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NewsRegulatoryFDA

FDA Proposes Enhancing its Regulatory Authorities Alongside FY 2024 Budget Request

FDA overlay dollar bills
March 9, 2023

The U.S. Food and Drug Administration (FDA) has announced it is requesting $7.2 billion as part of the president’s fiscal year 2024 budget, $128.2 million of which the agency intends to invest in food safety and nutrition modernization, including food labeling and animal food safety oversight. The agency also announced a number of legislative proposals that enhance its regulatory authorities alongside the funding requests.

According to FDA, while the agency is in the process of defining its new vision for the Human Foods Program, there is significant need for additional resources to strengthen its foundational food safety and nutrition capacity. FDA requests $128.2 million to strengthen consumer protection and implement lasting solutions for more efficient operations through continued investments in the New Era of Smarter Food Safety. Building on lessons learned from the infant formula supply chain response, the budget also includes funding to modernize infant formula oversight and strengthen efforts to respond to shortages of critical foods, empower consumers to make healthier food choices, and reduce exposure to toxic chemicals in the food supply through the Closer to Zero initiative.

The $128.2 million will also help position FDA to keep pace with innovative and novel technologies being used to develop animal food ingredients, as well as to address foundational gaps in the oversight of the animal food industry as ingredients are combined, packaged, and sold as animal food.

In addition to the $128.2 million for food safety and nutrition, FDA has requested $10 million in further investments in enterprise data and information technology (IT) modernization, $16 million for regulatory and mission support functions within the Office of the Commissioner, and $9.4 million for FDA buildings, facilities, and infrastructure improvements. The remainder of FDA’s $7.2 billion budget would be allocated to the agency’s medical, drug, and cosmetics activities.

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

  • Require animal drug sponsors to make post-approval safety-related labeling changes based on new data, develop programs for safe use of certain products, and require post-approval studies based on new safety information that becomes available after approval
  • Provide FDA the ability to exclude certain products or classes of products that the agency and the U.S. Environmental Protection Agency (EPA) agree are more appropriately regulated by EPA as pesticides, and facilitate an orderly transfer of regulatory responsibility from EPA to FDA of specified products that are currently registered as pesticides that the two agencies agree are more appropriately regulated by the FDA as animal drugs
  • Broaden FDA’s authority to request records or other information in advance of or in lieu of inspections to include all FDA-regulated product areas, explicitly to include food, tobacco, and cosmetics
  • Expand FDA’s mandatory recall authority to cover all human and animal drugs
  • Enhance tools to help reduce exposure to toxic elements in the food supply, including food consumed by infants and young children, including new authority to establish binding contamination limits in food and efficiently update such limits as new scientific information becomes available
  • Require industry to test final food products marketed for consumption by infants and children for toxic elements and allow FDA access to those records.
KEYWORDS: budgets FDA regulatory authorities

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