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Lester M. Crawford, Jr., D.V.M., Ph.D. - Consumer Federation of America

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.

Consumer Federation of America
Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,
April 22, 2002


Good morning, and thank you, Sylvia, for the introduction.

All I want to add to Sylvia's remarks is that I am told that my three previous stints with the Food and Drug Administration are something of a record. It that's so, I am not only proud of it -- I enjoy it. Each time I return to the agency, it feels more like a homecoming.

I am truly pleased to be here to discuss the priorities for food and food safety as we see them at the FDA. The very word "priority" brings up the subject you've heard discussed earlier this morning by the panel on bioterrorism. I doubt there is anyone in our government who can speak about the priorities of his or her organization without referring to last September 11, the second Pearl Harbor of our history. Certainly, this is the case with all of us in the public health and consumer protection community.

Of the many ways in which September 11 was a transforming experience, none was more universal than the sudden awareness of millions of Americans that we are all vulnerable. The safety and security of our daily lives -- something we'd always taken for granted -- suddenly became a matter of personal concern. Concern has prompted demands for government protection, and, given the nature of the potential threat, much of that protection has been, and is, expected to be provided by FDA.

This is understandable because our agency is responsible not only for the safety and effectiveness of drugs and medical devices, but also for the safety and wholesomeness of 80 percent of the national food supply -- practically all of it except for meat and poultry -- and there is no question but that food is a possible target for terrorism.

As a result, for the past seven months, security of our food has been FDA's Job One. I believe that this morning's panel discussion gave you some inkling of the extraordinary amount of thought, planning and resources that have been, and continue to be invested into making the FDA's counter-terrorism program as effective as possible.

We are rapidly building up our scientific, technical and manpower potential and linking it with counter-terrorism assets of other federal, state and local agencies. And we're building this defensive system on the basis of solid, in-depth food safety protections that FDA and its many partners erected since the early 1990s, when foodborne illness became a serious public health issue.

Incidentally, the effectiveness of this system was confirmed last week by two reports of the Centers for Disease Control and Prevention. One of them is highly positive: it shows a 23 percent overall drop in bacterial foodborne illness since 1996. Illness caused by the four common pathogens --Salmonella, Listeria, Campylobacter, and E.coli 0157:H7 -- has declined by 21 percent. The CDC report attributes this significant progress in part to our programs to prevent foodborne illness.

The second report, which also indicates that the food safety-associated surveillance system works, and works well, is much more somber: we have the first reported case of the variant Creutzfeld-Jakob Disease, or vCJD, in the United States. The disease, which is apparently caused by the consumption of meat from animals with BSE -- bovine spongiform encephalopathy, or "mad cow disease" -- has claimed more than 100 lives in the United Kingdom, where BSE was epidemic in the 1980s.

The Florida resident who was diagnosed with vCJD was born 23 years ago in the United Kingdom, lived there until about 5-6 years ago, and belongs to that country's highest risk category for the disease. All the indications are that her disease originated in the UK.

To me, these elaborate and effective food safety systems testify to the enduring commitment of our agency to the cause that led to FDA's creation, which is the protection of consumers. It's been always the intent of the American government that our food should be plentiful, varied, and readily available. Since 1906, when Congress passed the Food and Drugs Act, our government has assumed the responsibility that our food should also be safe, and much of that critical task has been entrusted to our agency.

I don't have to tell this audience how well the FDA has met these expectations in the past -- that accomplishment is reflected in the success of our society in achieving the world's highest standard of living and a quality of life that has attracted generations upon generations of immigrants.

What I can and do want to tell you is that in the wake of last September, the FDA's commitment to food safety, and to helping Americans live healthier lives, is stronger than ever. Let me give you a few examples of our commitment in action:

  • One threat to our public health and economy that we're watching very closely is the possible emergence in our country of BSE -- the "mad cow disease" I just mentioned.

BSE one of the most devastating new diseases to appear in the last 50 years. In the UK, it has led to the destruction of more than 180,000 head of cattle, and it is believed to have caused the death of more than 100 people who consumed the meat from these animals.

There is no evidence of BSE in the United States, at least in part thanks to an FDA rule prohibiting the use of most mammalian tissues -- which are the apparent carrier of the disease -- in feed for cattle and other ruminants. We're continually strengthening our enforcement of this feed rule by inspecting thousands of renderers and feed mills.

But the regulation is now five years old, and we believe it's time to take additional steps to make sure it gives us the best protection possible. We will therefore be publishing soon an advanced notice of proposed rulemaking.

  • Another important food safety issue that's high on our radar screen is the growing antimicrobial resistance in humans. It is caused by many factors, including the misuse and overuse of antibiotics in both humans and animals. If unchecked, antimicrobial resistance will threaten the lives of patients with weakened immunity or chronic conditions that require antibiotic treatment.

At FDA, we've addressed this hazard with several measures, including proposed changes in the data on which we base marketing approvals for drugs to be used in livestock and poultry. Currently, we are developing a general guidance on microbiological safety incorporating various strategies for helping assure that animal antimicrobials do not pose a hazard for humans.

In addition, we are preparing to propose a rule that will enable our agency to acquire more data on the use of antimicrobials in animals.

  • Food allergy is yet another food safety issue that's getting our close attention.

It affects about 7 million Americans, including up to 6 percent of children less than three years old, and their allergy attacks can be very severe -- they put about 30,000 Americans in hospital emergency rooms in a year, and result in the death of some 150 of them. Moreover, epidemiologists are telling us that this is a growing problem -- food allergies are skyrocketing in all developed and developing countries.

We are therefore concerned about the results of an inspection of food plants FDA carried out three years ago, which found that a quarter of the inspected products tested positive for peanut allergen, although that ingredient was not listed on the product labels. During the same year -- it was in 1999 -- there were 92 recalls of products that contained unlabeled allergens.

Our strategy has been to heighten consumer and industry awareness of the hazard presented by the eight most common allergens, which cause nine out of ten allergic reactions. They are milk, eggs, fish, wheat, tree nuts, peanuts, soybeans, and crustaceans, such as shrimp and crabs.

In addition, we've trained our investigators in inspecting plants for allergen control procedures; and we've published a guidance that encourages manufacturers to identify potential allergens even within collectively named ingredients, such as flavors and spices.

And we're going to do more. We're training more investigators in plant inspections for food allergens; we will evaluate industry practices to prevent cross-contact between their products and allergens; and we will seek improvement in allergen labeling.

Another major public health issue we're concerned about is the safety of dietary supplements. We're highly aware that more than half of Americans -- 158 million -- use these products, and that there is much uncertainty whether they're safe. Here is what we're doing to make sure that they are:

  • We're helping protect consumers against harm that could be caused by specific supplements: to give you just one of many examples, we've recently issued a warning that supplements containing kava may be associated with severe liver injury.
  • We're implementing a strategic program that will place the safety, composition and labeling of dietary supplements on a firm scientific and legal basis. As part of this process, we will soon publish a proposed rule for good manufacturing practices in the production of dietary supplements.
  • Finally, we're also trying to guide consumers through the thicket of confusing claims that are made for these products by posting on an FDA Website tips on how to tell dietary supplements truth from dietary supplements fiction.

Food safety is our foremost, but not the only concern associated with nutrition.

The FDA has always been trying to make American diet not only safer, but also healthier. I will remind you of the standards of identity that FDA established in the 1940s, when food adulteration and malnutrition were important hazards, and there was a need to make sure that staples had full nutritional value.

Today, one of our great concerns is obesity, a chronic disease that affects every third American. More than 60 percent of us are overweight. Excessive weight increases the risks of diabetes, heart disease and cancer, and contributes to premature death of 300,000 Americans in a year.

In direct and indirect costs, it adds $117 billion to our annual health care bill. Secretary Thompson has recently called overweight and obesity "among the most pressing new health challenges we face today."

The FDA is not in the business of making people to exercise more, which is a key strategy for shedding pounds, but we've taken two steps to help consumers control their weight already ten years ago. At that time, FDA introduced a highly informative food label, and issued rules for nutrient content claims that have cleared the way for manufacturers to reduce the fat and calories in all of their food products, and state the potential health benefits on the food label.

In the vast majority of cases, eating out is still a trip into the unknown in terms of calories and ingredients. But when eating at home, the fact is that today, the basic information consumers need for choosing a healthy diet is available on every food package, and it is up to each individual to decide what to put on the dinner table.

And we're still trying to do more: for example, we've proposed a rule to improve nutrition labeling by adding to it data on trans fats, and one of our major efforts is to find resources that would enable us to revitalize our nutrition program. We need to do more research to bring the food label information in line with the latest science.

We also recognize that the best way we can help reduce obesity is not to regulate more, but to educate more -- to find an effective way of advising our consumers what foods to include or reduce in their diet.

Given sufficient resources, we'd like to undertake such an outreach. But we believe that a project of this magnitude should be very broadly based, with FDA working side by side with other health-oriented agencies and consumer organizations such as CFA. This is a priority you and we need to get together about, and carefully consider.

I want to conclude this brief report by sharing with you good news is about a project that I find particularly satisfying: it is the greatest expansion of FDA's staff in 30 years. Thanks to appropriations secured with the help of Secretary Thompson, we are hiring 655 new employees for our field operations, all but 20 of whom will strengthen the safety and security of our food supply.

These new import investigators, compliance officers, criminal investigators and laboratory analysts will strengthen the surveillance of our food imports, which are a potential terrorist target, and which have skyrocketed from less than 1 million shipments in 1985 to 4.5 million shipments last year.

But these new employees are more than an addition to FDA's defenses against terrorism. They represent the future leadership of the Food and Drug Administration. They are the best guarantee that the FDA will remain what it has always been -- forward-looking, but dedicated to its traditional mission of protecting consumers, and protecting and promoting the public health -- in short, an agency that is on your side.

I am truly pleased to have yet another opportunity to pursue these 96 year-old, but ever-timely FDA goals, and I know I can count on your continued cooperation and support for our work.