Food Labeling
FDA Needs to Better Leverage Resources, Improve Oversight, and Effectively Use Available Data to Help Consumers Select Healthy Foods
GAO-08-597, Oct 9, 2008
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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.
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.
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Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
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Recommendations for Executive Action
Recommendation: The Commissioner, FDA, should better leverage resources to carry out food safety and other regulatory responsibilities, including administering and enforcing labeling requirements, by 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.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - Implemented
Comments: FDA has provided information on implementation of the Food Protection Plan, which was released in November 2007 under the previous Administration, to Congress and the public. For example, FDA posted on its website a one-year progress report on implementation. In the current Administration, the President established a multi-agency Food Safety Working Group to make recommendations to improve the food safety system. The group, chaired by the Secretaries of the Department of Health and Human Services and the Department of Agriculture, has recommended a new, public health-focused approach to food safety. The Food Safety Work Group established a website which provides the group's goals, activities, and achievements.
Recommendation: The Commissioner, FDA, should 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.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - Implemented
Comments: Since GAO issued its report, FDA has provided technical assistance to the Congress on these matters. In March 2009, President Obama established the multi-agency Food Safety Working Group to make recommendations on updating our food safety laws, fostering coordination throughout government, strengthening surveillance, and enhancing enforcement. In July 2009, the group issued its key findings on how to upgrade the food safety system for the 21st century, recognizing the need to modernize the food safety statutes. Some of the necessary legislative authorities it highlighted are the ability to require preventive controls and the ability to access food safety records at facilities. In July 2009, the House of Representatives passed H.R. 2749, the Food Safety Enhancement Act of 2009, which includes many of the recommendations of the President's Food Safety Working Group and provides the federal government with appropriate tools to accomplish its core food safety goals. Among other things, the legislation provides FDA with mandatory recall authority and grants FDA a new dedicated source of funding to help conduct its vital work of protecting the food supply. At this time, FDA continues to provide technical assistance to Congress as the Senate works on similar legislation, S.R. 510, the Food Safety Modernization Act.
Recommendation: The Commissioner, FDA, should 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.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA agreed with the critical need to be transparent with information related to serious food safety risks and noted that it already posts and maintains much of the information on its website, which it intends to keep as up to date as possible. Although it said it would look at ways to expand the information it posts, FDA did not give specific areas or timeframes for doing so.
Recommendation: The Commissioner, FDA, should ensure that labeling office managers have the information they need to oversee compliance with food labeling statutes and regulations by tracking regulatory meetings related to food labeling violations and analyzing whether regulatory meetings are an effective use of resources.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: Although FDA plans to track regulatory meetings, it has not started to do this yet.
Recommendation: The Commissioner, FDA, should ensure that labeling office managers have the information they need to oversee compliance with food labeling statutes and regulations by analyzing violation data in routine management reports.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA agreed that being able to track and analyze violation information would be useful, and that it plans to implement a routine review of violation data to inform FDA's compliance activities in the labeling area as resources permit. FDA has not taken action to analyze violation data in routing management reports.
Recommendation: The Commissioner, FDA, should 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.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Open
Comments: FDA partially implemented this recommendation. For Warning Letters issued since September 2009, FDA has issued and posted a Warning Letter close-out letter on its Website when a firm has sufficiently addressed violations/deviations cited in the Warning Letter, and each close-out letter is linked to the Warning Letter.
Recommendation: The Commissioner, FDA, should better leverage resources to carry out food safety and other regulatory responsibilities, including administering and enforcing labeling requirements, by 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.
Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration
Status: Closed - Implemented
Comments: FDA with the Centers for Disease Control and Prevention asked the Institute of Medicine (IOM) to undertake a review of front-of-package nutrition rating systems and symbols. An IOM committee will focus on the elements of the nutrition rating criteria and science underlying the front-of-package systems. FDA officials also reported that they have had many discussions with other federal partners about front-of-package labeling. FDA leveraged its resources further by signing on to the National Cancer Institute's Diet and Communication program regarding the Impact of Communication Strategies at Multiple Levels on Dietary Behavior Change, providing opportunity to further participate in discussions and share research information on communication strategies to promote healthy dietary behaviors.