The U.S. Food and Drug Administration (FDA) recently released the Justification of Estimates for Appropriations Committees for the agency’s fiscal year (FY) 2023 budget, covering the October 1, 2022 through September 30, 2023 time period.1 The agency is requesting a total budget of $8.4 billion, of which $1.2 billion is being requested for the Foods Program, a $120 million increase from FY 2022 funds. The requested food funding is intended to support FDA’s public health agenda for foods, which includes additional investments in food safety modernization, improved health equity through nutrition, and enhanced inspectional capacity. Agency funding priorities highlighted in the FY 2023 budget include reducing heavy metals in foods for infants and young children, more closely monitoring the marketing of dietary supplements, more quickly responding to foodborne outbreaks, and addressing emerging chemical and toxicology issues such as food-contact substances and allergens.
The budget also includes a package of legislative proposals to Congress that seek to expand FDA authority in areas such as record requests and remote inspections, destruction of certain imported products, product testing and contamination limits for foods marketed for infants and young children, dietary supplement enforcement, and oversight of potential food shortages. The budget proposal is a request to Congress for funding and legislative authorities. Congress must authorize any funding through the Appropriations process and similarly enact any legislative changes to the Federal Food, Drug and Cosmetic Act (FFDCA).
Budget Requests
For the Foods Program, FDA would allocate some of the requested funding as follows. Many of these requests are broadly worded in the budget and additional details are not available currently.
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Emerging Chemical and Toxicology Issues in Food. The FY 2023 budget proposal includes an increase of $19.5 million to address “emerging chemical and toxicology issues” in food. Among other things, the agency would use this funding to address allergens, Per- and Polyfluoroalkyl Substances (PFAS), and dietary supplements.
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Allergens – FDA would use a portion of allocated funding to “develop new allergen and gluten testing methods,” “hire staff to develop new compliance policies and coordinate industry compliance and increased enforcement activities,” and “expand scientific review capacity to assess the public health importance of allergens other than the major food allergens for which additional controls may be needed, including manufacturing controls and labeling.”
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PFAS – FDA is requesting funds to hire additional experts to evaluate PFAS, communicate potential risks to the public, and support state and federal agencies in coordinated responses to PFAS.
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Dietary Supplements – FDA would use allocated funds to “expand efforts related to guidance development, technical assistance and training for industry and FDA investigators” focused on dietary supplements.
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Healthy and Safe Food for All. The FY 2023 budget proposal includes a request for a $13.5 million increase in funding “to improve health equity through nutrition and reducing exposure to harmful toxins in food.” The agency also proposes to increase its regulatory capacity for dietary supplements, among other things.
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Heavy Metals in Foods – A portion of requested funding would be used to address heavy metals in foods. For example, funds would be used to extend outreach beyond children and parents to “other potentially vulnerable populations” and produce education materials “to help consumers make healthy choices that reduce their exposure to toxic elements.”
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Dietary Supplements – FDA would also increase its scientific and regulatory capacity related to dietary supplements by “funding necessary IT system development and new [full time employees] (FTE) to review additional product data, prioritize FDA investigations, and take compliance actions as needed to ensure that consumers who seek to augment their health with dietary supplements are protected from unsafe or otherwise unlawful products.”
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Maternal and Infant Health and Nutrition. The FY 2023 budget proposal includes a requested $18 million increase to address maternal and infant health issues, which would cover staffing increases to undertake premarket review of infant formula submissions and evaluate the safety of foods for infants, young children, and pregnant and lactating women, among other things.
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Closer to Zero Action Plan – According to the budget proposal, FDA would use allocated resources to increase staffing of risk analysts, consumer safety officers, toxicologists, and other experts, which would allow the agency to expand certain research on neurodevelopment and “develop more accessible and affordable laboratory detection methods necessary for ensuring industry compliance with interim action levels.” FDA would also “develop technical assistance education materials for the industry, which outline requirements for managing and minimizing the presence of toxic elements in their products.”
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Infant Formula – FDA would use appropriated funds to expand staffing dedicated to premarket review of new infant formulas in response to a reported increase in the infant formula submission rate and the increasing complexity of submissions. Additional capacity would also be used to address infant formula outbreak and recall situations.
Legislative Proposals
The FY 2023 budget also includes a number of legislative proposals. These proposals are requests to Congress to expand FDA authority in certain areas, which could be granted in potential future legislation by the amending of the FFDCA. The following are legislative proposals that would address key areas related to food. Beyond brief summaries in the budget request, the agency has provided little detail on how these legislative requests could be carried out by Congress.
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Expansion of FDA Inspection Authority – FDA is proposing that Congress amend Section 704(a)(4) to cover all FDA-regulated entities, including facilities that manufacture human and animal foods, which would give FDA the authority to review records or other information (in electronic or paper form) in advance or in lieu of an inspection. It also proposes to give FDA “explicit authority to conduct remote regulatory assessments with establishments, which may include remote interactive evaluations such as livestreaming video of operations, teleconferences, and screen sharing, so FDA may interact virtually with an establishment and assess its compliance with applicable laws and regulations.” The budget proposal does not specify where this authority might appear in the FFDCA. According to FDA’s budget justification, the proposal is intended to allow FDA to interact virtually with an establishment and assess compliance with applicable laws and regulations prior to or instead of conducting an in-person inspection.
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Product Testing Requirements for Foods Marketed for Consumption by Infants and Young Children – FDA is requesting Congress amend the FFDCA to give the agency authority to “(1) require industry to conduct toxic element testing of final products marketed for consumption by infants and young children and maintain records of these testing results for FDA inspection; and (2) provide FDA with new authority to remotely access records of these test results and to review these test results whenever necessary.” Currently, such testing is not mandatory.
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Enhancing FDA’s Authority to Better Protect Infants and Young Children – FDA is requesting Congress amend the FFDCA to allow the agency to “establish binding contamination limits in foods, including foods consumed by infants and young children, through an administrative order process.” Such an update, the agency claims, would “improve the efficiency, timeliness, and predictability of issuing binding limits to reduce exposure to toxic elements . . . updating limits as new scientific information becomes available.”
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Modernizing the Dietary Supplement Health and Education Act (DSHEA) – FDA is seeking to strengthen its implementation and enforcement of the DSHEA through amendments to the FFDCA that would “(1) require annual listing with FDA of individual dietary supplement products, including basic information about each unique product, and (2) clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products.” According to the agency, these amendments “would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.”
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Authority to Require Destruction of Imported Products that Pose a Significant Public Health Risk – FDA is requesting Congress revise FFDCA § 801 to give the agency the authority to require an owner or consignee to destroy any FDA-regulated product that “has been refused and presents a significant public health concern, thus removing their option to export such product under current section 801(a).” FDA is proposing that the importer of record would be required to pay the destruction costs up front so that the agency does not have to file legal action to recoup these costs.
We will continue to monitor the progress of FDA’s FY 2023 budget request and legislative proposals.
References
1 FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs (Mar. 28, 2022), https://www.fda.gov/news-events/press-announcements/fda-seeks-84-billion-further-investments-critical-public-health-modernization-core-food-and-medical; Food and Drug Administration, Fiscal Year 2023, Justification of Estimates for Appropriations Committees, https://www.fda.gov/media/157192/download.
