FOOD AND DRUG ADMINISTRATION AND

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES,

 

OFFICE OF ASSISTANT SECRETARY OF PLANNING AND EVALUATION

 

 

 

 

 

 

 

"EXPLORING THE LINK BETWEEN WEIGHT MANAGEMENT

 

 AND FOOD LABELS AND PACKAGING"

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Thursday, November 20, 2003

 

 

Lister Hill Audutorium

National Institutes of Health

Bethesda, Maryland

 

 

 

[TRANSCRIPT PREPARED FROM A TAPE RECORDING.]

C O N T E N T S

 

WELCOME     3

 

OPENING REMARKS     12

 

FRAME WORKSHOP AND CHARGE TO PARTICIPANTS     26

 

"CURRENT FDA FOOD LABELING POLICIES"     30

 

"CONSUMER INTERFACE WITH THE FOOD LABEL"     50

 

"FOOD INDUSTRY PERSPECTIVE ON CALORIE MODIFIED PRODUCTS AND FOOD LABELING"     63

 

"HOW DOES NUTRITIONAL LABELING AFFECT CALORIC INTAKES?"     80

 

"HOW PACKAGING UNKNOWINGLY INFLUENCES CONSUMPTION AND CALORIE INTAKE"     97

 

"HOW DOES THE CURRENT LABEL AND PACKAGING HELP OR HINDER THOSE ENGAGED IN WEIGHT-LOSS PROGRAMS?--FROM WEIGHT WATCHERS"     119

 

"HOW DOES THE CURRENT LABEL AND PACKAGING HELP OR

HINDER THOSE ENGAGED IN WEIGHT-LOSS PROGRAMS?--FROM

A GENERAL DIETICIANS PERSPECTIVE"     138

 

"WHAT LABELING OR PACKAGING CHANGES WITH RESPECT TO WEIGHT MANAGEMENT MIGHT STIMULATE PRODUCT REFORMULATION DECISIONS?"     159

 

WHAT CAN BE LEARNED FROM EXPERIENCES WITH LOGOS OR CERTIFICATION?--THE CASE OF THE SWEDISH KEY HOLE"     183

 

"MARKETING THE LABEL TO CONSUMERS"     199

 

FOOD PACKAGING AND LABELING     209

 

FOOD PACKAGING AND LABELING:  Q&A     244

 

 

RESTAURANTS     282

RESTAURANTS:  FIRST Q&A SESSION     326

 

 

RESTAURANTS PANEL, CONTINUED 341
P R O C E E D I N G S

WELCOME

     MR. LEVITT:  The microphone is working up here.  Are we on?  Rich Williams, can you hear me back there?

     MR. WILLIAMS:  Yes, I can.

     MR. LEVITT:  Okay.  Terrific.  Good morning, everyone.  My name is Joe Levitts.  I am Director of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration, Department of Health and Human Services.  And it is my pleasure to welcome you to today's workshop entitled "Exploring the Link Between Weight Management and Food Labels and Packaging."

     Today's meeting is being co-sponsored by the Food and Drug Administration, led by the Obesity Working Group, which Dr. Lester Crawford chairs, and I'm the vice chair, as well as the Office of the Secretary, Office of the Assistant Secretary for Planning and Evaluation in the Department of Health and Human Services.  And in a moment, I'll have the pleasure of introducing Ms. Ann-Marie Lynch, who is a Principal Deputy Assistant Secretary for Planning and Evaluation.

     This reflects the very top priority that the obesity issue is receiving by the entire Department, led by Secretary Tommy Thompson, as well as within our agency, led by our Commissioner Dr. Mark McClelland.

     This past summer, FDA established an obesity working group, and we are moving ahead rapidly.  We've already held a public meeting in October, also on the NIH campus.  And, of course, our workshop today.  We have a public docket, and we are receiving comments; and we'll urge additional comments following this meeting to be submitted there for our collective use.

     And, as people I think by now know, we're moving on a fast track, and our final report is due to the Commissioner on February 12th of 2004.

     Today's agenda has three parts.  Part One is short opening session.  As I said, following me, we'll also have a welcome by Ms. Ann-Marie Lynch, followed by our keynote presentation by FDA Deputy Commissioner Lester Crawford and our charge to the group by Tomas Philipson, Senior Advisor in the Commissioner's Office and a Visiting Scientist.

     The bulk of the morning will be devoted to prepared presentations.  We have a blue-ribbon list of people from FDA, from industry, from academia, from the weight loss community, even from foreign countries.  And in the afternoon, we are going to get a little more informal and convert the session into two roundtable discussions, one dealing with the food label and packaging, and the second dealing with restaurants.

     We want to be very clear that FDA is looking at both of these areas.  What can we do dealing with food labels and packaging, and what can be done vis a vis restaurants, recognizing that we need to look at the obesity issue as a whole, looking at both diet issues, as well as exercise issues.  And, yes, somebody asked me, I do have on my pedometer today.  And was able to walk over from the Metro.

     So, we're trying to do our part.

     As always, a lot of work goes into putting together a meeting like this.  I want to thank three people in particular.  First, is Rick Canady from FDA, who's sitting right over here.  Second, is Lana Bush, from ASPI, who is right behind him.  And the third is Amber Jessup from my center, who is right back there in the middle.  So, thank the three of you.  We know how much work it is to put on a meeting like this.

     Finally, I have just a few housekeeping announcements from the house here, so it's listed up here.  Number one, no food or beverage is allowed in the auditorium.  Number two, there is a message desk phone number.  It is as follows:  301-496-4062.  Three, pay phones are located behind the Visitors' Center.  Four, when we do get later into the area of interactive discussion, there is a microphone.  You need to press the "MIC" button, and I think you'll see it flash up red, so you know your microphone is on.  I think by now all presenters have checked in at the preparation room.  And finally, for those who do not have an NIH or a FDA ID, even though I have one, everybody in the building is required to wear their pass for--visitor's pass for security purposes.

     With those introductions, it is my pleasure to introduce to you Ann-Marie Lynch, Principal Deputy Assistant Secretary for Planning and Evaluation, DHHS.  I need to embarrass her for just one moment with her background.

     Ann-Marie advises the Secretary, Tommy Thompson, on health policy initiatives and is responsible for major activities in the areas of policy coordination, legislation development, policy research and evaluation economic analysis.  She joined the Administration in June 2001 as a Deputy Assistant Secretary, Office of Health Policy.  Prior to joining the Administration she had significant public and private sector experience, including serving as staff director of the Health Subcommittee of the U.S. House of Representatives Ways and Means.

     Ms. Lynch holds a master's degree in economics from Duke University, and a bachelor's in economics from Fairfield University.  Please, a warm welcome for Ann-Marie Lynch.

     [Applause.]

     MS. LYNCH:  Great.  Good morning.  I'm delighted to be here, and welcome you to this wonderful conference.  I just wanted to start with a few comments.

     First, in looking at the latest available information, we find that seven out of ten individuals die each year of a chronic disease.  More than 300,000 Americans will die this year from obesity-related heart disease, diabetes, and illnesses directly affected by overweight or obesity.

     In the year 2000, the total annual cost of obesity in the United States was estimated to be $117 billion--that includes direct medical care costs.

     Currently, about 15 percent of children and teenagers are already overweight, and excess weight significantly increases our children's risk factors for a range of health problems, including diabetes, heart disease, asthma, and emotional mental health problems.

     The good news is that obesity and co-morbidities are preventable through healthy eating, nutritious food in proper amounts, and physical activity.  And the bad news is that many Americans are not taking the steps to prevent obesity and its co-morbidities.

     The Administration has put forth a prevention agenda focused on a healthier U.S., which promotes four fundamentals of good health.  These are:  physical activity, healthy eating, regular preventive checkups, and avoiding risky behaviors.

     Secretary Thompson supports the Administration's prevention agenda through the Steps to a Healthier U.S.  Steps emphasizes innovative community activities, in cooperation among policy makers, local health agencies, and the public to invest in disease prevention.  And in September of this year, the Secretary announced 12 Step grants, totaling more than $13.7 million, strictly to promote community initiatives to promote better health and prevent disease.

     Our Administration is committed to community-based, evidence-based, scientifically-sound public health policies and initiatives that ensure that our nation's health and well being exist for today and most important for the future.  And we are pleased to have a role here today in helping the Secretary achieve his goal of ensuring that Americans are strong, healthy, and independent.

     We're working with the FDA to explore the connections between food labeling and weight management; and, to assist them, we've developed a focused research agenda addressing fundamental questions about the association, if any, between nutrition information on food labels and weight management in the U.S. population.

     We're pleased to sponsor the workshop, at which we hope will examine the available evidence to identify the options for providing information to consumers' weight management decisions.

     And right now, I'm pleased to introduce to you Dr. Lester Crawford.  Dr. Crawford brings a tremendous amount of experience to his position as Deputy Commissioner of the FDA.  He has served as the head of the FDA Center for Veterinary Medicine, Administrator of the Department's Agriculture, Food Safety, and Inspection Service, and the Executive Director of the Association of American Veterinary Medical Colleges.

     During 10 years at FDA and USDA, he played major roles in the mandatory nutrition labeling, the Guaranteed Agreement on Tariffs and Trade, and the controls of chemicals and microorganisms in the food supply.

     Most recently, he served as director of Virginia Tech Center for Food and Nutrition Policy.  He's also served as Executive Vice President of the National Food Processors Association; Chairman, Department of Physiology and Pharmacology at the University of Georgia.  He has a doctorate in Veterinary Medicine from Auburn University, and also earned a Ph.D. in Pharmacology from the University of Georgia.  His honorary doctorate is from Budapest University.  So, with that warm up--I'd like to [inaudible] Dr. Crawford.  Thank you.

OPENING REMARKS

     DR. CRAWFORD:  Thank you very much, Ann-Marie.

     [Applause.]

     And thank you also for your inspired leadership with respect to this conference and for your sponsorship of it.  We appreciate that very much, and it's always great to be working together in the Department of Health and Human Services.  I've been in Health and Human Services three other times, and two of those three times the FDA did not have diplomatic relations with the Department.  So, we're happy for what you have done to bring all that together.  It's very much appreciated.

     And thanks to Joe Levitt for his leadership.  We--Joe and I have found ourselves appointed by Commissioner McClelland to two impossible task forces.  This is one of them.  The previous one was the health claim ones.  But, through Joe's leadership, we actually produced something useful out of that one.  It was a surprise to me.  But I think it's going to work, and I think this is going to work, too.  And we've got a major problem, as all of you know, on our hands here.  And that does not happen to do with my use of the slides.  We probably are going to move our little cursor around here.  That's okay.

     MR. LEVITT:  Of course, figuring out how to move it is challenge.

     DR. CRAWFORD:  I think I'd use my middle finger.

     MR. LEVITT:  It's the one that says Koestler on there.

     DR. CRAWFORD:  All right, Rick, the next thing is the second slide.  We'll just do it this way.  Perfect.  Yes.  You do the left to the right.  The thing in the middle.

     We had a meeting this past weekend in Boston that many of you are familiar with is the Harvard food meeting that takes place every year under the leadership of former Secretary Glickman of Agriculture and Professor Ray Goldberg of Harvard.  And in that meeting, this is the 10th year of it, and a careful glance at the record, which is memorialized in a book I suppose each year, reveals that throughout the preceding nine years, there's never been a mention nor a paper on obesity.  This past weekend, 10 of the 16 presentations were on obesity and several interesting things came out of that.

     There was a person invited who was from the National Health Service in England, and her summary comment was that she believed that in the very near future that obesity, as it occurs today in England, which is about what it is here, would wreck their National Health Service; that there was no way they accommodate the increase in health claims and payments and in the infrastructure of that system.  She thought it was going to be compromised by the obesity epidemic in that country.

     And then the Deputy Minister of Agriculture of Canada made an even more ominous conclusion, based on his study of the situation in Canada.  We always think of ourselves as the only one having this major public health problem.  He believed that in their country and perhaps in others that for the first time in the last 100 years that the longevity increases that are announced at the end of every year by the World Health Organization were going to decrease in their country and perhaps in much of the developing world.

     In our country, we're having 300,000 obesity-related deaths per year.  We believe that can only escalate, and we have to be prepared.  Now, the other thing that must be said is that out of the flavor of that meeting and out of our general meeting on this subject, which we held earlier, it is clear that it is very easy, very tempting and facile, and, I think, useless to continue to blame the food industry as a victim in this kind of thing for some reason.  We all eat the food.  We all have freedom of choice.  This country is certainly free in that respect.  And if the portion size is too large, it doesn't take a very high intellect to understand that if you're gaining weight at the rate of 12 pounds a month or something like that, that this might be a little too much for you.  So I think we need to stop--we need to hold harmless the food industry as they join together, as they certainly are today, they did in the first meeting, and they did in some follow-up meetings to this as we move forward towards a mutual solution.  If we blame the psychiatrists of the United States or the food industry of the United States or the medical profession or the dietetic profession, than we will get nowhere, because we'll balkanize those interests, and there won't be any unifying message that we'll go forward with.  So let's get off that, and in order to begin that, we're going to go forward.

     Now, the obesity epidemic, as is mentioned here--we have now completed our circuitry through the slides.

     [Laughter.]

     And with many thanks to you for being here today, Mr. Levitt.

     [Laughter.]

     Here we go.  I got it.  Don't worry, Rick.  You can--over 30 percent of the U.S. population--Ann-Marie mentioned some of this, and the body mass index of 30 or higher is what we're going with here.  Thirteen percent of children, which is a doubling of what it was when NLEA was passed some 10 years ago, and the deaths I've already mentioned.  And we'll talk further during this session and elsewhere about co-morbidities.

     The Obesity Working Group has a charge for the Commissioner, which is from the Commissioner, which is publicly available.  Also, his excellent speech at the general meeting, which was held about a month ago, is still getting a lot of currency.  It was mentioned this morning in the Washington Post, in the A-section, and will be again around the world, and that is something that we believe is an enlargement of our charge and also an indication of the seriousness that he and Secretary Thompson take this to be.

     The--we have a six-month time frame.  We met yesterday with the Department officials about whether or not we're going to achieve this, and what we're going to do with it when it's accomplished.  But we're on that time frame, and we're obligated to finish by then.  And we haven't talked yet, Mr. Levitt, it was reamplified yesterday.  We have only that amount of time.

     We have an act--developed an action plan, and this is from the charge, to develop a clear, coherent, and effective public health message.  And the rest of that sentence was that unifies all the various sectors in solving this problem.

     We need a public education program.  Many people believe that the "E" in NLEA has never really been fully utilized, and I would be one that would agree with that.  I remember when we were working on NLEA--the--my part of it was in the Department of Agriculture.  We did not need the law in FSIS for meat and poultry.  What we needed was simply a declaration by the Administrator through the delegation of authority from the Secretary.  And we imposed this.  I remember when we were talking about it, we planned a major public health information program just from FSIS, which was funded at the $4 million category.  And I don't think that was ever completely funded, and it needs to be; and then perhaps even that figure was modest, because as we looked through this particular exercise that we're going through now and how many people actually read the food label, we find the figures to be disturbingly low.  And we also find it to be associated with people who have a real medical need to read the food label, like diabetics and people with metabolic diseases of other sorts.  And I think that we have to take some of the blame for that in the Government and probably also in the food industry and in the supermarkets.

     But the--we don't need blame.  We need a positive message going forward.  Enhancing the food label, if you're going to enhance it, it can't be like the Sears Roebuck catalogue.  It must be targeted.  It must be readable.  It has to accommodate people that have to wear bifocals.  It has to be something that gets the job done, and just changing it willy nilly is not what we're about.  But I would be surprised if in the Obesity Working Group report on February 12th of 2004, we don't have something in there about recommendations on the food label.

     The dialogue with the industry is going on.  We're following this up with two other focus group sessions before the end of the time that we have to finish the report.

     Then we're also facilitating the development of more and better therapeutics.  The Center for Drug Evaluation and Research is very much a part of our obesity working group, and they're weighing in with the latest information, and also the realistic projections of how good these medical devices and drugs are going to contribute to the solving of this problem.

     And I think we can't rule out the fact that there is some sort of magic potion there.  The research on leptins and various other compounds is very encouraging, but there's nothing in the bottle yet, nor in the syringe.

     Then identifying research on healthier foods and consumer behavior is certainly going to be a major part of it.  Then we have to enlist the help of the stakeholders.  When it's all said and done, the authority of FDA to solve this problem is not the same as we have to solve an illegal drug problem or an illegal food supplement problem, or something like that.  This is going to be involved I think for a long, long time, and the tools that we have at our advantage are some regulatory power, but mainly moral suasion and scientific suasion.

     The public meeting, which was held on October 23rd, just about a month ago, explored six key questions.  And the respondents, for those of you who weren't there, were asked to comment on these things.

     The effectiveness of the education campaigns.  Has that ever been vetted?  Has it ever been evaluated and audited.  And the answer seems to be no.  But the question is, how do you do that?

What are the most urgent research needs of the National Institutes of Health.

     Evan Hubbard is here today, and he has been very much a part of the planning of this and the development of it.  And there are certainly research needs that will be listed in the final report.  We need to know about those from you, and we need to include them in the report in terms of the recommendations to the Commissioner, and ultimately to the Secretary.

     Data.  What data exists on obesity prevention and treatment through behavioral and medical interventions.  That also should be a major part.

     Changes needed in food labeling to stimulate development and consumption of lower calorie foods.  When we talked about calories at the time of NLEA, when the Commissioner of FDA and the Administrator of FSIS did a country-wide tour of hearings at major medical centers and elsewhere, which took about six grueling weeks, we heard a lot about the calorie content.  But we heard mostly about fats.  And we heard almost nothing about carbohydrates.  And the passion about fats in the year 1993 was extraordinary.  It was, I think, we deluded ourselves into believing that if we could just get prominent labeling about fats and the division between saturated and unsaturated fats that people would read the label and wind up being svelte and happy forever.  That did not turn out to be the case, and we probably erred, if we erred, we erred on behalf of the prevailing sentiment in the medical and nutrition community.  And I would say also, looking back on those hearings and rereading some of the transcripts, we heard inspired commentary from just rank and file individuals.  And that's what we need to hear again.  They weren't necessarily nutritionists.  They weren't physicians, but they were impassioned about the problem of not being able to look on the label and find out what was in the food, from a nutritional point of view.

     And then what opportunities are there to develop healthier foods and what can FDA do to reduce overweight and obesity.  Within our authority and within what expect FDA to do, what can we do?

     Now, the stakeholder engagement, we've already--I mentioned these first two meetings, of course.  We're having a consumer roundtable to follow this up.  All of these meetings are open to the public.  They're not--we're not sequestering any group.  And then we're having the medical community roundtable, and then the Secretary's Prevention Summit is in early 2004.  And Ann-Marie and others in the Department will be heavily involved in that.  And I suspect that our report, if it's well received, will be major part of that.

     The qualified health claims initiative also is part of this.  That came out of the first task force that Joe and I headed up.

     Putting more information on the food label, stimulating competition based on health effects, a part of that.  Increased consumer consciousness of food's impact on health.

     We think we're getting there.  Commissioner McClelland has, again, made a number of speeches in various sectors, particularly within the medical community, and he's proclaimed, convincingly, that, of all the things that FDA is inspired to do and required to do, that prevention through nutrition is probably the most effective public health tool at our disposal.

     You can mention vaccines as something that's very important, but no less important is nutrition and nutrition information.

     We have to meet three conditions.  We have to have some degree of scientific evidence for health claims.  It has to be pre-approved by FDA, and the labeling cannot be misleading.

     Now, at this point, I'm going to pause, with gratitude to the Chairman and to everyone involved in this, particularly the audience; and introduce Tom Philipson, who is an economist working at FDA, on a sabbatical, who has brought commonsense, good judgement, and fine taste to the Food and Drug Administration.  He's from the University of Chicago, and, Tom, it's all yours.

FRAME WORKSHOP AND CHARGE TO PARTICIPANTS

     DR. PHILIPSON:  I'm going to be very brief, sort of setting the charge of the conference and also taking care of some logistical details because I'm going to be the main time police once we get going here, to discipline people to stay within their time.

     As Lester mentioned, the Obesity Working Group has organized this conference.  This is part of--this is a part of the effort of the Working Group, which, again, was launched in August, and we'll have a final report in mid-February.

     And in sort of setting the stage for today's conference, it was--we sort of came to this with a belief that the emphasis should be very much on the science as opposed to sort of opinionating around the topic.  So, we're really interested in what people have to bring in terms of facts to bear on this topic of labeling obesity.

     We're coming to the topic of labeling obesity in a sort of--on the Obesity Working Group in a sort of perspective where we're currently labeling products.  And, for good or for bad, that's very difficult for some consumers to be able to handle, to learn about their diets, which are daily diets or weekly diets, in an efficient manner.  So the type of labeling that we currently have is sort of not as consumer friendly, if you want, as you would like it be in order for people to understand the impact, in particular, for example, the caloric impact of their diet, and the [inaudible] on obesity.

     So, the conference was organized to try to understand, better understand, how current labeling is actually used by people in managing their weight and also whether new forms of labeling can help them do so better.

     And, as you noted on the program, we've included restaurants in this conference.  And the whole basis for that was that we wanted to think about, in a constructive manner, how to go from product-based labeling, which we're currently doing, into higher level labeling of meals, which could potentially more easily be used by consumers to learn about their diets.

     So, as Lester emphasized, this is not a blame of a restaurant in any way or another.  It's all about trying to facilitate for consumers to learn about their overall diets instead of using current product labeling to go up on a more aggregate level by potentially thinking about ways in which information could be provided, whether through the private sector or public sector, about their meals or potentially about their overall diet.

     So, in that--with that background, we have sort of two agendas within that--we're considering the package foods, both in the morning and the afternoon, and then additionally, we're considering restaurants, which is, of course, sort of the new area that we're trying to learn about here.

     There's going to be a report of this conference that will most likely be part of the final report of the Obesity Working Group.  But also we're accepting comments for the conference until December 12th, and there should be a web site in the packet indicating where public comments are available.

     We're particularly interested in those for the morning session, because there will be--due to time constraints--there will not be any public comments or public participation or audience participation in the morning.  There will be some limited audience participation in the afternoon regarding the panels.

     There will also be a transcript of the minutes--or minutes of the conference also on a web site provided in the packet.

     With those logistics in place, I'd like to start the program, and, like I said, I will be sort of prodding people.  There's a pretty--very tight schedule if you open the program, you'll see that we have a lot of speaker to go through, both in the morning and in the afternoon.

     But I'd like to start off with introducing Christine Taylor.  She's Director of the Office of Nutritional Product Labeling and Dietary Supplements in the Food Center for Safety and Applied Nutrition at FDA.  She will talking about current FDA food labeling policies.

"CURRENT FDA FOOD LABELING POLICIES"

     MS. TAYLOR:  Good morning and thank you very much.  It's indeed a pleasure to be here, and I confess I'm going to need some technical help to get my program up.

     I'm pleased to be here despite the fact I have the rather daunting task of in 15 minutes trying to set the whole context for the label and what it does in terms of calories.  So, bear with me as I try to set that context, because I think it's an important.

     UNIDENTIFIED SPEAKER:  Use the wheel.  Go down.

     MS. TAYLOR:  Excuse me, I'm doing a remedial read.  If we can start at the beginning. Great.  Thanks an awful lot.

     Anyway, please do bear with me as we try to make a kind of contextual background for the discussion we'll have today.  I think it's always good to start off with a few simple definitions, and that is the fact that when you say "the label," you're really talking about a lot of things.  There is, of course, the nutrition label, which is the infamous facts panel that I suppose most of us are very much aware of, at least those of use that work at the agency.  It's a required component of the packaged food label in the U.S.  It had its start really for very different reasons than perhaps we're talking about today in 1971.  But it really got its basis in 1990 with the Nutrition Labeling and Education Act, which allowed the agency to create this mandatory component of the food label.

     With that, we also got voluntary provisions for claims on labels, which I think also plays a role in some of the issues we're tackling today.

     But when you do say the label, just to keep in mind there are other things that are part of the label.  You have product identification.  You have ingredients statements.  You have manufacturer contact information.  You have other statements on the food label; things such as may contain peanuts, and other things such as that.

     So, the label itself is a fairly diverse unit.

     What I'm going to try to do today--these are my touchstones--is to give you a little bit o the conceptual underpinnings for how the label got started in 1990, talk specifically about the current provisions for calories, and then, at least from my perspective, talk a little about what we've been hearing and what the future might hold in store.

     Again, background definitions just so we are all aware we're talking about the same thing.

     When you talk about food labeling, you have the packaged foods component, which is under the purview of FDA.  And it is generally required, with some exceptions.

     You also have labeling on raw meats and poultry.  That is withing the U.S. Department of Agriculture.  Labeling for fruits, vegetable, and fresh fish is a kind of voluntary program.  It's voluntary unless it's not done.  So, it's a hybrid in many ways.  And that's implemented through the use of poster signs, placards, where fresh fruits, vegetables, and fish are sold.

     And then there is the issue of restaurants.  NLEA, the Nutrition Labeling and Education Act, did not direct the agency to do anything about restaurants.  And currently, there are no provisions in place for restaurant labeling.

     Probably the starting point for any kind of contextual background would be the nutrition facts panel.  The theme, I think, we'll sound today, and you'll hear it from a variety of FDAers, is that a lot of work went into developing that nutrition facts panel, as well as the claims that were a component of NLEA.  But there was a full recognition at the time that we were just beginning; that it was a flexible environment in which we were working.  We were doing the best we could with what we had at the time, and that things would change.  We would get a better understanding of how consumers interact with such things as food labels; and that, in the future, there would be a set of issues that would need to be addressed in terms of how best to improve the label.  And I think that's part of what's happening today.

     Certainly, at the time research was done, the question is:  was there enough research?  No, there's never enough research done for any of these things.  But a considerable amount of research was conducted at that time so the best possible label, as we understood it, could be put out.  There was full recognition that to be useful, this is a label that had to be used on all packaged foods, and I can't emphasize enough how the universal mandatory requirement does influence what you can and cannot do with the label.  And there was full recognition at the time that it was to serve as a tool for a variety of endpoints.  It had to derive from the health initiatives we had at that time.  But also there was considerable interest in its being stable over time so that consumers could have a uniform way of getting the message.

     For those of you that need to be reminded what we're talking about when we talk about the facts panel, this is the shortened version of it.  Larger packages are allowed to--or required to have additional information.  But this is basically the nutrition facts panel in its simplest form.

     The conceptual underpinnings for the facts panel I think are important as we begin to think about the changes that might be in place if calories are a particularly important component or some other kind of information.

     At the time, there was a great deal of interest in making sure that this tool, the nutrition facts panel, matched what were current recommendations for health initiatives.  And so, examination of dietary guidelines, health recommendations from the Government, those things became the core component of the facts panel.  And I do want to emphasize that many other declarations were allowed voluntarily; that there was not at all an effort to restrict it, but rather, given limited space, what was the absolute core amount of information consumers used, and then, at the manufacturers' discretion, if they wanted to list the 20 or 15 or however many nutrients that they felt were important for their product.  The label had that flexibility.

     The other component to keep in mind is that by going with what were the general recommendations put out by authoritative bodies that allowed the label to be stable over time, but we recognized that those recommendations would change and that someday we'd gather in a room just like this to begin to talk about modifying the label.

     Another important part of the conceptual underpinnings for the nutrition facts panel is a consistent format.  I remember those heady days very well where the design people were probably as powerful as anyone else in the room in terms of how that label would look.  There was considerable interest that it be the same kind of label for each and every food with the things in the same place so that consumers could use it as easily and as readily as possible.

     There was a considerable amount of research done on the design, and one of the other components at that time was a complete realization that we were dealing with a lot of constraints in terms of space.  And those were things that get lost sometimes in the shuffle as you think about the label. But it is being asked to do an awful lot in a very small space, and that's something to keep in mind.

     Now, as we did think about the core component of the nutrition facts panel, we did think a considerable amount about the consumer interface.  What we found from focus group research was that the most useable information was, in fact, the numbers, coupled--and that's an important thing to note--coupled with some kind of context.

     NLEA had told us to present the nutrition information within the context of the total daily diet.  And that meant for us that we had to not just only give the numbers, because there was evidence in front of us that if you put the number 100 milligrams in front of a consumer, they're likely to read 100 milligrams as more than one gram.  So they needed it in some kind of context.  But quite clearly, what we got from the focus groups was consumer interest in having those numbers anyway.  So you needed the numbers, and you needed the context.

     They felt that if we used pie charts, pictures, graphic signals alone, they were somehow being manipulated.  They kept saying give me the numbers.  They wanted to feel empowered that they could make choices.

     The context, though, we found was extremely important for how these numbers were then interpreted by consumers, and, as it says here, we coupled the numbers with the percent daily value.

     That being the context.

     Now, when we did the research in 1992, we did check to make sure that the percent daily value, given that any tool you'll use will have limitations and perhaps not work for all groups all the time, at least that the percent daily value was better than the other options we had available--bar graphs, pie charts, adjectival descriptors--high, low, medium in fat; high, low, medium in sodium.  Quite clearly, the research at that time indicated that consumers felt much more comfortable with the numbers and felt that the pie charts, the pie graphs or whatever were in some way fooling them.  We'd also found from earlier research that things such as stars and smiling faces and thumbs up and thumbs down, those kinds of things came out through the research we had as being vague, condescending, and childish.

     So we were finding that the consumers needed some kind of numeric context; at the same time, we could see from how they were using the label and interpreting the label, that they needed a context.

     We also were faced with the issue of some of our context being in the domain of a percent of calories; that many of the recommendations we had were being driven by your caloric intake.  We had gone then through the National Academy of Sciences' referenced daily allowances, dietary intakes, in order to try and come up with a number for calories.  And when we did a weighted average of the Academy's caloric recommendations, we got a number in the neighborhood 2,300 calories.  We did propose that number, but were convinced by comments that we should round it down.  And so, as you can see from today's label, we're using as basis for the label, when calories are an issue, the 2,000 calorie diet.  You do see it listed at the very bottom--whoops, the very bottom here, and then what it does say is the percent daily values are based on a 2,000 calorie diet.  This is for a slightly label where they can also put the context of the 2,500 calorie label.

     Finally, returning to conceptual underpinnings and the consumer interface, as we've worked with consumers in the food label, as much as you'd like to think that they would use the food label to build their diet, track it during the day, that's very unusual.  You have to be a highly motivated person in order to use the food package for that purpose.  And they get frustrated because frankly packaged foods are not the only thing they eat.  You do have restaurants and other sources of food that are not necessarily labeled.  So, the notion that the label has to address someone keeping a diary, while it's a desirable endpoint, for some anyway, it's not really pragmatically how the label gets used.

     What we've seen is that they use the label to compare two like foods.  They use it to make a choice, which really when you look back at NLEA that was part of what the purpose of the label was for is to help consumers make choices.  If they're going to eat cookies, they obviously compare, from what we've seen, two packages of cookies.  They might compare ice cream to frozen yogurt, but they're not going to compare ice cream to frozen broccoli.  It's just not a transition they make.  And consequently, you need to keep that in mind as you think about it.  If you're thinking about red lights, green lights, what does a consumer do if both bags of cookies have a red light on them?  What they're really wanting to do is be able to compare them numerically.  At least that is what they've told us now, and I think there's always room for more consumer research.

     Lastly, in terms of conceptual underpinnings, the nutrition facts panel is a tool. It assists consumers in implementing dietary choices, and it was never intended to do the whole job.  That's different than being able to do a better job.  But there is an expectation that people come to the food label both motivated and perhaps informed.  And we have to look at ways of how that interface affects flexibility in terms of modifying the food label.

     Also, clearly, it's a tool for many purposes.  Consumers vary a lot.  Their interests vary a lot.  Their needs vary a lot, and the use of the label undoubtedly varies.

     One last footnote before we actually talk about the label itself if that the Nutrition Facts Panel is based on serving size.  We recognized early on that when the food label was being constructed, the nutrition information had to be presented per some amount.  And, for a long time, there was a considerable exploration of per recommended serving sizes; that it would be incumbent on the agency to develop recommended serving sizes.  We explored that option and ran into incredible snags from someone saying, what do you mean you've got a recommended serving size for cheesecake, all the way down to what would that mean for a single label value.

     So based on notice and comment rulemaking, as well as our own efforts, we found that per recommended serving siz