food
drug
administration
et
al
brown
williamson
tobacco
et
argued
december
decided
march
food
drug
cosmetic
act
fdca
et
seq
grants
food
drug
administration
fda
designee
secretary
health
human
services
hhs
authority
regulate
among
items
drugs
devices
fda
asserted
jurisdiction
regulate
tobacco
products
concluding
fdca
nicotine
drug
cigarettes
smokeless
tobacco
devices
deliver
nicotine
body
pursuant
authority
fda
promulgated
regulations
governing
tobacco
products
promotion
labeling
accessibility
children
adolescents
fda
found
tobacco
use
nation
leading
cause
premature
death
resulting
deaths
annually
adult
smokers
begin
minors
regulations
therefore
aim
reduce
tobacco
use
minors
substantially
reduce
prevalence
addiction
future
generations
thus
incidence
death
disease
respondents
group
tobacco
manufacturers
retailers
advertisers
filed
suit
challenging
fda
regulations
moved
summary
judgment
ground
inter
alia
fda
lacked
jurisdiction
regulate
tobacco
products
customarily
marketed
without
manufacturer
claims
therapeutic
benefit
district
upheld
fda
authority
fourth
circuit
reversed
holding
congress
granted
fda
jurisdiction
regulate
tobacco
products
concluded
construing
fdca
include
tobacco
products
lead
several
internal
inconsistencies
act
also
found
evidence
external
fdca
fda
consistently
stated
lacked
jurisdiction
tobacco
congress
enacted
several
statutes
fully
cognizant
fda
position
congress
considered
rejected
many
bills
given
agency
authority
confirms
conclusion
held
reading
fdca
whole
well
conjunction
congress
subsequent
legislation
plain
congress
given
fda
authority
regulate
tobacco
products
customarily
marketed
pp
case
involves
agency
construction
statute
administers
analysis
governed
chevron
natural
resources
defense
council
reviewing
must
first
ask
whether
congress
directly
spoken
precise
question
issue
must
give
effect
congress
unambiguously
expressed
intent
must
defer
agency
construction
statute
long
permissible
see
ins
determining
whether
congress
specifically
addressed
question
issue
confine
examining
particular
statutory
provision
isolation
rather
must
place
provision
context
interpreting
statute
create
symmetrical
coherent
regulatory
scheme
gustafson
alloyd
addition
meaning
one
statute
may
affected
acts
particularly
congress
spoken
subsequently
specifically
topic
hand
see
estate
romani
finally
must
guided
degree
common
sense
manner
congress
likely
delegate
policy
decision
economic
political
magnitude
administrative
agency
cf
mci
telecommunications
american
telephone
telegraph
pp
considering
fdca
whole
clear
congress
intended
exclude
tobacco
products
fda
jurisdiction
fundamental
precept
fdca
product
regulated
fda
remains
market
must
safe
effective
intended
use
see
potential
inflicting
death
physical
injury
must
offset
possibility
therapeutic
benefit
rutherford
rulemaking
proceeding
fda
quite
exhaustively
documented
tobacco
products
unsafe
dangerous
cause
great
pain
suffering
illness
findings
logically
imply
tobacco
products
devices
fdca
fda
required
remove
market
fdca
misbranding
see
device
classification
see
provisions
fact
based
provisions
fda
previously
asserted
tobacco
products
within
jurisdiction
removed
market
impossible
prove
safe
intended
use
congress
however
foreclosed
ban
products
choosing
instead
create
distinct
regulatory
scheme
focusing
labeling
advertising
cigarettes
smokeless
tobacco
express
policy
protect
commerce
national
economy
informing
consumers
adverse
health
effects
see
thus
fda
ban
plainly
contradict
congressional
intent
apparently
recognizing
dilemma
fda
concluded
tobacco
products
actually
safe
fdca
banning
cause
greater
harm
public
health
leaving
market
safety
determination
focusing
relative
harms
caused
alternative
remedial
measures
substitute
required
fdca
various
provisions
act
require
agency
determine
least
consumers
product
therapeutic
benefits
outweigh
risks
illness
serious
injury
fda
tobacco
products
unsafe
obtaining
therapeutic
benefit
inescapable
conclusion
room
tobacco
products
within
fdca
regulatory
scheme
used
safely
therapeutic
purpose
yet
banned
simply
fit
pp
history
legislation
also
demonstrates
congress
spoken
directly
fda
authority
regulate
tobacco
products
since
congress
enacted
six
separate
statutes
addressing
problem
tobacco
use
human
health
statutes
among
things
require
health
warnings
appear
packaging
print
outdoor
advertisements
see
prohibit
advertisement
tobacco
products
electronic
communication
medium
regulated
federal
communications
commission
see
require
secretary
hhs
report
every
three
years
congress
research
findings
concerning
tobacco
addictive
property
make
receipt
certain
federal
block
grants
contingent
prohibiting
tobacco
product
manufacturer
retailer
distributor
selling
distributing
product
individuals
age
legislation
created
specific
regulatory
scheme
addressing
problem
tobacco
health
adopted
backdrop
fda
consistently
resolutely
stating
without
authority
fdca
regulate
tobacco
products
customarily
marketed
fact
congress
several
times
considered
rejected
bills
given
fda
authority
indeed
congress
actions
area
evidenced
clear
intent
preclude
meaningful
policymaking
role
administrative
agency
congress
tobacco
legislation
prohibits
additional
regulation
tobacco
product
labeling
respect
tobacco
health
consequences
central
aspect
regulation
fdca
circumstances
evident
congress
ratified
fda
previous
position
lacks
jurisdiction
regulate
tobacco
products
customarily
marketed
congress
created
distinct
scheme
addressing
subject
scheme
excludes
role
fda
regulation
pp
finally
inquiry
shaped
least
measure
nature
question
presented
chevron
deference
premised
theory
statute
ambiguity
constitutes
implicit
delegation
congress
agency
fill
statutory
gaps
see
extraordinary
cases
however
may
reason
hesitate
concluding
congress
intended
implicit
delegation
hardly
ordinary
case
contrary
agency
position
inception
fda
asserted
jurisdiction
regulate
industry
constituting
significant
portion
american
economy
fact
fda
contends
determine
tobacco
products
provide
reasonable
assurance
safety
authority
ban
cigarettes
smokeless
tobacco
entirely
highly
unlikely
congress
leave
determination
whether
sale
tobacco
products
regulated
even
banned
fda
discretion
cryptic
fashion
see
mci
telecommunications
given
tobacco
unique
political
history
well
breadth
authority
fda
asserted
obliged
defer
agency
expansive
construction
statute
congress
consistent
judgment
deny
fda
power
pp
matter
important
conspicuous
controversial
issue
regardless
likely
public
hold
executive
branch
politically
accountable
administrative
agency
power
regulate
public
interest
must
always
grounded
valid
grant
authority
congress
courts
must
take
care
extend
statute
scope
beyond
point
congress
indicated
stop
article
drug
affirmed
delivered
opinion
rehnquist
scalia
kennedy
thomas
joined
breyer
filed
dissenting
opinion
stevens
souter
ginsburg
joined
food
drug
administration
et
al
tioners
brown
williamson
tobacco
corporation
et
al
writ
certiorari
appeals
fourth
circuit
march
justice
delivered
opinion
case
involves
one
troubling
public
health
problems
facing
nation
today
thousands
premature
deaths
occur
year
tobacco
use
food
drug
administration
fda
expressly
disavowed
authority
since
inception
asserted
jurisdiction
regulate
tobacco
products
see
fed
reg
fda
concluded
nicotine
drug
within
meaning
food
drug
cosmetic
act
fdca
act
stat
amended
et
seq
cigarettes
smokeless
tobacco
combination
products
deliver
nicotine
body
fed
reg
pursuant
authority
promulgated
regulations
intended
reduce
tobacco
consumption
among
children
adolescents
id
agency
believed
tobacco
consumers
begin
use
reaching
age
curbing
tobacco
use
minors
substantially
reduce
prevalence
addiction
future
generations
thus
incidence
death
disease
id
regardless
serious
problem
administrative
agency
seeks
address
however
may
exercise
authority
manner
inconsistent
administrative
structure
congress
enacted
law
etsi
pipeline
project
missouri
although
agencies
generally
entitled
deference
interpretation
statutes
administer
reviewing
well
agency
must
give
effect
unambiguously
expressed
intent
congress
chevron
natural
resources
defense
council
case
believe
congress
clearly
precluded
fda
asserting
jurisdiction
regulate
tobacco
products
authority
inconsistent
intent
congress
expressed
fdca
overall
regulatory
scheme
legislation
enacted
subsequent
fdca
light
clear
intent
fda
assertion
jurisdiction
impermissible
fdca
grants
fda
designee
secretary
health
human
services
authority
regulate
among
items
drugs
devices
see
ed
supp
iii
act
defines
drug
include
articles
food
intended
affect
structure
function
body
defines
device
part
instrument
apparatus
implement
machine
contrivance
similar
related
article
including
component
part
accessory
intended
affect
structure
function
body
act
also
grants
fda
authority
regulate
combination
products
constitute
combination
drug
device
biologic
product
fda
construed
provision
giving
discretion
regulate
combination
products
drugs
devices
see
fed
reg
august
fda
published
proposed
rule
concerning
sale
cigarettes
smokeless
tobacco
children
adolescents
fed
reg
rule
included
several
restrictions
sale
distribution
advertisement
tobacco
products
designed
reduce
availability
attractiveness
tobacco
products
young
people
id
public
comment
period
followed
fda
received
submissions
time
history
subject
fed
reg
august
fda
issued
final
rule
entitled
regulations
restricting
sale
distribution
cigarettes
smokeless
tobacco
protect
children
adolescents
id
fda
determined
nicotine
drug
cigarettes
smokeless
tobacco
drug
delivery
devices
therefore
jurisdiction
fdca
regulate
tobacco
products
customarily
marketed
without
manufacturer
claims
therapeutic
benefit
id
first
fda
found
tobacco
products
affect
structure
function
nicotine
significant
pharmacological
effects
id
specifically
nicotine
exerts
psychoactive
effects
brain
cause
sustain
addiction
tranquilizing
stimulating
effects
control
weight
id
second
fda
determined
effects
intended
fdca
widely
known
foreseeable
may
deemed
intended
manufacturers
id
consumers
use
tobacco
products
predominantly
nearly
exclusively
obtain
effects
id
statements
research
actions
manufacturers
revealed
designed
cigarettes
provide
pharmacologically
active
doses
nicotine
consumers
id
finally
agency
concluded
cigarettes
smokeless
tobacco
combination
products
addition
containing
nicotine
include
device
components
deliver
controlled
amount
nicotine
body
id
resolved
jurisdictional
question
fda
next
explained
policy
justifications
regulations
detailing
deleterious
health
effects
associated
tobacco
use
found
tobacco
consumption
single
leading
cause
preventable
death
id
according
fda
ore
people
die
year
illnesses
cancer
respiratory
illnesses
heart
disease
ibid
agency
also
determined
way
reduce
amount
illness
mortality
reduce
level
addiction
goal
accomplished
preventing
children
adolescents
starting
use
tobacco
id
fda
found
adult
smokers
first
cigarette
age
half
already
become
regular
smokers
age
id
also
found
children
beginning
smoke
younger
age
prevalence
youth
smoking
recently
increased
similar
problems
existed
respect
smokeless
tobacco
id
fda
accordingly
concluded
number
children
adolescents
begin
tobacco
use
substantially
diminished
illness
correspondingly
reduced
data
suggest
anyone
begin
smoking
childhood
adolescence
unlikely
ever
begin
id
based
findings
fda
promulgated
regulations
concerning
tobacco
products
promotion
labeling
accessibility
children
adolescents
see
id
access
regulations
prohibit
sale
cigarettes
smokeless
tobacco
persons
younger
require
retailers
verify
photo
identification
age
purchasers
younger
prohibit
sale
cigarettes
quantities
smaller
prohibit
distribution
free
samples
prohibit
sales
displays
vending
machines
except
locations
id
promotion
regulations
require
print
advertising
appear
format
unless
publication
appears
read
almost
exclusively
adults
prohibit
outdoor
advertising
within
feet
public
playground
school
prohibit
distribution
promotional
items
hats
bearing
manufacturer
brand
name
prohibit
manufacturer
sponsoring
athletic
musical
artistic
social
cultural
event
using
brand
name
id
labeling
regulation
requires
statement
device
persons
older
appear
tobacco
product
packages
id
fda
promulgated
regulations
pursuant
authority
regulate
restricted
devices
see
fda
construed
giving
discretion
regulate
combination
products
using
act
drug
authorities
device
authorities
depending
public
health
goals
act
best
accomplished
fed
reg
given
greater
flexibility
fdca
regulation
devices
fda
determined
device
authorities
provide
appropriate
basis
regulating
cigarettes
smokeless
tobacco
id
agency
may
require
device
restricted
sale
distribution
use
upon
conditions
fda
may
prescribe
regulation
potentiality
harmful
effect
collateral
measures
necessary
use
fda
determines
otherwise
reasonable
assurance
safety
effectiveness
fda
reasoned
regulations
fell
within
authority
granted
related
sale
distribution
tobacco
products
necessary
providing
reasonable
assurance
safety
fed
reg
respondents
group
tobacco
manufacturers
retailers
advertisers
filed
suit
district
middle
district
north
carolina
challenging
regulations
see
coyne
beahm
fda
supp
moved
summary
judgment
grounds
fda
lacked
jurisdiction
regulate
tobacco
products
customarily
marketed
regulations
exceeded
fda
authority
advertising
restrictions
violated
first
amendment
second
brief
support
plaintiffs
motion
summary
judgment
mdnc
rec
tab
third
brief
support
plaintiffs
motion
summary
judgment
mdnc
rec
tab
district
granted
respondents
motion
part
denied
part
held
fdca
authorizes
fda
regulate
tobacco
products
customarily
marketed
fda
access
labeling
regulations
permissible
also
found
agency
advertising
promotion
restrictions
exceed
authority
id
stayed
implementation
regulations
found
valid
except
prohibition
sale
tobacco
products
minors
certified
order
immediate
interlocutory
appeal
id
appeals
fourth
circuit
reversed
holding
congress
granted
fda
jurisdiction
regulate
tobacco
products
see
examining
fdca
whole
concluded
fda
regulation
tobacco
products
create
number
internal
inconsistencies
various
provisions
act
require
agency
determine
regulated
product
safe
sold
allowed
remain
market
yet
fda
found
rulemaking
proceeding
tobacco
products
dangerous
unsafe
thus
fda
apparently
ban
tobacco
products
result
found
clearly
contrary
congressional
intent
ibid
apparent
anomaly
appeals
concluded
demonstrates
congress
intend
give
fda
authority
regulate
tobacco
also
found
evidence
external
fdca
confirms
conclusion
importantly
fda
consistently
stated
lacked
jurisdiction
tobacco
congress
enacted
several
statutes
fully
cognizant
fda
position
see
id
fact
reasoned
congress
considered
rejected
many
bills
given
agency
authority
see
id
along
absence
intent
enacting
congress
subject
tobacco
products
regulation
fdca
demonstrates
congress
intended
withhold
authority
fda
resolved
jurisdictional
question
agency
appeals
address
whether
regulations
exceed
fda
authority
violate
first
amendment
see
granted
government
petition
certiorari
determine
whether
fda
authority
fdca
regulate
tobacco
products
customarily
marketed
ii
fda
assertion
jurisdiction
regulate
tobacco
products
founded
conclusions
nicotine
drug
cigarettes
smokeless
tobacco
drug
delivery
devices
fda
found
tobacco
products
intended
deliver
pharmacological
effects
satisfying
addiction
stimulation
tranquilization
weight
control
effects
foreseeable
reasonable
manufacturer
consumers
use
tobacco
products
obtain
effects
tobacco
manufacturers
designed
products
produce
effects
fed
reg
initial
matter
respondents
take
issue
fda
reading
intended
arguing
term
art
refers
exclusively
claims
made
manufacturer
vendor
product
see
brief
respondent
brown
williamson
tobacco
product
drug
device
fdca
unless
manufacturer
vendor
makes
express
claim
concerning
product
therapeutic
benefits
see
id
need
resolve
question
however
assuming
arguendo
product
intended
affect
structure
function
body
absent
claims
therapeutic
medical
benefit
fda
claim
jurisdiction
contravenes
clear
intent
congress
threshold
issue
appropriate
framework
analyzing
fda
assertion
authority
regulate
tobacco
products
case
involves
administrative
agency
construction
statute
administers
analysis
governed
chevron
natural
resources
defense
council
chevron
reviewing
must
first
ask
whether
congress
directly
spoken
precise
question
issue
congress
done
inquiry
end
must
give
effect
unambiguously
expressed
intent
congress
see
also
haggar
apparel
holly
farms
nlrb
congress
specifically
addressed
question
reviewing
must
respect
agency
construction
statute
long
permissible
see
ins
auer
robbins
deference
justified
responsibilities
assessing
wisdom
policy
choices
resolving
struggle
competing
views
public
interest
judicial
ones
chevron
supra
agency
greater
familiarity
facts
circumstances
surrounding
subjects
regulated
see
rust
sullivan
determining
whether
congress
specifically
addressed
question
issue
reviewing
confine
examining
particular
statutory
provision
isolation
meaning
ambiguity
certain
words
phrases
may
become
evident
placed
context
see
brown
gardner
ambiguity
creature
definitional
possibilities
statutory
context
fundamental
canon
statutory
construction
words
statute
must
read
context
view
place
overall
statutory
scheme
davis
michigan
dept
treasury
must
therefore
interpret
statute
symmetrical
coherent
regulatory
scheme
gustafson
alloyd
fit
possible
parts
harmonious
whole
ftc
mandel
brothers
similarly
meaning
one
statute
may
affected
acts
particularly
congress
spoken
subsequently
specifically
topic
hand
see
estate
romani
fausto
addition
must
guided
degree
common
sense
manner
congress
likely
delegate
policy
decision
economic
political
magnitude
administrative
agency
cf
mci
telecommunications
american
telephone
telegraph
principles
mind
find
congress
directly
spoken
issue
precluded
fda
jurisdiction
regulate
tobacco
products
viewing
fdca
whole
evident
one
act
core
objectives
ensure
product
regulated
fda
safe
effective
intended
use
see
supp
iii
defining
fda
mission
information
better
patient
care
hearing
senate
committee
labor
human
resources
statement
fda
deputy
commissioner
schultz
fundamental
precept
drug
device
regulation
country
products
must
proven
safe
effective
sold
essential
purpose
pervades
fdca
instance
supp
iii
defines
fda
mission
include
protect
ing
public
health
ensuring
drugs
safe
effective
reasonable
assurance
safety
effectiveness
devices
intended
human
use
fdca
requires
premarket
approval
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approval
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act
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devices
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otherwise
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act
generally
requires
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prevent
marketing
drug
device
potential
inflicting
death
physical
injury
offset
possibility
therapeutic
benefit
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rulemaking
proceeding
fda
quite
exhaustively
documented
tobacco
products
unsafe
dangerous
cause
great
pain
suffering
illness
fed
reg
found
consumption
tobacco
products
presents
extraordinary
health
risks
tobacco
use
single
leading
cause
preventable
death
id
stated
ore
people
die
year
illnesses
cancer
respiratory
illnesses
heart
disease
often
suffering
long
painful
deaths
obacco
alone
kills
people
year
acquired
immunodeficiency
syndrome
aids
car
accidents
alcohol
homicides
illegal
drugs
suicides
fires
combined
ibid
indeed
fda
characterized
smoking
pediatric
disease
id
one
every
three
young
people
become
regular
smokers
die
prematurely
result
id
findings
logically
imply
tobacco
products
devices
fdca
fda
required
remove
market
consider
first
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provisions
concerning
misbranding
drugs
devices
act
prohibits
introduction
delivery
introduction
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commerce
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drug
device
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adultered
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light
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findings
two
distinct
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provisions
render
cigarettes
smokeless
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misbranded
devices
first
deems
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device
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health
used
dosage
manner
frequency
duration
prescribed
recommended
suggested
labeling
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findings
make
clear
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products
dangerous
health
used
manner
prescribed
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drug
device
misbranded
act
nless
labeling
bears
adequate
directions
use
manner
form
necessary
protection
users
except
directions
necessary
protection
public
health
given
fda
conclusions
concerning
health
consequences
tobacco
use
directions
adequately
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consumers
directions
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products
safe
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intended
effects
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products
within
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jurisdiction
act
deem
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devices
introduced
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commerce
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contention
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device
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devices
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impose
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classify
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products
future
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required
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findings
regarding
health
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use
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place
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statutory
obligation
classify
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products
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device
classification
provisions
therefore
make
evident
fda
regulate
cigarettes
smokeless
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act
require
agency
ban
fact
based
provisions
fda
previously
taken
position
tobacco
products
within
jurisdiction
removed
market
impossible
prove
safe
intended
us
public
health
cigarette
amendments
hearings
commerce
subcommittee
hereinafter
hearings
statement
fda
commissioner
charles
edwards
see
also
cigarette
labeling
advertising
hearings
house
committee
interstate
foreign
commerce
hereinafter
hearings
statement
department
health
education
welfare
hew
secretary
thony
celebrezze
proposed
amendments
fdca
given
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jurisdiction
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product
might
well
completely
outlaw
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cigarettes
congress
however
foreclosed
removal
tobacco
products
market
provision
code
currently
force
marketing
tobacco
constitutes
one
greatest
basic
industries
ramifying
activities
directly
affect
interstate
foreign
commerce
every
point
stable
conditions
therein
necessary
general
welfare
importantly
congress
directly
addressed
problem
tobacco
health
legislation
six
occasions
since
see
federal
cigarette
labeling
advertising
act
fclaa
pub
stat
public
health
cigarette
smoking
act
pub
stat
alcohol
drug
abuse
amendments
pub
stat
comprehensive
smoking
education
act
pub
stat
comprehensive
smokeless
tobacco
health
education
act
pub
stat
alcohol
drug
abuse
mental
health
administration
reorganization
act
pub
stat
congress
enacted
statutes
adverse
health
consequences
tobacco
use
well
known
nicotine
pharmacological
effects
see
dept
health
education
welfare
surgeon
general
advisory
committee
smoking
health
hereinafter
surgeon
general
report
concluding
cigarette
smoking
causes
lung
cancer
coronary
artery
disease
chronic
bronchitis
emphysema
nicotine
various
pharmacological
effects
including
stimulation
tranquilization
appetite
suppression
dept
health
human
services
public
health
service
health
consequences
smoking
women
finding
mortality
rates
lung
cancer
chronic
lung
disease
coronary
heart
disease
increased
women
men
smokers
smoking
pregnancy
associated
significant
adverse
health
effects
unborn
fetus
newborn
child
dept
health
human
services
public
health
service
people
smoke
cigarettes
smoking
prevention
education
act
hearings
subcommittee
health
environment
house
committee
energy
commerce
hereinafter
house
hearings
stating
smoking
widespread
example
drug
dependence
country
cigarettes
affect
chemistry
brain
nervous
system
dept
health
human
services
public
health
service
health
consequences
smoking
nicotine
addiction
hereinafter
surgeon
general
report
concluding
tobacco
products
addicting
much
way
heroin
cocaine
nicotine
drug
causes
addiction
nonetheless
congress
stopped
well
short
ordering
ban
instead
generally
regulated
labeling
advertisement
tobacco
products
expressly
providing
policy
congress
commerce
national
economy
may
protected
maximum
extent
consistent
consumers
ing
adequately
informed
adverse
health
effects
congress
decisions
regulate
labeling
advertising
adopt
express
policy
protecting
commerce
national
economy
maximum
extent
reveal
intent
tobacco
products
remain
market
indeed
collective
premise
statutes
cigarettes
smokeless
tobacco
continue
sold
ban
tobacco
products
fda
therefore
plainly
contradict
congressional
policy
fda
apparently
recognized
dilemma
concluded
somewhat
ironically
tobacco
products
actually
safe
within
meaning
fdca
promulgating
regulations
agency
conceded
tobacco
products
unsafe
term
conventionally
understood
fed
reg
nonetheless
fda
reasoned
determining
whether
device
safe
act
must
consider
risks
presented
product
also
countervailing
effects
use
product
including
consequences
permitting
product
marketed
id
applying
standard
fda
found
high
level
addiction
among
tobacco
users
ban
likely
dangerous
id
particular
current
tobacco
users
suffer
extreme
withdrawal
health
care
system
available
pharmaceuticals
might
able
meet
treatment
demands
suffering
withdrawal
black
market
offering
cigarettes
even
dangerous
currently
sold
legally
likely
develop
ibid
fda
therefore
concluded
taking
cigarettes
smokeless
tobacco
market
prevent
people
becoming
addicted
reduce
death
disease
others
record
establish
ban
appropriate
public
health
response
act
id
may
well
fda
asserts
factors
must
considered
developing
regulatory
scheme
achieves
best
public
health
result
products
id
fda
judgment
leaving
tobacco
products
market
effective
achieving
public
health
goals
ban
ibid
substitute
specific
safety
determinations
required
fdca
various
operative
provisions
several
provisions
act
require
fda
determine
product
safe
used
consumers
product
probable
therapeutic
benefits
must
outweigh
risk
harm
see
rutherford
commissioner
generally
considers
drug
safe
expected
therapeutic
gain
justifies
risk
entailed
use
contrast
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conception
safety
allow
agency
respect
provision
fdca
requires
agency
determine
product
safety
dangerousness
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aggregate
health
effects
alternative
administrative
actions
qualitatively
different
inquiry
thus
although
fda
concluded
ban
dangerous
concluded
tobacco
products
safe
term
used
throughout
act
consider
specifies
factors
fda
may
consider
determining
safety
effectiveness
device
purposes
classification
performance
standards
premarket
approval
devices
regulated
fda
must
least
reasonable
assurance
safety
effectiveness
device
see
ed
supp
iii
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reg
title
provides
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respect
persons
whose
use
device
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benefit
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use
device
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risk
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reading
provision
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therapeutic
benefits
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probable
risk
injury
applied
tobacco
products
inquiry
whether
purported
benefits
satisfying
addiction
stimulation
sedation
weight
control
outweigh
risks
health
use
accommodate
fda
conception
safety
however
one
must
read
probable
benefit
health
include
benefit
public
health
stemming
adult
consumers
continued
use
tobacco
products
even
though
reduction
tobacco
use
raison
tre
regulations
words
fda
forced
contend
evil
seeks
combat
benefit
health
implausible
fda
conception
safety
also
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provision
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product
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health
used
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manner
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duration
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thereof
according
fda
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product
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health
therefore
misbranded
comparison
leaving
product
market
ban
produce
adverse
health
consequences
aggregate
quite
simply
different
inquiries
although
banning
particular
product
might
detrimental
public
health
aggregate
product
still
dangerous
health
used
directed
section
focuses
dangers
consumer
use
product
stemming
agency
remedial
measures
consequently
analogy
made
fda
dissent
highly
toxic
drugs
used
treatment
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cancers
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fed
reg
post
opinion
breyer
although
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sense
drugs
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within
meaning
act
certain
patients
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benefits
outweigh
risk
harm
accordingly
drugs
properly
described
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health
true
tobacco
products
fda
documented
great
detail
cigarettes
smokeless
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means
obtaining
pharmacological
effect
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contends
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means
fdca
requires
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ban
outright
dangerous
drugs
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perverse
reading
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id
misunderstands
holding
fda
consistent
fdca
may
clearly
regulate
many
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products
without
banning
indeed
virtually
every
drug
device
poses
dangers
certain
conditions
fda
may
conclude
drug
device
used
safely
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purpose
yet
time
allow
product
remain
market
regulation
incompatible
fdca
core
objective
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device
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whole
clear
congress
intended
exclude
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products
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jurisdiction
fundamental
precept
fdca
product
regulated
fda
banned
must
safe
intended
use
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provisions
act
make
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refers
safety
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product
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effects
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health
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actions
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fda
must
determine
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benefits
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risk
harm
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according
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fda
concluded
although
tobacco
products
might
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certain
pharmacological
effects
unsafe
dangerous
used
purposes
consequently
tobacco
products
within
fda
jurisdiction
act
require
fda
remove
market
entirely
ban
contradict
congress
clear
intent
expressed
recent
legislation
inescapable
conclusion
room
tobacco
products
within
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regulatory
scheme
used
safely
therapeutic
purpose
yet
banned
simply
fit
determining
whether
congress
spoken
directly
fda
authority
regulate
tobacco
must
also
consider
greater
detail
legislation
congress
enacted
past
years
time
statute
enacted
may
range
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meanings
time
however
subsequent
acts
shape
focus
meanings
classic
judicial
task
reconciling
many
laws
enacted
time
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make
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combination
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assumes
implications
statute
may
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implications
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statute
fausto
particularly
scope
earlier
statute
broad
subsequent
statutes
specifically
address
topic
hand
recognized
recently
estate
romani
specific
policy
embodied
later
federal
statute
control
construction
earlier
statute
even
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ha
expressly
amended
congress
enacted
six
separate
pieces
legislation
since
addressing
problem
tobacco
use
human
health
see
supra
statutes
among
things
require
health
warnings
appear
packaging
print
outdoor
advertisements
see
prohibit
advertisement
tobacco
products
medium
electronic
communication
subject
regulation
federal
communications
commission
fcc
see
require
secretary
health
human
services
hhs
report
every
three
years
congress
research
findings
concerning
addictive
property
tobacco
make
receipt
certain
federal
block
grants
contingent
making
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manufacturer
retailer
distributor
tobacco
products
sell
distribute
product
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age
adopting
statute
congress
acted
backdrop
fda
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repeated
statements
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authority
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regulate
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absent
claims
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benefit
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fact
several
occasions
period
health
consequences
tobacco
use
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pharmacological
effects
become
well
known
congress
considered
rejected
bills
granted
fda
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circumstances
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congress
statutes
effectively
ratified
fda
position
lacks
jurisdiction
fdca
regulate
tobacco
products
congress
created
distinct
regulatory
scheme
address
problem
tobacco
health
scheme
presently
constructed
precludes
role
fda
january
surgeon
general
released
report
advisory
committee
smoking
health
report
documented
deleterious
health
effects
smoking
great
detail
concluding
relevant
part
cigarette
smoking
contributes
substantially
mortality
certain
specific
diseases
overall
death
rate
surgeon
general
report
also
identified
pharmacological
effects
nicotine
including
stimulation
tranquilization
suppression
appetite
seven
days
report
release
federal
trade
commission
ftc
issued
notice
proposed
rulemaking
see
fed
reg
june
ftc
promulgated
final
rule
requiring
cigarette
manufacturers
disclose
clearly
prominently
advertising
every
pack
box
carton
container
cigarette
smoking
dangerous
health
may
cause
death
cancer
diseases
id
rule
become
effective
january
request
congress
ftc
postponed
enforcement
six
months
see
cipollone
liggett
group
response
surgeon
general
report
ftc
proposed
rule
congress
convened
hearings
consider
legislation
addressing
tobacco
problem
hearings
deliberations
fda
representatives
testified
congress
agency
lacked
jurisdiction
fdca
regulate
tobacco
products
surgeon
general
terry
asked
hearings
whether
hew
authority
brand
label
packages
cigarettes
control
advertising
id
surgeon
general
stated
authority
existing
laws
governing
food
drug
administration
ibid
similarly
fda
deputy
commissioner
rankin
testified
food
drug
administration
jurisdiction
food
drug
cosmetic
act
tobacco
unless
bears
drug
claims
cigarette
labeling
advertising
hearings
house
committee
interstate
foreign
commerce
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hearings
see
also
letter
directors
bureaus
divisions
directors
districts
fda
bureau
enforcement
may
hearings
obacco
marketed
chewing
smoking
without
accompanying
therapeutic
claims
meet
definitions
food
drug
cosmetic
act
food
drug
device
cosmetic
fact
hew
secretary
celebrezze
urged
congress
amend
fdca
cover
smoking
products
light
findings
surgeon
general
report
provision
might
well
completely
outlaw
least
cigarettes
contrary
understand
intended
light
experience
amendment
acceptable
american
people
hearings
fda
disavowal
jurisdiction
consistent
position
taken
since
agency
inception
fda
concedes
never
asserted
authority
regulate
tobacco
products
customarily
marketed
promulgated
regulations
issue
see
brief
petitioners
see
also
brief
appellee
fda
action
smoking
health
harris
cadc
rec
tab
pp
years
since
enactment
original
food
drug
act
years
since
promulgation
modern
food
drug
cosmetic
act
fda
repeatedly
informed
congress
cigarettes
beyond
scope
statute
absent
health
claims
establishing
therapeutic
intent
behalf
manufacturer
vendor
fda
position
also
consistent
congress
specific
intent
enacted
fdca
act
adoption
fda
predecessor
agency
bureau
chemistry
announced
lacked
authority
regulate
tobacco
products
pure
food
drug
act
ch
stat
unless
marketed
therapeutic
claims
see
dept
agriculture
bureau
chemistry
service
regulatory
announcements
apr
announcements
opinion
chief
bureau
alsberg
congress
considered
rejected
bill
amend
food
drugs
act
june
extending
provisions
tobacco
tobacco
products
see
also
cong
rec
remarks
smoot
fda
admits
evidence
text
fdca
legislative
history
congress
even
considered
applicability
act
tobacco
products
see
brief
petitioners
given
economic
political
significance
tobacco
industry
time
extremely
unlikely
congress
intended
place
tobacco
within
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fdca
absent
discussion
matter
course
whether
congress
enacted
fdca
specifically
intended
act
cover
tobacco
products
determinative
ultimately
provisions
laws
rather
principal
concerns
legislators
governed
oncale
sundowner
offshore
services
see
also
tva
hill
us
speculate
much
less
act
whether
congress
altered
stance
specific
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case
anticipated
nonetheless
intent
certainly
relevant
understanding
basis
fda
representations
congress
background
congress
enacted
subsequent
legislation
moreover
enacting
fclaa
congress
considered
rejected
several
proposals
give
fda
authority
regulate
tobacco
april
representative
udall
introduced
bill
amend
federal
food
drug
cosmetic
act
make
act
applicable
smoking
products
two
months
later
senator
moss
introduced
identical
bill
senate
sess
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american
public
health
association
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moss
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regulate
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tar
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action
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health
harris
cadc
kluger
ashes
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senator
moss
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limit
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letter
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health
ash
executive
director
banzhaf
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goyan
app
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sens
hartke
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ford
stevens
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meanwhile
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cigarettes
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tab
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asserted
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use
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obtain
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thousands
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annually
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denying
ash
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commissioner
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act
fda
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cigarettes
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banzhaf
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matter
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cadc
rec
tab
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fda
also
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congress
long
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cigarettes
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health
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fda
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request
ash
commence
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establish
agency
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cigarettes
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letter
ash
executive
director
banzhaf
fda
commissioner
goyan
app
agency
stated
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rulemaking
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cigarettes
attached
filters
customarily
marketed
concluded
fda
jurisdiction
section
act
id
congress
considered
legislation
subject
smoking
health
hhs
assistant
secretary
brandt
testified
addition
major
cause
cancer
smoking
major
cause
heart
disease
serious
illnesses
result
unfavorable
pregnancy
outcomes
house
hearings
also
stated
cigarette
smoking
drug
dependence
smoking
addictive
many
people
id
nonetheless
assistant
secretary
brandt
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issue
regulation
tobacco
something
congress
reserved
within
department
authority
regulate
seeking
authority
id
also
testified
senate
stating
despite
evidence
tobacco
health
effects
addictiveness
department
view
congress
assumed
responsibility
regulating
cigarettes
smoking
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education
act
hearings
senate
committee
labor
human
resources
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senate
hearings
backdrop
congress
enacted
three
additional
statutes
next
four
years
incrementally
expanded
regulatory
scheme
tobacco
products
congress
adopted
alcohol
drug
abuse
amendments
pub
stat
codified
et
seq
require
secretary
hhs
report
congress
every
three
years
addictive
property
tobacco
include
recommendations
action
secretary
may
deem
appropriate
year
later
congress
enacted
comprehensive
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education
act
pub
stat
amended
fclaa
modifying
prescribed
warning
notably
debate
senate
floor
senator
hawkins
argued
act
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nder
food
drug
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act
congress
exempted
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products
cong
rec
congress
enacted
comprehensive
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health
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act
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pub
stat
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seq
essentially
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codified
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cigarettes
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reserved
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surgeon
general
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report
summarizing
abundant
scientific
literature
demonstrating
igarettes
forms
tobacco
addicting
nicotine
psychoactive
causes
physical
dependence
characterized
withdrawal
syndrome
usually
accompanies
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abstinence
surgeon
general
report
report
concluded
pharmacologic
behavioral
processes
determine
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addiction
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addiction
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heroin
cocaine
id
year
fda
commissioner
young
stated
congress
look
like
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regulate
tobacco
food
drug
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act
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smoking
think
widely
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harmful
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health
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committee
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fda
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whether
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sess
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health
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pub
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executive
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banzhaf
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power
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public
interest
must
always
grounded
valid
grant
authority
congress
anxiety
effectuate
congressional
purpose
protecting
public
must
take
care
extend
scope
statute
beyond
point
congress
indicated
stop
article
drug
quoting
cases
jam
reading
fdca
whole
well
conjunction
congress
subsequent
legislation
plain
congress
given
fda
authority
seeks
exercise
reasons
judgment
appeals
fourth
circuit
affirmed
ordered
food
drug
administration
et
al
tioners
brown
williamson
tobacco
corporation
et
al
writ
certiorari
appeals
fourth
circuit
march
justice
breyer
justice
stevens
justice
souter
justice
ginsburg
join
dissenting
food
drug
administration
fda
authority
regulate
articles
food
intended
affect
structure
function
body
federal
food
drug
cosmetic
act
fdca
unlike
majority
believe
tobacco
products
fit
within
statutory
language
interpretation
majority
nowhere
denies
following
two
salient
points
first
tobacco
products
including
cigarettes
fall
within
scope
statutory
definition
read
literally
cigarettes
achieve
effects
interaction
chemical
nicotine
cells
central
nervous
system
cigarette
manufacturers
smokers
alike
know
desire
chemically
induced
result
hence
cigarettes
intended
affect
body
structure
function
literal
sense
words
second
statute
basic
purpose
protection
public
health
supports
inclusion
cigarettes
within
scope
see
article
drug
fdca
given
liberal
construction
consistent
overriding
purpose
protect
public
health
emphasis
added
unregulated
tobacco
use
causes
ore
people
die
year
illnesses
cancer
respiratory
illnesses
heart
disease
fed
reg
indeed
tobacco
products
kill
people
country
every
year
aids
car
accidents
alcohol
homicides
illegal
drugs
suicides
fires
combined
ibid
emphasis
added
despite
fdca
literal
language
general
purpose
support
fda
finding
cigarettes
come
within
statutory
authority
majority
nonetheless
reads
statute
excluding
tobacco
products
two
basic
reasons
fdca
fit
case
tobacco
statute
requires
fda
prohibit
dangerous
drugs
devices
like
cigarettes
outright
agency
concedes
simply
banning
sale
cigarettes
proper
remedy
ante
congress
enacted
statutes
viewed
light
fda
long
history
denying
jurisdiction
considered
together
congress
failure
explicitly
grant
agency
authority
demonstrate
congress
intend
fda
exercise
jurisdiction
tobacco
ante
view
neither
propositions
valid
rather
fdca
significantly
limit
fda
remedial
alternatives
see
infra
later
statutes
tell
fda
exercise
jurisdiction
simply
leave
fda
jurisdictional
law
congress
found
see
infra
cf
food
drug
administration
modernization
act
stat
codified
note
following
supp
iii
statute
shall
construed
affect
question
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fda
authority
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latter
conclusions
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believe
important
indicia
statutory
meaning
language
purpose
along
fdca
legislative
history
described
briefly
part
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establish
fda
authority
regulate
tobacco
arguments
jurisdiction
tobacco
companies
majority
rely
upon
discussed
part
ii
based
erroneous
assumptions
thus
defeat
thrust
fdca
language
purpose
inferences
majority
draws
later
legislative
history
persuasive
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point
part
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easily
infer
later
laws
congress
intend
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scope
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iv
establishes
agency
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degree
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attach
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action
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alleviate
concern
congress
rather
administrative
agency
make
important
regulatory
decision
federal
pure
food
drug
act
contained
two
jurisdictional
definitions
drug
medicines
preparations
recognized
pharmacopoeia
national
formulary
substance
mixture
substances
intended
used
cure
mitigation
prevention
disease
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congress
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food
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offers
support
fda
drafted
new
language
testified
congress
third
definition
expand
fdca
jurisdictional
scope
significantly
see
hearings
subcommittee
senate
committee
commerce
reprinted
fda
legislative
history
federal
food
drug
cosmetic
act
amendments
hereinafter
leg
indeed
purpose
new
definition
make
possible
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great
many
products
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treatments
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drafters
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products
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substances
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devices
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emphasis
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see
also
hearings
senate
committee
commerce
sess
reprinted
leg
hist
statement
chief
walter
campbell
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drugs
studying
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written
statute
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drug
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sense
fdca
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hutt
philosophy
regulation
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food
drug
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drug
cosm
emphasis
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said
historical
expansion
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drug
creation
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devices
clearly
show
congress
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indicates
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definition
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congress
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fda
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one
president
much
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time
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interstate
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establish
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communications
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interest
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congress
suddenly
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agency
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years
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legislators
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delegation
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well
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fda
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cigarette
manufacturers
within
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statutory
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cigarettes
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changes
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makers
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proof
fda
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popular
product
see
kluger
ashes
ashes
americans
love
smoking
seemed
unlikely
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fda
decided
regulate
proved
particular
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courts
rule
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assertion
fully
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cf
southwestern
cable
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communications
act
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foreseen
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permian
basin
area
rate
cases
statutory
authority
regulate
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transportation
natural
gas
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authority
regulate
prices
charged
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producers
phillips
petroleum
wisconsin
independent
gas
producer
subject
regulation
despite
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gas
act
express
exemption
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production
facilities
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pursue
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matters
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companies
majority
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fdca
literal
language
general
purpose
particular
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history
favor
fda
present
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specific
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support
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companies
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mean
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apparatus
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conditioners
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therapeutic
products
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tobacco
companies
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conditioners
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underwear
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thing
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contravenes
established
purpose
statutory
language
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third
definition
clearly
broader
strict
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definition
leg
hist
definition
covers
products
alleged
treatments
diseased
conditions
another
companies
restriction
render
two
drug
definitions
superfluous
see
covering
articles
leading
pharmacology
compendia
intended
use
diagnosis
cure
mitigation
treatment
prevention
disease
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statute
language
supplies
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suitable
limitation
drug
must
chemical
agent
fdca
device
definition
article
affects
structure
function
body
device
achieve
primary
intended
purposes
chemical
action
within
body
dependent
upon
metabolized
achievement
primary
intended
purposes
emphasis
added
one
readily
infer
language
least
article
achieve
primary
purpose
chemical
action
within
body
dependent
upon
metabolized
drug
provided
otherwise
falls
within
scope
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definition
one
need
hypothesize
air
conditioners
thermal
pajamas
recognize
chemical
nicotine
important
tobacco
ingredient
meets
test
although
oversimplify
fda
determined
nicotine
enters
body
blood
carries
almost
immediately
brain
see
fed
reg
nicotine
binds
receptors
surface
brain
cells
setting
series
chemical
reactions
alter
one
mood
produce
feelings
sedation
stimulation
see
nicotine
also
increases
number
nicotinic
receptors
brain
surface
alters
normal
electrical
activity
see
nicotine
stimulates
transmission
natural
chemical
rewards
body
pleasurable
sensations
dopamine
causing
nicotine
addiction
see
upshot
nicotine
stabilizes
mood
suppresses
appetite
tranquilizes
satisfies
physical
craving
nicotine
helped
create
chemical
action
within
body
metabolized
physiology
simply
smoker
psychology
helps
explain
many
adult
smokers
believe
smoking
reduce
nervous
irritation
fed
reg
young
people
begin
smoking
say
relaxation
fed
reg
less
smokers
want
quit
year
succeed
chemistry
also
helps
explain
surgeon
general
findings
smokers
believe
smoking
makes
feel
better
smoke
situations
involving
negative
mood
present
purposes
chemistry
demonstrates
nicotine
affects
structure
function
body
manner
quite
similar
effects
regulated
substances
see
fda
regulates
valium
nodoz
products
indeed
addiction
sedation
stimulation
weight
loss
precisely
kinds
product
effects
fda
typically
reviews
controls
since
nicotine
cigarettes
plainly
food
chemical
effects
suffice
establish
drug
cigarette
delivers
device
purpose
fdca
tobacco
companies
principal
definitional
argument
focuses
upon
statutory
word
intended
see
companies
say
intended
context
term
art
see
brief
respondent
brown
williamson
tobacco
assert
statutory
word
intended
means
product
maker
made
express
claim
effect
product
body
ibid
indeed
according
companies
fda
inability
prove
cigarette
manufacturers
make
claims
precisely
agency
historically
said
lacked
statutory
power
regulate
tobacco
see
fdca
however
use
word
claimed
uses
word
intended
fda
long
ago
issued
regulations
say
relevant
intent
shown
manufacturer
expressions
also
circumstances
surrounding
distribution
article
fed
reg
codified
cfr
see
also
fed
reg
objective
intent
shown
article
knowledge
makers
offered
used
particular
purpose
thus
even
absence
express
claims
fda
regulated
products
affect
body
manufacturer
wants
knows
consumers
use
product
see
fed
reg
describing
agency
regulation
topical
hormones
sunscreens
fluoride
tanning
lamps
thyroid
food
supplements
novelty
condoms
marketed
without
express
claims
see
also
food
drug
administration
sometimes
nature
material
makes
drug
courts
ordinarily
reverse
agency
interpretation
kind
congress
clearly
answered
interpretive
question
agency
interpretation
unreasonable
chevron
natural
resources
defense
council
companies
effort
argue
former
point
language
legislative
history
tying
word
intended
technical
concept
called
intended
use
nothing
congress
discussion
either
intended
intended
use
suggests
express
claim
often
shows
intent
always
necessary
indeed
primary
statement
companies
direct
attention
says
manufacturer
determine
kind
regulation
applies
food
drug
representations
connection
sale
manufacturer
determine
whether
article
used
food
drug
reprinted
leg
hist
fda
objective
intent
interpretation
unreasonable
falls
well
within
established
scope
ordinary
meaning
word
intended
see
agnew
intent
encompasses
known
consequences
act
companies
acknowledge
fda
regulate
substance
ordinary
circumstance
manufacturer
makes
express
claim
unreasonable
conclude
agency
retains
power
product
effects
body
well
known
say
like
aspirin
calamine
lotion
need
express
representations
product
speaks
companies
also
deny
evidence
intent
sufficient
satisfy
statutory
word
intended
fda
long
interpreted
first
place
time
actually
make
express
advertising
claims
regarding
tobacco
properties
historical
representations
portend
present
expectations
late
example
american
tobacco
company
urged
smokers
reach
lucky
instead
sweet
kluger
ashes
ashes
advertisements
reynolds
rjr
emphasized
mood
stability
depicting
pilot
remarking
takes
steady
nerves
fly
mail
night
smoke
camels
smoke
plenty
rjr
also
advertised
stimulating
quality
cigarettes
stating
one
instance
get
lift
camel
another
camels
harmless
restoration
flow
natural
body
energy
claims
medical
proof
mildness
beneficial
effects
commonplace
see
brown
williamson
advertised
mentholated
cigarettes
tonic
hot
tired
throats
phillip
morris
contended
ecognized
laboratory
tests
conclusively
proven
advantage
phillip
morris
rjr
proclaimed
digestion
sake
smoke
camels
camels
make
mealtime
pleasant
digestion
stimulated
alkalinity
although
recent
decades
cigarette
manufacturers
stopped
making
express
health
claims
advertising
consumers
come
understand
companies
longer
need
express
chemical
action
cigarettes
stabilize
mood
sedate
stimulate
help
suppress
appetite
second
even
though
companies
refused
acknowledge
publicly
recently
nicotine
cigarettes
chemically
induced
effects
see
regulation
tobacco
products
part
hearings
house
subcommittee
health
environment
hereinafter
hearings
heads
seven
major
tobacco
companies
testified
oath
believed
nicotine
addictive
emphasis
added
fda
recently
gained
access
solid
documentary
evidence
proving
cigarette
manufacturers
long
known
tobacco
produces
effects
within
body
metabolizing
chemicals
long
wanted
products
produce
effects
way
example
scientist
explained
moke
beyond
question
optimized
vehicle
nicotine
cigarette
optimized
dispenser
smoke
fed
reg
scientist
urged
company
executives
hink
cigarette
pack
storage
container
day
supply
nicotine
think
cigarette
dispenser
dose
unit
nicotine
hink
puff
smoke
vehicle
nicotine
ibid
philip
morris
year
tobacco
industry
researchers
told
superiors
different
situations
different
dose
levels
nicotine
appears
act
stimulant
depressant
tranquilizer
psychic
energizer
appetite
reducer
agent
energizer
therefore
tobacco
products
may
sense
compete
variety
products
certain
types
drug
action
rjr
draft
report
prepared
authorities
philip
morris
said
nicotine
physiologically
active
nitrogen
containing
substance
similar
quinine
cocaine
atropine
morphine
hile
substances
used
affect
human
physiology
nicotine
particularly
broad
range
influence
manufacturer
study
stated
pharmacological
response
smokers
nicotine
believed
responsible
individual
smoking
behaviour
providing
motivation
degree
satisfaction
required
smoker
brown
williamson
evidence
fda
sufficiently
established
companies
intend
products
affect
body
within
meaning
fdca
majority
nonetheless
reaches
inescapable
conclusion
language
structure
fdca
whole
simply
fit
kind
public
health
problem
tobacco
creates
ante
majority
view
fdca
requires
fda
ban
outright
dangerous
drugs
devices
cigarettes
yet
fda
concedes
immediate
total
ban
inappropriate
ibid
argument
curious
leads
similarly
inescapable
force
precisely
opposite
conclusion
namely
fda
jurisdiction
must
ban
cigarettes
importantly
argument
fails
take
account
fact
statute
interpreted
requiring
fda
pick
dangerous
less
dangerous
remedy
perverse
statute
causing
rather
preventing
unnecessary
harm
whenever
total
ban
likely
dangerous
response
one
least
imagine
circumstances
suppose
example
commonly
used
mildly
addictive
sleeping
pill
say
kind
popular
contact
lens
plainly
within
fda
jurisdiction
turned
pose
serious
health
risks
certain
consumers
suppose
many
addicted
consumers
ignore
immediate
total
ban
turning
potentially
dangerous
substitute
less
draconian
remedy
say
adequate
notice
wean
gradually
away
safer
product
fdca
still
force
fda
impose
dangerous
remedy
following
reasons
think
first
statute
language
restrict
fda
remedial
powers
way
fdca
permits
fda
regulate
combination
product
device
cigarette
contains
drug
nicotine
device
provisions
fdca
device
provisions
explicitly
grant
fda
wide
remedial
discretion
example
fda
otherwise
obtain
reasonable
assurance
device
safety
effectiveness
agency
may
restrict
regulation
product
sale
distribution
use
upon
conditions
secretary
may
prescribe
emphasis
added
statutory
section
clearly
addresses
fda
power
ban
entitled
banned
devices
says
device
presents
unreasonable
substantial
risk
illness
injury
secretary
may
must
initiate
proceeding
make
device
banned
device
emphasis
added
points
statutory
subsections
believes
require
fda
ban
drug
device
entirely
even
outright
ban
risks
harm
regulatory
responses
see
ante
cited
provisions
thing
true
majority
contends
fdca
requires
fda
place
devices
one
three
classifications
class
iii
devices
require
premarket
approval
ante
case
fda
must
place
cigarettes
class
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enactment
later
statutes
play
critical
part
interpretation
fda
traditional
view
largely
premised
perceived
inability
prove
necessary
statutory
intent
requirement
see
fda
enforcement
letter
statutory
basis
exclusion
tobacco
products
fda
jurisdiction
fact
tobacco
marketed
chewing
smoking
without
accompanying
therapeutic
claims
meet
definitions
food
drug
device
cosmetic
statement
assert
jurisdiction
substance
unless
treated
food
bar
jurisdiction
agency
later
establishes
substance
intended
eaten
fda
denials
authority
sufficiently
resemble
kind
statement
make
critical
interpretive
difference
second
one
might
claim
courts
interpreting
statutes
assume
close
cases
decision
enormous
social
consequences
hearings
made
democratically
elected
members
congress
rather
unelected
agency
administrators
cf
kent
dulles
assuming
congress
want
delegate
power
make
rules
interfering
exercise
basic
human
liberties
background
canon
interpretation
however
believe
controls
outcome
insofar
decision
regulate
tobacco
reflects
policy
administration
decision
administration
politically
elected
officials
support
must
take
responsibility
importance
decision
taken
well
attendant
publicity
means
public
likely
aware
hold
officials
politically
accountable
presidents
like
members
congress
elected
public
indeed
president
vice
president
public
officials
entire
nation
elects
believe
administrative
agency
decision
magnitude
one
important
conspicuous
controversial
escape
kind
public
scrutiny
essential
democracy
review
take
place
whether
congress
executive
branch
makes
relevant
decision
according
fda
smokers
successfully
stop
smoking
year
even
though
say
want
quit
actually
make
attempt
see
fed
reg
citing
centers
disease
control
prevention
cigarette
smoking
among
adults
morbidity
mortality
weekly
report
fact
handful
try
quit
smoking
actually
succeed
illustrates
certain
reality
reality
nicotine
cigarettes
creates
powerful
physiological
addiction
flowing
chemically
induced
changes
brain
fda
found
makers
cigarettes
intend
physical
effects
hence
nicotine
drug
cigarette
delivers
nicotine
body
device
fdca
language
read
light
basic
purpose
permits
fda
assert
jurisdiction
agency
claims
majority
finds
cigarettes
dangerous
fdca
require
banned
result
majority
believes
congress
desired
thus
concludes
fda
authority
disagree
statute
require
cigarette
ban
even
wrong
ban
statute
restrict
agency
choice
remedies
jurisdiction
majority
also
believes
subsequently
enacted
statutes
deprive
fda
jurisdiction
later
laws
say
next
nothing
fda
authority
previous
fda
disclaimers
jurisdiction
may
helped
form
legislative
atmosphere
congress
statutes
emerged
legislative
atmosphere
law
unless
embodied
statutory
word
phrase
relevant
words
phrases
reveal
nothing
intent
change
jurisdictional
status
quo
upshot
today
holds
regulatory
statute
aimed
unsafe
drugs
devices
authorize
regulation
drug
nicotine
device
cigarette
finds
unsafe
far
particular
drug
device
risks
harms
administrative
regulation
seeks
rectify
majority
conclusion
reasons
set
forth
believe
law
require
consequently
dissent