Fast Facts

The FDA oversees the safety of about 80% of the nation’s food supply and promotes good nutrition.

According to the FDA, a 2011 law shifted the agency's focus from responding to illnesses to preventing food contamination. We examined actions the FDA has taken since then on food safety, which is a topic on our high risk list, and nutrition.

Among other things, we found the FDA budgeted at least $1 billion a year for food safety (98%) and nutrition (2%).

We recommended that the FDA develop performance measures for all of its food safety and nutrition objectives, and specify how it plans to carry out a strategic plan related to those areas.

 

This is a photograph of a sign marking the Food and Drug Administration.

This is a photograph of a sign marking the Food and Drug Administration.

Skip to Highlights
Highlights

What GAO Found

From the enactment of the FDA Food Safety Modernization Act (FSMA) in January 2011 through September 2017, the Food and Drug Administration (FDA) has conducted numerous food safety- and nutrition-related activities, determining its priorities for those activities based on statutes and its strategic goals. More specifically, FDA published 33 proposed or final key regulations and 111 draft or final key guidance documents, focused mainly on food safety. FDA also conducted other key activities related to food safety and nutrition, such as conducting inspections and developing risk-assessment tools, responding to foodborne illness outbreaks, and providing outreach and education.

FDA dedicated at least $1 billion annually, including salaries for at least 4,300 full-time equivalent (FTE) staff, to food safety and nutrition activities in fiscal years 2011 through 2016. About 98 percent of those resources were dedicated to food safety each fiscal year, and about 2 percent were dedicated to nutrition.

Since fiscal year 2011, FDA has set goals for its food safety- and nutrition-related activities but has not fully developed the necessary framework to assess progress toward those goals. Most recently, for fiscal years 2016 through 2025, the agency's Foods and Veterinary Medicine (FVM) Program, which is primarily responsible for carrying out these activities, has set a food safety goal to protect American consumers from foreseeable hazards and a nutrition goal to foster an environment that promotes healthy and safe food choices. These goals are supported by eight strategic objectives. The program has developed performance measures to assess progress toward five of these objectives but not for the other three. For each developed performance measure, FDA reports both targets set and measurements taken for specific time frames. For one such measure related to FDA's evaluation of food safety hazards, FDA targeted the completion of 50 percent of evaluations by their due dates in the first quarter of fiscal year 2017 and achieved 89 percent. Leading practices in performance management state that federal programs should use performance information to achieve program goals, and each objective should be tracked through performance measures that have targets and time frames. According to agency officials, the program is developing additional measures for its food safety- and nutrition-related objectives, but it had not finalized them as of January 2018. Until the program develops measures with associated targets and time frames for all eight objectives, FDA cannot fully assess progress toward achieving its goals.

FDA has identified food safety- and nutrition-related activities that it plans to undertake in fiscal year 2018, but its time frames for such activities in the longer term are unclear. According to FDA officials, the agency plans to pursue the food safety and nutrition strategies identified in the FVM Program's 10-year strategic plan. However, the specific time frames for the activities that would support those strategies are unclear because FDA has not developed a plan that includes actions, priorities, and milestones to implement the strategic plan. The strategic plan states that the FVM Program will develop such an implementation plan, and FDA officials told GAO that they expected to complete one, but as of January 2018, they had not done so. Until the program completes such an implementation plan, it will be difficult for FDA to ensure it is prioritizing and sequencing the necessary actions to achieve the program's objectives.

Why GAO Did This Study

FDA is responsible for overseeing the safety of about 80 percent of the nation's food supply and for promoting good nutrition. Federal oversight of food safety has been on GAO's high-risk list since 2007. According to FDA, FSMA aims to improve food safety by shifting FDA's focus toward preventing food contamination, rather than responding to foodborne illnesses.

GAO was asked to review FDA's food safety- and nutrition-related activities and resources. This report examines (1) FDA's key food safety- and nutrition-related activities since FSMA's enactment in 2011 and how FDA determined its priorities for those activities, (2) the resources FDA dedicated to those activities in fiscal years 2011 through 2016, (3) the extent to which FDA set goals for those activities in fiscal years 2011 through 2017 and is assessing progress toward those goals, and (4) FDA's planned food safety- and nutrition-related activities and associated time frames. GAO analyzed FDA documents and data for fiscal years 2011 through 2018 and interviewed FDA officials.

Skip to Recommendations

Recommendations

GAO is making three recommendations, including that FDA (1) develop performance measures with associated targets and time frames for all eight of its food safety- and nutrition-related objectives and (2) complete a plan that includes specific actions, priorities, and milestones for implementing the FVM Program's strategic plan. The agency agreed with GAO's recommendations and identified actions to implement them.

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration The Commissioner of FDA should ensure that FVM Program staff uniformly document the bases for their decisions for issuing either regulations or guidance related to food safety and nutrition, such as by using concept papers or guidance initiation sheets. (Recommendation 1)
Closed - Implemented
As of August 2020, FDA had fully implemented this recommendation. Specifiically, in August 2019, FDA stated that it had taken steps to implement our recommendation. According to FDA, pursuant to GAO's recommendation to share templates to foster greater consistency in documentation of decision-making, FDA's Center for Food Safety and Applied Nutrition (CFSAN) has developed and shared with its FDA Foods Program counterparts, project initiation forms for projects involving the development of regulations or guidance related to food safety, nutrition, and cosmetics. FDA provided us with copies of two project initiation form templates: one for regulatory actions and another for guidance documents. In addition, in October 2019, FDA provided us with a standard operating procedure document to help guide the Center for Veterinary Medicine's (CVM) use of CVM's initiation form. Finally, in August 2020, FDA provided us with CFSAN's standard operating procedure document, "Initiating a Regulation, Guidance, or Other Federal Register Notice," which sets forth CFSAN procedures for using the project initiation forms related to food safety, nutrition, and cosmetics.
Food and Drug Administration The Commissioner of FDA should ensure that the FVM Program develops performance measures with associated targets and time frames for all eight of FDA's food safety- and nutrition-related objectives. (Recommendation 2)
Open
As of August 2021, FDA had not fully implemented our recommendation, although the agency reported taking several steps over the past two years. For example, FDA told us that the agency has made progress in developing performance measures related to food safety by launching in 2019 an online Food Safety Dashboard--which displays measures to demonstrate progress in implementing Food Safety Modernization Act (FSMA) rules. Furthermore, in August 2020, FDA told us that following the agency's reorganization in 2018, FDA had aligned the Foods and Veterinary Medicine Program's (FVM) Program's performance measures and the dashboard with the FSMA rules, and that the current alignment covered most, but not all, of the food safety objectives within the FVM Program's strategic plan. At that time, FDA also told us that the agency was reviewing the strategic plan to ensure alignment of its performance measures with FDA's current priorities and structure. However, FDA has not provided a comprehensive list of current performance measures that correspond with each of the FVM Program's eight objectives related to food safety and nutrition. Those objectives are identified in the program's strategic plan for fiscal years 2016 through 2025. As we reported in GAO-18-174, FDA had developed performance measures--which should include the establishment of targets, measurements to be taken, and specific time frames for assessing progress toward strategic goals--for five of the objectives, but FDA had not developed performance measures for the other three objectives. One of those objectives related to food safety, while two objectives related to nutrition. In June 2021, FDA indicated that it was in the process of adding measures to the dashboard in calendar year 2021 and that it continued to work with CDC, HHS, and USDA partners to develop other measures related to food safety and nutrition. However, to fully implement this recommendation, FDA needs to provide an update on its review of the FVM Program's strategic plan and a current, comprehensive list of the program's food safety- and nutrition-related objectives and performance measures that include targets, measurements, and time frames for assessing progress. We will follow up with FDA and provide an update in FY 2022.
Food and Drug Administration The Commissioner of FDA should complete an implementation plan that includes specific actions, priorities, and milestones for the FVM Program's strategic plan. (Recommendation 3)
Closed - Implemented
In August 2020, FDA stated that it will not be issuing an implementation plan mapped to the previous strategic plan due to the agency's reorganization since then. However, the agency has developed several, new strategic planning documents that align with the agency's revised organizational structure and include objectives, actions, priorities, and milestones. Specifically, in 2018, FDA underwent a reorganization of its Office of the Commissioner that affected the structure and combined direction of the Food and Veterinary Medicine (FVM) Program, which is now comprised of the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Office of Food Policy and Response (OFPR, formerly the Office of Foods and Veterinary Medicine), and the Office of Regulatory Affairs (ORA). As a result of the reorganization, each center and office is responsible for developing strategic document(s) that outline its direction and priorities. FDA also reported that CFSAN, CVM, OFPR, and ORA continue to coordinate through the FDA Foods Program Governance Board process, and these components of the FDA Foods Program are developing specific plans that capture most of the information in the previous Food and Veterinary Medicine Strategic Plan. FDA also provided us with several examples of current strategic planning documents that outline specific actions, priorities, and milestones related to food safety and nutrition, such as the 2020 Leafy Greens STEC Action Plan, the New Era for Smarter Food Safety Blueprint, and the FDA Nutrition Innovation Strategy.

Full Report

GAO Contacts