FDA Has Limited Assurance That Companies Are Complying with Food Labeling Requirements

FDA’s use of oversight and enforcement tools has not kept pace with the  growing number of food firms. FDA’s  testing of nutrition information has been limited and has found varying  degrees of compliance. 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. Food Labeling Oversight Has Not Kept Pace with the Growing Number of Firms

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. 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. 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. However, we found that  FDA’s efforts have generally declined or held steady. 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. The European Commission has  proposed a mandatory, front-of-package labeling system. 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. 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. Analyzing these  data for routine reports could help inform labeling managers’ decisions and  help them target labeling resources. Objectives, Scope, and Methodology

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. 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). GAO Comments

1. 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. 3. 4. 5.
Why GAO Did This Study

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.

What GAO Found

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.