• Yesterday FDA released its fiscal year (FY) 2027 budget request of approximately 7.2 billion, an increase of 3.3% as compared to the FY 2026 enacted budget. FDA’s budget consists of budget authority—money allocated out of the Congressional budget— and user fees. The FY 2027 budget represents a 1.4 decrease with respect to budget authority, but a 7.7% increase with respect to user fees.
  • The Human Foods Program’s (HFP) proposed budget is approximately $1.29 billion, representing an increase of 9.2% from FY 2026 enacted. Only 1.0% of the proposed HFP budget is from user fees. The proposed FDA budget includes $9.0 million to HFP to support transitioning of routine domestic food safety inspections to states. It also includes at least $50 million across FDA programs “to support the Secretary’s vision to remove harmful chemicals from the food supply by addressing unsafe chemical additives used in food.” (The budget provides conflicting numbers, $50 million and $57 million, for this purpose). This allocation includes expansion of the Closer to Zero program, the development of models to predict PFAS levels in food-producing animals, and the exploration of legislative changes “to close the GRAS loophole.”
  • However, no legislative changes specifically relating to self-determined GRAS status are included in the legislative proposal section. FDA’s proposed GRAS rule is currently expected to be published by late spring or early summer.  
  • A legislative proposal under the heading “Ensure FDA Access to Industry Data to Strengthen Food Chemical Safety” would require post-market reassessments of chemicals added to food and submission of certain data and results to FDA. Another legislative proposal would establish a biennial registration user fee for all foreign human and animal food facilities (there is no cost currently associated with food facility registrations, whether foreign or domestic). Other food related legislative proposals encompass expanded oversight of infant formula (including expanded testing and reporting requirements), the required destruction of FDA-regulated imports refused entry and which present a public health concern (with no re-export option), and increased food-related information sharing with state, local, Tribal, and U.S. territorial authorities.