Lucas Shin - Sample Work

Freedom, Rights, and Commerce
v.
Public Health, Safety, and Accountability
Tobacco Industry in the United States: A Legal Review
Lucas J. Shin
November 20, 2015

1
Table of Contents
I. Introduction……………………………………………………………………………………
Tobacco Industry Background
Relevant Legislations and Cases
Overview of Paper
II. Legal Issue 1 - Advertisements…………………………………...……….………………….
First Amendment of the United States Constitution
“Central Hudson” Test: Takeaways from Central Hudson Gas v Public Service
Commission
Others
III. Legal Issue 2 - Liability……………………………………………………………………….
Product Liability & Causation
Strict Liability
Warnings - adequate or inadequate?
Assumption of Risk & Commonly Known Dangers; Individual Freedom &
Responsibility
IV. Conclusion …………………………………………………………………………………..
V. Bibliography/References……………………………………………………………………...

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Introduction
Tobacco Industry Background
The tobacco industry is one of the most lucrative markets in the world, attracting many
consumers to purchase its diverse products (e.g. chewables, cigars, cigarettes, etc.). According
to the Tobacco Atlas, estimates of annual revenues from the global tobacco industry are almost a
half-trillion US dollars. In 2010, the combined profits of the six leading tobacco companies was
$35.1 billion - rivaling the combined profits of Coca-Cola, Microsoft, and McDonald’s in the
same year.1
The tobacco industry is so big that its commercial production is a vital part of the
American and world economy. Thousands of farmers in the United States make their living from
raising tobacco leaves that are purchased by the tobacco industry. The tobacco industries also
contribute billions of dollars in tax revenue to the state and federal government every year,
demonstrating its value to the national economy.2
However, the tobacco industry has been subject to much scrutiny and is a constant target
of litigation. According to the Centers for Disease Control and Prevention (CDC), cigarette
smoking causes about one in every five deaths in the United States each year. In addition,
exposure to secondhand smoke causes an estimated 41,000 deaths each year among adults in the
United States. In 1964, the Smoking and Health: Report of the Advisory Committee to the
Surgeon General of the United States found and presented over 7000 scientific articles that
linked tobacco use with cancer and other diseases.3
Since then, the increasing evidence of the
deadly effects of tobacco consumption has led to a decline in support for producers and
manufacturers of tobacco, pressuring lawmakers to legislate binding regulations.
Relevant Legislations and Cases
To curb the number of new consumers who are smoking, the federal government of the
United States has implemented regulations. One of the regulations was the Public Health
Cigarette Smoking Act in 1970, which required a health warning on cigarette packages that
reads: "Warning: The Surgeon General Has Determined that Cigarette Smoking Is Dangerous to
Your Health," and also banned cigarette advertisements on certain media outlets, such as radio
and television. To further curb the negative effects of smoking, Congress enacted the Family
Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in 2009, giving the Food
and Drug Administration (FDA) broad authority to regulate the manufacture, distribution, and
marketing of tobacco products.4
The following is a brief outline of other important legislations and cases that influence
the legal landscape of today’s tobacco industry:
1
Alday, J. (2012, March 21). New Tobacco Atlas Estimates U.S. $35 Billion Tobacco Industry Profits and
Almost 6 Million Annual Deaths. Retrieved November 9, 2015.
2
Economic Facts About U.S. Tobacco Production and Use. (2015, August 18). Retrieved November 9,
2015.
3
The Reports of the Surgeon General. (1964). Retrieved November 9, 2015.
4
Harezse, J. (2009, August 1). US Food and Drug Administration. Retrieved November 9, 2015, from
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm

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● 1965 – Federal Cigarette Labeling and Advertising Act (FCLAA)
○ A comprehensive act requiring that each package of cigarettes adequately inform
that cigarette smoking may be hazardous to user’s health through the inclusion of
a warning label.
● 1986 – Comprehensive Smokeless Tobacco Health Education Act
○ An act that amended FCLAA to create a rotational warning system that requires
cigarettes to place one of four statutorily-prescribed health-related warnings on
cigarette packages and relevant advertisements.
● 2009 – Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
○ An act that gives the Food and Drug Administration (FDA) the authority to
regulate the manufacturing, distribution, and marketing of tobacco products for
the purpose of public health.5
● United States v. Philip Morris
○ A case that specified the language that tobacco companies must publish to correct
previous false and misleading conduct by the tobacco companies.6
● Central Hudson Gas & Electric Corp. v. Public Service Commission
○ A United States Supreme Court case that articulated a four-part test for
determining when restrictions on commercial speech violated the First
Amendment of the United States Constitution.7
● Tobacco Master Settlement Agreement (MSA)
○ A large settlement between multiple big tobacco companies and state
governments on liability and compensation. The MSA states: “No Participating
Manufacturer may take any action, directly or indirectly, to target Youth within
any Settling State in the advertising, promotion or marketing of Tobacco
Products, or take any action the primary purpose of which is to initiate, maintain
or increase the incidence of Youth smoking within any Settling State.”
Overview of Paper
This paper will examine and review the legal issues that affect the tobacco industry.
Much of the analysis in this paper will be conducted on the arguments of the tobacco companies
and those who are negatively affected by tobacco. One of the major issues that will be addressed
in this paper is the issue of tobacco advertisements. Since childhood, many minors are exposed
5
Administration, U. F. (2009, August 1). Tobacco Control Act Overview. Retrieved November 9,
2015, from Tobacco Products:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm
6
United States v. Philip Morris, No. 99-2496 (GK) (United States District Court for the District of Columbia
November 27, 2012)
7
Central Hudson Gas & Electric Corp. v. Public Service Commission, No. 79-565, (United States Supreme
Court June 20,1980)

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to tobacco products and are pressured into abusing them due (in part) to the influence of media,
such as television shows and popular culture.8
When it comes to advertisements, tobacco
companies frequently base their defense on the First Amendment of the U.S. Constitution, which
states that “Congress shall make no law . . . abridging the freedom of speech, or of the press.”9
Thus, the increasing government regulations against the tobacco industry is argued as an
infringement on a constitutional right.10
However, commercial speeches are not granted full,
absolute protection under the Constitution in contrast to non-commercial speeches,11
leaving
room for further legal interpretation and vulnerabilities for the tobacco companies.
The other issue will be the legal dilemma regarding liability. Who will be held
responsible for those that are affected by the negative effects/influences of tobacco? Who will
provide or pay for the victims’ illness? The rise of health care costs due to the harmful effects of
smoking has led to legal questions about which party is responsible and should compensate for
the emergence of these costs. A significant portion of the paper will be dealt with the study and
argument of product liability, and how they play a role in the legal argument among the
stakeholders.
For the purpose of this paper, all relevant major stakeholders except the government (e.g.
federal, states, agencies, courts, etc.) will be categorized under one of the two labels: The
numerous businesses that are part of the, or coordinate with, the tobacco industry (e.g. tobacco
producers, manufacturers, distributors, retailers, marketers, etc.) will be referred to as the
“Beneficiary” while those who were harmfully affected by the negative effects of tobacco and
their acquaintances (e.g. family members, particularly parents of minors who use tobacco) will
be referred to as the “Affected”.
8
Chapman, S. (1996). The ethics of tobacco advertising and advertising bans. British Medical Bulletin,
121-131
9
Arlen W. Langardt, Tobacco Advertising and the First Amendment: Striking the Right Balance, 5 Wm. &
Mary Bus. L. Rev. 331 (2014), http://scholarship.law.wm.edu/wmblr/vol5/iss2/2
10
Milberger, S., Davis, R., Douglas, C., Beasley, J., Burns, D., Houston, T., & Shopland, D. (2006,
December 15). Tobacco manufacturers’ defense against plaintiffs’ claims of cancer causation: Throwing
mud at the wall and hoping some of it will stick. Retrieved November 9, 2015.
11
Arlen W. Langardt, Tobacco Advertising and the First Amendment: Striking the Right Balance, 5 Wm. &
Mary Bus. L. Rev. 331 (2014), http://scholarship.law.wm.edu/wmblr/vol5/iss2/2

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Issue I - Advertisements
Tobacco companies spend billions of dollars on advertising and promotion every year,
strategically placing their products in multiple media sources (e.g. movies and television shows)
to expose their products to the mass consumer market. Both the extreme and “slight” portrayal
of tobacco usage in today’s media-dominated society is effective because they make smoking
appear as a normal, acceptable, and even “cool” behavior. Despite efforts to reduce the
promotion of tobacco products by the government, many of today’s shows still contain thousands
of images of tobacco that implicitly encourage people to smoke. Studies show that whenever
tobacco is being advertised, people are more likely to increase the rate of the consumption of
cigarette use, which affects their health negatively. In addition, tobacco advertising has the
unintended effect of influencing untargeted groups, such as minors. According to a study by the
FDA, 80% of current adult smokers began smoking before the age of eighteen, highlighting
minors’ early exposure and abuse of tobacco.
Therefore, the United States government has limited the extent to which tobacco
advertisements can be made and how much information can be contained in the advertisements.
It also regulated the industry (through compelled speech) to warn consumers of the negative
effect of smoking to their intended customers. This was done to ensure that the customers are
aware of the dangers of smoking and to influence their choices on whether to stop or continue.
There are different arguments from both the Beneficiary and the Affected on the extent of how
far tobacco products can be advertised – their arguments are discussed in this section.
First Amendment of the United States Constitution
The First Amendment of the Constitution of the United States reads: “Congress shall
make no law . . . abridging the freedom of speech, or of the press.”12
The Beneficiary
consistently argues that increasing government regulations against the tobacco industry’s ability
to advertise is a clear infringement of their First Amendment rights. Regulating the
advertisements of tobacco products interfere not only with the tobacco companies’ commercial
interests, but also their basic rights to openly communicate with their consumers.
While speeches for noncommercial purposes may be entitled to full protection under the
First Amendment, commercial speech is not given the same treatment. In the case of Ohralik v
Ohio State Bar Assn, the court emphasized that commercial speech operated as a category of
“lower value” of expression, deserving less constitutional protection than expressions of social or
political discourse. In 1942, the Supreme Court also declared in Valentine v Chrestensen that
while corporations could freely engage in political expressions as a protected form of speech, the
Constitution affords no special protection to commercial speech, and that there is “no such
restraint on government as respects purely commercial advertising [for protection].”13
Thus,
12
U.S. Constitution - Amendment 1 - The U.S. Constitution Online - USConstitution.net. (n.d.). Retrieved
November 2, 2015, from http://www.usconstitution.net/xconst_Am1.html
13
Valentine v. Chrestensen 316 U.S. 52 (1942). (n.d.). Retrieved October/November, 2015, from
https://supreme.justia.com/cases/federal/us/316/52/case.html

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based on the Supreme Court’s decision of Valentine v Chrestensen, tobacco industries’ freedom
to advertise and promote its products are not fully protected under the constitution.
Commercial speeches are also not fully protected if they directly oppose a compelling
governmental interest. One of the government's duty to protect the lives of its citizens. A
government may establish laws and policies that require businesses to reveal detailed
information about their products to bring greater transparency that can protect its consumers,
particularly in the areas where safety and public health are critical. Under this argument,
protection of commercial speech can be “relaxed” if the speech promotes certain activities that
the government wants to curb, such as smoking and gambling. Due to widespread exposure of
tobacco products (particularly among minors) and the rise of healthcare costs that resulted from
the increase of the Affected, it is in the government’s interests to reduce the promotion of
tobacco to solve this public health crisis.
“Central Hudson” Test: Takeaways from Central Hudson Gas v Public Service Commission
Since commercial speeches are not entitled to full protection under the First Amendment
(especially if they are against compelling government interests), the Supreme Court has
established a series of conditions to determine whether a company’s First Amendment right to
free speech is being violated and when commercial speech can be curbed. In Central Hudson
Gas v Public Service Commission, the Supreme Court articulated a four-part test (intermediate
standard review) for commercial speech:
● advertisements deserve constitutional protection only if they promote a lawful activity
and are not false, deceptive, or misleading;
● the government's interest in regulating commercial speech must be substantial;
● the regulation must directly advance the government's interest;
● the regulation must be no more extensive than necessary to serve that interest.14
In this case, Chief Justice William Rehnquist ruled that a certain degree of measures for
governmental interests, such as public health, must be maintained. In another case, Posadas de
Puerto Rico Associates v. Tourism Co. of Puerto Rico, the Supreme Court reaffirmed the four-
part test by upholding a ban on gambling advertisements, elaborating that the greater power to
ban a product or behavior (e.g. gambling or tobacco usage) necessarily includes the lesser power
to regulate advertising of the relevant product or service. From these rulings, government (both
federal and state) is permitted to regulate the advertising of industries that go against
governmental interests, such as cigarettes, alcohol, gambling, and firearms. Thus, these case
decisions allow the Beneficiary’s commercial speech (e.g. advertising) to be curbed on behalf of
the Affected.
However, the Beneficiary argues against this notion by questioning whether or not their
commercial interests and behavior actually contrasts with the government’s interests. The four-
part test elaborated in Central Hudson Gas v Public Service Commission said that the restriction
14
Tobacco Control Legal Consortium. Regulating Tobacco Marketing: A “Commercial Speech” Factsheet
for State and Local Governments.(2010) Retrieved from
http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-speech-2010.pdf

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of commercial speech must “directly advance the government's interest,” and that the
government must demonstrate that its regulation of commercial speech is narrowly tailored to
achieve its compelling interest. The Beneficiary complains that the Affected and the government
are being pre-judgmental, and that it is erroneous for the court to assume that tobacco advertising
alone is the problem and causation for the rise in preventable deaths and minors’ exposure.
During the case of R.J. Reynolds Tobacco Co. v. Food & Drug Administration, the Beneficiary
argued that the Family Smoking Prevention and Tobacco Control Act of 2009 (which would
have required nine written warnings such as "Cigarettes are addictive," "Tobacco smoke causes
harm to children," and also include alternating images of a corpse and smoke-infected lungs on
packages of tobacco products) violated the First Amendment because it did not adequately
advance the government’s interest. Describing the record as containing not “a shred of
evidence” that the graphic warning images would reduce the number of Americans who smoke,
Judge Janice Rogers Brown declared that the FDA failed to show that its rule would directly
advance the governmental interest of discouraging smoking.15
In addition, the Beneficiary also argues that lots of its new consumers are influenced by
their friends and family members who smoke rather than due to their own product
advertisements. Research shows that most people who started smoking were originally
influenced by other smokers (e.g. friends and family) rather than advertisements.16
Studies also
found that minors who are raised by parents who smoke are more likely to smoke. It has also
been identified that many people are not keen on advertisement and view them as merely a
marketing scheme, whereas peer influence is a more effective way of pressuring people into
starting tobacco usage.17
Only a few people reported that their tobacco taking behavior was
influenced by advertisement from tobacco companies. Since it is beyond the scope of the
Beneficiary's responsibility to tell their existing consumers to attract new customers through peer
influence, it cannot be held liable for the increasing number of tobacco users unless the Affected
can specifically prove tobacco advertising was a substantial contributing factor to an individual’s
initiation of tobacco usage.
Others
The Beneficiary complains that advertisements of different drugs need to undergo the
same restrictions from the government if the government were to play fair in the market. There
are many other advertisements promoting consumption of other drugs, (e.g. alcoholic beverages)
in America that do not face as much restriction as tobacco products. While tobacco usage carries
significant risk of chronic illness and death, drugs such as alcohol may cause an immediate
hazard. For instance, an individual who consumed lots of alcohol can commit many dangerous
activities that not only pose a high and immediate risk for him, but for others as well, such as
when an intoxicated individual drives under influence. Thus, the tobacco industry cannot be the
only industry that is to be regulated as heavily as it is. According to the Beneficiary’s point of
15
Mears, Bill. "Federal Appeals Court Strikes down FDA Tobacco Warning Label Law." CNN. Cable
News Network, 25 Aug. 2012. Web. Oct.-Nov. 2015.
16
Slama, Karen. Tobacco and Health. Boston, MA: Springer US. 2012. Print. Page 152
17

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view, all drugs have enormous risks on the health and safety of human beings. Therefore,
regulation should be uniform across all drug industries.18
The Beneficiary recommends that the government impose less restrictions on tobacco
advertising and instead invest on youth guidance and counseling to raise awareness of the
harmful effects of drug abuse. This can be done through community organizations and
programs, such as schools and churches,19
where minors are taught how to avoid tobacco usage
and resist influence from others who smoke. This recommendation, according to the
Beneficiary, will reduce minors’ curiosity on trying tobacco substances, raise their awareness of
the risks, and enable them to make decisions about tobacco based on informed reasoning.
18
19
Chapman, Simon. Public Health Advocacy and Tobacco Control: Making Smoking History.

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Issue II – Liability
Health problems relating to tobacco products have led to a rise in healthcare costs.
According to CDC (Centers for Disease Control and Prevention), cigarette smoking is the
leading preventable cause of death in the United States. Smoking not only diminishes the overall
health of its users, but also increases the risk of major diseases (e.g. cardiovascular disorders,
respiratory disease and cancer). The rise of health problems due to the increased use of tobacco
has called into question of liability: Who is to blame for the tobacco consumers’ injuries? The
following section will present the common legal arguments utilized by both the Beneficiary and
the Affected on the issue of liability.
Product Liability & Causation
The Affected often argue that the Beneficiary is to be held responsible for product
liability. Under any theory of liability, the manufacturers and sellers of products may incur
product liability when product defects cause injury to consumers. The Affected point to research
findings of causal relationships between tobacco usage and negative health effects, such as
cancer, to make a case against the Beneficiary for product liability.
In its defense, the Beneficiary calls into question whether tobacco products were directly
responsible for some patients’ declining medical conditions. Even if people who happen to
abuse tobacco products were diagnosed with lung cancer, the cause may not have originated
specifically from tobacco. For instance, consumers may already have had a weak cardiovascular
health before they began using tobacco. Studies from the CDC also estimated that most people
who use tobacco products (around 75 to 95%) tend to abuse other drugs (e.g. alcohol, etc.) as
well, meaning that tobacco may not have been the cause.20
From this, tobacco may not be the sole or direct reason for a user’s illness. Most
jurisdictions require compelling evidence to show that the exposure to substances specifically
from tobacco products led to the injury, not substances from other products. Identifying this
causation is difficult since most abusers also used other toxic substances. For instance, one of
the toxic particles in tobacco products is asbestos, which can raise the risk of lung cancer.
However, if a person contracted lung cancer subsequent to being exposed to other airborne
toxins, such as those found in cigarette smoke, he/she may have trouble establishing that asbestos
is a significant contributor. Even if the responsible toxin were to be identified, it is often
medically unclear to quantify and calculate the level of effect the toxin had in contributing to the
illness. The problematic task of medically identifying the causing link between a product and an
illness frequently brings ambiguity on the issue of liability. Therefore, the liability of tobacco
products should be evaluated on a case-by-case basis rather than merely by awareness of the
risks or correlation between tobacco usage and declining health. A direct causal link between
tobacco usage and illness needs to be found before setting the Beneficiary as liable.
20
Reeves, William.C. (2011,December). Mental Illness Surveillance Among Adults in the United States.
Retrieved from: http://www.cdc.gov/mmwr/preview/mmwrhtml/su6003a1.htm

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Strict Liability
The Restatement (Third) of Torts for Products Liability defines three types of product
defects that have traditionally been recognized in product liability law: manufacturing defects,
design defects, and inadequate warnings. The Affected argues that the Beneficiary is to be held
liable for its products because the warnings of product usage is inadequate.
The Beneficiary counters the Affected’s argument by saying that they have already
placed a multitude of warning labels. Its many labels (e.g. “Surgeon General’s Warning:
Smoking By pregnant women may result in fetal injury, Premature Birth, and Low Birth
Weight,” and “Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease,
Emphysema, And May Complicate Pregnancy”) exemplify significant attempts by the
Beneficiary to exercise care. The Beneficiary also add that different warning sentences have
been provided to different target groups and consumers to clearly communicate across all
demographic groups. The high costs and effort of setting these labels exempts the Beneficiary
from negligence and serves as evidence that it has exercised reasonable care.
Under the doctrine of strict liability, parties may be liable for the results of their acts
regardless of their intentions and efforts to exercise reasonable care. The Affected argues that
despite different warning labels the Beneficiary has placed, the Beneficiary is to be held
responsible for strict liability. The Affected’s argument on strict liability rests on the six points
set forth in Section 402A of the Restatement (Second) of Torts (listed below). Depending on the
jurisdiction, a manufacturer’s liability to an injured party can be determined if one or more of the
following requirements are met:
1. The product must be in a defective condition when the defendant sells it.
2. The defendant must normally be engaged in the business of selling (or otherwise
distributing) that product.
3. The product must be unreasonably dangerous to the user or consumer because of its
defective condition (in most states).
4. The plaintiff must incur physical harm to self or property by use or consumption of the
product.
5. The defective condition must be the proximate cause of the injury or damage.
6. The goods must not have been substantially changed from the time the product was sold
to the time the injury was sustained.
The Affected argues that tobacco products fit the requirement of “The plaintiff (i.e. users)
must incur physical harm to self or property by use or consumption of the product.” Thus,
according to the Affected, the Beneficiary is to be held liable under the rule of strict liability.
However, the Beneficiary argues that cigarettes are not defective products. In the case of
the class action lawsuit of Blankenship in 2001, the judge said:
“Just because a product is risky does not make it defective. In our society there are lots
of risky products that are not defective. Guns can shoot you, knives can cut you, and we

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all unfortunately know what eating too much fatty food can do to you. But that doesn't
make those products defective. Those are inherent risks of those product.”21
Thus, while the Beneficiary may admit that there is no such thing as a “safe” cigarette
and that they are inherently dangerous, it also argues that there was nothing in the design of
cigarettes that make them even more dangerous than they might otherwise be.
Warnings - adequate or inadequate?
“The Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control
Act or TCA) gave FDA immediate jurisdiction over cigarettes, cigarette tobacco, smokeless
tobacco, and roll-your-own tobacco.”22
However, concern remains by the Affected that the
existing FDA regulations are inadequate. The Affected believe that cigarettes are defective and
tobacco industry holds liability for not putting adequate warning labels to inform consumers,
particularly minors, of the product’s risks and dangers.
According to commentators on RegulateTobacco.org, FDA should prohibit internet sales
of tobacco products including e-cigarettes, and that the FDA should restrict e-cigarette marketing
and flavors that “appeal to kids.”23
The Affected highly urge that FDA issue stricter regulations
to protect minors from the risk of being exposed to tobacco by including that FDA regulate e-
cigarettes, cigars, dissolvable nicotine products, and hookah. Other additional recommendation
from the Affected includes prohibiting self-service displays of tobacco products to prevent
minors from being able to purchase them on their own. The Affected claim that failing to do so
would be neglecting a foreseeable risk of a significant number of minors eventually using
tobacco products.
Assumption of Risk & Commonly Known Dangers; Individual Freedom & Responsibility
The Beneficiary commonly argues that the general public is fully aware of the risks of
tobacco usage. Deciding to smoke is an “adult choice,” and cigarettes are a legal product. Not
only are the health risks of tobacco usage well known, but it is also heavily regulated by the
government where the tobacco industries have to label a warning on their product packages of
the product’s risks. On the surface of the cigarette packages reads the Surgeon General’s
warning that “smoking can cause a slow and painful death” (Public Health Cigarette Smoking
Act of 1970). The consumers, aware of the numerous risks and dangers associated with the
product, voluntarily decided to use tobacco on their own free will. Thus, not only was the danger
so well and commonly known, but the risks were also explicitly warned that the Beneficiary (e.g.
manufacturers) does not need to further warn its users of the danger.
21
Cummings, K. M., Brown, A., & Douglas, C. E. (2006). Consumer acceptable risk: how cigarette
companies have responded to accusations that their products are defective. Tobacco Control, 15(Suppl
4), iv84–iv89. http://doi.org/10.1136/tc.2004.009837
22
Tobacco-Free Kids. (n.d.).Brief Summary of the Proposed Deeming Rule Asserting FDA’s Jurisdiction
over other Tobacco Products, such as Cigars, Pipe Tobacco and E-cigarettes:
http://www.entnet.org/sites/default/files/Summary%20of%20proposed%20deeming%20reg%20(4).pdf
23
Tobacco-Free Kids. (n.d.). Sample Comment for Parents. Retrieved November 23, 2015, from Sample
Comment for Parents: http://regulatealltobacco.org/content/?page_id=438

12
Despite the widespread notoriety of tobacco’s damage on health and consumers
voluntarily using the products, the Affected decry the tobacco industry for negatively affecting
minors, who are prohibited from purchasing tobacco. The rise of minors who use tobacco
products, such as electronic cigarettes (also known as e-cigarettes), led for calls by the Affected
for more regulations on tobacco products, particularly new and emerging products such as e-
cigarettes.

13
Conclusion
Since the founding of America, upholding citizens’ freedom of speech has been one of
the highest priorities of the government. Preserving Americans’ rights to free speech is a
democratic value that must continue to be firmly protected. The Beneficiary have repeatedly
emphasized this value of maintaining freedom and having the government understand the limits
of its authority.
However, part of society’s role is not to only to respect individual freedom and
opportunity, but also to look out for those who have been wronged and to hold accountable those
who commit wrong. Most importantly, government has a moral responsibility to protect its
citizens (consumers) from harm, especially the young who are incapable of making full
independent decisions on their own. Government’s attempts to balance the dilemma between
Freedom, Rights, and Commerce v. Public Health, Safety, and Accountability have led to a
substantial neglect and failure to address the rise of tobacco usage among minors. Thus, the
government has stepped in to restrict and compel the Beneficiary’s marketing and advertisements
to fulfill public interests.
Despite this, the trend of minors abusing tobacco substances continue to rise. Dr. Robert
Block, president of the American Academy of Pediatrics, said that "almost 3,000 children under
the age of 18 starting to smoke each day.”24
This data is alarming given the attempt by the
government to maintain its interest regarding public health. A comparative case study of China
shows that despite China’s regulation requiring graphic images of tarred lungs on cigarette
packages intended to deter and warn consumers of the harmful effects of smoking, many minors
continue to smoke, indicating that warning labels alone will not significantly change the trend.
The legal scope of this dilemma has only become more complex as the development of new
products and marketing techniques from the Beneficiary, such as electronic cigarettes, have led
to gaps and loopholes that have yet to be clearly defined.
The author of this Article advocates that electronic cigarettes be labeled under the same
category as all other tobacco products and be subject under the same jurisdiction of the FDA. On
April 2014, the U.S. Food and Drug Administration (FDA) announced its proposed “deeming
rule,” which would regulate e-cigarettes as tobacco products. If the rule is passed and
implemented, the rule would expand FDA’s regulatory authority over a variety of tobacco
products, including electronic cigarettes, cigars, pipe tobacco, and hookah tobacco. For example,
these products would now be subject to the federal prohibition on sales to minors, the federal
prohibition on free sampling, federal warning label requirements, and the requirement that
tobacco manufacturers register with the FDA and seek the agency’s review of new tobacco
products. However, until such time as the rule is adopted, the FDA’s Center for Tobacco
Products does not have authority to regulate the sale or use of e-cigarettes as tobacco products.
The FDA Center for Drug Evaluation and Research has only a certain degree of authority to
regulate e-cigarettes as drugs or devices, such as when they are utilized for therapeutic purposes.
Given the large volume of comments the agency will receive, it will take at least a year, if not
longer, for the FDA to implement the final rule. Thus, it is unclear when the FDA will release
24
Mears, Bill. "Federal Appeals Court Strikes down FDA Tobacco Warning Label Law." CNN. Cable
News Network, 25 Aug. 2012. Web. Oct.-Nov. 2015.

14
final regulations on electronic cigarettes. Regulating this product may not be a perfect,
comprehensive solution, but it would be a substantial step forward in protecting minors from
products that are increasingly being wide-spread.

15
Bibliography/References
Administration, U. F. (2009, August 1). Tobacco Control Act Overview.Tobacco Products.
Retrieved November 9, 2015, from :
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.h
tm
Alday, J. (2012, March 21). New Tobacco Atlas Estimates U.S. $35 Billion Tobacco Industry
Profits and Almost 6 Million Annual Deaths. World Lung Foundation. Retrieved November 9,
2015: http://www.worldlungfoundation.org/ht/display/ReleaseDetails/i/20439/pid/6858
Arlen W. Langardt, Tobacco Advertising and the First Amendment: Striking the Right Balance,
5 Wm. & Mary Bus. L. Rev. 331 (2014), Retrieved from
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