The appropriations bill for FY 2026 prohibits FDA from using federal funds to implement FSMA 204 before the delayed July 2028 compliance date. Earlier implementation of the Traceability Rule could have enabled faster, more effective response to the ongoing cyclosporiasis outbreak linked to Taylor Farms lettuce.
The resource provides recommendations and examples for implementing FSMA Preventive Controls for Human Foods Rule requirements to control known or reasonably foreseeable biological hazards in fresh-cut produce.
The self-affirmed GRAS pathway has supported innovation in the food industry for decades by allowing companies to bring new ingredients to market based on robust scientific evidence. As FDA considers changing this pathway, manufacturers should understand both the criticisms driving the debate and the steps they can take to prepare for potential regulatory change.
Federally defining UPFs could allow U.S. regulatory agencies to pursue specific policies for the category. The importance of processing versus nutrient content and formulation in causing diet-related chronic diseases, as well as the value of defining UPFs, has been heavily debated.
Importantly, the proposal would not establish a premarket review and approval process for GRAS substances. Companies could still independently conclude that a substance is GRAS and market it while FDA evaluates the notice.
Two topics of increasing regulatory scrutiny—the "Generally Recognized as Safe" (GRAS) rule and a federal definition of ultra-processed food (UPFs)—have seen some movement at the U.S. Government's Office of Management and Budget, signaling progress on the Trump administration's food policy agenda.
FDA has announced the fiscal year (FY) 2027 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP).
The notice formalizes proposed reorganization plans that surfaced in April 2025 amid the federal government-wide RIFs and the mass overhaul of HHS that occurred shortly after President Trump took office, spearheaded by DOGE.
At least 1,947 people infected with Cyclospora who had exposure to Taco Bell have been reported in nine states. Michigan and Ohio are together reporting more than 10,000 cyclosporiasis cases. FDA is investigating three other outbreak clusters.
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