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Mark B McClellan, M.D., Ph.D. - National Food Policy Conference

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
National Food Policy Conference

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

Commissioner, Food and Drug Administration

May 8, 2003
Thank you. It's a pleasure to see you (John Cady) and Art (Jaeger) again, and it’s a real pleasure to follow Secretary Thompson. He’s been a strong advocate for better food safety and food security – his support has made a real difference in FDA’s ability to carry out its food safety mission. As he said, we’re here because this meeting is so important. All of you – consumer advocates, representatives of the food industry, nutrition scientists, and other food experts – have a collective comittment to the issues before the FDA that is integral to our ability to accomplish our mission. And your help is more important to us than ever. We are facing difficult new challenges. Some are largely security issues, such as the threat of terrorism to our food supply. Others are more purely rooted in protracted public health problems, such as the increasing prevalence of bigger waistlines. All of these challenges present a unique threat to our ability to protect and promote the public health. It’s clear to us at FDA that while we are working hard on these critical public health issues, more must be done. Now more than ever, we all must work together to find better solutions.

Food Security

First, I’d like to pick up on some of the Secretary’s remarks about food security issues. We all know that, because attacks are possible on our food supply, we have new challenges in protecting our food supply. But if we respond effectively, these new threats also present new opportunities to make our foods safer as well. To meet these critical new challenges, FDA has been making fundamental changes. My friend and colleague, Dr. Lester Crawford, last year briefed this gathering on the basic components of FDA’s counterterrorism programs focused on ensuring the safety of our food supply, particularly the five to six million food shipments we import each year. Since then, we’ve made a lot of progress in making our food supply more secure.

We completed a threat assessment of different categories of food, determining the most serious risks of intentional contamination during various stages of food production and distribution. The results are classified, but we are using the results to work with state and local governments and with industry to address the threats to food security. This includes discussions of food security and rapid response and recovery procedures with more than 35 industry groups and trade associations. We are implementing new procedures to share relevant sensitive information with our partners who need to know.

Thanks to the leadership of the President and the Secretary, we were able to hire well over 600 new field employees who are on the job now making the food supply more secure. They were part of our new front line under Operation LibertyShield, the government-wide initiative to increase our homeland security activities during the recent period of heightened alert. As part of that effort, we used emergency funds to begin surveillance and testing for agents of terrorism in the food supply for the first time ever, and we issued guidances relevant to everyone involved in food production and distribution on common-sense steps they can take to improve security.

We are also working hard to implement the important new food security regulations of the Bioterrorism Act on schedule and successfully by the end of this year. We appreciate the thoughtful comments we received on our first two proposed food security regulations, and we look forward to reciving your input on our recently proposed regulations on recordkeeping and detention. As the Secretary announced, the Department has just offered grants for food labs in order to strengthen our surveillance resources. This first-ever program through CDC will strengthen our food surveillance capacity and provide much-needed “surge capacity” in the event of a serious outbreak of foodborne illness. We’ll have additional details on the FDA website later today.

So this is a critical time. The changes in food security that we are implementing now amount to the most fundamental enhancements in our food safety activities in many years. They will have lasting consequences, and we need to do it right. We need your input on how we can achieve the greatest improvements in public health protection, with the least possible disruption and added costs for the foods we regulate.

This will be an ongoing process. To continue to meet the challenges of protecting the food supply in the face of these new threats, over the coming years I believe the best solution will be the adoption of a risk-based import surveillance system to replace our current import program, and to improve our ability to focus efforts on the highest-risk points in our food supply – points of high risk from both a security and safety standpoint. For imports, we need a system that is fully linked with Customs entry processes, and we are working closely with the Department of Homeland Security to Achieve this. Customs processes have historically been designed to address revenue and trade issues, not public health issues. That’s changing. We’re already moving in the direction of a modern, risk-based system for food imports.

We are moving toward a science-based, “life cycle” approach to assuring the safety of food products. This approach, based on the principles of efficient risk management, will enable us to achieve the greatest food protection with our limited resources. For example, when it comes to bulk imports, instead of a taking a snapshot at the border by examining and sampling a particular shipment, we’re trying to get a broader picture that covers the product’s history from raw materials, through production, transportation to the U.S. manufacturer or producer if there is one, storage, and to the ultimate consumer. We are also considering risk information in deciding how to manage food imports, whether by working with foreign countries and manufacturers to improve compliance with safe manufacturing abroad as an alternative to detailed inspections at the border, or by using better information on imports to focus border checks of final products that present significant potential risks, or by collaborating with domestic producers to improve checks on the safety of the ingredients they use.

We need these creative new strategies to protect our food supply from deliberate attack. And in many cases, these enhancements to our existing systems for food safety can help us prevent and contain conventional foodborne illness outbreaks. But we must continue to take other efforts aimed specifically at safeguarding our foods against the conventional threats, such as accidental contamination with bacteria and food spoilage.

This includes our ongoing adoption of a “Hazard Analysis and Critical Control Point” approach to food safety - which FDA has already applied to seafood and fresh juice, and which is voluntarily applied in the dairy industry. We are also working to reduce food borne illness associated with Salmonella enteriditis in shell eggs by working on regulations including labeling, refrigeration and other preventive controls. 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 need to make sure that our policies effectively address science-based concerns about whether any new bioengineered foods create risks of allergenicity, bioactivity, or toxicity. These are just a few of our ongoing efforts to improve food safety protections for consumers. We are comitted to making even more progress on these and other key food safety issues. We will look to you for places where we can partner in these efforts. And we welcome your input on where we can and should be focusing our efforts.

Epidemic of Obesity

Food-borne illnesses injure and kill too many people every year. But these risks are dwarfed by the risks in dietary choices and lifestyles that contribute to cardiovascular disease, diabetes, and other preventable diseases. In America, at least 300,000 deaths each year are associated with poor nutrition and lack of physical activity. As the Secretary passionately made clear, we must focus our activities on this public health threat as well. Being overweight or obese isn’t just a cause of heart disease or diabetes. Recent studies have also linked obesity to other risks, including an increased risk of cancer. We’re all comitted to finding ways to help quell this epidemic, FDA included.

One key part of our new medical innovation initiative is to publish new guidance for medical product developers in areas where we think regulatory pathways could be improved or better defined to lead to new treatments quickly. This is particularly true in obesity and diabetes. These working groups are already meeting, and we expect to issue the new guidance in the coming year to stimulate product development.

It’s also quite likely that, within our generation, genomics and proteomics will give us the knowledge we need to understand which foods may be particularly risky to us, so that we can make specific, individualized adjustments in our diets to prevent some serious diseases. So I think there is great potential ahead for health gains through better knowledge.

But we need more progress on these issues now, based on the best available scientific evidence. Our framework for making that needed progress begins with important facts about the nutrition problems we face today. First, diet-related health problems are more a matter of unhealthy diets than unhealthy foods. So advertising’s effects on food choices as part of an overall diet must be identified more effectively. Second, there is an imbalance within people’s dietary choices with respect to healthy foods and unhealthy foods, and we need a better communication strategy to address this. The Secretary just outlined a bold plan on public information and education to do just that.

Third, and most fundamentally, a major component of a healthy diet is that ‘energy in’ is matched by ‘energy out’. So it’s perhaps surprising that, in a debate that has often focused on foods alone, actual levels of caloric intake among the young haven’t appreciably changed over the last twenty years. While this seems counterintuitive, I think the reasons behind the rising incidence of obesity has much more to do with changes in diet choices people are making, and especially with lifestyle choices.

With improvements in food production, the cost of calories has gone way down. This is generally a good thing in a world with lots of starvation, and even here it means people can get the calories they need for less money. But unfortunately, here in the US, our propensity to exercise has also gone down. As Secretary Thompson has said, people need to exericise regularly- and just 30 minutes a day or a few thousand steps can make a big difference.

No question, this is hard. People are working longer days and driving more, and no wonder they prefer to spend the few hours before they go to sleep taking it easy watching television, or enjoying some time with their children. Whereas before we were paid to exercise in the form of labor expended in strenuous jobs, now in a services-oriented economy, it costs us to get exercise, through our gym memberships or through taking precious time away from other activities. Innovations that reduce the physical work we need to do in the office, at home, and in transportation, have increased productivity, but they also mean that we’re getting less physical activity. And on top of all this, preparing meals has also gotten much easier. Innovations in packaging, including the availability of a broad array of easily prepared meals, is something that people are willing to pay more for.

So in foods, tremendous technological progress has made it easier for people to get foods that taste better and are easier to use. These are valuable innovations. But we clearly need more innovation to help people deal with the hard problem of choosing a diet that is not only easier to prepare and better tasting, but better for their health. And as the nation’s most important consumer agency, FDA needs to find new ways to help.

First, FDA must do more to help consumers get good information so that they can make smarter choices about their diets and their lifestyle. We need to improve the nutrition label, including appropriate guidance on trans-fat content in foods. Our new proposed rule to regulate all dietary supplement manufacturing practices will also help make sure that consumers get accurate label information about the actual amount of active ingredients in the dietary supplements they use. FDA is already doing much in these areas, and we will do even more.

Second, we need to encourage competition based accurate, scientifically valid information about the health consequences to consumers of their diet choices. To this end, one of my first acts as commissioner was to appoint a “Better Information for Better Health” Task Force, to find ways to help consumers get better informed about the health consequences of their dietary choices, and to lay out a research agenda for further improving our understanding of how we can best achieve the goal of increasing consumer awareness. In this important effort, we are working closely with another premier consumer protection agency, the Federal Trade Commission. Our task force has had several formal meetings, including with health professionals, academics, consumer and industry groups, and has an open docket for public comments as well. The task force will make recommendations on how food labels can be used to help inform consumers about the health consequences of the foods they eat. In this process, any health claims that are made must be approved in advance by independent experts at the FDA, possibly including review by an FDA scientific advisory board.

A key goal of this effort is to focus competition and innovation in foods much more sharply on the health consequences of foods. 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 labeling and advertising support their efforts to do so. Right now, labels focus mainly on taste, ease of preparation, and price. The #1 focus should be on how a consumer’s health will be affected by including that food in their diet.

The evidence shows that a compelling way to reach consumers – especially some of the groups with the highest rates of obesity and preventable diseases – is to give them information right on the label not just about caloric or fat content, but about the consequences for health problems like heart disease, diabetes, and cancer. The problem is that right now, there’s not much of a path to enable such health claims to be made. So there has been only limited incentives for the food industry to develop better health-promoting foods. And as a result, companies have focused their efforts on competing in other areas like portion size and convenience. They’ve also succeeded are fortified with vitamins –something that they can and do promote on the food label. But these innovations don’t necessarily make foods healthier, and they aren’t going to help stem the tide of obesity. Right now, consumers turn to unproven and potentially dangerous remedies for weight loss such as dietary supplements and even smoking. So we know the demand for diet-concious alternatives is there. To create a marketplace that strongly encourages competition based on the health consequences of the foods we eat, we need a stronger and better- developed framework for science-based health claims.

A recent study by the Federal Trade Commission on peoples’ interpretation of food nutrition and health claims in advertising found that people are able to accurately interpret these kinds of qualified claims, even in cases where ther are limitations in scientific support, so long as the specific disclosures are clear and accurate. Right now, fresh fruits and other nutritious foods are often more expensive than alternative snacks and foods that are less likely to be an effective component of a balanced diet. Yet nothing on the label would indicate the important health benefit of eatinga diet high in fresh fruits and other products at the lower end of the food pyramid. Because qualified claims aren’t allowed, these products have no easy way on their label to compete with products that advertise their ease of preparation or their good taste. We need to adopt policies that would allow us to shift the competative balance to these healthier products.

This doesn’t mean that the FDA intends to relax its enforcement of food and supplement claims one bit. We are more comitted 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.

If we’re going to have an effective marketplace for responsible, science-based health information, FDA must do all it can to ensure that health-related information available to consumers is truthful and not misleading. As consumers are getting more involved than ever in taking steps to promote their own health, I view it as a public health threat if they waste their money and time on ineffective treatments as a result of misleading information that doesn’t reflect the scientific evidence.

So we’re also strengthening our enforcement actions against dietary supplement manufacturers and others who make health claims – claims about disease as well as structure-function – that aren’t supported by science. We’ve taken action against makers of dietary supplements with unsupported disease and structure-function claims. We intend to continue trying to stamp out misleading claims. We expect to use the full range of our statutory enforcement authorities and other tools to obtain compliance, including warning and untitled letters, public health alerts, the bully pulpit, seizures, injunctions, and other tools at our disposal to ensure that information provided to consumers is truthful and not misleading.


I want to close today like Secretary Thompson did, by asking for your renewed help with the many urgent and difficult food safety issues that FDA is facing today. We need to work together if we’re going to make our foods more safe and secure, and if we’re going to find better ways to prevent obesity and other preventable illnesses. There is much that we're doing at the FDA, and much more remains to be done. You’re critical to those efforts, and we need your help to meet these new threats to the health of the public. I look forward to working with you to achieve our shared goals.