Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods
Published: 2008-09-09T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: Two thirds of U.S. adults are overweight, and childhood obesity and diabetes are on the rise. To reverse these health problems, experts are urging Americans to eat healthier. Food labels contain information to help consumers who want to make healthy food choices. The Food and Drug Administration (FDA) oversees federal labeling rules for 80 percent of foods. GAO was asked to examine (1) FDA's efforts to ensure that domestic and imported foods comply with labeling rules, (2) the challenges FDA faces in these efforts, and (3) the views of key stakeholders on FDA actions needed to mitigate misleading labeling. GAO analyzed FDA data, reports, and requirements on food labeling oversight and compliance and interviewed agency and key stakeholder group officials.
section_title: What GAO Found
paragraphs: FDA's oversight and enforcement efforts have not kept pace with the growing number of food firms. As a result, FDA has little assurance that companies comply with food labeling laws and regulations for, among other things, preventing false or misleading labeling. Specifically: (1) FDA does not have reliable data on the number of labels reviewed; the number of inspections, which include label reviews, has declined. For example, of the tens of thousands of foreign food firms in over 150 countries, just 96 were inspected by FDA in 11 countries in fiscal year 2007--down from 211 inspections in 26 countries in 2001. (2) FDA's testing for the accuracy of nutrition information on labels in 2000 through 2006 was limited. FDA could not provide data for 2007. (3) Although the number of food firms in FDA's jurisdiction has increased, the number of warning letters FDA issued to firms that cited food labeling violations has held fairly steady. (4) FDA does not track the complete and timely correction of labeling violations or analyze these and other labeling oversight data in routine reports to inform managers' decisions, or ensure the complete and timely posting of information on its Web site to inform the public. (5) In addition to its official recalls database, FDA's Center for Food Safety and Applied Nutrition has continued to waste resources on a second recall database that FDA had agreed to eliminate in 2004, as GAO had recommended. FDA has reported that limited resources and authorities challenge its efforts to carry out its food safety responsibilities--these challenges also impact efforts to oversee food labeling laws. FDA's Food Protection Plan cites the need for authority to, among other things, collect a reinspection user fee, accredit third-party inspectors, and require recalls when voluntary recalls are not effective. Stakeholders from health, medical, and consumer groups identified actions they believe will mitigate misleading labeling and help consumers identify healthy food. Several stakeholders support a simplified, uniform front-of-package symbol system to convey nutritional quality to consumers. The United Kingdom, Sweden, and the Netherlands have developed voluntary nutrition symbols, while the European Commission has proposed requiring front-of-package labeling of key nutrients.

section_title: Letter
paragraphs: Two thirds of U.S. adults are overweight, and the incidence of childhood  obesity and diabetes has been rising. In an effort to reverse these growing  public health problems, medical professionals are encouraging Americans  to eat healthier, more nutritious foods. In 2005, the Department of Health  and Human Services (HHS) and the U.S. Department of Agriculture (USDA)  issued Dietary Guidelines for Americans. These guidelines and the food  guide pyramid, developed by USDA to visually convey the guidelines and  other nutrition information, help policy makers design and implement  nutrition-related programs. Federal agencies must promote this guidance  in carrying out federal food, nutrition, or health programs; meals served  under the school lunch program must be consistent with the guidance. This  guidance provides science-based dietary direction for consumers to limit  their sugar, fat, and salt; eat more whole grains, fruits, and vegetables; and  monitor portion size. According to the guidance, a healthy diet reduces the  risk for chronic diseases, such as heart disease, certain cancers, diabetes,  and stroke—all major causes of death and disability in the United States.
Food labels contain information to help consumers who want to follow the  dietary guidance and to make healthy food choices that best fit their dietary  needs. Within HHS, the Food and Drug Administration (FDA) is responsible  for administering federal food labeling requirements, in accordance with  the Federal Food, Drug, and Cosmetic Act, as amended. This act prohibits  labeling that, among other things, is false or misleading or fails to list the  amounts of certain nutrients. When industry, consumer groups, or others  believe that certain types of food labeling information is false or  misleading, or that changes to requirements are needed for public health,  or for other reasons, they may request or formally petition FDA to issue  regulations or guidance to address the problem.
FDA oversees industry compliance with the food labeling requirements as  part of its food oversight mission. FDA’s Center for Food Safety and  Applied Nutrition (CFSAN)—one of its six mission centers—is responsible  for food, cosmetics, and related products. Within CFSAN, the Office of  Nutrition, Labeling, and Dietary Supplements publishes regulations and  guidance on food labeling and provides policy interpretations for  overseeing compliance with statutes and regulations that, among others  things, prohibit false or misleading labeling. FDA’s Office of Regulatory  Affairs (ORA) undertakes inspections and enforcement activities for all  FDA centers.
FDA’s guidance for inspecting domestic or foreign food firms—such as  manufacturers, processors, and other food-handling businesses—directs  investigators to focus primarily on food safety issues and to review the  labels on at least three products during every food safety inspection. To  augment its inspection capacity, FDA contracts with states to carry out  food safety inspections, following FDA guidance. When FDA inspects food  shipments entering the United States from a foreign country, it may also  review food labels. To test for the accuracy of labeling information,  investigators may send samples of domestic or imported food to FDA  laboratories for analysis. FDA also may follow up on complaints from  consumers, consumer groups, individual firms, industry groups, or others  who believe they have identified food that violates FDA’s labeling  regulations.
FDA has a number of tools for responding when food labeling violations  are identified. It may ask companies to voluntarily recall any food that has  already entered the distribution chain. FDA may also send a warning letter  to a firm, which is a notice that enforcement actions may be forthcoming if  corrections are not made; according to FDA guidance, warning letters are  used for serious violations. For less serious violations, FDA may send an  untitled letter, which is an informal communication that corrective actions  are needed. At any point, FDA may hold a regulatory meeting with the firm  to resolve a labeling violation or work with a firm to obtain voluntary  compliance. When violations are not corrected, FDA may initiate actions to  seize and remove the food from the marketplace (a seizure) or enjoin a firm  from continuing a practice that violates food labeling statutes and  regulations (an injunction). For food imported from a foreign country, FDA  may issue an import refusal to prevent a shipment with a serious labeling  violation from entering the United States. FDA may also release a shipment  “with comment”—that is, allow the shipment with a labeling violation to  enter the United States with notice to the importer that subsequent  shipments might be refused entry if the violation is not corrected. In  addition, FDA maintains an “import alert” list to detain entries of foreign  foods that appear to have significant recurring or unusual violations.
In January 2007, we added federal oversight of food safety to our   High-Risk Series, which is intended to raise the priority and visibility of  government programs that are in need of broad-based transformation to  achieve greater economy, efficiency, effectiveness, accountability, and  sustainability. In particular, we have noted that federal expenditures by  FDA and USDA for food oversight have not been commensurate with the  volume of foods regulated by the agencies or consumed by the public. In  November 2007, a report for FDA’s Science Board—FDA Science and  Mission at Risk—pointed out the erosion in FDA’s science base and the  inadequacy of FDA’s information technology infrastructure. The report  cited numerous management challenges that have contributed to FDA’s  inability to fulfill its mission and that cannot be addressed with available  resources. Also in November 2007, FDA issued its Food Protection Plan:  An Integrated Strategy for Protecting the Nation's Food Supply (Food  Protection Plan), which recognized the need for several changes to ensure  the safety of the nation’s food supply and identified new authorities needed  to implement the new strategy, such as the authority to charge user fees for  certain reinspections. In a May 2008 letter (the May 2008 resource needs  assessment), FDA’s Commissioner identified the resources needed in broad  categories to, among other things, begin implementing the Food Protection  Plan to protect against new and emerging threats to food safety. We have  testified that FDA’s plan is a good first step, but pointed out that it does not  provide a clear description of resources and strategies that Congress will  need to assess the likelihood of the plan’s success. Also, with respect to  making the most of resources, in May 2008 we issued a special publication  entitled Federal User Fees: A Design Guide, which presented various ways  to design user fees to encourage greater efficiency, equity, and revenue  adequacy and to reduce the administrative burden on the agency and  payers of the fees.
You asked us to examine (1) FDA’s efforts to ensure that domestic and  imported foods comply with food labeling requirements, including those  prohibiting false or misleading labeling; (2) the challenges FDA faces in its  efforts to administer and enforce food labeling requirements; and (3) the  actions stakeholders from health, medical, and consumer organizations  believe are needed to mitigate the effects of food labeling practices they  consider misleading and to help consumers identify healthy food.
For this report, our definition of “food” includes conventional food, dietary  supplements, infant formula, and medical food; we excluded animal feed,  which the Federal Food, Drug, and Cosmetic Act includes in its definition  of food. We did not independently determine whether particular food labels  were false or misleading; the examples we cite are food labels that FDA or  a health, medical, industry, or consumer group characterized as false or  misleading. We also did not evaluate how efficiently FDA used its resources  or the impact of changing priorities; nor did we compare FDA resource  trends with other federal agencies. To examine FDA’s efforts to ensure that  domestic and imported foods comply with food labeling statutes and  regulations, we analyzed FDA’s and CFSAN’s plans and reports; guidance  and regulations; and data on labeling-related oversight, enforcement,  recalls, warning letters, and complaints. Regarding data for labeling-related  oversight, we analyzed the food establishments or facilities (which we call  firms) inspected for 7 fiscal years (2001 through 2007); nutrition labeling  samples for 7 fiscal years (2000 through 2006); warning letters and  enforcement actions related to imports for 6 fiscal years (2002 through  2007); and seizures and injunctions for 10 fiscal years (1998 through  2007)—the periods for which reliable and comparable FDA data were  available. To identify challenges, we reviewed FDA reports and testimonies  and analyzed funding and staffing data for FDA, CFSAN, and ORA for   10 fiscal years (1998 through 2007) and the Office of Nutrition, Labeling,  and Dietary Supplements, which began maintaining comparable data in  1999, for 9 fiscal years (1999 through 2007). We also reviewed FDA  oversight and enforcement authorities and court rulings regarding FDA  labeling. For comparison, we examined similar information for USDA’s  Food Safety and Inspection Service (FSIS) and the Federal Trade  Commission (FTC), which also oversee and enforce requirements related  to food labeling. For stakeholder positions, we analyzed the views of  health, medical, consumer, and industry groups obtained from interviews  and documents, such as reports and petitions. We assessed the reliability of  the data used in this report and found it to be sufficiently reliable for the  purposes used. We conducted this performance audit from January 2007  through September 2008 in accordance with generally accepted  government auditing standards. Those standards require that we plan and  perform the audit to obtain sufficient, appropriate evidence to provide a  reasonable basis for our findings and conclusions based on our audit  objectives. We believe that the evidence obtained provides a reasonable  basis for our findings and conclusions based on our audit objectives.  Appendix I contains more detailed information on our objectives, scope,  and methodology.
subsections: section_title: Background
paragraphs: The Federal Food, Drug, and Cosmetic Act, as amended, prohibits the  “misbranding” of food, which includes, among other things, labeling that is  false or misleading. In 1990, Congress amended the act to mandate that  certain nutrition information be provided on packaged foods in a specified,  standardized format—only recently have other countries, such as Canada,  initiated mandatory nutrition labeling. The act, and FDA regulations  implementing it, require food labels to include nutrient, ingredient, and  other important content information that consumers can use to make  healthy dietary choices, and to avoid allergens (such as peanuts) and other  ingredients (such as sulfites) that can cause life-threatening reactions in  people who are sensitive to them. For example, the act and FDA’s  regulations, with some exceptions, require that food labels include the  following:  a Nutrition Facts panel that identifies the serving size; the number of  servings per container; the number of calories per serving; and the  amount of certain nutrients, such as fiber, vitamins, fat, and sodium;   an ingredients list that identifies the product’s ingredients by their  common or usual names, in order of predominance by weight;   the required information in English; and  a declaration of the source (e.g., tree nuts) of major allergens.
Figure 1 depicts an example of a Nutrition Facts panel from FDA’s  regulations illustrating nutrition information and visual display.
The act and FDA regulations also require that health claims—that is, claims  characterizing the relationship of certain nutrients to a disease or a health- related condition—on food labels be authorized by FDA. For example, a  main dish that contains 140 milligrams (mg) or less of sodium per 100  grams may be labeled with the claim that “diets low in sodium may reduce  the risk of high blood pressure, a disease associated with many factors,”  provided there are no nutrients in the food at levels that would disqualify it  from making this claim. In regulations, FDA has authorized the use of  claims for 12 relationships between a nutrient and a disease or health- related condition.
For purposes of compliance, with certain exceptions, a food is subject to  enforcement action under FDA regulations if the number of calories or the  amount of certain nutrients, such as fat and sugar, is more than 20 percent  over the amount declared in the Nutrition Facts panel. The Institute of  Medicine established the reference nutrient values that FDA used (along  with the Dietary Guidelines for Americans) to establish the daily values for  nutrients on the Nutrition Facts panel. In addition, for compliance and  enforcement purposes, the amount of certain nutrients naturally occurring  in the food must be at least equal to 80 percent of the value declared on the  label; the amount of added nutrients in fortified or fabricated foods must be  at least equal to the amount shown on the panel. According to FDA, these  variations are allowed because, for naturally occurring nutrients, values  cannot be precisely controlled and depend on weather and soil conditions,  among other variables; in addition, values will vary because different  laboratories use different methods and testing devices.
FDA’s procedures for handling a product complaint require staff to obtain  sufficient information from the complainant to evaluate the complaint and  determine if it requires follow-up. Also, the complaint is to be documented  in the Field Accomplishments and Compliance Tracking System (FACTS).  For a food-labeling-related complaint, the information documented in  FACTS should include, among other things, any injury, illness, or adverse  event that was reported as having occurred as a result of incorrect labeling,  and any follow-up actions. Complaints of significant illness or injury must  receive immediate and thorough follow-up, while follow-up on those  complaints that do not involve injury or illness may be deferred until the  next scheduled inspection of the responsible firm, which may be in a few  weeks, months, or several years.
Similarly, FTC authorities prohibit unfair or deceptive acts or practices in  or affecting commerce, including false or misleading advertising of food  products. In some cases, FDA and FTC have certain overlapping  jurisdiction for regulating food advertising, labeling, and promotion. In a  1971 memorandum of understanding, the agencies agreed that FTC would  exercise primary responsibility for ensuring that food advertising is truthful  and not misleading, and that FDA would have primary responsibility for  ensuring that food labeling is truthful and not misleading.
section_title: FDA Has Limited Assurance That Companies Are Complying with Food Labeling Requirements
paragraphs: FDA’s use of oversight and enforcement tools has not kept pace with the  growing number of food firms. As a result, FDA has limited assurance that  companies in the food industry are in compliance with food labeling  requirements, such as those prohibiting false or misleading labeling. FDA’s  testing of nutrition information has been limited and has found varying  degrees of compliance. Actions in response to labeling violations, such as  issuing warning letters, have generally decreased or remained steady. In  addition, FDA has not analyzed data on labeling violations and follow-up  activities to inform its managers or the public. Furthermore, CFSAN has  continued to maintain a duplicate food recall system that FDA had agreed  to eliminate in response to a recommendation we made in a 2004 report.
subsections: section_title: Food Labeling Oversight Has Not Kept Pace with the Growing Number of Firms
paragraphs: While the number of domestic food firms has increased, FDA has not  increased the number of its inspections in response to this increase (see  fig. 2). Also, FDA does not have reliable data on the total number of labels  reviewed because investigators do not have to enter this information into  the FACTS database, which documents other inspection details. In the  absence of reliable data on the number of labels reviewed, and assuming  that investigators were reviewing three labels each time, as FDA officials  told us was the common practice, the number of labels reviewed would  have declined with the decline in the number of inspections.
FDA has conducted few inspections in foreign food firms and that number  has declined significantly—from 211 in 26 countries in 2001 to 95 in 11  countries in 2007—even as the United States has received hundreds of  thousands of different imported food product entry lines from tens of  thousands of foreign food firms in more than 150 countries. (See app. II for  information on the number of domestic and foreign food firms inspected  under FDA’s jurisdiction during fiscal years 2001 through 2007.) Table 1  shows the number of countries and foreign food firms inspected over this  period.
Appendix III lists the countries and the number of inspections FDA  conducted in each country, from fiscal years 2001 through 2007.
In addition, FDA reported inspecting about 1 percent of the different food  product entry lines that came into the United States annually during fiscal  years 2002 through 2007. However, unlike investigators who perform  inspections at manufacturing firms, the investigators who review labels on  imported foods are not able to see the manufacturing process, the  ingredients stored on shelves, the product formulation, and other  documents that provide key information that helps to identify labeling  violations.
section_title: Testing to Determine the Accuracy of Nutrient Information Is Limited and Outdated, and Shows Varying Degrees of Compliance
paragraphs: While FDA has tested some targeted nonrandom samples of food products  to determine the accuracy of nutrition information on their labels, it has  tested relatively few food products from some major exporting countries.  In addition, FDA has done no random sampling since the 1990s, when some  compliance rates varied considerably from the amount identified on the  Nutrition Facts panel. From fiscal years 2000 through 2006, FDA collected  targeted samples of 868 domestic products and 783 imported products for  tests of compliance with nutrition labeling regulations. FDA was unable to  provide information on samples taken and test results for fiscal year 2007  because, according to an agency official, the person who analyzed those  data had retired from FDA.
According to FDA officials, investigators often selected samples because  they noticed obvious labeling violations, such as a candy bar with a  Nutrition Facts panel that did not identify any fat or sugar. As table 2  shows, about 21 percent and 28 percent, respectively, of the domestic and  imported foods tested were in violation.
The number of samples of imported food FDA has tested for accuracy of  nutrition labeling does not relate to the volume of imports or the rate of  violations in products from a given country, as table 3 shows. One type of  food with a high percentage of violations was infant formula—4 of the 10  formula products sampled were in violation—because they lacked the  vitamins, minerals, or other nutrients required by law.
While FDA has conducted targeted, nonrandom sampling of labels on  imported and domestic food products suspected of having inaccurate  information (beyond the allowable ranges) for nutrients listed on their  labels, FDA has not conducted random sampling on nutrition labeling since  the 1990s. In 1994 and again in 1996, FDA tested 300 randomly selected  products to determine the extent to which nutrient information on the  Nutrition Facts panel was within the allowable range. According to FDA’s  analysis of these products, 87 percent (in 1994) and 91 percent (in 1996) of  the nutrients were within the allowable range. However, compliance rates  varied significantly for a few nutrients. For example, in 1994 and 1996,  respectively, 48 percent and 47 percent of the samples were not within the  allowable range for vitamin A; 48 percent and 12 percent of the samples  were not within the allowable range for vitamin C; and 32 percent and 31  percent of the samples were not within the allowable range for iron.  These variances are important because consuming too much or too little of  certain vitamins and iron may have adverse health consequences. FDA  officials cited resource constraints and other priorities as reasons for not  updating these studies and told us that FDA has no plans for future studies.
section_title: Actions in Response to Labeling Violations Have Generally Decreased or Remained Steady
paragraphs: FDA has available several tools to ensure that food labeling complies with  requirements: (1) issuing warning and untitled letters and holding  regulatory meetings and (2) taking enforcement actions—seizures,  injunctions, import refusals, and import alerts. However, we found that  FDA’s efforts have generally declined or held steady.
subsections: section_title: FDA Warning Letters for Food Labeling Violations Have Remained Steady
paragraphs: From fiscal years 2002 through 2007, FDA issued 463 warning letters to  firms with serious violations that included food labeling violations—often  with other food-safety-related violations—notifying them that enforcement  actions might be forthcoming if corrections were not made. The number of  warning letters issued annually that included food-labeling-related  violations held relatively steady during the period. On the other hand, the  number of letters issued for all FDA-regulated products (e.g., food, drugs,  and medical devices) decreased by nearly half—from 806 letters in fiscal  year 2002 to 434 in fiscal year 2007. However, as we conducted our study,  FDA continued to find additional warning letters that had been issued for  fiscal years 2002 through 2007. In addition, according to FDA, its Fiscal  Year 2007 Enforcement Story reported 471 warning letters for 2007. Thus,  the number of food-labeling-related warning letters, as well as total FDA  warning letters, may be higher than we report. Figure 3 shows the number  of warning letters issued annually for fiscal years 2002 through 2007.
The labeling-related warning letters addressed violations for different  product types—including candy, baked goods, seafood, and juice drinks— that were identified through inspections or testing product samples. About  52 percent (241 of 463) of the letters were for dietary supplements. Of the  463 food-labeling-related warning letters, 326 cited specific violations of  the misbranding provision of the Federal Food, Drug, and Cosmetic Act;  the other 137 letters cited other statutory provisions and regulations. As  shown in table 4, the 326 letters that cited the misbranding provision  included references to 677 violations in 15 different categories.
FDA officials explained that they try to focus their oversight efforts on the  labeling violations of public health significance and on the types of  products with widespread or persistent violations. For example, on  October 17, 2005, FDA issued 29 warning letters to manufacturers of cherry  juice and other fruit products for unapproved claims related to diseases,  and 25 letters on October 12, 2006, to makers of dietary supplement  products that had drug claims or unauthorized health claims.
FDA officials told us that warning letters are an important and very public  tool for ensuring compliance with FDA regulations and alerting other  companies of practices that are not acceptable. Furthermore, FDA, in  accordance with Freedom of Information Act requirements, makes these  letters available on its public Web site. However, we found several  problems with FDA’s public dissemination of warning letters that call into  question the accuracy of its numbers. For example, we tested the reliability  of this database and found that it was missing over 220 warning letters.  When we brought the missing letters to their attention, FDA officials told  us they posted them. Although FDA officials assured us that the database  was complete and accurate, in February 2008 and later, we found duplicate  letters in the database as well as additional letters that had been issued  during fiscal years 2006 and 2007. Therefore, the number of warning letters  posted on FDA’s Web site for fiscal years 2002 through 2007 may be  different from the number shown in figure 3. In April 2008, FDA officials  told us they were continuing to work on the database and to discuss  potential process improvements to help ensure that all letters are posted.
In fiscal year 2001, FDA had issued nearly twice as many warning letters for  all violations than in 2002. FDA officials attributed the decrease in warning  letters, in part, to new policies that transferred the approval of warning  letters from FDA centers and districts to the Office of Chief Counsel. FDA  officials told us that the target turnaround time for issuing a warning  letter—the elapsed time between the day officials identify the violation,  either through an inspection, laboratory test, or illness outbreak  investigation, and the day FDA issues a warning letter—is about 4 months.  This is a nearly fourfold increase over the 30-workday target time we  reported in February 2005. A longer lag time to issue a warning letter  increases the number of days for which consumers may consume the  misbranded food before FDA posts these serious problems on its Web site.
In addition, FDA estimated that it has sent one third as many untitled  letters—correspondence citing violations that FDA deems as not  warranting a warning letter—as warning letters. We did not assess untitled  letters because FDA did not centrally track the letters in a database, nor did  it maintain copies centrally until fiscal year 2008. Regarding regulatory  meetings, FDA could not tell us how many were held because these  meetings are handled exclusively by the district offices and are not  centrally tracked. FDA does not receive any information on the extent to  which districts are using these meetings and whether the different field  offices are using the same criteria for these meetings.
section_title: More Serious Enforcement Actions on Labeling Are Generally Limited
paragraphs: FDA has taken few enforcement actions—seizures, injunctions, and import  refusals—for food labeling violations and issued a number of labeling- related import alerts. FDA was able to provide us with data on seizures and  injunctions for 10 years and on import refusals and import alerts for 6  years.
Seizures: In fiscal years 1998 through 2007, FDA had initiated actions that  resulted in court seizures of 21 products in domestic commerce for food- labeling-related violations. Of the 21 seizures, most were of imported  products. Olive oil, dietary supplements, and mushrooms were the most  frequently seized products.
Injunctions: According to FDA documents, the courts enjoined two  companies in response to possible labeling violations for fiscal years 1998  through 2007. On February 3, 2006, FDA obtained a consent decree of  permanent injunction against Natural Ovens Bakery, Inc., for allegedly  introducing misbranded foods, including dietary supplements, and  misbranded and unapproved drugs into interstate commerce and for  causing foods to become misbranded. According to FDA documents, the  injunction was obtained after a 20-year history of noncompliance with FDA  regulations, and 3 years after an April 8, 2003, warning letter that FDA's  Minneapolis District Office had issued in response to inspections  conducted in December 2002, February 2002, and September 2001. The  other was a consent decree of permanent injunction, entered in September  2003 against a dietary supplement manufacturer—Hi-Tech  Pharmaceuticals, Inc.—for allegedly labeling dietary supplements with  drug claims, which violated food labeling requirements and caused FDA to  have to regulate the supplements as drugs and, specifically, as unapproved  new drugs. FDA considered this injunction to be food-labeling-related.
Import refusals: FDA refused entry to 15,226 imported food product entry  lines that had labeling violations from fiscal years 2002 through 2007. In  fiscal year 2002, while FDA examined the fewest labels, it refused entry to  the highest percentage of foods; conversely, in fiscal year 2005, FDA  examined the greatest number of labels, and refused entry to the lowest  percentage of foods over the 6-year period. In addition, over this period,  14,851 products that had labeling violations were released “with  comments”—meaning that FDA allowed the shipment with a labeling  violation to enter the United States with notice to the importer that  subsequent shipments could be refused entry if the violation was not  corrected. Releases with comment are intended to cover deficiencies FDA  regards as minor, nonhealth-significant. If FDA finds additional imports of  one of these products with the same violation 60 or more days after the  earlier shipment is released with comments, FDA may consider detention,  according to FDA officials. (See table 5.)
For import refusals, the most frequent labeling violations cited were the  lack of required nutrition information (25 percent); the failure to list the  common or usual name of each ingredient (18 percent); the failure to  accurately state the product’s weight, measure, or numerical count (13  percent); and the failure to provide the label in English (12 percent). (See  table 6.)
Of the nine countries with the greatest value of agricultural, fish, and  seafood imports to the United States in fiscal year 2006, Canada was the  largest—with a total value of $15.6 billion; Mexico was second with $9.8  billion, followed by China with $4.2 billion. As shown in table 7, during  fiscal years 2002 through 2007, Canada also had the most food labels  reviewed (45,377) and lowest rate of import refusals (2.6 percent) where a  labeling violation was cited, while Australia had the fewest label reviews  (697) and the highest rate of import refusals (14.3 percent) where a labeling  violation was cited.
Import alerts: As of January 28, 2008, FDA gave us information on active  import alerts for 64 food products that officials characterized as labeling  violations. For example, FDA issued import alerts for several different  types of biscuits imported from India that did not use the common or usual  name for ingredients. Once a product is on the import alert list, FDA does  not remove it until the firm appears to have corrected the violation,  according to FDA officials. Twenty of the 64 products on import alert were  added during fiscal year 2007, and 1 of the remaining 44 had been in effect  since April 2000. In technical comments on a draft of this report, FDA  indicated that 64 alerts seemed too low and that it may not have provided  us with all import alerts for labeling violations. However, FDA did not  provide additional information or documentation on those alerts.
section_title: FDA Has Collected but Not Analyzed Data on Labeling Violations and Follow-up Actions
paragraphs: FDA does not centrally track or analyze data on potentially serious  labeling violations or firms’ actions to correct those violations. We  repeatedly requested any routine reports on labeling compliance that FDA  managers used to help them carry out their program oversight  responsibilities. However, according to officials, they do not generate such  routine reports due, in part, to resource limitations and to limitations in  FDA information systems. For example, over the past decade, FDA has  never analyzed the results of the laboratory tests on the accuracy of  labeling information (e.g., the Nutrition Facts panel and declared allergens)  on domestic and imported foods. An official said they had always wanted  to develop computer programs that would identify trends, but did not have  the staff to do so. Also, FDA does not routinely analyze and report on  trends in labeling violations. As a result, FDA managers do not have  important information to inform their decision making on setting priorities  for overseeing compliance with labeling requirements and allocating  resources for labeling program activities.
Furthermore, FDA does not provide consumers and others with important  information on its public Web site to help inform their food purchasing  decisions. As we have previously noted, FDA’s Web site’s posting of  warning letters has not been kept current and complete. In addition,  although FDA maintains import refusals and warning letters, its Web site  does not provide the public with summary information on, and trends in,  serious labeling violations by, for example, product type, company, and  country.
In addition, from fiscal years 2001 through 2007, FDA documented  approximately 2,600 complaints from consumers on food labeling issues in  FACTS—its compliance tracking system. These data included complaints  that ingredients—such as allergens—in the food were not listed on the  label and may harm consumers’ health. However, the data concerning  complaints were not entered into FACTS in a way that would facilitate  analysis. Specifically, standard terminology was not used and information  on complaint resolutions was captured in different data fields. As a result,  FDA program managers cannot readily use these FACTS data to track the  timely and appropriate resolution of consumer labeling complaints.
section_title: CFSAN Continues to Maintain Duplicate Recall Database
paragraphs: According to our analysis of FDA’s Recall Enterprise System (RES)  database, 409 of the 1,295 food product recalls that firms carried out during  fiscal years 2003 through 2007 listed food labeling violations, such as failing  to list added chemical preservatives on labels, as a factor. While food  labeling was listed as a reason in each of the 409 recalls, it was not  necessarily the only reason nor was it necessarily the most serious  violation. In addition, almost 57 percent of the labeling-related recalls were  for violations that FDA classifies as high risk—that is, posing a reasonable  probability of causing serious adverse health consequences or death—such  as labels that fail to identify certain allergens in the food, such as tree nuts,  that are potentially deadly to individuals who are sensitive to them.
However, CFSAN maintains an unofficial database of food recalls and  reported that it was able to identify more labeling-related recalls than we  did in using the official RES. In the course of our work, we learned that  CFSAN has continued to maintain this unofficial database for food recalls  apart from the official RES. In October 2004, we first reported CFSAN’s use  of this duplicative recall database and the discrepancies between the  unofficial data and the official data. At the time, CFSAN program staff told  us they used the unofficial database to generate reports for Congress  because it contained the most accurate data. We pointed out that keeping  the second database raised significant questions about the validity and  reliability of the official system. We also pointed out FDA’s substantial  investment in the RES and the duplication of resources spent maintaining  two separate data systems. Although FDA agreed with our  recommendation to eliminate the duplicative recall database, it has  continued using resources to maintain the second system—resources that  could be used on other CFSAN work.
When FDA provided the RES data electronically for our independent  analysis, officials told us it was the official source for CFSAN recalls,  including the food-labeling-related recalls. We developed criteria for  selecting labeling-related recalls on the basis of various labeling terms and  sections on food labeling in the Federal Food, Drug, and Cosmetic Act.
FDA agreed that our criteria for identifying labeling-related recalls were  valid. In December 2007, FDA provided final fiscal year 2007 data to  complete our analysis. Subsequently, in April 2008, as part of our quality  assurance procedures, we provided FDA with our list of labeling-related  recalls to review for completeness. CFSAN officials informed us in May  2008 that by using their unofficial database, they identified about 250 food- labeling-related recalls that were not in our list. Of the 250, 171 were in the  official system data but were not captured by the criteria we used.  Regarding the remaining 79 recalls, we were unable to locate them in the  RES data provided to us. In technical comments on a draft of this report,  FDA noted that the 79 recalls had coding differences. However, FDA did  not provide us with the codes that corresponded to the RES data. We had  originally thought that these 79 recalls were missing from the official  database and, therefore, were not posted on the FDA public Web site— thus, we drafted a recommendation that FDA post all recalls in a timely  manner. However, after FDA commented that the differences could be due  to coding, we deleted this recommendation. It appears that the 409  labeling-related recalls we identified may be a minimum number and, thus,  may understate the number of recalls with labeling violations. Because we  did not receive the unofficial database, we did not independently analyze it  or assess its validity and reliability.
section_title: FDA Reports That Resource Constraints and Limited Authority Challenge Efforts to Carry Out Food- Related Responsibilities, Including Food Labeling
paragraphs: FDA’s Science Board Advisory Committee report, the Commissioner’s May  2008 resource needs assessment, and the Food Protection Plan cite  challenges to FDA’s efforts to carry out food safety and other food-related  responsibilities, in part, because its resources have not kept pace with its  increasing responsibilities—challenges that directly impact its oversight of  labeling requirements. In addition, FDA does not have certain authorities  that it reports would allow it to better leverage resources and carry out its  food-related missions. These authorities could help FDA administer and  enforce the food labeling requirements.
subsections: section_title: FDA Asserts That Resources Have Not Kept Pace with Growing Responsibilities
paragraphs: According to the Science Board report, the demands on FDA have soared,  but resources have not increased in proportion to demand. In the May 2008  resource needs assessment, FDA’s Commissioner identified the immediate  need for additional resources—for improvements in FDA’s science,  information technology, and program capabilities—to ensure the safety of  FDA-regulated imports and protect the food supply. Likewise, the Food  Protection Plan asserts FDA’s ever-expanding responsibilities—such as  safeguarding the evolving food demands of consumers; overseeing the  increasing volume, variety, and sources of imported food; and staying  ahead of the emerging threats to food safety and security—and all of the  skills, technologies, and initiatives that it is planning to meet these new  challenges. However, as we have testified, it is unclear what the total costs  will be to fully implement the plan; thus, we continue to have concerns  about FDA’s lack of specificity on the resource needs.
Although FDA received increased funding for new bioterrorism-related  responsibilities following September 11, 2001, staffing levels for CFSAN  have declined since then and funding (in constant dollars) has stagnated.  Between fiscal years 2003 and 2007, the number of FTE employees in  CFSAN headquarters dropped about 20 percent, from 950 to 763, and  inspection and enforcement staff decreased by about 19 percent, from  2,217 to 1,806 (see app. IV). While funding in nominal dollars increased  from $406.8 million in 2003 to $457.1 million in 2007, when adjusted for  inflation, funding in the 2 years is nearly the same—$465.7 million and  $465.8 million, respectively—in constant 2008 dollars. At the same time, as  we have previously noted, the number of FDA-regulated domestic food  firms increased more than 10 percent—from about 58,270 in 2003 to about  65,520 in 2007. Also, the number of different imported food product entry  lines has tripled in the past 10 years, and imports account for 15 percent of  the food supply. Appendix IV provides detailed information on FDA  funding and FTEs for each center.
For fiscal years 1999 through 2007, the FTE staff years for the Office of  Nutrition, Labeling, and Dietary Supplements reached its highest level in  2002 (88) and its lowest in 2007 (65), according to data provided by FDA  finance and other officials. Within the office, funding and staffing for food  labeling activities, as estimated by an FDA finance official, have remained  fairly steady since fiscal year 2005, the first year for which FDA staff were  able to separate resources for labeling-related activities from other Office  of Nutrition, Labeling, and Dietary Supplements work (see table 8).
FDA’s Science Board reported on the growing disparity between FDA  resources and responsibilities. Noting that the demands on FDA have  soared, while resources have not increased proportionately, the committee  concluded that the disparity has made it increasingly “impossible” for FDA  to maintain its historic public health mission. In the May 2008 resource  needs assessment, the FDA Commissioner identified the immediate need  for additional staff to enable the agency to affect its food-safety-related  goals. This would benefit administering and enforcing food labeling  requirements. In addition, according to FDA officials, the agency generally  does not address misleading food labeling because it lacks the resources to  conduct the substantive, empirical research on consumer perceptions that  it believes it would need to legally demonstrate that a label is misleading, as  the agency believes is required by court rulings, such as Pearson v. Shalala,  which is discussed in appendix V.
section_title: FDA Has Reported That Certain Authorities It Lacks for Food Programs, Including Labeling, Would Help It Leverage Resources and Carry Out Regulatory Responsibilities
paragraphs: The Food Protection Plan identified a number of legislative changes—new  authorities FDA recognized were needed, including, among others, the  authority to charge user fees for certain reinspections, accredit third-party  inspectors for certain reviews, and mandate recalls when voluntary recalls  are not effective. FDA has these authorities for certain other products it  regulates but not for food labeling activities or most food oversight efforts.  In addition, FDA has never used its detention authority under the  Bioterrorism Act of 2002 to detain potentially dangerous food because,  according to the agency, its other authorities and regulatory tools have  been adequate to date to protect public health.
Several FDA centers have the authority to collect user fees for particular  activities. For example, FDA’s Center for Devices and Radiological Health  has the authority to collect and retain user fees from firms for reviewing  and approving premarket applications for medical devices. The center uses  the fees to offset the costs of reviewing and approving these applications  and to increase staffing levels. In its Fiscal Year 2009 Justification of  Estimates for Appropriations Committees for FDA, HHS proposed a  reinspection user fee on food industry firms that fail to meet important  manufacturing and food safety requirements. This fee would cover the full  cost of reinspections and the associated follow-up work. We have  presented various ways to design user fees to encourage greater efficiency,  equity, and revenue adequacy and to reduce the administrative burden on  the agency and payers of the fees. For example, the extent to which a  program is funded by user fees should generally be guided by who  primarily benefits from the program. If a program primarily benefits the  general public (e.g., national defense), it should be supported by general  revenue, not user fees; if it primarily benefits identifiable users, such as  customers of the U.S. Postal Service, it should be funded by fees; and if a  program benefits both the general public and users, it should be funded in  part by fees and in part by general revenues. The guide may provide useful  direction to FDA as it proceeds with its proposed reinspection user fee.  (Funding data presented in app. IV also show user fees collected by some  FDA centers.)
Regarding the authority to accredit qualified third-party inspectors, which  the Food Protection Plan states will allow FDA to allocate inspection  resources more effectively, FDA plans to use these highly qualified parties  to, among other things, carry out certain voluntary reviews in foreign food  facilities, where few inspections and label reviews are currently done. As  we testified in May 2008, FDA’s Center for Devices and Radiological Health  has accredited third-party organizations to conduct voluntary inspections  of foreign firms that manufacture medical devices, and these third parties  completed six inspections in 4 years. We noted that an incentive for firms  to participate included the opportunity to reduce the number of inspections  conducted to meet FDA’s and other countries’ requirements. Disincentives  include bearing the cost of the inspections and the potential consequences  that could include regulatory action. We further noted that the small  number of inspections raised questions about the practicality and  effectiveness of using accredited third-party inspectors to quickly help FDA  increase the number of foreign firms inspected.
The Food Protection Plan does not describe how FDA expects to design  and implement the proposed accredited third-party inspection program to  inspect foreign food firms or how this proposal will help it leverage  resources. In contrast, USDA uses third-party Agricultural Commodity  Meat Graders—contracted for their expertise—to carry out certain reviews  in its livestock and meat grading and certification programs.
FDA’s Food Protection Plan also asserts that the agency needs mandatory  recall authority for food. It has this authority for infant formula and  medical devices that present a health hazard. Other agencies, such as the  National Highway Traffic Safety Administration and the Consumer Product  Safety Commission, use their recall authority to help protect consumers  from products that can cause serious injuries, such as unsafe infant car  seats. We have previously proposed that Congress consider giving FDA  mandatory food recall authority.
The Bioterrorism Act of 2002 gave FDA the authority to administratively  detain any article of food found during an examination, inspection, or  investigation, if it has credible evidence or information indicating that the  article of food presents a threat of serious adverse health consequences or  death, for labeling and other violations. However, FDA has never used this  authority.
According to the agency, its other authorities and regulatory tools, such as  its authority to refuse entry of imports under section 801 of the act, have  been adequate to date to protect public health. In contrast, USDA has  detention authority for meat and poultry products in interstate commerce  that its FSIS uses to prevent shipments under its jurisdiction from entering  U.S. commerce, if the agency has reason to believe that the food is  adulterated or misbranded. USDA reported that, from July through  September 2006, its import investigators detained 15 shipments—about  9,500 pounds—of imported meat products.
FDA officials acknowledged that implementing the Food Protection Plan  will require additional resources, and that FDA will need to partner with  Congress to obtain the additional statutory authorities to transform the  safety of the nation’s food supply. However, as we testified in May 2008,  FDA’s congressional outreach strategy is general. When we asked FDA  officials if they had a congressional outreach strategy, officials said that  they had met with various committees to discuss the Food Protection Plan.  When we asked if they had provided draft language to congressional  committees on the various authorities, FDA officials explained that they  had only provided technical assistance, such as commenting on draft bills,  to congressional staff when asked.
section_title: Key Stakeholders Suggested Actions to Help Mitigate Misleading Labeling and Assist Consumers’ Efforts to Identify Healthy Food
paragraphs: Key stakeholders—officials from health, medical, and consumer  organizations in the United States and Europe—advocate a uniform front- of-package symbol to help consumers select healthy food and avoid  misleading or confusing labeling. Some U.S. trading partners have  implemented voluntary front-of-package nutrition symbols and several U.S.  manufacturers and groceries are using front-of-package symbols. In  addition, many stakeholders identified or petitioned FDA for other actions  that they believe FDA should pursue to avoid misleading labeling and help  consumers identify nutritious foods. Some stakeholders noted that taking  such actions may require FDA to redirect resources.
subsections: section_title: Other Countries and Several Key Stakeholders Favor Uniform Front-of-Package Nutrition Symbols
paragraphs: Consumers have reported understanding certain labeling terms, such as  “sugar” and “vitamins,” and finding benchmarks (such as daily reference  values) helpful in comparing products, but they generally found nutrition  labeling confusing, especially certain technical and numerical information,  according to a recent synthesis of nutrition studies. For example,  consumers had difficulty in understanding the role that nutrients played in  their diet, and the relationship between sugar and carbohydrates as well as  the terms “cholesterol” and “fatty acids.” While a few studies suggest that  many consumers look at Nutrition Facts panels when they buy food for the  first time, some studies suggest that consumers may simply look at the  information but not process it further. The National Academies’ Institute of  Medicine, which is often called on to advise federal agencies on health  issues, reported in 2006 that there is little evidence that the information on  food labels has a significant impact overall on eating or food purchasing.  The institute had previously recommended that FDA and others increase  research on the nutrition label and pointed out that manufacturers’ use of  nutrition symbols underscores the need to improve strategies for using the  food label as an educational tool. In addition, in a November 2007 letter to  FDA, the American Medical Association (AMA) stated that there is  evidence that consumers have difficulty in making appropriate judgments  about which foods are the healthiest.
Several major health and consumer organizations in the United States, as  well as in Canada and Europe, advocate mandatory, uniform front-of- package nutrition rating systems to help consumers select healthy foods. In  the United States, the AMA and the American Heart Association advocate  such a system, and the Institute of Medicine’s 2006 report recommended  that food and beverage companies work with government, scientific, public  health, and consumer groups to develop and implement an industrywide  system. Furthermore, to help consumers choose more nutritious foods, the  scientists with expertise in nutrition and public health who developed the  2005 Dietary Guidelines for Americans expressed concern that  consumers did not have a scientifically valid system to show nutrient  density on food labels, and recommended that HHS and USDA develop this  system. In addition, the Center for Science in the Public Interest petitioned  FDA in 2006 to develop a simple, uniform, science-based rating system that  could be graphically represented on the front of food packages to give  consumers consistent, reliable nutrition information.
Although the European Union does not require nutrition labeling for all  foods, it does require it on foods that have health or nutrition claims or that  have voluntarily added vitamins or minerals, according to a European  Union official. In addition, several countries, including the United  Kingdom, the Netherlands, and Sweden, have implemented voluntary,  front-of-package nutrition labeling systems, while Canada is proposing  research on how such systems influence food purchases, among other  things, and consulting stakeholders. The European Commission has  proposed a mandatory, front-of-package labeling system.
Figure 4 shows the front-of-package nutrition symbols for systems in the  United Kingdom, the Netherlands, and Sweden, which help consumers in  those countries identify healthy foods.
Consumers and health organizations in many countries have a heightened  interest in the benefits of choosing healthy foods, including several that  have implemented (see fig. 4) or are considering front-of-package nutrition  labeling systems. For example:  The United Kingdom: The Food Standards Agency implemented a  voluntary front-of-package traffic light symbol to help consumers  distinguish between the healthiest choices (green light), less-healthy  choices (amber light), and least healthy choices (red light) with respect  to fat, saturated fat, salt, sugars, and usually calories, as well. Officials  report that preliminary sales data suggest that this system is influencing  consumers’ purchases toward healthier products. In addition,  manufacturers are developing new products and reformulating less- healthy products so that their foods may move into the amber or green  light category, according to U.K. officials. The United Kingdom’s  National Heart Forum (an alliance of 50 heart health organizations) has  endorsed the traffic light system.
The Netherlands: The Netherlands uses a voluntary front-of-package  “healthy choice” symbol, which was developed by the food industry and  endorsed by the Ministry of Health. According to a Ministry official,  standards for applying the symbol vary by food category, taking into  account the characteristics of each category—for example, fiber is  included in the criteria for bread products. A foundation was  established—the Choices International Foundation—to introduce the  symbol to other countries. The qualifying criteria for using the symbol  will be reevaluated every 2 years by an independent scientific  committee, according to the official.
Sweden: The National Food Administration uses a voluntary front-of- `package keyhole logo to identify the healthiest foods within particular  food categories. Products that carry the symbol are lower in fats, sugars,  and sodium and contain more fiber than other foods within the same  category. According to agency officials, the introduction of the keyhole  logo resulted in the development of healthier products and the  continuous reformulation of existing products.
Canada: The House of Commons’ Committee on Health’s 2007 report,  Healthy Weights For Healthy Kids, recommended that the country’s  health agency—Health Canada—phase in a mandatory, standard,  simple, front-of-package labeling requirement for prepackaged food,  starting with foods advertised primarily to children. In addition, the  Chronic Disease Prevention Alliance of Canada supports this  recommendation. As of April 2008, Health Canada commented that it is  taking several steps, including consulting with stakeholders and  proposing consumer research on, among other things, front-of-package  symbols.
European Union: The European Commission has proposed legislation  that would require prepackaged food to display information on calories,  fat, saturated fat, carbohydrates, sugars, and salt on package fronts,  according to documents released by the commission. A commission  official told us that member states would still be able to promote  additional national front-of-package labeling systems if they comply  with requirements of the proposed legislation. The European Union’s  Commissioner for Health stated that food labels can have a huge  influence on consumers’ purchasing decisions, and confusing,  overloaded, or misleading labels can be a hindrance to consumers. The  European Heart Network (an alliance of 30 heart health organizations in  26 countries) and the European Consumers’ Organization also support  mandatory front-of-package labeling.
In the United States, health and consumer associations have developed  nutrition symbols to help consumers. For example, the American Heart  Association developed the heart-check logo to help consumers identify  heart-healthy foods. Currently, over 800 products from over 100 companies  use the logo, and one major line of foods was developed with the heart- check criteria as a key driver, according to the association. While most  companies reformulate products before applying for the logo certification,  the association also works with companies on 20 to 40 products a year to  help them meet its criteria. In addition, the Whole Grains Council, a  nonprofit consumer group working to increase consumption of whole  grains, developed the Whole Grain Stamp to identify products with at least  a half serving of whole grains, with the grams of whole grain specified. A  “100%” banner can be placed on the stamps when all of the grain is whole  grain. The stamps have been used on over 1,700 products from 180  companies in the United States, Canada, and the United Kingdom.
In addition, manufacturers have developed numerous symbols to market  their foods to health-conscious consumers, and supermarkets have used  symbols to help consumers identify healthier foods. At a September 2007  FDA public hearing on front-of-package and other nutrition symbols,  several manufacturers and supermarket chains reported increased sales  and reformulations associated with their use of nutrition symbols. For  example, Kraft has reported that the more than 500 products carrying its  Sensible Solution symbol accounted for a sizable portion of its overall  revenue growth. Hannaford, a northeastern supermarket chain, reported  that it improved the nutrient quality of its store brand products before  introducing its symbol for nutrition quality that it calls Guiding Stars, which  is based on mathematical formulas giving a weighted value to many  nutrients. Hannaford also reported increased sales for products with stars.
According to the Institute of Medicine, however, the consistency, accuracy,  and effectiveness of the proprietary graphics currently in use have not been  evaluated or empirically validated, and they may fall short of their potential  as guides to more nutritious choices. Many stakeholders also share a  concern about the proliferation of such graphics. FDA officials told us that  the agency assigned an individual part time to focus on research on  nutrition symbols. In comments, FDA told us it has completed one study. In  addition, FDA plans to issue a summary of the 2007 public hearing and to  identify gaps in the information that stakeholders provided during or after  the hearing, at the request of FDA.
The Grocery Manufacturers/Food Products Association opposes  mandatory front-of-package nutrition symbols and maintains that nutrition  symbols should continue to be voluntary because the industry’s use of  symbols to communicate nutrition information is truthful, not misleading,  and consistent with FDA’s clear regulations for making representations  about nutrition. According to the association, in recent years, many food  companies have reformulated thousands of food products to improve their  nutrient profiles, and many manufacturers are using symbols and related  graphic designs on labels to supplement the Nutrition Facts panel. In  addition, the Keystone Center, an industry-funded nonprofit organization,  has held discussions to determine whether it should develop a voluntary  front-of-package system. In 2007, the center convened a group of experts  from industry, government, consumer, and academic organizations to study  the various systems used in the United States. As of July 2008, this group  had not released information on the status of its effort. According to FDA  officials, FDA acts as an observer in this group. However, FDA has not yet  collaborated with the relevant federal agencies and stakeholders with  nutrition expertise to evaluate labeling approaches and options.
section_title: Stakeholders Suggested Other Actions That FDA Should Take to Help Consumers Identify Healthy Foods
paragraphs: Several medical, health, and consumer association stakeholders suggested  FDA actions that they believe would mitigate misleading and confusing  labeling. While some stakeholders noted that these actions may require  FDA to redirect resources, they also believe such actions would help  consumers identify healthy foods.
Eliminate qualified health claims: Stakeholders, such as the AMA,  have suggested that FDA eliminate the use of qualified health claims on  food labels because consumers cannot distinguish among the four levels  of scientific support that FDA uses—significant scientific agreement,  scientific evidence that is not conclusive, limited scientific evidence that  is not conclusive, and very little scientific and preliminary evidence.  According to the stakeholders, these claims confuse or mislead  consumers and may encourage the consumption of foods with little or  no health benefits. This view was supported by findings from 2005 and  2007 FDA studies. In commenting on a draft of this report, FDA  questioned whether it had the authority to eliminate the use of such  claims. See appendix V for more information on FDA’s administration of  health claims.
Establish criteria for characterizing the amount of whole grains in  food: The use of the term “whole grain” increased in popularity after the  2005 Dietary Guidelines underscored the importance of these foods in  the American diet. Some studies suggest that consumers, as well as  dieticians and other nutrition experts, cannot accurately identify which  foods are primarily whole grain. In 2004, General Mills, Inc., petitioned  FDA to establish criteria for the phrases “excellent source of whole  grains,” “good source of whole grains,” and “made with whole grains” to  help prevent false or misleading labeling of grain products. FDA denied  the petition, but it acknowledged the need for action and stated that  claims such as “good source” have been used only with regard to  nutrients—not foods—and that FDA needs to consider how to classify  different kinds of statements and whether public comments are needed.  In 2006, FDA developed draft guidance that identified what foods it considered “whole grain.” FDA officials stated that they expect to  continue work on this issue when they can hire additional staff.
Prohibit foods that contain substantial amounts of saturated fat from  being labeled as “trans fat free”: FDA has not objected to products  being labeled as “trans fat free” that have less than 0.5 grams of trans fat  per serving, and does not restrict the amount of saturated fat in “trans  fat free” foods. However, as stakeholders pointed out, saturated fat, like  trans fat, raises low density lipoprotein (LDL or “bad cholesterol”) levels  in the blood, increasing the risk of heart disease. Initially, FDA proposed  limiting “trans fat free” labeling to foods with less than 0.5 grams of  saturated fat, but FDA later stated that insufficient scientific  information existed to support whether 0.5 was the appropriate level.  FDA is evaluating available research to determine how to best address  the issue.
Require the labels of foods commonly consumed in one sitting to show  total calories, fat, and other nutrition information: Several health and  consumer stakeholders believe consumers may be misled by Nutrition  Facts panels for foods, such as large sodas, candy bars, muffins, and  other foods, that are normally consumed in one sitting, but are labeled  as two or more servings. In 2005, the Institute of Medicine  recommended that FDA revise requirements so that foods typically  consumed in one sitting prominently display the total calorie content of  the product as well as the standard per-serving format. Industry- sponsored research found that the participants in four focus groups  generally favored the listing of nutrients for the whole container,  although some want nutrients listed for both the full container and per  serving. In April 2005, FDA published an advance notice of proposed  rulemaking requesting comments on this issue. In 2008, FDA noted that  it needed to review the comments submitted in response to the 2005  notice, and to coordinate this area with its plans to revise the daily  intake reference values (used to establish the daily values for the  Nutrition Facts panel) described in a 2007 advance notice of proposed  rulemaking. The Grocery Manufacturers/Food Products Association  opposes requiring nutrition information for the entire contents of the  package on the food label, noting that nutrition information for the  entire package would give consumers “permission” or “encouragement”  to eat the entire package.
Clarify the definition of “natural” as it applies to food: The Sugar  Association has petitioned, with the support of the Center for Science in  the Public Interest and others, that FDA define the term “natural” on the  basis of USDA’s definition, as articulated in its Foods Standards and  Labeling Policy Book. USDA policy defines “natural” to permit only  minimal processing, including roasting, drying, and fermenting, to  preserve or make food edible. Under this USDA policy, foods that go  through certain processes, such as chemical bleaching, that  fundamentally alter the raw product, are not considered “natural.” Both  groups assert that FDA allows manufacturers to label products as “100%  natural” even if they contain highly processed ingredients, citing  partially hydrogenated oils and high fructose corn syrup. However, the  Corn Refiners Association believes that USDA and FDA should have  different definitions of “natural” because, among other things, the two  agencies regulate fundamentally different products—USDA-regulated  meat and poultry products are understood to be less processed than  FDA-regulated foods. FDA acknowledged in 1993 that clarifying the  definition of “natural” would abate some of the complaints that the  term’s use is misleading. More recently, FDA noted that it lacks  resources to undertake a rulemaking to revisit the definition.
section_title: Conclusions
paragraphs: With its current approach to oversight and enforcement, FDA cannot be  assured that food firms are complying with labeling requirements. In light  of the resource constraints and many responsibilities that FDA has  reported, it is especially important that FDA start by making better use of  the tools and data it has available. However, FDA’s use of warning letters  and enforcement actions have at best held steady, despite increased  responsibilities. FDA is not using the information that it has to inform  managers’ decisions on setting priorities and allocating resources. FDA  does not maintain in an accessible format, or analyze in routine reports,  information it has on such areas as labeling violations discovered during  inspections, the results of tests on the accuracy of labels, warning letters,  recalls, and import refusals. Moreover, although information on whether  and how labeling violations are addressed is critical for effectively  overseeing the labeling program. FDA does not (1) centrally maintain  information on regulatory meetings and (2) know whether field offices are  applying the same criteria for meetings and whether meetings are effective.
While FDA posts information for the public on its Web site—such as  warning letters, import refusals, and import alerts—it does not ensure that  the information is complete and posted promptly. As a result, the public  may not have the information needed about products in violation of the law  to inform their purchase decisions. Furthermore, CFSAN has continued to  expend resources maintaining a duplicative data system for food-related  recalls, which it agreed to eliminate in 2004. We reiterate our prior  recommendation that FDA should eliminate this system.
Going forward, to better administer and enforce labeling requirements,  FDA has begun to pursue several authorities that are available to other  centers within FDA and other regulatory agencies. In particular, CFSAN  does not have the authority to charge user fees, accredit third-party  inspectors, or require recalls for most food. As a result, CFSAN is not as  well positioned as other programs that have these authorities to carry out  its responsibilities. FDA’s Food Protection Plan recognized the need for  additional resources and new authorities, to ensure the safety of the  Nation’s food supply. However, as FDA proceeds in seeking new authorities  it will need to ensure that any it chooses to pursue are designed and  implemented efficiently and appropriately and, in particular, that any user  fees it develops are well-designed and based on best practices and sound  criteria, such as that specified in GAO’s Federal User Fees: A Design  Guide. In addition, any FDA program for accrediting third parties would  likely benefit from lessons learned in another FDA-accredited third-party  program. Moreover, as we have previously testified, while FDA’s plan is a  good first step, it does not contain a clear description of resources and  strategies. Congress will need those details to assess the likelihood of the  plan’s success.
Finally, the many issues stakeholders raised about label information that  they believe confuse consumers compete for FDA’s attention and  resources. Nonetheless, FDA has information on the approaches that U.S.  industry and other countries are taking to give consumers simplified  nutrition information at a glance with front-of-package symbols. However,  given FDA’s competing priorities and its minimal progress in addressing  misleading labeling thus far, collaboration with other federal entities and  stakeholders could afford an opportunity for FDA to better leverage  resources to pursue front-of-package labeling or other initiatives for  minimizing consumer confusion.
section_title: Recommendations for Executive Action
paragraphs: We recommend that the Commissioner, FDA, take the following seven  actions: Ensure that labeling office managers have the information they need to  oversee compliance with food labeling statutes and regulations by  maintaining, in a searchable format, data on food labeling violations,  including the type of violation and information about corrective actions  taken or, if no action was taken, the reason why;   analyzing violation data in routine management reports; and  tracking regulatory meetings related to food labeling violations and  analyzing whether regulatory meetings are an effective use of resources.
Ensure that the public has timely access to information on food labeling  violations that may have serious health consequences by requiring all of the  centers and offices to post on FDA’s public Web site, within a specified time  frame, key information, such as all warning letters; statistics on serious  enforcement actions (e.g., import refusals) by country, type of food, and the  problem found (e.g., undeclared allergen); and information (e.g., product  identification and exposure symptoms) on violations that FDA classifies as  serious.
Better leverage resources to carry out food safety and other regulatory  responsibilities, including administering and enforcing labeling  requirements, by  providing Congress with specific, detailed information on the new  statutory authorities identified in the Food Protection Plan, such as the  authority to charge user fees, accredit third-party inspectors, and  mandate food recalls, with specific information on how these  authorities would help achieve its mission;  posting on FDA’s public Web site periodic updates of the status of  implementation of the Food Protection Plan, including goals achieved  and time frames for completing the remaining work; and  collaborating with other federal agencies and stakeholders experienced  in nutrition and health issues, to evaluate labeling approaches and  options for developing a simplified, empirically valid system that  conveys overall nutritional quality to mitigate labels that are misleading  to consumers.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to HHS for review and comment. In  written comments, FDA stated that the report raised some important issues  regarding its regulation of food labeling. FDA did not dispute the report’s  data, analyses, or specific findings. It commented, however, that the report  inappropriately references food labeling as part of its food safety mission,  although it acknowledges that there may be some aspects of food labeling  that can affect the safe use of food. That notwithstanding, FDA directs  investigators to review at least three labels during food safety inspections.  Moreover, food labeling responsibilities are part of FDA’s statutory mission,  and the Federal Food, Drug, and Cosmetics Act and FDA’s regulations set  out FDA’s labeling responsibilities. FDA also stated that within its overall  public health mission, it has a multitude of competing priorities. We  acknowledged FDA’s competing priorities in the report’s conclusions and  framed the recommendations so as to help manage these competing  priorities by better leveraging resources and using available tools and data  for risk-based decisions.
Regarding our first three recommendations for ensuring that managers  have the information they need to oversee compliance with food labeling  statutes and regulations—by (1) maintaining data on labeling violations  and the corrective actions taken, in a searchable format, (2) analyzing that  data in routine management reports, and (3) tracking regulatory meetings  on labeling violations to assess whether they are an effective use of  resources—FDA agreed that being able to track any and all information  that would allow investigators to better do their jobs would be useful to the  agency. However, FDA stated that data collection requires time and effort  and it is important to make sure that data entry does not become so  burdensome that it takes away from other investigative work. FDA did not  commit to taking any actions in response to these recommendations. We  maintain that FDA cannot make risk-based decisions, such as allocating  resources efficiently and effectively, without careful analysis of this type of  data on its regulatory programs—FDA’s systems already maintain  substantial data on food labeling and related violations. Analyzing these  data for routine reports could help inform labeling managers’ decisions and  help them target labeling resources. We stand by these recommendations.
With respect to our recommendation for ensuring the public has timely  access to information on labeling violations that may have serious health  consequences—that FDA require centers and offices to post key  information (e.g., warning letters or import refusals) on FDA’s public Web  site and specify time frames for doing so—FDA commented that it already  posts and maintains much of this information, and that it would keep the  information as up to date as possible, given resource and time limitations.  However, as we discuss in this report, FDA’s target time for issuing warning  letters and posting them is 4 months after violations are found. Providing  information that is complete and timely can help the public avoid  potentially dangerous food and make healthy food purchase decisions. The  draft we sent to FDA for comment recommended that FDA post all recalls  to its public Web site in a timely manner. We eliminated recalls from this  recommendation because, in technical comments, FDA told us that the  recalls in CFSAN’s unofficial database that we thought were missing from  RES were the result of coding differences. We stand by this  recommendation as amended.
Our final three recommendations are aimed at better leveraging resources.  Two are aimed at helping FDA keep the Food Protection Plan on track by  (1) providing specific, detailed information to Congress on how the new  authorities in the Food Protection Plan will help FDA achieve its mission  and (2) posting periodic updates on the status and time frames for  implementing the plan on FDA’s public Web site. FDA stated that the plan  was designed to address food safety and defense concerns, although some  of the actions presented in it may have some bearing on food labeling  issues. It was not our intent to suggest that the plan’s primary focus was on  food labeling; we have clarified this in the report. Nonetheless, in this  report and in recent testimonies, we have expressed our concerns that FDA  has not given Congress sufficient, detailed information on how it will  implement the plan and use the new authorities—information Congress  needs to support the initiatives. Furthermore, updates can reassure the  public of FDA’s progress. FDA did not explicitly address what action, if any,  it would take in response to these two recommendations. With respect to  our last recommendation—that FDA collaborate with other federal  agencies and stakeholders on evaluating options for developing a  simplified, empirically valid system for conveying overall nutritional quality  to help consumers—FDA agreed with the need to evaluate the  communication effects of nutrition symbols and presented a research  agenda. Because the agenda appears to be ambitious given FDA’s limited  resources, our recommendation will continue to encourage FDA to  collaborate with other federal agencies and stakeholders who may be able  to contribute resources, as it evaluates options to develop a simple, valid  system to communicate nutritional quality.
FDA’s written comments and our detailed evaluation appear in appendix VI.  FDA also provided technical comments, which we incorporated  throughout the report, as appropriate.
As agreed with your office, unless you publicly announce the contents of  the report earlier, we plan no further distribution of it until 30 days from the  date of this report. At that time, we will send copies of the report to the  appropriate congressional committees, the Secretary of Health and Human  Services, the Commissioner of the Food and Drug Administration, and  other interested parties. We will also make copies available to others upon  request. In addition, the report will be available at no charge on the GAO  Web site at http://www.gao.gov.
If you or members of your staff have any questions about this report, please  contact me at (202) 512-3841 or shamesl@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on the  last page of this report. GAO staff who made key contributions to this  report are listed in appendix VII.
section_title: Objectives, Scope, and Methodology
paragraphs: This report examines (1) the Food and Drug Administration’s (FDA) efforts  to ensure that domestic and imported foods comply with food labeling  requirements, including those prohibiting false or misleading labeling;   (2) the challenges FDA faces in its efforts to administer and enforce food  labeling requirements; and (3) the actions that stakeholders from health,  medical, and consumer organizations believe are needed to mitigate the  effects of food labeling practices they consider misleading and to help  consumers identify healthy food.
For the purposes of this report, our definition of “food” includes  conventional food, dietary supplements, infant formula, and medical food,  but not animal feed, which the Federal Food, Drug, and Cosmetic Act  includes in its definition of food. We did not determine whether any  particular food labeling was false or misleading. We also did not evaluate  how efficiently FDA used its resources or the impact of changing priorities;  nor did we compare FDA resource trends with other federal agencies’  resource trends. Regarding data for labeling-related oversight, we analyzed  the food firms inspected for 7 fiscal years (2001 through 2007); nutrient  labeling samples for 7 fiscal years (2000 through 2006); warning letters and  enforcement actions related to imports for 6 fiscal years (2002 through  2007); and seizures and injunctions for 10 fiscal years (1998 through  2007)—the periods for which reliable and comparable FDA data were  available. Funding and staffing data for FDA, the Center for Food Safety  and Applied Nutrition (CFSAN), and the Office of Regulatory Affairs (ORA)  were available for 10 fiscal years (1998 through 2007). For the Office of  Nutrition, Labeling, and Dietary Supplements, which began maintaining  comparable data in 1999, we report funding and staffing for 9 fiscal years  (1999 through 2007). Unless otherwise stated, data are presented by federal  fiscal year.
To determine FDA’s efforts to ensure that domestic and imported foods  comply with food labeling statutes and regulations, including those related  to false or misleading labeling, we analyzed FDA’s and CFSAN’s plans and  reports, guidance and regulations related to food labeling, and policies and  actions taken in response to petitions and complaints over the last 6 years.
We also analyzed data from the Field Accomplishments and Compliance  Tracking System (FACTS) and Operational and Administrative System for  Import Support (OASIS) on domestic, foreign, and import inspections  conducted by FDA, along with domestic inspections conducted by states  under contract with FDA. To determine the number of warning letters  issued by FDA, we worked with FDA's Freedom of Information Office and  ORA to address several problems we found during the course of our review  regarding the online database of warning letters. After addressing those  problems, we then searched that database for warning letters that were  related to food labeling and characterized each letter according to the  product and the violations cited. We also searched FDA's Recall Enterprise  System (RES) for recalls identified with food labeling violations as one of  the reasons for the recall. Regarding violations of Nutrition Facts panel  regulations, we analyzed data from FACTS for domestic and imported food,  and also analyzed studies conducted on the accuracy of nutrient labeling.  We analyzed data from this system on consumer complaints to determine  the extent to which they were tracked. Finally, we also analyzed data from  OASIS on food labeling violations for imported food and collected  information on seizures and injunctions focused on food labeling  violations.
To identify challenges, we analyzed funding and staffing data for FDA,  CFSAN, ORA, and the Office of Nutrition Labeling and Dietary  Supplements and reviewed FDA oversight and enforcement authorities,  and court rulings regarding FDA labeling. For comparison, we examined  some of the same information for the U.S. Department of Agriculture’s  Food Safety and Inspection Service and the Federal Trade Commission,  which also oversee and enforce requirements related to food labeling, such  as those prohibiting false or misleading information about food.
We assessed the reliability of the data from FACTS and OASIS that we used  in this report and found them to be sufficiently reliable for these purposes.  To assess the reliability of these data, we (1) performed electronic testing  for obvious errors in accuracy and completeness, (2) reviewed related  documentation, and (3) worked closely with agency officials to identify any  data problems.
In addition, we assessed the reliability of the data from the RES.  FDA  recently informed us that CFSAN has continued to use an unofficial  database that it agreed to eliminate in 2004, which contains additional  information on recalls that would potentially fit our criteria for analysis.   Despite any limitations of the RES, we believe these data to be sufficiently  reliable to indicate a minimum number of recalls for the time period we  reported.
To determine stakeholders’ views, we analyzed petitions, public responses  to petitions, and ideas presented during FDA’s November 2007 public  labeling meetings. We discussed these and other suggestions with health  and medical associations, including the American Cancer Society,  American Diabetic Association, American Heart Association, American  Dietetic Association, American Medical Association, and National  Academies’ Institute of Medicine; the Center for Science in the Public  Interest; the Grocery Manufacturers/Food Products Association; the  Association of Food and Drug Officials; and selected states (California,  Connecticut, Florida, New York, Texas, and Wisconsin) that the  Association of Food and Drug Officials and others groups identified as  being active in food labeling issues. In addition, we contacted officials of  health or related departments in Canada, the United Kingdom, Sweden, the  Netherlands, and the European Commission to collect information on their  use or plans for use of nutrition symbols. We did not independently verify  the statements of foreign law. We also analyzed consumer studies  conducted by FDA, industry, and others to identify whether the findings  supported or failed to support stakeholders’ views. These studies were  identified by health, consumer, and industry experts and through literature  searches. For the data we included in our report, we obtained frequency  counts, survey instruments, and other documents, to review the wording of  questions, sampling, mode of administration, research strategies, and the  effects of sponsorship. We used only data that we judged to be reliable and  valid.
We conducted this performance audit from January 2007 through  September 2008 in accordance with generally accepted government  auditing standards. Those standards require that we plan and perform the  audit to obtain sufficient, appropriate evidence to provide a reasonable  basis for our findings and conclusions based on our audit objectives. We  believe that the evidence obtained provides a reasonable basis for our  findings and conclusions based on our audit objectives.
section_title: FDA-Regulated and -Inspected Domestic and Foreign Food Firms, Fiscal Years 2001 through 2007
paragraphs: Nearly half of the domestic firms that are subject to FDA regulation are  food firms—manufacturers, processors, and other food businesses. Table 9  presents the number and percentage of domestic food firms that are  subject to FDA’s food regulations and the total number of domestic firms in  all industries (e.g., pharmaceuticals and medical devices) that are subject  to FDA regulation, for fiscal years 2001 through 2007.
Regarding firms inspected under all FDA regulatory programs, food-related  firms have accounted for between 15 percent and 30 percent of foreign  firms inspected and between 45 percent and 56 percent of domestic firms  inspected. Table 10 presents the number and percentage of foreign and  domestic food-related firms inspected and the total number of FDA- regulated firms inspected, for fiscal years 2001 through 2007, by FDA and  states under contract with FDA.
section_title: FDA Inspections of Food Firms in Foreign Countries, Fiscal Years 2001 through 2007
paragraphs: (This page is intentionally left blank.)
section_title: Funding and Staffing Information by FDA Mission, Fiscal Years 1998 through 2007
subsections: section_title: Center for Biologics Evaluation and Research
paragraphs: Center for Devices and Radiological Health National Center for Toxicological Research $1,278.1 Includes GSA rent, other rent, rent-related activities, White Oak Consolidation, and the FDA Buildings  and Facilities Appropriation.
Includes tobacco program, Office of the Commissioner, Office of Policy, Office of External Affairs,  Office of Operations/Orphan Grants Administration, Office of Management and Systems, and Central  Services.
Other activities funded in part by user fees, including Office of the Commissioner, Office of Policy,  Office of External Affairs, Office of Operations/Orphan Grants Administration, Office of Management  and Systems, Central Services, Export Certification, and Color Certification Fund.
section_title: FDA’s Administration of Health Claims in Response to the Pearson v. Shalala Ruling
paragraphs: The Nutrition Labeling and Education Act of 1990 (NLEA) amended the  Federal Food, Drug, and Cosmetic Act to include provisions that govern  the use of health claims on food labeling. For conventional foods, the NLEA  requires that any claim that expressly or by implication characterizes the  relationship of a nutrient to a disease or health-related condition must be  authorized by the Secretary of Health and Human Services (delegated to  FDA) through a regulation. Under the NLEA, FDA may authorize a health  claim for a conventional food if it determines, based on the totality of  publicly available scientific evidence, that there is “significant scientific  agreement” among experts—qualified by scientific training and experience  to evaluate such claims—that the claim is supported by such evidence.  Although the NLEA also provided for the use of health claims in dietary  supplement labeling, Congress did not require dietary supplement health  claims to be subject to the same statutory procedures and standards as  conventional food health claims. Instead, dietary supplement health claims  were to be subject to procedures and standards established in regulations  issued by the Secretary of Health and Human Services (delegated to FDA).
In 1991, FDA published a proposed rule in the Federal Register, proposing  the implementation of the statutory procedures and standards for health  claims for conventional food, and proposing to adopt those same  procedures and standards for dietary supplement health claims. However,  before the rule could be finalized, Congress passed legislation that  generally prohibited FDA from implementing the NLEA with respect to  dietary supplements until December 15, 1993. Therefore, in January of  1993, when FDA adopted the final rules for health claims for conventional  foods, it did not finalize rules for dietary supplement health claims.  However, 1 year later, after the prohibition of implementation of NLEA for  dietary supplements had expired, FDA adopted a rule that subjected  dietary supplement health claims to the same general requirements that  applied to conventional foods. Under those rules, any person wanting to  include a health claim on a conventional food or dietary supplement label  must petition FDA for authorization before including the claim on the label.  If FDA determines, based on the totality of publicly available information,  that there is significant scientific agreement in support of that claim, it will  authorize its use by issuing it in regulation.
FDA’s health claim regulations for dietary supplements were the subject of  several lawsuits in the 1990s. In a case known as Pearson v. Shalala, the  U.S. Court of Appeals for the District of Columbia Circuit held that the First  Amendment does not permit FDA to prohibit a potentially misleading  health claim on the label of a dietary supplement, unless FDA considers  whether a disclaimer on the product’s label could negate the potentially  misleading nature of that claim. Specifically, the court stated that although  inherently or actually misleading information in food labeling or  advertising may be prohibited, potentially misleading information cannot  face an absolute prohibition. Instead, potentially misleading information  may be regulated only if those regulations directly advance a substantial  government interest, and offer a reasonable fit between the government’s  goals and the means chosen to accomplish those goals. The court found a  substantial interest in protecting the public health and preventing  consumer fraud. However, it found that FDA’s regulation requiring health  claims to be supported by significant scientific agreement did not directly  advance the interest in public health, and, even though the regulations  directly advanced the interest in preventing consumer fraud, the fit  between the goals of the regulations and the means employed—an outright  ban without the possibility of a disclaimer—was not reasonable.
Following the decision in Pearson, FDA announced its plan to respond,  stating that it would deny, without prejudice, all petitions for the use of  dietary supplement health claims that did not meet the significant scientific  agreement standard while the agency conducted and completed a  rulemaking to reconsider the procedures and standards governing such  claims. Then, according to FDA, once a rule was finalized, the agency  would revisit the petitions it had denied. However, in 2000, citing concerns  over additional First Amendment challenges, FDA announced plans to  modify that policy. FDA stated that it would continue to approve dietary  supplement health claims that met the significant scientific agreement  standard, but it would exercise its enforcement discretion and not take  action against dietary supplement health claims that failed to meet the  standard under certain circumstances. Specifically, upon the submission of  a valid petition for preapproval of a dietary supplement health claim, if  FDA did not find significant scientific agreement, but, in evaluating the  weight of the evidence, did find that the scientific evidence in support of  the claim outweighed the scientific evidence against it, and consumer  health and safety were not threatened, the agency would inform the  petitioner of conditions under which the agency would refrain from taking  enforcement action against the health claim. If the scientific evidence  against the health claim outweighed the scientific evidence in support of it,  FDA would deny any use of the health claim.
Then, in 2002, the agency announced the availability of guidance, updating  its approach to implementing the Pearson decision. In large part, the  procedures remained the same; however, FDA included health claims for  conventional foods under the procedures, even though the Pearson case  directly addressed only dietary supplements. FDA stated that it believed  that such a move would precipitate greater communication in food labeling  and thereby enhance public health. In addition, FDA stated that including  health claims for conventional foods in its enforcement discretion policy  would help avoid further constitutional challenges. Subsequently, in 2003,  FDA announced the availability of two new guidance documents describing  interim procedures that, among other things, addressed a then recent U.S.  District Court for the District of Columbia decision that found the weight of  the evidence standard that FDA first articulated in guidance in 2000 was  inappropriate. According to the district court in that case, FDA should  evaluate qualified health claims based on the presence of “credible  evidence,” not the weight of the evidence. The 2003 guidance documents  set forth new procedures for qualified health claims for conventional foods  and dietary supplements. Specifically, qualified health claim petitions  would be evaluated using an evidence-based ranking system that would  rate the strength of the publicly available scientific evidence. A claim  would be denied if there was no credible evidence to support it. Otherwise,  based on the competent and reliable scientific evidence in support, a claim  would be assigned to one of four ranked levels—the first level being  “significant scientific agreement among qualified experts” and the  remaining three levels being for claims supported by some lower level of  credible evidence. Each of the three categories not ranked as supported by  significant scientific agreement would correspond to one of three  standardized qualifying statements (i.e., disclaimers). So long as the  qualified health claim bore the appropriate language, met other applicable  health claim regulations, and adhered to criteria established in FDA’s letter  of enforcement discretion in response to the petition, FDA would exercise  its enforcement discretion and refrain from acting against the health claim.
In November of 2003, FDA published an Advance Notice of Proposed  Rulemaking, recognizing the need to establish transparent, long-term  procedures that have the effect of law. In that announcement, FDA  presented several regulatory alternatives: (1) incorporate the interim  procedures and evidence-based ranking system we have previously  discussed into regulation; (2) subject health claims to notice-and-comment  rulemaking, as before Pearson, but reinterpret the “significant scientific  agreement” standard to refer to the evidence supporting the claim being  made, instead of the underlying substance-disease relationship; or (3) treat  qualified health claims as outside the NLEA and regulate them on a  postmarket basis (i.e., pursue the product as misbranded if the health claim  renders the label false or misleading because the claim lacks  substantiation). FDA does not plan to work on this proposed rulemaking  this year. In May of 2006, FDA issued guidance concerning FDA’s  implementation of qualified health claims process. In that guidance, FDA  reaffirmed the 2003 interim procedures and stated that “FDA is currently  considering various options regarding the development of proposed  regulations related to qualified health claims,” and “…n the meantime,  the agency plans to review qualified health claim petitions on a case-by- case basis.”
section_title: Comments from the Food and Drug Administration
paragraphs: The following are GAO’s comments on the Department of Health and  Human Service’s (HHS) letter dated August 19, 2008.
subsections: section_title: GAO Comments
paragraphs: 1. FDA commented that the report did not place food labeling in the  appropriate context, given FDA’s overall public health mission and  competing priorities. We believe the food labeling responsibilities are  part of that mission. The Federal Food, Drug, and Cosmetic Act  specifically describes FDA’s mission to include protecting the public  health by, among other things, ensuring that “foods are safe,  wholesome, sanitary, and properly labeled.” FDA also commented that  the report failed to account for all the varied initiatives that FDA and  HHS have undertaken to fight obesity and ensure that foods are labeled  in a manner that fosters consumer education and healthy choices. The  subject of this report is food labeling, not obesity. With respect to  labeling initiatives to help consumers make healthy food choices, the  report identifies several areas where stakeholders believe that FDA  falls short.  2. Although FDA said that it does not consider food labeling part of its  food safety mission, it does include reviewing labels as a required step  in a food safety inspection. Also, overseeing industry compliance with  labeling requirements is part of FDA’s food oversight responsibilities  and labeling laws help consumers ensure that the food they buy is safe  for them eat. That said, since FDA made this distinction, we revised the  wording in some places in the final report. 3. FDA took issue with the report’s frequent references to the Food  Protection Plan. FDA stated that the plan was developed to address  food safety and defense, although it may have some bearing on food  labeling issues. It was not our intent to suggest that the plan’s primary  focus was on food labeling, and we have clarified this in the report. The  report discusses the Plan’s potential to help FDA carry out its food  regulatory responsibilities and discusses certain provisions that, if  implemented, may be useful tools in monitoring and enforcing the food  labeling requirements.  4. FDA correctly noted that the report does not evaluate how efficiently  FDA used its resources or the impact of its changing priorities,  although we did examine resources for food labeling. For example, the  report provides 10 years of budget data on FDA, with detailed data for  each center, including (1) total staffing and funding, (2) the portion of  Office of Regulatory Affairs’ staffing and funding for inspections and  other oversight, and (3) staffing and funding supported by user fees.  However, because FDA was not able to provide risk-based priority  plans or annual work projections for all labeling activities, we could not  determine how efficiently labeling resources were used or the impact  of changing priorities on labeling.  5. FDA contended that most misleading food labeling violations do not  present a high risk to public health. However, FDA has not conducted  the research to identify which food labels are misleading and therefore  has little or no basis for determining the health impacts of misleading  labeling violations.  6. FDA commented that it does not believe that tracking and analyzing  data and providing routine reports on food labeling violations is the  best use of its resources, given competing priorities. We maintain that  risk-based decisions, such as allocating resources effectively, must  include careful analysis of this type of data on regulatory programs.  Moreover, FDA already collects most of these data so resource  investment to generate the reports should be minimal and worth the  benefits of ensuring that managers’ decisions are well-informed and  risk-based. As FDA rolls out several initiatives for improving its  information technology systems, which it states are under way, HHS  may want to provide FDA managers with training on using the systems  as management tools. 7. FDA said it agreed that being able to track any and all information that  would allow its investigators to better do their jobs would be useful to  the agency, but that data collection requires time and effort. FDA  continued, it is important to make sure that data entry does not become  so burdensome that it takes away from other investigative work.  However, as we previously noted, FDA already collects most of these  data. With a small resource investment, analyzing these data in reports  can help managers make more informed decisions.  8. FDA implied that it may not have the resources to keep data on the  public Web site up to date. However, providing consumers with  information that is timely and complete can help them avoid potentially  dangerous food and make healthy food purchases. 9. FDA commented that the report suggests in several places that the only  context in which FDA detains food is under the Bioterrorism Act, and  that that FDA has another type of detention authority that applies to  imported articles. However, the report does discuss FDA’s other  detention authority under section 801(a) of the Federal Food, Drug, and  Cosmetic Act. The report refers to these actions as “import refusals,"  which is the term that FDA currently uses for these enforcement  actions. We added a footnote in the text to note this.  10. FDA's statement—that its survey indicated that 70 percent of adults  said they look at the Nutrition Facts panel the first time they purchase a  food—is misleading.  In that survey, 44 percent of respondents told  FDA that they "often" read the panel the first time they purchase a food,  and 25 percent "sometimes" read the panel at that time; while 31  percent "rarely" or "never" read the panel.   11. FDA commented that (1) court decisions, beginning with Pearson v.
Shalala, hold that the First Amendment precludes FDA from  prohibiting the use of qualified health claims unless FDA can show that  the claim is inherently misleading, or if the claim is only potentially  misleading, that the use of a disclaimer would not remedy the claim’s  potential to mislead, and (2) that absent consumer research or other  evidence that satisfies the criteria set by the court in Pearson v.  Shalala, FDA does not have the authority to eliminate qualified health  claims as a class of claims. We added language to the report to  acknowledge FDA’s position.  12. FDA commented that, contrary to our report, FDA’s 2005 and 2007  qualified health claims experiments did not find that qualified health  claims might encourage the consumption of foods with little or no  health benefits. Our report states that, according to the stakeholders  we consulted, “… these claims confuse or mislead consumers and may  encourage consumption of foods with little or no health benefits.”  It  then states that “his view was supported by findings from 2005 and  2007 FDA studies.”  This statement is consistent with FDA’s findings.  According to its public Web site, those studies on qualified health  claims found  that “qualifying statements … were not understood by  consumers” and “even when … understood as intended, qualifying  statements had unexpected effects on consumers’ judgments about the  health benefits and overall healthfulness …. ”
section_title: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Erin Lansburgh, Assistant  Director; Beverly Peterson, Analyst-in-Charge; Kevin S. Bray; Abby Ershow;  Bart Fischer; Jennifer Harman; Natalie Herzog; Luann Moy; Allison O’Neill;  Minette Richardson; Carol Herrnstadt Shulman; and Marcia Whitehead  made key contributions to this report.