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. 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. 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. 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. 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. 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.