The U.S. Food and Drug Administration is requesting a total budget of $8.4 billion as part of the President’s fiscal year 2023 budget – a nearly 34 percent ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure.

The request includes $3.7 billion in budget authority – including an increase of $356 million and $3 billion in user fees – an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.

“The funding outlined in this year’s FDA budget request is critical to fulfilling the agency’s mission as we continue our work on a wide range of COVID-19 and non-COVID priorities. The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight. We also continue to look ahead at our role in public health, including at ways to modernize our efforts to keep pace with evolving science, technology and potential public health emergencies,” said FDA Commissioner Robert M. Califf, M.D. “Additional funding brings new ways to leverage opportunities to protect and advance the health of every American with reliable and science-based information. We look forward to continuing our work with Congress to help meet the critical public health challenges ahead.”

The FY 2023 request, which covers the period from Oct. 1, 2022, through Sept. 30, 2023, fully funds initiatives previously requested in the FY 2022 budget request and includes new efforts for high priority program areas.

Highlights of the agency’s request include:

• $43 million in additional investments in food safety modernization, including animal food safety oversight. The budget builds on the successes of human and animal food safety modernization activities and supports the agency’s continued implementation of the New Era of Smarter Food Safety and other core food safety efforts to enable the FDA to strengthen data-driven approaches to protecting consumers, allocating regulatory oversight resources based on risk and improving the FDA’s capacity to quickly respond to ongoing and evolving public health challenges. Building on the modernized food safety regulatory framework created by the FDA Food Safety Modernization Act, this funding will allow the agency to improve prevention-oriented food safety practices, strengthen data sharing and predictive analytics capabilities and enhance traceability to more quickly respond to outbreaks and recalls for human and animal food. The budget request advances mutual reliance efforts as part of the New Era of Smarter Food Safety by providing significant funding to state animal food programs. In partnership with states, the FDA will expand efforts to modernize, harmonize and transform the U.S. animal food inspection system to become more comprehensive and prevention oriented.
•  $14 million to improve health equity through nutrition. Through the Healthy and Safe Food for All initiative, the budget includes additional funding to reduce exposure to harmful chemicals and toxins in food. Additional funding and legislative proposals will focus specifically on better protecting mothers, infants and young children through contamination limits in food, product testing requirements, notification of anticipated significant interruptions in the supply of infant formula or essential medical foods, as well as modernization of dietary supplement regulation.

To complement the funding requests the agency’s budget proposal also includes a package of legislative proposals designed to bolster the FDA’s authorities to further its mission to protect and promote public health. Notable proposals include efforts to:

• Modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. It is estimated the current supplement market is between 50,000 and 80,000 products. Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market and take appropriate action to protect consumers.
• Require firms to notify the FDA of anticipated significant interruptions in the supply of infant formula or essential medical foods for patients with certain inborn errors of metabolism. This proposal would ensure the agency routinely receives timely and accurate information about likely or confirmed shortages in the U.S. and help the FDA to take steps to promote the continued availability of these foods. Additionally, the FDA is seeking authority to require firms to provide shortage notification for other FDA-designated categories of food during a declared public health emergency.

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