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THE FAMILY SMOKING PREVENTION AND

TOBACCO CONTROL ACT

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

ON

H.R. 1108

OCTOBER 3, 2007

Serial No. 110–69

(

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov

COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MIKE DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

DAVID L. CAVICKE, Minority Staff Director

(II)

(III)

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman

HENRY A. WAXMAN, California

EDOLPHUS TOWNS, New York

BART GORDON, Tennessee

ANNA G. ESHOO, California

GENE GREEN, Texas

Vice Chairman

DIANA DEGETTE, Colorado

LOIS CAPPS, California

TOM ALLEN, Maine

TAMMY BALDWIN, Wisconsin

ELIOT L. ENGEL, New York

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

JOHN D. DINGELL, Michigan (ex officio)

NATHAN DEAL, Georgia,

Ranking Member

RALPH M. HALL, Texas

BARBARA CUBIN, Wyoming

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

STEVE BUYER, Indiana

JOSEPH R. PITTS, Pennsylvania

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOE BARTON, Texas (ex officio)

(V)

C O N T E N T S

Page

Hon. Frank Pallone, Jr., a Representative in Congress from the State of

New Jersey, opening statement .......................................................................... 1

Hon. Joe Barton, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 3

Hon. Henry A. Waxman, a Representative in Congress from the State of

California, opening statement ............................................................................. 4

Hon. John B. Shadegg, a Representative in Congress from the State of Arizona, opening statement ...................................................................................... 6

Hon. Gene Green, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 17

Hon. Michael C. Burgess, a Representative in Congress from the State of

Texas, opening statement .................................................................................... 19

Hon. Lois A. Capps, a Representative in Congress from the State of California, opening statement ........................................................................................ 20

Hon. Nathan Deal, a Representative in Congress from the State of Georgia,

opening statement ................................................................................................ 21

Hon. Darlene Hooley, a Representative in Congress from the State of Oregon,

opening statement ................................................................................................ 22

Hon. Heather Wilson, a Representative in Congress from the State of New

Mexico, opening statement .................................................................................. 23

Hon. Tammy Baldwin, a Representative in Congress from the State of Wisconsin, opening statement ................................................................................... 23

Hon. Ralph M. Hall, a Representative in Congress from the State of Texas,

opening statement ................................................................................................ 24

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 25

Hon. Steve Buyer, a Representative in Congress from the State of Indiana,

opening statement ................................................................................................ 26

Hon. Tom Allen, a Representative in Congress from the State of Maine,

opening statement ................................................................................................ 27

Hon. Marsha Blackburn, a Representative in Congress from the State of

Tennessee, opening statement ............................................................................ 28

Hon. Hilda L. Solis, a Representative in Congress from the State of California, opening statement ........................................................................................ 29

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, prepared statement ...................................................................................... 30

Hon. Jim Matheson, a Representative in Congress from the State of Utah,

prepared statement .............................................................................................. 31

Hon. Edolphus Towns, a Representative in Congress from the State of New

York, prepared statement .................................................................................... 31

WITNESSES

Richard J. Bonnie, Harrison Foundation, professor of medicine and law; director, Institute of Law, Psychiatry, and Public Policy, University of Virginia .. 32

Prepared statement .......................................................................................... 35

Answers to submitted questions ...................................................................... 172

Fred Jacobs, M.D., commissioner, New Jersey Department of Health and

Senior Services ..................................................................................................... 37

Prepared statement .......................................................................................... 39

Answers to submitted questions ...................................................................... 201

Alan Blum, M.D., professor, Wallace Endowed Chair and director of the

Center for Study of Tobacco and Society, College of Community Health

Sciences, University of Alabama ......................................................................... 62

Prepared statement .......................................................................................... 64

Page

VI

Risa Lavizzo-Mourey, M.D., president and chief executive officer, Robert Wood

Johnson Foundation, Princeton, NJ ................................................................... 66

Prepared statement .......................................................................................... 68

Answers to submitted questions ...................................................................... 206

Scott Ballin, steering committee member, Alliance for Health, Economic, and

Agriculture Development, Washington, DC ....................................................... 71

Prepared statement .......................................................................................... 74

James Winkler, general secretary, General Board of Church and Society,

United Methodist Church .................................................................................... 96

Prepared statement .......................................................................................... 97

Henry Armour, president and chief executive officer, National Association

of Convenience Stores .......................................................................................... 99

Prepared statement .......................................................................................... 101

Jack E. Henningfeld, vice president, research and health policy, Piney Associates, Bethesda, MD .............................................................................................. 105

Prepared statement .......................................................................................... 107

Answers to submitted questions ...................................................................... 196

William V. Corr, executive director, Campaign for Tobacco-Free Kids ............... 113

Prepared statement .......................................................................................... 115

Answers to submitted questions ...................................................................... 189

SUBMITTED MATERIAL

Andrew C. von Eschenbach, M.D., Commissioner, Food and Drugs, Food

and Drug Administration, U.S. Department of Health and Human Services,

submitted statement ............................................................................................ 7

U.S. Smokeless Tobacco Company, submitted statement .................................... 138

Mike Szymanczyk, chairman and chief executive officer, Philip Morris USA,

submitted statement ............................................................................................ 209

(1)

H.R. 1108, FAMILY SMOKING PREVENTION

AND TOBACCO CONTROL ACT

WEDNESDAY, OCTOBER 3, 2007

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC.

The subcommittee met, pursuant to call, at 10:00 a.m., in room

2123 of the Rayburn House Office Building, Hon. Frank Pallone,

Jr. (chairman) presiding.

Members present: Representatives Pallone, Waxman, Gordon,

Green, DeGette, Capps, Allen, Baldwin, Engel, Solis, Hooley, Deal,

Hall, Wilson, Shadegg, Buyer, Burgess, Blackburn, and Barton.

Staff present: John Ford, Ryan Long, Robert Clark, Virgil Miller,

Chad Grant, Melissa Sidman, Erin Bzymek, and Brin Frazier.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. PALLONE. The hearing is called to order. Today we are having a hearing on H.R. 1108, the Family Smoking Prevention and

Tobacco Control Act introduced by Mr. Waxman. And I will recognize myself initially for an opening statement and thank everyone

for being here today. I am also a cosponsor of the legislation, which

aims to strengthen our Nation’s regulation of tobacco products and

restrict tobacco product marketing.

Every day, approximately 4,000 children try a cigarette for the

first time. According to the Center for Disease Control, every day

1,140 of our children become new daily smokers. And take a

minute to just think about these statistics. According to my calculations, this means that since the beginning of this year, January 1,

2007, 313,400 children have become tobacco addicts, and one-third

of those kids will end up dying prematurely because of tobacco-related illnesses.

In fact, tobacco use is the leading cause of preventable death in

the United States, killing more than 400,000 Americans every year.

That is more than AIDS, alcohol, car accidents, murder, suicides,

illegal drugs and fires combined. And tobacco use costs our health

care system, both public and private, over $96 billion annually.

Fourteen percent of our total Medicaid expenditure is spent on

treatments for smoking-related diseases.

With such implications, it is hard to believe that tobacco products

are exempt from the basic health and safety regulations that apply

to other consumer products. The FDA regulates toothpaste but not

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cigarettes. They monitor cereal but not chewing tobacco. And ironically the FDA regulates both over-the-counter and prescription

medications to help people quit smoking yet has no authority over

the cause of the addiction.

In 1996, the FDA began to implement a comprehensive rule to

prevent and reduce tobacco use by children. Only 4 years later, the

U.S. Supreme Court ruled that under existing law, the FDA lacks

the authority to regulate tobacco products or cigarette company

marketing practices. It is therefore up to this Congress to grant the

FDA the authority that they need.

The 1996 rule identified that the best way to reduce the harm

caused by tobacco was to reduce the number of children who became addicted in the first place. And we must build on this concept

and tackle the problem on a variety of points. We must ensure that

tobacco products are not marketed or sold to children. We must

identify harmful elements in tobacco products. We must require

more detailed warnings on cigarettes packs, and we must demand

scientific proof of claims made about lower risk products.

I happen to be a parent of three children who are nearing their

teens. Actually, one just turned 14 a couple days ago. And the practice of targeting young people with tobacco advertising particularly

concerns me. Since the multi-state tobacco settlement in 1998, tobacco companies have increased their advertising spending by 95

percent. And they are currently spending approximately $13 billion

a year. They use imagery that appeals to youth on their billboards

and in their print ads. They hand out free tobacco-themed merchandise and sponsor sports and entertainment events.

All of these practices aim to draw children into a lifetime of addiction. Studies have shown that teens are twice as likely to remember tobacco advertising than adults, and they remain loyal to

their brand as their addiction takes hold and they move into adulthood.

Mr. Waxman has taken the initiative and proposed a bipartisan

bill that seeks to address what has become a critical public health

problem. I am proud to be a cosponsor, along with many of my colleagues on the subcommittee. The bill will provide the FDA with

the authority to appropriately regulate tobacco products and restrict tobacco product marketing.

The Family Smoking Prevention and Tobacco Control Act would

allow FDA to monitor false or misleading advertising, as well as

marketing aimed at children. It will halt tobacco sales to minors

and will require tobacco companies to provide the FDA with the list

of ingredients and additives in their products. And finally, it forces

companies to substantiate their claims that some tobacco products

are lower risk. This summer, the Senate Committee on Health,

Education, Labor, and Pensions passed their version of the bill.

Both the Senate bill and the bill before us today are vital pieces

of legislation to curb the consumption of tobacco products, to reduce

the number of children using tobacco products, and to ultimately

save millions of lives.

Encouraged by the progress of our colleagues in the Senate, I am

convinced that in this Congress tobacco regulation legislation will

see the light of day. We are determined that it will. And I want

to commend Mr. Waxman again for not only this legislation but for

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so many years of attention to this issue. And I want to thank the

witnesses for appearing before us today to share their experience.

We look forward to your testimony, and I would now recognize the

ranking member of the full committee, Mr. Barton.

OPENING STATEMENT OF HON. JOE BARTON, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BARTON. Thank you, Mr. Chairman. This is a very important

hearing, and I appreciate you organizing it. I wish all the subcommittee members were here. I think everyone in the room agrees

that smoking is a bad habit, and for many people, it can lead to

very serious health consequences. I don’t smoke. I never have. I

never will, and I am going to do everything I can possible to make

sure that my 2-year-old son Jack never smokes either.

I do believe that some of the provisions in the bill before us have

merit. I am not so sure, however, that the Food and Drug Administration is a proper place to regulate tobacco. Even if it is, this legislation seems to me to overreach in its enthusiasm to stop smoking

by giving the agency virtually unlimited discretion.

The FDA is charged generally with ensuring the safety of products. It approves drugs and devices based on safety and efficacy.

This legislation would require the FDA to take on something that

is both enormous and completely outside of its regulatory experience. Under this legislation, the FDA is supposed to base its decision on the very vaguest of standards: ‘‘appropriate for the protection of public health.’’ I am not sure what that means. There is no

legal definition. There is, as far as I know, not even a history that

you could go through as a predicate for it.

This is the sort of vague language that is great for producing

headlines, but I don’t think it is going to be very good at producing

constitutionally protected regulations. And, with all due respect to

the authors of the legislation, we got to take a step back and really

think about it before we move forward.

As of this time, the FDA doesn’t even have the resources for

what it is already supposed to do. We have just tasked the FDA

with a new responsibility for the post-market safety of our Nation’s

drug supply. We now want the FDA to fix the infamous problems

we are having with imported food. And this subcommittee and the

Oversight Subcommittee have held hearings on that this year. It

seems to me that you just can’t keep piling more and more work

on the FDA without giving them the additional resources and expertise to do it. Nothing in that bill does that.

In 1996, the last time the FDA attempted to regulate tobacco, it

was with the intention of regulating it as a drug and to ban tobacco

products all together. Quite a bit has happened to the marketing

and sale of tobacco products since then. In particular, in 1998, we

had the master settlement agreement. It restricted advertising.

Congress also passed the Synar amendment that would require

States to enforce their law prohibiting the sale of tobacco products

to minors or risk losing up to 40 percent of their Federal substance

abuse block grant funding.

Smoking rates, in general, since then are declining, and kids in

particular are smoking quite a bit less. What hasn’t changed is this

particular legislation. In fact, it is basically the same legislation

4

that we looked at back in those days. It was a bill as far back as

2000 referred to this committee that uses, as far as we can tell, the

same language. It is hard to believe that there have been no

changes, no improvements, no rethinking of thoughts about this

particular issue since that time.

I think it is appropriate that we have the hearing. I think it is

appropriate that we listen to the witnesses before us today because

it is an issue that needs to be at least discussed and debated. I am

particularly looking forward to the testimony of Dr. Fred Jacobs of

the New Jersey Department of Health and Senior Services.

According to the General Accountability Office and testimony before the other body earlier this year, the States have received over

$52 billion in tobacco settlement payments from fiscal year 2002

through the fiscal year 2005, $52.6 billion. Of that amount, only 30

percent has gone to provide for health care services, and believe it

or not, only 31⁄2 percent has gone to tobacco control by smoking cessation programs. Three and a half percent. That is about $1.5 billion. According to a report released by the Campaign for TobaccoFree Kids, the States have allocated from tobacco settlement payments $538 million for tobacco prevention in fiscal year 2005,

which amounts to just one-third of the $1.6 billion annually that

the CDC recommends. I think that is a very poor record and something that we ought to look at very closely.

A peer-reviewed article from the July 2007 ‘‘Preventing Chronic

Disease’’ found ‘‘significant reductions in smoking prevalence

among Washington residents following the implementation of a

comprehensive tobacco control program funding at a level near that

recommended by the Centers for Disease Control and Prevention

indicate that the tobacco control programs are effective when the

investment is made and States are committed to improving public

health.’’

If we are serious about cutting the number of kids who smoke,

shouldn’t we insist that the States get serious about meeting the

CDC’s funding targets for their smoking cessation and education

programs with money from the tobacco settlement?

I have a little bit more, Mr. Chairman, but my time has expired.

I yield back, and again thank you for holding this hearing.

Mr. PALLONE. Mr. Waxman.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Mr. WAXMAN. Thank you very much, Chairman Pallone, for holding this hearing and for your leadership on this issue. I am pleased

to present to the committee this bill and to have this hearing on

the legislation. I am open to hear what the witnesses have to say,

and I know all of us here want to learn to see if the bill needs to

be changed in any way, but I think we need a bill.

Tobacco is the deadliest product on the market today when used

as intended. It kills over 400,000 Americans every year. That is

more than alcohol, murders, and car accidents combined, yet it is

one of the least regulated of all consumer products. It is really remarkable that a cigarette is subject to less regulation than a lollipop.

5

The price for this vacuum of regulation is paid by all of us, most

tragically by our children. In the absence of comprehensive regulation, tobacco companies can market freely to kids; even though,

kids aren’t allowed to buy tobacco, but they certainly find ways to

get it. The industry has the unfettered ability to engineer their

products to trigger quick and severe addiction. And they are able

to deceive the American public about the dangers of their products.

We saw that in a campaign that went on for decades.

But we have a moral obligation to do better. Chairman Pallone,

Chairman Dingell, Representative Tom Davis, and I have introduced the Family Smoking Prevention and Tobacco Control Act,

which will give FDA the authority to regulate the design, manufacture, marketing and distribution of tobacco products. Now, regulating tobacco is the single most important thing we can do right now

to curb the deadly toll of tobacco.

By giving FDA jurisdiction over tobacco products, this bill would

help to prevent the marketing and sales of tobacco to kids, enable

public health professionals to know what exactly is in a cigarette

and to learn what the industry knows about their addictiveness

and toxicity. It would empower the FDA to keep tobacco companies

from making false and misleading claims about the safety of their

products. It would allow FDA to require changes to the product

content or design to protect the public health by, for example, reducing the amount of nicotine to make cigarettes less addictive.

Now, some have raised concerns that FDA is not the right agency

for this job. I disagree. No other agency shares FDA’s strong scientific foundation, together with a public health mission and comprehensive regulatory authority.

FDA also possesses institutional familiarity with tobacco itself.

Not only does FDA currently regulate nicotine as a drug in smoking cessation products, but in the 1990s, FDA actually spent years

crafting a detailed framework for regulating tobacco. Ultimately

the Supreme Court struck down the exercise of regulatory authority, but the groundwork was laid for a sophisticated approach to tobacco regulation.

It is true that tobacco is different from other products regulated

by the FDA. We can’t have a safe and effective standard. That is

why the bill has a new standard appropriate for the protection of

public health. There is no question FDA needs new resources to do

the job, and that is why we have a user fee to help provide them

with those resources.

Experts in the public health community agree that this is the

right approach. The bill is supported by the Heart Association,

Lung Association, Cancer Society, and over 500 other organizations. I look forward to the hearing today, and I think it is legislation that will help protect our children and grandchildren from

what has been a tobacco epidemic. Thank you, Mr. Chairman.

Mr. BARTON. Mr. Chairman?

Mr. PALLONE. Yes.

Mr. BARTON. Parliamentary inquiry. The Republican sponsor of

this legislation is not a member of the committee, Mr. Davis of Virginia. We had asked that he be allowed to sit in on this hearing.

Has that been approved?

6

Mr. PALLONE. Yes, my understanding is that members from

other committees can sit on the dais, but they don’t participate in

either opening statements or questions. But they can sit on the

dais.

Mr. BARTON. Thank you.

Mr. PALLONE. So as soon as he comes in, he is welcome to join

us.

Mr. BARTON. OK.

Mr. PALLONE. I recognize the gentleman from Arizona, Mr. Shadegg.

OPENING STATEMENT OF HON. JOHN B. SHADEGG, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ARIZONA

Mr. SHADEGG. I thank you, Mr. Chairman, and I thank you for

holding this hearing. I think it is an important discussion to have.

I want to make it clear that I share the goals of the authors and

proponents of this legislation to reduce the use of tobacco in this

country and particularly to reduce its use by children.

My mother smoked most of her life and died of disease related

to her use of tobacco, and I have deep concern about its health consequences and about its addictive qualities and share the goal of

doing everything we can to reduce those incentives and that inclination in our society and to educate people about the potential

harm of tobacco and the danger that it causes particularly when

people become hooked on smoking at a young age.

Having said that, I would like to also express my deep disappointment that the Majority was not able to structure this hearing today in a way to create a panel so that the chairman of the

FDA, Commissioner von Eschenbach, could have testified and provided his testimony. I believe that would be the most useful testimony to elucidate us, as members of Congress, and the public at

large as to the fundamental question here which is what is the best

mechanism to achieve the goals this legislation seeks.

I believe Commissioner von Eschenbach would, more than any

other person, be able to provide insight regarding the FDA’s capability and suitability to handle this task. I note that in his prepared testimony, he has shared his view that he supports the goal

of the legislation to reduce tobacco use in this country but that the

FDA has ‘‘concerns with the bill’s proposed means to achieve those

objectives.’’

He goes on to state that they have concerns regarding whether

or not the bill could undermine the public health role of the FDA.

That is his first point, whether or not aspects of the bill may be

extremely difficult for the FDA to implement. And third, significant

concerns about the resources that will be provided under the bill

and the expectations it might create.

Mr. Chairman, I would ask unanimous consent that his testimony be made a part of this hearing at this point.

Mr. PALLONE. So moved.

[The prepared statement of Dr. von Eschenbach folows:]

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Mr. SHADEGG. I share the commissioner’s concerns. It seems to

me that it is worth noting that tobacco is already regulated by numerous Federal and State agencies, including the Federal Trade

Commission. I would hope the Federal Trade Commission is already taking action with regard to false or misleading claims made

by tobacco companies. And if it is not, we ought to be doing oversight on the Federal Trade Commission and pushing them harder.

I have concerns about adding the regulations of tobacco to an already resource and time-constrained agency and whether or not

that will achieve the goals intended. One of my concerns is that the

Food and Drug Administration is there to regulate food and drugs,

and I don’t view tobacco as either of those. I view food as being

good for you and drugs as being therapeutic and helpful. It seems

to be somewhat confusing to say to an agency, which is supposed

to regulate things that are good for you, is now going to regulate

a product which is inherently bad for you. And I hope that is not

viewed as the Government condoning the use of tobacco or expanding it.

I also am concerned about the lack of expertise within the FDA

to regulate tobacco and perhaps wonder whether or not some other

agency would be better to do this task.

I would note that the legislation calls for additional user fees,

which may indeed be necessary to accomplish its tasks. However,

I am worried that the cost of those user fees will be imposed upon

the lowest income Americans and will hit them the hardest and

now conflicts with the funding source advocated for the S-CHIP

Program.

Let me simply conclude by saying I do think this is a worthy discussion to have. I have great concerns about whether or not this

is the right agency, and I hope at some point we will be able to

hear, in terms of testimony and the questioning and answering,

from Commissioner von Eschenbach.

Thank you, and with that, I yield back.

Mr. PALLONE. Thank you, and next recognize our vice chair, Mr.

Green.

OPENING STATEMENT OF HON. GENE GREEN, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. GREEN. Thank you, Mr. Chairman, for holding the hearing

on the legislation to grant the Food and Drug Administration the

authority to regulate tobacco products.

I share my colleague from Arizona’s concern, and I would hope

we could schedule a hearing so we could hear from the FDA particularly. And I understand the tradition that the Federal witnesses sit on their own panel, but it is no secret that cigarette

smoking is the most preventable cause of death in this country. I

imagine there isn’t one person here today who hasn’t been affected

by cigarette smoking, whether personally or through the experience

of a family member or friend.

The need to reduce the level of cigarette smoking in this country

is a very personal issue for my family, as my wife and I watched

her father and two brothers suffer severely and eventually pass

away prematurely from lung cancer and smoking-related illnesses.

18

And I watched all three of them also try in their 40s and 50s to

do everything they could to kick that habit. It was so difficult.

To know that the bulk of their health problems are by and large

preventable is a sobering realization to the devastating effect of

smoking. According to statistics from the CDC, approximately 21

percent of American adults are cigarette smokers. Unfortunately,

many of these adults become addicted as teenagers, just like my

relatives, who tried smoking out of peer pressure or simple experimentation but too quickly became hooked.

More than 1,100 teenagers under the age of 18 become regular

smokers and adopt the habit that is not only deadly but extremely

difficult to break. Seventy percent of adult smokers indicate they

want to quit. Forty percent of smokers try to quit each year, but

the addiction too often wins out over the smoker’s will to quit and

need to improve his or her life and health.

The recognition of the health dangers that smoking poses to the

American public, both the FDA and Congress has worked for 10

years now to implement FDA regulations of tobacco products. Following the Supreme Court’s 2000 ruling invalidating FDA’s 1996

rule exerting regulatory authority over tobacco, clearly Congress

must act to explicitly give the FDA this authority.

I am proud to be a cosponsor of the bill. The Family Smoking

Prevention and Tobacco Control Act would subject tobacco products

to many of the FDA’s regulatory tools, such as premarket approval

of new tobacco products and mandatory inspections of manufacturing facilities. The bill would also create a new user fee system imposed on tobacco manufacturer’s to help the FDA absorb the cost

to tobacco regulation. It seemed like in the first 10 months of this

year, we have given or pointed out the FDA’s lack of enforcement,

whether it be the reform bill on the prescription drugs or with the

food inspections that we just had a hearing last week. So we know

they need additional funding.

Too many Americans have switched to certain brands based on

unsubstantiated claims that these new brands will reduce the

health risks we all know that are associated with smoking. It is

high time that science-based agency have the authority to regulate

the advertising of tobacco products and manufacturers’ claim of reduced risk or reduced exposure.

This bill is a true compromise piece of legislation. Like most compromises, no stakeholder got everything it wanted. There are certainly still stakeholders with concerns about the bill. Nevertheless,

I consider it victory that the American Lung Association, TobaccoFree Kids, and Philip Morris are on the same side of the tobacco

issue.

I would like to thank our colleague, Mr. Waxman, of our committee, and his Republican lead Congressman Davis of Virginia for

crafting this compromise. I look forward to hearing from the witnesses and yield back my time.

Mr. PALLONE. Thank you. the gentleman from Texas, Mr. Burgess.

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OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BURGESS. Thank you, Mr. Chairman. I appreciate the consideration for letting me go out of order. Mr. Chairman, this subcommittee has spent a fair amount of time this year talking about

the FDA could or should do a better job ensuring the safety of

drugs and ensuring the safety of our food supply. Indeed we

passed, just 2 weeks ago, some of the most sweeping legislation to

affect the FDA in probably 40 years, and I was grateful to be a part

of that process.

We have talked about how the FDA could better inform the

American people and about the therapeutic benefits, risks, and side

effects of FDA-approved drugs. So, Mr. Chairman, forgive me. I am

a little perplexed about the topic of discussion today. Used as directed, tobacco products in this country will kill 400,000 people

every year when use as directed. And that is not even to address

the number that are maimed and left infirm by the ravages of tobacco smoking.

I know something about whereof I speak. I was a physician for

25 years down in Texas before coming to Congress. Indeed, I am

a reformed smoker. I lost both parents to cigarette-related disease.

Both my parents died in their 80s of lung cancer, but perhaps the

most serious problem that I saw associated with cigarette smoking

was my father who was always eloquent and loquacious was rendered aphasic from a stroke at age 67 and died at age 83, never

being able to utter a single word during that time. I am no proponent of cigarette smoking.

So memo to the American people: cigarette smoking is dangerous

and addictive. Don’t do it. If you do it, stop now. Your life will be

better for it, and certainly your children’s lives will be better for

it. Why we need the FDA to weigh in on this is a mystery to me.

We are going to hear a lot of testimony this morning, and I appreciate the witnesses who have given of their time to come give us

the testimony.

Dr. Hemmingfield states that tobacco products are sophisticated

drug delivery systems, engineered and manufactured to increase

their potentials to cause and sustain addiction. We all agree there

is no therapeutic benefit to smoking cigarettes. So why are we

going to waste taxpayer dollars to regulate a product like that?

What have we got next in line, crystal meth?

I know that the proponents of this bill are going to spend some

time talking about how the Federal Trade Commission has failed

to regulate cigarette advertisements, and maybe we could better

spend our time to determine how the Federal Trade Commission

could do a better job at regulating this commercial speech.

Instead of doing the one thing that could benefit public health in

this country, outlawing cigarette use, proponents of this legislation

would enact into law an arrangement that the courts have perpetuated by huge legal settlements to keep the gravy train flowing,

and we saw that just last week with the passage of the S-CHIP

bill.

We are addicted to tobacco money. Let us be honest about this.

We ought to put that money where it would do some good. How

about paying back the Medicare system for all of the money that

20

tobacco has cost the Medicare system over the years? How about

paying the money to really make aggressive anti-smoking cessation

campaigns? But where are we going to get our tax dollars to fund

all the things that we have now committed ourselves to funding

with cigarette use?

Mr. Chairman, I see my time is up. I am going to submit my

whole statement for the record. It is full of valuable insight, and

I encourage all members and witnesses to read it. And I will yield

back the balance of my time.

Mr. PALLONE. Thank you. The gentlewoman from California,

Mrs. Capps.

OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Mrs. CAPPS. Thank you, Chairman Pallone, for holding this extremely important hearing, and I want to join my colleagues in

commending Henry Waxman for his tireless work on this bill and

tobacco issues in general over the years. Our country owes a debt

to him, and I agree with him and others that we do need to see

this bill passed and signed into law.

As a nurse, I especially support this bill’s approach to combating

one of, if not the most, serious health problem facing our country.

It is finally common knowledge that tobacco is unhealthy, dangerous, and deadly, but unfortunately it is still glamorized. Tobacco

companies have purposely glamorized this product in order to attract new customers, especially a vulnerable population like young

women.

If you could all please direct your attention to the posters that

are pink, the poster that is pink and has flowers, you will see immediately what I am talking about. A new cigarette product manufactured in hot pink packaging and the tag line ‘‘light and luscious’’

is undoubtedly meant to appeal to women.

Newsweek columnist Anna Quindlen recently wrote on the deliberate effort to make Camel No. 9 cigarettes appeal to young

women. She wrote about how her own daughter had tried them and

described them with words like ‘‘caramel, perfume, chai tea.’’ And

just when you thought that was bad enough, check out what they

came up with next. ‘‘Dressed to the nines.’’ This ad introduces readers to stiletto style cigarettes, which are advertised as the newest,

must-have fashion accessory to go along with the dress, the bracelets, and the lip balm.

While we expect this kind of sleazy marketing from tobacco companies, I have been terribly disappointed that they found a new

and unexpected ally in women’s fashion magazines. These magazines have historically served as legitimate sources for information

on women’s health, fitness, and fashion. But they have sold out the

well being of their readers to help big tobacco in their search for

new victims.

I was proud when 40 of my colleagues joined me in asking women’s magazines to reject these ads. When not one of these magazines bothered to formally respond to our letter, we wrote again.

This time, seven of them responded, but none will drop the ads.

Several tried to defend themselves by pointing to their editorials on

the dangers of smoking, and each made sure to emphasize that acVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
21

cepting the advertisements is completely legal. The publishing director of Vogue Tom Florio even wrote the following. ‘‘The goal of

Congress should be to create legal guidelines for the marketing,

distribution, and sale of tobacco products.’’

Well, there is an old saying, biblical in fact, ‘‘ask and ye shall receive.’’ H.R. 1108 will give the FDA the authority to effectively regulate advertising. It would be wonderful if more members of the

private sector would follow the lead of publications like Self magazine, which rejects all tobacco ads, but that is not the case. So we

will pass a law that will enable us to better protect public health.

I look forward to hearing from our witnesses today and would

like to finish with one final thought. If the Camel No. 9 advertising

blitz that greeted our students at the start of school is any indication of their intentions, I shudder to think of the tricks or treats

RJ Reynolds and its new friends in the magazine business have in

store for our young women and girls this Halloween. I yield back.

Mr. PALLONE. Thank you. I recognize our ranking member, Mr.

Deal.

OPENING STATEMENT OF HON. NATAHN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA

Mr. DEAL. Thank you, Mr. Chairman. I am glad we are taking

this opportunity today to evaluate Mr. Waxman’s contribution on

the issue of the FDA’s regulation of tobacco products.

I think all of us have certainly been aware of the harmful and

addictive effects of tobacco use and smoking, and I believe it is appropriate for us to take a look at ways to diminish the prevalence

of smoking in our society. It contributes to disease and death and

imposes a tremendous cost on our society as a whole.

That is especially true in the health care sector. One study has

found that if all current smokers in the Medicaid Program quit, our

Medicaid Program could save $9.7 billion. I am certainly sympathetic to the goals expressed by the authors of this legislation to

keep our children from having easy access to cigarettes and trying

to ensure that less people are in fact smoking every year.

But I do believe, however, that this issue needs the scrutiny of

the legislative process. Many of the issues that require that scrutiny have been enunciated by Mr. Shadegg and by Dr. Burgess.

There are many important considerations to be made in crafting

the legislation, and I look forward to our witnesses’ testimony on

these issues.

The tobacco industry is diverse, and legislation like this will affect each sector differently. There are also considerations to be

made about the country’s convenience stores, and I am glad they

are going to be here today to provide us with their views on this

proposal.

The panels before us represent a wide range of viewpoints, and

I believe their input will be useful as we evaluate the concerns that

they raise and other parties have raised about this legislation.

Overall, I think it should be a good hearing, and I look forward to

the testimony of the witnesses. And thank you all for being here

today, and I yield back my time.

Mr. PALLONE. Thank you. The gentlewoman from Oregon, Ms.

Hooley.

22

OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON

Ms. HOOLEY. Thank you, Mr. Chairman, for holding this hearing.

And like many of my colleagues before me, I want to recognize Mr.

Waxman for his extraordinary leadership on this issue. You have

truly been a champion for protecting our children from the dangers

of smoking.

I am a proud cosponsor of H.R. 1108 because I believe this bill

takes important steps to improve public health. I have seen the toll

on family and friends of what a lifetime of smoking can do. As a

former smoker, I think it is past time that we take responsible

steps to allow the FDA to regulate tobacco, like it does nearly every

other product that we put into our bodies.

It is nearly inconceivable to think that the FDA has considerable

authority to regulate the vegetables and fruit that we serve to our

families but cannot regulate cigarettes, which are known to cause

cancer and other serious health complications.

Smoking and its health effects have serious impact on women.

The Center for Disease Control and Prevention estimates that more

than 178,000 American women die from smoking-related diseases

each year. The risk of developing lung cancer is about 13 times

higher in female smokers than in non-smokers. Although we rightly put tremendous resources into treating breast cancer, lung cancer surpassed breast cancer in 1987 as the leading cause of cancer

death among women.

Smoking is also associated with an increased incidence of cervical

cancer and osteoporosis in women. Moreover, smoking is linked to

cardiovascular disease, the No. 1 killer among women. This bill is

not only beneficial for women’s health, but it is also important for

the well being of our children.

Every day, more than 1,100 young people under the age of 18 become regular smokers. When young people smoke, they are much

more likely to become lifelong smokers than those who start smoking at a later age.

This legislation will save lives. This legislation will help reduce

the incidence of teenage smoking and result in fewer lifelong smokers. Studies show that nonsmokers will have healthier adulthoods

than their smoking counterparts. If we can take common sense

steps to help reduce teenage smoking and ultimately improve

young people’s lives, then we must do so. This legislation takes

those steps.

I also want to note that this legislation prohibits the FDA from

banning tobacco products or reducing nicotine levels to zero. We

should not and will not prohibit adults from smoking. Those who

make the personal decision to smoke may continue to make that

choice. This legislation simply ensures that the FDA will have authority to regulate tobacco just like it has the authority to regulate

all our other food and drugs we consume.

In other words, H.R. 1108 takes common sense steps to regulate

a product that is known to cause harmful health effects. Thank

you, Mr. Chairman, for having this hearing.

Mr. PALLONE. Thank you. The gentlewoman from New Mexico,

Mrs. Wilson.

23

OPENING STATEMENT OF HON. HEATHER WILSON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW MEXICO

Mrs. WILSON. Thank you, Mr. Chairman. I will be very brief. I

wanted to thank you for holding this hearing. Like my colleagues

on this committee, I want to see us reduce the use of tobacco. But

I am not sure yet and what I want to learn about today is whether

this bill will help or hurt in that effort.

And I am particularly concerned about overlapping responsibilities or muddying the water with respect to clarity of responsibilities in making sure that agencies have the right resources to do

the tasks that we give to them.

There are a number of agencies involved in the regulation of tobacco now. This would shift those responsibilities, but it is unclear

to me at this point how much or what the result would be in the

ultimate goal, which is to reduce the use of tobacco.

So I look forward to the hearing today and learning more about

these issues. Thank you, Mr. Chairman.

Mr. PALLONE. Thank you. The gentlewoman from Wisconsin, Ms.

Baldwin.

OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF WISCONSIN

Ms. BALDWIN. Thank you, Mr. Chairman. I appreciate the fact

that you are holding this hearing, and I appreciate our witnesses

that will join us momentarily. We have heard some of the statistics

this morning, but I think that many of them bear repeating. Cigarette smoking is the leading preventable cause of death in the

United States, and it is responsible for about one in five deaths annually or about 438,000 deaths per year.

Smoking-related deaths account for more deaths than AIDS, alcohol, cocaine, heroin, homicide, suicide, and motor vehicle crashes

and fires combined. And yet 21 percent of all U.S. adults, approximately 45.1 million people are smokers.

I am sure we could have a fascinating discussion about why people continue to smoke, knowing the serious harm that cigarettes do

to their health. And while that is a conversation I think we should

have, we are here today to discuss steps that we can take right

now at the Federal level that will better educate Americans about

the dangers of smoking and regulate the marketing and distribution of tobacco products.

I am proud to be an original cosponsor of H.R. 1108, and I thank

Congressman Waxman for his tremendous leadership on this issue.

I am especially pleased that H.R. 1108 will focus and prohibit cigarettes from containing any artificial or natural flavors. I am concerned about these products. Sometimes they are strawberry flavored or other candy-like flavors. And it seems to me that these are

blatantly aimed at getting children to smoke, and it is really truly

appalling. And I am glad that this bill puts an end to these candyflavored cigarettes.

Additionally, I am pleased that the bill requires tobacco companies to disclose the contents of their products. Just like every other

company that produces an ingestible consumer product, tobacco

24

companies will have to submit a listing by quantity of all ingredients and additives to tobacco, paper, and filters for each brand they

manufacture. This is the right thing to do. We do it for drugs. We

do it for food. We should require it of cigarettes.

Again thank you, Mr. Chairman, for holding this hearing. I look

forward to our discussion today.

Mr. PALLONE. Thank you. Next is the gentleman from Texas, Mr.

Hall.

OPENING STATEMENT OF HON. RALPH M. HALL, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. HALL. Thank you, Mr. Chairman. And I thank Mr. Waxman

for his work in this area. You know I am of a generation that remembers how the Federal Government encouraged our members

and our people in the armed services to smoke by giving them cigarettes free, enticing them into the tobacco industry.

And now I see that generation that are dying out by 1,000 or

1,500 a day, and I have a hospital up in northeast Texas, the Sam

Rayburn Memorial Hospital, where these old fellows are put outside the air conditioning in the heat of the summer in 100 degree

weather several days in a row to smoke their cigarettes. In the

winter, put out of the warmth and the care of the same area, out

in the cold to do that.

I had a place built for them to smoke their cigarettes, and I got

some criticism for it. But I felt as they were enticed into the situation back in the time of stress when they were thousands of miles

away from home fighting for all of our freedom that they had some

rights.

And I still see a gleam of that that people think they have a

right to smoke and abuse their bodies, and that is a hard thing to

reconcile either way. I wish we could do away with every cigarette

in the world. I think we would be better off. And, of course, the

world would be better off. We would have more money to spend on

other health pursuits. I just appreciate you holding the hearing,

and I think it will spark some continued congressional debate over

the proper way to regulate tobacco.

And I would also like to thank the panelists for joining us. Your

insight and your expertise will certainly guide the continued examination of the issue. Smoking-related disease is a real serious problem in the country, which deserves a fair and honest debate. And

I firmly believe that we need to be doing more to reduce smokerelated diseases as we can be. I have some problems about taxing

it out of existence, though I am not totally against that if that is

what it takes.

My primary concern over the legislation before us today, though,

is the cost of further Federal Government expansion and whether

the user fees contained in the bill are just a tax increase by another name. There are many parts of the legislation I could support, but I want to make sure we think carefully about what we

are doing and how we are doing it.

For example, the legislation appears to treat all tobacco products

the same when it seems clear that it is a matter of common sense

and science that smokeless tobacco products are different than

cigarettes. They may be dangerous in themselves, but different

25

than cigarettes. They ought to be treated a little bit differently. We

are also concerned for the tobacco retailers with over 300,000 in

this country. How will the FDA regulate and enforce and adjudicate them, and how much additional staff will the FDA need?

How much will this cost?

It appears Internet retailers, Native American retailers, and

adult facilities are favored by the legislation. These groups share

a large percent of tobacco sales and should have the same regulations as all other retailers. I hope to work with the committee on

these concerns and make sure this legislation is both fair and addresses public health concerns. And, Mr. Chairman, I thank you,

and I yield back the balance of my time.

Mr. PALLONE. Thank you. The gentlewoman from Colorado, Ms.

DeGette.

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO

Ms. DEGETTE. Thank you very much, Mr. Chairman. In 1982,

then-Surgeon General C. Everett Coop said ‘‘cigarette smoking is

the chief single avoidable cause of death in our society and the

most important public health issue of our time.’’ Unfortunately,

that statement is just as true today as it was when he said it 25

years ago.

Tens of millions of Americans remain addicted to smoking, and

almost all of them started smoking when they were young. Also

true is that most smokers today would like to quit, but they are

unable to break this highly addictive habit.

I want to give a hallelujah to you, Mr. Chairman, for having this

hearing and even more to Mr. Waxman for having drafted such a

great comprehensive piece of legislation which I too am a proud cosponsor of.

Smoking prevention and tobacco control are issues that have

been missing in action for quite some time, at least as far as Congress is concerned. I am in my sixth term on this committee, and

we have a lot of hand-wringing in this committee over the years

about what we do about tobacco use and smoking cessation.

When I first came to Congress, I had a mock congressional hearing in my district on teen tobacco use, and there were some lowincome kids, Hispanic kids from a high school in my district, who

took it upon themselves to do a study. And they did a scientific

study in which they found that tobacco companies targeted advertising, billboards and other types of advertising, to low-income

neighborhoods and to communities of color. These kids were so unbelievable then-Chairman Bilirakis had them come here to testify

in a real congressional hearing, and they talked about their findings.

What happened after that hearing? Nothing. And then Congresswoman Bono and I introduced legislation, which we worked on for

many years, on smoking cessation to add that to Medicare because

it is estimated, of course, that Medicare will pay billions of dollars

over the next few decades to treat tobacco-related diseases. What

happened to that bill? We were told by the then chairman of the

committee that we couldn’t pass that legislation because it cost too

26

much to pay for smoking cessation programs and services, which

I find incredibly ironic, given the amount that we are spending to

treat lung cancer, emphysema, heart disease, and other smokingrelated diseases.

In my early years in Congress, I also introduced legislation to

raise the smoking age from 18 to 21 just as we had done with alcohol, and, of course, you can imagine how that went over with the

committee at that time.

And then I tried to get rid of crop insurance for tobacco, which

met with about the same result. And so, Mr. Chairman, I think it

is really great that we are having a hearing on this bill, but I think

it is even greater that we actually might do something about this

problem, that we actually might pass Mr. Waxman’s bill, that we

actually might give the FDA the ability to regulate tobacco, which

to my mind, is a no brainer.

So, Mr. Chairman, I look forward to working with you and Mr.

Waxman and everybody else so that we can truly prevent teens

from starting to use tobacco and prevent millions of deaths. Thank

you.

Mr. PALLONE. Thank you. Next is the gentleman from Indiana,

Mr. Buyer.

OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF INDIANA

Mr. BUYER. Thank you. When it comes to making decisions on

behalf of a country, I utilize principle-oriented decision-making. So

what I do is I put any issue through a paradigm. The paradigm

goes like this. I say what is its impact upon individual liberty?

Does it promote personal responsibility and accountability? Does it

promote economic opportunity? Is the marketplace open, fair, and

competitive? And does it protect American citizens at home and

abroad. Whatever the issue, I put it in that paradigm.

So now let us take the issue that is before us. I ask the question

of is what we are trying to do is regulate human behavior? I think

that is what we are trying to do here. So as, I guess, we look out

across the spectrum, there are a lot of things out there with regard

to products that have an impact upon the human physiology. And

if we are going to regulate one product, what about all these other

products?

Now, if the real goal here is education and harm reduction, that

is what we should be focusing on because I assure you my wife,

God bless her, is driving me crazy because she goes through all the

series of foods, all the bad foods, which I eat, and here are the good

foods. So, let us see, she has a list. She has salt. She has refined

sugar, caffeine, nicotine, alcohol, go through all that list of things

that are bad for you.

Now, are we going to go down the road of saying OK, let us start

regulating all of these other things? Because when I look at this,

let us see, we could regulate trans fats, refined sugar, salts, alcohol, supplements, caffeine. All of these things are having an impact

upon human physiology. But no, let us go ahead and let us go after

nicotine.

As a matter of fact, are we really going after nicotine? Because

it is really cigarettes. Because if we really wanted to have a harm

27

reduction strategy, we would talk about moving people from cigarettes to smokeless tobacco as a harm reduction strategy. No, that

is not even taken into account in this. And with regard to advertising, yes, OK, right. They use Joe Camel and all of that. They

should not have been targeting cigarettes to children, but what is

the difference between McDonald’s using Ronald McDonald and

promoting trans fats to children. And now we are dealing with

childhood obesity.

And let us go ahead and take it to the extreme. Let us see. What

about all the advertising by the candy industry for the Easter

bunny that also adds to what, tooth decay and childhood obesity.

So then what are we going to do? We are going to outlaw Halloween, Valentine’s Day, the Easter bunny. We can do a lot of

things out there to regulate human behavior. Now that gets pretty

ridiculous when you think about all of that.

Going back to it, the focus, I believe, what we should have is on

education and harm reduction strategy. That is exactly what my

wife is doing to me: taking me away from refined sugar products

to Splenda. Taking me off of my Diet Dr. Pepper, which I love, and

move me then to non-caffinated drinks. So I picked up Gatorade.

Then she shows me how much salt is in Gatorade, and now she has

me on Propel. My son calls it Gatorade for girls. That is what I

drink today.

So I am on this harm reduction strategy by my wife, and that

is what we should be focusing on, Mr. Chairman. I yield back.

Mr. PALLONE. I was going to ask you if your wife was a Democrat. I am sorry. I yield to the gentleman from Maine, Mr. Allen.

OPENING STATEMENT OF HON. TOM ALLEN, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF MAINE

Mr. ALLEN. Thank you, Mr. Chairman. This is a tough act to follow. I will come back to tobacco here. I want to thank you for holding this hearing. The use of tobacco products kills over 400,000 people and costs our Nation more than $167 billion a year, based on

lost productivity of $92 billion and health care expenditures of $75

billion a year.

For decades, tobacco companies have mislead the American public and Congress about the health consequences of smoking, the addictive nature of smoking, and their manipulation of nicotine levels. Perhaps of greatest concern, the tobacco companies have targeted substantial marketing efforts toward children in order to

boost their profits and hook future generations on their products.

An estimated 41⁄2 million children and adolescents smoke, and another 1 million use smokeless tobacco; 151⁄2 million kids are exposed to second hand smoke at home.

According to HHS, 1 million children will start smoking each

year. One-third of those children will eventually die of a smokingrelated illness. Regrettably, Maine has one of the highest teenage

smoking rates in the country, despite the fact that we have reduced

by 60 percent teen smoking in Maine over the last 10 years. And

even though Maine leads the Nation in its commitment to dedicating tobacco settlement money to tobacco prevention and treatment,

Maine still has more than one out of every five high school students smoking. That figure is unacceptably high. It is extremely

28

difficult to get young adults to quit smoking once they have started.

The continued efforts by the tobacco industry to market their

product to young people is further evidence that despite the master

settlement restrictions, this industry continues to recruit replacement smokers to keep businesses going.

I am proud to be an original cosponsor of Representative Waxman’s bill, which grants the FDA the same authority over cigarettes and other tobacco products that it already has over countless

other consumer products. The bill would allow the FDA to discourage children from starting smoking and encourage adults to quit in

part by reigning in advertising, bolstering existing sales restrictions, and strengthening warning labels.

It would also allow the FDA to order the elimination or reduction

of harmful and addictive ingredients in tobacco. Significantly the

bill would require tobacco companies to disclose what tobacco products and their smoke contain. Secondhand smoke, for example, contains 250 chemicals known to be toxic or carcinogenic, according to

the Center for Disease Control. Giving the FDA the power and authority to regulate tobacco products will protect our children, improve the public health, and ensure that consumers have more information about tobacco products to make better decisions.

I look forward to the testimony of our distinguished panel and

yield back the balance of my time.

Mr. PALLONE. Thank you. The gentlewoman from Tennessee,

Mrs. Blackburn.

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE

Mrs. BLACKBURN. Thank you, Mr. Chairman. I appreciate your

calling the hearing today, and I am looking forward to hearing

from our witnesses.

Back in the mid 1980s, I was president of the Middle Tennessee

Board of the American Lung Association, and I was very involved

in our smoking cessation programs, in education and awareness,

asthma programs and training programs for parents. I am allergic

to cigarette smoke, I have a child that is allergic to cigarette

smoke, and very well aware of the harmful effects that come from

cigarette smoke.

However, I think that the policy that is set forth in this bill has

some serious flaws, and I do think that it misses the mark on protecting the public from tobacco. And I make these as somebody who

has read the bill and just disagrees with it, disagrees with the

premise on it.

We all know that the FDA is responsible for ensuring the safety

of all domestic and imported food, drugs, medical devices, biologics,

cosmetics. The list goes on and on, and as we have heard from

countless hearings, the FDA does not have the resources to handle

additional product regulation. They struggle with the intra-agency

communication, and they struggled with even giving us a list of

what their best practices are.

The bill grants the FDA unlimited authority to impose new, undefined tobacco restrictions and places burdensome standards on

29

tobacco manufacturers, farmers, sellers. The FDA is not prepared

to regulate and enforce the bill’s provision for the 300,000 retailers

that are selling tobacco products nationwide.

Always there are two sides to every issue, and I am also concerned about the impact the bill would have on Tennessee tobacco

farmers. U.S. Smokeless Tobacco Manufacturing Company has

called Tennessee home for more than 75 years and employs close

to 600 people through the State. The company purchase about half

of all the dark tobacco grown in Tennessee from approximately 200

growers.

Many of those are in my district, and while the bill’s provisions

are not directed at tobacco farmers, these constituents would be

negatively impacted by broad regulations that place no limits on

FDA authority to regulate tobacco leaf. It is only fair to consider

the impact that this bill would have on those individuals.

In 1992, Congress passed the Synar Amendment, which withheld

Federal funds until States met an 80 percent compliance rate for

preventing tobacco sales to minors. All 50 States are now in compliance. Since implementation, this approach has been to prevent

youth usage, and those rates have declined. We should be working

with our States, with manufacturers, producers, packagers, distributors, and retailers on new initiatives versus implementing an

unworkable Federal layer that has no proven track record.

As you all know, we are in the midst of a debate on expansion

of the SCHIP program. Many of my colleagues have voted to fund

SCHIP with an increase in the Federal excise tax on tobacco. If

H.R. 1108 attempts to eradicate smoking, how much would Congress have to increase the tobacco tax in order to pay for the

SCHIP expansion bill?

Consumers believe that if the FDA approves a product, then it

is safe. So why would we give tobacco the FDA stamp of approval?

Thank you, Mr. Chairman. I appreciate the hearing, and I am looking forward to our witnesses. I yield back.

Mr. PALLONE. Thank you. The gentlewoman from California, Ms.

Solis.

OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Ms. SOLIS. Thank you, Mr. Chairman, and good morning. And

thank you to our witnesses for being here. In my opinion, the bill

that we have before us, H.R. 1108, Family Smoking Prevention and

Tobacco Control Act, I think is a bill going in the right direction

and especially as it affects hundreds of thousands of Latinos. I am

talking in particular about the youthful age of our community because we see a higher incidents of smoking rates amongst young

Latinos and Latinas. And that is alarming for me because you

think with all the money that we have spent to try to inform our

community about the devastating health effects and consequences

of smoking that you would see that there would be a downturn.

That is not the case.

And part of it is because the tobacco industry has become very

clever in targeting their message. While other corporations ignore

our community and don’t expand outreach in many ways to them,

30

the tobacco companies have done a great job, in my opinion, of targeting Latino youth. And what they have done is they are running

ads in Spanish and English. They put up Spanish speaking role

models, and they make it sound as though it is cool. And they actually say that, cool cigarettes. It is good to have this image of smoking the cool cigarettes while saying that somehow this is part of

our culture and part of our morals or mores, put more appropriately.

And I find that rather insulting because I know that that is not

the case, and it is just like the alcohol and other groups that also

go way out of their way to focus narrowly to a community that is

underserved in so many ways by health care insurance and has

very high rates of cancer, in particular among Latinos, young

males as well as Latinas.

And the statistics are there. I won’t repeat them, but I do want

to enter my statement into the record and just say that I am not

pleased with the manner in which our corporations, in particular

in this case the tobacco industry, is treating my community.

I also say that about young teens because I know Congresswomen Capps, Schakowsky, and I have sent letters to magazines

that target young women and glamorizing, more or less, smoking.

That somehow that is in style, and that is the way you should be

if you want to be accepted by society.

So I know that there are a lot of Members of Congress that

would like to see more regulation, more science, more research

done, on the ill effects of tobacco and what it has on all of our community. So I yield back the balance of my time and would ask that

my statement be placed in the record.

Mr. PALLONE. Thank you. I think that concludes our opening

statements from the members. Additional statements for the record

will be accepted at this time.

[The prepared statements follow:]

PREPARED STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF MICHIGAN

Mr. Chairman, thank you for holding this hearing on a very critical public health

issue, tobacco use, and, more specifically, on H.R. 1108, the Family Smoking Prevention and Tobacco Control Act.

The harmful effects of tobacco products and its toll on human lives have been

known for decades. In spite of efforts to decrease the number of smokers, cigarette

smoking remains the leading preventable cause of death in the United States. Cigarette smoking is responsible for about 1 in 5 deaths annually, or about 435,000

deaths per year. In addition to the 45.1 million U.S. adult smokers, it is estimated

that each day more than 1,000 persons younger than 18 years of age become addicted to tobacco products. Not only has tobacco use claimed lives, but it also has

caused serious financial losses. The use of tobacco costs the United States more than

$167 billion annually in terms of lost productivity and healthcare expenditures.

In 1996, the Food and Drug Administration attempted to address this problem by

issuing a final rule asserting regulatory authority over tobacco products. This rule

would have made great strides in reducing the prevalence of underage smoking and

use of smokeless tobacco products through strict distribution, marketing, and labeling provisions.

Unfortunately, in 2000, after several court challenges, the U.S. Supreme Court

ruled that FDA did not have the authority to regulate tobacco products. Since then,

there have been numerous attempts to pass legislation granting the FDA this authority.

States have done their part to address this issue. In 1998, the attorneys general

of 46 States signed the Master Settlement Agreement with the four largest U.S. tobacco companies to recover billions of dollars in costs associated with treating smokVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00036 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
31

ing-related illnesses. These funds have been used to pay for tobacco-control programs. Now is the time for the Federal Government to do its part.

H.R. 1108 has broad support from the public health community. We will look

closely at this legislation and engage in a fair process that is inclusive of the public

health community, industry, and other interested stakeholders.

I appreciate this hearing, Mr. Chairman. I thank Representative Waxman for his

leadership on this issue. I look forward to the testimony of our witnesses and the

input of our Members.

PREPARED STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF UTAH

Thank you, Mr. Chairman, for holding this hearing today on the Family Smoking

Prevention and Tobacco Control Act, H.R. 1108.

I am a cosponsor of this legislation, as I have been of similar legislation since I

first came to the House in the 107th Congress.

I represent the second district of Utah, where an estimated of 7.4 percent of our

high schoolers smoke and an estimated 2.4 million packs of cigarettes are bought

or smoked by kids in Utah each year. Not surprisingly, helping our kids to become

far less likely to start smoking, we can instill in them these good habits to carry

into adulthood. Indeed, only 10 percent of smokers begin after age 18. Slightly less

than one-in-10 adults in Utah smoke, and that’s better than half the national average of 21 percent. But we still want to do better, and we can with this legislation

with its restrictions on advertising to kids, improved warning labels, and for the

first time, product standards to reduce the harm of tobacco products.

In my State of Utah, the State and Federal tax burden for each Utah household to cover smoking costs is $537 each year, while the average American household is

spending $630 each year for that same purpose. That’s nearly $100 for each Utah

family. And even that figure does not include the private health care expenditures

or lost productivity caused by smoking.

Mr. Chairman, I am glad that we are moving this legislation forward—for the

kids in Utah—and kids, who without this legislation, may be on their way to becoming addicted to tobacco products. There are far too many in this country.

I believe we can give the FDA the tools it needs to make cigarettes less addictive,

to ban products marketed to kids such as candy-flavored cigarettes, to stop those

who repeatedly and illegally sell these products to our kids, and to stop the marketing of these products to the next generation of smokers.

Thank you.

PREPARED STATEMENT OF HON. EDOLPHUS TOWNS, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF NEW YORK

Mr. Chairman, I am very concerned about the slowing down of the decline of tobacco use and the potential use of tobacco among adolescents, particularly those

from homes without access to either health insurance, or adequate health care.

However, while I am generally in favor of the underlying principles of H.R. 1108,

I believe that we have to be careful about giving the Food and Drug Administration

authority that it has demonstrated it cannot handle. By that I mean the provisions

in the bill that would put the FDA in the position of inspecting and regulating hundreds of thousands of sellers of tobacco across the Nation.

I am a co-sponsor of the bill because I want to ensure that the manufacture of

tobacco is appropriately regulated. However, I believe that the Synar amendment,

which has been aimed at decreasing youth access to tobacco, has been working. I

don’t think we should willy nilly overstep State authority to regulate this aspect of

tobacco when we have gotten substantial results. Under the 1992 Synar amendment, States have the authority to conduct unannounced inspections and over the

past 10 years all States and the District of Columbia have reached the goal of

achieving retailer violation rates of no more than 20 percent—that’s sales of cigarettes to minors. That’s not enough. We would like zero sales to minors, however,

studies cited by the U.S. substance abuse and mental health administration show

that the retailed violation rates were in the 60–90 percent range prior to the Synar

amendment, so we have seen great progress.

Conversely the continued squeeze on FDA funding has prompted the agency to

shut down regional offices and some field facilities to make more efficient use of limited resources. How will this streamlining by the FDA affect the proposed inspection

programs in this bill? My concern is that the FDA will not have the trained inspector workforce needed to do frequent oversight. Reductions in FDA inspection operVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
32

ations have caused problems in areas like food safety. There are 12 percent fewer

FDA employees in field offices who concentrate on food issues and safety tests for

U.S.-produced food have dropped nearly 75 percent. Downsizing at FDA has also resulted in cuts in budget and staff and the FDA’s field force has dropped from 4,000

in 2003 to some 3,400 today. What makes us think that added additional inspection

burdens on the FDA will be successful?

Every State regulates tobacco sellers now and the States have shown the ability

to reduce illegal tobacco sales. I believe that a continued partnership with States

in terms of retail tobacco sales will be fruitful. I look forward to exploring whether

FDA should become involved in regulation of retail tobacco sales or whether another

approach that does not place the entire burden on the FDA can be workable. Thank

you, Mr. Chairman and I yield back the balance of my time.

Mr. PALLONE. We will now turn to our witnesses.

I want to welcome you all, and let me indicate who we do have.

First of all, on my left is Richard J. Bonnie, who is John S. Baddle

professor of law and director of the Institute of Law Psychiatry and

Public Policy at the University of Virginia. And second, from my

home State is Dr. Fred Jacobs who is our commissioner for the

New Jersey Department of Health and Senior Services, and I want

to particularly welcome him not only for being here today to discuss the tobacco issue but also because of all you do on health care.

And I know I have had some conversations with you about New

Jersey’s efforts to expand health insurance and try to provide universal health care. And just want to commend you for all that you

do, Dr. Jacobs. Thank you for being here today.

And I think I already indicated that we had submitted into the

record, at Mr. Shadegg’s request, the statement from the FDA. So

let me just mention your statements, of course, are part of the

hearing record. And each of the witnesses may, in the discretion of

the committee, submit additional brief and pertinent statements in

writing for inclusion in the record. And so I will begin by recognizing Dr. Bonnie for 5 minutes. Thank you.

STATEMENT OF RICHARD J. BONNIE, HARRISON FOUNDATION, PROFESSOR OF MEDICINE AND LAW; DIRECTOR, INSTITUTE OF LAW, PSYCHIATRY, AND PUBLIC POLICY, UNIVERSITY OF VIRGINIA

Mr. BONNIE. Good morning, Mr. Chairman, Mr. Deal, and other

members of the subcommittee. I am, as the chairman said, on the

faculties of medicine and law at the University of Virginia, and I

recently served as chair of the committee on reducing tobacco use

of the Institute of Medicine, a component of the National Academies.

The committee’s work was funded by the American Legacy Foundation, and I am here today to testify about the committee’s report

entitled ‘‘Ending the Tobacco Problem: A Blueprint for the Nation’’

a copy of which should be at your side. A summary of the report

also has been submitted for the record.

As everyone here knows and has been indicated by the members,

tobacco use, especially cigarette smoking, has been one of the Nation’s major public health problems for most of the 20th century

and continues at an unacceptable level in the 21st century. Indeed,

it has become one of the world’s major public health challenges.

Even though the tobacco leaf grows naturally, the tobacco problem is fundamentally a man-made problem. Cigarettes became one

33

of the most successful consumer products in history in only a few

decades and became an ever-present icon of American life, embedded in the culture and promoted by a powerful industry.

Unfortunately, cigarettes are one of the most dangerous consumer products ever marketed. They are highly addictive and deadly, as even the tobacco companies now concede. If tobacco cigarettes

were being introduced into the marketplace for the first time, there

can be no doubt that they would be banned under any one of several consumer protection statutes.

Of course, banning tobacco products is not feasible or wise. The

challenge the country faces today is to develop a feasible strategy

for rooting out a problem that has become deeply entrenched in our

economic and cultural life. There are still 45 million cigarette

smokers, and another 9.7 million users of other tobacco products.

Most of them regret taking up the habit and struggle to quit.

The title of the committee’s report probably got your attention.

Let me explain what the committee means by ending the tobacco

problem. In the committee’s view, the Nation’s long-term goal

should be to reduce tobacco use so substantially that it is no longer

a significant public health problem. That doesn’t necessarily mean

eliminating tobacco use. The blueprint outlined in the report aims

to set the Nation irreversibly on a course for achieving this objective.

Optimists might say that we are already well on our way to ending the problem. After all, the prevalence of smoking among adults

has been cut in half from 42 percent to 21 percent since 1965. The

prevalence of daily smoking among high school students is now at

its lowest level since annual monitoring began 30 years ago. An increasing proportion of the indoor environment around the country

is now smoke-free.

The tobacco companies are defending themselves in an increasing

number of lawsuits, and State juries outraged by the industry’s deceptive conduct have imposed very large punitive damage awards.

Why not just keep doing what we are doing and wait for these historical currents to bring the problem to an end?

The IOM committee concluded that maintaining our present

course will not end the tobacco problem. There are already signs

that the prevalence of smoking among adults is flattening instead

of decreasing, and the rate of youth initiation has hovered around

20 percent for most of the past two decades even though it is down

at the moment.

The high rate of youth smoking is especially troubling because at

least 80 percent of people who smoke begin to do so as adolescents

when they cannot fully appreciate the grip of addiction and the future risk to their health.

Moreover, quitting after decades of use is difficult. Despite the

fact that 70 percent of smokers say they want to quit and 40 percent have a specific intention to do so within the next month or so,

the annual rate of cessation among people younger than 65 is low

and remains low.

Meanwhile, the tobacco industry is spending more than $15 billion annually marketing its product to smokers and potential smokers in ever more creative ways, as we have just seen, while public

and private resources devoted to preventing smoking and helping

34

people quit are dwindling. It will probably come as a surprise to

most Americans, but the States use very little of the billions of dollars they are receiving under the Master Settlement Agreement to

reduce tobacco use, as Congressman Barton noted earlier.

Taking these realities into account, the committee believes that

the annual toll of more than 400,000 smoking-related deaths will

continue well into the 21st century. It is time to change course. For

four decades, the tobacco industry successfully framed a public debate around the health consequences of smoking and the illegitimacy of governmental efforts to prevent or discourage people from

smoking whenever and wherever they wanted.

But that debate as I think is entirely clear from the comments

made by the members, is over. The dangerous properties of tobacco

and its impact on the public health are now beyond dispute. And,

as our report shows, aggressive measures to reduce smoking rest

on a solid scientific and ethical foundation.

The only debate now should be about how best to accommodate

the legitimate interests of addicted smokers within a comprehensive national policy designed explicitly to reduce smoking and other

forms of tobacco use.

In its blueprint for the Nation, the committee offers a twopronged strategy for putting the Nation on an irreversible course

toward ending the tobacco problem. This strategy involves

strengthening current tobacco control measures while transforming

the regulatory environment for tobacco products. This is not an either/or question. This is both.

First, we have to invest in traditional tobacco control measures.

The evidence is in. These interventions do work. The report contains almost 100 pages documenting the effectiveness of traditional

tools of tobacco control, such as excise tax increases, indoor smoking restrictions, comprehensive State-based programs, media-based

prevention campaigns, school-based programs, and cessation therapies and services.

Specifically the committee urges States to fund tobacco control

programs at the level that has been recommended by the CDC, to

license all retail establishments that sell tobacco, and to ban the

sale or shipment of tobacco products directly to consumers through

mail order or the Internet.

The committee also urges Congress to help fund State tobacco

control activities and to fund a national youth-oriented media campaign. Further, the committee recommends that all insurance managed care and employee benefits plans, including Medicaid and

Medicare, cover reimbursement for effective smoking cessation programs as a lifetime benefit.

Mr. PALLONE. Mr. Bonnie, you are 2 minutes over, so I am going

to ask you to summarize the rest if you don’t mind.

Mr. BONNIE. I am sorry, Mr. Chairman.

Mr. PALLONE. That is all right.

Mr. BONNIE. All right, well if I might refer specifically then to

the second part of the committee’s strategy with regard to the

change of the legal structure of tobacco control. Tobacco products,

as the committee knows, are not ordinary consumer products. And

for no other lawful consumer product can it be said that the acVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00040 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
35

knowledged aim of national policy is to suppress consumption altogether rather than to promote safe or responsible use.

And as has been noted, these products are essentially unregulated. So Congress should enact a Federal regulatory statute that

is suited to the unique history and characteristics of tobacco products. There are many elements of the bill, of course, the committee

did not and the national academies would not endorse any particular piece of legislation. And I am speaking on behalf of the committee.

But the elements of the bill and the goal of the bill, are fully

compatible with all the recommendations that appear in the committee’s report. Thank you, Mr. Chairman.

[The prepared statement of Mr. Bonnie follows:]

STATEMENT OF RICHARD J. BONNIE

Good morning, Mr. Chairman and members of the committee. My name is Richard

Bonnie. I am Harrison Foundation Professor of Medicine and Law, Professor of Psychiatry and Neurobehavioral Sciences, and Director, Institute of Law, Psychiatry

and Public Policy at the University of Virginia. I recently served as Chair of the

Committee on Reducing Tobacco Use of the Institute of Medicine, a component of

the National Academies, chartered by Congress in 1863 to advise the government

on matters of science and technology. The committee’s work was funded by the

American Legacy Foundation. Thank you for inviting me to testify today about the

committee’s report entitled Ending the Tobacco Problem: A Blueprint for the Nation.

A summary of the report is included with my statement and submitted for the

record.

As everyone here knows, tobacco use—especially cigarette-smoking—has been one

of the Nation’s major public health problems for most of the 20th century and continues at an unacceptable level in the 21st century. Indeed, it has become one of

the world’s major public health challenges.

The tobacco problem is fundamentally a man-made problem. Cigarettes became

one of the most successful consumer products in history in only a few decades and

became an ever-present icon of American life—embedded in the culture and promoted by a powerful industry. Unfortunately, cigarettes are one of the most dangerous consumer products ever marketed. They are highly addictive and deadly, as

even the tobacco companies now concede.

If tobacco cigarettes were now being introduced into the marketplace for the first

time, there is no doubt that they would be banned under any one of several consumer protection statutes. Of course, banning tobacco products is not feasible or

wise. The challenge the country faces today is to develop a feasible strategy for rooting out a problem that is deeply entrenched in our economic and cultural life. There

are still 45 million cigarette smokers and another 9.7 million users of other tobacco

products. Most of them regret taking up the habit and struggle to quit.

The title of the committee’s report probably got your attention. Let me explain

what the committee means by ‘‘ending the tobacco problem.’’ In the committee’s

view, the Nation’s long-term goal should be to reduce tobacco use so substantially

that it is no longer a significant public health problem. The blueprint outlined in

the report aims to set the Nation irreversibly on a course for achieving this objective.

Optimists might say we are already well on our way to ending the problem. After

all, the prevalence of smoking among adults has been cut in half—from 42 percent

to 21 percent—since 1965. The prevalence of daily smoking among high school students is at its lowest level since annual monitoring began 30 years ago. An increasing proportion of the indoor environment is smoke-free. The tobacco companies are

defending themselves against an increasing number of lawsuits, and state juries

outraged by the industry’s deceptive conduct have imposed very large punitive damage awards. Why not just keep doing what we are doing and wait for these historical currents to bring the problem to an end?

The committee concluded that maintaining our present course will not end the tobacco problem. There are already signs that the prevalence of smoking among

adults is flattening and the rate of youth initiation has hovered around 20 percent

for most of the past two decades even though it is down at the moment. The high

rate of youth smoking is especially troubling because at least 80 percent of people

36

who smoke begin to do so as adolescents when they cannot fully appreciate the grip

of addiction and the future risk to their health.

Moreover, quitting after decades of use is difficult. Despite the fact that 70 percent of smokers say they want to quit, the annual rate of cessation among people

younger than 65 remains low. Meanwhile, the tobacco industry is spending more than $15 billion annually marketing its products to smokers and potential smokers in ever more creative ways

while public and private resources devoted to preventing smoking and helping people quit are dwindling. It will probably come as a surprise to most Americans that

the states use very little of the billions of dollars they are receiving under the Master Settlement Agreement to reduce tobacco use.

Taking these realities into account, the committee believes that the annual toll

of more than 400,000 smoking-related deaths will continue well into the 21st century.

It is time to change course.

For four decades, the tobacco industry successfully framed a public ‘‘debate’’

around the health consequences of smoking and the illegitimacy of governmental efforts to prevent or discourage people from smoking whenever and wherever they

wanted. But that debate is over. The dangerous properties of tobacco and its impact

on the public health are now beyond dispute and, as our report shows, aggressive

measures to reduce smoking rest on a solid scientific and ethical foundation. The

only debate now should be about how best to accommodate the legitimate interests

of addicted smokers within a comprehensive national policy designed explicitly to

reduce smoking and other forms of tobacco use.

In its blueprint, the committee offers a two-pronged strategy for putting the Nation on an irreversible course for ending the tobacco problem. This strategy involves

strengthening current tobacco control measures while transforming the regulatory

environment for tobacco products.

First, we have to invest in traditional tobacco control measures. The evidence is

in: These interventions work. The report contains almost 100 pages documenting

the effectiveness of the traditional tools of tobacco control, such as excise tax increases, indoor smoking restrictions, comprehensive state-based programs, mediabased prevention campaigns, school-based programs, and cessation therapies and

services. Specifically, the committee urges states to fund tobacco control programs

at the level recommended by the CDC, to license all retail establishments that sell

tobacco, and to ban the sale or shipment of tobacco products directly to consumers

through mail order or the Internet.

The committee also urges Congress to help fund state tobacco control activities

and to fund a national youth-oriented media campaign. Further, the committee recommends that all insurance, managed care, and employee benefit plans, including

Medicaid and Medicare, cover reimbursement for effective smoking cessation programs as a lifetime benefit.

If all these measures were implemented with fidelity and the efforts were sustained, the committee projects that the prevalence of smoking could be cut in half,

to about 10 percent by 2025. That would mean that about 11 million fewer people

would be smoking in 2025 than would be the case if current trends continue.

That would be a great accomplishment, but even if the investment were sustained

for 20 years, it would not end the tobacco problem. More than 25 million Americans

would still be smoking. And there remains the distinct possibility that the investment will not be sustained, momentum will be lost, and adult smoking rates will

be 15 percent or higher 20 years from now.

To put the Nation on a sure course for ending the tobacco problem, we also need

to change the legal structure of tobacco control. Tobacco products are not ordinary

consumer products. For no other lawful consumer product can it be said that the

acknowledged aim of national policy is to suppress consumption altogether rather

than to promote safe or responsible use. Yet, these dangerous products are essentially unregulated. Congress should enact a Federal regulatory statute that is suited

to the unique history and characteristics of tobacco products.

Congress should empower the Food and Drug Administration to regulate the manufacture, marketing, and distribution of tobacco products, and should permit the

states to undertake additional interventions to complement Federal regulations in

all domains except packaging and product characteristics. The committee concluded

that the necessary authority should be conferred on FDA because it is the Nation’s

preeminent public health regulatory agency and because it is the only agency with

the necessary combination of experience in product regulation and scientific expertise on tobacco-related disease and nicotine addiction. Among the key elements in

the committee’s proposed regulatory program are graphic package warnings modeled after those required in Canada; limiting advertising to a text-only, black-andVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00042 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
37

white format; banning any activities by tobacco companies that target youth; and

aggressive regulation of retail outlets to help reduce initiation and promote cessation.

The committee also reaffirmed recommendations by a previous IOM committee

(Clearing the Smoke, 2001) that FDA be empowered to assure that any claims stating or implying that novel cigarette products reduce the risks of tobacco-related disease have a scientific basis, and that it be authorized to promulgate standards for

tobacco products aiming to protect the public health. The committee specifically

urges FDA to explore the feasibility of gradually reducing the nicotine content of

cigarettes. The FDA already regulates pharmaceutical preparations containing nicotine, such as patches, ‘‘gum’’ and it seems odd, to say the least, that it has no authority to regulate the much more dangerous preparation containing nicotine that

makes these other preparations medically necessary.

Some people have worried that FDA regulation of tobacco would be construed by

the public as government endorsement of the safety of the product. It seems highly

unlikely that such a gross distortion of public understanding could occur when public and private agencies, including FDA itself, are taking aggressive steps to discourage people from using tobacco products and to help people quit. Of course, FDA

should monitor public perceptions about the dangers of tobacco use as a key component of its overall surveillance programs, and should develop or require appropriate

corrective communications to counter any misperceptions that may emerge concerning the health consequences of tobacco use or concerning the effects of using specific

products.

I have only touched on some of the many recommendations in the committee’s report. However, the specific proposals are perhaps less important than the message

and design of the blueprint as a whole. In the committee’s view, it is time to transform the Nation’s tobacco policy. Containing the problem is no longer good enough.

The Nation should commit itself to the strong and sustained measures needed to

end this critical public health problem.

I would be pleased to answer your questions. Thank you.

Mr. PALLONE. Thank you. And I should mention that your full

statement is submitted for the record. We just try to keep to the

5 minutes. Dr. Jacobs, again thank you for being here.

STATEMENT OF FRED JACOBS, M.D., COMMISSIONER, NEW

JERSEY DEPARTMENT OF HEALTH AND SENIOR SERVICES

Dr. JACOBS. Thank you very much, Mr. Chairman. Chairman

Pallone, Congressman Ferguson, distinguished members of the

Subcommittee on Health, I am very honored to be here today to

testify in support of H.R. 1108, the Family Smoking Prevention

and Tobacco Control Act. And I am delighted that all 10 esteemed

members of the New Jersey congressional delegation are cosponsors of this important legislation that would give the Food and

Drug Administration the authority to regulate tobacco products.

It has been more than 40 years since the U.S. Surgeon General

first alerted the Nation that smoking is hazardous to our health.

And, in my view, because smoking is the Nation’s leading preventable cause of death, the FDA should have had the power to regulate tobacco products 40 years ago.

There is no greater public health threat than smoking and secondhand smoke. No other product on the market today can cause

death, lifelong disability, or cancer if used as directed. Last year,

New Jersey implemented its landmark indoor smoke-free air act to

reduce the harmful effects of secondhand smoke, and we also raised

the legal age to purchase tobacco from 18 to 19 to decrease the likelihood of students in high school purchasing cigarettes. And we increased the State’s cigarette excise tax for the fourth time to $1.77

per pack, the highest in the Nation at the time.

38

And cigarette smoking continues to decrease among New Jersey

middle school and high school students, according to the 2006 New

Jersey youth tobacco survey. And current smoking rates have

dropped dramatically among middle school students and among

high school students since 1999. During this same 7-year period,

current use of any tobacco product has also significantly declined

among high school students and middle school students as well.

The New Jersey Department of Health and Senior Services has

worked with community-based organizations, tobacco control advocates, and New Jersey teens to encourage young people to remain

smoke-free or quit smoking if they have already started.

And the effort has paid off as the declining rates of tobacco use

demonstrate. So we, in the State of New Jersey, have enacted important tobacco control initiatives in ways that will prevent illness

and save lives for generations.

So I come before you today not only as the commissioner of the

New Jersey Department of Health and Senior Services, but as a

lifelong anti-tobacco advocate, a former chairman of the New Jersey Breaths advocacy group, and a physician who specialized in

pulmonary disease for more than 45 years.

I have seen firsthand in my practice in thousands of patients

how tobacco ravages the body. There are more than 4,000 toxic

chemicals in cigarette smoke. 69 of them are known carcinogens.

Exposure to these toxic contaminants can lead to respiratory infections, asthma, emphysema, lung cancer, heart disease, stroke, and

death.

In other words, smoking causes disease in nearly every organ of

the body, as former U.S. Surgeon General Richard Carmona told us

in 2004 when he released the new comprehensive report on smoking and health. More than 400,000 people die in the U.S. each year

from tobacco-related illnesses. That has already been discussed.

And that includes 11,300 in New Jersey. And up to 62,000 adult

non-smokers die each year in the U.S. from the effects of secondhand smoke, according to the U.S. EPA, and this includes up to

1,800 people in New Jersey.

It is our responsibility as public officials to protect the public

health and safety. An important step we can take to provide this

protection is to vest the FDA with the authority to regulate the levels of tar, nicotine, and other harmful components of tobacco products and to ensure effective oversight over the tobacco industry’s efforts to develop, introduce, and promote products that they claim

to be ‘‘less harmful.’’

We must use every tool in our arsenal to promote smoking cessation, to reduce the risk of tobacco-related diseases, and to prevent our young people from becoming enticed by and addicted to tobacco products. After all, the future survival of the tobacco industry

depends on addicting our children.

Up until now, education, prevention, and advertising, funded in

part by New Jersey’s excise tax have been our strongest tools. And

we all know that despite our best efforts, we have been outmatched

by the advertising power, the lobbying clout, and the ingenuity of

big tobacco.

Our efforts in New Jersey are continuing. We still need to expand our outreach to smokers, encouraging them to quit and eduVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00044 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
39

cating them about the highly effective quit services that New Jersey offers. We still need to promote tobacco use prevention among

our children and teens, and we need to continue offering specialized smoking cessation programs for those teens who already

smoke.

And we still need to promote and enforce tobacco age of sale laws

to better ensure that licensed vendors of tobacco products do not

sell to minors. And we still need to extend secondhand smoke protection in the workplace to workers on the casino floors in New Jersey.

This fall, I am traveling around the State as part of a major public awareness campaign to educate students, parents, school

nurses, and pediatricians about the dangers of exposing children to

the toxic effects of secondhand smoke in cars and in homes. And

by the end of the year, I hope to have spoken before approximately

50 groups.

I know I am getting to the end of my time, and I just want to

emphasize in the last few seconds that we as public officials need

more tools in our arsenal. The Nation needs the Family Smoking

Prevention and Tobacco Control Act. The FDA needs premarket authority over all new tobacco products, and the FDA needs to set national standards controlling the manufacture of tobacco products

and the identification of public disclosure of ingredients in such

products.

I urge you to protect the public health by approving the Family

Smoking Prevention and Tobacco Control Act. Thank you very

much for this opportunity to testify, and, of course, I will be happy

to answer any questions. Thank you, Mr. Chairman.

[The prepared statement of Dr. Jacobs follows:]

STATEMENT OF FRED M. JACOBS, M.D.

Chairman Pallone, Congressman Ferguson, distinguished members of the Subcommittee on Health, good morning.

I am honored to be here to testify in support of H.R.1108, the Family Smoking

Prevention and Tobacco Control Act.

And I am delighted that ten esteemed members of New Jersey’s congressional delegation are co-sponsors of this important legislation that would give the Food and

Drug Administration the authority to regulate tobacco products.

It has been more than 40 years since the U.S. Surgeon General first altered the

Nation that smoking is hazardous to our health.

And in my view—because smoking is the Nation’s leading preventable cause of

death and disability—the FDA should have had the power to regulate tobacco products 40 years ago.

There is no greater public health threat than smoking and secondhand

smoke.What other product on the market today that is unregulated can cause death,

life-long disability or cancer if used as directed?

Last year, New Jersey implemented its landmark indoor Smoke-Free Air Act to

reduce the harmful effects of secondhand smoke.

We also raised the legal age to purchase tobacco from 18 to 19 to decrease the

likelihood of high school students purchasing cigarettes, and increased the state cigarette excise tax for the fourth time. At the time, that increase made the total tax

of $1.77 per pack the highest in the Nation.

I am happy to report that cigarette smoking continues to decrease among New

Jersey middle-school and high-school students, according to the 2006 New Jersey

Youth Tobacco Survey.

Current smoking rates have dropped from 10.5 to 3.2 percent among middle

school students and from 27.6 percent to 15.8 percent among high school students

since 1999.

40

During the same 7-year period, current use of any tobacco products, including cigars, smokeless tobacco, cigarettes, and bidis—small, hand-rolled imported cigarettes—also significantly declined from 38.9 percent to 24.5 percent among high

school students and from 18.9 to 8.4 percent among middle school students.

The New Jersey Department of Health and Senior Services has worked with community-based organizations, tobacco-control advocates and New Jersey teens to encourage young people to remain smoke-free or to quit smoking if they have already

started. The effort has paid off as the declining rates of tobacco use show.

So we in the State of New Jersey have enacted important tobacco-control initiatives in ways that will prevent illness and save lives for generations.

I come before you today not only as the Commissioner of the New Jersey Department of Health and Senior Services, but also as a lifelong anti-tobacco advocate, a

former chairman of the New Jersey Breathes advocacy group and a physician who

specialized in pulmonary diseases.

And as a physician for nearly 40 years, I have seen first hand in thousands of

patients how tobacco ravages the body.

There are 4,000 toxic chemicals in cigarette smoke and 69 of them are known carcinogens. Exposure to these toxic contaminants can lead to respiratory infections,

asthma, emphysema, lung cancer, heart disease and death.

In other words, smoking causes diseases in nearly every organ in the body as

former U.S. Surgeon General Richard Carmona told us in 2004 when he released

a new comprehensive report on smoking and health.

More than 400,000 people die in the U.S. each year from tobacco-related illnesses—including 11,300 in New Jersey. And up to 62,000 adult nonsmokers die

each year in the U.S. from secondhand smoke, according to the U.S. EPA. This includes between 1,000 and 1,800 New Jersey residents.

It is our responsibility as public officials to protect the public health and safety.

And an important step we can provide for the public’s health is to vest the FDA

with the authority to regulate the levels of tar, nicotine and other harmful components of tobacco products and to ensure effective oversight over the tobacco industry’s efforts to develop, introduce and promote products that they claim to be ‘‘less

harmful.’’

We must use every tool in our arsenal to promote smoking cessation to reduce

the risk of tobacco-related diseases, and to prevent our young people from becoming

enticed by and addicted to tobacco products.

Up until now, education, prevention and advertising—funded in part by New Jersey’s excise tax—have been our strongest tools. And we all know that despite our

best efforts, we have been outmatched by the advertising power, lobbying clout and

ingenuity of Big Tobacco.

Our efforts in New Jersey are continuing. We still need to expand our outreach

to smokers encouraging them to quit and educating them about the highly effective

quit services that New Jersey offers: NJ Quitline, QuitNet and the Quitcenters. We

still need to promote tobacco use prevention among our children and teens. We need

to continue offering specialized smoking cessation programs for those teens who already smoke. We still need to promote and enforce tobacco Age of Sale laws to better

ensure that licensed vendors of tobacco products do not sell to minors. And we still

need to extend secondhand smoke protections in the workplace to workers on casino

floors in New Jersey.

This fall, I am traveling around the state as part of a major public awareness

campaign to educate, students, parents, school nurses and pediatricians about the

dangers of exposing children to the toxic effects of secondhand smoke in cars and

in homes. By the end of the year, I hope to have spoken before approximately 50

groups.

But we public health officials need more tools in our arsenal. This Nation needs

the Family Smoking Prevention and Tobacco Control Act. The FDA needs premarket

authority over all new tobacco products. The FDA needs to set national standards

controlling the manufacture of tobacco products and the identification, public disclosure and amount of ingredients in such products.

I would urge you to protect the public health by approving the Family Smoking

Prevention and Tobacco Control Act.

Thank you for this opportunity to testify.

I would be happy to answer any questions.

ATTACHMENT—SUMMARY OF MAJOR POINTS

There is no greater public health threat than smoking and secondhand smoke.

41

We must use every tool in our arsenal to promote smoking cessation in order to

reduce the risk of tobacco-related diseases, and to prevent our young people from

becoming enticed by and addicted to tobacco products.

It is our responsibility as public officials to protect the public health and safety.

And an important step we can provide for the public’s health is to vest the FDA

with the authority to regulate the levels of tar, nicotine and other harmful components of tobacco products and to ensure effective oversight over the tobacco industry’s efforts to develop, introduce and promote products that they claim to be ‘‘less

harmful.’’

New Jersey has taken a number of steps over the past two years to improve indoor air and decrease the likelihood that high school students will smoke. Last year,

New Jersey implemented its landmark indoor Smoke-Free Air Act to reduce the

harmful effects of secondhand smoke. New Jersey also raised the legal age to purchase tobacco from 18 to 19 to decrease the likelihood of high school students purchasing cigarettes, and increased the state cigarette excise tax for the fourth time.

Mr. PALLONE. Thank you, Dr. Jacobs. We will now have 5 minutes from the members, and I will start with myself. I am going

to try to get in one question for each of you, if I can, in the 5 minutes here. Let me start with Professor Bonnie.

The FDA, in their written testimony, say that H.R. 1108 would

be difficult to implement, undermines the public health roles of the

FDA, and does not provide adequate resources for the agency to

carry out the additional responsibilities. And I wanted to ask you,

professor, did the IOM committee consider these arguments? If so,

how did they reach the conclusion that the FDA is the most appropriate agency to regulate tobacco products? And how do you respond to criticisms of a bill that FDA regulation of tobacco would

legitimize its use?

Mr. BONNIE. Well, I apologize again for going over my time earlier, but that is also quite a large question that you just asked me.

Mr. PALLONE. I realize that.

Mr. BONNIE. The committee did think about these matters, and

I think, first of all, it should be recognized this is a challenge. Regulating this product is not like regulating other products, as I think

the commissioner has indicated. And it is going to take some development of scientific knowledge and regulatory attention to develop

a plan for doing so.

On the other hand, I think if the FDA is adequately resourced

to do the job, there is no other agency that is better suited to do

it than the FDA. It would be a challenge for any agency, but I don’t

know what the alternative frankly is. There is no better alternative

if we are going to grapple with the regulatory challenges. I don’t

think the alternative is to leave the product unregulated.

The question is which agency is better suited. The committee discussed this at length and concluded that the FDA, the preeminent

public health regulatory agency, has the scientific expertise to do

this. As was indicated earlier, it regulates various nicotine products

that are made medically necessary because of the nicotine in the

tobacco products.

In addition, it has tremendous range of regulatory experience

that is most directly applicable to the product itself, even though

it is a different kind of product, and it presents different challenges. So I think the committee did discuss this and concluded

that there really is no agency that is better suited to do it.

Mr. PALLONE. I appreciate that. I think we face the same thing

with every issue. Like we just finished with PDUFA and MDUFA,

42

and I had a lot of criticism. I said, why are you giving additional

power to the FDA because they don’t do a good job? And I had the

same answer which is who am I going to give it to?

Mr. BONNIE. Right.

Mr. PALLONE. So I think you are right. What about the——

Mr. BONNIE. The legitimation issue?

Mr. PALLONE. Yes.

Mr. BONNIE. We did also talk about this and commented on it in

the report. I think it is a compared-to-what question. I think it

might be helpful if the committee were to think about what is the

situation now. Here you have this product that everyone concedes

is the most dangerous consumer product ever marketed, that is essentially unregulated, and where the only form of regulation, essentially from the national government, is an invisible warning on

the side of the pack.

Now, meanwhile we try very hard to get people not to smoke and

to convince them not to smoke. But what do people think when a

product of this kind is essentially regulated in more or less a laissez-faire manner without regulation? What inferences would they

draw then?

Now, let us compare it to the situation that would exist if the

Congress confers the authority on the FDA that would be represented in this bill. The FDA would be directed to serve the public

health interest by aggressively regulating the manufacture, distribution, and marketing of this product.

To take a very specific example, explicitly the Act would enlarge

and strengthen the public health warnings. It would also confer on

the agency the authority to even strengthen them further and to

provide graphic warnings, pictures of which actually appear in the

committee’s report.

In addition, there would be strong and aggressive efforts undertaken not only by the State governments but other private agencies, as well as by the FDA and other agencies of the Federal Government to continue to aggressively try to convince people that

they should not start and that they should quit.

How in the face of all of that people would draw the inference

that somehow it is being approved by the FDA in the face of all

those efforts that the Government would be taking essentially escapes me. I do not think that this is really a serious problem. But

even if it were to happen, the FDA should also monitor and survey

through surveillance mechanisms consumer perceptions not only

about smoking but about specific products. And if there were to be

a problem in terms of misperceptions about the health consequences of tobacco use, then obviously the FDA should respond.

Mr. PALLONE. All right. Now, I have just a little bit of time here

for Mr. Jacobs. But I wanted to ask you, you already heard some

criticism about States who are not using all their money from the

MSA, the agreement for tobacco cessation. Did you want to respond

to that? And do you think this reflects any lack of urgency at the

State level? And I guess you could also, if you could, Dr. Jacobs,

explain the success that New Jersey has had with some of these

anti-smoking initiatives.

Dr. JACOBS. All right, thank you very much, Mr. Chairman. Well,

as you know, we were spending $30 million a year. Smokeless

43

States advised $45 million. We did $30 million when I was chair

of New Jersey Breathes. This is back to the early part of the 21st

century.

And then as New Jersey’s financial troubles became known to everybody—I guess they are not a secret—a decision was made a couple of governors ago to cut this down from $30 milion to $10 million. It has been increased to $11 million. That is what is spent

now on our comprehensive tobacco control program in the department, which includes things like Quitline, Quitnet, the Quitcenters,

that do increase the rate of quitting by a factor of tenfold over trying alone, but still very low. It is still only about 30 or 40 percent

success after 6 months because nicotine is so addicting that once

you start, it is very hard to stop. And, of course, you have this additional benefit from that that it is hard.

We, of course, in New Jersey and I am sure in other States as

well, have priorities when it comes to limited funding. And our particular problems with the budget gap that we have been facing and

will face again next year—we just had a cabinet meeting yesterday

with the Governor on this issue—makes it incumbent upon us to

look to the private side, to maximize the resources we have. Myself

going around and speaking to all of these groups is one way to do

it. We have been very successful in getting passage of the SmokeFree Indoor Air Act. It took 10 years of effort to do that. There are

certain gaps yet, but we are working on those.

I am very proud of what New Jersey has done, and I don’t think

we need to apologize that we haven’t spent all of the money on the

Tobacco Control Act, given the financial context of that money. And

it doesn’t excuse the Federal Government from stepping up to the

plate and doing their job as well.

Mr. PALLONE. Thank you. Recognize Mr. Deal.

Mr. DEAL. Thank you. Mr. Bonnie, did your committee or your

group undertake to give any estimate as to how much the cost

would be in extra funding required or additional employees at FDA

if they undertook the regulatory processes outlined in this legislation?

Mr. BONNIE. No, the committee did not do cost assessment of

what it would take.

Mr. DEAL. In general terms, would it be a substantial investment

of resources and personnel, do you think?

Mr. BONNIE. I don’t know what substantial means. I think that

the committee’s sense was that again some agencies should have

regulatory authority here. A lot of the attention has been focused

on the review of new products and particularly those products that

purport to reduce exposure to toxicants or to reduce risk ultimately

of tobacco-related disease.

And the challenge that it would take to gear up to conduct that

kind of review and then, of course, review the products that would

be submitted, it obviously would be dependent on how many applications were submitted for that kind of review.

I think it should also be emphasized though that even though

that particular aspect of the bill has gotten the most attention, and

of course it is the most of the pages frankly of the bill, and it is

built on the foundation that the Institute of Medicine laid in a 2001

report called ‘‘Clearing the Smoke’’—that very, very important

44

pieces of this legislation aim to reduce prevalence all together rather than the harm reduction features of the bill.

And the resources that would be needed in order to implement

those portions of the bill, I think, are potentially considerably less

than those that would have to be devoted to this more complex regulatory challenge. Although it, in turn, depends upon how many

products would then be submitted.

So I think there is a lot of guesswork here in terms of exactly

what the requirements are going to be. We do know when the

agency geared up in the mid 1990s to do this what the resources

were to enforce—at least initially to develop and enforce the 1996

Tobacco Rule. So there is at least that kind of evidence.

But so many of these proposals essentially would involve

strengthening the warnings and doing the necessary science on

that and then monitoring it. Some Federal agency should be doing

that. And so I think the question would be again not about FDA

but the cost of that kind of regulation, which it seems to me would

be strongly supported, I think, by even members of the committee

that have problems with this bill.

So again I think the committee thought that the benefits of the

regulation would justify whatever cost that could be incurred, but

we did not do a cost assessment.

Mr. DEAL. I believe your testimony indicated there are about 45

million people who are smokers today in this society. Is that the

correct figure?

Mr. BONNIE. Yes.

Mr. DEAL. We just heard in Mr. Pallone’s question and some of

the comments in opening statements about the fact that States are

not using a significant portion of their master settlement money for

efforts to have cessation of smoking among that 45 million.

What is the suggestion as to what we do with regard to those?

That is a significant number of people that we shouldn’t just ignore

it appears to me. Did the institute, for example, take a look at that

particular issue as to what should be done in that regard and how

should that be done? Should it be through the master settlement

funding or what other approach, if any, should be done if it appears

that States like New Jersey and others are diverting more and

more of those funds to purposes totally unrelated? Was there any

study done on that?

Mr. BONNIE. Yes, indeed again I am glad the congressman asked

this question because the committee’s blueprint does go on both

tracks to try to strengthen the traditional tobacco control activities

that have largely been at the State and local level. And we continue to need to be doing that; although, FDA regulation and activities could supplement what is being done.

An important part of this bill is actually to remove one of the obstacles that now exist to more aggressive regulation at the State

and local level by loosening the preemption and allowing the States

to engage in regulations that supplement whatever Federal regulations are adopted.

With regard to the funding of State programs, the committee did

carefully look at what has been happening with the master settlement funds, also looked at tobacco excise taxes because States, of

course, have been increasing tobacco excise taxes in recent years,

45

some of which in some States have been specifically designated for

supporting tobacco control programs.

There may be constitutional limitations that may prevent setasides of that kind in all the other States. But obviously it would

be possible for the States to take a look at their revenue streamsin

both cases and to devote additional monies to these tobacco control

programs. And we have urged them to do that.

Another problem that is related to this, of course, is the disparities in excise taxes that ends up, of course, with possible smuggling

across State lines as some places begin to increase the excise taxes

even more. So what we recommended that the States do is that the

States that have the lower excise taxes increase their excise taxes

to the level of the top quintile of the States in order to reduce this

disparity. That would have the benefit of reducing consumption

and also producing these additional revenues that could be used

then to fund the tobacco control programs.

So we offered that kind of strategy as a way to solve a multiple

number of problems as well as, of course, the suggestion that the

master settlement funds could be set aside specifically to do some

of these activities. And Virginia, for example, is one of the States

that actually does that.

Mr. DEAL. Thank you.

Mr. PALLONE. We will continue with some of the members, but

just so everyone knows we have three votes at 15 minutes followed

by two 5-minutes. So I will recognize Mr. Waxman, and then we

will see how much time is left.

Mr. WAXMAN. Thank you very much, Mr. Chairman. Mr. Bonnie,

you answered Chairman Pallone’s question about whether FDA

was the appropriate place to have this regulatory authority over tobacco. Did the IOM committee look at other agencies of the Government, Federal Trade Commission, or Center for Disease Control?

And why did you decide that those agencies were not appropriate?

Mr. BONNIE. Well, we did talk about other possibilities. I might

say, even as a historical matter, the IOM first looked at this question in 1994 when a committee on preventing nicotine addiction in

children and youth was established, and issued a report called

‘‘Growing Up Tobacco Free’’ which then provided some of the scientific foundation for what the FDA did subsequently in its tobacco

rule.

In that committee, this issue was also addressed, and what the

committee concluded at that time, again, was that it might be that

there would be alternative ways to go about it and that there might

be concerns about contaminating the FDA’s overall mission, as

Commissioner von Eschenbach has suggested. There might be concerns about undermining the agency’s overall mission by giving

them authority here.

And the committee at that time thought that there might be a

legitimate concern there, but the alternative that we thought was

most plausible then was establish a separate agency. Now, of

course, I don’t think there is any interest in any member of Congress to establish a new agency.

But at that point, we had looked at the regulatory agencies and

thought none of the other ones would be suitable for the broad regulatory authority that would be needed. You needed a public health

46

regulatory agency in order to be able to do it. Now, the Consumer

Product Safety Commission, I think, thinks of itself, in some respects when it is involved in injury prevention and disease prevention activities as having a public health sort of regulatory posture.

But, of course, it is a highly under-resourced agency that, I

think, if we were worried about the FDA we would have all the

more worries about the Consumer Products Safety Commission,

which, of course, does not have the depth of regulatory experience

in any of the areas that would be relevant that the FDA does.

And, of course, the Federal Trade Commission again has a particular regulatory orientation, but it is not a public health regulatory agency with all the scientific expertise, of course, that the

FDA would have.

So we actually did think about the other possible regulatory

agencies and though there was really no alternative to the FDA

within the existing array of Federal regulatory agencies.

Mr. WAXMAN. We talk about children being most affected. What

approach do you think we could take that is directed at children

as opposed to adult smokers or adults who might consider to be

smokers?

Mr. BONNIE. In terms of the initiatives that the Congress should

take? Well, for example—well, I guess I will mention two, I think

an overall part of the strategy is, in the committee’s view, to have

more aggressive regulation of the retail environment, not only to

tighten and enforce youth access restrictions and, of course, all the

States have at some level, and that there is a Federal role that is

being played there now in terms of the Synar Amendment.

Not only should those activities be strengthened but the overall

retail environment and the marketing that goes on in the retail environment also needs to be more strongly addressed than is now

the case. That is one of the areas where preemption under existing

Federal law impedes more aggressive State action.

So one of the things, the important things that the Congress

could do is to get the Federal Government out of the way of efforts

of the States to engage in more active regulation of the retail environment that largely would be aimed at preventing exposure of

kids to pro-smoking messages in that environment.

The other factor is to license the retailers in order to be able to

set up appropriate regulatory mechanisms and, of course, the tobacco rule, if it were adopted, would set up a regulatory strategy

that could support the State efforts in that area.

The second thing, of course, is mass advertising. I emphasized

how important the retail environment is, and we should not forget

that while we are talking about regulation of advertising in magazines, for example. But the committee, of course, did look at, as the

1994 committee did, the committee did look at the messages to

which youth are being exposed in various mass media, including

the magazines and recommended a text-only, black and white approach to the regulation of advertising arguing and believing that

that would be consistent with the constraints of the first amendment.

So reviving the provisions of the FDA tobacco rule by granting

authority to the FDA to do that and directing it, as the bill does,

47

to reenact that regulation would be an important part of that strategy.

Mr. WAXMAN. Thank you very much for your answers to my

questions and for the terrific work that the IOM did giving us

these recommendations.

Mr. PALLONE. We have 9 minutes left. Did the gentlewoman from

Tennessee want to ask questions now or——

Mrs. BLACKBURN. Thank you, Mr. Chairman. I probably could go

ahead.

Professor Bonnie, I did have a couple of questions for you. Litigation that is currently pending against cigarette companies, if we

now had FDA certifying cigarettes as being less harmful, what will

that do to some of these impending lawsuits? Did you all look at

that? Have you given any thought to that?

Mr. BONNIE. I am sorry, Congresswoman, my recall about what

is precisely said about this in the report is not precise. We did, in

recommending stronger FDA regulation, we did take into account

that, of course, there would be some questions that would be raised

about what the effect of that would be on various litigation and tort

remedies.

And I think in general the approach that was taken is the usual

approach, I think, that is reflected in other product regulation statutes, which would be that if the State tort action, as would any direct regulatory action, were incompatible with the decision that

had been explicitly made by the Federal regulatory agency, that

that litigation would then be preempted by the Federal rule.

But, I think, beyond that and particularly for actions that relate

to fraud and deception, as an example, that those actions would

survive. I think in general that was the approach that was taken.

The general attitude that the committee had with regard to preemption is that the Federal rules with regard to packages and to

product regulation, direct regulation of the product by the FDA basically should have preemptive effect on State action.

Mrs. BLACKBURN. OK.

Mr. BONNIE. But all other regulations should be——

Mrs. BLACKBURN. Let me ask you this then. I think Philip Morris

has more patents filed than anyone else on cigarettes that are less

harmful or reduced risk. And one of the things it seems in Tennessee, whether it is intellectual property in dealing with our entertainers and our song writers, copyright, patent, intellectual

property protection, is always a key component for us in these discussions.

So what is going to happen if the FDA mandates a patented Philip Morris technology for a safer cigarette, an approved cigarette?

Then do you have all your other manufacturers having to pay licensing fees to Philip Morris? Have we looked at that angle if you

are going to get in there and micromanage that?

Mr. BONNIE. I would love to be able to answer your question, but

this is not something that the committee addressed in this report.

Mrs. BLACKBURN. So you didn’t think through to the end——

Mr. BONNIE. The focus of this committee report overall was on

preventing, reducing use and reducing prevalence of use. The harm

reduction issue and what we should do about regulating new prodVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
48

ucts was ancillary really to the function of this particular report.

Those issues were addressed in——

Mrs. BLACKBURN. Do you have a personal thought?

Mr. BONNIE. Do I personally have a thought? No, I am not adequately informed enough to be able to answer your question.

Mrs. BLACKBURN. OK, did you think activities from like DHS and

CDC and all the other agencies that are working on smoking cessation and education, should they all be drawn in under the FDA?

Mr. BONNIE. Again now I am speaking on—excuse me—trying to

recall the committee deliberations so that I am speaking on behalf

of the committee.

Mrs. BLACKBURN. OK.

Mr. BONNIE. And I think it is accurate to say that the committee’s view was that the FDA authority here would not be in lieu

of all the other efforts that would be being made by other Federal

agencies.

Mrs. BLACKBURN. It would be in addition to?

Mr. BONNIE. Would be in addition to those efforts and particularly those that are designed to focus on the prevention of smoking

and helping people quit. Obviously there are tremendous activities

that are going on elsewhere in the Federal Government.

Mrs. BLACKBURN. OK, thank you. Mr. Chairman, I have been

reading Dr. Eschenbach’s testimony while I have been sitting here

this morning. I am disappointed that we don’t have somebody from

the FDA to participate in this, and I would hope that at some point

we do have the opportunity to hear from him or somebody from the

agency. I yield back.

Mr. PALLONE. I would just point out that we did invite them, and

I don’t really understand why they are not here. But we do have

their written testimony at this point that we can reference. We will

now stand in recess. The two of you can stay, I hope, right? We will

be back in about maybe half an hour or so and continue with the

questions. And so the subcommittee stands in recess until that

time.

[Recess.]

Mr. PALLONE. And the next person to be recognized is our vice

chair, Mr. Green, for questions.

Mr. GREEN. Thank you, Mr. Chairman. Dr. Bonnie, the IOM report discusses some of the significant successes that the tobacco

control movement has had to date. Almost all of these successes

though have been on the State level. The report lists increased tobacco excise taxes, and I know Texas has dramatically increased

theirs. Youth access restrictions, prevention programs, media campaigns, cessation programs, grass roots community advocating,

smoking restrictions such as those implemented last year in my

home town.

In fact, I congratulate my city council member, Cheryl Ovalado

for her leadership on that effort. And I am proud of the work that

Texas is doing on the State level, the research. In fact, it is even

doing it at my alma mater, University of Houston.

Yet despite all these steps, smoking rates remain high. And the

IOM report recognizes we may have hit a limit on these programs’

effectiveness and further recognize that almost all these steps address the demand side of the smoke equation. Dr. Bonnie, how can

49

congressional efforts help address the cigarette tobacco supply

problem in order to lower smoking rates? And does the available

force, do they adequately meet these goals?

Mr. BONNIE. Well, I guess speaking for myself, I think I would

begin by enacting this bill. But just to put what you said in context, the committee was a little bit more optimistic than your statement indicated that we might, by strengthening the steps that

Texas and other States have been taking, that we might continue

to make a dent in smoking prevalence.

But it would have to be sustained. It would have to be strengthened and sustained over a period of time, or backsliding is a continuing risk, and particularly because obviously the tobacco industry is—unless other steps are taken—going to continue its efforts

to market the product and support smoking.

So it is for two reasons then, I think, that we need to focus on

the need for Federal action not to displace but to help supplement

the State actions that you just referred to. So one is on the supply

side. So here obviously we have a product that basically has not

been regulated, and where substantial restrictions on the nature of

the product or on access to it have not yet been taken.

And in order to really do that with regard to the product, you

have got to have Federal action. The State can’t obviously deal

with alterations in the product itself.

But in addition, I don’t want to underemphasize by emphasizing

the need to move to supply side because everything that we have

been doing so far has been on the demand side because of basically

Federal exemption. So in order to move forward, we need to begin

to regulate on the supply side, but also we need to strengthen the

Federal role on the demand side as well.

And this bill does that, and I think it is important to emphasize

the other features of this bill that would strengthen activities on

the demand side, such as the strengthening of the warnings, such

as the regulation of marketing and advertising by restricting efforts to promote the use of the product.

Mr. GREEN. OK, the IOM report does not advocate the banning

of the tobacco products, and I know after the House passed the

CHIP program with the tax increase in it, I heard from a lot of constituents who say well, if it is so bad, don’t tax it, just ban it.

Some statistics I want to make sure we get into the record that

I know you are familiar with. Twenty-three percent of high

schoolers currently smoke. Twenty-one percent of adults—that is

about 45 million smokers—currently smoke. And 400,000 Americans die every year from their own smoking, and tens of thousands

more die from second hand smoke.

Smoking kills more people than alcohol, AIDS, car accidents, illegal drugs, murders, and suicides combined. And can you explain to

our committee the rationale why the IOM wouldn’t just recommend

just banning it in the conclusion, the prohibition of tobacco products is not appropriate?

Mr. BONNIE. Well, you can imagine, we did discuss this at considerable length because of the charge that we had about developing a blueprint for the Nation to reduce tobacco use. And one of the

very first issues that we were asked to address is actually to look

at the question of how would we gauge the success over a period

50

of time of any substantial efforts that were made to reduce use and

what the goal is.

And what we concluded is that at this point, we could just talk

about ending the tobacco problem as a significant public health

problem with a 20-year frame of reference. It might very well be

that at some point further down the path, when you have significantly reduced prevalence, that you would face the question about

why not take the next step.

But clearly with 45 million smokers smoking and otherwise

using other products that are addictive, it is clearly not feasible to

adopt a prohibition approach. Obviously you would have to take

into account the cost of trying to enforce a prohibition, the inevitable development of illicit markets and so on.

So I think nobody on the committee thought that for the foreseeable future that prohibiting these products is a feasible option. So

the question then is what do you do. In order to eventually move

in the direction of substantially reducing the use of the product,

and there are only really two choices that we have.

One is basically to continue the regulatory environment that we

now have, and the other is to engage in aggressive measures to try

to discourage the use of the substance and to reduce prevalence in

the way that this bill proposes to do.

Mr. GREEN. Thank you, Mr. Chairman.

Mr. PALLONE. Mr. Buyer.

Mr. BUYER. Tell my wife I had a V–8 for lunch, all right? In her

attempts to keep me healthy, she is killing me.

I went down a whole laundry list of a lot of products out there

on the market today that we could regulate, and we seem to be sort

of focusing on tobacco. There is a statement that was made that

while tobacco is the plant, humans created this product. There is

no health benefit. You could say the exact same thing as trans fats

and refined sugar. Humans created those things, and we get a lot

of bad effects from them. You know that. Coronary heart disease,

the high insulin rates, the diabetes problems that we have to deal

with with regard to our diet. And so I am just letting you know

I am being very cautious and careful here with regard to the regulatory impact of this bill and what type of slippery slope are we

going to take.

I would endorse the harm reduction strategy, I guess, as my wife

is doing to me. And we do that through individual choice. So let

me ask this question of the panel. Of the tobacco products that are

out there on the market today, are there some that are worse than

others, or some that are better for one’s health than others?

Dr. JACOBS. Well, obviously there is a magnitude of difference in

terms of the use and the abuse of cigarette smoking, and things

that you inhale. Where you inhale the smoke itself is obviously

more dangerous. But it is not like using other tobacco products is

safe. So all of them have a risk.

The difference between tobacco products and all of the other

things that you mention is that tobacco products are addicting, and

they are heavily marketed because of their addicting potential. So

it is difficult to stop, and you have documented evidence of the danger, particularly when it is marketed to underage kids who can’t

51

really make a rational choice about it based on their own life experience.

So whether you deal with trans fats or refined sugars or all the

rest of the items you mentioned, there, I think, an educational program is at the basis of where that ought to be addressed. And that

is what we are doing in New Jersey on childhood obesity and secondhand smoke in homes. We are not going to regulate secondhand

smoke in homes. We are not going to tell parents you can’t smoke

in your home when there are kids present. How are we going to

enforce that?

But I believe strongly that if we educate people about what their

conduct does in terms of harmful impact on their own children,

that they will make a legitimate effort to alter that kind of conduct,

such as smoking in homes and cars.

So when it comes to the specific answer to the question, which

tobacco products are safer than others, there are no safe tobacco

products. Some are more dangerous than others, and if we want to

do a risk reduction strategy and pick the low-hanging fruit, you

would go directly to cigarette smoking because that is the one that

has the greatest addiction potential and the greatest harm.

Mr. BUYER. One of the challenges I have of picking FDA—and I

know, Mr. Bonnie, you had to go through this decision-making

process. When you look at the core mission of FDA and that they,

by way of their culture, are focusing on the efficacy and safety of

drugs and devices, that the culture is all about safety and health

of a society. And now if we are going to take a tobacco product, and

based on the testimony just now given by Dr. Jacobs, it is making

choices among harm.

All right, so this is a different mindset, and so if it is about prevention and its education, there are some steps that we can take.

And so let me ask you is smokeless tobacco, would that be a useful

step to advocate and permit sampling of such a product if we are

trying to wean people off of cigarettes?

Mr. BONNIE. You are asking me this question?

Mr. BUYER. Yes.

Mr. BONNIE. All right, well, I agree with everything that Dr. Jacobs said. So the problem is that all of these products are uniquely

dangerous and are addictive. And so the slope is not as slippery,

I think, as you were suggesting. And we also have to add that more

than 80 percent of the users of any of these products began when

they are kids, when they then not in a position really to appreciate

the grip of addiction.

So for all those reasons, we need to regulate these products in

order to continue to reduce the amazingly large public health——

Mr. BUYER. Let us get to the sampling question.

Mr. BONNIE. OK.

Mr. BUYER. Would you want to permit sampling as part of a

harm reduction strategy to move them from cigarettes to smokeless

than not at all?

Mr. BONNIE. So what a regulatory agency needs to do, and the

overall goal of regulation, is to prevent and discourage the use of

all these products because that is what the public health demands.

We also then have to deal with the issue of when people are using

the products. What should be done as a matter of regulatory philosVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00057 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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ophy in order to help them make choices that will reduce the danger to them.

And I think part of the new frontier, frankly, of tobacco control

is the overall issue of harm reduction and whether or not people

who cannot quit should have alternatives. But to say that alternative choices will be available is not to say that all of these products would not be regulated in order to protect the public health,

and it certainly is not going to be, I don’t think, would be the goal

of any regulatory agency to encourage people to use a dangerous

and addictive product.

So I don’t think that the regulatory agency, if you give FDA the

authority, is going to be in the position of basically announcing to

the public that our overall goal is to encourage people to use a

smokeless tobacco, as an example.

The goal is going to be to regulate all of these products in order

to discourage people from using them to begin with and to the extent that it could be done, to reduce the dangers associated with

the use of those products.

But I can’t imagine that it is going to become part of the agency’s

objective for exactly the reason that you said: to encourage people

to think that there is a safe alternative in using these products.

Mr. PALLONE. Thank you. I recognize Mr. Gordon for a nanimous

consent request.

Mr. GORDON. Thank you, Mr. Chairman. I have a bill I wish to

introduce. I am involved in a hearing in another committee, like a

lot of folks. So let me just quickly say I ask unanimous consent to

submit a statement by the U.S. Smokeless Tobacco Company, a

constituent of mine, to be included as a part of the hearing record.

Mr. PALLONE. So ordered.

Mr. GORDON. Thank you, Mr. Chairman.

Mr. PALLONE. And now I recognize the gentlewoman from Colorado, Ms. DeGette.

Ms. DEGETTE. Thank you very much, Mr. Chairman. I want to

thank both of you gentlemen for coming. You are both fabulous witnesses, and it is welcome testimony that we are hearing.

I think I will start with you, Dr. Bonnie, and chime in, Dr. Jacobs. Some people in this hearing and in general argue that the

Federal Government really doesn’t need to regulate tobacco because States and local governments are doing it.

And I think, Mr. Bonnie, you mentioned the Federal preemption

issue a little while ago. I wanted to talk to you about my home

State of Colorado because we are one of three States joining Maine

and Delaware who have actually funded a tobacco prevention and

cessation program at levels recommended by the CDC. And we

have a comprehensive smoke-free bill that the legislature passed

which prohibits smoking in workplaces, restaurants, bars, casinos.

But Colorado is not allowed to prohibit billboards with tobacco

advertisements from being posted next door to a school. Is that

what you are talking about, why we need Federal regulatory authority?

Mr. BONNIE. Yes.

Ms. DEGETTE. And under this legislation, would the FDA be able

to issue regulations that could control the types of advertising that

I am talking about?

53

Mr. BONNIE. I think under this legislation not only would FDA

have the authority, subject of course to the constitutional constraints of the first amendment, which we could also discuss, but

not only would FDA have the authority to regulate the advertising

and marketing of the products, that as long as it was compatible

with Federal regulation, the States would also have the authority

to engage in——

Ms. DEGETTE. And I think you concluded—and, Dr. Jacobs, I am

sure you would concur—that the main problem we have right now

in terms of U.S. smoking is that young people are continuing to

smoke and tobacco companies are continuing to target young people, correct?

Dr. JACOBS. Yes, that is right. That is not to say that you can’t

have an impact on the rate at which young people smoke. And New

Jersey has done that. I left the numbers out of my oral testimony

for the sake of time, but you have it in the written material.

So that in our State, for instance, we have a group called Rebel.

It is a national movement. It is called Reaching Everyone by Exposing Lies. It is a high school group. There are 6,000 of these

young kids in that group, about 300 schools. And they are the army

that get out there. But once you start smoking, it would be helpful

if we could ask, require tobacco companies to reduce nicotine content in cigarettes.

I think that if there is dose response curve to addiction and you

move down that dose response curve, logic would tell us it is easier

to wean someone off of a substance to which they have a lower addiction potential than a higher addiction potential. And the recent

data of Massachusetts——

Ms. DEGETTE. Let me stop you, and I apologize. I don’t have

much time. That is a good thing to do, but the better thing to do

would be to try to prevent them from becoming addicted to tobacco

in the first place.

Dr. JACOBS. Absolutely.

Ms. DEGETTE. And part of that would be eliminating advertisements targeted directly to young people.

Dr. JACOBS. But these, of course, are not mutually exclusive

goals.

Ms. DEGETTE. Right, exactly. We need to do it all. Now, I want

to ask you about something I mentioned briefly in my opening

statement. I told Mr. Waxman while we were on the floor voting

I may be actually spurred to reintroduce this bill by this hearing.

Several sessions of Congress, I introduced this legislation that I

came up with. Right now, under Federal law, we tell States that

they will lose Federal aid if they don’t raise their drinking age to

21.

So this bill I introduced said it is exactly the same bill, but for

tobacco. That if States raise their age to which retailers could sell

tobacco to 21, that would seem to me to really eliminate some of

the problem of these young people getting addicted. What do you

think about that kind of idea?

Dr. JACOBS. We did that. Well, we didn’t go to 21. We went from

18 to 19 in New Jersey to get the age of sale past high school.

Ms. DEGETTE. Right.

54

Dr. JACOBS. That was the idea. From 19 to 21, I think fine, but

I think that was the idea. Enforcing the tobacco age of sale laws

is an ongoing requirement. It is a bit of a challenge. It does take

resources to do that.

Ms. DEGETTE. Right, but we do it with alcohol, and it is a challenge. But we do it. And my concept in doing this bill to age 21

is it would make it consistent with alcohol. And then instead of targeting 14-year-olds, like they do now, because the age is 18, if it

is 21, maybe they are only targeting 18-year-olds. And that at least

helps you capture high school students, which, I think, are a really

vulnerable target group. Mr. Bonnie, did you have any comment on

that? I know it is probably not part of your book.

Mr. BONNIE. Thank you. It is not. The committee did not take

a position on the issue that you have just mentioned, but my own

personal view would be I would be careful about this. On the one

hand, as you have said, I think in terms of targeting, there is no

doubt that the young adult audience of potential consumers is receiving a lot of industry attention, let us say 18 to 24 years old.

And there is some indication that initiation rates among that group

are not falling and may even be increasing. So it is certainly a concern from a public health standpoint.

On the other hand, I do think, as Dr. Jacobs said, that we have

to worry about the practical issues of enforcement, of encouraging

compliance and then promoting enforcement. And, of course, we

focus on the retail outlets in terms of commercial distribution, but

a lot of the distribution, of course, occurs outside the retail outlets

in terms of social sources.

So I think the issue is a bit of a complicated question. My own

personal advice to you would be that this is one area where local

options should be available. So if the Federal Government sets the

floor, as the tobacco rule did, at 18, you should allow State and

local governments to experiment with higher ages, just as Dr. Jacobs said. So that would be my personal view about this matter.

Ms. DEGETTE. OK, thank you. Thanks so much for that advice.

Mr. PALLONE. The gentlewoman from California.

Mrs. CAPPS. By default I concede. Thank you both for your excellent testimony, and there seems to be an agreement in the communities now that anti-smoking campaigns are finding it difficult to

compete with the purchasing power of big tobacco advertising. I

want to ask each of you a different question relating to this overall

topic.

Dr. Bonnie, could you please touch on what the committees found

out about the effectiveness of tobacco companies’ advertising? The

companies argue that the goal of advertising is simply to attract

current smokers to their brand, like brand competition. But I

would argue that they are trying to go after new smokers as well.

And I want to know your thoughts on this, and especially did you

conduct any studies during your study of this overall topic specifically on the effect of advertising on children and teens?

Mr. BONNIE. Well, the committee certainly looked very carefully

into the issue that you are raising. The committee, of course, did

not do studies of its own.

Mrs. CAPPS. I know.

55

Mr. BONNIE. It reviewed the available evidence, and I think

there is, I think the committee had no doubt that the effect of advertising is not just simply about brand changes. That the advertising and marketing of the products has the effect of, if not the purpose of, increasing the overall demand for the product by recruiting

new users, whatever the age that they may be, and also to have

the effect of encouraging current smokers to continue to smoke.

And that is, I think, an often overlooked feature of this just in

terms of the various messages that are being conveyed by the products by the marketing.

So I think that the committee’s view, based on that evidence, was

that a essential component of an overall strategy that is designed

to reduce the prevalence of smoking has got to be to restrict the

marketing and advertising of these products, that by its nature is

designed to encourage consumption.

Mrs. CAPPS. Right, thank you. I appreciate particularly in your

testimony that you talked about the vulnerability of teenagers and

young children because of their lack of decisionmaking in terms of

long-term effects and that kind of thing. And that also this is by

nature the new market. The younger and younger, the lifespan is

going to be extremely lucrative for a tobacco company and also for

the adjunct advertising mechanisms that they use.

I really appreciate, Dr. Jacobs, your being here from the perspective of someone out there in the trenches, if you will, doing this

work at the State level. We need the cooperation to reduce and get

rid of this illness-causing habit. We need to employ every level of

grass roots to the non-profit sector to, I think, I believe regulatory

bodies.

I wonder if you could discuss how this particular bill, H.R. 1108,

might help your State to be more effective in the kind of anti-smoking messages that actually compete with deceptive advertising. You

are trying to get out there a message that runs counter to what the

tobacco companies are doing through their lucrative advertising

medium.

Do you think the passage of this bill could, for example, you are

concerned about your young women, as I am. Do you think there

would be a way to prevent publications from using ads like those

for Camel No. 9 that I displayed?

Dr. JACOBS. I would hope so. Of course, Professor Bonnie is the

expert on the first amendment issues here, but leaving that aside

for a second, if it could be done, so that truthful advertising that

wasn’t deliberately targeted to a youthful age group that must be

targeted by these companies if they are to survive as corporations.

Mrs. CAPPS. Exactly.

Dr. JACOBS. I think we lose sight of that. Their corporate survival depends on their addicting our young people. That is simply

the fact. So we need to do that. The other thing, of course, is to

the extent that we have greater uniformity in the States, we will

have less problem with importing cigarettes and other items that

may be a different composition from Delaware and Pennsylvania

and New York, which are freely transported now in and out of New

Jersey.

Mrs. CAPPS. Thank you very much. Any other comments

from——

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Mr. BONNIE. I would like to comment on this first amendment

question if you still have the time.

Mrs. CAPPS. I have 23 seconds. They are all yours.

Mr. BONNIE. It is a very important part of the bill, and questions

have been raised about the constitutionality. The committee again

looked carefully at this, and the view that we have taken, which

I believe to be an accurate description of the law, is that a textonly black and white restriction of the kind that was in the 1996

and would be revived here, is fully compatible with the first

amendment because it protects the core first amendment interest

that users, current users of tobacco products, and the companies

that are communicating with them have, in receiving information

about the product, information about price, information about contents, and we end up with products that purport to reduce exposure to dangerous substances or to reduce risk, to receive information about the relative risk of the products. It is about receiving information, and a text-only, black and white format for advertising

full protects the right to receive information.

What it gets rid of is the other messages that are being conveyed

implicitly about what are thought to be, by the companies, benefits

of using the product or perceived benefits of using the product

through color and through images. And that would be restricted,

and that is particularly dangerous, of course, with children.

Mrs. CAPPS. Thank you. Just to hone in on that point, you don’t

see constitutionally if this bill passes and all the ifs that the FDA

could then regulate against such kind of advertising as I demonstrated in the posters?

Mr. BONNIE. That is the committee’s view, and I think eventually, if and when, and certainly it will go to the Supreme Court if

it is adopted. My view is that if this case is properly and well argued that—based on current case law at least—that it would survive constitutional review.

Mrs. CAPPS. Thank you very much. I yield back.

Mr. PALLONE. Thank you. Dr. Burgess.

Mr. BURGESS. Thank you, Mr. Chairman. It is great to have a

panel here with two lawyers and a doctor, even if one of them is

the same person. That is a fascinating discussion about the first

amendment. I never really thought about it in those terms, so the

first amendment would apply to a PDF file that it is black and

white and not to a larger font size, a bolding or italicized print.

Maybe we ought to make that applicable to political advertising,

and our lives would all be a lot easier over the next 2 years. What

do you think? In political advertising, do you think we ever use

that penumbra of psychological influences in political advertising to

try to sway the voting public one way or the other?

Let me ask a question. I apologize for being gone during most of

the question and answer period. You heard my comments as the

hearing got underway this morning. Dr. Jacobs, in your testimony,

the statement ‘‘we must use every tool in our arsenal to promote

smoking cessation.’’ And I think we probably both agree the biggest

tool we have in our arsenal is don’t ever start. It is the most effective way to lead to smoking cessation. But why do we even allow

it? Why do we even have cigarettes? Why do we even allow them

57

to be a legal entity in this country? If we are really serious about

using every tool in the arsenal, wouldn’t we just outlaw cigarettes?

Dr. JACOBS. I guess if that was a feasible idea. Certainly from

a public health standpoint it is a toxic, class A carcinogen. We

would outlaw it the same way you outlaw the free sprinkling of asbestos fibers around the room. It is the same thing, but I think, as

Professor Bonnie has pointed out in the IOM report, with 45 million addicted people in the United States right now, there would

be substantial resources that would have to be brought to bear on

that in order to accommodate that particular large population.

I think from a public health standpoint, I would like to get rid

of cigarettes. They don’t do any good to anybody except the people

who sell them, I guess.

Mr. BURGESS. Well, they do us a lot of good because of the tax

revenue that we collect off of them.

Dr. JACOBS. They do, and, you know, it is an interesting point

you raise because in one of the budget hearings we have at the legislature in New Jersey, someone asked me that very question. They

said, Dr. Jacobs, you are advocating people stopping smoking.

What happens if they all stop and the hundreds of millions of revenue we have are gone? What are you saying about that?

Well, listen, you are talking to the chief public health officer in

the State. My goal is to stop people from smoking. If we do it, you

will have to find the money some place else, but you are never

going to get me to say we are going to encourage people to keep

smoking because we need the money. That is simply not a balance

we can have.

That is not to say that the revenue isn’t put to important uses.

It is. But you don’t use money to fund the functions of government

by going ahead and killing people who are actually using that particular substance. So I think you cannot make that argument.

Mr. BURGESS. Well, on the issue of using every tool in the arsenal to promote smoking cessation, should we earmark a portion of

the funds that we collect from the tobacco companies to really aggressive steps toward alleviating that burden of addiction from the

47 million people who are so addicted? We have new medications

such as Chantix, the new medication that is out there that apparently has the ability to block at the receptor level, so a very powerful tool now that is within the hands of practitioners.

Yet I will tell you, as a practitioner, as an OB/GYN practitioner,

if I told someone they need to stop smoking, very rarely would I

be able to get them into a program that their insurance company

would participate with them and lead them to a state of smoking

cessation.

So to say to the smoking public we want you to stop and not provide them the tools to stop when we are collecting money from the

company that we want to help them stop purchasing, it just seems

to me that we should really be digging down and aggressively promoting smoking cessation activities rather than having the FDA

regulate tobacco.

Again, I raise the question that was partly in jest, but partly, if

we are talking about a delivery system, crystal meth is—I mean it

is an ideal delivery system if your goal is to get high from methamphetamine. They don’t rely on any penumbra of advertising acVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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tivities. They just simply make a much more addictive product, put

it out there, and it sells itself.

Well, why don’t we do something to help break that cycle of addiction, and rather than focusing on the FDA regulating tobacco,

why don’t we put those monies toward smoking cessation activities? It would seem to be a much more judicious use of our time

and effort.

We just gave the FDA enormous new power. Probably not in the

last 40 years has the FDA had the tools at their disposal that we

just gave them last month, and now we are going to saddle them

with something that is virtually impossible. And on top of that, it

just thwarts their mission at every turn.

Mr. BONNIE. Well, I think that—No. 1, I don’t think either of

these things are mutually exclusive. I think we should be doing

both. And No. 2, I don’t share your philosophy that the FDA is

somehow outgunned in all of this or underresourced. If they are

underresourced, then I think that there is a remedy for that in the

Congress.

If you have a Food and Drug Administration that has a goal and

a mission, then they have to be adequately resourced and funded

to do that goal. And if they are not adequately funded and

resourced, then it is, I think, the responsibility of the Congress to

see to it that they are. Not just in this, but in everything else they

do.

Mr. BURGESS. Correct, but, Doctor, their mission is to see that

the drug supply and the food supply in this country is safe, that

drugs are safe and effective. You can’t argue that nicotine is ever

going to be safe. It is always effective in that it causes addiction,

but it is never going to be safe.

Mr. BONNIE. Well, I don’t disagree with that. I don’t think it is

ever going to be safe in the present form certainly. And I don’t

know what the future will bring in terms of nicotine therapy, but

neither do you. We just don’t know.

Mr. BURGESS. I would be willing to live without it as a country.

That is a trade-off I would readily accept.

Mr. BONNIE. But I don’t know that at this stage of the game that

we can make the kind of choice, particularly the comparison with

crystal meth. Crystal meth, of course, is not a legal product. I know

you are saying this in jest, but this is not a legal product. Tobacco

cigarettes are a legal product. They are sold by legal outlets after

being manufactured legally in the United States, with certain age

groups excepted.

That being the case, there is a responsibility, if you are authorizing the sale in a legal structure, to at least have some relatively

fair level playing field between those who are looking to improve

the public’s health by reducing consumption and those who have a

corporate responsibility to increase consumption. And that is not a

level playing field now.

Mr. PALLONE. We are 2 minutes over so I will—let me move on.

Mr. BURGESS. But Mr. Bonnie sat here faithfully——

Mr. BONNIE. All right, quick points. Obviously the regulatory criteria would be different under this bill and not safe and effective.

There is no reason that a single agency can’t have different responsibilities where the regulatory criteria are different in order to deal

59

with different types of social problems. And I do think that a public

health agency’s mission could accomplish both of those things.

Mr. BURGESS. But it could just as well be accomplished by the

Federal Trade Commission and not even come under the preview——

Mr. BONNIE. Well, I think a public health agency like the FDA

has the public health expertise to do it that the FTC would not

have. Second, on the dependency on the money, which I think you

are right, that this is one of the problems of relying upon the tobacco excise taxes to fund other social programs.

I think we would never end up reducing smoking substantially

overnight and presenting this problem of getting off the addiction

that public agencies have to tobacco revenues. It would obviously

be over a longer period of time if we are aggressively implementing

a policy to reduce the prevalence of smoking. And clearly State

agencies can project what the revenues and can become less dependent on.

Mr. BURGESS. I don’t disagree with him, but I think it would be

a lot more aggressive——

Mr. PALLONE. Gentlemen, we are up to 3 minutes. I got to cut

you off here, gentlemen. Let us move on to the next question. Mr.

Engel of New York.

Mr. ENGEL. Well, thank you, Mr. Chairman. I want to thank you

for holding this hearing. It is very important, and I am proud to

be a cosponsor of this bill. It just boggles my mind that so many

people still don’t understand the damage that they do to their

health and their life by smoking. And I think it just makes sense

to give the FDA the broad regulatory authority over manufacturing, distribution, and marketing of the use of tobacco products. I

just think it is good, plain common sense, and we ought to pass

this bill forthwith.

Mr. Bonnie, this book that we have here, the IOM discusses some

of the concerns raised by certain portions of the public health community, including some we will hear in our next panel of witnesses.

The committee outlines of the concerns, and I am going to quote

it. It is that quote that ‘‘the proposed regulatory framework making

reduced exposure or reduced harm claims in section 911 is too demanding and may impede the development of reduced exposure

products by stifling innovation and retarding competition with safe

products.’’

And that is a quote; however, ultimately the IOM concludes, and

I am going to quote it again ‘‘the fears about this legislation are

overstated and that Federal tobacco product regulation is an essential element of the long-term strategy for achieving substantial reductions in tobacco use, in tobacco-related morbidity and mortality.’’ That is a quote, so you came to that conclusion even after

looking at the other side. So can you please explain how and why

the IOM reached its conclusion?

Mr. BONNIE. All right, so the IOM, as you quoted, considered the

objections that have been raised to giving the agency Federal regulatory authority. And again I want to emphasize that there is a

whole series of aspects of this bill that do not involve—that give

the agency authority over the manufacture, marketing, and distribution of these products, that do not involve the issue of supVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00065 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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posed risk reduction products and that are essential components of

a strategy designed to reduce tobacco use.

Again I mention the issue of strengthening warnings and regulating the retail environment. Those are very, very important parts

of this bill.

With regard to the issue of regulation of supposedly reduced risk

products, the committee consulted not only the members who have

economics background, but actually consulted other economists to

think about what the potential incentive effects could be for adopting a regulatory program, such as that is envisioned in the bill in

light of the criteria.

And the argument has been that the criteria by requiring scientific evidence to support the claims that they want to make, that

the criteria are so demanding that it would lock in benefits that

some companies may now have, and it would discourage competition because of what would have to be done in order to substantiate

those claims. The committee’s view was that the claims need to be

substantiated in order to avoid the kind of disaster that we had

with regard to the light and low tar cigarettes in the past where

people were mislead into believing that they were actually smoking

a safer product.

So substantiation of the claims is a non-negotiable item. They

should be substantiated, or they should not be made, and then the

issue is well how demanding is that going to be in terms of encouraging innovation. And the committee’s conclusion was that actually

this might liberate more competition, particularly by niche small

companies that were actually trying to develop these products rather than deter it.

Mr. ENGEL. Thank you. Let me ask you about another recommendation that the committee has recommended. All insurance,

managed care, and employee benefits, including Medicare and Medicaid, cover reimbursement for effective smoking cessation programs as a lifetime benefit. Did the committee look at the cost associated with this recommendation?

Mr. BONNIE. I think yes. With regard to the recommendations

about prevention and cessation activities, I think that here is a situation where in every case when you look at the cost effectiveness

of the intervention to reduce prevalence by reducing initiation and

my promoting cessation. The public health benefits are so astounding for doing so that they do, in every case, substantially outweigh

the costs of actually engaging in these activities.

And cessation is actually, as Congressman Burgess said earlier,

the benefits of cessation are very, very, well established if you can

actually increase the demand for cessation and to provide the reimbursement that people need in order to be able to do it. It is the

most undeveloped part of our tobacco control strategy. So we definitely looked at the costs of those interventions.

Mr. ENGEL. Thank you. Makes sense to me. Dr. Jacobs, I am

wondering if I can ask you one quick question. Is there anything

in this bill that would impede the progress of States in their attempts to decrease the prevalence of tobacco use?

Dr. JACOBS. I don’t think so. I think the bill itself will, of course,

give us more tools in terms of having the Federal Government

weigh in on this issue in a more level comprehensive way, so that

61

those States that don’t have to begin at ground zero. You have already set a floor of regulation, which you can, if you need to, you

can add to and build on. I think that would be the main value for

us.

Mr. ENGEL. OK, thank you very much. Thank you, Mr. Chairman.

Mr. BUYER. Mr. Chairman, in a question I had for Mr. Bonnie

in the discussion with regard to harm reduction strategy, we had

the discussion about reduced risk products and components and the

need to educate about alternatives. I had asked the question on

sampling but never received a response with regard to whether

sampling should be permitted or not. And I would ask that he address that. Is that permitted, Mr. Chairman?

Mr. PALLONE. Let me say the following. I didn’t realize that Mr.

Engel still had the time.

Mr. ENGEL. No, I am finished, Mr. Chairman.

Mr. PALLONE. You are? Thank you. Now, you want to ask an additional question?

Mr. BUYER. No, what I am asking, Mr. Chairman, is with regard

to the ban on sampling that is in the bill, I had asked Mr. Bonnie

about sampling, and he was not responsive to that. And I had

asked that he be given time to be responsive.

Mr. PALLONE. If you would quickly, because we have to move on.

Mr. BONNIE. All right. Well, I think actually it will be very quick

because the provision of the bill that you are mentioning is what

now? What is the provision of the bill?

Mr. BUYER. That does not permit sampling as part of a harm reduction strategy. You testified that we should, with regard to regulatory scheme or schematic, permit alternatives out there with regard to products and components for people to transition from cigarettes to something else. If we are going to do that, shouldn’t we

permit sampling so they know what to go toward?

Mr. BONNIE. Mr. Chairman, I would be happy to respond to this

question in writing afterwards.

Mr. PALLONE. Sure, that would be great. And let me mention

to——

Mr. BUYER. We still don’t get an answer.

Mr. PALLONE. Well, he is going to——

Mr. BONNIE. Well, the committee actually did not address this

question at all.

Mr. PALLONE. Yes, we would be happy to have you——

Mr. BONNIE. And I would be happy to do it on my own in writing.

Mr. PALLONE. And let me also mention that you may get additional questions from other committee members within the next 10

days or so that we would ask you to respond to as well. Thank you

both. I apologize to Dr. Jacobs. I didn’t get an opportunity to talk

to you at all today because I would have liked that opportunity.

But I came in here. It has been real busy, so hopefully I will give

you a call, and I can come to Trenton in the near future.

Dr. JACOBS. Any time, Mr. Chairman.

Mr. PALLONE. Thank you. Thank you, both. And I would ask the

next panel to come forward. OK, I think we are ready to begin. I

want to thank you all for being here. Let me just introduce everybody. I will start on my left. I guess there is a slight change beVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00067 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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cause Dr. Blum maybe has to leave early. First we have Dr. Alan

Blum, who is a professor, and Wallace Endowed Chair in Family

Medicine at the College Community Health Sciences for the University of Alabama, where he is also director of the Center for

Study of Tobacco in Society. And then we have Dr. Risa LavissoMourey, who is president and CEO of the Robert Wood Johnson

Foundation in Princeton, New Jersey. And then we have Scott

Ballin who is an attorney, steering committee member for the Alliance for Health, Economic, and Agricultural Development in Washington. Mr. James Winkler, general secretary of the General Board

of Church and Society for the United Methodist Church. Mr. Henry

Amour who is president and CEO of the National Association of

Convenience Stores, and Dr. Jack Hemmingfield, who is vice-president for Research and Health Policy, Piney Associates in Bethesda,

Maryland. And then last is Mr. William Corr, who is executive director of the Campaign for Tobacco-Free Kids. And again I would

say we ask you to limit your comments to 5 minutes. Your written

statements will be made part of the record in their entirety, and

we may ask additional questions in writing for you afterwards

within 10 days or so. So we will start with Dr. Blum.

STATEMENT OF ALAN BLUM, M.D., PROFESSOR, WALLACE ENDOWED CHAIR AND DIRECTOR, THE CENTER FOR STUDY OF

TOBACCO, SOCIETY, COLLEGE OF COMMUNITY HEALTH

SCIENCES, UNIVERSITY OF ALABAMA

Dr. BLUM. Thank you, Mr. Chairman, members of the committee.

The mission of the FDA is to ensure the safety of medications that

treat disease, not substances that cause it. I feel strongly as a practicing family physician who has devoted the past 30 years to curbing the smoking pandemic, perhaps a longer continuous period

than anyone else in this room, that an overstressed FDA is the

wrong agency at the wrong time to regulate tobacco products.

And I am proud this afternoon to report that yesterday the congress of delegates of the American Academy of Family Physicians,

the largest subspecialty medical organization in the United States,

considered the arguments against and for the bill and decided to

withdrawal its endorsement of this bill, pending strengthening and

amendments.

By having to promulgate manufacturing and health standards for

cigarettes under H.R. 1108, the FDA will be communicating the

perception that cigarettes are now safer to smoke. Since smoking

prevalence is directly proportional to the degree of perceived harm

from smoking, FDA sanction of cigarettes may lead to an increase

in smoking prevalence.

The tobacco industry will most certainly take advantage of this

bill to tell consumers through TV, newspapers, and the Internet

that cigarettes are now regulated by the same agency that oversees

our food and medicine.

Indeed, Philip Morris, maker of the world’s top selling cigarette,

Marlboro, is already testing the waters. It is setting a new standard for chutzpah by enlisting the Nation’s doctors and spreading

the company’s deceitful propaganda. For the first time in more

than half a century, a cigarette maker is communicating directly

to physicians by means of personal letters offering to supply unlimVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00068 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
63

ited copies of ‘‘If You Decide to Quit Smoking’’ a 52-page booklet

that avoids mention of the word addiction, contains a total of three

sentences that refer to diseases caused by smoking, and includes

17 color photographs, all of healthy, smiling people, and none of

persons made ill from smoking or of their diseased hearts or lungs.

Television ads for Philip Morris’s Youth Smoking Prevention

Campaign have been condemned as cynical and ineffective by the

very health organizations that have joined with Philip Morris in

backing this bill. Yet the company touts this program and its recruitment of college students at career fairs on university campuses

across the country and half-page ads such as this in the campus

newspaper that I am from, even though the only jobs it offers these

students are on the Marlboro sales team, delivering fresh cigarettes

to supermarkets, convenience stores, pharmacies, and bars.

A student at one of these career fairs told me that Philip Morris

is a great company. They don’t just sell cigarettes. They help prevent smoking.

Such tactics aimed at burnishing the company’s nicotine-stained

image among doctors, parents, college students, and university officials will flourish with the enactment of this bill. FDA regulation

of tobacco products under H.R. 1108 would provide an unprecedented, unmerited legitimacy to cigarette makers, sending the message to consumers that cigarettes, however problematic, are now

Government sanctioned.

William Godshall, the most effective tobacco control advocate

ever to work for the American Cancer Society, cites the more than

400 cigarette brand products on the U.S. market today, each with

differing amounts of chemical additives and thousands of poisons

in the smoke. He rightly questions the feasibility of correlating

smoking-related deaths and diseases with the brands of cigarettes

consumed, which the FDA would have to do if it is to make any

valid assessment and recommendation about individual tobacco

products.

As Dr. Michael Siegel at Boston University’s School of Public

Health has pointed out, the public is simply not aware that there

are over 4,000 poisons in cigarette smoke, including more than 40

cancer causers. If a consumer were informed that one such poison

or two carcinogens had been reduced or removed from a cigarette

brand, as Philip Morris intends to do, then he or she is going to

infer that the problem is being taken care of or even solved. This

ignores the dozens of other cancer causers in the cigarette and the

other diseases cigarettes cause.

In short, there is no evidence that tinkering with the levels of

various components of cigarette smoke will result in a safer product, yet this is precisely the strategy that Philip Morris is counting

on through H.R. 1108 to perpetuate the myth that research can

discover a safe cigarette.

Assisted by the University of Virginia and Duke University,

which have taken over $40 million from Philip Morris, the company

is on track in its plan to turn back the clock half a century to the

Frank Statement to Cigarette Smokers issued by the tobacco industry in 1954, which pledged aid and assistance to the research effort

into all phases of tobacco use and health.

64

At this year’s annual shareholders meeting of Philip Morris, company CEO Louis Camilleri praised this bill and promised that the

company’s new $350 million research center will solve societal

problems raised by tobacco.

FDA regulation, a new safe cigarette research center, lucrative

research grants to a docile, academic community are the sheep’s

clothing that this wolf has donned to deceive the public and to ensure Marlboro’s continued sale success.

Does anyone with even a rudimentary knowledge of public health

believe in the wisdom of yet another quest for a safe cigarette? The

only safe cigarette is an invisible cigarette.

Tobacco control advocate David Sweanor goes further, arguing

that Philip Morris is trying to preserve the status quo by preventing effective competition from noncombustible tobacco products.

Lastly, primary prevention, not taking up cigarettes in the first

place, is universally agreed upon as the answer to end the tobacco

pandemic. Reducing demand through paid mass media education is

the cornerstone of primary prevention, yet nothing in this bill addresses or encourages major multimedia anti-smoking campaigns.

Indeed, by creating the impression that the cigarette pandemic is

being addressed by the Federal Government, this bill could be a

disincentive for State and local governments to devote additional

anti-smoking resources. We need to fight smoke with fire, not symbols, not ineffective bills crafted with the secretive input from

America’s biggest cigarette company.

This bill is a godsend for Philip Morris. No one else will benefit.

[The prepared statement of Dr. Blum follows:]

STATEMENT OF ALAN BLUM, M.D.

The mission of the Food and Drug Administration (FDA) is to ensure product safety and to approve medications that treat disease, not substances that cause it. By

all accounts, the FDA is struggling with the challenge of regulating an expanding

universe of products and threats. It is the wrong agency at the wrong time to undertake oversight of tobacco products.

By having to promulgate health standards for cigarettes, the FDA will be communicating the perception that they are now safer to smoke. Thus H.R. 1108 will increase doubt among consumers that cigarette smoking is truly injurious and lethal.

The tobacco industry will most assuredly take advantage of this bill to remind

consumers through the broadcast and print media and the internet that cigarettes

are now regulated by the same agency that oversees the safety of our food and medicine.

Industry leader Philip Morris, maker of the world’s top-selling cigarette, Marlboro,

is already testing the waters. It’s setting a new standard for chutzpah, by enlisting

the Nation’s doctors in spreading the company’s deceitful propaganda. For the first

time in more than half a century, the cigarette giant is communicating directly to

physicians by means of personal letters offering to supply their waiting rooms with

unlimited quantities of If you decide to quit smoking—-a 52-page booklet that avoids

mention of the word ‘‘addiction,’’ contains a total of three sentences that refer to diseases caused by smoking, and includes 17 color photographs, all of healthy, smiling

20-somethings and none of persons made ill from smoking or of their diseased

hearts and lungs.

TV ads for Philip Morris’ Youth Smoking Prevention campaign have been rightly

condemned as cynical and ineffective by some of the very health organizations that

have joined with Philip Morris in backing this bill. Yet the company touts this program in its recruitment of college students at career fairs on university campuses

across the country (as well as on its Web site www.cantbeattheexperience.com), even

though the only jobs it offers these students are in the Marlboro sales force, delivering fresh cigarettes to supermarkets, convenience stores, pharmacies, and bars.

Such tactics aimed at burnishing the company’s nicotine-stained image among

doctors, parents, college students, and university officials will flourish with the enVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
65

actment of this bill. FDA regulation of tobacco products under HR 1108 would provide an unprecedented and unmerited legitimacy to cigarette makers and would

send the misleading message to consumers that cigarettes, however problematic, are

now government-sanctioned.

William Godshall, perhaps the most knowledgable and effective tobacco control

advocate ever to work for the American Cancer Society, sees a parallel between the

countless medications and food products overseen by the FDA and the more than

400 cigarette brand variations on the US market, each with differing amounts of

scores of chemical additives and thousands of poisons in the smoke. He rightly questions the feasibility of correlating smoking-related deaths and diseases with the

brands of cigarettes consumed, which the FDA would have to do if it is to make

any valid assessments and recommendations about individual tobacco products.

The public is not generally aware that there are over 4000 poisons in cigarette

smoke, including more than 40 cancer-causers. If a consumer is informed that one

such poison or carcinogen has been reduced or removed from a cigarette brand, then

he or she is going to infer that the problem is being taken care of or even solved.

This ignores the dozens of other cancer-causers in that cigarette. In short, there is

no evidence that tinkering with the levels of various constituents of tobacco smoke

will result in a safer product.

Neither the technology to remove carcinogens from cigarette smoke nor the

science to prove that the removal of any toxin from cigarette smoke reduces mortality yet exists. Such studies would take decades to detect any reduction of harm from

tobacco use. Moreover, it would be highly unethical to conduct such ongoing research on persons who smoke without providing constant cessation interventions.

Having served as a member of the University of Alabama Institutional Review

Board, which oversees research protocols to ensure the protection of human subjects,

I cannot imagine that prospective comparison studies of different cigarettes would

be approved by any legitimate scientific institution.

Yet this is precisely the strategy Philip Morris is counting on to perpetuate the

myth that research can discover a safe cigarette. Assisted by the University of Virginia and Duke University, which have thus far accepted over $40 million from the

manufacturer of Marlboro in the past year, Philip Morris is on track in its plan to

turn back the clock half a century to the ‘‘Frank Statement to Smokers’’ issued by

the tobacco industry (in reaction to the myriad scientific studies implicating smoking in a host of diseases), which pledged ‘‘aid and assistance to the research effort

into all phases of tobacco use and health.’’

In his remarks to shareholders at this year’s annual meeting of Philip Morris,

Louis Camilleri, ceo of its parent company, boasted of his support of this bill and

promised that the company’s new $350 million research center in Richmond will

seek to solve ‘‘societal problems raised by tobacco.’’ FDA regulation, the research

center, and related grants to universities and medical schools make up Philip Morris’ formula for Marlboro’s continued sales success.

Does anyone with even a rudimentary knowledge of public health seriously believe in the wisdom of yet another quest for a safe cigarette? Philip Morris has

played this game before with its earlier cigarette research centers in the 1950s and

1970s (One of the most complete and fully integrated facilities for tobacco research

in existence anywhere in the world. Its every detail has been designed for translating the scientific theories and findings of basic research into practicalities.).

It is deja vu all over again, and proponents of this bill are wittingly or unwittingly

aiding and abetting the biggest member of Big Tobacco in institutionalizing junk

science.

Philip Morris’ endorsement of both the FDA bill and the Institute of Medicine report supporting FDA regulation is eerily reminiscent of the Tobacco Industry Research Committee’s Frank Statement of 1954: ‘‘We accept an interest in people’s

health as a basic responsibility, paramount to every other consideration in our business...We always have and we always will cooperate closely with those whose task

it is to safeguard the public health...In charge of the research activities of the Committee will be a scientist of unimpeachable integrity and national repute. In addition there will be an Advisory Board of scientists disinterested in the cigarette industry. A group of distinguished men from medicine, science, and education will be

invited to serve on this Board. These scientists will advise the Committee on its research activities. This statement is being issued because we believe the people are

entitled to know where we stand on this matter and what we intend to do about

it.’’

And in 2007: ‘‘Philip Morris USA believes regulation of tobacco products by the

FDA could potentially create a new framework within which manufacturers can

refocus their efforts to pursue reduced harm products.’’

66

Since smoking prevalence is directly proportional to the degree of perceived harm

from smoking, FDA sanction of cigarettes will lead to an increase in smoking prevalence compared to what would have occurred in the absence of this legislation.

Primary prevention—-not taking up cigarettes in the first place—-is universally

agreed upon as the answer to end the devastating health toll caused by smoking.

Reducing demand through paid mass media education is the cornerstone of primary

prevention. Nothing in this legislation addresses or encourages major multi-media

anti-smoking campaigns. Indeed, by creating the impression that the cigarette pandemic is being addressed by the Federal Government, the bill could be a disincentive for state and local governments to devote additional resources.

We need to fight smoking with fire, not symbolic, tokenistic regulation. This bill

is a godsend for Philip Morris. No one else will benefit.

Mr. PALLONE. Let me just mention to everyone that we have a

15-minute vote and then two 5-minute votes. So we probably have

time for Dr. Lavizzo-Mourey, and then we are going to have to take

a recess. So I recognize Dr. Lavizzo-Mourey.

STATEMENT OF RISA LAVIZZO-MOUREY, M.D., PRESIDENT AND

CEO, ROBERT WOOD JOHNSON FOUNDATION, PRINCETON, NJ

Dr. LAVIZZO-MOUREY. Thank you, Mr. Chairman, Ranking Member Deal, and members of the subcommittee. Thank you for the opportunity to testify on the need for H.R. 1108, the Family Smoking

and Prevention Control Act.

I am Dr. Risa Lavizzo-Mourey, the president and CEO of the

Robert Wood Johnson Foundation, which is the largest philanthropy in the country, devoted exclusively to improving the health

and health care of all Americans. For more than a decade, the Robert Wood Johnson Foundation has worked successfully to reduce

the prevalence of tobacco use using a two-pronged approach.

First we have focused attention on policies and programs that

are most effective, and second we have focused attention on actionoriented evidence-based policies aimed at preventing people from

starting to smoke, helping current smokers to quit smoking, and

protecting nonsmokers from the serious health harms of secondhand smoke.

Our Nation has made significant progress in reducing tobacco

use, especially at the State and local level. However, tobacco is still

the leading cause of preventable death in this country. And we

have heard the statistics this morning. I won’t go into them, but

they are in my written testimony.

Most troubling is that our progress in reducing smoking has

stalled among youth and adults in recent years. The good news,

however, is that there is strong consensus among our Nation’s public health experts on what actions are needed. Both the Institute

of Medicine, as we have heard already, and the President’s Cancer

Panel have reached the same conclusions in their issued reports

this year.

An effective national strategy to reduce tobacco use must include

a dual approach. First, stepped-up initiative at the local and State

level, such as smoke-free air laws, tobacco price increases, public

education and cessation practices preventing kids from smoking

and protecting nonsmokers, and helping smokers quit.

And second, the opportunity that is before you today: enactment

of Federal legislation granting the FDA authority over tobacco

products.

67

Mr. Chairman, the FDA regulation is especially needed to address the continuing problem of tobacco marketing that appeals to

children and misleads the public about the health risks and undermines the efforts of smokers to quit. Unfortunately, there is abundant evidence that the tobacco industry continues to engage in

harmful practices, and I want to cite just a few examples that demonstrate how the industry continues to appeal to children and target vulnerable populations.

We all remember the 1998 State Tobacco Settlement and the tobacco industry’s promises to stop marketing to children. What has

happened since then? Well, since 1998, the total marketing expenditures by the tobacco industry have doubled, reaching $13.4 billion

in 2005, according to the FTC. This is nearly $37 million a day to

market addictive and deadly products.

Cigarette advertising increased in youth-oriented magazines, as

frequently as 2 years after the settlement. And even today, tobacco

companies continue to run ads in magazines portraying smoking as

cool and glamorous.

The settlement, as you know, did not restrict in-store advertising

and tobacco companies know that 75 percent of teens visit a convenience store at least once a week and therefore they have increased their advertising and promotions in these stores. Science

tells us that this kind of marketing works. In fact, a study supported by the Robert Wood Johnson Foundation and published this

May in the journal called Archives of Pediatrics and Adolescent

Medicine has found that the more the cigarette industry markets

to teens, the more they are exposed to cigarette advertising in retail stores, the more likely they are to smoke. The study also found

that restricting these retail marketing practices would reduce

youth smoking.

In addition, the tobacco companies have regularly introduced

new candy, fruit-flavored products. For example, recently R.J. Reynolds introduced a flavored version of Camel with very enticing

names. These kinds of youth-oriented practices work. We know

that they work and the tobacco companies have a long history of

targeting other specific populations, most recently, marketing to

women and girls as we have already heard with Camel No. 9, the

same kind of notorious efforts that we have long eschewed. Camel

No. 9 continues the tobacco industry’s long history of targeting

women and girls beginning back in 1968 with ‘‘You’ve come a long

way, baby.’’ I can tell you as a physician, even though they say

smoking is glamorous, there is nothing at all glamorous about the

increased death rates from lung cancer that have occurred as a result of this legacy of marketing to girls and women.

The tobacco companies have similarly targeted African-Americans and Hispanics, especially children in these communities, and

one of the most egregious and recent examples is Kool Mix, a marketing campaign that used a hip hop theme.

Mr. Chairman, let me just conclude by saying the FDA is uniquely qualified to achieve the goals because of its regulatory experience, the scientific knowledge and public health mandate this agency has. Thank you.

[The prepared statement of Dr. Livizzo-Mourey follows:]

68

TESTIMONY OF RISA LAVIZZO-MOUREY, M.D.

Chairman Pallone, Ranking Member Deal, and Members of the Subcommittee,

thank you for this opportunity to testify about the need for H.R. 1108, the Family

Smoking Prevention and Tobacco Control Act. I am Dr. Risa Lavizzo-Mourey, President and CEO of the Robert Wood Johnson Foundation, the Nation’s largest philanthropy devoted exclusively to improving the health and health care of all Americans.

For more than a decade, the Robert Wood Johnson Foundation has worked successfully to help reduce the prevalence of tobacco use through a two-pronged approach. First, we have funded research to learn which policies and programs are

most effective. Second, we have focused attention and fostered action on evidencebased policies aimed at preventing people from starting to smoke, helping current

smokers quit and protecting non-smokers from the serious health harms of secondhand smoke.

Tobacco use is still the leading cause of preventable death in our country—causing

more than 400,000 preventable deaths in the United States each year, sickening

millions more, reducing the productivity of our workforce and undermining our Nation’s economic competitiveness due to $100 billion a year in tobacco-related health

care bills.

Today we are asking you, the Congress, and the Federal Government to provide

the leadership needed to address this significant threat to the health of our Nation.

One of the most important things you can do now would be to give the FDA authority over tobacco products.

Our country has made significant—although by no means sufficient—progress, especially at the state and local level. A growing number of states and localities have

increased taxes on tobacco products, enacted smoke-free air laws that cover all

workplaces and public places, and funded tobacco prevention and cessation programs. Collectively, we have also made great strides in getting effective tobacco cessation treatments into clinical practice and through state and national quitlines,

and many health and health care policy changes have boosted access to and use of

evidence based treatments.

The best measure of progress is that fewer Americans, both youth and adults, are

smoking. Youth smoking rates have declined by 37 percent since peaking in 1997,

and adult smoking rates have steadily declined as well.

But we have not yet turned the corner on this pervasive health threat which continues to take an enormous toll in health, lives and money in our country. Nearly

one in four high school students still smokes and nearly 21 percent of all Americans

remain addicted to this deadly product. Most troubling of all is the fact that our

progress in reducing smoking has stalled among both youth and adults in recent

years.

Our challenge today, Mr. Chairman, is to resist complacency and for all levels of

government to redouble efforts to reduce tobacco use. The good news it that we

know what to do, and there is a strong consensus among our Nation’s public health

experts about the science-based actions that must be taken. As both the Institute

of Medicine and the President’s Cancer Panel recommended in landmark reports

issued this year, this strategy must include both stepped-up initiatives at the state

and local level and enactment of Federal legislation granting the FDA authority

over tobacco products.

As the IOM concluded, ‘‘Incremental reforms’’ will not end the Nation’s tobacco

problem. A more fundamental shift must occur. It is time for Congress and other

policymakers to change the legal structure of tobacco policy, thereby laying the foundation for a strategic initiative to end the Nation’s tobacco problem—that is, reducing tobacco use to a level that is insignificant from a public health standpoint.’’

These expert conclusions regarding FDA authority are critical.

Mr. Chairman, there are many reasons why we need FDA regulation of tobacco

products in addition to and in support of the ongoing efforts to reduce tobacco use

at the state and local government. I will name two:

• FDA authority over tobacco has a high probability of stopping tobacco marketing

that targets our children and undermines the effective prevention measures in

states and communities.

• FDA authority over tobacco has a high probability of stopping tobacco industry

practices that undermine efforts to help smokers quit. These include the manipulation of tobacco products to make them more addictive and the deceptive marketing

of light and low-tar cigarettes and other so-called ‘‘reduced risk’’ products.

Mr. Chairman, we all know that the tobacco companies continue to engage in

these harmful practices today.

69

While the 1998 tobacco settlement, known as the Master Settlement Agreement

or MSA, curtailed some tobacco marketing to children, the MSA addressed less than

20 percent of all tobacco marketing expenditures. Federal Judge Gladys Kessler

found last year that tobacco companies continue to market in ways that appeal to

young people and continue to recruit children as new tobacco users. In Judge

Kessler’s words: ‘‘Despite the provisions of the MSA, Defendants continue to track

youth behavior and preferences and market to youth using imagery which appeals

to the needs and desires of adolescents. Defendants are well aware that over 80 percent of adult smokers began smoking before the age of 18, and therefore know that

securing the youth market is critical to their survival.’’

The tobacco companies have circumvented MSA restrictions by dramatically increasing overall marketing expenditures and constantly finding new ways to market

their products, many of which appeal to kids. Between 1998, the year of the MSA,

and 2005, the last year for which data is available, the major tobacco companies

nearly doubled their total marketing expenditures from $6.9 billion to $13.4 billion,

according to the Federal Trade Commission. That is nearly $37 million each and

every day—much of it appealing to kids.

There are many examples of how the tobacco companies continue to market in

ways that appeal to children:

• The MSA did not place specific restrictions on advertising in print media, such

as magazines. As a result, cigarette advertising increased in youth-oriented magazines in the two years after the MSA, and tobacco companies continue to place magazine ads that portray smoking as cool and glamorous.

• The MSA did not restrict in-store advertising. Knowing that 75 percent of teens

visit a convenience store once at least once a week, the cigarette companies have

increased their advertising and promotions in and around these stores. In fact, retail marketing now makes up about 90 percent of all cigarette marketing expenditures, according to the Federal Trade Commission. Science tells us this kind of marketing influences youth behavior. A study supported by the Robert Wood Johnson

Foundation and published this May in the journal Archives of Pediatrics and Adolescent Medicine found that the more cigarette marketing teens are exposed to in

retail stores, the more likely they are to smoke. The study also found that restricting these retail-marketing practices would reduce youth smoking.

• While the MSA banned large billboards, it permitted outdoor signs up to 14

square feet in size, even if placed right next to schools or playgrounds.

• Since the MSA, the tobacco companies have regularly introduced new candy and

fruit-flavored tobacco products that clearly are intended as starter products for new

tobacco users, most of whom are children. The R.J. Reynolds company, for example,

introduced new flavored Camel cigarettes with names like Twista Lime, Warm Winter Toffee and Mocha Mint. A 2005 Harvard School of Public Health study concluded, ‘‘Flavored cigarettes can promote youth initiation and help young occasional

smokers to become daily smokers by masking the natural harshness and taste of

tobacco smoke and increasing the acceptability of a toxic product.’’ Survey data reveal that youth are almost twice as likely as adults to be aware of these flavored

products and their advertising, and youth smokers are much more likely than older

ones to have tried them.

Unfortunately, this youth-oriented marketing works. According to the 2005 National Survey on Drug Use and Health, more than 81 percent of youth smokers prefer the three most heavily advertised cigarette brands—Marlboro, Camel and Newport. Numerous studies have found an association between tobacco marketing and

youth smoking initiation and progress to regular use. As the National Cancer Institute found in a 2002 report, ‘‘the conclusion that there is a causal relationship between tobacco marketing and smoking initiation seems unassailable.’’

In addition to targeting youth, the tobacco companies also have a long history of

targeting specific populations that have had historically lower smoking rates, and

that tobacco companies regarded as potential new ‘‘customers,’’ including girls and

women and African American and Hispanic youth.

The most recent example of tobacco marketing to women and girls is R.J. Reynolds’ Camel No. 9 cigarette introduced earlier this year by the same company that

brought us the notorious Joe Camel. The Oregonian newspaper has aptly called

Camel No. 9 ‘‘Barbie Camel.’’. Camel No. 9 comes in a shiny black box with a tiny

pink camel and pink and teal borders. Ads in the most popular fashion magazines

associate Camel No. 9 with everything a teenage girl aspires to be: glamorous, sophisticated and beautiful. And then there are the promotional giveaways: berry lip

balm, cell phone jewelry, cute little purses and wristbands, all in hot pink.

Camel No. 9 continues the tobacco industry’s long history of targeting women and

girls, dating back to the ‘‘You’ve Come A Long Way Baby’’ campaign Philip Morris

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launched in 1968. These campaigns have cynically equated smoking with independence, sophistication and beauty and preyed on the unique social pressures that

women and girls face. The marketing of cigarettes as ‘‘slims’’ or ‘‘thins’’ and later

as ‘‘low-tar’’ and ‘‘light’’ also played into young women’s concerns about weight and

health.

As a physician, I can tell you that there’s nothing glamorous or beautiful about

cancer and heart disease, which have been the main consequences for women. While

death rates for most cancers have declined among women, rates have skyrocketed

for lung cancer. Since 1987, lung cancer has been the leading cancer killer among

women, surpassing breast cancer. Heart disease is the overall leading cause of death

among women, and smoking accounts for one of every five deaths from heart disease. Altogether, more than 178,000 women die of tobacco-related diseases each

year. This is the lethal legacy of the tobacco industry’s targeting of women and girls.

The tobacco companies have similarly targeted African-Americans and Hispanics,

especially children in those communities. One of the most egregious recent examples

is Brown & Williamson’s marketing campaign for Kool cigarettes, called Kool Mixx.

This hip-hop themed campaign featured images of musicians, disc jockeys and dancers on cigarette packs and in advertising. It even included radio giveaways with cigarette purchases.

Again, the evidence is powerful that this targeted marketing works, especially on

children. Take Lorillard’s Newport cigarettes, which have been marketed to African

Americans longer and more heavily than any other brand. While about 42 percent

of African-American adults who smoke prefer Newport, 80 percent of African-American youth smokers prefer this brand.

This marketing has a devastating impact on the health of African Americans.

While African Americans smoke at roughly the same rates as whites, they die at

a higher rater from smoking-caused diseases. African American men bear an especially high burden of death and disease, with lung cancer rates almost 40 percent

higher and average death rates about 30 percent higher than for white men.

The tobacco industry has similarly targeted Hispanic communities. As they have

done with women and African Americans, the industry has sought to associate

smoking with the culture, music and aspirations of the Hispanics and Latinos. One

recent ad campaign for Kool cigarettes featured multicultural images, concerts with

Latino musicians and aspirational slogans such as ‘‘It’s about pursuing your ambitions and staying connected to your roots.’’ It is truly offensive that the tobacco industry would exploit ethnic communities to sell a deadly and addictive product.

Mr. Chairman and members of the Subcommittee, these examples make it abundantly clear why the FDA needs the authority and resources to effectively regulate

tobacco products and their marketing. With the authority that you can give, the

FDA can finally stop tobacco marketing and sales to children; eliminate special flavored cigarettes that appeal to and target youth smokers; prevent tobacco companies from deceiving the public about the health risks of their products and undermining efforts to help smokers quit; and take other necessary steps to protect public

health and save lives. These steps will significantly enhance state and local efforts

to reduce tobacco use and help address the tobacco industry’s targeting of specific

populations, resulting in an excess burden of disease borne by many of the most vulnerable among us. The FDA is uniquely qualified to help achieve these goals because of its regulatory experience, scientific knowledge and public health mandate.

With the powerful public health combination of FDA authority over tobacco products

and enhanced efforts at the state and local level, we can achieve the goal that the

Institute of Medicine has set for us—to eliminate tobacco use as one of the most

pressing public health problems in the United States.

Thank you for your attention to this issue and the opportunity to testify.

Mr. PALLONE. Thank you, and I apologize. We are going to have

to take about half an hour break for the 3 votes and then we will

be back. Thank you all. The committee stands in recess.

[Recess.]

Mr. WAXMAN [presiding]. The subcommittee will come back to

order. Chairman Pallone is managing a resolution on the House

floor and asked me to chair the continuation of the hearing from

this morning.

Mr. Ballin, I think you are next. Is that right?

Mr. BALLIN. Yes, sir.

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Mr. WAXMAN. There is a button on the base of the mic and we

will have the clock going. Of course, all of your full statements will

be in the record and we would like to ask you if you could to keep

to the 5-minute time.

STATEMENT OF SCOTT BALLIN, ATTORNEY, STEERING COMMITTEE MEMBER, ALLIANCE FOR HEALTH, ECONOMIC, AND

AGRICULTURE DEVELOPMENT, WASHINGTON, DC

Mr. BALLIN. Mr. Chairman, it is an honor to be here today. In

some ways I think I have come full circle on this issue. I testified

before this subcommittee in support of FDA oversight way back in

the early part of the 1990s and had the privilege to work with Congressmen Mike Synar and Bob Whittaker at that time, both who

served on this subcommittee and who were the first to introduce

legislation to give the FDA regulatory authority over tobacco products, and I would be remiss if I did not recognize you who I worked

with over the years and your staffs. You have been a leader not

only on this issue but on many other tobacco-related issues, and I

commend you for that continued leadership today as well.

I think I am here supposedly as a minority witness but I would

rather be thought of as a witness for both the majority and the minority because I am here to encourage both parties to work together in crafting FDA legislation that will serve the public health

and establish a regulatory structure that will serve those needs 10

to 15 years down the road. This legislation is long overdue and

Congress needs to act and act soon. FDA is the right agency to regulate tobacco products. I know that some of my colleagues probably

think that our suggestions today with some amendments will detract from the focus of this legislation but I think there are some

things that need to be considered as this subcommittee looks at the

amendments that will have to be addressed by this committee during a markup.

The testimony we have submitted for the record today hopefully

will be of some assistance to members of the committee from both

parties as well as from those from both the tobacco and non-tobacco

States. We have patiently waited 15 years for enacting of this critically important legislation and spending a few more weeks to make

potential improvements would in our opinion be time well spent.

Our organization, AHEAD, was formed as an outgrowth of a

project funded by the Robert Wood Johnson Foundation that

brought public health advocates and growers together in the mid–

1990s to talk about contentious tobacco issues. I personally learned

a great deal from that experience about the critical importance of

dialog and engagement, and if there is anything I want to emphasize today in my testimony, it is that challenging views, opinions

and behaviors as well as listening and looking for opportunities for

changes can have a significant and positive effect on outcomes.

I am not going to go into details as to why this legislation is

needed. We heard a lot of that this morning, and for me personally

and for our organization, AHEAD, oversight by FDA is a given.

AHEAD strongly agrees with much of what has been said and articulated by the other witnesses here today in support of FDA. I

think that where we may have some differences of opinion is how

best to move forward to accomplish our shared goals and objectives.

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My experience over the last several years has led me to conclude

that in addition to giving the agency authority, we also need to

have great engagement between the stakeholders to discuss the

complex issues, debate and dialog those issues which many of those

issues were raised this morning. Some of these discussions can and

will obviously take place at FDA as part of the regulatory process

but even that may take some time, and I strongly support and encourage discussions outside of the legislative process to address

some of these issues as has been done this morning during some

of the discussions and dialogs with this committee.

Good decisionmaking can’t be done in a vacuum and we can’t

merely rely on using the tobacco industry’s past bad behaviors as

an excuse for not challenging or engaging them in the dialog.

Stakeholders need to look beyond their own agenda if for nothing

other than to understand what other factors, both positive and negative, need to be considered. We need more interaction between the

scientific research community, experts in advertising and marketing, agronomists, tobacco and pharmaceutical companies, scientists,

producers as well as the consumer who often gets left out of these

discussions. Today’s environment isn’t just about big tobacco’s past

and potential future abuses. It is also about changing the competitive environment between the tobacco companies, old and new,

pharmaceutical industries and the biotech companies. It is also

about technological advances in making it feasible to reduce and

remove toxins and pesticides from tobacco leaf.

Our suggestions for this legislation are contained in our testimony but I would like to just sort of review them very quickly.

First, we would like to say and suggest that all tobacco and nicotine products be brought under the same umbrella at FDA through

maybe a center on tobacco and nicotine and that there should be

classification panels similar to the medical device panels used to

review combustible products, non-combustible products and therapeutic products. We also suggest regulating products based upon

risks and relative risks and intended uses so that users of tobacco

and nicotine products are fully informed about the products they

use. We also support expanding and upgrading the scientific advisory committee to include experts in agronomy and plant technology, labeling and marketing and consumer affairs. We also

would suggest that there be greater interagency cooperation, and

that was alluded to earlier this morning.

Conspicuously absent from today’s hearings are the tobacco and

the pharmaceutical companies. It would be of great interest to hear

from them publicly and for the record as to where they stand on

a number of the issues pertaining to the FDA regulation. The socalled tobacco industry is no longer the monolithic giant it once

was, and as long as tobacco remains legal, the industry must be

more transparent and accountable in what they do.

Also missing from today’s hearing are the voices of the tobacco

producers who produce the tobacco that goes into tobacco products

and also is used in nicotine products, and I hope that there will be

a time that they can also come to this committee. We also encourage this committee to contact the Agriculture Committee and ask

them to hold some hearings on the importance of agricultural proVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00078 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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duction of tobacco, looking at the health and safety issues related

to that aspect because that will impact FDA regulation.

Mr. Chairman, I would like to thank you in particular for your

leadership on this and we look forward to working with you in the

future.

[The prepared statement of Mr. Ballin follows:]

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Mr. WAXMAN. Thank you very much, Mr. Ballin. I appreciate

your testimony.

Mr. Winkler, I am looking forward to hearing from you.

STATEMENT OF JAMES WINKLER, GENERAL SECRETARY, GENERAL BOARD OF CHURCH AND SOCIETY, UNITED METHODIST CHURCH

Mr. WINKLER. Thank you, Mr. Chairman. I am Jim Winkler, general secretary of the United Methodist General Board of Church

and Society of the United Methodist Church. As you may know, our

denomination is the third largest in the United States with more

than 8 million members in nearly 35,000 local congregations.

I am also chair of Faith United Against Tobacco, a broad-based

coalition of faith leaders. Since it was founded in 2002, Faith

United Against Tobacco has grown to include over 20 national faith

denominations and organizations. In addition to our agency, the coalition includes the Ethics and Religious Liberty Commission of the

Southern Baptist Convention, the National Council of Churches,

the Presbyterian Church USA, the Commission on Social Action of

Reformed Judaism, the Seventh Day Adventists, the American Region of the World Sikh Council, and the Islamic Society of North

America. Other broad-based groups such as Church Women United

and the Health Ministries Association, which represents thousands

of faith community nurses across the country, have also joined

Faith United Against Tobacco.

I appreciate this opportunity to testify in favor of H.R. 1108,

Family Smoking Prevention and Tobacco Control Act, lifesaving

legislation to authorize the Food and Drug Administration to regulate tobacco products. We have made enactment of the tobacco legislation introduced by yourself and Mr. Davis one of our top legislative priorities for this Congress. The legislation is long overdue,

and on behalf of the many members of our faith groups united in

our coalition, I strongly urge Congress to take action now and

enact this critically important legislation with all due speed.

In addition to our national effort to convince Congress to enact

FDA regulation of tobacco, Faith United Against Tobacco has

worked successfully across the country to enact tobacco control

measures such as increased tobacco taxes, full funding of tobacco

prevention programs and smoke-free-workplace legislation. In Indiana in 2005, for example, there was a very serious effort to dramatically cut funding for that State’s landmark tobacco control program. A group of faith leaders led by United Methodist, Southern

Baptist and faith community nurses formed the Hoosier Faith and

Health Coalition and took the lead in preventing these cuts from

happening, which has saved many Hoosiers, particularly children,

from tobacco addiction. Similar collaborations exist in other States

including Alabama, Kentucky, New Jersey, North Carolina, Ohio

and Texas.

Our focus on the Federal level has always been on enacting legislation to give FDA authority over tobacco products. Recently, 24

national faith leaders from our coalition sent a letter to every

Member of the Senate and the House urging support for the FDA

legislation. The signers of this letter represent very diverse groups

including Christian, Jewish, Muslim and Sikh denominations

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whose members include tens of millions of Americans from every

part of the country. I think it is also important to note that the 24

leaders who signed this letter hold widely diverse positions on

other important social and political issues but we are and we will

remain united in our desire to reduce smoking, especially among

children and in our commitment to the enactment of this legislation authorizing the FDA to regulate tobacco products.

Our faith traditions teach us it is morally wrong to know the

good that should be done and not do it. It is also morally wrong

to leave the most impressionable and vulnerable among us, our

children, unprotected from tobacco enticements that confront them

and so we in the faith community believe that those who are called

to positions of leadership and power have a moral imperative to exercise their power to safeguard the men, women and children of

our country from falling into the pitfalls of tobacco abuse.

All members of Faith United Against Tobacco believe that Congress must do a better job of protecting our children from tobacco

addiction and the suffering of tobacco-caused illness and death. As

political leaders, you have an obligation both morally and as guardians of our citizens to act to protect our children and families. You

have the means to curb the cycle of allurement and addiction, of

disease and death caused by tobacco.

Mr. Chairman, I want to thank you especially for your leadership

in this effort. We are happy to work alongside you. Thank you.

[The prepared statement of Mr. Winkler follows:]

STATEMENT OF JAMES WINKLER

Good morning, Chairman Pallone, Representative Deal and Members of the Subcommittee. I am James Winkler, General Secretary of the General Board of Church

and Society of The United Methodist Church. As you may know, The United Methodist Church is the third largest religious denomination in the United States, with

more than 8 million members worshipping in nearly 35,000 local congregations in

the United States.

I am also the Chair of Faith United Against Tobacco, a broad-based coalition of

faith leaders. Since it was founded in 2002, Faith United Against Tobacco has grown

to include over 20 national faith denominations and organizations. In addition to the

General Board of Church and Society of The United Methodist Church, our coalition

includes the Ethics & Religious Liberty Commission of the Southern Baptist Convention, the National Council of Churches in Christ, the Presbyterian Church

(USA), the Commission on Social Action of Reform Judaism, the Seventh-day Adventists, the American Region of the World Sikh Council, and the Islamic Society

of North America. Other broad-based groups, such as Church Women United and

the Health Ministries Association, which represents thousands of faith community

nurses across the country, have also joined Faith United Against Tobacco.

I appreciate this opportunity to testify in favor of H.R. 1108, the Family Smoking

Prevention and Tobacco Control Act, life-saving legislation to authorize the Food

and Drug Administration (FDA) to regulate tobacco products. We have made enactment of the tobacco legislation introduced by Representatives Henry Waxman and

Tom Davis one of our top legislative priorities for the 110th Congress. This legislation is long, long overdue, and, on behalf of United Methodists and the many members of the other faith groups united in our coalition, I strongly urge you to take

action now and to enact this critically important legislation with all due speed.

In addition to our national effort to convince Congress to enact the FDA regulation of tobacco legislation now before you, Faith United Against Tobacco has worked

successfully across the country to enact tobacco control measures such as increased

tobacco taxes, full funding of tobacco prevention programs, and smoke-free workplace legislation. In Indiana in 2005, for example, there was a very serious effort

to dramatically cut funding for that state’s landmark tobacco control program. A

group of faith leaders, led by United Methodists, Southern Baptists, and faith community nurses, formed the Hoosier Faith and Health Coalition and took the lead

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in preventing these cuts from happening, which has saved many Hoosiers, particularly children, from tobacco addiction. Similar collaborations exist in other states,

including Alabama, Kentucky, New Jersey, North Carolina, Ohio, and Texas.

Our focus at the Federal level has always been on enacting legislation to give the

FDA authority over tobacco products. Recently, twenty-four national faith leaders

from our coalition sent the attached letter to every Member of the U.S. Senate and

House of Representatives, urging support for the FDA legislation. The signers of

this letter represent very diverse groups, including Christian, Jewish, Muslim, and

Sikh faith denominations, whose members include tens of millions of Americans

from every part of the country. I think it is also important to note that the 24 leaders who signed this letter widely diverse positions on other important social and political issues. But we are, and we will remain, united in our desire to reduce smoking, especially among children, and in our commitment to the enactment of this legislation authorizing the FDA to regulate tobacco products.

Many Americans now know the terrible statistics about the toll of tobacco on our

families—over 1200 Americans die each day, every day from tobacco use. Another

1200 will die tomorrow; and the day after that; and every single day of the year.

In all, 400,000 Americans die every year from tobacco-caused illnesses; hundreds of

thousands of others suffer every year from tobacco-caused illnesses such as lung

cancer and heart disease; and every day over 1,000 of our children become addicted

to this deadly product.

For us in the faith community, there are tragic faces attached to these frightening

statistics. Every day clergy in our faith groups assist families in burying mothers

and fathers, sisters and brothers who die absolutely preventable and premature

deaths caused by tobacco addiction. And, more often than not, these addictions

began at a young age. We, then, are left with the difficult task of trying to comfort

their grieving survivors. Every one of these people who dies of tobacco use leaves

behind families and friends who miss them very much and suffer their untimely and

tragic loss.

I speak this morning from personal experience. My father, uncle, and brother are

United Methodist clergy. All of them have dealt with church members over the

years who have become addicted to tobacco and each of them have dealt directly

with the negative effects of cancer on their congregations and the families who have

suffered from this product.

Literally, millions of Americans have died before their time, often in their prime—

at the peak of their careers, with a spouse and children at home, and with many

other responsibilities and joys before them. The families of America must not continue to be lured toward a future that is cut short due to lack of knowledge about

the ingredients and addictive nature of tobacco. Men and women deserve to know

the toxic chemicals rolled into every cigarette. Young sons and daughters deserve

to enjoy their youth without being confronted with tobacco marketing tailored to

their age. Like the many Members of Congress from both parties and across the political spectrum who are cosponsoring this legislation, the faith groups in our coalition join America’s public health community in viewing FDA regulation of tobacco

as a critically needed tool to reduce tobacco use. This legislation would allow the

FDA to prevent tobacco companies from adding ever more deadly and addictive ingredients; require larger and more informative health warnings; prohibit candy-flavored cigarettes; prevent tobacco sales to underage children; and limit advertising

and promotion of tobacco products that lure children into a deadly habit. Like many

of you, we find it incredible that the FDA can ensure the safety of everyday items

like cold medicines, cookies, dog food and nicotine cessation products, but has no authority over tobacco, a product that causes more preventable deaths than any other.

The United Methodist Church is unwavering in its declaration to ensure protection for all of God’s children especially from harmful and addictive products. Our

Faith Coalition is simply asking that tobacco products be subject to the same common sense consumer protections that apply to other products. Why should manufacturers of nicotine cessation products that help people quit smoking be subject to

FDA regulation, but not the products that kill over 400,000 Americans every year?

No one wants excessive government regulation. What we are asking for is not overly

burdensome; it would simply assure the protection of consumers, particularly our

children. There is broad consensus in the faith community, both conservative and

liberal, that this product must be regulated, and that is why we support this bill.

We also support this bill for moral and spiritual reasons. Our faith traditions inform us that our bodies are gifts from God and, therefore, should be treasured and

treated with dignity. This means, among other things, that tobacco companies

should not be allowed to entice our children to pollute their bodies. While each adult

person bears responsibility for whether he or she chooses to engage in tobacco use,

responsibility also falls upon those in authority, who have the power to end tobacco

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deception, to end the marketing of these products to children and to significantly

reduce the illness and death that these practices can produce.

Our faith traditions teach us that it is morally wrong to know the good that

should be done and not do it. It is also morally wrong to leave the most impressionable and vulnerable among us, our children, unprotected from the tobacco enticements that confront them. And so, we in the faith community believe that those who

are called to positions of leadership and power have a moral imperative to exercise

their power to safeguard the men, women, and children of our country from falling

into the pitfalls of tobacco abuse.

I find it unconscionable that Congress, knowing the deadly effects of tobacco use,

continues to leave tobacco companies virtually unchecked, left to use their own discretion to determine what carcinogenic chemicals to include in their products. I find

it unconscionable that Congress, knowing that the overwhelming majority of adult

smokers began their habit as minors and without the full knowledge of the dangers

of tobacco would do nothing more than call unfortunate the tobacco companies’ marketing targeted at children.

Almost 10 years ago, in 1998, Congress debated comprehensive tobacco control

legislation but failed to enact anything. In 2004, the Senate overwhelming passed

legislation virtually identical to the bill before you, but it was killed in a conference

committee. And on August 1, the Senate Committee on Health, Education, Labor

and Pensions passed this bill. Throughout this time tobacco companies have continued to spend billions of dollars every year marketing their deadly products to children and, as a result, far too many high school students smoke and far too many

people will die prematurely from tobacco-caused diseases.

All members of Faith United Against Tobacco believe that the United States Congress must do a better job of protecting our children from tobacco addiction and the

suffering of tobacco-caused illness and death. As political leaders, you have an obligation, both morally and as guardians of our citizens to act to protect our children

and families. You have the means to curb the cycle of allurement and addiction, of

disease and death, caused by tobacco. You owe it to the families of America to do

so. We, therefore, urge you to act quickly to enact H.R. 1108, bipartisan legislation

to provide the Food and Drug Administration authority to regulate tobacco products.

Chairman Pallone, Representative Deal, and other Members of the Committee, I

thank you for permitting me to testify this morning. I will be happy to entertain

any questions.

Mr. WAXMAN. Thank you very much, Mr. Winkler. I appreciate

your testimony.

Mr. Armour.

STATEMENT OF HENRY ARMOUR, PRESIDENT AND CEO,

NATIONAL ASSOCIATION OF CONVENIENCE STORES

Mr. ARMOUR. Thank you, Mr. Chairman, for giving me the opportunity to testify before you today. My name is Henry Armour. I am

the president and CEO of the National Association of Convenience

Stores. Founded in 1961, NACS is a not-for-profit trade association

representing more than 2,200 retail member companies in the

United States and abroad. NACS is the preeminent representative

of interests of the convenience store operators. The convenience

store industry in the United States, with over 145,000 stores, posted $569 billion in total sales in 2006. More than 70 percent of

NACS members are small family businesses owning and operating

10 or fewer stores.

I appreciate this opportunity to share the convenience store industry’s views regarding H.R. 1108. Tobacco sales are a highly important component of our members’ businesses. Convenience stores

sell more than 60 percent of the cigarettes sold in the United

States in more than 20 million transactions per day.

I want to make clear that NACS takes no position with respect

to the manufacturing provisions in H.R. 1108. That is not our

issue. Our industry simply wants to sell legal products responsibly

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under regulatory regimes that are fair and effective. With respect

to retail sales, the overall approach taken in this bill has not

changed much from previous legislative proposals that Congress

has considered over the past decade. The facts on the ground, however, have changed dramatically.

During the past 10 years, the rates of retail noncompliance nationwide fell from 40.1 percent in 1997 to 10.9 percent in 2006. You

can see a chart over here to my left showing that decline. Virtually

every State has shown consistent improvement, and in 2006 for the

very first time every single State in the Nation reduced its rate of

sales to minors below the threshold set by Congress. Our goal is

to completely eliminate illegal tobacco sales and clearly the regulatory scheme in place has been and continues to be very effective

in making progress towards achieving this goal. In our view, some

of the specific provisions and omissions in the bill are less effective

than they might be.

H.R. 1108 puts at risk a retailer’s license to sell tobacco even if

that retailer has an excellent compliance program. I disagree with

this approach. While there may be fines imposed for any violation,

losing the ability to sell tobacco often means that a convenience

store goes out of business and is sold. Forcing a store transfer is

too harsh a sanction if a business owner has done everything in his

or her power to prevent a violation and may likely result in less

diligent owners operating the store.

Another problem with this legislation is that it makes the FDA

responsible for duplicating the regulation of retailers when States

are already doing this well. We all know and have heard this morning that the FDA has its hands full trying to keep our food supply

and pharmaceutical products safe and adding responsibility to regulate over 300,00 retail establishments that are not currently

under its jurisdiction will undoubtedly put even greater strains on

the agency.

This legislation also does not adequately cover sales made

through the Internet or on Native American lands. A cigarette purchased over the Internet or an Indian reservation is no less harmful to the youths of America and should be regulated in the same

manner as all other cigarette sales.

There are other concerns with this legislation but there is one

particular issue that I would like to call to your attention. In 1997

the FDA prohibited the sale of over-the-counter smoking cessation

products like Nicorette gum in convenience stores. I must say that

the reasoning behind this decision baffles me. If we are serious

about wanting people to stop smoking, we should want them to be

able to get products that help them quit in convenient settings and

in those places where they would purchase cigarettes. This legislation ought to fix this mistaken policy.

If the committee is going to legislate with respect to retail sales,

then it should with the current effective system, not against it. Setting standards for State regulation, closing loopholes for Internet

and Native American sellers, providing incentives for retailers to

have good compliance programs and allowing convenience stores to

sell smoking cessation products are critical elements to sound regulation of tobacco sales.

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We would welcome the opportunity to work with you to address

these concerns. I thank you for your time and the opportunity to

share NACS’s view with you. Thank you very much.

[The prepared statement of Mr. Armour follows:]

TESTIMONY OF HENRY ARMOUR

My name is Henry Armour and I am President and CEO of the National Association of Convenience Stores (NACS). Founded in 1961, NACS is a non-profit trade

association representing more than 2,200 retail and 1,800 supplier company members in the United States and abroad. NACS is the pre-eminent representative of

the interests of convenience store operators. The convenience store industry in the

United States, with over 145,000 stores across the country, posted $569.4 billion in

total sales in 2006. More than 70 percent of NACS members are small family businesses owning and operating 10 stores or less.

I appreciate this opportunity to share the convenience store industry’s views regarding H.R. 1108, the Family Smoking Prevention and Tobacco Control Act. Tobacco sales are a highly important component of NACS member’s businesses. Convenience stores sell more than 60 percent of the cigarettes sold in the United States

in more than 20 million transactions per day. Such sales, on average, constituted

nearly thirty four percent of the in-store sales at NACS members’ retail locations

in 2006. Tobacco is a legal product that is important to the economic viability of

the convenience store industry. I have firsthand experience with the everyday realities of operating a business and selling tobacco products. Before coming to NACS,

I owned and operated a chain of more than 50 retail outlets in the states of Washington, Oregon, and California.

I want to make clear that NACS takes no position with respect to the manufacturing provisions in H.R. 1108—that is not our issue. Our industry simply wants to

sell legal products responsibly under regulatory regimes that are fair. And we do

have quite a bit of experience with the retail sale of tobacco products. In our view,

H.R. 1108 should take a different approach to the regulation of retail tobacco sales.

My testimony will explain why we believe a system of state regulation with Federal

goals—like the current system—is the right one and why the approach taken in

H.R. 1108 should be changed to reflect the lessons we have learned.

THE CURRENT SYSTEM FOR REGULATING TOBACCO RETAILING IS WORKING

Underage Sales Are Falling. H.R. 1108’s overall approach to retail sales has not

changed much from previous legislative proposals that Congress has considered and

failed to enact for the past decade. While the overall approach has been largely stagnant, however, the facts on the ground have changed dramatically.

The Department of Health and Human Services recently released the latest numbers regarding state efforts to enforce laws against tobacco sales to minors. Since

the mid–1990s, states have faced the possibility of losing some of their substance

abuse and mental health services grant funds if they have not reduced the rate of

violations of these laws to below 20 percent. This Federal standard, known as the

Synar Amendment, has produced consistently improving results.

During the past 10 years, the violation rates nationwide have fallen every single

year. In fact, the percentage of retail violations found nationally fell from 40.1 percent in 1997 to 10.9 percent in 2006. Virtually every state has shown consistent improvement. And in 2006, for the first time, every single state in the Nation reduced

its rate of sales to minors below the threshold set by the Congress. I have included

a copy of this latest report as exhibit A to my testimony. There does not appear to

be any other way to read this report than to conclude that our current system of

regulating retail sales of tobacco is making progress. In light of these clear findings,

Congress should not impose costly regulations that are unnecessary and counterproductive. Instead, Congress should continue its successful policy of working with

states to ensure that they diligently regulate tobacco sales.

Retailers Are Taking Action to Reduce Underage Sales. Part of the reason for the

success of the Synar Amendment is the effort put forward by retailers. Convenience

store operators and other retailers have dedicated considerable resources and money

trying to prevent tobacco sales to minors by investing in employee training, signage,

company-operated stings, incentives for employees, and enforcement of company

policies. Some retailers have even installed electronic age verification (EAV) devices

to help eliminate these sales.

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ing. This Coalition developed the ‘‘We Card’’ training program, which provides education and training to help retailers prevent underage tobacco sales. The program

includes development and dissemination of retailer best practices to tobacco retailers across the country. The ‘‘We Card’’ training materials include signage, training

videos, training guides, posters, interactive on-line training, and daily reminder calendars. To date, over one million ‘‘We Card’’ kits have been distributed to retailers

nationwide. ‘‘We Card’’ offers hundreds of classroom training sessions that train almost 10,000 retailers annually. Indeed, since its inception, ‘‘We Card’’ has held over

2,070 classroom training sessions in all 50 states in the U.S. and U.S. territories.

In the past decade, over 100,000 owners, managers and frontline employees have

been trained by ‘‘We Card.’’

In addition to NACS, ‘‘We Card’’ has been endorsed by the National Grocers Association, the National Retail Federation and the National Association of Police Organizations. Forty-four state coalitions have been assembled to support state level

training and education and 236 regional, state and local trade associations support

the ‘‘We Card’’ initiative. Several governors, mayors, state attorneys general, and tobacco control boards throughout the United States have also endorsed this program.

Many retailers have strengthened their efforts to reduce the sales of tobacco products to minors by incorporating ‘‘We Card’’ into a multi-pronged approach to combat

this problem. In addition to the training and signage included in the ‘‘We Card’’ program, many companies have set stringent company policies. Retailers across the

United States understand that solely training employees and setting a ‘‘No ID-No

Sale’’ policy is not enough to eliminate these sales. Without enforcement of their policy, the inclusion of incentives and/or use of additional tools retailers would not be

able to be successful. For example, many companies conduct mystery shopper programs. Through these programs, companies hire teenagers to conduct company operated stings in order to obtain an accurate account of their compliance rate, and continually remind their employees of the company’s tobacco retailing policy. These

mystery shopper programs are becoming more prevalent throughout the industry.

Additionally, many retailers have instituted incentive programs for their employees.

Many employers are providing incentives, either through bonuses or other benefits,

for those employees who pass a company operated sting. Some retailers also have

adopted zero tolerance policies. For those companies, if an employee is caught even

once selling to a minor that person is terminated on the spot. Retailers are also

looking at other, non-traditional, avenues to assist in this effort. Many companies

are purchasing EAV devices to help eliminate calculation errors. An EAV will electronically read birth date information stored on state driver’s licenses to determine

whether a consumer can purchase an age-restricted product, thus removing an element of human error.

Independent studies have shown that retail education and training as well as asking for proper identification can help prevent underage tobacco sales. A University

of Idaho study conducted for the Idaho Department of Health compared retailers

using the ‘‘We Card’’ program to retailers using other materials or no materials at

all. The study found:

• The violation rate among retailers using ‘‘We Card’’ materials was 7.22 percent,

while the rate for other retailers was 16.96 percent.

• Retailers displaying ‘‘We Card’’ materials were 12.9 times more likely to ask for

identification than not to ask for identification, while other retailers were 4.9 times

more likely to ask for identification than not to ask for identification.

SHORTCOMINGS OF THE RETAIL PROVISIONS OF H.R. 1108

Not only does NACS differ with the overall approach to tobacco retailing taken

by H.R. 1108, some of the specific provisions and omissions in the bill are less effective than they should be and/or are unfair.

Retailers Should be Encouraged to Sell Responsibly. The first thing to note is that

in most areas of regulation we do not hold people liable for things over which they

do not have control. Penalizing activity that we have no ability to control loses does

not deter illegal conduct—it is simply punitive. That is important to note when legislating on this subject. When I ran a chain of convenience stores, I had compliance

plans in place to try to ensure that we followed the laws with respect to selling agerestricted products like tobacco. For example, we conducted comprehensive training

for all employees to ensure that they were trained on their responsibilities for checking ID cards and we had a zero tolerance policy if they failed to follow the rules,

including immediate termination if tobacco was sold to a minor. We also conducted

sting operations on our own stores to try to detect problems and correct them. But

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er’s license to sell tobacco even if that retailer has an excellent compliance program

but has one or two bad employees who unintentionally (or intentionally) sell to minors. I believe that is the wrong approach. While there may be fines imposed for

any violation, losing the ability to sell tobacco often means that a convenience store

goes out of business. That is just an economic reality given the very thin margins

in the industry and the number of adults who frequent convenience stores in order

to buy tobacco. Closing the store is too harsh a sanction if a business owner has

done everything in his or her power to prevent a violation. And such a harsh sanction against companies with quality compliance programs may have the unintended

consequence of stores being sold to individuals with no such training programs. In

addition, having a provision requiring an adequate compliance program as a condition to avoid the loss of a license to sell tobacco can be a powerful incentive for retailers to do the right thing. In our view it would help us make real progress on

this issue if retailers had this incentive for implementing strong compliance programs.

The States, not FDA, Should Have Primary Enforcement Responsibility. Another

problem with this legislation is that it makes the Food and Drug Administration

responsible for duplicating the regulation of retailers when states are already doing

a good job in this area. We now have a decade of experience with the Synar amendment in place and retailer noncompliance rates have gone down every single year.

As I said earlier, the national weighted average noncompliance rate in 1997 was

40.1 percent and last year that number fell to 10.9 percent. While our goal is to

completely eliminate tobacco sales to minors, the current system is a real success

story and is certainly making progress toward achieving our goal.

Rather than creating a new Federal bureaucracy for retail sales, Congress should

be looking at ways to improve upon the successes we have gained through the Synar

Amendment’s incentive to states. We are willing to work with the Committee in setting standards that state regulations must meet, making Synar’s requirements

tougher, or otherwise, but it is difficult to see why adding an already overtaxed FDA

on top of the current system of state regulation will improve the system. We all

know that the FDA has its hands full just trying to keep our food supply safe and

adding the responsibility to regulate 300,000 retail establishments that are not currently under its jurisdiction will undoubtedly put even greater strains on the agency.

Innovative legislative activity relating to the retailing of tobacco is occurring in

the States. Pennsylvania, Texas, Idaho, Colorado, Michigan, Florida, Ohio and others have laws that offer an affirmative defense for retailers who take necessary compliance measures to avoid underage sales. These laws incentivize retailers to take

appropriate measures to ensure their businesses comply with the law and the approach has been quite successful. H.R. 1108 would remove some of these incentives

and make retailers subject to a loss of their license to sell tobacco even if they do

everything right. That change threatens to undo some of the progress made by these

states.

Pennsylvania, Missouri and Iowa have enacted laws that place the shared responsibility upon retailers, minors and clerks. In Missouri, the law allows for the assessment of a fine upon clerks as well as retailers. The person making the underage

sale is then subject to a fine of $25 for the first offense, $100 for the second offense

and $250 for subsequent offenses. In Pennsylvania, minors purchasing or attempting to purchase tobacco products are required to participate in tobacco education

programs, lose their driving privileges, or be fined. In fact, many states have passed

laws creating penalties for minors who purchase or possess tobacco and have been

successful in curtailing underage smoking.

Vermont law provides that people under age 18 who possess tobacco will be fined

$25 and, if the fine is not paid within 60 days, will lose their driver’s license for

up to 90 days or their initial eligibility for a driver’s license will be delayed by up

to 1 year. If a person under age 18 misrepresents his or her age to buy tobacco,

then that individual will be subject to a $50 fine or 10 hours of community service

or both. Vermont’s approach is working. Vermont’s 2005 Youth Risk Behavior Survey showed that smoking rates among eighth graders in the State have steadily fallen from 26 percent in 1997 to 22 percent in 1999 to 13 percent in 2001 to 8 percent

in 2005. For all Vermont students surveyed (including students in grades 8 through

12), smoking rates fell from 36 percent in 1997 to 31 percent in 1999 to 22 percent

in 2001 to 16 percent in 2005. In all, Vermont experienced a drop of more than 50

percent in youth smoking over a 4-year period. In fact, the Campaign for TobaccoFree Kids called Vermont’s results ‘‘among the most impressive in the Nation.’’ The

Centers for Disease Control and Prevention (CDC) has noted that the number of

states and localities imposing such penalties is increasing.

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H.R. 1108 fails to include any penalties for minors who attempt to purchase tobacco. That means they have absolutely no deterrent and the same 17-year old can

attempt to buy cigarettes at a store over and over again and get tobacco from older

friends, family members, the Internet or elsewhere without threat of sanction. This

is a major flaw in the legislation. We have penalties when minors possess age-restricted products like alcohol because we understand that taking action on both the

supply and the demand side of the equation is more comprehensive and produces

better results.

Some States have used incentives based on new technology to try to get better

results. New York and Connecticut, for example, have passed state legislation giving

retailers an affirmative defense if they purchase and use EAV (electronic age verification) devices solely for the purpose of age verification on sales of age-restricted

products.

All of these state activities have affected where minors get tobacco products. According to the most recent Youth Risk Behavior Surveillance study conducted by the

CDC, the percentage of students who said they purchased their cigarettes from a

store or gas station fell from 38.7 percent in 1995 to 15.2 percent in 2005. Minors

now report that friends and family members are more frequent sources of tobacco

products than convenience stores. This demonstrates that we need to adjust our

thinking to address all of the ways that minors get tobacco. It also shows that

States, localities, and private efforts are having an effect and should be given the

opportunity to make further improvements.

THE RETAIL PROVISIONS OF H.R. 1108 CAN AND SHOULD BE IMPROVED

If the committee moves forward with H.R. 1108, it must address some of the most

difficult—and growing—problems in tobacco retailing.

Internet and Native American Sales. The improving compliance rates I noted earlier do not cover sales made through the Internet or on Native American lands. We

do not know how often these retailers check IDs to make sure their customers are

old enough to purchase tobacco. What we do know is that what you typically see

when you attempt to purchase tobacco on the Internet is woefully inadequate. In

many cases, when a customer clicks on a pack of cigarettes on a website to try to

purchase tobacco, a box appears. The wording can vary slightly but often says that

by clicking ‘‘OK’’ the purchaser verifies that he or she is 18 years old. As if this

‘‘honor system’’ approach were not inadequate enough, many of these sites only have

one box—the one that says ‘‘OK.’’ A minor could not respond that he was underage

even if he wanted to do so. H.R. 1108, however, revives 10-year old FDA regulations

that exempt Internet and mail order purchases from the requirement for checking

IDs. This makes no sense. Internet cigarette sales are now about 14 percent of the

national market. That is big business. IDs can be checked at the point of delivery—

and often are when alcohol is shipped—so there is no reason to exempt these sales

from regulation.

Any legislation also should address tobacco sales on Native American reservations. Without explicit provisions making clear that the law should be enforced on

reservations, the history on these issues shows that such sales will be ignored. Yet,

Native American tobacco retailers have increased their share of the retail tobacco

market over the past several years and there is no reason why they should not

abide by the same rules, and deal with similarly effective enforcement mechanisms,

as their off-reservation competitors. This can be done without violating tribal sovereignty and is essential if Congress’s goal is to have a fair and comprehensive bill.

A cigarette purchased over the Internet or on an Indian reservation is no less harmful to the youths of America and should be regulated in the same manner as all

other cigarette sales.

Sales of Smoking Cessation Products. A number of other problems exist in this

legislation, including placing responsibility in the wrong place for labels and setting

unrealistic penalties, but there is one issue in particular that I would like to call

to your attention. Several years ago, FDA entered into a consent decree preventing

convenience stores from selling over-the-counter a popular smoking cessation product, Nicorette gum. This was done when the product first became available over-thecounter so there was no evidence of any kind that there were issues with sales of

these products in convenience stores. Indeed, products like Nicorette are sold over

the counter today at drug stores from a shelf right above cartons of cigarettes. Why

drug stores can offer these products and the local convenience store cannot baffles

me. If Congress is serious about wanting people to stop smoking, it should enable

people to get products that help them quit in convenient settings and in those places

where they would purchase cigarettes. Prohibiting such sales is counter-productive.

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CONCLUSIONS

As noted, the current system of state regulation to try to meet Federal goals is

making measurable progress. This approach should be preserved. If the Committee

is going to legislate with respect to retail sales, then it should work with the current

system—not against it. Four elements are critical.

First, the legislation should preserve the role of states as the regulators of retail

tobacco sales but could set additional Federal goals that states must meet. Such legislation could range from compliance targets like those set in the Synar Amendment

to detailed model legislation that states must adopt and enforce. NACS has advocated for this type of approach in the past and experience has shown that it is the

right way to address retail sales. The bottom line is that states have the experience

and resources to regulate retail sales—the FDA does not. States have a record of

a decade of solid progress in reducing tobacco sales to minors—the FDA does not.

States have the enforcement and judicial personnel to enforce the law and provide

due process to retailers—FDA does not. In fact, just a cursory glance at the newspapers demonstrates that the FDA is an agency that is already stretched incredibly

thin. It is being asked to address more issues—including new questions about the

safety of imported food and drugs—without enough resources. Adding the responsibility of policing more than 300,000 retailers of tobacco products across the Nation

is a prescription for disaster for the FDA and will not improve efforts to curb youth

smoking. Instead, it may make things significantly worse. State regulation to meet

Federal standards is an approach that works in this area. Let’s do what works.

Second, any new legislation should explicitly address tobacco sales over the internet and on Indian reservations and require all tobacco retailers to obey the same

rules.

Third, Congress should adopt appropriate incentives for companies to implement

effective compliance programs by protecting them from losing their license to sell

tobacco products.

Finally, Congress should lift the ban on the sale of smoking cessation products

in convenience stores.

I thank you for your time and for the opportunity to share NACS’ views with you.

I welcome any questions you may have.

Mr. WAXMAN. Thank you very much, Mr. Armour.

Dr. Henningfield.

STATEMENT OF JACK E. HENNINGFIELD, VICE PRESIDENT,

RESEARCH AND HEALTH POLICY, PINEY ASSOCIATES, BETHESDA, MD

Mr. HENNINGFIELD. Mr. Chairman and members of the committee, thank you for the opportunity to testify and serve. I have studied drug addiction and health for three decades at Johns Hopkins

Medical School, the National Institute on Drug Abuse, and through

my consulting at Pinney Associates to GlaxoSmithKline on smoking cessation medications. H.R. 1108 is vital to get FDA off the

bench and onto the field to help address a category of product that

kills more than 400,000 Americans every year.

Many people do not understand how FDA could help prevent tobacco use, addiction and related diseases. Let me help you to understand. Many people think of tobacco products as relatively simple concoctions of tobacco and flavorings that people smoke for simple pleasure, with full awareness of the dangers, and that smoking

is a completely free choice. But nothing could be further from the

truth. Tobacco products are sophisticated drug delivery systems.

They are engineered and manufactured to increase addiction risk

and without any regulatory oversight to draw the line on practices

that unnecessarily increase harmful and addictive effects. Over

time, FDA authority could lead to less addictive and less harmful

products and regulation of marketing to reduce deception.

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Existing and future tobacco products need to be regulated. Existing products are used by more than 50 million Americans, killing

more than 1,000 every day. Setting standards for chemicals that

can heighten addictiveness such as ammonia and acetaldehyde and

flavorings such as menthol, chocolate, cherry, honey and others

could be steps towards less addictive and less attractive tobacco

products. Developing performance standards for toxicants such as

heavy metals, arsenic, tobacco-specific nitrosamines, carbon monoxide, formaldehyde could reduce toxin exposure to those who continue to use tobacco.

Regulation is needed to prevent deceptive designs that are killing

Americans. Today more than two-thirds of cigarette smokers smoke

light cigarettes. My sister was one of them. As she told me, you can

tell Marlboro Reds are worse; they felt stronger and they left my

throat raw compared to lights. Let me tell you a few things she

didn’t know. She assumed there were Government standards. She

thought they were regulated. She thought there were standards for

light cigarettes. She thought the FTC test method for tar and nicotine reflected health effects or at least actual intake as is the case

for food labeling. She assumed a cooler, smoother smoke meant it

was weaker and less harmful. She couldn’t believe the Government

would allow such a scam.

Cigarette ventilation is one deadly scam you can see for yourself

if you have really good eyes. If you tear the paper from a cigarette

filter and hold it to a light, you can see bands of tiny holes about

three-eighths to one-half inch from the end. This is right where

they can be easily covered by fingertips or lips and unbeknownst

to most smokers, blocking some of the holes can easily double or

triple delivered tar and nicotine. I did a demonstration on this a

few years ago for my son’s third grade class, and his classmates reacted with clarity and passion. Their comments included ‘‘that is

cheating. They can’t do that.’’ That is cheating and there is a

means of stopping it and preventing such deception for food products, for dog food, and for drugs but not for tobacco, not until tobacco is regulated by FDA.

New generations of products appear to be following the same

commercially effective model of light cigarettes. Lights are just the

tip of the iceberg, and new products and new marketing campaigns

are used to assuage fears about tobacco so as to hook more people

and to keep those who are using to keep using. These products will

need their own standards and they will need standards that are

studied and developed before the products are allowed to be marketed so that marketing does not inappropriately promote use.

FDA is the right agency and the only agency with appropriate experience to develop and enforce product performance standards.

FDA was designed to assess safety in ingredients and resultant

toxicant exposures for a broad range of products. Furthermore, tobacco products are drug delivery systems at heart. Even the tobacco industry admits this in their own documents. Moreover, tobacco products are designed to heighten and deceive and heighten

addiction risk.

Finally, let me emphasize that FDA authority will not make tobacco products safe, is not the answer to American’s tobacco problem in its own right. It should not be seen as a substitute for comVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00112 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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prehensive tobacco control efforts. In fact, FDA regulation should

be viewed as a partner in tobacco. The bill will bring the most sophisticated health regulatory body in the world to the table finally

in partnership with tobacco control experts seeking to reduce tobacco use and prevent it in children. FDA will then be positioned

to serve these efforts because it will restrict the ability of the industry to modify their products, use descriptors and marketing that

undermine prevention and cessation. I therefore urge expeditious

passage and implementation of the Family Smoking Prevention

and Control Act. Thank you very much.

[The prepared statement of Mr. Henningfield follows:]

STATEMENT OF JACK E. HENNINGFIELD

Thank you for the opportunity to testify on H.R. 1108, the Family Smoking Prevention and Tobacco Control Act, that would provide ‘‘the Food and Drug Administration with effective authority to regulate tobacco products.’’ FDA regulation is not

only the right thing to do, it is urgent. More than 4 million Americans have died

prematurely since FDA asserted jurisdiction and issued its Final Rule to regulate

cigarettes and smokeless tobacco in 1996. Although we have made modest progress

in reducing tobacco use, I believe FDA regulation would have made the progress significantly greater. Furthermore, the tobacco industry is unleashing new products,

new claims, and clandestinely modifying conventional products at a terrifying rate,

with no plausibly-effective regulatory mechanism in sight, except for the approach

embodied in the Bill. Even the FTC has thrown in the towel and apparently given

up on its own widely criticized and deeply flawed method of cigarette testing.

BASIS FOR TESTIMONY

I am speaking on my own behalf and not as a representative of the organizations,

of which I am a member, consult for, or voluntarily serve. I am an Adjunct Professor

of Behavioral Biology (Adjunct), Department of Psychiatry, The Johns Hopkins University School of Medicine; and Vice President for Research and Health Policy,

Pinney Associates. I was trained in behavioral science, pharmacology, and other disciplines relevant to understanding addictive substances. I have focused on tobaccorelated issues for nearly three decades. From 1980 to 1996, I conducted and led tobacco and other drug research at the National Institute on Drug Abuse (NIDA).

While at NIDA, I was liaison frequently to the FDA on tobacco products and tobacco

addiction treatment. I contributed to numerous Surgeon General’s reports as well

as reports by other agencies. I presently serve on the World Health Organization

(WHO) Tobacco Regulation Study Group (TobReg) which provides scientific guidance

for implementation of several articles of the international tobacco treaty, the WHO

Framework Convention on Tobacco Control (FCTC); a treaty (signed by not yet ratified by the United States) which includes many directives in harmony with the proposed FDA tobacco regulation.

By further way of disclosure and to provide you with some basis for my perspective, let me tell you that part of my role at Pinney Associates is to advise companies

on how to minimize the risk of abuse, addiction, misuse and harmful effects of drugs

with a known or suspected potential to cause addiction, including opioid analgesics,

stimulants, sedatives, and many others. In many cases it is not only the chemical

entity itself but the formulation and marketing of the drug that poses the challenge

for risk minimization. This work includes advising GlaxoSmithKline Consumer

Healthcare on its treatments to help people quit smoking. I also share two patents

on a tobacco dependence treatment product under development which has given me

additional perspectives on FDA regulation. On the tobacco side, I have reviewed

thousands of pages of previously secret document and testified on behalf of the US

Department of Justice (DOJ) and other plaintiffs against the tobacco industry concerning the many ways by which this industry has been able to manipulate its products to heighten their addiction risk under the cover of darkness left by the regulatory vacuum. I have gained first hand experience in understanding the challenges

and benefits of FDA regulation of the tobacco industry and its products through

these activities.

Tobacco products are sophisticated drug delivery systems—engineered and manufactured to increase their potential to cause and sustain addiction

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Tobacco products are diverse and all are harmful and share the common feature

of being designed to cause and sustain addiction to nicotine. The World Health Organization said in its 2006 World No Tobacco Day report, an effort to which I contributed: all tobacco products are deadly and addictive in any form or disguise. Products vary widely in their form and degree of sophistication in engineering. The most

elaborately designed and manufactured product, the cigarette, accounts for the vast

majority of the more than one thousand tobacco-attributable deaths that occur every

day in the United States.

For most consumer products, extensive research and design expertise by manufacturers is often used to improve safety and reduce risk. However, this is not true for

cigarettes: much of the research and engineering has been dedicated to increasing

their risk of causing and sustaining addiction and high levels of use. In fact, many

features are intended to make it easier to inhale the deadly poisons deep into the

lungs where the damage is greatest. Why? Because this increases the addictive impact of nicotine by producing explosively fast absorption in the massive alveoli bed

of the lung. This undoubtedly helps explain why lung cancer risk increased in the

1980s and 1990s even though machine measured tar levels declined. It also may

help to explain the increasing proportion of the especially deadly deep airway small

cell adenocarcinomas relative to squaemous cell lung cancer in the recent decade.

Cigarette design and manufacture is extensively researched and engineered to

control features that contribute to deceiving smokers into thinking they are getting

less harmful exposures, to make it easier to take up smoking, and to cause and sustain addiction. Much of this was summarized in the FDA’s Final Tobacco Rule

(1996) and more recently in the 1700-page findings by Judge Kessler in her ruling

in the U.S. Department of Justice litigation against the tobacco industry. She wrote:

‘‘Every aspect of a cigarette is precisely tailored to ensure that a cigarette smoker

can pick up virtually any cigarette on the market and obtain an addictive dose of

nicotine.’’ (Paragraph 1368). Further, Judge Kessler concluded: ‘‘Defendants have

designed their cigarettes to precisely control nicotine delivery levels and provide

doses of nicotine sufficient to create and sustain addiction.’’ (Paragraph 1366)

The remarkable range of features includes control over the following aspects of

cigarette design, delivery, and addictive impact. Ignition propensity and burn rate

are controlled with burn accelerants and paper porosity to help control nicotine dosing and make cigarettes convenient to use. Smoke particle size is engineered to facilitate efficient inhalation of smoke deep into the lung. Smoke temperature and

harshness are controlled to make it easier to take up smoking, to inhale deeply and

provide smoother smoke that fools the smoker into assuming it not as harmful.

Smoke and ash color are controlled with chemicals in the tobacco and paper to make

the process as neat and attractive-appearing as possible. Ingredients are further

added to smooth, flavor and make the smoke more attractive to target populations,

even if they yield additional carcinogens to the smoke (such as burned chocolate

does). Still other chemicals are added that prolong shelf life and control humidity,

which, in turn, helps control nicotine dosing and smoke sensations. The inclusion

of some of these ingredients on FDA’s Generally Recognized as Safe (GRAS) list is

virtually meaningless when they are used in cigarettes. These ingredients have not

been tested and approved for use in burned products. They are ‘‘GRAS’’ for use in

food, not for inhalation in combination with burned tobacco material.

A number of chemicals used in manufacturing process further alter the

addictiveness of the product through manipulation of the chemical form of nicotine

(e.g., ratio of free-base or unionized nicotine to ionized nicotine). These compounds

increase the amount of free base nicotine, probably increasing the addictiveness of

cigarettes because free-base nicotine is more readily released from the cigarette and

absorbed in the mouth. For example, ammonia compounds can alter the free base

fraction of the smoke while also making it easier to inhale. The practice of manipulating the free base fraction of nicotine is not unique to cigarettes: smokeless tobacco

products marketed as ‘‘starter’’ products (an industry term) are mildly alkaline to

yield a smaller proportion of free base nicotine than the more alkaline maintenance

products such as Copenhagen. Why? Too much nicotine delivered too rapidly to the

novice user can cause acute nausea and discourage further use. By contrast, highly

tolerant smokeless users who have ‘‘graduated’’ (another industry term) to higher

levels of daily use seek stronger and faster doses to satisfy their addictions.

Cigarette filter technology is also extremely sophisticated and reduces certain

throat burning sensations but not necessarily the deadliest of the toxicants. Filters

can help ensure that nicotine is readily delivered in a form that can be easily inhaled deep into the lung where addiction potential is maximized, and lung disease

risk is increased by the inhalation of smoke particles that carry nicotine molecules

into the lung. Filters also commonly include elaborate ventilation systems (described

in greater detail below), which can increase the free-base fraction of nicotine and

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enable smokers to obtain addictive levels of nicotine regardless of its advertised

yield.

It is time to rein in the addictiveness and harmfulness of tobacco products by giving FDA the authority to enact performance standards to regulate and restrict levels

of ingredients (added or residual) that are toxic, and to reduce the ability of the industry to maximize the addictive potential of their products.

It is vital to give FDA the authority to regulate tobacco products and develop

product performance standards as will be accomplished through H.R. 1108. FDA

could develop performance standards that, over time, could lead to less addictive

and less harmful products. One key feature of the legislation is that mere compliance with a performance standard cannot be used as the basis for product claims.

This will help ensure that communications about the dangers are not weakened.

After all, the products will still remain highly toxic and addictive by any ordinary

standards and communications should not be used to imply anything contrary to

these facts.

Performance standards can and should be developed for all smoke constituents including those that affect addictiveness and attractiveness as ammonia compounds,

acetaldehyde, menthol, flavorings, as well as substances emitted in the normal

course of use of the products, such as carbon monoxide gas and carcinogens. In addition, performance standards could cover substances that may not have been intended for the final product but are residual from tobacco growing, storage and processing, such as pesticide and herbicide residues, as well as contaminants including

heavy metal residues, cyanide, insect parts and other materials. Performance standards can also be developed for product emissions commonly known as tar but which

include deadly carcinogens such as tobacco specific nitrosamines, and formaldehyde.

Nicotine content and dosing need to be regulated. Nicotine is regulated in medicines and it must be regulated in tobacco products where content and delivery are

often much higher than is allowable in medicines. For example a typical ‘‘pinch’’ of

some of the most popular snuff products contains 10–20 mg nicotine compared to

4 mg in the highest dose of nicotine gum or lozenge.

Tobacco delivered nicotine, particularly from cigarettes, is particularly addictive

because of the various ingredients and design features that function to increase the

addictiveness of the products. For example, the level of free base nicotine allowed

in cigarette smoke needs to be examined and considered for performance standard

development. Other ingredients that appear to synergistically increase the

addictiveness of the product such as acetaldehyde need to be examined from this

perspective in performance standard development.

Perhaps most controversial is whether performance standards should be developed with the intent of phasing nicotine out of cigarettes. I have published papers

on the potential benefits (e.g., making tobacco products less addictive) and obstacles

(e.g., precipitating increased use, mass withdrawal, and inadequate treatment infrastructure for tobacco dependence) for such an effort. However, I am in agreement

with the World Health Organization, that at present it would be premature to attempt to drastically alter levels through regulation. The bill will give FDA the flexibility and authority to develop the additional science, as necessary, to set performance standards for nicotine content and delivery.

Regulatory flexibility to address emerging science and evolving products is part

of FDA’s strength that will be enabled by the Bill. If we think of tobacco products

as analogous to deadly globally spread viruses, then we must also think of them as

constantly evolving, requiring vigilant oversight and the sort of authority to regulate

that FDA exerts over foods and drugs. This means that performance standard setting and evaluation will be a continuous process as long as tobacco products are

marketed. This is also important because we need to assume that in any sciencebased regulatory process, new science will emerge that requires an agency like FDA

to reconsider and, if needed, modify previously issued regulations. By contrast, as

described below, the light cigarette fraud emerged and persisted over several decades and was not even irrefutably unmasked until the 2001 publication of National

Cancer Institute Monograph 13. But yet the fraud continues unabated in the regulatory vacuum!

Product misrepresentation, health and harm reduction related claims need to be

regulated.

With the recognition by the Surgeon General in 1964, that cancer risk was related

to overall tobacco exposure, cigarette smokers were encouraged to quit. Those who

did not quit were encouraged to reduce their exposure. The focus was on ‘‘tar’’ because this conglomerate smoke condensate contained many substances that separately and together were clearly implicated in cancer and lung disease. This gave

birth to the Federal Trade Commission’s method for tar and nicotine assessment

and communications. Nicotine was included in part because of its presumed role

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(probably over estimated at the time) in heart disease. The intentions of the FTC

were good but it is not a science and health agency, and it adopted a method that

was well understood and easily defeated by the tobacco industry. Armed with a

flawed method and little expertise in understanding drug delivery systems, assessing drug delivery, or monitoring and evaluating health effects, the FTC was no

match for the tobacco industry. The industry co-opted the FTC’s ratings of tar and

nicotine as marketing tools to reduce smokers concerns about smoking. By designing

cigarettes that generated lower tar and nicotine ratings, labeling those below certain

levels ‘‘light’’ and ‘‘reduced tar and nicotine’’ the industry had a powerful force to

prevent or at least delay life-saving smoking cessation by many people.

After reviewing evidence and listening to various experts, Judge Kessler, in the

Findings from the DOJ trial concluded as follows: ‘‘they [tobacco company defendants] also knew that the [FTC] Method was totally unreliable for measuring actual

nicotine and tar any real life smoker would absorb’’ (Paragraph 2627). Further, ‘‘By

engaging in this deception, Defendants dramatically increased their sales of low tar/

light cigarettes, assuaging fears of smokers about the health risks of smoking’’

(Paragraph 2629)

The light cigarette fraud continues: Regulation is needed to prevent deceptive designs that are killing AmericansToday, more than two thirds of cigarette smokers

smoke light cigarettes. My sister was one of them. As she told me: ‘‘You can tell

Reds (Marlboro Regular Cigarettes) are worse: they felt stronger and left my throat

raw compared to Lights. Let me tell you a few things she didn’t know and that angered her when she found out. She assumed that there were government standards

for light cigarettes and that the FTC testing method intended to measure tar and

nicotine yield reflected health effects or at least actual intake as is the case for food

labeling. She assumed that cooler, smoother smoke meant that it was weaker and

less harmful. She had no idea that a hidden ventilation system was diluting the poisons for smoking ventilation by allowing fresh air to be ‘‘inhaled’’ by smoking machines, whereas she and other smokers were probably taking in two to three times

as much tar and nicotine than indicated by the ratings. She couldn’t believe ‘‘the

government’’ would allow such a scam.

Since the light and low-tar scam began with a vengeance in the late 1960s America has lost tens of millions of its citizens prematurely as they smoked light cigarettes to their graves, all the time not knowing that tobacco industry marketing of

‘‘light’’ and ‘‘low’’ cigarettes was completely misleading and that these products were

not any less harmful than other cigarettes. In 2001, the National Cancer Institute

in Monograph 13 finally concluded definitively: ‘‘Epidemiological and other scientific

evidence’’ does not indicate a benefit to public health from changes in cigarette design and manufacturing over the past 50 years.’’

How did it happen? What can we learn? Looking into lights—through their holes.

Most aspects of cigarette design that contribute to harm and addiction require sophisticated equipment and procedures to detect, such as CDC’s approach to measuring free-base nicotine. However, cigarette ventilation is one deadly scam you can see

for yourself. If you tear the filter paper from a cigarette filter and hold it up to the

light, you can see bands of tiny vent holes about 3/8 to 1/2 inch out from the filter

end. This is right where they can be easily covered with lips or fingers. Unbeknownst to most cigarette smokers, blocking of the holes with lips or fingers can

easily double or triple delivered tar and nicotine. On most cigarettes they are difficult to see because the designs that are intended to hide them. When the cigarettes are smoked according to the FTC method, the holes leak anywhere from

about 20–90% air into the testing apparatus, thereby contributing to the deceptively

low advertised rating. I did this demonstration a few years ago for my son Vincent’s

third grade class and his classmates reacted with clarity and passion. Their comments included: ‘‘that’s cheating!’’ and ‘‘they [the companies] can’t do that’’.

By analogy, this is like punching holes in a fruit drink container, allowing some

of the beverage to leak out, then testing the residual beverage for calorie and sugar

content and listing those figures on the box even though consumers may consume

several times more sugar than was listed on the package or in advertisements. That

would be cheating, and there is a means of stopping and preventing it with food

products, but not for tobacco products—not until tobacco is regulated by FDA, which

routinely addresses such issues with food and drug products. In fact, for any food

or beverage in America, including Kraft cheese, Miller Lite beer, Oreo cookies, and

potato chips made by tobacco company affiliates, such fraudulent misrepresentation

of products can result in the products being pulled from shelves and/or penalties.

Manufacturers can’t even claim dog food is low fat if it is not true. Companies that

market addictive drugs for therapeutic use must formulate and market them to reduce risk of addiction and other adverse side-effects, or the drugs can be refused

approval, pulled from the market, or be subject to new limitations on marketing,

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as has happened to several potentially addictive medications in recent years. Tobacco products are not therapeutic but many of the same principles apply.

‘‘Light’’ and ‘‘low tar’’ cigarettes can be considered the first generation of putative

but fraudulent ‘‘harm reduction’’ products designed to address smokers concerns

about health but not really to reduce their health risks. Light cigarettes may just

be the tip of the iceberg though.

New generations of products appear to be following the commercially effective

model of light cigarettes, which is to ensure that new products are highly addictive

to sustain use, with designs and marketing efforts to assuage fears about tobacco.

There is the theoretical potential to reduce actual toxin exposure and an Institute

of Medicine Report released in 2001 acknowledged this, giving the potential product

category a new name: Potential Reduced Exposure Products or PREPS. It urged,

however, regulation by FDA to provide a framework for evaluation of the products,

determine what communications would be appropriate, and monitor their use and

impact. Absent with such regulation, products termed PREPS by an unfettered industry could be the next generation of lights, further undermining prevention and

cessation, and killing many of their users.

Fortunately, we have learned a lot in the past decade that will arm FDA in its

regulation of PREPS, lights, and all other tobacco products. Much of this information emerged thanks to the 1990s investigation by FDA as part of its Tobacco Rule

development. More information emerged through litigation against tobacco companies that made public millions of pages of previously secret internal tobacco industry

documents, giving birth to a new research discipline called ‘‘tobacco document research,’’ which involves increasingly sophisticated analysis to determine what the

industry knew about health effects and addiction engineering, as well as many of

its actual practices. We also have empirically derived knowledge from NIH and CDC

research relevant to tobacco product design and effects. Perhaps most importantly,

we have learned, through the tobacco industry documents, how much more the industry knows than it discloses, how much it knows about designs and ingredients

to heighten addiction risk, and how much more we need to learn if we are to more

effectively prevent continued product manipulation. I believe that an empowered

FDA could demand and evaluate such information, and put it to use to serve public

health.

For example, as you have learned, the State of Massachusetts cigarette testing

program shows nicotine levels had gradually increased in many brands since the

late 1990s. There has been considerable debate as to why this was done. My opinion

is that this was done to make it easier for cigarette smokers to get their daily addictive fix of nicotine when faced with restrictions on smoking and higher costs that

drive their daily cigarette intake down. To tobacco companies, keeping their customers addicted and satisfied is better than allowing cigarette smokers to reach that

point that sustaining nicotine is such a hassle that they are more driven to quit.

However, that is my opinion, and in the absence of regulatory oversight there is no

way to find out the basics: the how, what, why and when. You see, regulation would

give FDA the authority to demand an explanation and even to ban the manipulation

if it deemed that it was contrary to the interests of public health. FDA could freeze

levels; it could even require reduction of various toxicants and nicotine over time.

It is time that the American public be truthfully told what the tobacco industry

knows about the ingredients, delivery, and effects of the products, and that the

products they buy and use are honestly labeled regarding ingredients and maximum

possible exposure levels. We would not tolerate such deception with food manufacturers or the makers of any other products consumed by Americans. It is time to

stop protecting the tobacco companies and start making them play by the same

rules as the manufactures of other products consumed by Americans. The deception

continues and is poised to worsen: tobacco products are mutating undeterred by regulatory oversight. Learning the truth and developing appropriate communications

for consumers for existing products and the pipeline of new drugs or consumed products, is central to FDA’s mission.

Absent regulation, the deadly deception I have described continues. Cigarettes

and smokeless tobacco products are designed to addict, designed to go beyond the

addiction risk of their relatively crudely manufactured ancestors. Cigarettes are designed to taste smooth and garner misleadingly-low tar and nicotine ratings because

consumers react to such information as meaning substantially-less harmful. Tobacco

products are researched, designed, manufactured and marketed to maximize the

likelihood of trial, the graduation from trial to addiction, and to retain their addicted users despite efforts to quit. Products are fine tuned to attract various populations, including the young, with flavors, designs, and dosing characteristics. This

is far beyond simply satisfying existing needs and desires of adults.

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And the problem appears to be worsening: More Americans than ever before are

concerned about smoking, and want to quit. But without regulation these individuals will turn to light cigarettes or new tobacco products that falsely claim (at least

implicitly) to be less harmful. These products have been shown to reduce the motivation to quit smoking because of the false reassurance that the smoker is ‘‘doing

something’’ that represents a healthier step in the right direction. But delaying tobacco cessation is deadly: disease risk is more strongly related to years of smoking

than to the number of cigarettes smoked per day.

Worse still, the pipeline of new products and claims is growing. Some of you may

have seen advertisements in widely-circulated magazines such as Parade, trumpeting cigarettes such as Omni and Eclipse that are ‘‘lower in carcinogens’’ and ‘‘may

present less risk of cancer, chronic bronchitis and possibly emphysema.’’ Eclipse, delivers very high levels of the deadly odorless gas carbon monoxide. Marketed versions were also reported to deliver glass fibers from its aluminum and glass inner

chamber that can penetrate the lung.

Philip Morris is now test marketing what many smokers might be truly waiting

for, a Marlboro with reduced risk claims: Marlboro Ultra Smooth. Philip Morris has

admitted that it is premature to make harm reduction claims for the product though

they tout the product’s potential to reduce exposure to harmful substances. In the

void of regulation, however, Philip Morris is test marketing the product and creating

the illusion of reduced harm with through its clever name and descriptions of the

potential of the product to reduce certain substances. Furthermore, it is using messaging such as ‘‘Filter Select’’ and ‘‘new carbon filter’’ which might be reasonably

construed by a consumer to indicate advances in filtration of harmful elements.

One widely-advertised cigarette, Quest from Vector, even claimed to be ‘‘nicotine

free’’ supporting the claim by asserting it met the ‘‘standard’’ of Benowitz and

Henningfield. Now, without detracting from my own work with Dr. Benowitz, we are

not FDA, and we never intended a recommendation for reducing the addictiveness

of cigarettes to stand in place of FDA evaluation and regulation. This would be

laughable if it were not deadly and still being perpetuated.

I am not here to testify, that products such as Quest and Marlboro Ultra Smooth

are in fact as deadly as conventional products. The problem is there is no way to

know if they are potential steps in the right direction or as fraudulent and deadly

as light cigarettes. And there will be no way to tell until we have an authorized

and empowered FDA to find out.

There is also an increase in widely advertised smokeless tobacco products from

‘‘for when you can’t smoke,’’ implying you don’t need to quit smoking because you

can use their products when you can’t smoke. The lure is increased by touting new

products and implied benefits. One product is packaged to resemble a medicinal cessation product with its label reading ‘‘for when you can’t smoke.’’ These manufacturers are using Americans as guinea pigs without informed consent. They are introducing new products; modifying products with new designs and ingredients; and

making claims, implicit and explicit, without regulatory oversight from the one

agency, FDA, that is charged with the oversight of consumable products that have

health effects, and require consumer communications that are honest and do not

mislead. These efforts not only are deceptive, they help the industry thwart tobacco

prevention and cessation efforts.

Regulation is overdue and urgent. For several decades, the tobacco industry anticipated but fought FDA regulation, as illustrated by Philip Morris scientist William Dunn’s warning to his superiors in 1969: ‘‘I would be more cautious in using

the pharmic-medical model—do we really want to tout cigarette smoke as a drug?

It is of course, but there are dangerous FDA implications to have such a

conceptualization go beyond these walls.’’ Dr. Dunn was right in his apparent assumption that FDA authority could have reined in many deceptive practices of the

tobacco companies.

FDA is the right agency and the only agency with appropriate experience to develop and enforce product performance standards.

I have heard the entire range of arguments about why FDA should not be granted

regulatory authority, including that FDA was not designed to evaluate cigarettes.

The fact is that FDA was designed to assess safety, ingredients, and resultant exposure to a broad range of drugs and foods. Tobacco products are drug delivery systems at heart. They are sophisticated and complicated with many ingredients, just

as many drugs are. Even the tobacco industry admits this in their documents. Moreover, they are designed to deceive, and designed to heighten addiction risk.

Foods and drugs that are designed and/or marketed to deceive, whether by intent

or not, can be judged as misbranded or recalled, and lead to various correctional actions ordered. This happens frequently and routinely many times each year for foods

and drugs. FDA has more experience and sophistication in the regulation of drugs

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and drug delivery systems than any agency in the world. This is the same expertise

that needs to be applied to tobacco.

For any product, whether food, drug or dog food, FDA can ask and must be given

answers to the basic questions that many consumers of those products undoubtedly

believe are being addressed for tobacco products: WHO is the product for? WHAT

is in it? WHY is it designed and manufactured as proposed or done? HOW is it manufactured? WHEN were changes made? FDA can require surveillance to detect unintended consequences of products already marketed or proposed for marketing approval if it has residual concerns.

Finally, what is communicated to consumers about product content will be vital,

so that eventually tobacco products, like other consumable products, are labeled in

meaningful ways that do not confuse or obscure the truth, do not inappropriately

make or imply claims, and do not unintentionally undermine efforts to prevent tobacco use from beginning and tobacco users from quitting.

FDA’s authority will not make tobacco products safe, and should not be seen as

a substitute for comprehensive tobacco control efforts to reduce all forms of tobacco

use and disease. In fact, FDA regulation should be viewed as a partner in these efforts and be positioned to serve these efforts because it will restrict the ability of

the industry to modify products and descriptors to undermine prevention and cessation. For all of these reasons and more, FDA regulation of all tobacco products

is vital in setting our Nation on a healthier path. Directing the FDA to develop its

regulatory system with urgency, empowering it to rise to the challenge of tobacco

regulation, and providing it with the support to get the job done can be accomplished through H.R. 1108.. I therefore urge its most expeditious passage and implementation.

Mr. WAXMAN. Thank you very much, Dr. Henningfield.

Mr. Corr, I think the last time I chaired a hearing on tobacco,

you were on this side, not that side. We are pleased to welcome

you.

STATEMENT OF WILLIAM V. CORR, EXECUTIVE DIRECTOR,

CAMPAIGN FOR TOBACCO-FREE KIDS.

Mr. CORR. Thank you, Mr. Chairman, very much for those remarks, and Mr. Sullivan, thank you both for your patience. We

know this has been a long day and we appreciate you giving us the

opportunity to testify.

This legislation, Mr. Chairman, as you know, and its predecessor

bills have been under consideration and evaluation in multiple

Congresses. In this Congress, this legislation has 200 cosponsors.

The public overwhelmingly supports this bill. Five hundred and

nineteen public health medical and faith organizations support it.

As you heard this morning, the Institute of Medicine has recommended it, and the President’s cancer panel in August recommended that FDA be given the authority to regulate tobacco

products.

You have heard from other witnesses about the tobacco company’s behavior. I would like to take just a moment to show you what

it looks like. Tobacco companies design and market products to influence and addict our children. The company’s business model in

fact, depends upon the addiction of children to replace the lifetime

customers who die each year. Please look at these couple of ads and

consider who they are designed to attract. This first one, it is hard

to see possibly but it is ‘‘back to school special.’’ If you look in the

lower right-hand corner, you will see a hand with chalk writing on

the board. The key question is this designed for adults who want

to switch brands or is this designed for our children? Here are

some ads that as you will see are on a Good Humor ice cream

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freezer, and here is an ad that appeared in Sports Illustrated in

2006.

Consider also flavored products. Who are these ads for? It may

be hard to see but the ad is Camel, pleasure to burn. And this is

Liquid Zoo coming in any number of flavors—coconut, chocolate,

strawberry, mint. Again, who are these products designed for,

switching adults or for children? And as just was pointed out, the

companies are still marketing light and low-tar products with their

implied health benefits, even though the companies know well that

there are no health benefits.

Beyond these marketing abuses, tobacco companies manipulate

nicotine and other ingredients to assure addiction. They add and

delete additives without oversight, even though some of them are

addicting or deadly. These slides, if I may, involve the companies’

claims of reduced-risk products to show you how they have designed deceptive marketing that misleads adult users in order to

keep them as customers. This first ad compares the carcinogen levels and the claim is made that with Eclipse there is an 80 percent

reduction in carcinogens. There is no evidence to back this up.

There is no regulatory agency with objective scientific credentials

to evaluate these claims. In the next ad for Omni, you will see reduced carcinogens, premium taste, and the company claims they

are introducing the first cigarette to significantly reduce the major

causes of lung cancer in smokers. These kinds of claims are going

totally unregulated. And last, beyond these marketing abuses, companies are manipulating the ingredients.

This is a list of possible, probable and known cancer-causing

chemicals in cigarette smoke. There are over 60 known carcinogens

in cigarette smoke. Some of these can be easily removed in the

manufacturing process but have not been because it is entirely at

the discretion of the companies.

Regulating tobacco company marketing and advertising and regulating the content of tobacco products are two of the key authorities that are contained in this legislation that are urgently needed.

Mr. Chairman, FDA is the only agency that can carry out the responsibilities of this legislation. It is the only Federal agency that

combines scientific expertise, regulatory expertise and a public

health mandate. No other Federal agency combines these three essential capabilities.

In light of this kind of industry behavior and recognizing that

only FDA has the ability to implement this legislation, I would like

to comment very quickly on something Commissioner von

Eschenbach said in his written testimony. He said, ‘‘We are concerned that the public will believe that products approved by the

agency are safe and that this will actually encourage individuals to

smoke more rather than less.’’ As was pointed out earlier, the current status quo allows the public to be mislead repeatedly by the

companies with misleading ads like ‘‘light and low tar.’’ But more

importantly, what I want to bring to the committee’s attention is

that there are provisions in H.R. 1108 that address this very issue.

The bill authorizes FDA to stop any statement by the companies

that would mislead the public like being ‘‘FDA approved.’’ The bill

mandates new warnings covering the top 30 percent of the front

and back of the pack. This is a mockup of what Camel No. 9 would

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look like with such a written warning, and FDA has the authority

under the bill to expand this to 50 percent of the top, front and

back of the product and to use graphic pictures. So imagine a consumer picking up a pack of cigarettes with half of the pack a diseased lung, and the question is, is this a Government stamp of approval?

Just to point out to you as well, the Senate HELP Committee

added additional provisions because they also addressed this issue

as it came up in their markup. They have added a congressional

finding and they added an explicit prohibition on company statements implying that FDA has regulated their products.

Mr. Chairman, I realize that my time is expired. I wanted to

make some other remarks about the testimony of the retailers but

we will add those for the record.

[The prepared statement of Mr. Corr follows:]

TESTIMONY OF WILLIAM V. CORR

Chairman Pallone, Ranking Member Deal, and members of the Health Subcommittee, thank you for this opportunity to testify in support of H.R. 1108, a bill

to provide the U.S. Food and Drug Administration (FDA) with the authority to effectively regulate tobacco products and their marketing and to reduce the harms associated with tobacco use. My name is Bill Corr, and I am the Executive Director of

the Campaign for Tobacco-Free Kids, the Nation’s largest non-profit, advocacy organization solely devoted to reducing the harm caused by tobacco use and exposure

to secondhand smoke.

H.R. 1108 has the potential to save many lives. Today, America’s most dangerous

consumer product—tobacco—is also the one consumer product that no Federal agency oversees for health and safety purposes. Far from being the excessive regulation

that some have claimed, this carefully crafted, thoughtfully balanced legislation

would correct the glaring absence of regulation of tobacco products and bring the

type of government oversight to the manufacture, marketing and sale of tobacco

products that is already provided to other consumer products.

As you know, H.R. 1108 was introduced on February 15, 2007, but the need for

legislation giving FDA authority over tobacco has been discussed for years, and legislation similar to H.R. 1108 has been before the Congress for close to a decade. A

bill virtually identical to H.R. 1108 was debated and overwhelmingly approved by

the full Senate in 2004.

It is essential for Congress to act if the public is to be protected. In 1996, after

a two-year investigation, the U.S. Food and Drug Administration asserted jurisdiction over tobacco under current law. Then, in March 2000, the U.S. Supreme Court

ruled that the FDA did not have the statutory authority to regulate tobacco products, and that only Congress could grant FDA this authority. The Court commented

that ‘‘tobacco use, particularly among children and adolescents, poses perhaps the

single most significant threat to public health in the United States.’’

In May of this year the Institute of Medicine issued a report, ‘‘Ending the Tobacco

Problem—a Blueprint for the Nation,’’ in which it strongly recommends that Congress enact the pending legislation granting FDA broad regulatory authority over

the manufacture, distribution, marketing and use of tobacco products. In addition,

the President’s Cancer Panel issued a new report in August with a call to action

on how to significantly reduce tobacco use and its devastating toll in the United

States and around the world. The report of this prestigious panel of national experts

appointed by the President, including Dr. LaSalle Leffall of the Howard University

College of Medicine, Lance Armstrong and Dr. Margaret Kripke of The University

of Texas M.D. Anderson Cancer Center, concluded: ‘‘The Panel recommends foremost that the influence of the tobacco industry—particularly on America’s children—be weakened through strict Federal regulation of tobacco products sales and

marketing.’’

Thus, it is no surprise that H.R. 1108 has broad bipartisan support including liberals and conservatives and Representatives from every geographic region of the

country. It has been endorsed by every major national public health organization,

many organizations representing health care providers (see attached letter), and

representatives of a wide range of faith groups. Virtually identical legislation was

also previously endorsed by every major tobacco-farming group.

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The Campaign for Tobacco-Free Kids has measured voter support for FDA regulation of tobacco products and, not surprisingly, it has broad support across the country from 70 percent of voters in a national poll. State surveys from around the country have consistently found similar high levels of support, crossing party and ideological lines. It even has majority support among smokers. Voter support is particularly strong for the specific provisions of FDA regulation. When asked whether tobacco companies should be required to take measures to make cigarettes less harmful; whether tobacco companies should be prevented from making claims that some

products are less harmful than others unless FDA determines those claims are true;

or whether FDA should restrict tobacco marketing aimed at children, voter support

for each of these elements exceeds 75 percent.

It is truly time for Congress to act.

WHY THIS BILL IS NEEDED

H.R. 1108 is essential for the protection of the public health. More than five decades after the Surgeon General’s historic 1964 report, more than 400,000 Americans

die prematurely every year from tobacco, roughly 1200 people every day. The critical

word is ‘‘prematurely.’’ Fifty percent of the people who die from tobacco die in middle age.

Death from tobacco is almost always the last chapter of a book that begins in

childhood. Every day, approximately 4,000 kids will try a cigarette for the first time.

Another 1,000 will become new, regular daily smokers, and one-third of these kids

will eventually die prematurely as a result. The fact is that almost 80 percent of

the adults who smoke began their deadly habit before age 18.

While some hoped that the 1998 Master Settlement Agreement (MSA) would end

tobacco marketing to children, in August 2006, Federal District Court Judge Gladys

Kessler found tobacco companies liable for engaging in a 50-year conspiracy to defraud the American public—which included continuing to market in ways that appeal to young people and continuing to recruit children as new tobacco users. The

MSA, while helpful, addressed less than 20 percent of the marketing and promotional expenditures by the tobacco companies, and it did not completely eliminate

even those practices. The tobacco companies have easily overcome these restrictions

by dramatically increasing marketing expenditures and constantly finding new and

sophisticated ways to market their products, many of which impact kids. Between

1998, the year of the MSA, and 2005, the latest year for which data are available,

the major cigarette companies almost doubled their marketing and promotional expenditures from $6.73 billion to a staggering $13.1 billion—more than $35 million

each and every day—much of it aimed at kids. As Judge Kessler concluded in her

opinion: ‘‘In fact, the overwhelming evidence set forth in this Section—both Defendants’ internal documents, testimony from extraordinarily qualified and experienced

experts called by the United States, and the many pictorial and demonstrative exhibits used by the Government—prove that, historically, as well as currently, Defendants do market to young people, including those under twenty-one, as well as

those under eighteen. Defendants’ marketing activities are intended to bring new,

young, and hopefully long-lived smokers into the market in order to replace those

who die (largely from tobacco-caused illnesses) or quit.’’ It’s no wonder that our surveys continue to show kids are almost twice as likely as adults to remember tobacco

advertising.

Judge Kessler also concluded that tobacco company marketing to kids is likely to

continue in the future: ‘‘Similarly, Defendants continue to engage in many practices

which target youth, and deny that they do so. Despite the provisions of the MSA,

Defendants continue to track youth behavior and preferences and market to youth

using imagery that appeals to the needs and desires of adolescents. Defendants are

well aware that over 80 percent of adult smokers began smoking before the age of

18, and therefore know that securing the youth market is critical to their survival.

There is therefore no reason, especially given their long history of denial and deceit,

to trust their assurances that they will not continue committing RICO violations denying their marketing to youth.’’

In addition to allowing virtually unfettered promotion of tobacco products, the absence of any meaningful regulation continues to allow the tobacco industry to manipulate their products in ways that can make them more addictive and/or more

harmful. The introduction of so-called reduced risk products, with no oversight, can

also deceive consumers and undermine their efforts to reduce their risk by luring

them into switching to products that they falsely believe are less hazardous rather

than quitting. It can also attract new smokers with the promise of less harm.

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The lesson is clear: more must be done. The status quo is not working and current

efforts are inadequate. The need for FDA oversight of the tobacco industry is as

great today as ever:

• The tobacco industry continues deceptive marketing that undermines prevention

efforts and appeals to children. • Tobacco products remain toxic and addictive and tobacco companies are free to

manipulate products to make them more appealing and addictive. • There continue to be unsubstantiated health claims made for new and low tar

products. • There are still critical gaps in the industry’s acknowledgement of the health effects of its products.

WHAT THIS BILL WILL DO

This legislation will provide the FDA with the authority it needs to appropriately

oversee the marketing, manufacture and sale of tobacco products. This authority

will benefit public health by reducing illegal sales of tobacco to kids, by limiting

marketing that influences kids to begin smoking and misleads smokers to discourage them from quitting, by ensuring that new products that purport to reduce harm

actually do so, and by requiring tobacco companies to make changes in the products

that make them less harmful to smokers unable to quit.

Key principles of the legislation include:

• Ensures that oversight of tobacco is based on sound science and conducted by

an agency and personnel with scientific expertise and the ability to make adjustments based on new scientific evidence;

• Requires the tobacco industry to make the type of disclosures to FDA that other

manufacturers are already required to make and that are essential to enable the

agency to make well-informed decisions and take effective action;

• Establishes common-sense standards for product regulation and agency action

that are practical, achievable and directed towards a single common goal—to protect

the public health and reduce the number of Americans who die prematurely as the

result of their use of tobacco products;

• Recognizes that how a product is marketed can also have a major impact on

the number of people who needlessly die from tobacco use and establishes marketing

standards that are both consistent with the First Amendment and the FDA’s public

health mission; and

• Provides the FDA with the resources to do the assigned job capably and without

detracting from FDA’s other important missions.

I want to highlight just a few key provisions of the bill and also address some

of the concerns that have been raised about the legislation.

Marketing: Since the Master Settlement Agreement, the tobacco industry has doubled its marketing expenditures with knowledge of the impact of its marketing on

children; continued marketing ‘‘light’’ and ‘‘low tar’’ cigarettes despite clear evidence

that they do not reduce the risk of disease and the public is misled by how they

are labeled and sold; and introduced new tobacco brands backed by new unsubstantiated and unproven health claims that mislead the public. It has become even

clearer that state lawsuits, prior voluntary codes, and current laws have not prevented the tobacco industry from marketing to children or misleading the public.

This bill would put in place a number of specific advertising restrictions that FDA

previously determined, after a two-year investigation, impact tobacco use by children. It also would require the elimination of the use of the terms ‘‘light’’ ‘‘low tar’’

and similar terms, unless the industry could scientifically demonstrate that products labeled ‘‘light’’ and ‘‘low tar’’ actually reduce the risk of disease, and would otherwise prevent the use of other health claims unless a manufacturer presents scientific evidence to support those claims. These are not radical concepts. Manufacturers of drugs and medical devices regulated by FDA are not allowed to make claims

without adequate scientific substantiation because of the adverse impact on the

health of potential consumers. This bill would finally force the tobacco industry to

play by these reasonable rules.

Equally as important, this bill recognizes that the tobacco industry has often circumvented rules designed to curtail both marketing to children and misleading of

the public and provides FDA the needed authority to adopt new rules to address

new conditions as they arise.

A perfect example is the marketing of smokeless tobacco products to children.

Smokeless tobacco companies in the United States have a long history of creating

new products that appeal to kids and marketing them aggressively to children, including adding candy flavors. Even after the Smokeless Tobacco Master Settlement

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1 Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and

Nicotine. Smoking and Tobacco Control Monograph No. 13. Bethesda, MD: U.S. Department of

Health and Human Services, National Institutes of Health, National Cancer Institute, NIH Pub.

No. 02–5074, October, 2001. http://cancercontrol.cancer.gov/tcrb/monographs/13/.

2 The ingredient disclosure requirements of the 1984 Comprehensive Smoking Education Act

have proven wholly inadequate for this purpose. They do not provide the government with information to identify what chemicals and other ingredients are in each brand of cigarettes, the

quantity of the different chemicals, in each cigarette or the type of information that is needed

to understand or evaluate or warn the public about what is in each brand of cigarette.

Agreement, smokeless tobacco companies continued to advertise heavily in magazines with high youth readership and to market to youth through a number of channels, including sports events like auto racing and rodeos that are widely attended

by children. Since 1970, smokeless tobacco has gone from a product used primarily

by older men to one used predominantly by young boys. In 2005, the most recent

year for which FTC data is available, the total marketing expenditures of the top

five smokeless tobacco companies in the U.S. were more than $250 million.

Any advertising regulations must be consistent with the First Amendment. The

bill states that the authority to develop regulations that impose restrictions on the

advertising and promotion of tobacco products must be consistent with, but can be

exercised to the full extent permitted by, the First Amendment. Given the history

of the tobacco industry’s aggressive and misleading marketing, strong authority to

restrict marketing is justified.

The kinds of Federal restrictions on tobacco marketing contained in H.R. 1108 are

consistent with the Supreme Court’s analysis in Lorillard Tobacco Company v.

Reilly. They would survive constitutional challenge because they are carefully tailored, scientifically proven measures to protect the recognized legitimate interests

of the government in protecting 1) children from marketing that contributes to tobacco addiction and 2) adults from misleading marketing that encourages tobacco

use and discourages quitting. Federal action is clearly needed because over 50 years

of voluntary and state governmental efforts to change the tobacco industry’s behavior have not solved the problem.

Establishing Appropriate Standards for the Content of Tobacco Products: Today,

tobacco products contain more than 60 known cancer-causing substances, and the

incidence of disease among smokers has actually increased, not decreased, over the

years, according to the National Cancer Institute. 1

Even as the tobacco industry touted that it had reduced tar and nicotine levels

in its products, the level of potent carcinogens, like nitrosamines, increased without

any public agency having any authority to evaluate the impact of that change.

No Federal agency currently has the authority to require tobacco companies to

disclose, in a meaningful way, what is in each product; to require manufacturers

to provide evidence of the impact of product changes or to require manufacturers

to make technologically feasible changes to products to reduce the number or quantity of harmful substances in tobacco products and the smoke of tobacco products.

H.R. 1108 would address this gap in a practical and reasonable way. It recognizes

that the standard FDA normally applies to many products under its jurisdiction—

whether the product is ‘‘safe and effective’’—does not make sense for tobacco products because there is no such thing as a ‘‘safe cigarette.’’ A ‘‘safe and effective’’

standard would thus dictate a total ban on tobacco products, and with close to 50

million Americans addicted to tobacco use, virtually all public health experts recognize this as infeasible and unproductive. H.R. 1108 recognizes that the goal is therefore to reduce the number of people who needlessly die prematurely from tobacco

use. Thus, the standard in the bill is one based on what actions are ‘‘appropriate

to protect the public health,’’ taking into account the impact of any proposal on the

health of the ‘‘population as a whole, including users and non-users’’ of tobacco products. The bill puts in place measures to prevent kids from starting to smoke and

to ensure that smokers are not dissuaded from quitting by misleading claims, and

it establishes a process to reduce the harm from tobacco products to those who are

unable to quit. 2

The standard in H.R. 1108 recognizes the unique issues raised by the regulation

of tobacco products. This standard looks at the overall impact on the number of people who will die needlessly from tobacco and allows the FDA to broadly consider all

factors that will affect whether a proposed product change will increase or decrease

the death and disease caused by tobacco. It instructs the FDA to look at how a mandated product change will impact individual tobacco users but also look at its impact

on the number of tobacco users by examining its effect on discouraging smokers

from quitting or encouraging non-smokers to start. The goal is protecting the pubic

and saving lives, and the standard set forth in H.R. 1108 is right on the mark.

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Preventing Unsubstantiated Health Claims While Encouraging Real Scientific Innovation to Reduce the Harm Caused by Tobacco Products: For decades, tobacco

manufacturers have been marketing ‘‘light’’ and ‘‘low tar’’ products with claims that

these cigarettes are less risky, leading millions of consumers to switch to these products thinking they are actually reducing their risk of disease or that they were taking a first step towards quitting. The National Cancer Institute, the U.S. Surgeon

General and other credible scientific bodies have subsequently concluded that ‘‘light

and ‘‘low tar’’ products did not reduce the risk of disease and did deter millions of

smokers from quitting. Subsequent to the release of the scientific evidence demonstrating that ‘‘light’’ and ‘‘low tar’’ products have not reduced the risk of disease,

tobacco companies have continued to mislead consumers and have come out with

new products whose advertising includes even more specific claims of reduced risk.

The absence of any regulatory body to review health claims has led to a public

health tragedy that has thwarted the well-intended personal efforts of tobacco users

who have attempted to reduce their risk of disease. This bill would address that

problem in a manner consistent with sound scientific standards. It requires FDA to

prevent unsubstantiated and unproven claims, while permitting a manufacturer

who produces a genuinely less hazardous product, and develops sound scientific evidence of its impact, to responsibly make claims about any such innovative product.

This provision by itself has the potential to save many lives. Before a manufacturer can make a health claim for a product, the legislation simply requires that

manufacturer to demonstrate to FDA that the product significantly reduces the risk

of disease when compared to other tobacco products, and when used in the manner

a consumer will actually use the product. It also requires the manufacturer to show

that any public health benefit for individual users will not be offset by the harm

caused by marketing of the product resulting in increased tobacco use or decreased

cessation.

This section will benefit manufacturers who develop a genuinely safer product and

will adversely impact only those manufacturers who have been making unproven

claims or marketing their products in ways that encourage non-tobacco users to

start or discourage users who would otherwise quit.

Concerns of Tobacco Product Retailers: Convenience store owners have expressed

concerns about provisions in the bill, including those that require retailers to check

the ID of young persons seeking to purchase tobacco products. The youth access provisions of the original FDA regulations in place from 1996 to 2000 were effective

in reducing illegal sales to youth. Congress appropriated funding for this program,

and FDA enforced the youth access restrictions, not by employing Federal agents,

but by contracting with state and local officials, such as health departments and police departments. By 2000, the FDA had contracts with every state to conduct the

compliance checks and had an extensive outreach program that provided resources

and information to retailers. This was a program that was producing solid results

in reducing illegal youth access to tobacco in a manner sensitive to state and local

interests.

This bill does hold store owners responsible for illegal tobacco sales to children,

a policy supported by 87 percent of voters, but it establishes detailed procedures to

protect retailers who diligently require young people to show government-issued

IDs, including procedural protections that were not in place between 1996 and 2000.

In addition, no fines are incurred until repeated violations occur, and retailers are

warned after the first violation that additional compliance checks will be conducted.

The only retailers who will be punished will be those who repeatedly sell tobacco

to kids illegally.

During consideration of this legislation by the Senate HELP Committee, additional provisions were added by the Committee to accommodate the concerns of retailers. Those provisions include: clarifying that retailers receive formal notice of

violations; establishing a graduated system of fines for violations that eliminates uncertainty for retailers; mandating the provision of a hearing by phone or at a nearby

facility; and a number of other procedural protections. The public health community

has not opposed any of these accommodations.

Impact on FDA’s Ability to Regulate Food, Drugs, Devices and Other Products

Currently Under Its Jurisdiction: We recognize that there are concerns about FDA’s

resources and whether it is successfully carrying out its current responsibilities. The

bill responds to these concerns by providing new resources for FDA to create a new

office and hire new, additional staff to carry out the activities required by this legislation. The new responsibilities would be funded through a user fee on the tobacco

industry, so it would have no impact on the funding provided to FDA to carry out

its other important activities. The user fees are allocated among the manufacturers

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port this legislation care deeply about the many important tasks of the FDA including drug and device approval and the work the agency does to protect our food supply. But we also believe that a key to improving the Nation’s health is reducing the

harm caused by tobacco products.

Recognizing that the tobacco responsibilities should be implemented by new staff,

the Senate HELP Committee, during its consideration of the legislation, created a

new center for tobacco products to carry out the purposes of this legislation. This

provision was designed to clarify the intent of the bill’s authors that FDA authority

over tobacco products will not interfere with other FDA activities.

FDA IS THE RIGHT AGENCY TO REGULATE TOBACCO PRODUCTS

Some have argued that the FDA is not the right agency to regulate tobacco products, but that is essentially an argument for no regulation of tobacco products at

all. It is an argument for the continuation of the unacceptable status quo in which

tobacco products kill more than 400,000 people in the United States each year. This

is because FDA is the only agency with the scientific expertise and regulatory experience to effectively regulate tobacco products to reduce the death and disease they

cause.

There is no question that tobacco products are uniquely lethal and different from

any other product on the market. In fact, if tobacco products were introduced for

the first time today, they wouldn’t be allowed on the market at all. But the reality

is there are nearly 50 million addicted tobacco users in the United States and public

health experts recognize it is not feasible to ban tobacco products. The question then

is this: What government agency is best qualified to regulate this dangerous product

to reduce the death and disease it causes? The FDA is the only agency that can do

the job well.

Some have argued that other Federal agencies, such as the Federal Trade Commission (FTC), the Centers for Disease Control and Prevention (CDC), the National

Institutes of Health (NIH), the Environmental Protection Agency (EPA), or even the

Agriculture or Treasury Departments (USDA/DOT) would be more appropriate to

handle the job of tobacco product regulation. But the FDA is a public health regulatory agency, and the others are not. The FTC’s primary orientation is law enforcement and broad consumer protection; the NIH’s is research; the CDC is primarily

focused on preventing disease outbreaks, injury and disability. EPA works to develop and enforce regulations that implement environmental laws enacted by Congress; the Alcohol and Tobacco Tax and Trade Bureau at the Treasury Department

describes its mission as ‘‘to collect taxes owed;’’ and USDA is primarily involved

with the business of farming, not in overseeing non-food manufactured products

such as cigarettes.

These other agencies do not have the requisite expertise to regulate the design

and content of tobacco products or to know about the accuracy of health claims

about these products. The FTC, for example is, by its own admission, an ‘‘agency

of lawyers and economists’’ and is not a science-based agency. The FDA is the only

agency with the scientific expertise, regulatory experience and skills, and public

health mission to effectively regulate tobacco products and the health claims about

them.

Impact on Tobacco Companies: Some tobacco companies have argued that this bill

will give an advantage to one tobacco manufacturer over others, that some tobacco

companies cannot comply with stringent FDA regulations and that industry leaders

will benefit by the bill’s restriction of tobacco marketing. None of these arguments

have merit.

When the FDA sets safety standards for foods and drugs, its focus is on safety

and efficacy, not the size of the manufacturer or the impact on market share. For

those other products, the only manufacturers who are hurt are those who can’t meet

FDA’s public health standards. This bill does the same for tobacco products and creates a level playing field for all manufacturers.

That said, it should be noted that H.R. 1108 contains several provisions that consider small manufacturers’’ resources and take into account that they may need

more time and technical assistance to comply, including making clear that FDA

should take into account the financial resources of the different manufacturers in

setting effective dates for good manufacturing standards, and that FDA should minimize, consistent with the public health, economic loss to domestic and international

trade.

In addition, the Senate HELP Committee went even further during its consideration of the legislation, creating a special office within FDA tasked with providing

assistance to small tobacco product manufacturers. The Senate Committee also

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added a representative of small manufacturers to the Tobacco Products Advisory

Committee as a non-voting member.

The bill’s marketing restrictions are also fair and balanced. Today, close to 90 percent of all new long term smokers began as children. It is a strength of this legislation, not a weakness, that it provides a comprehensive attempt to restrict marketing

that appeals to children. The tobacco industry claims its marketing is about brand

competition among smokers; the industry’s own documents and Judge Kessler’s decision last August reflects powerful evidence that the industry’s advertising is a major

contributor to tobacco use by youth. What is of paramount importance to public

health is the size of the overall market for tobacco products, NOT the market share

of any particular company. We believe that this legislation will significantly reduce

the number of people who use tobacco and who become sick and die as a result.

State and Local Authority: The legislation achieves a reasonable balance between

Federal and state or local authority over tobacco. It allows the states to continue

to regulate the sale, distribution, and possession of tobacco products and would expand state authority to regulate tobacco product marketing and promotion. To ensure consistent product standards nationally, however, the legislation reserves to

the Federal Government the right to regulate the product itself, which is consistent

with the way the FDA regulates other products under its jurisdiction.

We believe that states and localities ought to be able to control the time, place

and manner of tobacco advertising in their communities, and this legislation will

allow them to do that for the first time in almost forty years. The bill cuts back,

but does not fully eliminate, the exemption for the tobacco industry passed in 1969

as part of the Federal Cigarette Labeling and Advertising Act. That act prevented

the states from regulating cigarette advertising, even purely local forms of cigarette

advertising. The bill returns to state and local governments the ability to impose

limitations on the time, place and manner of marketing and advertising practices,

but not on the content of ads. The states already have this authority for smokeless

tobacco products and other products regulated by FDA, and it has not created problems for the marketplace.

The sponsors of this legislation were careful to specifically make clear that the

legislation does not curtail any of the areas states have traditionally used to reduce

tobacco use. Under the legislation, state and local governments would—continue to

be free to adopt measures regulating exposure to secondhand smoke; restricting

youth access to tobacco products; and enacting fire safety standards for tobacco

products. In short, the bill in no way restricts states from pursuing policies such

as smoke-free laws, tobacco taxes, fire-safe measures, age requirements, identification checks, retailer licensing and fines, and other restrictions on the sale and distribution of tobacco products that have been instrumental in reducing tobacco use.

States would also be able to impose additional reporting requirements on tobacco

manufacturers (as Massachusetts, Texas and Minnesota have done) if there was any

information FDA was not getting or not sharing that a state thought would be useful.

The bill does give the FDA exclusive authority in such areas as tobacco product

standards, pre-market approval, adulteration, misbranding, labeling, registration,

good manufacturing standards, or modified risk products. States could not establish

requirements in these areas. This approach is consistent with Federal law regarding

FDA regulation of drugs, devices, and food because—it provides for a consistent national standard.

Permitting Cross Category Comparative Health Claims: The bill permits the FDA

to authorize tobacco manufacturers of one type of tobacco product to make health

claims comparing the risks of its tobacco to other forms of tobacco products, but only

if the manufacturer has presented sufficient scientific evidence that the advertised

product is indeed safer and will reduce the user’s risk of disease—in this regard,

the bill is explicit. There has been a debate about whether the use of smokeless tobacco by committed, addicted smokers who can’t or won’t quit can be a useful harm

reduction strategy. This bill sets the scientific standard for FDA making such a determination, but doesn’t prejudge the scientific result. If a smokeless tobacco manufacturer provides the FDA with adequate scientific evidence that a specific product

or group of products is less hazardous than a cigarette product and will reduce the

risk of disease among certain tobacco users, FDA is authorized to permit the smokeless manufacturer to make an approved claim. However, in making such a determination, FDA is required to consider the population-wide impact of permitting such

claims, including the impact of any claims on the number of smokers who would

otherwise quit using tobacco altogether and the number of people who begin using

tobacco products.

Limitations on FDA’s Authority Over Tobacco Growers and Leaf Tobacco: The bill

contains a number of specific prohibitions against the exercise of FDA authority on

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tobacco farms. The bill establishes FDA authority over tobacco manufacturers and

their products and prohibits FDA from regulating leaf tobacco. Even FDA’s standard-setting authority is limited to standards for manufactured tobacco products.

Many tobacco growers believe American producers, much more easily than their foreign competitors, will be able to swiftly produce the quality tobacco leaf manufacturers require, and that consequently the legislation may provide American growers

with a comparative advantage over foreign competition.

Mr. Chairman, in summary, the Campaign strongly supports this bill, and we

firmly believe that it will help protect our kids from tobacco companies and their

deadly products and deceptive advertising. It will help more adult tobacco users to

quit, and it will greatly benefit the public health of the Nation.

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Mr. WAXMAN. Thank you very much. We will be pleased to add

any further comments you have for the record.

Before we start questioning, let me indicate that two of our witnesses had to leave to do another engagement so members of the

committee will be afforded the opportunity to submit questions in

writing to any of our witnesses after the hearing and of course for

those of you here, we would welcome you to respond to those questions.

Let me start off with Dr. Henningfield. Dr. Blum and others have

raised concerns about the authority given to FDA under the bill to

regulate the design and contents of cigarettes. Some have suggested that tinkering with the ingredients in a cigarette in the

hopes of making it less dangerous is a fool’s errand and that it

amounts to conducting R&D for the tobacco industry while misleading consumers into thinking that cigarettes are safe. Do you agree

with that assessment?

Mr. HENNINGFIELD. No, I don’t. Currently, we know that even an

old-fashioned simple cigarette is deadly and addictive just like an

old-fashioned muzzle-loading rifle is deadly. Modern cigarettes are

more like armor-piercing bullets with laser guidance and rapid fire.

That is the difference and that is part of the reason, for example,

why police departments often oppose armor-piercing bullets: they

kill more people more rapidly. Modern cigarettes are designed with

a lot of different kinds of innovations, chemical and physical, to increase their ability to pierce the armor. Last night I looked at a

Camel snus Web site where it explained that the pleasure occurs

about 5 minutes after you put the snus in your mouth. Snus is a

type of oral smokeless tobacco product. Now, the flavor, which I

thought they used to say is where the pleasure was, occurs as soon

as you put it in the mouth. They have obviously designed it to deliver the nicotine to the brain in about 5 minutes. That is by design, and in my experience, that was designed to be very effective

at hooking people.

Mr. WAXMAN. Well, what would you think about the idea of lowering or even eliminating the nicotine in cigarettes completely?

Would it reduce or—I know the bill wouldn’t allow nicotine to be

completely eliminated, but with respect to reducing the nicotine to

extremely low levels, is there any scientific evidence that there is

a level of nicotine below which it is no longer addictive?

Mr. HENNINGFIELD. We know that there is a threshold and people that have looked at this agree. Whether or not lowering nicotine over time is something that could or should be done is another

question. I believe that FDA needs to have the authority to do that

but I myself who have argued how that could work have argued in

my writings with others that before you would implement such a

policy, we need a lot of things in its place including treatment, including more research as to how to do it. So I think the agency

should have the authority. The tobacco industry itself has argued

that that would be tantamount to prohibition. They understand the

power of nicotine to addict. So I don’t think it is something FDA

should launch as a first effort. I concur with the FDA’s own conclusion in the 1990s on this matter.

Mr. WAXMAN. Mr. Corr, let me follow up that question with you.

I am interested in how well you think the bill would address a comVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00138 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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plex scientific issue like regulating nicotine levels. I know that

some have raised concerns that if FDA lowered the amount of nicotine in cigarettes, consumers would simply smoke more or inhale

more deeply, possibly endangering their health more than if the

levels had remained the same. Is this really a danger, and under

this bill, would FDA be required to order a change in nicotine levels if there was evidence that it would cause people to smoke more

or inhale more deeply to get the nicotine they need out of the cigarette?

Mr. CORR. Mr. Chairman, this legislation gives FDA the authority it needs to make science-based public health decisions. The

standard for many of its decisions will be appropriate for the protection of public health. In the instance you are talking about, FDA

would have to make a decision based on the science as to what

level of—what the consequences might be, as Dr. Henningfield just

said, of reducing nicotine. There are no mandates with regard to

nicotine levels in this bill. There is simply authority for the agency

to act consistent with public health.

Mr. WAXMAN. And you would disagree with Dr. von Eschenbach

when he says that there is little science available to FDA on which

to base decisions on tobacco product standards. He doesn’t think for

that reason that FDA ought to have jurisdiction. You made it very

clear in your presentation that you thought FDA was the place to

have this regulatory agency. I guess he is fearful that they don’t

have the science at that agency. How would you respond?

Mr. CORR. This legislation would anticipate that FDA would act

based upon sound science. They would have the regulatory authority and the mandate to protect public health. Dr. Henningfield can

speak to the state of current science but the agency’s responsibility

would be to compile the science and to make sound public health

decisions. Once again, the bill does not mandate any particular action with regard to product standards. It simply gives the agency

the authority to protect public health.

Mr. WAXMAN. Thank you very much.

I want to yield to my colleague.

Mr. SULLIVAN. Thank you, Mr. Chairman, and I want to thank

the witnesses for being here today and we all I think can agree

that we don’t want kids smoking and we want to do all we can to

make sure they don’t. I think everyone wants that. We don’t want

kids buying cigarettes. We hope they don’t even start. We don’t

want any kid to start down that path but this is a big issue about

the regulatory efforts of the agency to regulate this product, and

I have a question for Mr. Ballin. Mr. Ballin, you have written extensively about the difference between combustible tobacco products, non-combustible tobacco products and alternative nicotine

products. Does the legislation before us today adequately reflect

those differences, and if not, how could it be improved to do so?

Mr. BALLIN. Well, in the testimony I have submitted, we have

suggested that it might be more appropriate for all nicotine and tobacco products to be brought under one umbrella and that we address the overlapping regulatory issues for combustible products,

non-combustible products and also the therapeutic products so that

we can label things according to risk and relative risk, restrict advertising and marketing of those products based on risks and relVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00139 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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ative risks so that the consumer for the first time when they go

into the CVS and look at that wall of all those various products

will understand what those products do and do not do. We are far

from that because there have been certain scientific research studies that when people are asked what is more dangerous, they get

it all wrong. A lot of people think smokeless products are a lot

more dangerous than cigarettes. They also think that some of the

nicotine replacement therapies are more dangerous than cigarettes.

We have got a lot of sorting out to do with respect to making sure

that consumers are fully educated, understand the risks and relative risks of the products available to them.

Mr. SULLIVAN. And also in your view, does this bill provide adequate incentives for the industry to develop reduced-risk products

like smokeless tobacco?

Mr. BALLIN. Well, I think one of the things that we have suggested but it is not our suggestion, it was the Institute of Medicine

as well as others, that there have to be incentives for industry, and

I am not just talking about the tobacco industry. I am also talking

about giving incentives to pharmaceutical companies and other

biotech companies who are working in these areas to develop these

products. I didn’t see much in the bill that does that. I think there

needs to be greater encouragement with regulatory oversight. You

have to have the oversight in order to be able to do it effectively.

You just can’t say go do this because we are going to end up along

the same lines that Dr. Henningfield has mentioned, going down

the low-tar, low-nicotine road. You have got to have regulation but

we also have to give incentives for companies to change their behaviors.

Mr. SULLIVAN. Thank you.

And Mr. Armour, in your opinion, does H.R. 1108 give massive

new authority to the FDA to regulate the retailing of tobacco products? I know that socially responsible retailers go to great lengths

to assure their employees do not make illegal sales. States already

regulate retail outlets so they can be given standards to follow

without adding huge costs. Is this not the case if FDA regulates retail sales correctly?

Mr. ARMOUR. Congressman, the short answer is yes. As you saw

from the chart, the States have done an excellent job in reducing

non-compliance since 1997 and I think in the testimony this morning, it was pointed out that there were State by State interesting

ways to reduce youth access to tobacco and our concern is by creating an entirely new bureaucracy at FDA duplicating State efforts

that we are going to replace or put a whole other system there that

interferes with what has been an effective system. I think it is important, as I said in my testimony, we don’t oppose it at all. We

take no position on FDA regulation of the manufacturing process

of cigarettes. We do have problems with H.R. 1108 with respect to

retailing because we think at State level it has been done effectively. We think that the Federal Government can set standards as

it did in the Synar amendment to further reduce youth access to

tobacco.

Mr. SULLIVAN. Thank you very much. I appreciate that. I think

that was a good answer. I appreciate it. Thank you.

I yield back.

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Mr. WAXMAN. Thank you very much.

Mrs. Capps.

Mrs. CAPPS. Thank you, Mr. Chairman, and Mr. Corr, thank you,

each of you. This has been a long day for you and some of us have

had to come and go, but I believe the topic is of such importance

that I am glad you stayed and thank you very much for the testimony each of you have given.

Mr. Corr, I am interested in learning a little bit more from you

how this legislation would impact the labeling for a product like

Camel No. 9 which clearly targets young women and girls. You referred to it in your testimony, and I don’t know if you remember

way back to the opening statements but we will get the charts up

again, and I am co-chair now of the Congressional Caucus for

Women’s Issues and several of us, and not just us, have made it

a point to become involved in this issue that does directly relate

to, we feel, enticing new consumers of tobacco. It is my understanding that the legislation before us would require the removal of

terms such as ‘‘light’’ and ‘‘low’’ and ‘‘mild’’ which have misled

smokers into believing that these products might be less risky or

less harmful than other regular cigarettes. Is that correct?

Mr. CORR. That is correct, Congresswoman Capps.

Mrs. CAPPS. And there seems to be a lot of bright pink in the advertising on the packaging for Camel No. 9. I would think that the

use of pink coloring and terms such as ‘‘luscious’’ would be directed

toward attracting young girls to this product. I wonder if you have,

because your organization does target young children and teenagers and hoping that they don’t smoke and working toward that

goal, would this legislation do anything about the colors? Could it

be useful to structure the advertising such as is used now in the

magazines that young women are attracted to for Camel No. 9 as

one example of the kind of packaging and promotional materials?

Would it do anything about the use of terms such as ‘‘luscious’’?

Mr. CORR. Congresswoman, the legislation as you pointed out

does ban terms like ‘‘light,’’ ‘‘low’’ and ‘‘mild.’’ It also gives FDA the

authority to consider other aspects of advertising and marketing

and its impact on young people. For example, based on evidence

that terms like ‘‘luscious,’’ colors, imagery were being used in a way

that influenced and attracted young people, the agency would have

the authority to prohibit that.

Mrs. CAPPS. And in your work with young children, have you determined that they are vulnerable to, they are easily persuaded by

such colors and use of such language?

Mr. CORR. There is a well-established record to that effect. It is

why the FDA in its 1996 rule requires that all advertising and promotion in publications, at point of sale, and on outdoor billboards

would be black-and-white text only; removes the imagery and colors that are so attractive to young people. It still allows, as Mr.

Bonnie pointed out this morning, the companies to continue to communicate other information to adults consistent with the first

amendment.

Mrs. CAPPS. Well, I took it upon myself to, as I was waiting in

line at the grocery store to pick up a magazine like this one and

thumbing through it like we are inclined to and I have seen a lot

of young kids doing the same kind of mimicking their parents or

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the older adults that they are with but when you turn to a page

like this, and you see it blown up there, but this is what it looks

like in this month’s issue of Glamour magazine, and I don’t mean

to pick on them particularly but they are one of several women’s

magazines that run these very ads and have been doing so now for

several months right around back-to-school time. This ad over here

is the one that is very deceptive because it is called Dress to the

Nines. You notice this fashionable shoe is replicated in the word

‘‘stiletto’’ over here and if you look down here to see where you can

get some of this free stuff, you are directed to camelsmokes.com. There are two pages worth of tobacco advertising right here and if

you thumb through, this page looks like several other pages of

fashion layouts in a magazine that is known for this. Young kids

are thinking about what to buy. When they go back to school, they

want to look like the big girls and this is what they pick up.

Mr. CORR. In the absence of FDA regulation, you and others have

raised this to the attention, the consciousness of the American people and to these magazines. Possibly they will stop it. It is just a

matter of time before you see another kind of advertising like this

that they will come up with. It is why it is imperative that the

FDA have the authority on an ongoing basis to evaluate and regulate advertising and promotion to protect public health.

Mrs. CAPPS. Thank you. I understand that when Camel No. 9

was launched, promotional events were planned in several States

to generate interest in the new cigarette. At these events, women

were given pink-colored goody bags with promotional items, many

with the Camel logo on them, including makeup, hand lotion and

even cell phone jewelry, which is typically used not by career

women but by teenagers, teenage girls. It is my understanding that

under this legislation, FDA would be allowed to restrict these types

of giveaways. Is this true?

Mr. CORR. Yes, it is, Congresswoman. Any kind of brand name

on these products, recognizable patterns of color, those types of

things would be prohibited.

Mrs. CAPPS. There is a history with this with Joe Camel, right?

Mr. CORR. There is a long history with this.

Mrs. CAPPS. Thank you very much all of you.

I yield back.

Mr. WAXMAN. Thank you, Mrs. Capps.

Mr. Deal.

Mr. DEAL. Thank you, Mr. Waxman.

I apologize to the panel members for not having been here for

hearing all of your testimony. We had an important bill on the floor

of the House that we have been debating and that is where I was.

And I will not bore you with further questions because I don’t know

what you have already answered and I would certainly not want

to be duplicative of questions you have already entertained.

Mr. Chairman, I would ask unanimous consent that the written

testimony from the chairman of Phillip Morris USA be included in

the record.

Mr. WAXMAN. Without objection.

Mr. DEAL. Let me just say though to all of you that obviously

there are some different points of view that have been expressed

both by others as they looked at the legislation. I do think it is

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helpful for us to hear those concerns, if possible to have the legislation address those concerns, and I thank Mr. Waxman for his willingness to listen to concerns and make concessions even prior to

this hearing here today as this legislation was being crafted. I do

thank all of you for taking your time and we regret that we prolonged your day with votes but that is just the nature of the beast

here, and with that, I would yield back my time.

Mr. WAXMAN. Thank you, Mr. Deal.

I too want to join in thanking each of you for your presentation

and willingness to wait this long day for this hearing and I want

to continue to work with all of you on this legislation. We want to

get the very best product because I think we all share the same

goals.

That concludes the hearing and we stand adjourned.

[Whereupon, at 3:30 p.m., the subcommittee was adjourned.]

[Material submitted for the record follows:]

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STATEMENT OF MIKE SZYMANCZYK

CHAIRMAN AND CHIEF EXECUTIVE OFFICER, PHILIP MORRIS USA

On behalf of the nearly 11,000 employees of Philip Morris USA (PM—USA) I am

very pleased to submit these remarks, and to express our strong support for H.R.

1108, legislation that would give the Food and Drug Administration (FDA) authority

to regulate tobacco products. Almost five years after we announced our full support

for FDA regulation, PM—USA remains committed to passage of comprehensive regulation of tobacco products. H.R. 1108 can serve to create a uniform set of Federal

standards for the manufacture and marketing of tobacco products. In addition, regulations promulgated pursuant to this legislation should provide clear guidelines and

oversight of products that could potentially reduce the harm caused by tobacco use.

H.R. 1108 is the result of many difficult choices and compromises by all those who

have been involved in this process over the last several years. The bill clearly provides the framework for comprehensive FDA regulatory authority over tobacco products. We commend you for moving forward with this bipartisan legislation that provides important policy solutions to many of the complex issues involving tobacco

products.

We applaud Congressman Waxman and Congressman Davis for the leadership

they have shown on this issue. Likewise, we appreciate the leadership shown by

Senator Kennedy and Senator Cornyn in introducing companion legislation in the

United States Senate. We look forward to working with you and your colleagues in

the Senate to enact this legislation intended to benefit adult consumers by reducing

the harm caused by tobacco consumption, and to establish clear rules that will be

applied to, and hopefully enforced uniformly, throughout the tobacco industry. Uniform enforcement of such rules by the FDA will be critical to reducing the harm

for adult tobacco product consumers.

HARM REDUCTION—FIRST AND FOREMOST

We believe that adult consumers should be and will be a primary beneficiary of

FDA regulation. H.R. 1108 will serve to accomplish this goal by providing a new

framework within which manufacturers can re-focus their efforts in reducing the

harm of their products. As in many other industries, the companies that do the best

job of exceeding their consumers’ expectations, while meeting regulatory standards,

will both benefit their consumers and achieve the best business results.

Our goal, which we believe would ultimately provide both societal and shareholder

value, is to design the best products we can, and then, ideally under the full regulatory oversight of the FDA, make them available to adult smokers who do not quit.

It seems clear to us that we will not be able to make progress in this area unless

two critical conditions are met: first, that manufacturers such as ourselves develop

successfully and make available products that reduce smokers’ exposure to harmful

compounds compared to conventional cigarettes, and second, that current smokers

are given a reason—through communication of truthful, non-misleading information

that avoids unintended consequences—to switch to these products. For people who

continue to smoke, we believe that this is the best way to meaningfully reduce the

overall harm caused by smoking.

We have invested in extensive research programs that focus on advancing our

knowledge about tobacco and tobacco smoke to support our efforts to develop and

launch new product designs. We believe these product technologies and related approaches show promise for the future, and that the FDA should be empowered as

quickly as possible by enactment of this legislation to evaluate products and their

potential for reducing the risk of contracting smoking-related diseases.

We respectfully urge our future regulators at the FDA to keep in mind that innovation in developing new products is crucial to the ultimate success of this legislation. In order to have any real impact, reduced exposure and other potential harm

reduction products must be acceptable to adult tobacco users. We see little benefit

to consumers or society if harm reduction is not pursued in the context of tobacco

products that adult consumers will enjoy using. As the 1998 Canadian Experts’

Committee, which addressed potential harm reduction products for smokers, concluded, ‘‘[i]f smokers would not buy these products, product modification initiatives

would fail.’’

Importantly, once the FDA concludes as a matter of science that a new product

has the potential to offer reduced exposure or reduced risk, H.R. 1108 grants the

agency an essential role in performing its own assessment and oversight of any

claims, explicit or implied, made about the product by the manufacturer regarding

exposure- or risk-reduction. Crafting appropriate claims regarding these products reVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00215 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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quires great care and attention. We are mindful of the critical need for manufacturers to work closely with the FDA on consumer messages.

Once again, as with determinations regarding the scientific issues of potential exposure and risk reduction, we believe H.R. 1108 correctly gives FDA jurisdiction

over communications to consumers. Future FDA regulations should ensure that consumers are not mistakenly led to believe that the use of a particular tobacco product

reduces the health risks as much as quitting. At the same time, we do not believe

future regulations should be utilized as a tool to suppress information that is truthful and not misleading.

We are keenly aware that some members of the public health community are opposed to the very concept of developing and offering ‘‘reduced exposure’’ or ‘‘reduced

risk’’ tobacco products. They are concerned that the availability of such products

might discourage smokers from quitting or encourage people to start using tobacco

products. These advocates appear to believe that the only acceptable message for the

government to communicate, irrespective of potential alternatives, is a directive not

to consume tobacco products at all. PM—USA strongly believes if products that

could ultimately reduce the harm caused by smoking are developed, it would be

wrong to deny adult smokers access to information about the facts of reduced exposure or reduced risk products and the potential benefits of such products. Section

911 sets out rigorous requirements that must be met before manufacturers could

communicate about these types of products. We agree fully with the need for such

rigorous requirements while urging future FDA regulators to take note of the Institute of Medicine admonition in its 2001 report that ‘‘[the] regulatory process should

not discourage or impede scientifically grounded claims of reduced exposure, so long

as steps are taken to ensure that consumers are not misled...’’ We believe that approach is both good policy and required by the first amendment.

REDUCING YOUTH SMOKING—A CRITICAL PRIORITY

In 1998 PM USA created a Youth Smoking Prevention department with the objective of helping to prevent kids from smoking cigarettes. We are committed to this

effort because we firmly believe that kids should not smoke.

H.R. 1108 aims to help reduce youth smoking. Among other things, it would prohibit self-service transactions (except in adult-only facilities), establish a national

minimum age of 18, require age verification for anyone younger than 27 years of

age, and prohibit the sale of unpackaged cigarettes (so-called ‘‘loosies’’). We commend the cosponsors of this legislation for taking these steps. We believe that by

working together, we can all contribute to continuing the reduction in youth smoking rates that has occurred over the past decade.

A number of other provisions in the legislation deserve further discussion and

comment.

SECTION 901—FDA AUTHORITY OVER TOBACCO PRODUCTS

H.R. 1108 creates a new chapter within the Food, Drug, and Cosmetic Act to regulate tobacco products. Importantly, tobacco products will not be regulated as a drug

or device. Moreover, the bill explicitly states that one of ‘‘the purposes of this Act’’

will be ‘‘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.’’ While the bill extends the scope of FDA’s authority to all manufacturers

of tobacco products selling tobacco products in the United States, it also makes clear

that FDA does not have the authority to regulate tobacco growers. FDA will not be

on the farm.

SECTION 903—MISBRANDED TOBACCO PRODUCTS

Pursuant to the legislation, tobacco products will be deemed misbranded if their

label is false or misleading or they are not correctly labeled. Of real significance to

America’s tobacco growers and their families and communities, a tobacco product

will be misbranded if the label does not contain an accurate statement of the percentage of the tobacco used in the product that is domestically grown and the percentage that is foreign grown.

SECTION 904—SUBMISSION OF HEALTH INFORMATION

The bill requires, within six months of passage, submission to the Secretary of

documents and information concerning ingredients, compounds, paper, filter and

other components of tobacco products as well as content, delivery and form of nicotine. PM USA fully supports this requirement with appropriate safeguards to proVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00216 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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tect our trade secrets, which this bill provides. We think the FDA should be able

to give smokers confidence that the ingredients added to cigarettes do not increase

the inherent health risks of smoking, including increasing the addictiveness. Further, we have no objection to disclosing the results of our own ingredients testing

to the FDA so it can assess every ingredient we use. The same is true for other information that may be requested by the Secretary under this section including information related to research activities and findings, scientific information on reduced

risk products and technology and marketing research.

SECTION 905—ANNUAL REGISTRATION

H.R. 1108 requires the registration of every entity that owns or operates any establishment in any state engaged in the manufacture, preparation, compounding, or

processing of tobacco products. While these same requirements extend to foreign

manufacturers of tobacco products, it will be critical for FDA to ensure the evenhanded application of the legislation to these foreign manufacturers, including

through appropriate inspections.

SECTION 906—GENERAL PROVISIONS RESPECTING CONTROL OF TOBACCO PRODUCTS

The section allows for regulations requiring good manufacturing practices (GMPs)

with input from the public and interested parties and provides for a three-year

delay for compliance to ensure that manufacturers have ample opportunity to comply.

SECTION 907—PRODUCT STANDARDS

H.R. 1108 grants the Secretary the authority to adopt performance standards for

tobacco products if ‘‘appropriate for the protection of the public health.’’ Although

broad, the delegation of authority to the FDA to issue product standards is fully

supported by PM USA. It will allow FDA to reduce harm by imposing mandatory

design changes on tobacco products. These standards could include provisions to regulate nicotine yields and other constituents and components of cigarettes. It also

will ban the sale of candy or fruit-flavored cigarettes.

We believe future FDA regulators should be very cautious and avoid doing what

no one should want: to impose changes that are so radical that tobacco products are

effectively banned, or consumers are driven away from the legitimate market towards illicit, completely unregulated products. In fact, the legislation explicitly directs FDA to consider whether a standard would create a significant new demand

for contraband, including counterfeit, products, in determining what would, and

would not, be ‘‘appropriate to protect public health.’’ We urge future FDA regulators

to fully consider the warning voiced by the FDA in the 1996 tobacco rule regarding

this subject:

Black market and smuggling would develop to supply smokers with these products ... [which] would be even more dangerous than those currently marketed, in

that they could contain even higher levels of tar, nicotine, and toxic additives.

In addition, a product standard may not have the effect of ‘‘banning all cigarettes’’

or reducing nicotine yields ‘‘to zero’’; this power is explicitly reserved to Congress.

SECTION 911—MODIFIED RISK TOBACCO PRODUCTS

Much of my earlier testimony is focused on the importance of harm reduction.

These provisions are essential to that goal and must be implemented by FDA in a

careful, thoughtful manner in order to be successful in achieving everyone’s goal of

reducing the harm caused by tobacco products. In its 2001 report, the lnstitute of

Medicine committee made two important, fundamental recommendations: (i) determinations about what is, and what is not, a reduced-risk or reduced-exposure product should be made by the government on a purely scientific basis and (ii) any

claims made about such products should be strictly regulated to ensure that consumers are not misled. We believe H.R. 1108 gives FDA the necessary level of authority and discretion to achieve both.

Significantly, the bill creates a special rule for certain products where the label,

labeling or advertising contains an explicit or implied statement that the product

contains a reduced level of a substance, or presents a reduced exposure to a substance if the Secretary makes such a finding based on a number of criteria. We believe the bill appropriately and reasonably empowers FDA to approve applications

for products that make exposure-reduction claims for 5-year periods, utilizing criteria that appear to have been substantially derived from the 2001 Institute of Medicine Report.

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SECTION 920—USER FEES

H.R. 1108 requires the Secretary to require tobacco product manufacturers and

importers to pay for providing, equipping and maintaining adequate service for regulating tobacco products. PM—USA believes the collection of such user fees is reasonable, assuming appropriate oversight and strict collection and enforcement by

the agency.

SECTION 102—REPROMULGATION OF FDA’S 1996 FINAL RULE

Within 30 days of enactment of H.R. 1108 the Secretary is required to publish

a final rule on the advertising of, and access to, tobacco products, which shall become effective no later than one year after the date of enactment. The rule will be

identical in its provisions to the advertising and access regulations promulgated by

the FDA in 1996. Prior to making any amendments to the rule, the Secretary would

be required to publish a proposed rule.

In addition, under section 906(d) of the legislation, FDA would have authority to

impose additional or different restrictions on the sale, distribution, advertising and

promotion of tobacco products if the Secretary determines that the regulation would

protect the public health and, as the bill specifies, the marketing and advertising

restrictions are consistent with the first amendment.

The bill explicitly provides that FDA will not be permitted to prohibit the sale of

any tobacco product to adults age 18 and over. Further, it does not permit the Secretary to require that tobacco products be available only by prescription.

The timing of these requirements is important. At the same time that we will be

making the transition into the new regulatory environment, we understand that

FDA will also be transitioning into its new role, including putting the necessary regulatory structures and resources into place.

As such, it will be critically important for FDA and the industry to work closely

together in order to provide for a smooth transitional period, such as was accomplished with the State Attorneys General with respect to the transition into the

MSA and with other government agencies that have been granted new or additional

authority over tobacco products. For example, it will be important to work out reasonable timelines for the substantial new requirements that are contemplated by

the legislation.

PM—USA will also work with FDA and other interested stakeholders to make

sure that any advertising or marketing restrictions comport with the first amendment.

SECTION 201—CIGARETTE LABEL AND ADVERTISING WARNINGS

This section of H.R. 1108 specifies nine new warning labels required to appear

on cigarette packages and advertisements. The warnings must comprise at least the

top thirty-percent of the front and rear panels of the package, and at least twentypercent of the related advertisements. It will be unlawful for a manufacturer, importer, distributor or retailer to advertise any cigarette unless its advertising bears

one of the required warning labels. PM—USA fully supports these provisions regarding the new warning labels and their size and placement. PM—USA also supports the grant of authority to FDA to modify or enlarge these warnings in the future through a rulemaking process where the potential benefits, risks and unintended consequences of such proposed changes will be thoroughly examined.

I will conclude by reiterating a point made earlier: a comprehensive national tobacco policy should bring more, not less, beneficial competition to the U.S. tobacco

industry. We do not believe that H.R. 1108 is designed to, or would in fact, give any

one tobacco company a commercial advantage over others, notwithstanding the assertions of some manufacturers. Tobacco companies know very well that the first

amendment of the Constitution guarantees that the FDA could not ban tobacco

product advertising. An appropriate and constitutionally sound regulation of tobacco

products and advertisements would effectively ensure the continuation of vigorous

competition in the market place.

The most significant restrictions placed on the tobacco industry in recent history

were those contained in the Master Settlement Agreement (MSA). Those changes,

which restrict billboard and transit advertising among other things, did not lock in

any single company’s market share. In fact, since the adoption of the MSA, there

are examples of both new brands and pre-existing ones that have increased their

market share.

History and the facts simply do not support the contention that constitutionally

proper advertising or marketing restrictions will lessen competition, create a monopoly or lock in market share. Indeed, we believe that, with clear guidelines and overVerDate 11-SEP-98 09:27 Oct 22, 2008 Jkt 000000 PO 00000 Frm 00218 Fmt 6633 Sfmt 6633 Q:\DOCS\110-69 SCOM1 PsN: SCOM1
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sight, there should be an opportunity for increased competition as both new and existing manufacturers work to develop and commercialize products that could potentially reduce the harm caused by tobacco use.

Thank you for allowing us to submit these views to the committee. Thank you for

your leadership and commitment to this issue. Please know that we will work tirelessly to secure enactment of H.R. 1108, which represents a truly historic opportunity to establish a comprehensive and coherent national tobacco policy.

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