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Scott Gottlieb, MD - Grocery Manufacturers of America Annual Meeting

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

Speech before
Grocery Manufacturers of America Annual Meeting

Remarks by
Scott Gottlieb, MD

Deputy Commissioner for Medical and Scientific Affairs
Food and Drug Administration

November 30, 2005

Thank you for having me here today and for your kind introduction.

As many of you know, I still practice medicine, and I want to relate to you a story from my work this weekend, in the hospital where I was on call.

During a typical shift I will see and admit dozens of patients, but on this particular weekend, two stand out.

I will alter my description of them some to conceal their identity, but the salient points will remain the same.

They were both about fifty and they both had diabetes from an early age. They had similar jobs and similar lives in many respects, but when it came to the consequences of their disease, the similarities quickly ended.

One patient, in good health, was at the hospital for a minor, elective procedure. The other was there convalescing from a gruesome consequence of her chronic disease.

Many things might have separated the different courses that disease took in these two otherwise similar individuals, but not least of them were their lifestyles.

One adhered to strict diet regimens and exercised regularly, the other, was not so exacting. Their lifestyles, in that respect, were quite different, and so was the consequence of their disease.

This is my second tour at the Food and Drug Administration, and I have nurtured during my time there a deep admiration for its unique mission in promoting public health, and the dedication of its professional staff to these goals.

That mission, the policies that the Agency promulgates and the products and information it approves, spans the full spectrum of disease, and the course of illness. Right from the very beginning, before signs and symptoms are even made manifest, to the end stages of illness, when all that is left is palliative medicines.

And while FDA's medical centers might have a lot to offer my two patients, to help blunt the march of their diabetes, it is only through preventative measures that one of my patients was able to stave off the worst consequences of her disease, while the other bore them full brunt.

This is where the special role that the FDA's Center for Food Safety and Nutrition lines up so well with the agency's mission to promote public health, and why I believe that technology around food and diet, and CFSAN's role in promoting it, will be increasingly important if we are really going to reduce the burden of disease in America. Under the leadership of Bob Bracket and Mike Landa, the professional staff at CFSAN is hard on work on a number of important initiatives that advance these goals.

The good news is that we have more opportunities to use diet to promote health and prevent disease than perhaps ever before. First, people are increasingly seeking to manage their own care, to participate in the prevention and treatment of their own ills.

Simultaneous to this cultural change, we're also witness to a revolution in the understanding of health and disease, spurred on by the sequencing of the human genome, and a better understanding about how ones risk for disease can be identified, and how diet and disease interact.

There is extensive evidence to show that there is considerable variation in diet and disease patterns and that many of the dietary patterns are predictive of chronic disease. Increasingly, there is evidence that this dietary effect is mediated by genetic background.

But unfortunately, the ability to identify genetic markers of risk, and identify people who are susceptible to diseases that have not yet manifested themselves, as well as susceptible to the consequences of their diagnosed illnesses, has far outpaced our ability to intervene with drugs and devices. And while medical products are catching up to the diagnostic tools spawned by the genomic discoveries of this past decade, its going to be a long time before drugs are developed to mitigate or prevent what we are able to diagnose with our new genetic tools.

That leaves diet alone as one of the few and perhaps most important tools for intervening to help mitigate peoples risk from illness, or prevent disease altogether. But we need to take steps today, FDA included, to design a framework for doing things in order to achieve these goals.

The intersection of genetics and targeted nutrient intervention is not a new phenomenon. Diseases collectively known as "inborn errors of metabolism" long have been treated by diet manipulation.

Clearly, there is a correlation between food, diet and disease. An outgrowth of this from the food industry side has been the plethora of food products marketed with associated health claims.

The emergence of the functional foods market also shows acknowledgement from food industry partners that nutritional components impact health.

Herbal and homeopathic remedies long have been used in medical and health practice worldwide for their role in health improvement, ailment management and prevention.

But this is where a lot of the promising work that has been done begins to tail off. And this is where I think FDA wants to do more, working in collaboration with the scientific community, to develop a framework that maximizes the public health value of food and diet as a tool for mitigating and even preventing disease.

We have seen a lot of innovation in food production. Innovations in food preparation and in packaging, for example, is something busy people are willing to pay more for, and changes in production or delivery that allow other advances, whether its fresher produce and poultry or a longer shelf life for bread, are all advances that have expanded choices and commanded consumer attention.

Now, we might say that our public policies on nutrition don't have anything to do with these advances, or that we're already doing our best to provide variety and innovation in food production given the state of nutrition science. But given all of the unhealthy diet choices people make and the difficulty people have in getting information about the health benefits of their individual food choices, as well as the growing burden of diseases that we know are impacted by diet and lifestyle, I'm not sure that we should settle for that.

One place where I think there hasn't been enough innovation and progress is in the development of diet options, and dietary approaches that help people reduce their risk for certain diseases and their complications.

And one problem, I believe, is that we aren't doing as much as we can in getting the latest, truthful, non-misleading, science-based information about health and diet 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.

The bottom line is this: if food producers can't sell their products based on a truthful claim about the nutritious value, then that doesn't leave a lot of incentive for them to develop those kinds of products in the first place.

The result is clear -- there has often been too little innovation in areas that count most to the public health, in diets and diet choices that are actually good for you.

The good news is that technology, and advances in food production, are expanding the opportunities to develop foods that are much healthier for you.

In addition to our better understanding of the interplay between disease and diet, we are also starting to see more foods that are fortified or improved to make them more nutritious, and much more may be ahead.

This is another place where advances in genomics and our understanding of the genetic basis of disease, is leading to promising new opportunities.

For example, 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.

Here too, there are profound policy questions we need to address to help encourage the development of potentially useful innovations. For example, where does food end and pharmacology begin? If nutrigenomics reveals that certain nutrient components in various concentrations can prevent or reverse disease, where is the boundary between food as nutrition and food as medicine? These are profound issues that we need to address.

So there are opportunities ahead for health gains through innovation to improve how people can use foods to make their diets healthier and improve their lives.

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 clear regulatory pathways that enable 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 need the most, innovation in the nutritional benefits of foods and innovations in diets that are healthy and balanced, and offer opportunities to help mitigate illness, such as the DASH diet and its scientifically demonstrated impact on hypertension and heart disease.

So we have been 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. And 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.

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.

Our efforts start with steps to continue to improve the nutrition label and the information people get about the foods they eat in order to provide new information about diet choices that science is showing us can have a profound impact on health and disease prevention.

We know, for example, from a number of studies, that trans fats depress HDL cholesterol levels in serum, which is the "good" cholesterol, and raise levels of LDL cholesterol, or the "bad" form, as well as total cholesterol, and triglycerides. Trans fats, consumed as 2% of daily energy, nearly double the risk of heart disease, whereas polyunsaturated fats and monounsaturated fats, consumed as 5% of daily energy, significantly reduce the risk.

The consumption of nuts, which are a good source of unsaturated fats, has been found in at least three high quality studies to be linked with a significantly reduced risk of heart disease. And some studies found that as few as two servings of fish each week halves the risk of sudden death from heart disease.

Our trans-fat nutrition labeling rule will provide information on food labels about the amount of trans fat in foods so that consumers can select foods with lower levels of trans fat. The rule will require food manufacturers, processors, and distributors to label the amount of trans fat in a serving of food on the Nutrition Facts panel.

As a result, Americans will have information they need to reduce their intake of trans fat as part of a heart-healthy diet. We estimate within 3 years after the effective date, trans fat labeling will prevent from 600 to 1,200 cases of Coronary Heart Disease and 250-500 deaths each year.

Based on informal reports from industry, the requirement to declare trans fat on product labeling is already changing consumer demand and prompting product reformulation.

In another example, we also know that breads made from 100 percent whole grains, with all the vitamins, minerals, fiber and phytochemicals intact, might help cut the risk of heart disease, cancer.

CFSAN has, as one of its priorities for the coming year, the development of a regulatory strategy on label claims for whole grains. As a part of this priority we expect to define the term "whole grain" and establish the framework for appropriately using claims about whole grains considering the recommendations of the Dietary Guidelines.

We also know, thanks to advances in science, that new classification of carbohydrates that emphasizes the biological effect of whole food instead of the traditional designation by chemical structure can do more to help people make healthier decisions about foods.

Ad we know that different types of carbohydrates, for example, differ in their effects on plasma glucose and insulin response.

So we have also drafted a proposed rule that would define nutrient content claims to describe the carbohydrate content of foods, and an advanced notice of proposed rulemaking to solicit public comments on available data and information relative to carbohydrate-related label claims and consumer understanding and behaviors related to such claims. We hope these will be published this fiscal year.

We will also be updating our measures for percent daily values to reflect the National Academy of Sciences reports. And we will be working on guidance for how we evaluate evidence-based food claims to encourage the development of better scientific information to support health statements on foods.

Taken together, all of these efforts represent a significant update to the food label based on science that has been developed in recent years, and it represents a major opportunity to re-educate consumers about the food label, and the impact of diet on their health.

This kind of guidance for individual food shoppers is increasingly important, and we need to take advantage of the opportunity to engage consumers in the health impact of their diets and the choices they make in the grocery store.

As people shop for food, they should have at their fingertips accurate, helpful, and understandable information about the most important nutritional implications of the products on the shelves. And they should be able to easily fit individual food products into overall healthy diets. People shouldn't need a calculator or an advanced degree in math or nutrition to calculate the components that comprise a healthy meal.

To these ends, in April of this year, FDA published in the Federal Register its advance notice of proposed rulemaking (ANPRM) requesting input from our stakeholders on how to give more prominence to calories on the food label.

Some ideas for how to do this include increasing the font size for calories on the label, adding a percent "Daily Value" column for calories on the Nutrition Facts panel and possibly eliminating the column listing calories from fat.

In conjunction with the ANPRM on the prominence of calories on the food label, on the same day (April 5, 2005) we also published our ANPRM asking for comment on issues regarding the labeling of serving size on food packages.

That is, either requiring dual column nutrition labeling for multiple serving packages that could reasonably be consumed as a single serving or simply requiring such packages to be labeled as single servings.

We have also encouraged food manufacturers to take advantage of existing flexibility in the serving size regulations to label as single servings those packages where the entire contents can reasonably be consumed in one eating occasion.

And we have encouraged manufacturers to use dietary guidance messages on food labels, particularly on "reduced/low calorie" foods, and to use appropriate comparative labeling statements to provide consumers with information on healthy substitutions.

Some manufacturers have already started to make voluntary label changes.

Kraft Foods, for example, announced last year that they would provide both single serving and entire package nutrition labeling for their snack items containing up to four servings per package. The Coca Cola Company also indicated plans to provide dual column labeling for their 20 ounce sodas to display information for both the 8 ounce serving and the full 20 ounce container.

And last Friday (11.25.05) we announced a proposed rule to expand the nutrient content claims for "lean" products, I urge you to submit your comments on this proposed rule that will provide the industry a greater opportunity to competitively market food products on the basis of their contribution to a healthy diet.

We also need to find better ways for making 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.

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 and to opportunities to prevent disease.

So 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, and products and diet choices that are described by truthful, non-misleading information that allows consumers to assemble meals that enable healthy diets. And we need to stimulate appropriate consumer interest in such products, and thereby encourage much more competition based on the health consequences of foods.

To do these things, we need a stronger and more extensive regulatory framework for science-based health claims. To these ends, two years ago FDA issued the Consumer Health Information for Better Nutrition Task Force Report.

The report put forward interim procedures to implement this initiative to make available more and better information about foods and dietary supplements. To help Americans improve their health and decrease the risk of contracting diseases by making sound dietary decisions.

The initiative is designed to foster two complementary goals concerning the labeling of food and dietary supplements. The first is to encourage makers of conventional foods and dietary supplements to make accurate, up-to-date, science-based claims about the health benefits of products.

And second, to help eliminate bogus labeling claims by taking on dietary supplement marketers and others who make false or misleading claims.

We developed interim Guidance that provided the industry a framework for petitioning for the use of Qualified Health Claims on food labels. Since that time, we have received petitions on numerous substances and foods and their relationship to reduction of disease risk.

At the same time, we established a consumer studies research agenda to identify the most effective way to present truthful and non-misleading information to consumers as the science becomes available.

We have completed our own study on qualified health claims, and have identified research conducted by other groups that addressed topics on our own research agenda.

The results of our own consumer research studies were posted on the web in October, and on November 17, 2005, we held a public meeting to gather further comments on the effectiveness of these kinds of label claims in giving consumers information they can understand and use to select healthier diets.

The results of the studies, including our own, that were presented at that meeting indicate that we are not there yet in getting consumers to understand the difference in levels of scientific evidence supporting the relationships between consumption of a food or substance and decreased risk of disease.

But the basis for allowing this information on food labels is clear. We simply must create a framework for people to get truthful, non-misleading health information about the foods they eat and the diets they choose if we're going to take advantage of the opportunity to inspire the use of healthy diets as a means to mitigate and prevent disease.

We received a lot of thoughtful suggestions at our public meeting, and we will be working through the guidance and scientific information we received to develop a pathway forward for enabling this kind of useful communication in a way that consumers can use effectively.

Some suggestions, for example, included testing qualifying language more like that used in the Federal Trade Commission's copy testing, since FTC found its language did successfully convey strength of the science.

In short, we need to continue to work together to find the best way to convey these important messages on food and supplement labels to help consumers in their selection of healthier diets.

With the support of the food industry and research conducted by the academic community and others, we can and must find better ways to empower consumers to make healthier dietary choices, and in a way that is generally non-misleading and scientifically rigorous.

Just because FDA is working to make better information available where the science base is strong but not certain doesn't mean that we intend to relax enforcement of the accuracy of health claims on foods and dietary supplements one bit. Working with our partners at the FTC, we are more committed than ever to making sure that food and supplement claims 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 products as a result of misleading information that doesn't reflect the scientific evidence.

Finally, and in closing, it is also clear that even as food options expand, so do the variety of places where people get their meals. And with more and more people eating out, the opportunity to get good information about diet and nutrition in restaurants is increasingly important.

This isn't an area where FDA has a direct role to play, the law is very clear where our authority begins and where it ends. But one of the recommendations that came out of FDA's Obesity Working Group report had to do with how to make the kinds of information I've just been talking about available to consumers when they are consuming away-from-home foods. With so many people from the restaurant industry here today, I wanted to say just a few words on this subject.

One of the key recommendations urged FDA to establish a dialogue with the away-from-home-foods industries such as restaurants, quick-service food establishments, institutional food service establishments and other convenience outlets that prepare and sell food.

In June of 2004, FDA signed a contract with the Keystone Conference Center to conduct this national stakeholder policy dialogue. Keystone has completed two such conferences, and the third and final dialogue session is being held right now, as I'm speaking to you (November 30-December 1, 2005).

The point of these dialogues is to consider what can be done voluntarily, given the best available scientific evidence, to support consumers' ability to manage energy intake to prevent undue weight gain and obesity, within the scope of away-from-home foods.

The forum is intended to produce options for the industry to address these issues.

It's very clear, that as our understanding of disease continues to advance -- so will our appreciation for the prominent role that diet plays in promoting health. Our basic understandings of genomics are just the beginning.

The policy choices we make today, and the work we do to develop better foods and better approaches to diet that take account of what we are learning, may well decide if we're able to mitigate the substantial burdens of disease in this country.

Whether we are able to offset alarming trends in the incidence of cancer and heart disease and obesity, or whether we'll become more and more dependent on medicines and medical devices to intervene in diseases after most of the more ravaging effects are already made fully manifest.

My own clinical experience has taught me that diet can make a profound different in how people experience disease, and the scientific advances we're all seeing every day I think reminds us that diet can be a powerful tool for preventing disease and illness in the first place.

We're going to need creative ideas if we're going to take advantage of it. That means new and creative approaches to making health information available to consumers on the foods they eat. And even more innovation aimed at producing food products that don't just taste better or look better but products that are also better for you.

We have some great opportunities to work together to find more effective ways to combat obesity and other preventable illnesses. I know that the professional staff at CFSAN are hard and work on these goals, and dedicated to the special role that CFSAN plays in promoting public health.

The public health challenges that we face today 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.