An Overview Of Issues, Objectives and Measurement

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Waxman/Kennedy

Product

Industry

PRODUCTFDA Primary Regulator of Manufacture, Marketing and Distribution of Tobacco ProductsSet National Manufacturing Standards (Control of Ingredients)Oversight and Control all aspects of harm reduction productsPublic Disclosure of Research (Past, Present)

INDUSTRY

“TOBACCO CONTROL”

PRODUCT

INDUSTRYImpose Appropriate Regulatory ControlsPromote CessationStrengthen Legislation Against Illicit Trade

“TOBACCO CONTROL”

Youth

Adults

YOUTHto ensure that the Food and Drug Administration has the authority to address issues of particular concern to public health officials, especially the use of tobacco by young people and dependence on tobacco”

to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers”

ADULTS

“FAMILY SMOKING PREVENTION”

“FAMILY SMOKING PREVENTION”

The use of tobacco products by the Nation’s children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults.

Virtually all new users of tobacco products are under the minimum legal age to purchase such products.

Reducing the use of tobacco by minors by 50 percent would prevent well over 10,000,000 of today’s children from becoming regular, daily smokers, saving over 3,000,000 of them from premature death due to tobacco-induced disease. Such a reduction in youth smoking would also result in approximately $75,000,000,000 in savings attributable to reduced health care costs.

Tobacco product advertising is regularly seen by persons under the age of 18, and persons under the age of 18 are regularly exposed to tobacco product promotional efforts.

Tobacco company documents indicate that young people are an important and often crucial segment of the tobacco market. Children, who tend to be more price sensitive than adults, are influenced by advertising and promotion practices that result in drastically reduced cigarette prices.

Tobacco product advertising often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors.

Children are exposed to substantial and unavoidable tobacco advertising that leads to favorable beliefs about tobacco use, plays a role in leading young people to overestimate the prevalence of tobacco use, and increases the number of young people who begin to use tobacco.Advertising, marketing, and promotion of tobacco products have been especially directed to attract young persons to use tobacco products and these efforts have resulted in increased use of such products by youth. Past efforts to oversee these activities have not been successful in adequately preventing such increased use.Children are more influenced by tobacco marketing than adults: more than 80 percent of youth smoke three heavily marketed brands, while only 54 percent of adults, 26 and older, smoke these same brands.

Tobacco advertising and marketing contribute significantly to the use of nicotine-containing tobacco products by adolescents.

Tobacco advertising expands the size of the tobacco market by increasing consumption of tobacco products including tobacco use by young people.

The use of tobacco products in motion pictures and other mass media glamorizes its use for young people and encourages them to use tobacco products.

Comprehensive advertising restrictions will have a positive effect on the smoking rates of young people.

Restrictions on advertising are necessary to prevent unrestricted tobacco advertising from undermining legislation prohibiting access to young people and providing for education about tobacco use.

Because past efforts to restrict advertising and marketing of tobacco products have failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale, promotion, and distribution of such products are needed.

Text only requirements, although not as stringent as a ban, will help reduce underage use of tobacco products while preserving the informational function of advertising.

Marketing(Ad/Promotion)

Portrays Use as Socially AcceptablePortrays Use as HealthfulOverestimate Peer PrevalenceIncrease InitiationIncrease ConsumptionImpact Brand ChoiceUndermines Legislation (Access)

Favorable Beliefs about Tobacco RESTRICTIONS

Stimulus Youth Impact(s) Solution(s)

FACTS/BELIEFS => ACTIONS

<=>

Seen Regularly

“FAMILY SMOKING PREVENTION”

Establishing the FactsDeveloping ProgramsSetting GoalsMeasuring Progress

Youth tobacco involvement has been a central theme in supporting tax increases, smoke-free legislation, advertising

and promotion restrictions and retail licensing

Awareness/Influence/PerceptionProduct Design (i.e., Flavors)Initiation/Experimentation/TrialRegular/Frequent UseDependenceRetail AccessCessationRecidivism

Reported exposure to pro-tobacco messages in the media: trends among youth in the United States, 2000-2004

The relationship between tobacco advertisements and smoking status of youth in India

Tobacco industry targeting youth in Argentina The impact of tobacco promotion at the point of sale: A

systematic review Impact of tobacco advertising and promotion on increasing

adolescent smoking behaviors Influence of tobacco marketing and exposure to smokers on

adolescent susceptibility to smoking Progression to established smoking: the influence of

tobacco marketing Receptivity to tobacco advertising and promotions among

young adolescents as a predictor of established smoking in young adulthood

Effect of cigarette promotions on smoking uptake among adolescents

Cigarette promotional items in public schools

Asian Pacific Journal of Cancer Prevention

American Journal of Health Promotion

Tobacco Control

Nicotine & Tobacco Research

Cochrane Database Systematic Review

Journal of the National Cancer Institute

American Journal of Preventive Medicine

American Journal of Public Health

Preventive Medicine

Archives of Pediatric & Adolescent Medicine

Tobacco Industry Advertising, Promotion and Youth Influence

(Published Studies)

Virginia Slims Superslims Lights, which come in a lipstick-size pack of 20 cigarettes, are "clearly designed to appeal to teen girls," says Cheryl Healton of the American Legacy Foundation, an anti-smoking group. Source: USA Today, online, 11/2008

Mint, Wintergreen, Spearmint, Cherry, Berry Blend, Vanilla, Apple, Peach, Citrus

The advertisements and packaging employ stylish designs and bright colors that further emphasize the flavor.11 In fact, nearly every aspect of the marketing for these flavored tobacco products, except the health warnings, is strikingly similar to the marketing used for similarly flavored candies and sweetened beverages. (Pick Your Poison: Responses to the Marketing and Sale of Flavored Tobacco Products, A Law Synopsis by the Tobacco Control Legal Consortium, February 2009)

On December 11,1991, the Journal of the American Medical Association (JAMA) published three articles on R.J. Reynolds' "Joe Camel" campaign. One article described a study done with preschoolers in the state of Georgia that concluded that Joe Camel was almost as recognizable to 6 year olds as Mickey Mouse. Another article stated that said the ad campaign had successfully grown Camel's share of the market among underage smokers from 0 .5%to 32 .8%.

Billions of dollars and a variety resources have/are used to address youth tobacco issues:oMedia programs to address adolescent

prevention and cessationoSchool and Community based prevention

programs oPeer-group activities and programsoEmphasis on the role of Parents

Is smokeless tobacco a good substitute for cigarettes? In 1986, the Surgeon General concluded that the use of smokeless tobacco "is not a safe substitute for smoking cigarettes. It can cause cancer and a number of noncancerous conditions and can lead to nicotine addiction and dependence." Since 1991, the National Cancer Institute (NCI), a part of the National Institutes of Health, has officially recommended that the public avoid and discontinue the use of all tobacco products, including smokeless tobacco. NCI also recognizes that nitrosamines, found in tobacco products, are not safe at any level. The accumulated scientific evidence does not support changing this position.

What about using smokeless tobacco to quit cigarettes? Because all tobacco use causes disease and addiction, NCI recommends that tobacco use be avoided and discontinued. Several nontobacco methods have been shown to be effective for quitting cigarettes. These methods include pharmacotherapies such as nicotine replacement therapy and bupropion, individual and group counseling, and telephone quitlines.

Pro-skateboarder Tony Hawk, who started the extreme sports movement, has turned away big-money offers from tobacco companies.

This poster, featuring Hawk in action, clearly demonstrates that this mega-sports star would rather use his celebrity status to teach kids about the dangers of using tobacco

Christy Turlington Poster Produced in 2001 (Celebrities Against Smoking).

This poster features baseball star Torii Hunter, outfielder for the Los Angeles Angels of Anaheim and a five-time Gold Glove winner, promoting an anti-spit tobacco message. Torii is a superb role model for young people, encouraging them to be tobacco free and use physical activity as a healthy alternative

This tobacco-free sports poster featuring Olympic gold medalists Picabo Street (Alpine skiing) and Dominique Dawes (gymnastics), Oregon State University football star Ken Simonton, Brazilian soccer star Sisi, and World Cup champion mountain biker Alison Dunlap emphasizes that you cannot excel in sports by using tobacco.

Intersection with FDA Tobacco Legislation Programs?

Adolescent use of tobacco products in past monthAdolescent use of cigarettes in past monthAdolescent use of spit tobacco in past monthAdolescent use of cigars in past monthChildren/Adolescent initiation of cigarette useAverage age at first tobacco useSmoking cessation attempts by adolescentsChildren’s exposure to tobacco smoke at homeNonsmoker’s exposure to environmental tobacco smokeAdolescent exposure to tobacco advertising and promotions

20,000,000

22,000,000

24,000,000

26,000,000

28,000,000

30,000,000

32,000,000

34,000,000

36,000,000

7.5

8.0

8.5

9.0

9.5

10.0

10.5

11.0

11.5

12.0

2000

2002

2004

2006

2008

2010

2012

2014

2016

2018

2020

2022

2024

2026

2028

2030

2032

2034

2036

2038

2040

2042

2044

2046

2048

2050

Nu

mb

er o

f 12

-17

Ye

ar

Old

s

Fra

ctio

n o

f th

e 1

2-1

7 Y

ea

r-O

ld P

op

ula

tion

(%)

Change in the 12-17 Year-Old PopulationNumber of 12-17 Year-Olds 12-17 Year-Old Fraction of 12+ Pop

Source: U.S. Census Bureau

The change in the 12-17 year-old population goes from24,233,207 in 2000 to 34,045,685 in 2050

"Trying a cigarette is not equivalent to being a smoker, and it is unfair to adolescents to treat them as if it were. Further, it does not lead to good public policy and it makes careful monitoring of the effect of the policy impossible. Policy should be based on good data," Kovar says.(Copyright 1998 PR Newswire, Inc., August 10, 1998)

Looking at HP 2010, adolescent tobacco use goals are based on current prevalence of any use during the past 30 days

Groups Pop (000’s)

% Age 12-17

Notes

12-17 Year-Olds 25,241 2007 NSDUH estimate

Ever Smoked in Lifetime 5,971 23.8 Even one cigarette

Smoked in Past Month 2,482 9.9 Smoked on 1+ of past 30 days

Smoked 100 in Lifetime 1,442 5.7 Part of Adult Definition

Smoked 20 of Past 30 Days 985 3.9 “Frequent smoker”

Smoked 100 in Lifetime and 20 of Past 30 Days

869 3.4 Consistent with adult definition68.5% of adolescents who smoked in the past 30 days smoked on average one or less

cigarettes/day. Approximately, 78% smoked five or less cigarettes/day.

12-17 Year-Olds Who Smoked in the Past 30 Days. Meet the NDSS Criteria?

No Yes Total

(% of Total) (% of Total) (% of Total)

1-20 Days 60.0 5.1 65.1

21-30 Days 17.1 17.8 34.9

Total 77.1 22.9 100.0

~568K 12-17 Year-Olds

Dependence

National Survey on Drug Use and HealthSponsor: SAMHSA

The primary source of statistical information on the use of illegal drugs by the U.S. population

~68,000 Age 12+ Annual

Youth Risk Behavior SurveySponsor: CDC

Focus on behaviors among youth causing the most important health problems

~14,000 9th – 12th Grades

Bi-annual

National Youth Tobacco SurveySponsor: CDC / Legacy

The NYTS was designed to provide a baseline for comparing progress toward meeting the Healthy People 2010 goals for reducing tobacco use among youth

~27,000 6th – 12th Grades

Bi-annual

Monitoring the Future Sponsor: NIDA

An ongoing study of the behaviors, attitudes, and values of American secondary school students, college students, and young adults

~50,000 8th, 10th and 12th Grades

Annual

Global Youth Tobacco Survey (GYTS)Initiated in 1999 the World Health Organization (WHO) and Centers for Disease Control and Prevention’s (CDC's) Office on Smoking and Health developed the Global Youth Tobacco Survey (GYTS) to track tobacco use among young people across countries using a common methodology and core questionnaire. The GYTS surveillance system is intended to enhance the capacity of countries to design, implement, and evaluate tobacco control and prevention programs.

Sample Composition – School –based (public/private) survey of students age 13-15 Methodology – Collected in the classroom, anonymous, self-administered questionnaire

Advertising Receptivity Beliefs and Expectancies Smoking Susceptibility Dependence Friends/Family Smoking Mood Problems Smoking Behavior Stressors Temptations to Smoke Self-Efficacy Validity of Self-Report

Beliefs and Expectancies

 Tobacco Motives Inventory Thomas A. Wills, Ph.D.

 Adolescent Smoking Consequences Questionnaire

Johanna M. Lewis-Esquerre, Ph.D.

 Fishbein-Azjen-Hanson Questionnaire

Mary Jane S. Hanson, Ph.D., C.R.N.P.

 Postive Negative Outcome Expectancies

Madeline Dalton, Ph.D.

 Smoking Decisional Balance Wayne F. Velicer

 Short form- Smoking Consequences Questionnaire

Mark G. Myers, Ph.D.

Categories

Since FFY 2003, all States and U.S. Jurisdictions have been required to meet the federally established RVR target of 20.0 percent. FFY 2007 is the second year that all States and DC were found in compliance with all Synar regulatory requirements.. (Source: SAMHSA Website)

40.1

25.4

20.5 20.0

17.516.3

14.112.8

11.610.8 10.5

0

5

10

15

20

25

30

35

40

45

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Ave

rag

e R

VR

(%

)

NOTE: Weighted by State Population, data f rom all states and D.C. included

Goal

Adolescents purchased less than one percent of the cigarette volume sold in retail outlets in 2007 (Youth Risk Behavior Survey, Tax Burden on Tobacco)

Store, 16.1

Vending Machine, 1.0

Someone Else Bought Them, 26.5

Borrowed Them, 28.0

Stole Them, 6.3

Some Other Way, 11.7

A Person 18 or Older, 10.4

Source: Youth Risk Behavior Survey (Adolescents LE 17 Years-Old)

2007 YRBS

“Retail”

Over 95% of youth got their first cigarette from social sources (2002 California Youth Tobacco Survey)

How Usually Got Own

Cigarettes During Past

30 Days

1997 2007 % Point %(%) (%) Change Change

Store 29.8 16.1 -13.7 -45.9

Vending Machine 1.7 1.0 -0.7 -40.4

Someone else bought them 22.9 26.5 3.6 15.6

Borrowed them 33.0 28.0 -5.0 -15.2

Stole them 3.6 6.3 2.7 73.1

Some other way 9.0 11.7 2.7 30.2

A person 18 or older * 10.4 10.4 NA

TOTAL 100.0 100.0

Note: Adolescents 17<= years-old

Source: Youth Risk Behavior Survey, Public Use Data

* Category not included in 1997 survey

Retail Access

There was a 40%+ decline in adolescents indicating a retail outlet as their usual source of cigarettes!

15

25

35

45

55

65

75

85

Pre

vale

nce

(%)

MTF 8th Grade MTF 10th Grade MTF 12th Grade YRBS 9-12 Grades NSDUH Age 12-17

EVER USED (1999-2008)% Chg % Pt Chg

MTF Cigarettes8th Grade -53.5 -23.610th Grade -45.0 -25.912th Grade -30.8 -19.9

YRBS Grades 9-12 -28.6 -20.1

NSDUH Age 12-17 -36.1 -13.4

0

5

10

15

20

25

30

35

40

45

Pre

vale

nce

(%)

MTF 12th Grade 10th Grade 8th Grade YRBS 9-12 Grades

NSDUH Age 12-17 NYTS Grades 9-12 NYTS Grades 6-8

CURRENT USED (1999-2008)MTF Cigarettes % Chg % Pt Chg

8th Grade -61.1 -10.710th Grade -52.1 -13.412th Grade -41.0 -14.2

YRBS Grades 9-12 -42.5 -14.8

NSDUH Age 12-17 -34.2 -5.1

NYTS* Grades 6-8 -42.7 -4.7NYTS* Grades 9-12 -29.6 -8.3*2000-2006

In the past year, among 12-17 year-olds. (2007 National Survey on Drug Use and Health) - 3.96 million used a cigarette / 1.2 million used a cigarette for the first time (~3,300/day)

0

5

10

15

20

25

30

35

1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Pre

vale

nce

(%)

MTF 8th Graders MTF 10th Graders MTF 12th Graders NSDUH Age 12-17

EVER USED (1999-2008)% Chg % Pt Chg

MTF Smokeless8th Grade -31.9 -4.610th Grade -40.2 -8.212th Grade -33.3 -7.8

NSDUH Age 12-17 -21.4 -2.1

0

2

4

6

8

10

12

14

1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Pre

vale

nce

(%)

MTF 8th Graders MTF 10th Graders MTF 12th Graders YRBS Grades 9-12 NSDUH Age 12-17

CURRENT USED (1999-2008)MTF Smokeless % Chg % Pt Chg

8th Grade -22.2 -1.010th Grade -23.1 -1.512th Grade -22.6 -1.9

YRBS Grades 9-12 1.3 0.1

NSDUH Age 12-17 4.3 0.1

NYTS* Grades 6-8 -27.8 -1.0NYTS* Grades 9-12 -7.6 -0.5* 2000-2006

In the past year, among 12-17 year-olds. (2007 National Survey on Drug Use and Health) - 1.30 million used smokeless tobacco / 0.6 million used smokeless tobacco for the first time

0

5

10

15

20

25

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Pre

vale

nce

(%)

YRBS Grades 9-12 NSDUH Age 12-17 NYTS Grades 9-12 NYTS Grades 6-8

CURRENT USED (1999-2008)Cigars % Chg % Pt Chg

YRBS Grades 9-12 -23.2 -4.1

NSDUH Age 12-17 -22.2 -1.2

NYTS* Grades 6-8 -43.7 -3.1NYTS* Grades 9-12 -20.3 -3.0* 2000-2006

In the past year, among 12-17 year-olds. (2007 National Survey on Drug Use and Health) - 2.37 million used a cigar / 1.1 million used a cigar for the first time.

3.3

65.6

20.9

5.74.5

3.0

66.5

17.8

6.8 6.0

0

10

20

30

40

50

60

70

Never Go to Store All/Most of the Time Some of the Time Hardly Ever Never

% o

f 12

-17

Ye

ar-

Old

s

See Ads in Retail Outlets1999 2004

Source: National Youth Tobacco Survey

When you go to a convenience store, supermarket or gas station how often do you see ads for cigarettes and other tobacco products or items that have tobacco company names or pictures on them?

2.3

44.743.6

7.0

2.42.5

35.9

45.0

12.6

4.0

0

5

10

15

20

25

30

35

40

45

50

Don't Go Movies/Watch TV

Most of the Time Some of the Time Hardly Ever Never

% o

f 12

-17

Ye

ar-

Old

s

Smoking on TV/in Movies1999 2004

Source: National Youth Tobacco Survey

When you watch TV or go to the movies, how often do you see actors smoking?

9.1

20.0

32.7

38.2

11.4

25.8

38.5

24.2

0

5

10

15

20

25

30

35

40

45

Most of the Time Some of the Time Hardly Ever Never

% o

f 12

-17

Ye

ar-

Old

s

See Tobacco Ads on the Internet1999 2004

Source: National Youth Tobacco Survey

When you are searching the Internet on a computer how often do you see ads for tobacco products?

Youth appear to be having a more difficult time getting tobacco (SAMHSA, WE CARD)

The prevalence of “ever” and “current” youth smoking has been falling (since the MSA)

Experimentation with cigarettes by youth appears to have also declined (convergence of “ever” and “current” cigarette use)

Waxman/Kennedy

Establishing the FactsDeveloping ProgramsSetting GoalsMeasuring Progress

FDA Regulation Means Setting Measurable Goals

Emphasis on Prevention, Cessation and Nonsmoker Protection

Continued Focus on Youth IssuesExposure to Secondhand SmokeDenormalization (PR and Consumer Contact)Tax Increases

Evolving Interaction with Other Groups Increasing Emphasis on State-Level Programs

and Information Marginalizing Federal Preemption Ratification of FCTC

Emphasis on Prevention, Cessation and Nonsmoker Protection

Evolving Interaction with Other GroupsReaching out to Federal Agencies, Advocacy

Groups, Health Organizations (IOM)Joint ProjectsLinking DatabasesSharing Goals

Increasing Emphasis on State-Level Programs and Information

Marginalizing Federal Preemption Ratification of FCTC

Emphasis on Prevention, Cessation and Nonsmoker Protection

Evolving Interaction with Other Groups

Increasing Emphasis on State-Level Programs and Information

Marginalizing Federal Preemption Ratification of FCTC