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FDA Announces FY 2026 User Fees

By Nicholas S. Prust on July 30, 2025
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  • In Federal Register notices published on July 30, 2025, FDA announced user fees for fiscal year (FY) 2026 for several of its food programs operating under the Food Safety Modernization Act (FSMA).  These include:
  • FDA’s third-party certification program (90 FR 35906 (July 30, 2025)). The FD&C Act directs to FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities. The FD&C Act also directs FDA to establish a reimbursement (user fee) program to assess fees and require reimbursement for FDA’s work in administering this third-party certification program.
    • User fees for the third-party certification program are determined based on estimated costs, considering factors such as hours worked, travel costs, and inflation. Based on its estimated cost assessment, FDA set user fees for the certification program as follows:
      • Initial application fee for accreditation body seeking recognition: $53,440
      • Annual fee for recognized accreditation body: $2,498
      • Annual fee for accredited certification body: $3,122
      • Initial application fee for a certification body seeking direct accreditation from FDA: $53,440
      • Renewal application fee for recognized accreditation body: $32,724
  • FDA’s voluntary qualified import program (VQIP) (90 FR 35863 (July 30, 2025)). FDA also announced the 2026 user fee of $9,620 for its voluntary qualified importer program (VQIP). VQIP provides expedited review and import entry of food entering the U.S. from participating importers.
  • Certain reinspections and failures to comply with recall orders (90 FR 35910 (July 30, 2025)). FDA announced 2026 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections. These fees will be charged based on time spent by FDA at an hourly rate of $339 if domestic travel is required and $376 is foreign travel is required.
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  • Posted in:
    Food, Drug & Agriculture
  • Blog:
    The Daily Intake
  • Organization:
    Keller Heckman
  • Article: View Original Source

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