Researchers observed inflammatory responses, gut barrier damage, and immune effects relevant to allergy development in experiments with two emulsifiers, soy lecithin and DATEM. Study author Dr. Cezmi Akdis said the findings support “a more comprehensive framework” for evaluating food additive safety.
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.
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.
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.
The findings from a pre-competitive, industry–academia research collaboration provide a scientific foundation for discussions on quality standards and risk management in the plant-based dairy-alternative beverage sector.
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