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Lester M. Crawford, D.V.M., Ph.D. - Association of Food and Drug 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
Association of Food and Drug Officials
Annual Conference

Remarks by

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

 

June 21, 2004

Good morning, and thank you for the kind introduction. I’m very pleased to be here, and I want to thank AFDO for hosting such an important dialogue on current challenges and opportunities impacting the public health.

It appears you have quite a power-packed schedule today (five keynotes, including mine), and I know you’re going to enjoy hearing from my colleagues Diane Gorman from Health Canada and Ernesto Rubio from Mexico, as well from USDA and CDC.

As today’s schedule illustrates, advancing the public health is truly a collaborative effort that brings together many different organizations and agencies from around the world.

AFDO is an essential piece of this collaborative effort. You bring together government, industry and consumers both here in the U.S. and worldwide to discuss and debate important public health topics, and figure out how to address them in the most effective and efficient manner. I’d like to thank you for all of your support of our various initiatives at FDA, and for your commitment to advancing America’s health.

COMBATING BIOTERRORISM

Nowhere is this kind of collaboration more essential than in the area of counterterrorism.

In the wake of 9/11, Americans face new and sophisticated bioterror threats. In particular, our food supply has been widely recognized as a potential terrorist target: it is a life-sustaining, universally-consumed commodity; it is susceptible to contamination; and a significant amount of it -- up to 80% of our seafood, and 20% of fresh produce -- is imported from countries where we have no security presence.

Based on these considerations, the FDA was granted by Congress the lead responsibility for a broad-based, multifaceted program to protect the security of our food supply. We are currently implementing a number of unprecedented counterterrorism initiatives, with a heavy infusion of resources, and in close cooperation with an entire spectrum of federal, state, local and international agencies.

New Food Security Regulations

Specifically, FDA has implemented four new food security regulations to significantly extend our ability to prevent and respond to food safety threats:

  • Prior Notice of Imported Foods
  • Registration of Food Facilities
  • Administrative Detention
  • Establishment and Maintenance of Records (final rule upcoming)

These new rules represent innovative solutions to 21st century problems. They offer us comprehensive new information on food production and distribution for the first time, including a complete inventory of all food facilities both foreign and domestic, comprehensive information on all imported foods, and information on precisely who is handling food throughout the entire chain of custody on either side of the border. Through their cross-border “life cycle” based approach, these new rules allow FDA to better identify potentially dangerous foods, as well as respond quicker to new threats and handle ongoing outbreaks more efficiently.

Since the Bioterrorism Act was passed, our agency has done a herculean job implementing it. We've set up Internet-based programs where firms can register and send, round the clock, prior notices of intended imports. We've developed the necessary rules and guidances, and conducted extensive outreach to explain the Bioterrorism Act to food exporters in Canada, Mexico, South America, and elsewhere around the world. We’re working closely with U.S. Customs and Border Protection (CBP) to design and implement these new regulations. We're also working with Canada and Mexico on food security systems and infrastructure at both borders.

By the end of this summer, this in-depth, comprehensive protective system will be fully in place and functioning.

The essential backbone and muscle of these new provisions are rooted in new resources and authorities granted to our agency by the U.S. Congress.

Within a few months of 9/11, Congress authorized a $195 million supplemental appropriation for the recruitment of 655 new FDA Field employees, the great majority of whom are safeguarding our food. Three hundred of these new staffers are now posted at 90 major United States ports of entry; 33 are criminal investigators; and 100 are chemists and analysts who have been added to the existing network of food-safety labs, plus a new Food Emergency Response Network. At present, 72 state and federal laboratories have submitted laboratory qualification checklists for membership in FERN.

FERN

I’d like to take a few moments to tell you more about this Food Emergency Response Network, or FERN as we call it.

FERN is a national initiative designed to integrate America’s laboratory infrastructure in order to better detect and respond to bioterror threat agents at the local, state, and federal levels. The primary objectives of the FERN are fourfold:

  1. Prevention (federal and state surveillance sampling programs to monitor the food supply),
  2. Preparedness (strengthen laboratory capacity and capabilities),
  3. Response (surge capacity to handle terrorist attacks or a national emergency involving the food supply), and
  4. Recovery (support recalls, seizures, and disposal of contaminated food to restore confidence in the food supply).

FERN offers a tiered screening and confirmation testing laboratory system composed of federal, state, and local governmental laboratories. In particular, this network is responsible for analyzing food samples implicated in threats, terrorist events, or contamination; responding to large-scale emergencies involving food; and conducting ongoing programs to monitor food for the presence of threat agents.

The FERN initiative was begun at the behest of the White House Homeland Security Council and Interagency Food Working Group, and both FDA and USDA’s Food Safety and Inspection Service (FSIS) have been directed to lead this effort. FERN’s role in protection of the nation’s food supply was further outlined in the Homeland Security Presidential Directive 9 (HSPD-9).

I’d like to emphasize here that the success of FERN relies on full collaboration and participation at not just the federal level, but also importantly at the state and local levels. And so, we are requesting ongoing cooperation and support through state laboratory officials’ participation with our federal partners in the formation, development, and operation of the FERN.

A variety of committees and workgroups have already been formed. These include the FERN Steering Committee as well as other committees dealing with analytical methods, surveillance, proficiency testing, training, and communications. State and federal participants on these groups will assist in the development of FERN policies and operating guidelines, participate in conference calls, and attend conferences and planning meetings.

State participants of the FERN include agricultural, public health, veterinary diagnostic, and environmental laboratories. Laboratories from a variety of federal agencies are also members of the FERN Steering Committee. These laboratories represent the FDA, FSIS, the Environmental Protection Agency, the Department of Defense, Bureau of Customs and Border Protection, the Agricultural Marketing Service, and the Animal and Plant Health Inspection Service. Other federal members of the FERN include the Federal Bureau of Investigation, the Department of Homeland Security, and the Centers for Disease Control and Prevention. In addition, the FERN is working closely with the Laboratory Response Network (LRN) and the National Animal Health Laboratory Network (NAHLN) to ensure there are no gaps in our nation’s safety net for human health.

This is an ambitious effort, but it is an important one. And we hope we can count on your support of this strategic initiative by allowing your employees to work with us to bring it to completion. Your support of the FERN and its mission is vital for protecting our nation’s food supply. I’d like to thank you in advance for your assistance and I look forward to our close collaboration in the months ahead.

In addition to our new food security regulations and the FERN initiative, FDA has taken a number of other important steps to combat bioterrorism. For example, we've issued guidances on security measures for every major type of food business and facility, both domestic and foreign. We initiated a scientific assessment of the vulnerability of our food to attacks with biological, chemical, and radiological agents. We've participated in interagency counter-terrorism exercises; developed a rapid food-pathogen detector; carried out hundreds of inspections of food facilities based on appraisal of their vulnerability to terrorism; and we've multiplied many times over spot inspections of imported food products.

We're spending $5 million working with the National Center for Food Safety and Technology; Joint Institute for Food Safety and Applied Nutrition; and National Center for Natural Products Research on research in three broad food and animal feed security areas. All told, we have more than 25 intramural research projects on food security.

All this does not mean that we've eliminated the possibility of a terrorist attack on our food supply. But I’m happy to say we are far, far better prepared to prevent, mitigate, or cope with it than we were three years ago.

Medical Countermeasures / Project BioShield

Protecting consumers against terrorism and emerging disease also requires that Americans have access to safe and effective medical countermeasures. To that end, over the past year, FDA has worked closely with scientists and product developers and has taken new steps to speed the development of these safe, effective treatments.

For example, FDA collaborated with CDC and other sister agencies on the development and distribution of anthrax and smallpox vaccines. The agency also issued an important new guidance on the development of Radiogardase (“Prussian Blue”) for treatment of internal contamination with thallium or radioactive cesium.

FDA has also encouraged the development of new medical countermeasures through our support for the Project BioShield Act of 2004. This legislation was introduced to address the existing lack of reward for developing safer, more effective countermeasures. If/when it gets signed into law, BioShield will give FDA the authority to make new medical countermeasures available more quickly in the event of a terrorist attack.

This legislation has cleared the Senate and is currently awaiting action in the House. We are optimistic that Congress will soon finalize its work on this and send the BioShield legislation to the President for his signature.

GOOD MANUFACTURING PRACTICES

I’d like to spend the rest of my time this morning discussing some important steps FDA is taking to improve the safety and efficacy of the products we regulate by updating the way these products are manufactured. What we’re talking about here are the so-called Good Manufacturing Practices, or GMPs for short. FDA is developing a roadmap for food and medical product manufacturers that will allow for better quality products, more effective risk management, and improved public health for all Americans.

Pharmaceutical GMPs

Our regulations for drug manufacturing haven’t been substantially updated in 25 years. Meanwhile, best practices in manufacturing have undergone significant progress, particularly in other high-tech industries which have adopted “six sigma” and other quality improvement methodologies.

And so, what we're doing is overhauling and upgrading a body of outdated standards and requirements called the pharmaceutical Good Manufacturing Practices. We want to make sure that our regulations encourage progress, savings and quality improvements in medicine. Our new regulatory approaches are being designed to encourage companies to continuously seek out and apply cost-reducing and precision-enhancing innovation in manufacturing and technology.

This project is still underway, and we are already seeing major progress in industry. We anticipate the pharmaceutical GMP initiatives will be completed by the end of this summer.

Food GMPs

Good Manufacturing Practices for foods are just as critical. FDA is currently undertaking two important initiatives – the modernization of the current food GMPs and development of GMPs for dietary supplement manufacturers – which are aimed at improving the quality of the foods that we eat and reducing the risk of adverse health effects to consumers.

The food GMPs were originally promulgated in the late 1970’s and were last revised in 1986 in response to the identification of several newly emerging food-borne pathogens such as Salmonella enteriditis, and hemorrhagicE. coli. Food GMPs are an important part of the nation’s control over food safety problems. Processing failures from a lack of the application of modern GMP controls are a major cause of food product recalls.

Since the last revision of food GMPs, we have continued to greatly expand our understanding of food-borne illness and have recognized the importance of several new bacterial, viral, and protozoan foodborne pathogens, such as Listeria monocytogenes, Norovirus, and Cryptosporidium. In many cases, these pathogens can be adequately controlled only by the implementation of appropriate GMPs by food-processing establishments.

Food allergens and certain other food ingredients are now recognized as a hazard for sensitive individuals. Cross-contamination of food products with a food allergen may also be prevented through the implementation of appropriate GMPs in food processing.

Rapid advances in food processing technology have also occurred since the GMPs were last revised. Modernization of the GMPs will be essential in creating opportunities for incorporation of newer technologies and better manufacturing techniques and process controls.

We believe this effort, like our work on current good manufacturing practices for medical products, will improve the safety of conventional foods and dietary supplements.

FDA (CFSAN) began the effort to examine the underlying health basis and enforceability of its preventive controls, including GMPs by establishing a Food GMP Modernization Working Group in July of 2002. This Working Group initiated research in two areas: the impact of current GMPs on food safety, and the impact of revised GMPs on food safety and the likely economic impact of such revisions.

To date, the GMP Modernization Working Group has completed: A literature review related to GMPs; and a solicitation of expert opinions, which will contribute to a qualitative evaluation of food risks and the ability of different preventive measures to address those risks.

I am pleased to announce that as a part of this continuing process to modernize the food GMPs, FDA will hold three public meetings this summer to obtain stakeholder input (especially from small businesses) on ways in which the food GMPs should be updated. These meetings will be held in different regions of the country, with one in College Park, MD, one in Chicago, IL and one in Monterey, CA. The three meetings were just announced in the Federal Register and include a list of specific questions about food GMP modernization that FDA would like participants to address.

FDA intends to evaluate the data and information received from these public meetings to determine appropriate revisions to food GMP regulations. We will be accepting written comments through September 10, 2004, at which point we will proceed with rulemaking.

In concert with this review and modernization of food GMPs, FDA is also pushing hard on finalizing the first GMP guidelines for dietary supplement manufacturers.

Consumer interest in dietary supplements has increased exponentially in recent years. According to a recent Institute of Medicine report, American consumers are spending $18 billion annually on dietary supplements and there are about 29,000 such products on the market, with another 1,000 new products introduced each year.

Last spring, FDA proposed comprehensive new regulations that will set manufacturing and labeling standards for the first time for all dietary supplements marketed in the United States, focusing on their quality, consistency and potency.

When finalized, this rule will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled. It will also place dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.

In short, the dietary supplement GMPs will eliminate the “buyer beware” situation Americans now commonly face when they purchase these types of health products.

In keeping with our risk management strategy, FDA will continue to coordinate future revisions of the food GMPs with dietary supplement GMPs to ensure we are doing all we can to protect and advance the public health.

Dietary Supplement Enforcement Strategy

FDA is also outlining a science-based approach to enforcement in order to protect American consumers from unsafe and/or misleading dietary supplements.

FDA has focused its enforcement efforts over the past year to ensure consumers are not being harmed as a result of claims that overstate the effectiveness of dietary supplement products. In the last 6 months alone, FDA has:

  • inspected 180 domestic dietary supplement manufacturers;
  • sent 119 warning letters to dietary supplement distributors;
  • refused entry to 1,171 foreign shipments of dietary supplements; and
  • seized or supervised the voluntary destruction of almost $18 million worth of mislabeled or adulterated products.

Most notably, dietary supplements containing ephedrine alkaloids have been taken of the market. These products were extensively promoted for aiding weight control and boosting sports performance and energy. The totality of the available data showed little evidence of ephedra's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These effects are linked to significant adverse health outcomes, including heart attack and stroke.

In March FDA requested that 23 companies cease distributing dietary supplements containing androstenedione, which are marketed to stimulate testosterone and muscle growth but have anabolic steroid effects in the body. This set of products poses substantial safety risks to all Americans, particularly our nation’s youth and athletes.

One of the key messages of this effort is that there are no safe quick fixes when it comes to losing weight and improving athletic performance, and it is only through proper diets, nutrition and exercise that we can improve our performance and more importantly improve our health.

Over the next several months, we will be building out our enforcement strategy and utilizing every tool available under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.

This includes developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data) evidence-based reviews, and adverse event information -- the approach that formed the scientific foundation for FDA's recent rulemaking on ephedra.

CONCLUSION

I thank you for your attention, and for the opportunity to share with you some of FDA’s current priorities for protecting and advancing the public health. Thank you.