FDA: Oversight Responsibilities and Funding from Fiscal Years 2008 through 2024

What GAO Found

The Food and Drug Administration (FDA) regulates a wide variety of products used by U.S. consumers. These products include human food, human and veterinary medical products, cosmetics, and tobacco products. According to FDA, the products for which it has oversight responsibilities accounted for about 21 cents of every dollar spent by U.S. consumers in 2024.

FDA's oversight responsibilities changed during the period of GAO's review-fiscal year 2008 through fiscal year 2024. For example, in 2009, the agency received authority to regulate new types of products, such as cigarettes and other tobacco products. In 2011, FDA was directed by law to increase the number of required food safety inspections. In 2022, FDA's authority to regulate cosmetics was expanded to include recall authority for certain products.

FDA's overall funding increased from fiscal years 2008 through 2024, largely from user fees. Over this 17-year period, the agency went from being funded mostly through discretionary appropriations (which FDA refers to as budget authority) to being funded in nearly equal amounts by user fees and budget authority. User fees are paid by manufacturers and other regulated entities.

Food and Drug Administration (FDA) Overall Funding, by Funding Source, Fiscal Year 2008 through Fiscal Year 2024

Increases in FDA's user fee funding during this time came from both new user fee authorizations (e.g., tobacco products) and the growth of existing user fees (e.g., human drugs).

Food and Drug Administration (FDA) Funding by Product Areas and Funding Source, Fiscal Year 2008 and Fiscal Year 2023

FDA has faced staffing challenges related to recruiting, retaining, and training staff as reported by GAO and others from January 2020 through January 2025. These staffing issues have presented challenges for FDA's food and drug inspections. For example, in 2024,

GAO reported that because of staffing challenges the agency was not able to complete as many drug inspections as it had in prior years. GAO and others also reported during this same period that FDA had challenges with managing other resources, such as its information technology systems for collecting safety and quality complaints.

Why GAO Did This Study

FDA, an agency within the Department of Health and Human Services (HHS), regulates more than $3.9 trillion worth of food, medical products, and tobacco products produced in the U.S. and abroad. Prior to 2020, GAO reported that FDA faced challenges that could affect the agency's ability to perform its oversight responsibilities. These concerns contributed to the addition of FDA's oversight of medical products and food safety to GAO's High-Risk List in 2009 and 2007, respectively. In addition, these concerns contributed to two other areas on GAO's High-Risk List: (1) HHS's leadership and coordination of public health emergencies, and (2) skills gaps in the federal workforce.

Given the breadth of these concerns, GAO undertook a review at the initiative of the Comptroller General in consultation with congressional committees to provide the Congress with contextual information on FDA's capacity to meet its oversight responsibilities.

This report provides information on changes in FDA's responsibilities, funding, and staffing from fiscal year 2008 through fiscal year 2024. It also provides information on challenges affecting FDA's capacity to meet its oversight responsibilities that GAO and others identified in reports issued from January 2020 through January 2025.