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worldlungfoundation.org

Please
 allow
 this
 letter
 to
 serve
 as
 the
 official
 submission
 of
 comments
 from
 World

Lung
 Foundation
 to
 the
 Food
 and
 Drug
 Administration
 regarding
 Docket
 No
 FDA-­‐
2011-­‐N-­‐0867
 concerning
 Harmful
 and
 Potentially
 Harmful
 Constituents
 in
 Tobacco

Products.

World
 Lung
 Foundation
 is
 a
 non-­‐profit,
 public
 charity
 organization
 registered
 in
 the

State
 of
 New
 York.
 Its
 mission
 is
 to
 reduce
 the
 toll
 of
 lung
 disease,
 which
 kills
 10

million
 people
 each
 year.
 The
 organization’s
 primary
 area
 of
 emphasis
 is
 tobacco

control.

WLF
 is
 one
 of
 five
 principal
 partners
 in
 the
 Bloomberg
 Initiative
 to
 Reduce
 Tobacco

Use,
 a
 global
 effort
 to
 advance
 tobacco
 control
 using
 proven
 interventions.
 WLF
 has

helped
 build
 capacity
 in
 global
 tobacco
 control
 in
 low
 and
 middle-­‐income
 countries

and
 one
 specific
 area
 of
 focus
 has
 been
 social
 marketing
 using
 mass
 media.
 In
 the

past
 four
 years,
 WLF
 has
 developed
 and
 launched
 80
 mass
 media
 campaigns
 across

20
 countries
 worldwide.
 WLF
 has
 also
 published
 a
 number
 of
 peer-­‐reviewed

research
 papers
 supporting
 the
 use
 of
 graphic
 imagery
 in
 mass
 media
 to
 reduce

tobacco
 consumption.

Mass
 Awareness
 Communications:
 Focus
 on
 a
 Few
 Dangerous
 Ingredients
 for

Which
 There
 Is
 Substantial
 Evidence

Numerous
 studies
 show
 that
 the
 use
 of
 new
 information,
 especially
 of
 a
 strong,

emotive,
 graphic
 nature
 can
 motivate
 tobacco
 users
 to
 quit
 and
 can
 delay
 initiation

among
 youth.1
 There
 is
 also
 strong
 evidence
 that
 health
 warnings
 on
 tobacco

products
 are
 powerful
 motivators
 of
 cessation.2
 Communicating
 to
 mass
 audiences

about
 some
 of
 the
 specific,
 dangerous
 constituents
 in
 cigarettes
 offers
 an

opportunity
 to
 communicate
 new
 information
 about
 the
 health
 harms
 associated

with
 these
 products.

While
 there
 is
 an
 exhaustive
 list
 of
 the
 thousands
 of
 complicated
 chemicals
 found
 in

tobacco,
 and
 7,000
 constituents
 found
 in
 smoke
 and
 secondhand
 smoke,3
 many
 of

them
 are
 unfamiliar
 to
 the
 public.
 There
 is
 a
 precedent
 for
 selecting
 a
 few
 chemicals

to
 communicate
 the
 potential
 risks
 of
 smoking
 cigarettes.
 Such
 information
 has
 been

used
 in
 behavior
 change
 campaigns
 and
 on
 cigarette
 pack
 warnings
 globally.

We
 recommend
 that
 if
 a
 mass
 awareness
 campaign
 is
 tried
 as
 a
 strategy
 to

communicate
 the
 ingredients
 and
 their
 harms
 that
 this
 more
 focused
 approach
 is

employed.

Several
 examples
 (below)
 use
 components
 of
 cigarette
 ingredients
 and
 smoke
 to

inform
 about
 the
 dangers.

 These
 include
 the
 highly
 successful
 “Sponge”
 campaign

from
 New
 South
 Wales,
 Australia
 that
 used
 a
 sponge
 as
 a
 metaphor
 for
 lungs
 and

depicted
 graphically
 the
 amount
 of
 tar
 a
 pack
 a
 day
 smoker
 is
 likely
 to
 ingest.

 When

the
 “sponge”
 campaign
 first
 aired
 in
 Sydney
 in
 1983,
 a
 decrease
 of
 nearly
 3%
 was

attributed
 to
 this
 campaign.4
 The
 campaign
 has
 since
 been
 run
 in
 a
 dozen
 countries,

including
 China
 and
 Russia,
 to
 strong
 impact.
 Post
 evaluation
 showed
 the
 campaigns

increased
 awareness
 of
 tobacco
 harms.

 In
 India,
 smokers
 exposed
 to
 campaign

were
 significantly
 more
 likely
 to
 say
 that
 they
 intend
 to
 quit
 in
 the
 future
 than
 those

who
 were
 unexposed
 to
 the
 campaign.
 (70%
 vs.
 66%)
 We
 also
 include
 a
 new
 pack

warning
 from
 Canada,
 and
 a
 2002
 poster
 from
 New
 York
 City
 that
 was
 part
 of
 a

smoke-­‐free
 campaign.

In
 addition,
 people
 who
 saw
 ads
 from
 a
 2008
 smoke-­‐free
 campaign
 in
 Mexico
 City,

reported
 higher
 levels
 of
 understanding
 of
 the
 toxic
 ingredients
 in
 cigarette
 smoke,

specifically
 arsenic
 and
 ammonia.5

For
 campaigns
 and
 for
 the
 warnings
 on
 cigarette
 packs,
 we
 recommend
 choosing
 a

few
 recognizable
 chemicals
 or
 constituents
 for
 which
 there
 is
 substantial
 evidence

of
 health
 impact
 and
 developing
 statements
 that
 explain
 those
 effects,
 e.g.,

“cigarettes
 contain
 cyanide,
 a
 chemical
 used
 in
 rat
 poison”
 or
 “cigarettes
 contain

benzene,
 which
 is
 known
 to
 cause
 cancer.”

 This
 would
 be
 more
 likely
 to
 resonate

with
 smokers
 than
 a
 long
 list
 of
 nitrosamines
 compounds
 most
 people
 know
 little
 or

nothing
 about.

It
 is
 especially
 important
 to
 use
 simple,
 clear
 language
 to
 reach
 across
 a
 wide

spectrum
 of
 demographic
 groups,
 especially
 the
 young,
 since
 most
 smokers
 start
 to

smoke
 in
 early
 adolescence.3
 We
 recommend
 constructing
 statements
 that
 can
 be

understood
 among
 consumers
 who
 read
 at
 a
 5th
 grade
 level.

Furthermore,
 all
 statements
 and
 content
 should
 be
 message-­‐tested
 among
 the
 target

audiences,
 as
 best
 practice
 protocols
 suggest,6,7
 before
 spending
 is
 initiated
 on

printing
 or
 producing
 materials,
 especially
 if
 large
 amounts
 of
 money
 are
 to
 be
 used,

for
 instance
 for
 a
 mass
 media
 campaign
 using
 television.

Making
 the
 Full
 List
 Accessible
 to
 the
 Public

We
 recommend
 making
 the
 full
 list
 of
 ingredients
 available
 on
 the
 FDA
 website.

Each
 ingredient
 could
 be
 accompanied
 by
 information
 about
 health
 impacts,
 e.g.,

whether
 the
 substance
 is
 a
 known
 human
 carcinogen
 or
 is
 harmful
 to
 human
 or

animal
 health,
 based
 on
 inclusive
 chemical
 data
 sets
 as
 suggested
 by
 TPSAC.

For
 context,
 it
 would
 also
 be
 useful
 to
 list
 other
 products
 the
 chemical
 is
 used
 in,

such
 as
 gasoline
 or
 detergent,
 as
 well
 as
 diseases
 or
 conditions,
 the
 substance
 has

been
 linked
 to,
 such
 as
 leukemia
 or
 heart
 disease.

Avoid
 Comparisons
 and
 Industry
 Marketing

Comparisons
 between
 brands
 may
 unintentionally
 mislead
 consumers
 to
 conclude

that
 a
 brand
 containing
 fewer
 chemicals
 is
 safer.
 A
 disclaimer
 could
 be
 included
 with

published
 lists,
 explaining
 that
 a
 shorter
 list
 of
 chemicals
 found
 in
 one
 brand
 does

not
 connote
 a
 safer
 product.

In
 addition,
 tobacco
 companies
 should
 not
 be
 allowed
 to
 use
 confusing
 marketing

terms
 about
 ingredients
 and
 constituents,
 such
 as
 “all
 natural”
 or
 “no
 additives”

which
 have
 been
 shown
 to
 confused
 the
 public
 in
 the
 past.8,9

Perhaps
 most
 importantly
 any
 discussion
 of
 the
 ingredients
 and
 components
 of

tobacco
 products
 should
 not
 lose
 sight
 of
 the
 critical
 point
 that
 tobacco
 itself
 is
 an

addictive
 product
 that
 kills
 up
 to
 one
 in
 two
 long-­‐term
 users
 worldwide.10
 In
 the

United
 States
 that
 includes
 not
 only
 400,000
 smokers
 each
 year
 but
 another
 40,000

exposed
 to
 tobacco
 smoke.11

Bibliography

1. National
 Cancer
 Institute,
 The
 Role
 of
 the
 Media
 in
 Promoting
 and
 Reducing

Tobacco
 Use,
 Tobacco
 Control
 Monograph
 No.
 19.

2. Borland
 R,
 Yong
 H,
 Wilson
 N,
 Fong
 GT,
 et
 al,
 How
 reactions
 to
 cigarette

packet
 health
 warnings
 influence
 quitting:
 Findings
 from
 the
 ITC
 Four-­‐
Country
 Survey.
 Addiction
 DOI:
 10.1111/j.1360-­‐0443.2009.02508.

3. U.S.
 Department
 of
 Health
 and
 Human
 Services.
 How
 Tobacco
 Smoke
 Causes

Disease:
 The
 Biology
 and
 Behavioral
 Basis
 for
 Smoking-­‐Attributable
 Disease:
 A

Report
 of
 the
 Surgeon
 General.
 2010.

4. Dwyer
 T,
 Pierce
 J,
 Hannam,
 CD,
 et
 al,
 Evaluation
 of
 the
 Sydney
 “Quit
 for
 Life”

anti-­‐smoking
 campaign,
 Part
 2,
 Med
 J
 Aust
 1986;
 144:344-­‐7

5. Thrasher,
 J.F.,
 Huang,
 L.,
 Pérez-­‐Hernández,
 R.,
 Niederdeppe,
 J.,
 Arillo-­‐
Santillán,
 E.,
 Alday,
 J.
 (Feb.
 2011)
 Evaluation
 of
 a
 social
 marketing
 campaign

to
 support
 Mexico
 City's
 comprehensive
 smoke-­‐free
 law.
 Am
 J
 Public

Health;101(2):328-­‐35.

6. National
 Cancer
 Institute.
 Pink
 Book
 -­‐
 Making
 Health
 Communication

Programs
 Work.

http://www.cancer.gov/cancertopics/cancerlibrary/pinkbook/page1http://

7. World
 Lung
 Foundation,
 Campaign
 Resources,

www.worldlungfoundation.org/ht/d/sp/i/5835/pid/5835

8. McDaniel
 PA,
 Malone
 RE,
 American
 Smokers
 perceptions
 of
 “natural”

cigarettes
 and
 tobacco
 industry
 advertising
 strategies.
 Tobacco
 Control
 Tob

Control
 2007;16:e7
 doi:10.1136/tc.2006.019638

9. Brown
 A,
 NcNeill
 A,
 Mons
 U,
 Guignard
 R,
 Do
 Smokers
 in
 Europe
 think
 all

cigarettes
 are
 equally
 harmful?
 European
 Journal
 of
 Public
 Heath,
 vol.
 22,

issue
 supplement
 1,
 pp.
 35-­‐40

10. WHO:

http://www.who.int/tobacco/mpower/mpower_report_tobacco_crisis_2008
.pdf

11. CDC
 Smoking
 and
 Tobacco
 Use
 fast
 facts

http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/