FDA recently proposed the most significant changes to its GRAS framework since 1958. For companies managing ingredient compliance, the proposed mandatory filing obligations raise questions about statutory authority, agency capacity, and whether its design matches its stated objectives.
As a public health and medical practitioner, Dr. Overton does not have a background in food policy or food safety, but has held roles in both Trump administrations. She will replace Dr. Marty Makary, who parted ways with the agency in May.
Aligning with the agency’s priority of supporting agency in phasing out synthetic colorants from the food supply, the petitions seek expanded or new uses for gardenia (genipin) blue, safflower extract, and acetone-extracted carrot oil.
Antimicrobial resistance (AMR) is recognized as a crucial threat to global public health. Antimicrobial use in animal agriculture can contribute to the emergence and spread of increasingly drug-resistant foodborne pathogens, impacting human medicine.
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.
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