Tobacco in the Colonies
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What was the role of tobacco in the colonial
period?
How was smoking viewed by most people in the
1950s?
What happened in 1964?
Why is it so hard to quit smoking?
Federal Cigarette Labeling and
Advertising Act - 1965/1969
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Required hazard labeling on cigarettes
Banned cigarette advertising in electronic medial
regulated by the FCC
 Why not ban it everywhere?
Prevented state additional requirements
 Which requirements were they worried about?
 What happened in torts in 1965?
What about non-tort concerns?
Public Health Impact of Tobacco
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#1 preventable cause of illness
#1 problem is heart disease
 6 out of 7 smokers do not live to get lung
cancer
Emphysema is the big lung issue - nasty way to
live, then you die
Slow progress in limiting smoking
May have plateaued after the tobacco settlement
In Defense of Tobacco
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Limits retirement
 Saves Medicare and Social Security
 Great for private pension plans as well
Tobacco will reduce life-time health care costs if
you smoke enough
 Ideally you will also eat a lot of burgers
Improves job opportunities for young, cheaper
workers
Politics of FDA
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Chairman Kessler was appointed by Bush I
 Liked publicity
 Wanted to keep his job when Clinton can into
office
Banned silicone breast implants - just to be safe
 Made 4.5 billion for trial lawyers and got to keep
his job
FDA v. Brown & Williamson Tobacco Corp.
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The FDA decided to regulate tobacco
What was the politics?
What had it said about tobacco regulation over
the past 50 years?
FDA Authority
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Anything sold in interstate commerce with the
intent to affect the structure or function of the
body is a drug
Drugs must be proven safe and effective
FDA Regulation of Tobacco
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Does it fit within the definition of a drug?
What would be the effect of applying the safe and
effective test to tobacco?
Does this create a regulatory paradox?
How is it different from chemotherapy?
Statutory Provisions
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The Act prohibits "[t]he introduction or delivery
for introduction into interstate commerce of any
food, drug, device, or cosmetic that is adultered
or misbranded." 21 U. S. C. §331(a)
§352(j) deems a drug or device misbranded "[i]f it
is dangerous to health when used in the dosage
or manner, or with the frequency or duration
prescribed, recommended, or suggested in the
labeling thereof."
Tobacco Labeling
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Second, a drug or device is misbranded under the
Act "[u]nless its labeling bears ... adequate
directions for use ... in such manner and form, as
are necessary for the protection of users," except
where such directions are "not necessary for the
protection of the public health." §352(f)(1).
Is it possible to label tobacco so it can be used
safely?
Chevron - Step One
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Does tobacco fall under the statute?
 Is it specifically named?
 Is it specifically prohibited?
Why is there a question of ambiguity in what the
statute means?
 Doesn't tobacco affect the body?
Chevron – Step Two
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What was congressional intent?
What is the evidence that congress did not intend
for the FDA to regulation tobacco?
 Alternative regulatory schemes and agencies?
Renewed and expanded the FDA Act without
addressing tobacco
United States Supreme Court Opinion
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The majority (Scalia) said this was evidence that
Congress did not intend for the FDA to regulate
tobacco, and that such intent trumped Chevron
Minority (Breyer) said just look at the law
Politics trumps principle
Lorillard Tobacco Company v. Reilly, 533
U.S. 525 (2001)
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What is MA trying to do?
Types of Preemption
 Explicit
 Implicit
How is the United States Supreme Court's
preemption analysis similar to a Chevron
analysis?
Preemption Language
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Congress unequivocally precludes the
requirement of any additional statements on
cigarette packages beyond those provided in
§1333. 15 U. S. C. §1334(a).
Congress further precludes States or localities
from imposing any requirement or prohibition
based on smoking and health with respect to the
advertising and promotion of cigarettes. §1334(b).
What did Congress Intend with the
Cigarette Labeling Act?
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What was MA's defense against preemption?
What did the court find was the congressional
intent?
 The context in which Congress crafted the
current pre-emption provision leads us to
conclude that Congress prohibited state
cigarette advertising regulations motivated by
concerns about smoking and health.
Justice Steven's Irony
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Justice Stevens finds it ironic that we conclude that
"federal law precludes States and localities from
protecting children from dangerous products within 1,000
feet of a school," in light of our prior conclusion that the
"Federal Government lacks the constitutional authority to
impose a similarly-motivated ban" in United States v.
Lopez, 514 U. S. 549 (1995).
Why is this case different?
What could the state do?
Smokeless Tobacco and Cigars
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Are these covered by the Act?
 Why?
What does the court see as the limitation on state
regulation of their advertising?
What is the state's justification for limiting
advertising near schools?
Why was 1000 feet too far?
Actions v. Speech
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Could the state ban the sale of tobacco to
minors?
Can it ban the use unattended sales such as
vending machines?
Can it ban tobacco sales entirely?
Why is this different from bans on advertising?
Could Congress preempt state bans on tobacco
sales?
What Should We Do About Tobacco Use?
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What is the public interest?
What are the individual liberties issues?
Are the other substances people want to use that
we ban?
Is tobacco different in any physiological, as
opposed to political sense?
How well do the other bans work?
What are the unintended consequences?
What About Obesity?