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Lester M. Crawford, D.V.M., Ph.D. - IFT 2004 Chief Food Officials

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

Speech before
IFT 2004 Chief Food Officials

Remarks by

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of the FDA


July 13, 2004

Thank you, Barbara (Byrd Keenan, Executive VP of IFT), for the introduction. It's an honor to be invited, and a pleasure to be here and meet old friends.

Some of you may remember that addressing the IFT conference exactly a year ago, on July 13, 2003, I predicted that the coming "hot button" food-related topics of the Food and Drug Administration would include implementation of the Bioterrorism act, and an exhaustive exploration of how to confront the obesity epidemic.

I will allow that these were pretty safe guesses. The bioterrorism legislation was by then a year old, and most of the implementing rules had to be issued by December. The obesity issue also was already high on the FDA agenda, and we were trying to address it by allowing more health-associated claims on food labels.

Developments since then have shown that the picture I saw in my crystal ball for the most part was accurate: Confronting the hazards of bioterrorism and obesity are, indeed, programs that figure prominently among the most important tasks of our agency. But the picture was incomplete -- because today, food issues make up almost a half of my priority agenda for the FDA.

All of our preeminent projects are guided by two strategic objectives: achievement of science-based risk management of public health issues, and advancement of more efficient development and production of regulated products. These principles, I believe, serve best the FDA's mission.

More specifically, our priorities aim at


  • modernizing the good manufacturing practices and reducing the uncertainties surrounding the introduction of new health care and food products;
  • confronting the obesity epidemic and the threat of bioterrorism;
  • reforming FDA's inspections policies;
  • improving the labeling of prescription drugs;
  • and resolving the drug importation issue.

As you can see, several of these top tasks are designed to protect and, to such extent as we can, improve the safety, quality, and variety of our food supply, 80 percent of which is in FDA's purview.

These undertakings are in various stages of progress. I will now give you an overview of what we're doing, and what we're planning to do, to carry out four of our foremost food programs: promote biosecurity; confront obesity; reform the GMPs; and illuminate the decision-making along what we call the "critical path" of new product development.

When I discussed our protections against potential terrorist attacks on food a year ago, the preparatory work mandated by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 was in full progress, and we were exerting major efforts to meet the law's demanding deadlines.

Today, I can report that we've succeeded. Although the bioterrorism statute is mainly designed to protect imports, we are significantly strengthening the security and safety of all food, both domestic and foreign.

As you may remember, our main job last year was to develop the four major rules for implementing the law's requirements for the registration of food facilities; prior notice of imported food shipments; record-keeping; and administrative detention. These four measures comprise the bulk of the protections written into the act, and today, they are in force.

The registration of food facilities is guided by an interim final regulation that our agency published in October jointly with the Customs Bureau, which us our partner in protecting the safety and security of imported food. The same month, we launched an electronic system that enables food firms to register around the clock and seven days a week by accessing a special site on the Internet. The system is so efficient that it immediately provides each firm with a registration number.

In passing the Bioterrorism Act, the intent of Congress was to protect the food supply, not make life and business more complicated for the food industry. And that is also the spirit in which we're implementing the law, by issuing guidances that explain the rules and then phasing in their enforcement in a way that would cause the minimum hardship for the industry.

For example, our two registration guidances explained that we intend to first concentrate on educating firms how to comply with the rule, and that we will make sure that our enforcement of it is appropriate to each situation. We've gone particularly out of our way to communicate our rules and intentions to the suppliers abroad, and the effectiveness of our education campaign is reflected in the registration statistics. As of June 24, 109,000 foreign firms complied with the requirement -- more than one half of the 208,000 food facilities registered so far.

The prior notice interim final rule, issued also last October jointly with the Customs, is in force, although we've kept it open for comments until today. It provides for at least two hours of advance notice of shipments arriving by road, at least four hours if it's arriving by air, and at least eight hours if arriving by water.

The prior notice may be submitted electronically either to the Customs Bureau or to our agency, and we will try to harmonize the prior notice timeframes of both agencies. So far, we've been getting about 150,000 prior notices a week. The phase-in period for this rule will end a month from now -- on August 12 -- and we plan to publish the final rule, which has received many comments, next spring.

The last two main provisions, which call for the maintenance of food-tracking records and administrative detention, are also in advanced stages of implementation. The proposed rule for records-keeping and inspection was addressed in some 200 written comments which we are studying, and we plan to publish the final rule soon. We've already released the final rule for FDA's new authority to administratively detain food or feed suspected of potentially causing severe harm to consumers or animals.

Although we're still in the Bioterrorism Act's phasing-in period, we're rapidly stepping its protections. We now have our own inspectors in 90 ports of entry -- that's more than double of two years ago -- adn they have increased six-fold the number of food examinations at the border. In addition, we have commissioned 8,150 Customs officers to carry out these examinations in ports where we have no presence.

These are the highlights of a program that's without question our best defense against an attack on our food supply by an outside enemy. Our second most crucial food program is designed to confront a very serious food hazard that's already affecting our population, and is of of our own making. I am referring to the overweight and obesity epidemic, which is putting almost two-thirds of American adults, and 15 percent of our teenagers, at risk of various diseases associated with excessive body weight.

The intensive FDA probe of this menace that I forecast last year got underway in August, when we created an Obesity Working Group and charged it with exploring all aspects of the problem and devising ways of confronting it. We had a very busy seven months getting briefed by experts from academia and other government agencies, consulting the public, and studying technical literature. We also discussed the issues in depth with with representatives from the packaged food and restaurant industries.

It was a major project, but the results are worth it. The report we published in March is an authoritative, comprehensive and insightful overview of the obesity problem, and of the ideas how to overcome it. We examined what's known -- and what's not known -- about the causes of obesity, means of weight management, and the effectiveness of nutrition related programs. We also surveyed the existing therapies for obesity.

What have we learned? The overriding lesson of our inquiry is that the obesity epidemic has no single cause: it is the confluence of numerous factors acting together over time. Controlling obesity, therefore, will be a long-term process requiring numerous coordinated programs. And to succeed, we have to persuade our public that weight maintenance is governed by an iron equation: calories in must equal calories out.

This will not be an easy task. Our Working Group found that a surprisingly large segment of our population is not aware that excessive weight is a health problem. It is a blind spot that cuts across gender, socioeconomic status, age and ethnicity. Studies indicate that many people consider the extra pounds of minor significance, and therefore have little incentive to get rid of them.

Another hurdle to be overcome is the exaggerated opinion of many consumers about their diet. For example, a survey of the U.S. Department of Agriculture found that four out of ten people who prepare meals at home overestimate their nutritional quality. Research by the American Dietetic Association Foundation showed that parents significantly underestimate how often their children snack in addition to regular mealtimes.

In other words, the very first step toward a solution -- a recognition that there is a problem -- will require an intensive nation-wide campaign to correct misperceptions about nutrition and body weight.

Beyond this elementary ground work we have to contend with the fact, which is also amply documented, that the current food label has been nowhere nearly as effective in helping shape dietary choices as it was believed to be. When it was first introduced, in 1993, the daily value columns that show how each food serving fits into a diet of 2,000 or 2,500 calories was expected to help moderate consumption. Clearly, that's not what has happened.

In 1992, fewer than 56 percent of Americans were overweight, and fewer than 23 percent were obese. Today, 65 percent of all Americans are overweight, and over 30 percent are obese. Children and adolescent obesity rate is double of two decades ago. In 1992, the obesity-associated mortality was 300,000 a year; today, it is 100,000 higher.

And yet, throughout the years, surveys have shown that more than two-thirds of food shoppers read the food label, in most cases before they buy a new and unfamiliar product. One reason why the label has not been persuasive enough, our research indicates, is that many consumers do not understand the information on the Nutrition Facts panel.

For example, a national survey conducted in 1996 found that less than half of respondents could accurately identify the meaning of the percent daily value for fat. Another study concluded that the daily values column is not helpful in estimating the healthful qualities of the product.

Our research pointed to three promising approaches for changing the popular misconceptions and attitudes that have been fuelling the obesity epidemic.

One of them is upgrading the food label. In our view, its emphasis on fat should be replaced with emphasis on calories as the truly decisive factor in weight maintenance. We plan to evaluate such possible changes as increasing the type size for calories, eliminating the listing of calories from fat, and adding a column for calories as a percent daily value for the entire contents of snack-sized food packages. We'll be consulting the public and industry about such revision.

Next, we will encourage food manufacturers to label as a single serving such food items -- for example, snack packages and bottles of soda -- that are usually consumed on a single occasion. We're also encouraging firms to make it easier for consumers to compare different types of food by using labeling statements that are permissible under current regulations. For example, such label could state that "one medium apple has 47% fewer calories than one ounce of potato chips."

Finally, we're evaluating petitions from food manufacturers who want to label nutrient content claims for the carbohydrate content of foods. We plan to define such terms as "net", "low" and "impact" that would provide consumers with more accurate information when shopping for food.

The second major recommendation of our report is for a nation-wide education campaign, primarily directed at children, to get out the "Calories Count!" message. This is a project that's vigorously advanced by the Department of Health and Human Services in association with the Girl Scouts, the National Association of State Universities and Land Grant Colleges, the National 4-H program, and the Department of Education.

The third set of recommendations, which we're already implementing, is to encourage restaurants to provide nutrition information about the meals on their menus. We're urging the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign, and we're encouraging consumers -- who spend 46% of their food dollars eating out -- to routinely request nutrition information in restaurants. We plan to run a pilot program to test this proposal in a controlled restaurant setting.

In addition to containing the risks of bioterrorism and the obesity epidemic, we're in the process of launching two initiatives aimed at strengthening food safety and easing some of the uncertainties surrounding the development of new food products.

The purpose of the former initiative is to modernize the Current Good Manufacturing Practices in manufacturing, packing and holding human food. They haven't been revised in 20 years, and no longer serve their purpose as well as they should because the food industry, and American eating habits, have significantly changed.

You know that as well as anyone. Since the GMPs were last updated, food firms have used new technologies to put on the market an endless and constantly growing variety of processed, packaged and refrigerated products, and they have become a popular part of the American diet. Portable soup, drinkable yogurt, squeezable peanut butter, and bagged lettuce salads did not exist two decades ago. Neither did low-carb foods, Tex-Mex foods, or vanilla-flavored sodas, all of which are today best-sellers. Another significant addition to our menu is millions of shipments of fresh produce imported in- and out-of-season from around the globe.

All of these developments have increased food safety hazards. On top of that, we've seen an emergence of new food pathogens, and a demand and expectation of millions of consumers want to be protected from the hazards of food allergens. This was not the case two decades ago. So although our food supply is as safe as any in the world, the 20 year-old rules safeguarding it need to be updated.

Recently, this conclusion was borne out by three studies in which we've looked at the microbiological, chemical and physical safety hazards associated with the current GMPs, and the controls at the processor level to prevent these risks.

One of our studies reviewed the voluminous scientific and technical literature on these issues; a second paper summarized views we had solicited from experts with extensive knowledge and experience in this area; and the third survey examined the food product recalls in the United States from 1999 to 2002.

The latter probe included 842 recalls, 51% of which were Class I -- hazards that can cause death or serious injury -- and the rest were Class II, whose health consequences are reversible or temporary. Our findings were most illuminating of the recent problems affecting food safety, and I will therefore give you their highlights:

The most striking fact to emerge from this survey is that 715 of the recalls -- 85% of the total -- probably occurred due to GMP-related shortcomings. The main problem was improper or inadequate labeling, which accounted for 52% the recalls. The vast majority of the shortcomings involved undeclared allergenic ingredients.

Microbial contamination was the reason for 23% of the total. Eleven percent of the recalls were due to unapproved color additives, and poisonous substances and foreign object accounted each for 4% of the recalls. The causes of the remaining 6% could not be determined.

The largest category of the unsafe products were bakery goods, which made up 20% of the recalls. Fishery and seafood products accounted for 13% of the recalls; multiple food dinner products for 9%; ice cream for 6%; non-chocolate candy for 5%, and vegetable, fruit, cheese and snack food products added each 4% to the total.

Next to incorrect or inadequate packaging and labeling, the most frequent among the usually multiple processor-level deficiencies were ineffective employee training, which was involved in 40% of the recalls. In addition, failed standard operating procedures were implicated in 31% of the recalls; contamination of raw materials in 12%; improper proportion of ingredients and chemicals in 11%, and poor sanitation in 10%.

It is also interesting that 61% of the safety problems resulting in recalls were discovered by FDA and other authorities, 22% by consumers, and only 17% by the manufacturing firms.

These results, and the information gathered in the two other surveys, suggested the extent to which the food GMPs need updating. One obvious possibility is adoption of modern sanitation measures in the production of prepared foods, which are usually consumed weeks after they leave the production facility. Employee training and education is another area that may need improvement. But what rules should be changed and how are not decisions that we want to take without first consulting with our stakeholderes.

We're therefore scheduling three public meetings to discuss this issue: one in College Park, Maryland, on July 19, one in Chicago, on July 21, and one in San Jose, California, on August 5.

What do we want to accomplish at these meetings?

The overriding goal is to secure the maximum input from knowledgeable stakeholders -- experts like yourselves -- in exploring the best, potentially most effective science-based measures and approaches that would help manufacturers reduce the likelihood of producing foods that are not safe. Without ignoring the very frequent problems involving labeling, it is our intention to primarily address the most serious risks of contamination with chemical, microbiological, or physical impurities.

In dealing with these issues, we will be careful to distinguish between practices that may directly harm the health of consumers, and those whose hazards are likely to be marginal. Our guiding principle will be reliance on science-based systems that are guided by evidence, both regarding the nature of the problems and their solutions. What we're after is a set of requirements that will enable manufacturers to focus their resources on strengthening the safety of their products.

Naturally, we'll be looking for information and ideas in scientific and technical literature, but I can't emphasize enough how important it is for us to benefit from the experience of food technologists, microbiologists and industry professionals.

Please, regard this as my personal invitation to each of you to participate in this initiative, and give us a hand.

Before leaving this subject, I should add that updating the food GMPs is only one facet of a broad modernization process we've recently initiated with a similar reform of the pharmaceutical GMPs. Eventually, we intend to modernize the GMPs of all industries whose products are regulated by the FDA.

Finally, I want to give you a preview of our very latest, and I think it's fair to call it boldest, innovation we want to introduce for the benefit of consumers and the food industry. Essentially, we want to use our regulatory tools, insights and experience to facilitate the development of new products. The way we want to achieve this goals is by reducing and managing the risks that affect amanufacturer's decisions whether to develop a new product, or not.

We've already launched such project in the pharmaceutical arena, where the unpredictability of obstacles during pre-clinical and clinical trials causes more than nine out of every ten new compounds to fail reach the market. We call this perilous journey from the sponsor's lab to the patient's bedside "critical path," and our intention is to help develop assays, standards and computer models that would make it possible to identify which compound is likely to be successful, and which not.

Food producers do not have clinical trials to worry about, but they also face uncertainties when contemplating the development of new food products. Some of the questions they face may involve the performance of new production technologies; some may be of regulatory nature; and some may bear on the outlook for public acceptance of the product. This is their "critical path" whose decisions we want to make less risky, and we're in an early thinking stage how it can be done.

We believe that our agency has an obligation to reduce barriers and clear up uncertainties affecting technological progress that contributes to the safety of regulated products. This is part of our mission of protecting and advancing the public health.

We also are uniquely positioned to understand the impediments along the critical path. For one thing, FDA, alone among other organizations and agencies, reviews virtually all food and medical technology developed by industry and government. Much of this information is confidential and cannot be shared. But it enables us to identify the critical gaps in technical knowledge which is necessary to translate a concept into a viable product.

We also have unmatched experience and know how in establishing regulatory standards that encourage innovation toward better product quality. And we can help dispel the doubts of consumers about new foods and technologies, thanks to high consumer confidence we've earned in the 98 years of FDA's existence. We're therefore in the best position to address some of the most difficult questions along the critical path in food industry.

Filling the gaps in predictive knowledge will have to be a cooperative project -- for example, the development of rapid methods for the detection and identification of pathogens in foods is an effort beyond FDA's resources alone. They are sure to be other critical path research projects where we'll need your help, and I assure that you will hear from us. As a person who's been involved in food issues all his life, I am convinced of the importance of reducing the risks of your industry's critical path, and I believe it's incumbent on all of us to advance this project by doing the best and most we can.

I have tried to give you an overview of the FDA priorities involving the protection and improvement of the security, safety, wholesomeness and availability of food. The common denominator and overarching aim of these and all other priority projects of our agency is to reduce and manage the risks affecting the health of our public, and thereby advance the vitality of our nation. Food technologists have an important role in this mission, and we at the FDA count on your support and help.