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Highlights

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.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 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.
Closed - Implemented
FDA's labeling managers now use the Compliance Management System (CMS) for information they need to oversee labeling compliance and track the correction of labeling violations. According to FDA, CMS captures enforcement actions, the relevant regulations and citations from the Food Drug and Cosmetic Act and the Code of Federal Regulations associated with the actions, and a firm's response to the violations and actions, including details of any corrective actions taken or not taken and why. FDA doubled the number of warning letters issued between FY 2009 and FY 2010 from 26 to 52 for violations associated with mislabeling and misbranding as they pertain to food labeling, and further increased the number issued in FY 2011 to 72, demonstrating that managers' use of CMS data achieves the intent of this recommendation.
Food and Drug Administration 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.
Closed - Implemented
FDA has implemented changes in response to requirements in the 2011 FDA Food Safety Modernization Act (FSMA), which address this recommendation. FSMA identifies the specific risk factors FDA must take into account in determining the risk level of a facility, including, among other things, the known safety risks of the food manufactured, processed, packed, or held at a facility and the compliance history of the facility, including food recalls, outbreaks of foodborne illness, and violations of food safety standards. The risk factor data and analyses to determine the risk levels required under FSMA gives labeling managers information on a facility's food labeling compliance history and labeling violations, which achieves the intent of this recommendation.
Food and Drug Administration 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.
Closed - Implemented
In 2010 FDA told us it would track regulatory meetings over a period of time and, if it determined that the information was useful, it would continue to track these meetings. It decided to do so. In May 2012 FDA reported to us that training and outreach was underway to ensure that labeling office managers were aware that the Compliance Management System (CMS) allowed them to track regulatory meetings and that FDA intended managers to fully utilize that tracking feature. FDA also told us that it was separately providing investigators information on the regulations and guidelines regarding food labeling and misbranding, to provide additional direction. FDA has implemented this recommendation.
Food and Drug Administration 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.
Closed - Implemented
Citing its Transparency Initiative, FDA told us it has increased the amount of information it makes available to the public. It now posts Warning Letters, information on seizures and injunctions and the outcome of inspections, to provide the public information to inform consumers' decisions on products to buy and consume. In addition, in December 2011, FDA began posting Untitled Letters related to food manufacturing and labeling issues. It also revamped the posted recall information in response to the January 2011 FDA Food Safety Modernization Act (FSMA), which called for a more consumer-friendly search engine for the public to access recall information. To address this, FDA began presenting recall data in the form of a user-friendly table. The table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm. Its goal, according to FDA, is to post press releases within 24 hours of receipt from the recalling firm. These measures largely achieve the intent of this recommendation.
Food and Drug Administration 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.
Closed - Implemented
FDA provided technical assistance to the Congress on all aspects of the Food Protection Plan and in particular on user fees, accrediting third parties, and food recall authority, which help leverage FDA's resources. In March 2009, the President established the multi-agency Food Safety Working Group to make recommendations on updating food safety laws, fostering coordination throughout government, strengthening surveillance, and enhancing enforcement. In July 2009, the Working Group issued key findings on how to upgrade the food safety system for the 21st century, and recognizing the need to update the food safety statutes. In January 2011, the FDA Food Safety Modernization Act (FSMA), a sweeping food safety reform law, was enacted. It incorporated key components of the Food Protection Plan, giving FDA mandatory food recall authority and the authority to require certain user fees and accredit third parties to carry out certain inspections. FDA has continued to work with the Congress to ensure the full implementation of these key authorities. FDA's actions achieve the intent of the recommendation.
Food and Drug Administration 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.
Closed - Implemented
With the Food Protection Plan and now the FDA Food Safety and Modernization Act (FSMA), FDA better leverages its resources by using its public Web site, www.fda.gov/fsma, to provide information to the public, ensure transparency, and maintain outreach as implementation progressed. The Web site contains background materials in various formats and multiple languages, videos, fact sheets, and questions and answers that address key provisions in the law. FDA has included an interactive timeline that highlights some of the specific deadlines that FDA has met. Progress reports are periodically posted on the Web site to provide timely implementation, updated daily, for the public and Congress. FDA held several public meetings beyond those required under the key provisions of FSMA or in connection with its rulemaking, to give the public an opportunity to share views and inform FDA's development of guidance and regulations. Although the recommendation pertained to the Food Protection Plan, FSMA incorporated many important Plan provisions; FDA actions to post its progress implementing the FSMA provisions achieve the intent of the recommendation.
Food and Drug Administration 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.
Closed - Implemented
Together with the Centers for Disease Control and Prevention, FDA asked the Institute of Medicine (IOM) to undertake a review of front-of-package nutrition rating systems and symbols. An initial IOM effort focused on the elements of the nutrition rating criteria and science underlying the front-of-package systems. Also FDA officials have had many discussions with other federal partners about nutrition labeling approached and options. FDA also signed 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 FDA opportunity to share research information on strategies for communicating healthy dietary behaviors. In October 2011, IOM released the second report from its study on front-of-package nutrition labeling, with recommendations to FDA on an approach to developing a uniform system. FDA has allowed a few groups, including the Grocery Manufacturers Association and Wal-Mart, to introduce front-of-package systems, which it will evaluate. HHS has contracted for a plan for evaluating front-of-package labeling.

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