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Health Policy Brief
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E-Cigarettes and Federal Regulation.
Policy makers have begun developing rules
for how popular alternatives to traditional
cigarettes can be marketed and sold.
what’s the issue?
E-cigarettes, virtually nonexistent 10 years
ago, have skyrocketed in popularity. Though
often shaped like a traditional cigarette, they
are fundamentally different in both design
and ingredients and are widely believed by
supporters and critics to be a safer alternative and a potentially valuable tool in weaning people off tobacco cigarettes. How much
safer, however, and how well they function as
a smoking cessation device are key questions
subject to a fierce debate.
Instead of the traditional combustible cigarette lit with a match or lighter, e-cigarettes
use a battery-operated heating element, called
an atomizer, that vaporizes a liquid solution
from a small cartridge of flavored liquid, frequently called “juice,” into an aerosol mist that
resembles smoke. The liquid, or e-liquid, usually, but not always, contains nicotine. Supporters say e-cigarettes are a perfect smoking
cessation device because they provide a sufficient nicotine buzz without many of the more
dangerous substances and harmful chemicals
of a conventional cigarette.
©2014 Project HOPE–
The People-to-People
Health Foundation Inc.
10.1377/hpb2014.14
Opponents, however, say there’s no evidence that smokers won’t simply continue to
use both products. Mitch Zeller, director of
the Food and Drug Administration’s (FDA’s)
Center for Tobacco Products, recently told a
congressional panel that because there is so
little scientific evidence about e-cigarettes, all
he could comfortably say was that “they have
the potential to do good; they have the potential to do harm.”
E-cigarettes are currently unregulated at the
federal level. But in April 2014 the FDA moved
to change that, issuing a proposed rule that
would give the agency the authority to regulate e-cigarettes as a tobacco product, banning
their sale to people under 18 and prohibiting
free samples, among other constraints. The
FDA will accept comments on the proposed
rule until August 8, 2014, and could well extend that time. Then it is likely to spend many
more months crafting its final rule.
Scores of studies are currently under way
to assess three key questions: What is the efficacy of e-cigarettes as a smoking cessation
device? Will they encourage more conventional tobacco smoking or less? And what is the
safety of the vapor itself for users and people
around them?
Meanwhile, large tobacco corporations have
already moved into the roughly $2 billion market, with the nation’s three largest tobacco
companies all now owning an e-cigarette company or creating their own product.
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what’s the background?
The first e-cigarette was patented in 1965 by
Herbert Gilbert, an American, who said in a
2013 interview that he was simply trying to
eliminate the burning process in tobacco.
“Under the 2009
Tobacco Control
Act, the FDA
must consider
the risks and
benefits of
e-cigarettes
to the whole
population, not
simply whether
the product
is ‘safe and
effective.’”
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Gilbert couldn’t interest anyone in his patent
in the mid-1960s, when few were questioning
the safety of conventional cigarettes. But in the
mid-2000s a pharmacist in China, Hon Lik,
developed his own e-cigarette and patented it
around the world, including the United States.
recent growth: Since the mid-2000s e-cigarettes have seen exponential growth, and the
term “vaping” has entered the general vocabulary, referring to the act of inhaling vaporized
nicotine-laced liquid. The popularity of vaping
rests in large part on its ability to allow people
to smoke without the 60 or so carcinogenic
substances created by burning cigarette tobacco. One Wall Street analyst who follows the tobacco industry noted that US consumption of
e-cigarettes and a related product that also vaporizes nicotine might surpass consumption
of combustible cigarettes within the next decade. The analyst predicts that profit margins
of e-cigarettes might also surpass combustible
cigarette margins within the next three years.
Statistics from the Centers for Disease Control and Prevention’s (CDC’s) Morbidity and
Mortality Weekly Report show that between
2011 and 2012, the percentage of students in
grades 6–12 who had tried e-cigarettes more
than doubled to nearly 7 percent. A 2013 report in the journal PLoS ONE noted that by
2012 about 8 percent of all US adults and 32
percent of smokers had tried e-cigarettes.
Currently, the entire market is in a state of
flux—there is no federal regulation, there is
no critical mass of peer-reviewed literature,
and the private sector is in the midst of a series
of intellectual property lawsuits over various
e-cigarette designs. Indeed, Fontem Ventures
BV, a subsidiary of Britain’s Imperial Tobacco,
paid $75 million in late 2013 for a portfolio of
e-cigarette patents from a Hong Kong–based
firm cofounded by Lik. A few months later,
in March 2014, Fontem Ventures BV sued 11
American e-cigarette makers including tobacco giant Lorillard in federal court alleging
various patent infringements.
Overall, the e-cigarette market today comprises a mixture of small mom-and-pop retail
outlets, which tend to sell a variety of e-liquids
and more sophisticated e-cigarettes, as well as
large companies. Two years ago Lorillard paid
$135 million for blu eCigs. In 2013 tobacco
company Reynolds American started marketing its Vuse brand in select markets, and
in June 2014 it announced that the company
would begin selling nationwide. In February
2014 Altria, parent company for tobacco giant Philip Morris USA, purchased e-cigarette
maker Green Smoke for $110 million. Last
year Altria began test-marketing its own ecigarette, MarkTen, with a national rollout
set for this year.
feder al efforts: The Family Smoking
Prevention and Tobacco Control Act of 2009
gave the FDA authority to regulate cigarettes—and the tobacco in cigarettes—as well
as roll-your-own and smokeless tobacco. The
Tobacco Control Act allows the FDA to oversee the manufacture, marketing, distribution,
and sale of regulated tobacco products and to
protect the public from the harmful effects of
tobacco products using science-based regulations. But it left unregulated such prominent
tobacco products as cigars, pipe and hookah
tobacco, nicotine gels, and e-cigarettes.
The law does give the FDA authority to
“deem” other products that meet the statutory definition of tobacco—a product “made
or derived from tobacco” and “intended for
human consumption”—as subject to its regulatory oversight. The nicotine found in the
liquid used in most e-cigarettes provides that
nexus with the Tobacco Control Act, because
the nicotine is derived from tobacco.
On April 25, 2014, the FDA began its formal
“deeming” process by publishing its proposed
rule on how it plans to regulate e-cigarettes.
The comment period will extend to August 8,
2014, and already has attracted thousands of
formal comments from all sides of the debate.
what’s the policy?
The FDA didn’t originally set out to regulate
e-cigarettes using the Tobacco Control Act. Beginning in 2008 the agency tried to regulate
e-cigarettes as unapproved drug and device
combination products, because they were often marketed as tobacco cessation aids to help
people quit smoking. Under that standard, ecigarette makers must prove that their product is safe and effective as advertised, which
can cost hundreds of millions of dollars in
clinical trials to prove. The e-cigarette makers
sued the FDA in federal court, and in December 2010 the US Court of Appeals for the D.C.
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3,200
youth
Each day 3,200 youth under the
age of 18 try their first tobacco
cigarette, and more than 700
of them go on to become daily
smokers.
Circuit ruled in Sottera, Inc., v. Food and Drug
Administration that as long as Sottera’s products are not marketed for therapeutic use—in
this case, as smoking cessation devices—then
the FDA could only regulate e-cigarettes as tobacco products.
The FDA did not appeal the decision, but on
April 25, 2011, it announced that it would propose regulations to extend its “tobacco product” authority to cover e-cigarettes. Three
years later to the day, that process began with
the publication of the proposed 67-page rule
in the Federal Register. It calls for, among other things, a ban on free samples and sale to
minors; a warning label, a required submission of ingredient listings; and a prohibition
against “modified risk descriptors” such as
“light,” “low,” and “mild.”
Not every requirement will take effect at the
same time. For example, e-cigarette makers
will not be required to disclose ingredients until two years after the final rule is announced.
The proposed rule also covers cigars, pipe tobacco, nicotine gels, hookah tobacco, and certain dissolvable tobacco products not already
under the FDA’s regulatory authority.
“Initial industry
reaction to the
proposed rule,
according to
press reports,
was relatively
positive, with
e-cigarette
makers praising
the FDA’s
‘scientific-based
approach.’”
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The proposed rule also explicitly acknowledges the lack of scientific data and specifically requests “health and behavioral data
about the effects of using e-cigarettes” as well
as data on the co-use of e-cigarettes with the
“initiation and continuation” of other tobacco
products. This is particularly important because e-cigarettes, notes the FDA, may have
the potential to curb smoking-related illnesses and deaths. But that depends on the extent
to which e-cigarettes actually can help a large
number of adult smokers to quit. “If…there is
significant initiation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then
the public health impact could be negative,”
the FDA wrote in its proposed rule.
Initial industry reaction to the proposed
rule, according to press reports, was relatively
positive, with e-cigarette makers praising the
FDA’s “scientific-based approach.”
Advocates who oppose e-cigarettes generally welcomed the proposals as well, although
they were quick to point out the absence of any
effort to restrict advertising or flavors, which
range from bubble gum to cherry to mint to
Turkish tobacco and beyond. An FDA spokesperson said the agency must first gain legal jurisdiction over e-cigarettes under the Tobacco
Control Act before applying any possible future restrictions on advertising or flavorings.
Meanwhile, many states and local municipalities have already determined that e-cigarettes are either a nuisance, a health threat, or
a potential revenue source. Minnesota taxes
e-cigarettes at the same rate as tobacco (the
only state to do so thus far), 38 states have
passed laws banning the sale of e-cigarettes to
minors, and many city and state laws already
prohibit the public use of e-cigarettes.
what’s the debate?
Most people believe that e-cigarettes are a
safer alternative to combustible tobacco cigarettes for consumers who already smoke. But
under the Tobacco Control Act, the FDA must
consider the risks and benefits of e-cigarettes
to the whole population, not simply whether
the product is “safe and effective,” the traditional standard the FDA uses when it evaluates
a medical product.
The crux of the debate over e-cigarettes is
whether their potential value as a smoking
cessation tool outweighs any negative impact.
Those potential negative impacts may range
from possibly dangerous secondhand smoke
or vapor to the so-called gateway effect, in
which people start with e-cigarettes, only to
move on to combustible cigarettes.
This gateway argument is important for
public health authorities to consider, if only
because cigarette smoking remains the leading cause of avoidable death in the United
States. Fifty years after the first Surgeon General’s report on smoking and health, there
are still nearly half a million tobacco related
deaths annually. Each day 3,200 youth under
the age of 18 try their first tobacco cigarette,
and more than 700 of them go on to become
daily smokers.
For now, however, it is not a debate that can
be resolved, simply because, as the FDA states
in its proposed rule, “We do not currently have
sufficient data about e-cigarettes to determine
what effects they have on the public health.”
To help fill that void, the agency is currently
funding more than three dozen studies about
e-cigarettes looking at everything from user
behavior to marketing to toxicology to the precise makeup of the “juice” that the atomizers
turn into vapor that users blow out of their
nose or mouth.
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215
per month
The CDC released a report that
said calls to poison centers
involving e-cigarette liquids with
nicotine rose from one per month
in September 2010 to 215 per
month in February 2014.
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Some risks have already been identified. A
study published in May 2014 in Nicotine and
Tobacco Research found that e-cigarettes that
use tank systems, which allow larger quantities of juice to be vaporized, and often have
larger batteries that heat with higher temperatures, can also produce formaldehyde, a
known carcinogen, at the same levels as combustible cigarettes. A practice known as “dripping,” in which e-cigarette users drip liquid
nicotine on the heating coil, can increase the
amount of formaldehyde.
The liquid nicotine added to the juice is
also highly toxic, even when diluted in the
juice, potentially causing vomiting and seizures and even death for a small child. Some
manufacturers already package their juice in
child-proof containers, but there is no standard, since e-liquids are not yet regulated by
the FDA. The number of calls to poison centers linked to e-liquids jumped threefold in
2013 to 1,352, according to figures from the
National Poison Data System cited by the New
York Times. And in April the CDC released a
report that said calls to poison centers involving e-cigarette liquids with nicotine rose from
one per month in September 2010 to 215 per
month in February 2014.
E-cigarette proponents are hoping that the
product’s benefits as a smoking cessation tool
will soon be definitively proven. The authors
of a study that appeared May 20, 2014, in the
monthly journal Addiction interviewed nearly
6,000 smokers trying to quit on their own and
found that about one in five using e-cigarettes
had stopped smoking at the time of the survey, while only half that number—about one in
10—had been able to stop using conventional
nicotine patches and gum. E-cigarette advocates argue that unlike the patch or nicotine
gum, e-cigarettes mirror the entire smoking
experience, which makes it a far more enjoyable and potentially effective cessation device.
So far, however, the research is contradictory. A randomized control study published in
2013 in The Lancet and funded by the Health
Research Council of New Zealand found that
e-cigarettes helped smokers quit at “similar”
levels to nicotine patches. And a study published in JAMA Internal Medicine in March
2014 found that using e-cigarettes was not
associated with greater rates of quitting cigarettes or reducing cigarette consumption after
one year.
It’s likely that one or more e-cigarette makers might soon try to market their product
as an approved smoking cessation device. Although that would require approval through
the FDA’s drug and device authority, it would
also give the product an enormous opportunity in the roughly $2 billion smoking cessation market. Currently, no e-cigarettes are
approved as such.
what’s next?
Until the FDA issues its final rule, possibly
not until next year, and then decides whether
or not it will regulate e-cigarette advertising,
expect to see a market that harkens back to
advertising techniques once common with tobacco cigarettes, using cartoons and celebrities and loaded language.
The advertising campaign of Lorillard’s blu
e-Cigs, for example, includes a one-minute
video ad with television personality Jenny
McCarthy that simultaneously plays on people’s health concerns and their desire to protect their personal autonomy. “Now that I’ve
switched to blu, I feel better about myself,”
says McCarthy, hunched over an e-cigarette in
a nightclub, adding: “Finally, with blu, I took
back my freedom.”
The market is also continuing to grow,
spurred by the big three tobacco companies—
Altria, Reynolds, and Lorillard—that are cashrich and have extensive retail distribution
networks and brand building capabilities.
Thousands of comments from parties on all
sides of the e-cigarette debate continue to pour
into the FDA’s website. By law, the FDA is required to review them all. n
h e a lt h p o l ic y b r i e f
About Health Policy Briefs
Written by
T.R. Goldman
Health Journalist
Editorial review by
Jordan Paradise
Associate Professor of Law
Seton Hall University School of Law
Jessica K. Pepper
Postdoctoral Fellow
UNC Center for Regulatory Research
on Tobacco Communication
Rob Lott
Deputy Editor
Health Affairs
Health Policy Briefs are produced under
a partnership of Health Affairs and the
Robert Wood Johnson Foundation.
Cite as:
“Health Policy Brief: E-Cigarettes and
Federal Regulation,” Health Affairs, July
10, 2014.
Sign up for free policy briefs at:
www.healthaffairs.org/
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resources
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for Electronic Cigarettes.” Therapeutic Advances in
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Jessica K. Pepper and Noel T. Brewer. “Electronic
Nicotine Delivery System (Electronic Cigarette)
Awareness, Use, Reactions, and Beliefs: A Systematic
Review.” Tobacco Control (November 20, 2013).
Dominic L. Palazzolo. “Electronic Cigarettes and
Vaping: A New Challenge in Clinical Medicine and
Public Health. A Literature Review.” Frontiers in Public Health 1 (November 18, 2013).
Jordan Paradise. “No Sisyphean Task: How the FDA
Can Regulate Electronic Cigarettes.” Yale Journal
of Health Policy, Law, and Ethics 13, no. 2 (Summer
2013).
Food and Drug Administration. “Deeming Tobacco
Products to Be Subject to the Federal Food, Drug,
and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations
on the Sale and Distribution of Tobacco Products and
Required Warning Statements for Tobacco Products;
Proposed Rule.” Federal Register 79 no. 80 (April 25,
2014).
Konstantinos E. Farsalinos and Riccardo Polosa.
“Safety Evaluation and Risk Assessment of Electronic Cigarettes as Tobacco Cigarette Substitutes:
A Systematic Review.” Therapeutic Advances in Drug
Safety 5, no. 2 (February 13, 2014).