U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

            FOOD AND DRUG ADMINISTRATION

 

              FDA OBESITY WORKING GROUP

 

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            FDA PUBLIC MEETING ON OBESITY

 

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                      THURSDAY,

 

                  OCTOBER 23, 2003

 

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            The meeting was convened in the Jack Masur

Auditorium at the National Institute of Health,

Bethesda, Maryland at 9:00 a.m., LESTER M. CRAWFORD,

D.V.M., Ph.D., Chair, presiding.

 

PRESENT:

 

LESTER M. CRAWFORD, D.V.M., Ph.D.

Deputy Commissioner of Food and Drugs

Chair, FDA Obesity Working Group

 

MIKE LANDA

Deputy Chief Counsel, FDA

 

JOSEPH LEVITT

Vice Chair, FDA Obesity Working Group

Director, Center for Food Safety and Applied

  Nutrition

 

DAVID G. ORLOFF, M.D.

Director, Division of Metabolic & Endocrine Drugs

Center for Drug Evaluation and Research, FDA

 

PETER J. PITTS

Associate Commissioner, Office of External Relations,

FDA

 

ALAN J. RULIS, PH.D.

Senior Advisor for Applied Nutrition

Center for Food Safety and Applied Nutrition, FDA

                      I‑N‑D‑E‑X

 

AGENDA ITEM                                     PAGE

 

WELCOME                                            3

Lester M. Crawford, D.V.M., Ph.D.

 

KEYNOTE ADDRESS                                    7

Tommy G. Thompson

Secretary of Health and Human Services

Department of Health and Human Services

 

Cristina V. Beato, M.D.                           24

Acting Assistant Secretary for Health

Department of Health and Human Services

 

OPENING ADDRESS                                   10

Mark B. McClellan, M.D., Ph.D.

Commissioner, FDA

 

INTRODUCTION OF FDA PANEL                         33

 

OVERVIEW OF THE FDA OBESITY WORKING GROUP         34

OPENING REMARKS                                   34

Lester M. Crawford, D.V.M., Ph.D.

 

OVERVIEW                                          36

Alan Rulis, Ph.D.

 

BUILDING A KNOWLEDGE BASE ABOUT OBESITY           46

Donna Robie Howard, Ph.D.

Special Assistant to the Senior Advisor for

  Applied Nutrition; Center for Food Safety and

  Applied Nutrition, FDA

 

Rick Canady, Ph.D., DABT                          67

Senior Science Policy Analyst

Office of Science and Health Coordination, FDA

 

HIGHLIGHTS AND SUMMARY                            77

Joseph A. Levitt

 

PUBLIC PARTICIPATION SESSION                      81

Moderated by Joseph Levitt

 

OPEN DISCUSSION                                  276

 

CONCLUSION AND NEXT STEPS                        279

                P‑R‑O‑C‑E‑E‑D‑I‑N‑G‑S

                                         (9:11 a.m.)

                       WELCOME

            CHAIRMAN CRAWFORD:  I want to welcome all

of you to the public meeting on obesity.  I am Les

Crawford, Deputy Commissioner of the Food and Drug

Administration.  I am also Chair of the FDA Obesity

Working Group, the group that is sponsoring today's

meeting.

            When Commissioner McClellan asked us to

chair the working group in August of this year, one of

the major charges he gave to us was to initiate a

dialogue with the many organizations and individuals

who are concerned about obesity.

            The need to confront the epidemic of

overweight and obesity, which now includes almost

two‑thirds of our population, is very likely to be

with us for the next several years.  And it may well

bring about important regulatory innovations.

            Today's meeting is the first of many

discussions that we will have as we work together over

the years to meet the many challenges presented by

this very serious public health problem.

            We hope to learn more about our efforts to

help Americans to improve their diets, to make healthy

choices, and to exercise.  We're also interested in

exploring your views and insights on the six focus

areas that form the foundation of our dialogue.  These

are education, research, therapeutic treatments, food

labeling, product research and development, and

significant opportunities for FDA to make a difference

in confronting the epidemic of overweight and obesity.

            You are a very diverse and capable

audience today representing food and pharmaceutical

firms and trade associations, leading consumer

organizations, the research and academic communities,

medical and voluntary health organizations, the media,

consulting firms, our international colleagues, law

firms, state government agencies, and associated

organizations, and organizations that educate

consumers about how to adopt healthy lifestyles.

            The federal government is also

well‑represented, including all of the HHS agencies,

the Office of the Surgeon General, FDA, the National

Institutes of Health, Health Resources and Services

Administration, the Agency for Health Care Research

and Quality, as well as the many key offices of the

U.S. Department of Agriculture, the Federal Trade

Commission, and the Library of Congress.

            I would especially like to recognize the

efforts of my fellow HHS agencies for the support and

outstanding efforts that they are undertaking to work

with us to confront obesity.  I would like to

recognize these efforts and briefly introduce to you

the leadership of these agencies.

            I would ask that they please stand and

remain standing.  And if we could hold our applause

until the end?  The first is Rear Admiral Dr.

Moritsugu, the Deputy Surgeon General.  Dr. Cristina

Beato, the Acting Assistant Secretary for Health, will

be with us a bit later; Dr. Robert Graham, the Acting

Deputy Director, Agency for Health Care Research and

Quality; Elizabeth Majestic, Acting Deputy Director,

National Center for Chronic Disease Prevention and

Health Promotion, Center for Disease Prevention and

Control; and Dr. Susan Yanovski, Director, Obesity and

Eating Disorders Program, National Institute of

Diabetes and Digestive and Kidney Disease.

            I would also like to thank Tracy Self and

ask her to stand ‑‑ she's the Assistant Secretary for

Public Affairs ‑‑ and Stacey Maazer, Special Assistant

to Dr. Beato, for being with us here today.  If we

could, applause?

            (Applause.)

            CHAIRMAN CRAWFORD:  We are enthused about

today's meeting.  And we look forward to hearing the

diversity of views that are represented by

participants.  Our agenda is full, and time is

limited.  So, again, we welcome you.  And let's begin

our meeting.

            At this point, Secretary Thompson has

taped a message for us.  He was unable to be here in

person, but he has taped remarks so that he could be

a part of our meeting today.

            Before running the tape, I would like to

say a few words of introduction.  We are very

privileged to have Secretary Tommy Thompson join us as

we begin our dialogue on what efforts FDA can take to

confront obesity.

            Secretary Thompson is a leading voice in

the United States bringing the message of prevention

in the communities everywhere.  He's, in fact, the

face of disease prevention in America.

            Obesity, especially obesity in children,

is a special concern for the secretary, as you will

see in a moment, particularly when you recognize the

devastating impact that obesity can have on the health

and well‑being of Americans and their families.

            Secretary Thompson has challenged HHS

agencies to intensify our efforts and follow his

leadership in taking action to help consumers to

improve their diets, to make healthy choices, and

exercise.  It is this challenge that brings us here

today.

            Following the secretary's remarks, Dr.

Cristina Beato will address the meeting.  Dr. Beato is

the Acting Assistant Secretary for Health.  She leads

HHS efforts to reduce health disparities to combat

HIV/AIDS, to encourage prevention strategies, to

reduce chronic diseases, and to advance women's

health.

            Now, if we could have the tape at this

point?

                   KEYNOTE ADDRESS

            MR. THOMPSON:  Hello.  I'm Tommy Thompson,

the Secretary of Health and Human Services.  I am so

pleased to be able to send greetings to all of my

friends attending the FDA's obesity workgroup meeting.

I would like to thank Dr. McClellan and Dr. Crawford

for hosting this very important meeting.

            As some of you have discussed with me last

July in my obesity roundtable meeting, we Americans

are increasingly supersizing ourselves and our nation.

Unfortunately, this trend continues to grow.

            Today every state except Colorado has an

obesity rate higher than 15 percent.  And obesity is

the second leading cause of preventable deaths in the

United States, accounting for more than 300,000 deaths

each year and costing American taxpayers up to $117

billion in direct and indirect costs.

            Overweight and obese people have a much

higher chance of developing Type II diabetes, heart

disease, certain cancers, high blood pressure, high

cholesterol, and other ailments.

            The challenge that lies ahead is

formidable but one that all of us must address.  I

have taken action by launching an initiative for

improving health through the steps to a healthier U.S.

            I have asked each division of the

Department of Health and Human Services to be able to

prioritize disease prevention and health promotion

initiatives.  We have the opportunity to improve the

health of more Americans than ever before.  And I

think it is critical that we do as much as possible to

meet this challenge.

            I applaud Mark and Les and the staff at

FDA for doing this part in addressing this very

important issue.  And I am so very grateful to all of

you for all of the work that you have already done on

obesity.

            I look forward to continuing to work with

you in the future.  God bless you.  God bless the

United States of America.

            (Applause.)

            CHAIRMAN CRAWFORD:  It is now my distinct

pleasure to introduce to you FDA Commissioner Mark

McClellan.  Dr. McClellan is the moving force leading

the agency in its efforts to make a significant

difference in addressing the obesity epidemic.

            Within the past year, Dr. McClellan has

charted an aggressive course to begin building the

foundation needed to address the problem of obesity.

Some of these efforts include working with the

agency's executive leadership to establish our

strategic plan, which will complement and strengthen

our efforts as we go forward to confront the obesity

challenge, providing consumers with better nutrition

information by allowing the labeling of food packages

with qualified health claims, and working with the

administration on aging and the National Alliance for

Hispanic Health to provide elderly Hispanic consumers

and their care‑givers with important health

information.

            Under his leadership, we now have the

opportunity through the FDA Obesity Working Group to

strengthen and expand our efforts to support consumers

in their efforts to be healthy, improve their diets,

and be physically active.  It is my pleasure to

introduce FDA Commissioner Mark McClellan.

            (Applause.)

            DR. McCLELLAN:  Thank you, Les.  And

thanks to all of you for being here.

                   OPENING ADDRESS

            DR. McCLELLAN:  I want to particularly

commend Les Crawford and his coconspirator in this

effort, Mr. Joe Levitt from our Center for Food Safety

and Applied Nutrition, for their leadership in moving

this task force.  I also want to thank Dr. Alan Rulis,

who has been instrumental in this and many other

activities on applied nutrition.  Dr. Christine Taylor

I think will be here soon as well.

            Les mentioned something about me being a

moving force.  Actually, one of the things you learn

when you run an agency is that you don't move much of

anything by yourself, that things only happen as a

result of the commitment and dedication and

professionalism of the workforce in the agency.  And

that is nowhere more true than at FDA, where we don't

give out a lot of grants, we don't deliver a lot of

health services.

            It really is the people at the agency that

make all of the difference for public health.  And I

have been tremendously impressed by the leadership

throughout the agency to help take on this new and

important challenge of obesity in our country.

            The Obesity Working Group is charged with

a difficult task, but I think with Joe and Les at the

helm and with the backing of our professional staff at

FDA, I know we will make important steps in advancing

the public health.

            On behalf of FDA, I would also like to

offer my appreciation for the deep commitment of

Secretary Tommy Thompson to take on this urgent public

health issue.  As you just heard again from the

secretary, he is passionate about the issues that we

are here to discuss today.

            And so is my good friend Dr. Cristina

Beato.  I want to thank her for helping to bring

disease prevention to the forefront of the national

public health agenda.

            Dr. Richard Carmona, our nation's Surgeon

General, who is out traveling today, has also been an

instrumental part in our efforts to improve the

nation's health literacy and to take on obesity.  He

is represented here very ably by Admiral Moritsugu.

I want to thank the admiral for his assistance in all

of these efforts as well as Admiral Graham, here from

the Agency for Health Care Research and Quality.

            And, as Les mentioned, our hosts in this

auditorium here at NIH have been important partners

and contributors to this effort, as has Dr. Julie

Gerberding and the staff of the CDC.

            I especially want to thank all of you, the

academic experts, the consumer organizations, the

health professionals, the education experts and

leaders, the government groups, and, most importantly,

the interested public who are participating in this

effort here today.

            Healthy living and healthy choices for

disease prevention are a top priority for the

Department of Health and Human Services, helping more

Americans achieve a healthy weight is a top priority

for all of us working on the nation's public health

problems.

            That's for a simple reason.  Quite simply,

obesity is an urgent public health threat of epidemic

proportions.  Today, nearly two‑thirds of all

Americans are overweight.  And more than 30 percent

are obese.

            The rising incidence of obesity and

oversight has dramatic consequences for our health, as

you heard from Secretary Thompson and others:  heart

attacks, heart failure, high blood pressure,

respiratory problems, arthritis, many cancers.  The

list is long.  The list is sobering.

            The trends for our children are

particularly worrisome.  Recent research from the

Centers for Disease Control shows that about 13

percent of children age 6 to 11 are overweight, almost

double the rate of 2 decades ago.  Increasingly,

diseases that were once thought to go along with older

ages, such as Type II diabetes, are occurring in

children.

            The issue of obesity challenges us in

every aspect of our efforts to protect and advance the

public health.  And that's why it needs to be front

and center on our public health agenda.

            And so we are taking some new steps at FDA

to help people improve their health by avoiding

obesity.  Improved nutrition labeling, new steps to

encourage foods that compete based on their health

consequences.  Other steps I'm going to tell you more

about in just a few minutes because I would like to

build on them.

            We need to do more.  FDA has a big role to

play in this effort, in education of the public, about

public health problems in labeling and information

about foods, both foods in the grocery stores and

foods that we eat out, in helping to make available

safe and more nutritious foods and diet choices, in

promotion of foods, advertising, and labeling

promotion of their health consequences, in such

emerging areas as neutrogenomics in developing medical

products for obesity.  The list is long.  And to make

sure that we are taking a comprehensive approach to

these problems, we formed a working group at FDA to

find new and innovative ways, the best ways to help

people lead healthier lives through better nutrition.

            I've asked this working group to come up

with a report by February that includes a specific

action plan for setting out our further comprehensive

efforts to combat obesity.  Some of the opportunities

that are available include further research and

efforts to define healthy diet choices, new

opportunities to aid in the development of therapeutic

treatments, medical treatments for obesity, possible

further changes to the food label, and a serious

dia