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Mark B McClellan, MD, PhD - Harvard School of Public Health

This text contains Dr. McClellan's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Speech before
Harvard School of Public Health

"Changing the American Diet"
Remarks by
Mark B McClellan, MD, PhD
Commissioner, Food and Drug Administration
July 1, 2003

Thank you. It's a pleasure to address this conference, dedicated to both thoughtful examination and decisive action regarding one of our most pressing public health problems: improving our diet. The consequences of poor diets, including the growing prevalence of excess weight, and growing risks of diabetes, high blood pressure, heart disease, arthritis, respiratory difficulties and many cancers that go along with it, is endangering and diminishing the lives of millions of Americans. Many of you here have struggled to identify the causes of these ominous trends and, more importantly, what we can do about them. I'm here to thank you for that but, more importantly, to urge you to do more.

Because we simply aren't getting the job done. From the standpoint of government, our current advice to the public, our public policies to reduce obesity, just haven't been effective enough. I am challenging those of you who do research and who offer advice on public policy to figure out, with us, how we can get more up-to-date science-based information and assistance out to the public to help them improve their diets. And I am challenging the food industry to figure out, with help from us, how we can make healthier diets more appealing and attractive to Americans. We've got more nutritional knowledge, more marketing knowledge, and more biomedical knowledge to bring to bear on improving diets than ever before, and we need to do it urgently.

I think we can meet this urgent challenge. We can find better ways to help Americans improve their diet and nutrition. We can find better ways to encourage the development of foods and better nutrition information that helps consumers improve their dietary choices. We can get food producers to compete for business by addressing these important public health needs, and we can get medical product developers to work more effectively on treatments that can help. We can do these things. And that's mainly what I want to talk about this morning.

Helping consumers improve their nutrition is an increasingly urgent part of our mission at FDA. But it's not the only critical task that we are facing. As the agency that's responsible for 80 percent of the United States food supply -- practically everything we eat except for meat and poultry, which are regulated by the U.S. Department of Agriculture -- we see the FDA's public health mission related to food and nutrition as becoming increasingly complex. First, we have to take new steps to keep our food supply safe from natural pathogens that can cause foodborne outbreaks and human suffering. Second, we must act quickly to enhance our food safety mission to include effective food security measures -- protecting the public not only against what can go wrong, but also against threats from those who would deliberately harm Americans through our food supply. And third, we have to do all we can to promote better consumer dietary and lifestyle choices that can potentially do the most of all to improve the health and well-being of Americans.

Today, thanks to recent legislation, new resources, and new scientific knowledge, we have tremendous new opportunities to protect the public and help the public improve their own health. But because we are facing important new public health threats, we need to go beyond our traditional approaches. All of you -- consumer advocates, representatives of the food industry, nutrition scientists, and other food experts -- have a collective commitment to the issues we face at FDA that is integral to our ability us fulfill our mission. And your help is needed more than ever. Now more than ever, we all must work together to find better solutions.

All of you have heard about reports of terrorist groups working with agents that could be used in attacks on the food supply. With the help of bipartisan legislation passed by Congress last year, we are addressing these potential terrorist threats by implementing the biggest expansion of FDA's food safety activities in many, many years. We have added over 650 new food safety monitors in the field. And we are preparing to implement major new regulations that will improve our ability to assess import risks, identify and track illness outbreaks, notify affected food producers, and detain foods that present a potential health risk. These regulations and our enhanced inspectional capabilities will substantially upgrade our ability to protect the food supply against deliberate as well as accidental threats, but we need to do it right. We need your input on how we can use these new means to achieve the greatest improvements in public health protection, with the least possible disruption and added costs for the foods we regulate. And we must do it quickly, because these new measures have to be implemented before the end of the year.

We are using this opportunity to move toward a science-based "life cycle" approach to assuring the safety and security of food products. This approach is based on the principle of efficient risk management, a core principle of the agency's new strategic action plan -- a plan that, I'm proud to say, reflects the consensus views of our top professional staff. The principle of efficient risk management is to use the best science -- including not only toxicology and microbiology but also risk management science and even economic science -- to identify the ways in which we can achieve the greatest food protection with our limited resources, and without imposing unnecessary burdens and costs on our society.

For example, we're expected to import over 6 million food shipments this year - a huge volume that continues to grow rapidly. One critical step in improving our import security involves better surveillance: increased examinations and targeted sampling at the border supported by better information about food imports and threats, increased inspection and lab capacity, and new sampling and analysis techniques. But heightened surveillance is not the only key element in our new food security strategy. Deterrence and mitigation is another key element in reducing security risks, through working more effectively with industry to identify specific threats and address them. This includes activities ranging from improved plant and transportation security to implementing improvements in production processes that reduce the risk of contamination. Improved response and recovery capabilities is a third major part of our food security strategy. This includes enhanced food labs with surge capacity and broader testing capabilities, as well as enhanced research and development of medical countermeasures.

In all of these efforts, we're considering risk-based strategies based on better information and new collaborations to minimize the cost and difficulty of improving food security. This includes working with foreign authorities and manufacturers to improve production and shipping practices abroad as an alternative to detailed inspections at the border; using better information on imports to focus border checks on products that present significant potential risks; and cooperation with domestic producers to improve checks on the integrity of ingredients and to implement common-sense steps to reduce security risks.

We need these innovative new strategies to protect our food supply from deliberate attack. And in many cases, if we do it right, these enhancements to our existing systems for food safety will help prevent and contain conventional food borne illness outbreaks.

But urgent as these new security threats are, we also must continue strengthening the protection of our foods against such conventional threats as accidental microbial contamination and food spoilage. This includes the ongoing expansion of a "Hazard Analysis and Critical Control Point" approach to food safety - a risk management approach that FDA has already applied to seafood and fresh juice, which is voluntarily used by the dairy industry, and which we hope to see applied more widely. We are working to reduce the incidence of listeria infections in food products. And we're working with state authorities and the shellfish industry to reduce the risk of serious vibrio infections in oysters and other shellfish. And we are working to make sure that our policies effectively address potential science-based concerns about whether any bioengineered foods may be associated with any allergenicity, bioactivity, or toxicity.

One of our greatest responsibilities in the food area is protecting the American public from exposure to BSE, or mad cow disease, even as its presence has been noted in an increasing number of countries around the world. It's a task we've so far accomplished by effectively enforcing a ban on the use of ruminant proteins in feed for cows and other cervids, combined with tight restrictions administered in conjunction with USDA on the importation of potentially risky protein materials. And in another area where our vigilance is increasing, the Institute of Medicine is releasing a report today on potential risks of dioxin exposure through the food supply. Overall, the report's recommendations build on FDA's risk management strategy for dioxins. For example, the report recommends increased data collections to support decisions - something that FDA has already started to do. Despite the high cost of analyzing samples of dioxin, FDA has increased our food sampling for dioxin ten-fold within the past several years. And as the report suggests, we need to build further collaborations among stakeholders to leverage further data collection and analysis to support even better measures to protect the food supply.

These are just a few of our new and continuing efforts to improve food safety and food security protections for consumers. We need to do these things, and to remain vigilant when it comes to food safety, because despite all our advances, food-borne illnesses still account for 76 million illnesses, 325,000 hospitalizations, 5,200 deaths, and up to $23 billion in potentially avoidable health care costs each year. That's too much, and we're determined to bring it down. We have been making progress in key areas: according to statistics published earlier this year by the Centers for Disease Control, illnesses from the four most common foodborne pathogens declined by 21 percent between 1996 and 2001. In one area, Salmonella enteritis infections, we particularly need to do more, because the incidence of Salmonella infections in shell eggs has not significantly declined since 1998. We are working on regulations designed to reduce infections through effective preventive controls and microbial testing.

Yet from a numerical standpoint, all of these important new steps we are taking to protect the food supply are dwarfed by the health risks that can potentially be avoided through better diet and lifestyle choices. The problems are even more alarming when you look at extrapolations into the future of the trends of recent years. Americans are getting heavier than ever, and our health is suffering as a result. According to some estimates, at least 300 thousand deaths each year are associated with the heart disease, diabetes, cancer, and other serious chronic diseases that result from unhealthy nutritional choices and lack of physical activity. The avoidable medical costs of obesity exceed $50 billion each year, well over 5 percent of total U.S. health care expenditures, at a time when we can ill afford these costs. And the total economic costs of obesity approach $100 billion each year.

And this is where I especially want to challenge all of you today. In a little while, I'm going to talk about grades for the scientific evidence on dietary choices that people could make to improve their health. But if we were to get a grade on our own public policies and guidance on nutrition and health over the past decade, I'm not sure we'd want to take the report card home to mom. We're certainly not doing well from the standpoint of results. We've seen steady and substantial increases in adult obesity in the United States since the late 1980s. Today, almost two-thirds of all Americans are overweight; in 1988-92, the prevalence was less than 56%. In 1988-1992, less than 23% of American adults were obese; by 1999- 2000, the figure had increased by a quarter, to over 30%. And the trends for our children are even more worrisome. Recent research from the CDC shows that 13% of children aged six to 11 are overweight -- almost double the rate two decades ago. World Health Organization surveys show that that weight is on the rise all over the world, but the body mass index averages and trends in America are among the highest in the world.

Research has given us a pretty good understanding of the causes of these trends. In recent years, we are seeing the result of an imbalance within people's dietary choices. The most important imbalance is between calories in versus energy out.

One of the lifestyle choices we're making is that we're spending more time driving and in sedentary jobs, and we’re doing less walking, exercising or physical work. This trend in worklife has made us better off in a financial sense - it's increased our economic output and personal incomes. But it also means that we're burning fewer calories, and getting rid of the resulting excess weight is not easy. Innovations affecting our energy absorption and metabolism haven't kept pace with the rest of economic progress. And as a result, millions of Americans are turning to weight-control methods that have been proven to be unsafe, like smoking, or to potentially dangerous approaches, like unproven dietary supplements.

We have seen a lot of innovation in food production. It's much easier to make a good meal, and calories are dirt cheap. Innovations in food preparation, storage, and packaging, including the availability of a broad array of easily prepared meals, are something that busy people are willing to pay more for. So while exercising is getting harder, having a tasty dinner at home is getting a whole lot easier. Technological progress has made it easier for people to get cheaper, more varied foods that taste better and are easier to use. That’s valuable. But we clearly need more innovation to help people choose a diet that is not only easier to prepare and better tasting, but better for their health.

Now, we might say that our public policies on nutrition don't have anything to do with these trends, or that we're already doing our best given the state of nutrition science. But I'm not sure that we should settle for that. For example, research by Dr. Willett and his colleagues suggests that, based on the Nurses Health Study and other high-quality longitudinal epidemiologic studies, after controlling for lifestyle covariates, following the recommendations from the government's Food Pyramid was not associated with significantly better overall health outcomes. And there is now considerable evidence that eating a diet low in fat, as many nutrition experts in and out of government have recommended, may also not improve health outcomes and particularly heart disease risk, if fats are replaced with equivalent or possibly greater calories from carbohydrates. Moreover, there is also some evidence that consumers are not becoming better informed about dietary and other choices they can make to reduce their disease risks. For example, since 1995, according to FDA surveys, there has been a decline in the level of consumer awareness of some dietary risk factors - not to mention the limits of consumer understanding about the different health consequences of different types of fat.

I know that a number of these fundamental nutritional issues are not fully settled; indeed that's part of the problem. My point is simply that we aren't doing a great job in getting the latest, science-based information to consumers, and we're not doing a great job of encouraging innovations in food and medical technology that can help make it easier for consumers to eat a nutritious, balanced diet given their other lifestyle choices. That shortcoming would justify increased policy attention under any circumstances. But it is an alarming situation when considered in conjunction with the health trends of the past decade.

If we don't start making progress now to reverse these trends, our next generation may grow up less healthy to such an extent that it could threaten the steady and impressive population health gains that we have seen over the past century - gains that were in no small part due to healthier diets and better nutrition. Our public health policies on nutrition have not prevented us from moving in the wrong direction, and the past decade or so has been particularly concerning. And so, throughout our agency and throughout the Department of Health and Human Services, under Secretary Thompson's leadership we are focusing on new ways to address the worsening problem of obesity and preventable disease.

At FDA, where we always try to focus our efforts where we can have the most "bang for the public health buck", our strategic action plan places great emphasis on promoting better diets at the same time we're encouraging the development of more nutritious foods.

As FDA has long emphasized, diet-related health problems are primarily a matter of unhealthy diets, not inherently healthy or unhealthy foods. FDA has also emphasized that our policies need to be solidly based on the latest science, and must emphasize protecting and helping consumers. That's not changing. But we are pursuing new initiatives to improve consumer understanding, and to improve the choices of healthy and nutritious diets available to consumers, to reverse the trends of the past decade.

For example, one key part of FDA's new medical innovation initiative is to try to facilitate the development of better treatments for obesity and diabetes. These are areas where we think regulatory pathways could be improved or better defined, and where we intend to give priority attention to potentially valuable new products. In the past, the FDA has approved a number of anti-obesity therapies, but we've received only two products that demonstrated some effectiveness in achieving long-term weight loss without unacceptable side effects. That's not enough, and we're trying to do something about it. So our new working groups are already meeting, and we expect them to issue new regulatory guidance on the most efficient ways to demonstrate that a new product is safe and effective, to reduce the high cost and uncertainty of developing new products in these key areas. These working groups are reaching out to researchers and product developers to get the latest scientific advice, including new insights from genomics and endocrinology, on how FDA can improve its regulatory processes to facilitate the development of safe and effective new treatments for obesity and diabetes that are now on the research horizon.

Some promising innovations are also occurring in food production, and we need to facilitate these developments as well. We have already started to see many foods that are fortified or improved to make them more nutritious, and much more may be ahead. In addition, while the first generation of genetically modified food products were designed to increase crop yields, the next generation of genetic modification might be aimed at making these foods healthier in a person’s diet. Foods might even be designed with the specific genetic profiles of different categories of people in mind. So people particularly susceptible to cholesterol might choose to buy avocados grown to be low in saturated fats.

It's quite possible that, within the next decade or two, genomics will not only provide many valuable insights into the development of highly effective, individualized medical treatments; it may also give us the knowledge we need to understand which foods may be particularly risky or beneficial for particular persons, so that we can make specific, individualized adjustments in our diets to prevent some serious diseases. There is a small but growing field called "nutrigenomics" that is seeking to combine the increasing insights from genomics to our understanding of how dietary choices affect our health. Nutrigenomics envisions a future in which personalized genetic profiling takes the guesswork out of deciding what you should eat. By adjusting nutrient composition in a person’s diet according to genetic profiles, gene-based nutrition planning could one day play a significant role in preventing chronic disease.

So there are opportunities ahead for health gains through innovation to improve how people can use foods to make their diets healthier. But in order to provide proper incentives for the development of these "next-generation" foods, as well as for making short-term improvements in foods already on the market and healthy dietary choices based on them, it's not enough simply for us to determine that the foods are safe. There has to be a clear regulatory path that enables food producers to make truthful, science-based claims about the health benefits offered by their products. If food producers cannot let consumers know about the benefits for health to the same extent that they can promote the product's taste, its ease of preparation, or its price, we won't see the innovation that we most desperately need - innovation in the nutritional benefits of foods and innovations in helping consumers follow a healthy, balanced diet. This is a hard problem: consumers can reach conclusions about taste, ease of preparation, and price themselves. But for a product's health benefits, they depend on us not only to help prevent them from getting misleading information, but to facilitate their getting up-to-date accurate information about nutrition and health.

At FDA, we firmly believe that there is more that we can and must do to help consumers get good, up-to-date, science-based information so that they can make choices that are based on a better understanding of the health consequences of their diets. We need to continue to improve the nutrition label. This includes providing information on the trans-fat content in foods. And it also includes providing better guidance about the recommended consumption of trans fats, saturated fats, and cholesterol. This is not easy to do. Foods themselves are not inherently unsafe, or we wouldn't allow them on the market. But the latest nutrition science provides some reasonably clear evidence on which foods should generally be consumed in abundance, which should be consumed more sparingly, and what an overall desirable diet might look like. Consumers don't so much need information about individual foods as they need information about how individual food choices can fit into a healthy overall diet. And so there needs to be better, clearer information on nutrition labels connecting an individual food product to a consumer's overall diet.

This kind of guidance for individual food shoppers is important. Despite the growing custom of eating out, 76 percent of all meals in the U.S. are prepared at home. As they stroll through the aisles of the supermarkets, Americans should have at their fingertips accurate, helpful, and understandable information about the most important nutritional implications of the products on the shelves. People shouldn't need a calculator or an advanced degree in math or nutrition to calculate what makes a healthy diet.

So we have to find a way to make the key information we require to be placed on individual food products easier for consumers to understand and use from the standpoint of what constitutes a healthy meal and a healthy diet. Right now, we communicate some very useful information about the nutritional value of individual foods, and we provide some help in thinking about how foods can contribute to a healthy diet. But combining foods into a healthy diet is still too complicated. Instead of doing the math, consumers often do simple substitutions, such as trading off a low-calorie cola with a high-calorie dessert. We need to find better, simpler ways to help consumers understand the nutritional value of entire diets.

For example, you might envision a coding system on foods or key food ingredients that would place them, based on a reasonable portion measure, into a nutritional category for a desirable diet. Some of these might be recommended to be used sparingly, and others more frequently. We are open to any good ideas here, including ideas for how to help consumers get better information for the quarter of their food consumption that occurs in restaurants. We are facing some difficult challenges when it comes to helping consumers get the information they need to make better informed choices about their overall diets, and we are going to need some creative thinking.

Important as the nutrition label is, it doesn't connect directly to what consumers care deeply about: their own health. To really encourage the development of better consumer understanding of how their food choices contribute to a healthy diet, and to change consumer behavior, we need to do more to connect food choices directly to their health consequences. We need to encourage more competition based accurate, scientifically valid information about the health consequences of dietary choices. To this end, one of my first acts as commissioner was to appoint a "Better Information for Better Health" Task Force. Its mission is to find effective ways of informing consumers about what the latest science has to say about the health consequences of their dietary choices, to take some first steps toward increasing the focus on health in product development and promotion, and to lay out a research agenda that would help us make further progress toward the goal of greater science-based competition among food producers to improve health. Properly regulated, allowing products to compete based on advertisements and labels that focus on the health consequences can help to shift the market toward developing more nutritious foods and healthier diets.

Right now, however, advertisements and claims on labels focus primarily on taste, price, ingredients, and ease of preparation. There are only a few claims allowed about on product labels about health consequences, even though we know that dietary choices have enormous health consequences. We need to do more to help consumers channel their interest in healthy foods and healthy diets in more effective ways, by creating a marketplace that offers a wide variety of food products that truthfully offer significant health benefits, products that will facilitate the choice of a healthy diet. And to stimulate appropriate consumer interest in such products, and thereby encourage much more competition based on the health consequences of foods, we need a stronger and more extensive regulatory framework for science-based health claims.

Let me give you a couple of examples of the kinds of health information that I'd like to see move from the academic journals to having an impact on the dietary choices of mainstream consumers. Considerable recent research, including controlled feeding and epidemiologic studies, has provided pretty good evidence that replacing saturated and trans fats with mono- and poly-unsaturated fats can significantly reduce important health risks. According to some studies, this substitution can potentially reduce the risk of heart disease by up to 30 to 40 percent. That is a big impact. But today, the labels on foods that are low in trans fats and, more importantly, that can reduce overall intake of trans and saturated fats in overall diet, can't disseminate this type of information to consumers. And so perhaps it's no surprise that many people don't have a clear understanding of the health consequences of their choices about mono- and polyunsaturated fats versus products high in saturated and trans fats. And it’s no surprise that companies instead focus their marketing and their product development instead on whether a food is simply "low fat" and whether it springs ready to eat out of the box.

As another example, one of the major health messages that the entire Department of Health and Human Services is promoting widely is that people should consume fresh fruits and vegetables in abundance in their diet - at least five servings a day, if not more. But today, despite growing evidence indicating the health benefits of such a diet, there is nothing on the label of products that are high in fresh fruits and vegetables that would tell the shopper, "there is considerable scientific evidence that, if you eat more products like this in your diet, you may have a better chance of avoiding diabetes and other chronic diseases that go along with obesity." We're trying to get this message out in our public health programs, but those programs are no match for product marketing campaigns.

A diet with many servings of fresh fruit and vegetables may not be as cheap or as easy as a diet high in other foods that taste better and may be easier to prepare. But the evidence shows that consumers are willing to pay more and go to a little more trouble for better health, especially if they're encouraged by truthful information that's on food packages and advertisements. Right now, focus of food promotion is mainly on taste, ease of preparation, and price, and a bit of promotion of foods that are fortified with vitamins and minerals. The #1 focus should be on how a consumer's health will be affected by including that food in their diet.

As we start down the road to finding effective ways to encourage more product competition and innovation around health benefits, we are working closely with another premier consumer protection agency, the Federal Trade Commission. Our task force working on better information for better health has had many formal meetings, including with health professionals, academics, consumer and industry groups, and had a docket for public comments. The task force is about to make some preliminary recommendations on how food labels can better inform consumers about the health consequences of the foods they eat, through an appropriate level of FDA oversight. The claims we have in mind will have to be approved in advance by FDA's expert staff, possibly in conjunction with reviews by independent scientific experts working with us.

This is a top priority FDA activity that will require considerable research, exploratory work, cooperation, and resources. I know that many of the key questions in nutrition are not fully settled today; as I've tried to make clear, I'm very concerned about the need for urgent progress in policy-relevant research. But when it comes to encouraging consumption of fresh fruits and vegetables, foods that can help consumers meet their protein and calorie needs with lower levels of saturated and trans fats, as well as for foods that may help reduce the risk of particular diseases, like omega-3 fatty acids for heart disease, or lycopene for prostate cancer or possibly folate for colorectal cancer, there may be enough science there that it's worth consumers being aware of it. And it's certainly the case that we need to encourage more development of foods and diets that focus on these and other ways of reducing obesity, heart disease, and other health risks.

These issues are not settled; they are a moving target. I know that updating our guidance to the public can be frustrating and potentially confusing to consumers. We're going through such issues right now as we engage in the process of updating the Food Pyramid. We go through such issues all the time as we develop new evidence on medical treatments, including relatively old treatments like aspirin and postmenopausal hormone therapy. But from a public health standpoint, I don't think we can remain locked in while nutrition science continues to improve, or wait patiently for the day when we get absolutely definitive evidence from large-scale, long-term, randomized clinical trials. We know a lot now, we are learning a lot more, and all of these changes in knowledge ultimately lead to better public understanding, better choices, and better health. In fact, we'd like applied nutrition science to progress much more quickly, and for many of the scientific and policy reasons I've discussed, I'm expecting more rapid progress.

Many of the health claims about such dietary choices as abundant consumption of fruits and vegetables, and substitution in favor of unsaturated fats, and relatively frequent consumption of foods high in omega-3 fatty acids are in the category of considerable good evidence but not definitive evidence. In these cases, and probably in more cases in the future as the science expands, the evidence seems pretty good -- good enough that I think many Americans would appreciate being more aware of it with proper qualifications, even though future more definitive studies might revise our conclusions somewhat about the health benefits of these steps.

Of course, the lack of absolutely definitive research on the health consequences of these dietary choices will have to be truthfully imparted to consumers. There is some encouraging recent applied research on consumer understanding of such qualified evidence. For example, a recent study by the Federal Trade Commission on peoples' interpretation of food nutrition and health claims in advertising suggests that most people are able to accurately interpret health claims that have simple qualifications describing how the scientific evidence is not completely definitive. We need more consumer research on these issues, and we need it quickly, but many of the available consumer studies are encouraging.

Getting this kind of information to consumers is important if we're going to have a positive role to play in helping people make smarter choices about their diets. Because claims that are qualified aren't allowed, right now many of the food products I've described that are likely to be healthier have no easy way on their label to compete with products that advertise their ease of preparation or their good taste. This simple fact has slowed the widespread adoption of eating habits based on much of the valuable research of the past decade. And since these foods are safe, even if only half or less of the health benefits apparent in the research to date actually pans out in the long run, we will have saved many lives over the years by making this information more available in the meantime.

Just because FDA is working to make better information available where the science base is strong but not certain doesn't mean that the FDA intends to relax its enforcement of the accuracy of health claims on foods and dietary supplements one bit. We are more committed than ever to making sure that food and supplement labels are based on sound science, and aren't written in a way that is false or misleading to consumers. Since consumer choices have the greatest impact on public health, FDA must do all it can to ensure that health-related information available to consumers is truthful and not misleading. Consumers are getting more involved than ever in taking steps to promote their own health, which is a very good thing. And so I view it as a clear public health threat if they then waste their money and time on ineffective treatments as a result of misleading information that doesn't reflect the scientific evidence.

There are many difficult questions related to public policy on nutrition and health. If the questions were easy, we presumably wouldn't have such an enormous disease burden associated with poor dietary choices. But I am optimistic about our ability to meet these challenges.

About 35 years ago, a winner of the Nobel Prize in Medicine said that our best work in health was behind us, because all that was left was the chronic diseases and everyone knows that there’s little to do about those diseases. And for thousands of years, many pessimists have said that you just can't change human behavior. I'm glad that, in many cases, the evidence refutes them. Fortunately, there is overwhelming evidence that science and technology as well as individual choices can improve, especially when our public policies support desirable changes. We've made tremendous medical progress against heart disease, diabetes, and many other chronic illnesses in the last 35 years. And far fewer people are smoking today, more are exercising on their own, and far more are eating more diverse and potentially healthy diets, than they did 35 years ago as well. We've learned over and over again that behavior will change, that people will choose to live better lives when they have accurate and compelling information about their choices. And when coupled with appropriate public health policies and consumer protections, we've seen that food and medical products respond to the demands of consumers and the new insights of science.

And so in closing I want to ask for your best ideas and your help with the many urgent and difficult food issues that FDA is facing today. We have some great opportunities to make our foods safer and more secure, and to find more effective ways to combat obesity and other preventable illnesses. The public health challenges are great, but the opportunities to make a real difference for the health of the public have also never been greater. Thank you very much.