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U.S. Department of Health and Human Services

About FDA

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<< Return to FY 2005 Budget Proposal


Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005




  FY 2003
FY 2004
FY 2005
Increase or
Program Level
Budget Authority
Cost of Living-Pay 3/
Food Defense -
Administrative Efficiencies
Budget Authority FTE
1/ Includes a Budget Authority rescission of 0.59 percent for a total of $2,438,000 for the Foods program.
2/ In FY 2004, a total of 104 Human Resources FTE was transferred from the FDA to the Department as part of the Secretary's One HHS Initiative.The Foods Program's share of this transfer was 28 FTE.
3/ Pay increases shown on separate line, and not reflected in individual initiative areas.
4/ Foods program portion of $65,000,000 Food Defense Counter terrorism funds. Additional increase of $1,250,000 is in NCTR and $3,000,000 in Other Activities (Crisis Management).


Historical Funding and FTE Levels


Fiscal Year Program Level Budget Authority User Fees Program Level FTE
2001 Actuals $287,504,000 $287,504,000 0 2,445
2002 Actuals 5/1 $393,256,000 $393,256,000 0 2,734
2003 Actuals $406,824,000 $406,824,000 0 3,167
2004 Enacted $410,674,000 $410,674,000 0 2,987
2005 Estimate $470,405,000 $470,405,000 0 3,032

5 1/Includes FDA's FY 2002 Appropriation and the Counter terrorism Supplemental.




  • Ensure that the food supply, quality of foods, food ingredients, and dietary supplements are safe, nutritious, wholesome, and honestly labeled and that cosmetics are safe and properly labeled;
  • Set standards and develop regulations for the food industry;
  • Take timely and appropriate action on new food ingredients and dietary supplements before they go on the market to ensure their safety and effectiveness;
  • Research ways to provide the necessary basis for regulatory decisions;
  • Identify food-related health hazards;
  • Take corrective action to reduce human exposure to food related health hazards and the possibility of food-related illnesses and injuries;
  • Safeguard the American public by defending the food system against terrorist attacks, major disasters, and other emergencies; and,
  • Educate and train consumers and industry on food safety and food security.



Scope of Responsibility


The Foods Program promotes and protects the public's health by ensuring that the food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled for the American public. Consumers spend over twenty cents out of every consumer dollar on FDA regulated products, and 75 percent % is spent on foods. The Foods program regulates $240 billion worth of domestic food, $15 billion worth of imported foods, and $15 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale, with approximately 50,000 food establishments (includes more than 30,000 U.S. food manufacturers and processors and over 20,000 food warehouses) and 3,500 cosmetic firms. These figures do not include the roughly 600,000 restaurants and institutional food service establishments and the 235,000 supermarkets, grocery stores, and other food outlets regulated by state and local authorities that receive food safety guidance, model codes, and other technical assistance from FDA. The U.S.food supply is among the worlds safest,and FDA will continue to ensure consumer confidence in the food we eat.




The Foods Program regulates all food except meat, poultry, and frozen and dried eggs,which, are regulated by the U.S. Department of Agriculture. The Center for Food Safety and Applied Nutrition (CFSAN), in conjunction with the Agency's field staff (ORA), are responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled for the American public.The terrorist attacks of September 11th have also added a food security/defense dimension to the FDA's current food safety efforts. Additionally, as we enter the 21st Century,current trends in the food industry promise better nutrition, greater economies and wider choices for the U.S. consumer than ever before. To illustrate:

  • The volume and diversity of imported foods has risen dramatically over the last few decades, and foods once considered exotic are now found throughout the U.S.;
  • The globalization of the food supply means that foods we consume are being produced by a much larger number of source countries.
  • The biotechnology explosion has opened new frontiers in product development, thus providing us the ability to genetically alter foods to make produce more resistant to disease, add desirable consumption characteristics to the foods, and to prolong shelf life; and,
  • The dietary supplements industry has grown dramatically, as has consumption of dietary supplements.

Each of these developments presents food safety regulatory and food security/defense challenges for FDA. The Agency's job is to give consumers the confidence to enjoy the benefits of these expanded food choices.

CFSAN's primary responsibilities include:the safety of substances added to food, e.g., food additives (including ionizing radiation) and color additives; the safety of foods and ingredients developed through biotechnology;seafood Hazard Analysis and Critical Control Point (HACCP) regulations;regulatory and research programs to address health risks associated with food borne chemical, and biological contaminants;regulations and activities dealing with the proper labeling of foods (e.g., ingredients, nutrition health claims) and cosmetics;regulations and policy governing the safety of dietary supplements, infant formulas, and medical foods;safe and properly labeled cosmetic ingredients and products; food industry postmarket surveillance and compliance; consumer education and industry outreach; cooperative programs with state and local governments; and, international food standard and safety harmonization efforts.The terrorist attacks of September 11th has increased CFSAN's role in the nation's counter terrorism efforts, as in 2003 and beyond the Center has the responsibility for development and implementation of food security concerns in the Public Health Security and Bio terrorism Preparedness and Response Act of 2002 (the Bio terrorism Act) . Although our food supply is among the world's safest, the increase in variety of foods and the convenience items available has brought with it public health concerns. Because a growing proportion of the American food supply is imported, CFSAN also works with international organizations (World Health Organization, Codex Alimentarius Commission--an international food standard-setting organization of the Food and Agriculture Organization) and occasionally directly with foreign governments to ensure their understanding of U.S. requirements and to harmonize international food standards.

In support of the Foods program, ORA conducts risk-based domestic and foreign postmarket inspections of food manufacturers to assess their compliance with Good Manufacturing Practice (GMP). ORA inspects thousands of domestic firms that have been identified as high-risk food establishments consisting of manufacturers, packers/repackers, and warehouses processing products. These include: modified atmosphere packaged products acidified and low acid canned foods, seafood, custard filled bakery products, soft, semi-soft, soft-ripened cheese and cheese products, un-pasteurized juices, sprouts or processed leafy vegetables, fresh vegetables shredded for salads and processed root and tuber vegetables, sandwiches, prepared salads, infant formula, and medical foods. In addition to overseeing regulated products on a surveillance or "for cause" basis when a problem is encountered, ORA staff responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters that may impact FDA regulated goods. To complement the regular field force, the Office of Criminal Investigations (OCI) investigates instances of criminal activity in FDA-regulated industries.


Foods Program Increases for FY 2005
(By FDA Strategic Goal)


FDA Strategic Goal FY 2005 Increase What the Increase Buys Related Performance Goal(s)
Strong FDA Cost of Living-Pay +$5,755,000
  • Ensures that the Foods Program is able to continue to support its highly specialized staff.
  • Complete review and action on the safety evaluation of food and color additive petitions with 360 days of receipt;
  • Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days; and,
  • Review 95% of premarket notifications for food contact substances within the statutory time limit of 120 days.
Counter terrorism Protecting America from Terrorism Food Defense -CTT--+(+ $60,750,000)
  • 15 new State Labs added to Food Emergency Response Network (FERN). Laboratory equipment, supplies, training and security to enhance State capability to assist in FDA's Food Defense activities;
  • A secure food laboratory IT network (eLEXNET) for the real time sharing of information on a national basis;.
  • Increased domestic and import inspections of FDA regulated foods;
  • Increased research on prevention technologies, agent characteristics, new methods, and dose response relationships; and,
  • Improved coordination and integration of existing food surveillance capabilities with the Department of Homeland Security's integration and analysis function, as part of the government-wide Bio-Surveillance Initiative.
  • Increase national laboratory capacity to test food samples in the event of a terrorist attack;.
  • Expand federal/state/local involvement in FDA's eLEXNET system by having 104 laboratories participate in the system by the end of FY 2005;.
  • Increase Inspectional Coverage of Domestic Firms and Imported Goods to reduce the risk of contaminated product entering domestic commerce;.
  • Develop effective protection strategies to "shield" the food supply from terrorist threats; and,
  • Improve early attack warning and bio-surveillance capabilities at the national level to prepare against a potential terrorist attack.




Budget Authority

Cost of Living- Pay: +$5,755,000

FDA's request for pay cost increases is essential to accomplishing its mission. Without a specially trained national cadre of scientific staff, FDA's ability to adequately carry out the mission of protecting public health and providing consumer safety will be compromised. FDA must maintain staffing levels and scientific capabilities that meet the demands of an increasing workload and new challenges. Payroll costs, which account for over 60 percent of our total budget, significantly impact all FDA activities.

The total Agency request for pay increases is $14,352,000. The foods portion of this increase is $5,755,000. Without this, the FDA's ability to fulfill its mission to protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use will be significantly reduced.

Food Defense - Counter terrorism: + $60,750,000 and +103 FTE (includes+$5,000,000 for biosurveillance)

FDA must uphold its responsibility for ensuring the safety of approximately 80 percent of the nation's food supply. The possibility of food products being used as a vehicle for attack is particularly worrisome because such an event potentially affects everyone in the U.S. FDA must have the capability to assess and then reduce risks associated with unexpected and potentially widespread health and safety threats. Resources would allow the FDA to invest in the protection of citizens by supporting the following priorities and objectives:

  • Increasing Analytic Surge Capacity in the Event of Terrorist Attack on Food; FDA will develop a nation-wide laboratory testing capacity for biological, chemical and radiological threat agents;
  • Developing effective protection strategies to "shield" the food supply from terrorist threats;
  • Increasing inspectional coverage of domestic firms and imported goods to reduce the risk of contaminated product entering domestic commerce;
  • Improving early attack warning and bio-surveillance capabilities at the national level to prepare against a potential terrorist attack; and,
  • Providing capacity for a rapid, coordinated response to a threat(s) or attack(s) on the food supply.

Specific activities include:

Food Emergency Response Network (FERN) and eLEXNET

  • Enhancing the capabilities of state food testing so they are capable of handling pathogens associated with Bio terrorism at a BL-2 level or higher;
  • Equipping additional state food chemistry labs with the instrumentation needed to rapidly screen foods for the array of toxic chemical of concern;
  • Integrating the Food Emergency Response Network (FERN) with the nations' food testing laboratories and complimenting CDC's Laboratory Response Network (LRN) to detect routine threat agents in food. FERN will strengthen both federal and state food testing capabilities and would be called upon to respond to a terrorist attack or national emergency involving the food supply;
  • Providing equipment, supplies, and training to promote security and to enhance state capability to assist in FDA's Food Security activities;
  • Providing for laboratory testing to validate new methods and to provide for technology transfer and proficiency testing programs to standardize intra- and inter-agency laboratory performance;
  • Providing a total of $28,000,000 ($23,000,000 in new budget authority and $5,000,000 from base resources) to states for 15 FERN laboratories; and,
  • Completing the expansion of available data and providing needed security and real-time communication features in eLEXNET, a food laboratory IT network for the real time sharing of information on a national basis. eLEXNET supports the FERN and can be interfaced appropriately with the public health IT systems. Substantial strides during the past year have been made in the development of eLEXNET.


  • Investing in the following types of research:

    -- Prevention Technologies - FDA studies food prevention technologies to improve the safety of food and establish guidelines and or performance standards for industry. Information is needed about new technologies and / or technology enhancements that can increase food safety and protect against potential exposure to non-traditional pathogens, toxins and chemicals during possible high threat situations. For example, critical information is needed to determine if prevention strategies such as changing pasteurization times and temperatures could be used to safeguard foods and beverages while maintaining the quality that the consumer expects;

    -- New Methods - FDA fulfills its responsibility of ensuring the safety of the food supply through reliance on surveillance and monitoring methods. New microbiological, chemical, and radiological methods must be developed, validated, and used to detect, enumerate and identify potential non-traditional agents that may threaten the food supply. A particular emphasis is the need to develop biosensors and other technologies that could permit continuous monitoring of foods both during production and at import entry sites;

    -- Agent Characteristics - Additional assessments of the abilities of non-traditional microbial pathogens to survive and grow in foods during processing and storage, or the stability and activity of chemical agents while present in foods, and the potential for their inactivation during food processing are essential to improving FDA's ability to detect, quantitate and control food borne pathogens, toxins and chemicals that threaten the food supply; and,

    -- Dose Response Relationships/Threat Assessments- An understanding of the dosage amounts needed to inflict human disease or produce adverse reactions, where exposure occurs through consumption of different food matrices, is essential to accurately estimate the threat posed by such exposures. In turn, knowledge of dose response helps determine methods development performance parameters (e.g., sensitivity, ruggedness, statistical confidence) that assure safety and security of the food supply.

Inspections, Bio-Surveillance, Incident Management

  • Hiring more inspectors to increase inspectional coverage of domestic firms and imported goods to reduce the risk of contaminated product entering domestic commerce;
  • Improving coordination and integration of existing food surveillance capabilities with the Department of Homeland Security's integration and analysis function, as part of the government-wide Bio-Surveillance Initiative; and,
  • Continuing to expand FDA's capability for emergency preparedness and response, related to any incident or emergency involving contamination of any FDA regulated product. This would include preparing and responding to intentional acts of contamination and significant public health emergencies. At the current time, FDA has insufficient capacity to communicate in a secure environment with its headquarters and field staff, especially during emergency situations. The Emergency Operations Network Incident Management System project will allow integrated access for all FDA offices to incident management, surveillance, and alert information.


Administrative Efficiencies: - $6,774,000 and - 58 FTE


To fully embrace the President's Management Agenda, FDA is delayering its organizational structure, performing competitive sourcing reviews, modernizing its financial management system, and consolidating its information technology infrastructure. The Foods portion of these management improvements consists of -$6,774,000 and - 58 FTE.




In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological Health) and was rated as "results not demonstrated" due to a lack of long-term outcome goals. To address this concern, long-term outcome goals were developed.

For FY 2005, the Office of Management and Budget conducted a second program review that treated FDA as a single agency program. In this review, FDA received a rating of "moderately effective" and score of 77 percent, up from 59 in FY 2004. This was due to considerable improvements in developing long-term agency-wide outcome goals that will demonstrate its effectiveness and impact on the public health. FDA also reduced the number of performance goals, and made various management improvements that further streamline its infrastructure while supporting core, mission-critical public health activities.

The Foods Program shares in an agency-wide outcome goal of reducing administrative overhead through the reduction of the number of administrative staff. All of the Agency's outcome goals support the Department's priorities and Administration's initiatives with the intent to improve the health and well-being of the American public.




Base resources will be used to conduct science-based risk management in all agency regulatory activities so that the Agency's limited resources can provide the most health promotion and protection at the least cost to the public. These activities include efforts to:

  • Continue FDA's national network of academic centers of excellence to strengthen scientific standards for compliance and threat assessment and reduction;
  • Continue to evaluate the CDC food borne disease outbreak surveillance system data to identify and analyze outbreaks associated with FDA-regulated products, for number of outbreaks, etiologic agents, morbidity and mortality, seasonality, geographic location, site of food preparation, contributing factors and whether the product is domestic or imported;
  • Continue to develop food safety prevention standards and guidance to fill the gaps in public health protection from farm to table---modernizing GMP's for food establishments;
  • Sustain enhancements to the strategic data systems for surveillance and inspection activities of the food supply that help FDA inspectors focus on and analyze products suspected to have microbiological and chemical contamination;
  • Participate in national surveillance and emergency response programs, such as the Food borne Disease Active Surveillance Network (FoodNet) and PulseNet. FoodNet, a collaborative project with the CDC and USDA, conducts active surveillance for food borne diseases and related epidemiology studies; PulseNet is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be food borne;
  • Serve as project leader for the National Food Safety System (NFSS) by leading an effort to improve coordination and communication among public health and food regulatory officials, particularly around food borne illness outbreaks, to more effectively implement existing food safety programs;
  • Perform data cleanup on the Field Accomplishment and Compliance Tracking System (FACTS) to improve the accuracy of our inventory of food firms; This entails evaluating and standardizing poor quality data and resolving duplicates -- then applying the same logic in real-time to incoming records from the U.S. Customs Service and the FDA field force; and,
  • Provide the operations and maintenance support necessary for the import and domestic product monitoring equipment and information systems, and provide rapid methods to test products in the field.


Domestic Inspections


Consumers rely on the FDA to prevent dangerous and unreliable products from entering into commerce. Public safety and confidence could be jeopardized by a failure to maintain levels of surveillance activities. The Foods Program needs to sustain levels of laboratory analyses for chemical and microbiological contaminants to meet public expectations. Base funding will enable FDA to:

  • Conduct domestic inspections of food safety activities at the following levels: 14,900 inspections conducted by FDA, and 10,200 inspections conducted via state contracts or partnerships;
  • Support deployed Radiation Emergency Response teams working with other Federal and State agencies to monitor radiation threats to the food supply and provide technical and food processing assistance;
  • Achieve further adoption of the Food Code and continue to expand the percentage of the total U.S. population covered by the Food Code;


What is the FDA Food Code?

The FDA publishes the Food Code, a model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. Local, state, tribal, and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.

It also serves as a reference of best practices for the retail and food service industries (restaurants and grocery stores and institutions such as nursing homes) on how to prevent food borne illness. Many of the over 1 million retail and food service establishments apply Food Code provisions to their own operations.

  • Inspect at least 95 percent of the over 7,200 domestic firms that have been identified as high-risk food establishments consisting of manufacturers, packers/repackers, and warehouses processing products. These include: modified atmosphere packaged products acidified and low acid canned foods, seafood, custard filled bakery products, soft, semi-soft, soft-ripened cheese and cheese products, un-pasteurized juices, sprouts or processed leafy vegetables, fresh vegetables shredded for salads and processed root and tuber vegetables, sandwiches, prepared salads, infant formula, and medical foods. Inspections will utilize associated laboratory support for sample analysis;
  • Identify the food source and contaminant of food borne illness outbreaks ranging from chemical and microbiological, and/or physical hazards;
  • Conduct state contract audit inspections to ensure consistent application of regulations nationwide by FDA and the states;
  • Continue to fund state contracts, partnerships and grants related to FDA-regulated products so that FDA inspects and monitors the food industry frequently enough to ensure application of appropriate preventative controls to ensure a safe, wholesome, and nutritious food supply for compliance and inspection activities;
  • Replace outdated field laboratory equipment to improve the accuracy and timeliness of food product analyses to determine compliance with safety requirements;
  • Provide criminal investigation of reported product tampering, counterfeit products and other fraudulent criminal activities involving regulated products;
  • Develop laboratory analytical methods to permit the analyses of products for chemical and microbiological hazards; and,
  • Continue to analyze more than 8,000 food samples for pesticides and environmental contaminants.


Imports, Import Monitoring and Foreign Inspections


Products enter the U.S. through one of approximately 300 ports located throughout the country. FDA relies on risk-based electronic screening of line entry data that is produced by import filers in the Operational and Administrative System for Import Support (OASIS) system to make the majority of entry decisions. The food program adjusts the risk-based criteria to meet program priorities. In FY 2005, FDA will be responsible for ensuring the safety of more than eight million import line entries for food, food related, and cosmetic products. These highly diversified entries include increasingly more products from countries that are typically categorized as emerging economies, with start-up regulatory infrastructures. FDA uses the OASIS data management and reporting system to expedite import entry review, oversee importer and filer evaluation data integrity, and follow-up on refused entries. Only a very small percentage of imported food entries are directly inspected through field examinations and analyzed through laboratory analysis. Thus, the safety of the U.S.food supply relies greatly on export countries complying with U.S. safety standards. Given FDA's reliance on third party oversight and compliance, it is in FDA's interest to enhance the food safety systems in foreign countries and, thus, improve the quality of imported food products. Base funding will:

  • Maintain performance of physical exams at 60,000 and conduct sample analyses on imported products with suspect histories; maintain performance of filer evaluations at 1,000 for assessing the admissibility of regulated imported articles;
  • Maintain performance of examinations of FDA refused entries of food products as they are delivered for exportation to ensure that the articles refused by FDA are being exported;
  • Continue to train import inspectors to enhance and streamline import sample collection processes at ports of entry, which provide more rapid identification of suspect agents;
  • Modernize the import data system to enable better detection of tainted food, and deter and detain food thought to be contaminated;
  • Conduct foreign inspections, focusing on top priority high‑risk foods so that the Agency can further assure that products offered for import are safe, effective, and properly labeled; and, education/training to enhance food safety systems in foreign countries and thus, improve the quality of U.S.food imports;
  • Continue to support operations and maintenance of OASIS to ensure continuity of import operations in the event of a disabling threat to existing facilities, until the existing system is replaced; and work with the U.S. Customs Service to better leverage resources to strengthen efforts in detection and interdiction of contaminated foods and enhance the safety of imported products through surveillance at the border; and,
  • Maintain the recent gains in the frequency and quality of imported food inspections, and modernize the import data system to enable better detection of tainted food, and to detain food suspected to be contaminated.


FDA Seizes Adulterated Honey

In 2003, at the request of the FDA, U.S. Marshals seized adulterated imported bulk and finished product honey from a honey farm in Texas. U.S. Marshals seized 266 drums of honey (each containing 639 pounds of bulk honey) and five totes (each containing a net weight of 3,000 pounds) after FDA tested and confirmed the presence of an unapproved food additive, chloramphenicol. In accordance with the Federal Food, Drug and Cosmetic Act, food products that contain chloramphenicol, an antibiotic, are adulterated and are not permitted to be sold in or imported into this country. The continued monitoring of food production and distribution at many levels has enabled FDA to detect this adulterated honey since the agency learned of the presence of chloramphenicol in imported honey. Chloramphenicol is a broad-spectrum antibiotic drug used to treat life-threatening infections in humans, usually when other alternatives are not available. The use of this antibiotic is limited because of its potentially life-threatening side effect, idiosyncratic aplastic anemia. For the very small number of the population susceptible to this side effect, exposure to chloramphenicol could be serious or life threatening. Because of the current uncertainty regarding the dose-response relationship between chloramphenicol ingestion and aplastic anemia, it is not possible to define a safe level for the presence of this antibiotic in food products. The agency will continue to detain or seize any honey imports that contain chloramphenicol to ensure that this product is not released for human or animal consumption in the United States.


Dietary Supplements


The dietary supplement industry is now one of the world's fastest growing industries with over 1,500 establishments claiming to manufacture dietary supplements and sales of $17.1 billion in 2000. Between1994 and 2000, consumer spending on dietary supplements nearly doubled, with over 158 million consumers, and sales continuing to grow at more than 10 percent per year. Nearly 20 million consumers use dietary supplements with prescription products. FDA is committed to making safe products available to consumers, and has published a dietary supplement strategy that sets clear program goals. It is a science-based regulatory program that will fully implement the Dietary Supplement Health and Education Act of 1994 (DSHEA). Base funding will enable FDA to:

  • Respond to at least 95 percent of premarket notifications for new dietary ingredients within the statutory time frame of 75 days;
  • Review the 30-day postmarket notifications for structure and function claims in a timely manner; and,
  • Continue the collaborative effort on dietary supplement research with the National Center for Natural Products Research in Oxford, Mississippi.


Bovine Spongiform Encephalopathy (BSE)


Bovine Spongiform Encephalopathy, or "Mad Cow Disease" is a deadly chronic, degenerative disorder affecting the central nervous system. BSE and Chronic Wasting Disease (CWD) both belong to a group of progressive degenerative neurological diseases that are always fatal, known as transmissible spongiform encephalopathies (TSEs). There are several TSE diseases that affect humans and the best known is Creutzfeldt-Jakob disease (CJD). Potential products regulated by FDA's Foods Program that can contain these substances are ruminant protein-containing cosmetic products that are packaged and ready for sale, and bovine-derived materials intended for human consumption as either finished dietary supplement products, or for use as ingredients in dietary supplements. Base funding will enable FDA to:

  • Continue to identify food and cosmetic products containing brain, spinal cord, and other specific risk materials, including the origin of the animal and country, and infectious agents in foods;
  • Conduct any necessary standard setting or compliance activities relating to BSE that may include, if appropriate, the development of proposed and final rules concerning the ban of bovine prohibited materials from cosmetics, dietary supplements, food additives, infant formula and all other food products; and, the re-evaluation of certain gelatin products;
  • Conduct research on decontamination or deactivation procedures;
  • Conduct research on BSE recovery and identification methods from foods and cosmetics; and,
  • Conduct research on the risk factors and mechanism for Chronic Wasting Disease (CWD), which affects elk, deer and other domestic game or pen-reared animals.


International Activities


It is important that FDA leverage scarce resources with the international community to provide benefits and incentives for all participants while accomplishing the Agency's foods mission of ensuring the safety of the domestic food supply. FDA will participate in, and raise visibility in, 18 Codex Committees and Task Forces. There are 13 meetings scheduled on a wide variety of products, one meeting of the Codex Commission and an estimated four working groups arising from the various Codex Committees and Task Forces. These meetings ensure that source country standards, quality systems, and audits conform to the requirements of the Federal Food, Drug, and Cosmetic Act.


Premarket Activities


FDA focuses premarket resources to provide for scientifically sound and timely reviews of the safety of food and color additives and food contact substances prior to their entry into the marketplace. To accomplish this, FDA needs to continue to improve the scientific knowledge base that will lead to safer food products and to a better understanding of the complexities of the products the agency regulates. The FDA Modernization Act established a notification process for food contact substances. Since the premarket notification program became fully operational in January 2000, many of the simpler food additive petitions that could have been completed within 360 days are now being handled under the notification program as food contact substance notifications, thus decreasing the workload for this goal. However, since the remaining petitions are usually more complex and time-consuming ones, the Agency anticipated that performance on this goal could decline initially. Once the notification and the recent improvements to the petition review process are well established, FDA expects performance on this goal to increase substantially toward full performance in succeeding years. With base funding, FDA will:

  • Continue to reduce the possibility of food-related deaths or injuries and improve the health and well-being of consumers by ensuring that decisions related to approvals of petitions and notifications are scientifically justified and benefit the public health;
  • Continue to develop premarket review standards for new products and emerging technologies such as antimicrobial ingredients used in the preparation of processed foods, address the human food safety aspects of genetically modified foods, address the use of novel ingredients added to conventional foods, and ingredients new to infant formulas and medical foods;
  • Continue to improve the premarket review process for food and color additives using advanced computer and telecommunications technologies;
  • Complete review and action on the safety evaluation of 75 percent of food and color additive petitions within 360 days of receipt;
  • Continue to provide pre-filing assistance to petitioners through the publication of detailed guidance for food contact substances and food and color additives; and,
  • Review 95 percent of premarket notifications for food contact substances within the statutory time limit of 120 days.

Other Program Activities

Under the Federal Food, Drug, and Cosmetic Act, Section 704, FDA is granted general authority to inspect food establishments, and under FFD&C Act Section 903, the Agency shall be responsible for research relating to foods and cosmetics in carrying out this Act. FDA will:

  • Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 samples;
  • Continue to evaluate the risks of pesticides and chemical contaminants, and the level of food nutrients in the U.S.diet, based on the revised FDA Total Diet Program. Data will provide information on levels of pesticides, industrial chemicals, toxic elements, and vitamins and minerals in foods that is more representative of today's consumer eating habits; and,
  • Continue to advance FDA's egg safety, as well as other compliance and enforcement programs, by continuing research on egg safety as well as education and outreach activities on the proper handling, storage and cooking of eggs. FDA also continues to implement all enforcement efforts of the rule on egg refrigeration/temperature and labeling.


Information Technology


CFSAN Adverse Events Reporting System (CAERS): CFSAN has developed a comprehensive system for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements. The CFSAN Adverse Events Reporting System (CAERS) replaces the patchwork of adverse event systems that were maintained by individual Offices within CFSAN. CAERS will be used as a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace. Information gathered in CAERS will also assist FDA in the formulation and dissemination of CFSAN's post-marketing policies and procedures. CAERS database went "live" in June 2003, and the first "version" is now being employed by its users. In this first version, all new consumer complaints and new adverse reports received after June 15, 2003, are recorded into the system and all complaints and adverse reports are reviewed by CAERS' medical staff. Additionally, industry outreach is achieved by sending a letter to the manufacturer informing them of the receipt of an illness or injury in the adverse report alleged to be caused by their product. CAERS will also be investigating ways to capture increased numbers of adverse events, in order to improve post-marketing surveillance on CFSAN regulated products. CAERS continues to undergo enhancements, development, and maintenance to improve the system based on user needs and collaborative efforts. Additionally, as funds become available, CAERS plans to improve data links with other Adverse Events Reporting Systems and other food injury reporting systems and enter older adverse reports into its database.

Food Additives Regulatory Management (FARM): FARM provides information management tools for food additive petition reviewers to maximize productivity and expedite the petition review process and subsequent safety decisions. This comprehensive image-based electronic document management and workflow automation system also helps FDA perform associated activities such as responding and managing Freedom of Information requests and correspondence. All paper and electronic documents are converted to standard formats and stored in a well-organized electronic document management system. Each reviewer will be able to retrieve documents at their desks using a combination of attribute and full-text search capabilities supported by a thesaurus maintaining nomenclature control.




Base resources will be used to better enable consumers to make informed decisions weighing benefits and risks of FDA-regulated products. FDA will:

  • Continue to implement the Consumer Health Information for Better Nutrition initiative which seeks to make available more and better information about foods and dietary supplements, to help American consumers prevent diseases and improve their health by making sound dietary decisions;
  • Continue to participate in the FDA Task Force on Consumer Health Information for Better Nutrition; This task force is developing a framework to help consumers obtain accurate, up-to-date, and science-based information about conventional food and dietary supplements; This includes the development of additional scientific guidance on how the "weight of the evidence" standard will be applied, as well as the development of regulations that will give these principles the force and the effect of law;
  • Continue task force efforts to encourage makers of conventional foods and dietary supplements to make accurate, science-based claims about the health benefits of their products, and to help eliminate bogus labeling claims by taking on those dietary supplement marketers who make false or misleading claims;
  • Continue to strengthen enforcement actions against dietary supplements that make false or misleading claims as well as an aggressive enforcement strategy against such claims;
  • Host bi-monthly Health Fraud Coalition Conference Calls (members include National Association of Attorneys General, FDA, FTC, Health Canada, and Mexico); and,
  • Ensure enforcement activities focus on products with specific marketing strategies. These products include: dietary supplements and unsubstantiated structure function claims; examples include treatment for autism, treatments for mental retardation and epilepsy, sports performance enhancement, and aging; and dietary supplements containing prescription drug ingredients.




Base resources will be used to promote improved patient and consumer safety by reducing risks associated with FDA-regulated products. The Foods program will continue to enhance FDA's Adverse Event Reporting Systems, which are designed to compile and assess large numbers of physician, health professional data and conclusions and provide likely associations and causative agents for follow‑up through investigation and clinical testing. CAERS (also under Efficient Risk Management) will integrate its multiple adverse event reporting systems currently in existence, including the current system for dietary supplements.

In December of 2003, FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products. Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug.In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy. FDA also notified manufacturers that it intends to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication;




Base resources will be used to strengthen FDA's capability to identify, prepare for, and respond to terrorist threats and incidents.


Defense of the U.S. Food Supply

The events of September 11, 2001, heightened the nation's awareness and placed a renewed focus on ensuring the protection of the nation's critical infrastructures. A terrorist attack on the food supply could pose both severe public health and economic impacts, while damaging the public's confidence in the food we eat. Several food incidents since the fall of 2001 highlight the significance of FDA's food defense activities. In the fall of 2002, a competitor of a restaurateur in China added a chemical compound to his competitor's food and killed dozens of people and sent hundreds more to hospitals. Also in the fall of 2002, three individuals were arrested in Jerusalem for allegedly planning to carry out a mass poisoning of patrons at a local café. One of the arrested individuals worked as a chef at the café. In January 2003, several individuals were arrested in Britain for plotting to add Ricin to the food supply on a British military base. Each of these incidents shows the potential for the nation's food supply to be used in an attack. FDA, at the direction of the Department of Health and Human Services, has established a 10-Point Program for ensuring the safety and security of the food supply. Based on this, FDA is employing overall strategies to (1) develop increased awareness among federal, state, local, and tribal governments and the private sector by collecting, analyzing, and disseminating information and knowledge (Awareness); (2) develop capacity for identification of a specific threat or attack on the food supply (Prevention); (3) develop effective protection strategies to "shield" the food supply from terrorist threats (Protection); (4) develop capacity for a rapid, coordinated response to a food borne terrorist attack (Response); and (5) develop capacity for a rapid, coordinated recovery from a food borne terrorist attack (Recovery).


Food Safety and Security


The Foods Program helps to protect the safety of the U.S. food supply by targeting efforts to minimize health and safety risks facing the U.S. public, and by quickly and accurately assessing and effectively managing those risks. FDA must work to develop profiles of possible or probable food threats and points of attack and must have the capacity to quickly and accurately identify potential or actual outbreaks at any point in the food chain, and take prompt action to mitigate their effects. Base funding will enable FDA to:


State Contracts/Grants


  • Maintain the number of state partnerships and grants related to FDA-regulated products for FDA to continue to inspect and monitor the food industry frequently enough to ensure application of appropriate preventative controls to ensure a safe, wholesome, and nutritious food supply for compliance and inspection activities; and,
  • Maintain FDA's presence in its retail, state audits and targeted inspection activities, and increased state partnerships and grant activities;


Laboratory Preparedness


  • Continue the development of methods science within FDA to support the critical infrastructure needed for the FERN, which will provide integrated laboratory solutions and disseminated testing capacity to support public health preparedness and response to an act of Bio terrorism involving the food supply;
  • Continue the laboratory accreditation program covering all Center foods facilities to harmonize practices in food laboratories conducting regulatory testing to ensure acceptance of FDA laboratory results throughout the world (this will include enhanced data quality systems and support for instrument validation);
  • Continue to develop uniform scientific practices for accreditation of FDA's general-purpose and specialty field labs to the international standard for regulatory sample analysis;
  • Continue the upgrade of field laboratory capabilities to rapidly detect Bio terrorism contamination;
  • Continue diagnostic tests to produce tools that are needed for field and import examinations to determine if a product has been tampered with or is otherwise tainted;
  • Continue to expand, by 25 for a total of 104, the number of state health and agriculture laboratories and capabilities of current laboratories connected to the eLEXNET. This expansion will allow the laboratories to exchange data on select biological agents (possibly including anthrax, botulinum toxin, brucellosis and other potential infectious diseases) and food pathogens and assist in the Department's Counter terrorism efforts. This system is the first Internet-based food safety system that consolidates a repository of pathogenic findings in the nation's food supply by Federal, state, and local government labs, and will link state and local organizations with the Federal partners to respond more quickly to outbreak situations;
  • Continue enhanced efforts in rapid analysis of suspect foods to asses for biological and chemical agents that could be intentionally introduced into a food;
  • Develop preventative standards, education campaigns and research to improve food safety and security through rapid tests of detection and reduction;
  • Streamline techniques for the rapid detection and assessment of bacterial strains of bio terrorist agents (pathogens/chemicals); and,
  • Provide technical assistance to develop irradiation techniques and methods to kill anthrax spores in the mail by participating with industry, which already uses irradiation to sanitize poultry, ground beef, spices, and medical equipment.


Prior Notice and Foods Registration System


  • Continue regulatory guidance in an expedited time period in order to implement Title III of the Bio terrorism Act. The FDA is required to propose and issue final regulations for the following four provisions: Section 305 (Registration of Food Facilities); Section 306 (Establishment and Maintenance of Records); Section 307 (Prior Notice of Imported Food Shipments); and Section 303 (Administrative Detention); and,
  • Maintain the Food Registration and Prior-Notice system.



FDA Unified Registration and Listing System


Under the stringent time constraints mandated by the Bio terrorism Act of 2002, FDA fully implemented an on-line Food Facility Registration Module which is capable of handling 5,000 on-line registrations, (required from domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States), simultaneously via the Internet. In addition to responding to these requirements, FDA provided unified account management and single on-line entry point to be used for all of FDA Listing systems. As specified under the Bio terrorism Act, a paper process, including a paper processing facility, has been established to accept registrations via mail, fax, etc. to enter these into the electronic system, and to respond via paper to facilities doing business utilizing paper forms.


Information Technology


FDA Unified Registration and Listing System: The Unified Registration and Listing System (FURLS) supports the requirements of the Bio terrorism Act of 2002 as it relates to Food Facility Registration, Drug Facility Registration and Listing, and Prior Notice of Food Shipments into the United States. FDA began the FURLS effort by identifying opportunities for unification between the FDA Drug Facility Registration and Listing requirements with those of the Food Facility Registration Requirements.

Electronic Laboratory Exchange Network (eLEXNET): eLEXNET is the nation's first Internet-based data exchange system that allows Federal, State, and local laboratories to electronically share food safety sample and test data for various food-borne pathogens. The laboratories are able to access eLEXNET, regardless of their current system environment or level of automation.




Imports and Foreign Inspections


  • FDA completed 78,659 field examinations of imported food shipments, exceeding the goal of 48,000 by 64 percent. This is more than a five-fold increase from the 12,000 field import examinations conducted in FY 2001.


Domestic Inspections


  • In conjunction with the states, FDA conducted 7,363 domestic inspections of firms that produce "high risk" foods exceeding our performance goal of 6,650 establishments. The field performed more high risk inspections than the target (7,200) because of changes in the risk category of firms between the time that the inventory was calculated and when the inspections were conducted. The food firm inventory and firm risk categories change even when the overall totals appear stable. The field often needs to perform more firm inspections than the target to be sure of meeting the high risk target.


Fruits and Vegetables


  • Developed a strategy for addressing the multiple outbreaks of E. coli 0157:H7 from contaminated lettuce. The strategy calls for working with industry to collect specific information to fill in gaps such as using a questionnaire on lettuce-specific practices to see if any patterns emerge. The strategy also includes research, both basic and applied. Based on information gained, the strategy calls for identifying interventions to avoid or minimize contamination in the field or packing houses, to treat lettuce post-harvest, and education/outreach relative to safer production practices. Some of these actions have already been initiated; and,
  • FDA and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) conducted a train-the-trainer program on Good Agricultural Practices and Good Manufacturing Practices (GMP's) for the production of fresh produce from September 12 - 20, 2003 at the Cummunidad Andina in Lima,Peru. Participants included selected growers, state and federal officials, and consultants from Peru, Venezuela, Equador, Bolivia, and Columbia. Participants were trained in good agricultural and manufacturing practices, with lectures, case studies, practical exercises, and an overview of FDA's registration, record keeping, and prior notice proposed rules implementing the Bio terrorism Act of 2002. Participants took part in an extensive, commodity specific, farm exercise based on conditions realistic for the region. An examination, administered on the last day, resulted in a class average of 92 percent.


Cooperative Programs


  • At the end of FY 2003, forty-two states and territories that together represents 76 percent of the U.S. population, had adopted codes patterned after either the 1993, 1995,1997,1999 or 2001 versions of the Food Code. This meets our goal for FY 2003.


Transmissible Spongiform Encephalopathies (TSEs)


  • Worked with both USDA's APHIS and FSIS to effectively respond to the BSE situation in Canada. For approximately a month after the May discovery of a cow in Canada with BSE, FDA and USDA had daily interagency phone calls to coordinate response to the situation. When the daily calls were no longer considered necessary, the agencies agreed to continue to communicate as needed to ensure that we respond as one government to the Canadian situation. FDA is currently in discussions with APHIS about what would be needed to allow import of additional bovine commodities from Canada.


Food Allergens


  • Created an Allergen Inspection Database. FY 2002 Establishment Inspection Reports (EIRs) have been coded and entered into the database. CFSAN successfully completed the evaluation and summarization of the data from 500 allergen inspections conducted in FY 2002.


Food Safety
Food and Color Additives


  • For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of three of the three food additive petitions that qualify for expedited review. A petition qualifies for expedited review if the food additive is intended to decrease the incidence of foodborne illnesses through its antimicrobial actions against human pathogens that may be present in food;
  • For the petition receipt cohort of FY 2002, completed within 360 days of filing, the safety evaluation of six of the eight (75 percent) food and color additive petitions that do not qualify for expedited review. This meets our goal of completing at least 70 percent of these petitions within 360 days;
  • Completed the evaluation of all (3) biotechnology final consultations received in FY 2002;
  • Completed processing of 28 of 30 (93 percent) GRAS Notifications received in FY 2002 within 180 days. This exceeds our goal of completing at least 80 percent of GRN’s within 180-day statutory timeframe;
  • Completed review of all 111 Food Contact Notifications within 120-day statutory timeframe;
  • Drafted a Report to the Appropriations Committee that provides an estimate of the costs of carrying out the premarket notification program. The report is currently going through Administration clearance;and,
  • On August 26th and 27th FDA convened a meeting of the Additives and Ingredients Subcommittee of its Food Advisory Committee to assist in gathering information, and to get independent expert consideration of questions that FDA has raised regarding natural rubber latex (NRL) allergy as it relates to food safety. In accordance with Title 21 CFR 177.2600 Rubber articles intended for repeated use, natural rubber is an approved indirect food additive when used as a component of a repeat-use, food-contact article such as a food-service glove. Nevertheless, FDA has received reports of latex allergic individuals experiencing allergic reactions to foods believed to have been prepared by workers wearing NRL food-service gloves. FDA has been gathering and analyzing information from a variety of sources relating to the incidence of food-mediated latex allergic reactions and presented that information to the Additives and Ingredients Subcommittee.

    During the two day meeting, the Subcommittee heard from a variety of sources, including experts from Center for Devices and Radiological Health and Center for Biologics Evaluation and Research, as well as experts from outside of FDA. The Subcommittee reached a consensus that a potential hazard may exist, but concluded that the science establishing a risk from the use of NRL food-service gloves is very weak. The committee recommended that FDA consider establishing specifications for food service gloves (for example, residual protein and/or donning powder levels) to address the potential hazard, and that well-designed clinical studies would be helpful to better understand the levels of exposure that would be required to elicit a systemic response in a latex allergic individual.

Seafood Safety

  • In our strategy to increase above the level of 85 percent the number of seafood processors that are in compliance with the seafood HACCP program, CFSAN has: continued prioritization in the compliance program of inspections of processors in industry sectors that lag behind in HACCP implementation and continued prioritization of inspections of processors that lack HACCP plans; issued to districts lists of the firms that still did not have HACCP plans to help the districts target inspections toward such firms; and, developed a research plan to develop a better understanding of what proper controls should look like in industry sectors that lag behind in HACCP implementation.

What is HAACP?

HACCP involves seven principles:

Analyze hazards. Potential hazards associated with a food and measures to control those hazards are identified. The hazard could be biological, such as a microbe; chemical, such as a toxin; or physical, such as ground glass or metal fragments.

Identify critical control points. These are points in a food's production--from its raw state through processing and shipping to consumption by the consumer--at which the potential hazard can be controlled or eliminated. Examples are cooking, cooling, packaging, and metal detection.

Establish preventive measures with critical limits for each control point. For a cooked food, for example, this might include setting the minimum cooking temperature and time required to ensure the elimination of any harmful microbes.

Establish procedures to monitor the critical control points.Such procedures might include determining how and by whom cooking time and temperature should be monitored.

Establish corrective actions to be taken when monitoring shows that a critical limit has not been met -- e.g., reprocessing or disposing of food if the minimum cooking temperature is not met.

Establish procedures to verify that the system is working properly--for example, testing time-and-temperature recording devices to verify that a cooking unit is working properly.

Establish effective record keeping to document the HACCP system.This would include records of hazards and their control methods, the monitoring of safety requirements and action taken to correct potential problems. Each of these principles must be backed by sound scientific knowledge: for example, published microbiological studies on time and temperature factors for controlling foodborne pathogens.


Why is HACCP Needed?

New challenges to the U.S.food supply have prompted FDA to adopt a HACCP-based food safety system on a wider basis. One of the most important challenges is the increasing number of new food pathogens. For example, between 1973 and 1988, bacteria not previously recognized as important causes of food-borne illness--such as Escherichia coli O157:H7 and Salmonella enteritidis--became more widespread. There also is increasing public health concern about chemical contamination of food: for example, the effects of lead in food on the nervous system. Another important factor is that the size of the food industry and the diversity of products and processes have grown tremendously--in the amount of domestic food manufactured and the number and kinds of foods imported. At the same time, FDA and state and local agencies have the same limited level of resources to ensure food safety. The need for HACCP in the United States, particularly in the seafood and juice industries, is further fueled by the growing trend in international trade for worldwide equivalence of food products and the Codex Alimentarious Commission's adoption of HACCP as the international standard for food safety.


Chemical Contaminants, Pesticides and other Hazards


  • Completed the development phase of its action plan by presenting and receiving advice on the plan from FDA's Food Advisory Committee and the Contaminants and Natural Toxicants Subcommittee of the Food Advisory Committee. Implementation of this action plan has begun by completing the preliminary or exploratory survey on acrylamide occurrence in foods and acrylamide analyses of FDA's FY/03 Total Diet Study Survey food samples. Major studies on acrylamide formation in foods and on toxicology and health effects, as outlined in the action plan,are underway at FDA, CDC, and NIH;
  • Announced on July 22, 2003the availability of a level 1 draft guidance for industry entitled: "Channels of Trade Policy for commodities with Residues of Pesticide Chemicals, for which Tolerances have been Revoked, Suspended, or Modified by the Environmental Protection Agency" (EPA). This guidance is intended to present general policy on FDA's planned enforcement approach for foods containing such residues in accordance with the provision in section 408(1)(5) (the "channels of trade provision") of the Federal Food and Drug and Cosmetics Act, as amended by the Food Quality Protection Act (FQPA);
  • Collected and analyzed 11,331 food samples for pesticides and chemical contaminants, exceeding our goal by 3,331 or 142 percent of our intended target; and,
  • Published a proposed rule and direct final rule for radionuclides quality standards for bottled water on march 3, 2003 This final rule will ensure that the minimum quality of bottled water --as affected by uranium, combined radium-226/-228, gross alpha particle radioactivity, and beta particle and photon radioactivity --remains comparable with the quality of public drinking water that meets the EPA's standards.





  • FDA sponsored a regional outreach meeting on food safety and security that was held in Buenos Aires , Argentina on September 1st and 3rd. Three hundred representatives from 10 nations in South America participated. The U.S. delegation consisted of representatives from FDA, USDA's FSIS, the CDC, and Department of Homeland Security/Customs Border and Protection (CBP). The program consisted of presentations on U.S. food safety and security programs, U.S. import requirements, and concurrent sessions on regulations and guidance for specific commodities (including produce, seafood, juice, dairy and egg products, meat and poultry. The delegation hosted a press conference to discuss the meeting and to report progress on the implementation of the Bio terrorism Act and participated in a field trip to a food distribution warehouse in Buenos Aires, and a dairy processing plant outside the city. A regional dairy processing safety program was held in Montevideo ,Uruguay immediately following the meeting in Argentina . Trainers included representatives from CFSAN, the Center for Veterinary Medicine and ORA. In addition to a review of how dairy products are regulated in the United States and a review of best practices, the trainers provided an update on the progress of the new Bio terrorism regulations. Over 150 representatives from 10 nations participated. The response to both meetings was overwhelmingly positive.
  • FDA launched a public education campaign targeted to Hispanic men on the risks from Vibrio vulnificusin raw oysters in the summer of 2003. Facets of the campaign included a partnership with community-based health organizations and outreach through the Hispanic media. FDA provided information in the form of a fotonovela (illustrated storybook that shows what may happen if people with weakened immune systems eat raw oysters contaminated with Vibrio vulnificus) and by distributing public service announcements. This Education Campaign was carried-out through Hispanic media nationwide (i.e., news paper, radio, and television) with special emphasis in Florida and Texas media. This effort reached an audience of over 3 million people.


Nutrition, Health Claims and Labeling


  • FDA published Guidance for Industry titled: "Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements" on December 20, 2002. This document updates the Agency's approach to implementing the court of appeals decision in Pearson v. Shalala (Pearson)to include conventional foods and provides guidance to industry on the circumstances under which FDA will consider exercising its enforcement discretion for health claims that do not meet the "significant scientific agreement" standard of evidence.
  • This document also describes the process that FDA intends to use to respond to future health claim petitions. Finally, the document clarified that the Agency will use the "reasonable consumer" standard in evaluating food labeling claims.
  • The FDA Task Force on Consumer Health Information for Better Nutrition issued its report on July 10, 2003. The report contains the following guidance documents and publications:

    -- A guidance document entitled "Interim Evidence-based Ranking System for Scientific Data"; A Notice of Availability about FDA's guidance on qualified health claims was published in the Federal Register on July 11, 2003;

    --A report entitled, "Interim Procedures for Qualified Health Claims in the Labeling of Conventional food and Human Dietary Supplements",which sets the procedures FDA will use for the timely review of qualified health petitions, beginning September 2003;These procedures are intended to be interim until such time as notice-and-comment rulemaking for a qualified health claim petition regulatory framework is completed;

    -- A report entitled "Possible Regulatory Framework for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements", which presents a framework for proposed regulation of qualified health claims;This document developed three regulatory alternatives for consideration and comment;and,

    -- A report on July 10, 2003, entitled "Consumer Studies Research Agenda -- Improving Consumer Understanding and Product Competition on the Health Consequences of Dietary Choices",which presents a description of proposed consumer research studies and a timeline for peer review of the protocol as well as OMB approval;

FDA Task Force on Consumer Health Information for Better Nutrition

In2003, FDA announced the establishment of the Task Force on Consumer Health Information for Better Nutrition. The Task Force is charged to provide recommendations to develop new procedures for the review of qualified health claims and to propose a consumer studies research agenda within six months. Under the leadership provided by FDA's Task Force, whose report was made public on July 10, 2003, FDA published guidance extending applicability of qualified health claims to conventional foods; established a process for reviewing qualified health claim petitions; developed scientific guidance for industry on evidence-based ranking of scientific evidence for such claims; established a consumer studies research agenda; and increased enforcement against unsubstantiated dietary supplement claims. FDA also published a final rule to require labeling of trans fat, the first major change to the Nutrition Facts panel in a decade.

  • Completed the review of fifty-four pre-market notifications for new infant formulas, with objections given for only one. All were completed within the statutory timeframe;
  • Reviewed and issued decisions on 10 nutrient content and health claim petitions. Of these, four claims were denied, regulations were published for two claims, and four other claims were permitted as qualified health claims by exercise of enforcement discretion;
  • Prepared and transmitted a report to Congress explaining the Agency's initiative to make available to consumers more and better information about the health benefits of foods and dietary supplements. House Report 107-623 of the Agriculture, Rural Development, FDA and Related Agencies 2003 Appropriations Language directed FDA to consider the health claim that "consumption of omega-3 fatty acids in salmon can prevent and reverse heart disease." This initiative will include consideration of a qualified health claim on omega-3 fatty acids for conventional foods such as salmon;

Revealing Trans Fats to Reduce Risk of Coronary Heart Disease

In 2003, CFSAN published final regulations requiring food manufacturers to list Trans Fat on Nutrition Facts panels by January 1, 2006. This additional information will give consumers a more complete picture of fat content in foods -- allowing them to choose foods low in saturated fat, trans fat, and cholesterol -- all of which raise LDL ("bad") cholesterol that increase the risk of coronary heart disease (CHD). Along with saturated fat and cholesterol, trans fat on the food label gives consumers information needed to make food choices that help reduce the risk of CHD. This revised label will be of particular interest to people concerned about high cholesterol and heart disease.

According to the National Heart, Lung, and Blood Institute of the NIH, more than 12.5 million Americans have CHD, and more than 500,000 die each year-- making CHD one of the leading causes of death in the U.S. Increasing the understanding of consumers regarding the impact of dietary choices on risk of CHD is a key FDA goal (i.e., "Better Informed Consumers") in addressing this public health threat. The labeling of Trans fats is a key part of this effort.

  • Issued an advance notice of proposed rulemaking (ANPRM) in the Federal Register to solicit information and data that could be used to establish new nutrient content claims about trans fat on July 11, 2003. The ANPRM also solicited information and dates to establish qualifying criteria for trans fat in existing claims that have a limit on saturated fat and health claims that contain a message about cholesterol-raising lipids. The ANPRM requests comment on whether we should consider statements as footnotes in the Nutrition Facts panel or in conjunction with claims to enhance consumers' understanding about how to use the information to make heart-healthy food choices;
  • Published in the Federal Register a proposed rule to amend the regulation for sodium levels for foods that use the nutrient content claim "healthy" on February 20, 2003. The proposal establishes sodium levels for the definition of "healthy" that are not so restrictive as to preclude the use of the term "healthy", and not so broadly defined as to cause the term to lose its value in identifying useful products for constructing a healthful diet. The Agency based the proposed sodium requirements on the presumption they represent levels that are achievable by manufacturers, but sufficiently restrictive to provide consumers with a meaningful definition of the term "healthy" that will asses them in constructing a diet consistent with dietary guidelines;
  • Published in the Federal Register a proposed rule to reopen the comment period for the proposed rule, published in the Federal Register of July 9, 1996, revising its infant formula regulations.The proposed rule would establish requirements for current good manufacturing practice (CGMP) and audits, establish requirements for quality factors, and amend its quality control procedures, notifications, and records and report requirements for infant formula. FDA is reopening the comment period to update comments and to receive any new information;
  • Convened the Infant Formula Subcommittee of the Food Advisory Committee on November 18-19, 2003. The meeting's purpose was to discuss the scientific issues and principles involved in assessing and evaluating whether a "new" infant formula supports normal physical growth infants when consumed as a sole source of nutrition.This was the second meeting of a series of advisory committee meetings to discuss the scientific issues involved in evaluating whether a new infant formula supports normal physical growth; and,
  • Convened the Contaminants and Natural Toxicants Subcommittee of the FDA Food Advisory Committee on March 18-19, 2003. The purpose of the meeting was to discuss the scientific issues and principles involved in assessing and evaluating Enterobacter sakazakii contamination in powdered infant formula, risk reduction strategies based on available data, and research questions and priorities.



Dietary Supplements


  • Filed and responded to 58 notifications for dietary supplements containing new dietary ingredients within the 75 day period. The notifications are reviewed for science-based evidence of safety. Letters are issued to the notifier to acknowledge receipt and, when necessary, to identify deficiencies and safety concerns;
  • HHS and FDA announced a series of actions designed to protect Americans from the potentially serious risks of dietary supplement products containing ephedra/ephedrine on February 28, 2003. Among these actions, FDA proposed a new warning label for all ephedra-containing dietary supplements. In seeking comments on the new warning label and other issues, FDA reopened a proposed rule entitled: "Dietary Supplements Containing Ephedrine Alkaloids". The comment period of the proposed rule has ended;
  • Announced a significant enforcement initiative targeted at misleading claims about dietary supplement-associated health benefits on December 18, 2002. Over the last six months, the FDA issued 73 warning letters and cyber letters to marketers of dietary supplement products; seized products worth almost $9 million; refused import of 368 shipments of dietary supplement products offered for entry; and supervised the voluntary destruction of $515,000 worth of dietary supplements promoted with unsubstantiated structure/function claims; and,
  • Worked with the FTC with the mutual goal of consumer protection, and formed a Dietary Supplement Enforcement Working Group to closely coordinate their enforcement efforts against health care fraud. In addition, FDA and FTC chair an interagency health fraud steering committee that meets regularly to coordinate activity on these issues. The workgroup currently includes federal agencies in the U.S. and Canada. Mexico has been invited to join the group.




  • Announced, on December 2, 2002, the availability of a draft guidance document entitled "Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients". This draft guidance is intended to provide the cosmetic industry with suggested wording for a label statement alerting consumers to the possibility of increased skin sensitivity, particularly sunburn, associated with the use of such products, as well as protective measures to use; and,
  • Developed a web-based, online, interactive registration system with which manufacturer, repackers and distributors of cosmetic products can register their cosmetic formulations. The system also will allow industry to update and/or discontinue old formulations.


FDA continues its food processing and packaging research and outreach programs at the National Center for Food Safety and Technology (Moffett Center) in Illinois, with a focus on contemporary food safety and security issues. The application for the cooperative agreement supporting NCFST has been received from the Illinois Institute of Technology, reviewed,approved, and the funding provided. NCFST is significantly expanding its research program through the development of a BSL-3 level laboratory and conduct of critical research to enhance food security, particularly in assessing food technologies that can reduce this risk.




Implementation of Bio terrorism Legislation — Registration and Prior-Notice


FDA published an interim final regulation that requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. The interim final rule implements the Public Health Security and Bio terrorism Preparedness and Response Act of 2002 (the Bio terrorism Act), which requires domestic and foreign facilities to register with FDA by December 12, 2003, even in the absence of a final regulation. Registration is one of several tools that will enable FDA to act quickly in responding to a threatened or actual terrorist attack on the U.S.food supply by giving FDA information about facilities that manufacture/process, pack, or hold food for consumption in the United States. In the event of an outbreak of foodborne illness, such information will help FDA and other authorities determine the source and cause of the event. In addition, the registration information will enable FDA to notify quickly the facilities that might be affected by the outbreak. The FDA expects about 420,000 facilities to register under this requirement.

FDA also published an interim final regulation that requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the United States. The interim final rule implements the Public Health Security and Bio terrorism Preparedness and Response Act of 2002, which requires that the prior notification of imported food to begin on December 12, 2003, even in the absence of a final regulation. This will allow FDA to know, in advance, when specific food shipments will be arriving at U.S.port's of entry and what those shipments will contain. This advance information will allow the FDA, working with U.S. Customs and Border Protection (CBP), to more effectively target inspections and ensure the safety and security of imported foods. The FDA expects to receive about 25,000 notifications about incoming shipments each day.

Proposed rules have also been published for Maintenance of Records and Administrative Detention of suspect foods provisions under the Act.


Food Security: New Legislation


  • Completed the IT System for Food Facility Registration and began operation on October 16, 2003. In conjunction with FDA's Office of the Chief Information Officer, CFSAN helped to define requirements for the system and subsequently tested the "contractor-developed" system. CFSAN will coordinate and post on the CFSAN Web site all documentation for the Bio terrorism Act for industry access. CFSAN has the responsibility for processing information into the registration system and for the System Help Desk. These projects are being done under contracts that started in October 2003; and,
  • Worked to meet the requirement of Title III, Subtitle A, Section 302 of the Public Health Security and Bio terrorism Preparedness and Response Act of 2002 to submit an annual report to Congress describing progress made in counter-terrorism research. FDA has completed a review of its food security research efforts and provided a summary of its activities and accomplishments for FY 2003. The full FDA Counter terrorism Research Report for FDA and HHS was transmitted to Congress on October 16, 2003.


Food Security: Emergency Preparedness


  • Completed training on the Food Facility Registration and Prior Notification of Imports. The training was held on February 25 and March 12, 2003, and 48 CFSAN personnel and 52 ORA staff attended one or both sessions. On March 11 and May 13, 2003, FDA provided training to officials from all 50 states. Training on the final Bio terrorism regulations is underway. Training for "first responders" was held on October 15, 2003, and 178 CFSAN personnel attended. A worldwide "Satellite downlink" public broadcast on the final regulations for Food Facility Registration and Prior Notification of Imports was held on October 28. The remaining training activities scheduled for November are: (1) an orientation session for all FDA employees responsible for handling and referring inquiries about the Bio terrorism legislation; and (2) specialized Bio terrorism training for FDA speaker and experts;
  • Participated in numerous emergency response exercises including all levels of government, including, the TOPOFF 2 Exercise. In May,2003, FDA participated in the TOPOFF 2 terrorism exercise, a full scale, fully functional exercise intended to simulate two separate terrorist acts, as well as the ensuing response for federal, state, and local governments. TOPOFF 2 was a congressionally mandated interagency exercise on a national and international scale. Additional exercises include:

    -- Numerous internal exercises in FY 2003 - e.g., BSE and a food contamination exercise;

    --Exercises with other federal agencies - e.g., Crimson Winter with USDA (Foot and Mouth Disease); and,

    --Participation with HHS in joint exercises with USDA at the Deputy Secretary level;

  • Published a final guidance document related to food security entitled: Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance. This guidance is designed as an aid to operators of food establishments (for example, firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients). It identifies the kinds of preventive measures that operators may take to minimize the risk that food under their control will be subject to tampering or other malicious,criminal or terrorist actions;
  • Published a final guidance document related to food security entitled: Importers and filers: Food Security Preventive Measure Guidance. This final guidance is designed as an aid to operators of food importing establishments, storage warehouses, and filers. It identifies the kinds of preventive measures that they may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist action;
  • Published draft Guidance for Industry titled: Cosmetics Processors and Transporters Cosmetics Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on appropriate measures that cosmetics establishments may take to minimize the risk that cosmetics under their control will be subject to tampering or other malicious, criminal, or terrorist actions;
  • Published draft Guidance for Industry titled: Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance. This draft guidance represents the Agency's current thinking on the kinds of measures that retail food store and food service establishment operators may take to minimize the risk that food under their control; will be subject to tampering or other malicious, criminal, or terrorist actions;
  • Published Guidance for the Dairy Industry entitled: Dairy Farms, Bulk Milk Transporters, Bulk Milk Transfer Stations and Fluid Milk Processors --Food Security Preventive Measures Guidance on July 11, 2003. This guidance is designed as an aid to operators of dairy farms, bulk milk transportation operations, bulk milk transfer stations and fluid milk processing facilities. It identifies the kinds of preventive measures operators of these establishments may take to minimize the risk that products under their control will be subject to tampering or other malicious, criminal, or terrorist actions;
  • Completed and placed on the CFSAN intranet a laboratory security document entitled: "Framework for Ensuring the Security of CFSAN Laboratory Facilities: Secure Handling and Use of Select Agents in the Center for Food Safety and Applied Nutrition". This document was developed to provide guidance for establishing and maintaining accountability of hazardous materials, with particular reference to "Select agents" as required under the Bio terrorism Act of 2002; and,
  • Expanded federal, state and local involvement in FDA's eLexnet system by having 55 laboratories participate in the system. This exceeded the performance goal.


Program Activity Data

  FY 2003
FY 2004
FY 2005


Petitions Filed 8 18 18
Petitions Reviewed* 14 20 20
* Number reviewed includes those approved, withdrawn, or placed in abeyance because of deficiencies during the FY and some submissions that were received in the previous FY.  
Notifications Received 98 110 130
Notifications Reviewed** 91 110 130
**Number reviewed includes those that became effective or were withdrawn.  


Notifications Received a 44 40 40
Notifications Reviewed b 54 40 40
aNumber of submissions received in current FY include some received late in the FY.
bNumber of submissions reviewed includes some submissions that were received in the previous FY.


Submissions Receiveda 58 75 80
Submissions Reviewedb 58 72 76

***A single notification may address one or more new dietary ingredients. For example, FDA has received at least 15 notifications that pertain to 2 up to16 new dietary ingredients in a single notification.

aNumber of submissions received in current FY includes some received late in the FY that will be completed in the next FY when the 75-day due date occurs.
bNumber of submissions reviewed in the current FY includes some submissions that were received in the previous FY where the 75-day due date occurred in the current FY.


Field Foods
FY 2003
FY 2004
FY 2005
Domestic Food Safety Program Inspections 7,218 7,000 7,750
Imported and Domestic Cheese Program Inspections 523 800 800
Domestic Low Acid Canned Foods/ Acidified Foods Inspections 623 600 600
Domestic Fish & Fishery Products (HACCP) Inspections 2,561 3,700 3,700
Import (Imported Seafood Program Including HAACP) Inspections 702 700 700
Juice HACCP Inspection Program (HACCP) 311 200 200
Interstate Travel Sanitation (ITS) Inspections 1,629 1,900 1,900
State Contract Food Safety ( Non HACCP) Inspections 5,909 7,177 7,177
State Contract Domestic Seafood HACCP Inspections 902 986 986
State Partnership Inspections 1,579 2,000 2,000
Total FDA and State Contract Inspections 21,957 25,063 25,813
State Contract and Grant Foods Funding $4,600,000 $9,600,000 $32,600,000
--An estimated $28 million will be provided to the States for the Food Emergency Response Network; it will include $23 million in new funds for FY 2005 and $5 million in recurring funds from the FY 2004 appropriation.
Domestic Field Exams/Tests 9,748 5,385 5,385
Domestic Laboratory Samples Analyzed 14,505 17,000 17,000
FY 2003
FY 2004
FY 2005
All Foreign Inspections
Import Field Exams/Tests
Import Laboratory Samples Analyzed
In the spring of 2003, Operation Liberty Shield, a one-time multi-department, multi-agency national plan resulted in increased protections for America's citizens and infrastructure. By leveraging its resources with partners, FDA increased surveillance of domestic and imported foods and enhanced collaboration with state and other government agencies. FY 2003 Food Import Field Exams increased due to unanticipated activities that were the result of this one-time initiative.
Import Line Entry Decisions
Percent Physical Exams Import Entries


Field Cosmetics
FY 2003
FY 2004
FY 2005
All Inspections 142 100 100
Domestic Field Exams/Tests 519 75 75


Import Field Exams/Tests 2,894 700 700
Import Laboratory Samples Analyzed 254 100 100
Import Physical Exam Subtotal 3,148 800 800
Import Line Entries 753,809 900,000 1,000,000
Percent Physical Exams of Import Entries 0.42% 0.09% 0.08%


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