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.
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.
The 102nd meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) took place in June 2026 in Nanjing, China. Key outcomes included the establishment of new, temporary acceptable daily intakes (ADIs) for two substances.
Sprinkles may seem like a minor decorative detail on a birthday cake or holiday cookie, but they sit at the intersection of several fast-moving regulatory concerns: the phaseout of certain FD&C dyes, the clean label movement, allergen management, and GMO transparency.
The action aligns with the wishes of FDA and U.S. Health Secretary RFK Jr. for industry to voluntarily phase out synthetic, petroleum-based dyes from the nation’s food supply.
This episode of Food Safety Five discusses new research linking sorbitol to fatty liver disease, studies suggesting potential health risks associated with both “natural” and artificial color additives, and a major collection of papers examining the health impacts, policy, and marketing practices behind ultra-processed foods (UPFs).