Story: Tobacco News Analysis and Commentary: E-cigarette Experimentation Increases Among Youth, But Use Among Nonsmokers Remains Low and Regular Use Rates are Still Unknown, http://tobaccoanalysis.blogspot.co.uk/2013/09/electronic-cigarette-experimentation.html.36 E-cigarettes May Not Be Gateway to Smoking: Study - US News and World Report, http://health.usnews.com/health-news/news/articles/2013/10/30/e-cigarettes-may-not-be-gateway-to-smoking-study.37 See generally Food Drug and Cosmetic Act, 21 U.S.C. §§ 301-399D (2006).38 21 U.S.C. § 321(g)(1) (2006) (defining drug); 21 U.S.C. § 321(h) (2006) (defining device). 39 “These comments reveal the understanding even in 1934 that the crux of FDA jurisdiction over drugs lay in manufacturers' representations as revelatory of their intent.” Action on Smoking & Health v. Harris, 655 F.2d 236, 238-39 (D.C. Cir. 1980).40 Food & Drug Admin. v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 127, 120 S. Ct. 1291, 1297, 146 L. Ed. 2d 121 (U.S.N.C. 2000).41 Sottera, Inc. v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010).42 Id. at 627 F.3d 891, 898.

43 Id. at 627 F.3d 891, 897. 44 Id.45 21 U.S.C.A. § 387f (d).46 21 U.S.C.A. § 387g.47 21 U.S.C.A. § 387j.48 http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM305770.pdf49 21 U.S.C.A. § 387f (d).50 http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm.51 Melissa Block, E-cigarettes: A Nearly $2bn Industry, A Regulatory Wild West : NPR, http://www.npr.org/2013/10/21/239269426/e-cigarettes-a-nearly-2bn-industry-a-regulatory-wild-west.52 Coming Soon to the E-cigarette Regulation Debate: A Sliver of Clarity - Chris Opfer - The Atlantic Cities, http://www.theatlanticcities.com/politics/2013/11/coming-soon-e-cigarette-regulation-debate-sliver-clarity/7517/.53 http://www.ohiohouse.gov/stephanie-kunze/press/rep-kunzes-bill-prohibiting-minors-from-buying-e-cigarettes-passes-ohio-house54 http://www.newsworks.org/index.php/local/the-latest/62507-pa-moves-to-ban-sale-of-e-cigarettes-to-minors