In November 2003, the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) issued its end-of-year report on FDA’s Foods Program Priorities. These program priorities were goals FDA intended to meet during fiscal year (FY) 2003 and were the most ambitious yet, with 150 “A” list, or highest priority, goals. Despite the large number of priority items, CFSAN completed 92% of its “A” list goals (138 out of 150 goals). This achievement reflects the success of a management strategy that focuses CFSAN resources on issues that most benefit American consumers.
Initiated in 1999, the process of formally setting program priorities was designed to set ambitious but achievable goals while “raising the bar” each year. Each year, CFSAN has increased the number of its goals, while still achieving a high completion rate. As a result, CFSAN nearly doubled its number of accomplishments since 1999 (Figure 1).
Of the many accomplishments in FY 2003, there are three significant areas to highlight. First, CFSAN met all of its goals with respect to implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). Second, CFSAN began revitalizing its Applied Nutrition program by issuing several new guidance documents, developing a consumer studies research agenda and increasing enforcement against unsubstantiated dietary supplement claims. Third, CFSAN continued its emphasis and progress in all of its program areas, including completing the risk assessment for Listeria, modernizing its adverse event reporting system, issuing a proposed rule on good manufacturing practices for dietary supplements, and issuing a final rule on trans fatty acids.
Food Security in 2003
In 2003, FDA and the U.S. Customs and Border Protection (CBP) jointly issued two interim final food security regulations that implement key provisions of the Bioterrorism Act. The act provided FDA new authority to protect the nation’s food supply against actual and threatened terrorist acts, as well as other food-related emergencies. Both of the new food security regulations are designed to focus FDA’s efforts to monitor and to inspect imported foods and to allow for quick identification and notification of food processors and other establishments affected in any deliberate or accidental contamination of food.
The first new regulation, “Prior Notice of Imported Food Shipments,” requires food importers to provide FDA with advance information about imported food shipments. Prior notification will tell FDA when specific food shipments will be arriving at U.S. ports and what those shipments contain. FDA will review this information and determine in advance of the food’s arrival, whether or not to inspect the food offered for importation. Through this process, FDA can more effectively target inspections and focus its resources on high-risk shipments.
To support this effort, FDA and CBP worked collaboratively to establish a process that allows FDA to commission thousands of CBP officers in ports and other locations to conduct, on FDA’s behalf, investigations and examinations of imported foods. This unprecedented FDA-CBP collaboration significantly strengthens the implementation of the Bioterrorism Act to ensure the safety and security of imported foods. FDA and CBP expect to receive about 25,000 notifications about incoming shipments each day.
Prior notice applies to food for humans and other animals, including dietary supplements and dietary ingredients; infant formula; beverages (including alcoholic beverages and bottled water); fruits and vegetables; fish and seafood; dairy products and shell eggs; raw agricultural commodities for use as food or components of food; canned and frozen foods; bakery goods, snack food, and candy (including chewing gum); live food animals; and animal feeds and pet food. FDA has excluded some foods from the prior notice requirement. For example, food carried by an individual arriving in the U.S. for personal use, products that are subject to the exclusive jurisdiction of the U.S. Department of Agriculture (USDA) at the time of importation, food made by an individual in their personal residence and sent by that individual as a personal gift to an individual in the U.S., or food that is imported then exported without leaving the port of arrival until export are exempt.
Anyone who has information about the product being imported—including individuals, brokers, importers, and U.S. agents—can submit prior notice to FDA. Prior notice must be submitted electronically either through an FDA Internet-based system (operational 24 hours a day, seven days a week) or through CBP’s Automated Broker Interface of the Automated Commercial System, through which entry of most imported food is filed. To be valid, the notice must be received and confirmed for review electronically by FDA within a specified timeframe that varies based on the mode of transportation used to deliver the food to the U.S.
The second new regulation, “Registration of Food Facilities,” requires all facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA. The regulation requires the owner, operator, or agent in charge of a domestic or foreign facility to provide the name and address of the facility, trade names, and the categories of food the facility handles. Foreign facilities must provide the name of a U.S. agent for the facility. Facilities are also required to update any changes to required registration information within 60 days of the change. Once all facilities are registered, FDA anticipates it will have a complete and detailed roster of about 420,000 foreign and domestic food facilities. In the event of a bioterrorism incident or an outbreak of foodborne illness, FDA can use the registration information to locate and to notify facilities that may be affected.
FDA strongly encourages facilities to register online at www.access.fda.gov. FDA is able to accept electronic registration from anywhere in the world 24 hours a day, 7 days a week. Registering online should take about 15 minutes if an individual has their paperwork in order. When the required fields on the registration screen are filled in, an automatically generated electronic confirmation of registration and a registration number will be immediately sent back. Facilities also may register by fax or mail, either on paper or on a CD-ROM. FDA will enter the registration information into its registration database in the order registrations are received; however, this is a much slower process. Registration is free. The regulation specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, certain fishing vessels, and facilities regulated exclusively by USDA.
In an effort to increase awareness of the food security regulations and the new requirements they bring, FDA has posted fact sheets, guidance documents, tutorials and brochures on its website; conducted outreach via satellite downlink meetings and videoconferences; and met with government and embassy officials, industry members and trade organizations both here and abroad to provide information and answer questions.
FDA understands that some food facilities affected by the interim rules still may need assistance understanding the requirements and how to comply, and accordingly, FDA and CBP will exercise enforcement discretion for the initial months following the effective date of the rules. The guidance for how the two agencies will exercise their enforcement discretion is contained in two compliance policy guides published in December 2003. These guidance documents, however, do not affect FDA’s or CBP’s ability to conduct inspections for food safety and security concerns or take any other action under the Federal Food, Drug, and Cosmetic Act or other applicable laws. This policy will not affect CBP’s ability to assess penalties or to take enforcement action under any other authority.
Although not yet finalized, FDA plans to issue two additional final regulations to implement other provisions in the Bioterrorism Act. The first of those final regulations will require food firms and transporters to establish and maintain records that FDA can use in a traceback investigation to identify the immediate previous sources of food and food ingredients received, as well as the immediate subsequent recipients of food released. The second regulation will specify procedures that FDA will use to detain foods that may pose a risk of serious adverse health consequences or death to humans or animals. These two additional measures will enhance FDA’s ability to safeguard American consumers. FDA published as proposed these regulations in May 2003; the final regulations are expected in March 2004.
Not all food security measures are outlined in formal regulations. Some measures can be taken voluntarily and are addressed in FDA guidance documents. In March and December 2003, FDA issued four separate food safety and security guidance documents on the kinds of measures that food establishments may take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal, or terrorist actions. The guidance documents are directed to: operators of firms that produce, process, store, repack, re-label, distribute, or transport food or food ingredients; operators of food importing establishments, storage warehouse, and filers; operators of retail food stores and food service establishments (for example, bakeries, bars, bed-and-breakfast operations, cafeterias, camps, child and adult day care providers, church kitchens); and cosmetics processors and transporters.[8-11]
After Sept. 11, 2001 FDA hired a significant number of employees to bolster its ability to monitor imports. The effects of this hiring are now being realized. In FY 2003, FDA completed more than 78,000 field examinations of imported food shipments entering U.S. ports of entry. This exceeded FDA’s goal of 48,000 field examinations and is more than six times the number of examinations FDA conducted just two years ago.
A Revitalized Applied Nutrition Program
In December 2002, FDA announced a major effort, the Consumer Health Information for Better Nutrition Initiative, a major effort to enhance the availability of high-quality health information intended to help consumers make sound dietary decisions. Not only is this initiative a top priority for FDA, but it also marks a revitalization of the CFSAN’s Applied Nutrition program.
As part of the initiative, FDA established a task force comprised of government experts on health information and nutrition from FDA, the Federal Trade Commission (FTC) and the National Institutes of Health (NIH). The task force was formed to develop a framework to help consumers obtain accurate, up-to-date, science-based information about conventional food and dietary supplements. Quickly setting to work, the task force designed and recommended a new process to provide more science-based, FDA-regulated information to consumers about the nutritional benefits of foods and dietary supplements. As detailed in their final report, this process is designed to improve information on dietary health benefits for consumers and will encourage product manufacturers to compete based on scientifically demonstrated health benefits of their products.
FDA also published a guidance document which gives manufacturers and distributors of both conventional foods and dietary supplements advice for formulating truthful and non-misleading messages about the health benefits of their products. In this document, FDA clarifies how the “reasonable consumer” standard will be used to evaluate labeling claims, because FDA believes that consumers, when given accurate health information, will be better able to make dietary choices that improve their health.
Additionally, FDA published an interim ranking system for qualified health claims, which describes a process for systematically evaluating and ranking the scientific evidence for qualified health claims. This ranking system will categorize the quality and strength of the scientific evidence for each proposed qualified health claim.
Recognizing that it was important to determine how this new initiative will impact consumers, FDA developed a consumer studies research agenda. The agenda is designed to improve FDA’s understanding of the most effective way to present scientifically based, truthful, and non-misleading information to consumers, as well as to identify the kind of information known to be misleading.
As FDA expands and enhances its efforts to help consumers get better information, the agency is committed to an enforcement program that targets misleading claims about dietary supplement-associated health benefits. Enforcement actions in FY 2003 included: issuing 73 warning letters and cyber letters to marketers of dietary supplement products; seizing almost $9 million worth of products; refusing import of 368 shipments of dietary supplement products offered for entry; and supervising the voluntary destruction of $515, 000 worth of dietary supplements that were promoted with unsubstantiated structure/function claims.
CFSAN made progress in other program areas, as well, including the completion of a risk assessment on the relationship between foodborne Listeria monocytogenes and human health. The assessment, which considered 23 ready-to-eat food categories, is a scientific analysis that outlines clear measures industry, retailers, and consumers can take to dramatically reduce the risk of this foodborne pathogen.
Minimizing risk in “high-risk” foods was another area in which FDA excelled in FY 2003. In that year, FDA conducted 7,363 domestic inspections of firms that produce “high-risk” foods. This figure exceeds FDA’s goal to annually inspect 95% of the “high-risk” domestic food establishments.
Minimizing risk in other regulated areas was also a priority for the agency. In June 2003 CFSAN’s Adverse Events Reporting System, a comprehensive system for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements became operational. This new system replaces a patchwork of older systems that CFSAN had relied on to track adverse events in the past. Used as a monitoring tool, FDA will be able to identify potential public health issues that may be associated with the use of a particular product already in the marketplace. The adverse event reports will also assist FDA in formulating policies and regulations.
FDA also focused on diminishing risks associated with poorly or improperly labeled dietary supplements. In FY 2003 CFSAN published a proposed rule addressing Good Manufacturing Practices (GMPs) for dietary supplements. By establishing GMPs, Americans will get more accurately labeled and properly manufactured dietary supplements. With new industry-wide standards proposed for the manufacturing, packing and holding of dietary supplements, the agency expects a reduction in the risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals or other impurities. The proposal would further require that manufacturers ensure that the identity, purity, quality, strength and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.
Another major accomplishment took place in July 2003 when FDA published a final rule on trans fat labeling. This marked the first change in the Nutrition Facts panel in a decade. Effective January 2006 manufacturers of most conventional foods and some dietary supplements will be required to list trans fatty acids, or trans fat, on all Nutrition Facts panels. This additional information will give consumers a more complete picture of the fat content in foods which in turn allows them to choose foods low in saturated fat, trans fat and cholesterol, all of which are associated with an increased risk of heart disease.
FDA is currently seeking information that could be used to establish new nutrient content claims about trans fat. In order to facilitate this effort, FDA issued an advance notice of proposed rulemaking to gather information and data 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. In addition, FDA wants comments on whether the agency should consider statements about trans fat as a footnote in the Nutrition Facts panel or as a disclosure statement in conjunction with claims so that consumers can understand how to use the information to make heart-healthy food choices.
Finally, FDA continued to play a leadership role in Codex Alimentarius by attending international meetings, providing a delegate for eight cross-cutting committees/task forces and participating in the development of standards and codes of practice.
CFSAN Changes and Future Goals
On Dec. 1, 2003 CFSAN Center Director, Joseph A. Levitt, Esq. announced his retirement from federal service effective Dec. 31, 2003. Mr. Levitt’s six-year tenure as Center Director was marked by continuing productivity increases, clear, innovative management and a rigorous process for setting and achieving priorities. That same day, FDA Commissioner Mark B. McClellan, M.D., Ph.D., announced Robert E. Brackett, Ph.D., as the new Center Director, effective Jan. 1, 2004.
Other changes include the progress in erecting CFSAN’s adjunct building in College Park, Maryland. This 81,000 sq. ft., three-story building, scheduled for completion in the fall of 2004, is adjacent to the Harvey W. Wiley Building and will house CFSAN employees from the Office of Food Additive Safety and the Office of Cosmetics and Colors.
By establishing program priorities each year, FDA’s Foods Program has created an easily understood metric by which to measure its achievements. The program priorities, which have been used successfully for the past five years, not only help focus CFSAN’s efforts but they also bring transparency to the goal-setting process and clarity to the CFSAN mission. Using a science-based approach with a cadre of accomplished and skilled staff, CFSAN continues to set and meet goals that will most benefit the American consumer.
Monica Revelle is a writer and editor in CFSAN’s Office of Nutritional Products, Labeling and Dietary Supplements. She has worked for FDA for 12 years, previously serving as a public affairs specialist in FDA’s Office of Public Affairs.
1. CFSAN 2003 Program Priorities Report Card, www.fda.gov/~dms/cfsann03.htm.
2. Additional information on both of FDA’s food security regulations, www.cfsan.fda.gov/~dms/fsbtact.html.
3. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, www.fda.gov/oc/bioterrorism/bioact.html.
4. For additional information on Food Safety and Terrorism, access www.cfsan.fda.gov/~dms/fsterr.html.
5. For additional information on the Compliance Policy Guides, access www.cfsan.fda.gov/~furls/cpgreg.html and www.cfsan.fda.gov/~pn/cpgpn.html.
6. The Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Proposed Rule can be accessed at www.cfsan.fda.gov/~lrd/fr03059a.html.
7. Administrative Detention of Food for Human or Animal Consumption Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Proposed Rule, www.cfsan.fda.gov/~lrd/fr03059b.html.
8. Additional information on the Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance, www.cfsan.fda.gov/~dms/secguid6.html.
9. Additional information on the Importers and Filers: Food Security Preventive Measures Guidance can be accessed at www.cfsan.fda.gov/~dms/secguid7.html.
10. Additional information on the Retail Food stores and Food Server Establishments: Food Security Preventive Measures Guidance, www.cfsan.fda.gov/~dms/secgui11.html.
11. Cosmetics Processors and Transporters Cosmetics Security Preventive Measures Guidance can be accessed at www.cfsan.fda.gov/~dms/secgui10.html
12. Consumer Health Information for Better Nutrition Initiative—Task Force Final Report, www.cfsan.fda.gov/~dms/nuttftoc.html.
13. Guidance for Industry: Qualified Health Claims in the Labeling of Conventional Foods and Dietary Supplements can be accessed at www.cfsan.fda.gov/~dms/hclmgui2.html.
14. “Interim Evidence-Based Ranking System for Scientific Data,” can be accessed at www.cfsan.fda.gov/~dms/hclmgui4.html.
15. The “Consumer Studies Research Agenda, www.cfsan.fda.gov/~dms/nuttf-d.html.
16. The Dietary Supplement Enforcement Report can accessed at www.fda.gov/oc/ whitepaper/chlon_summary.html.
17. The report, “Quantitative Assessment of the Relative Risk to Public Health from Foodborne Listeria monocytogenes among Selected Categories of Ready-to-Eat Foods,” www.foodsafety.gov/~dms/lmr1-toc.html.
18. Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements; Proposed Rule, can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html.
19. Information on trans fat can be accessed at www.fda.gov/oc/initiatives/transfat.