FDA Pursues Most Sweeping Food Chemical Safety Overhaul in Decades as GRAS Reform, Dye Phase-Out, and PFAS Limits Converge
The FDA is simultaneously overhauling its GRAS ingredient notification system, phasing out petroleum-based food dyes by year-end, and confronting PFAS contamination in produce, marking the broadest transformation of US food chemical regulation since the 1958 Food Additives Amendment.
Overview
Three regulatory initiatives are converging at the US Food and Drug Administration in 2026, together representing the most comprehensive reassessment of food chemical safety since Congress passed the Food Additives Amendment in 1958. The agency is preparing a proposed rule to end the decades-old practice of allowing companies to self-certify food ingredients as safe without FDA review, working to eliminate all petroleum-based synthetic food dyes from the American food supply by year-end, and grappling with new research showing that PFAS contamination in conventionally grown produce is far more pervasive than previously understood.
Each initiative alone would constitute a significant shift in food policy. Their simultaneity reflects both the political momentum of the administration’s Make America Healthy Again agenda and mounting scientific evidence that the existing regulatory framework has failed to keep pace with industrial food chemistry.
The GRAS Overhaul: Closing a 28-Year Loophole
The most structurally significant of the three initiatives is the FDA’s forthcoming proposed rule on Generally Recognized as Safe, or GRAS, notifications. Since 1997, the FDA has operated a voluntary notification system under which companies may introduce food substances they have independently determined to be GRAS without submitting safety data to the agency. The result, as Mark Hartman, the FDA’s director for food chemical safety, acknowledged at an American Chemistry Council conference in February, is that the agency lacks visibility into how many GRAS substances currently exist in the food supply. “No one knows,” Hartman said.
The proposed rule, which has completed its initial review at the White House Office of Management and Budget and is expected to be published in late spring or early summer, would require companies to notify the FDA before introducing any new GRAS substance and provide supporting safety data. Exemptions would be limited to substances already listed by the FDA, those that have received a “no questions” letter, or those covered by existing regulation.
The shift comes at the direction of HHS Secretary Robert F. Kennedy Jr., who in March 2025 instructed the FDA to explore rulemaking to eliminate the self-affirmation pathway. Kennedy has described the current system as treating new chemicals as “innocent until proven guilty” and has signaled the administration’s intent to act on a citizen petition filed by former FDA Commissioner David Kessler that challenges the GRAS status of certain refined carbohydrates used in ultra-processed foods, including corn syrups, maltodextrin, and extrusion-modified flours.
A parallel white paper on a systematic post-market assessment framework for ingredients already in the food supply is also expected this spring. The FDA has begun formal safety reassessments of phthalates, propylparaben, butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT), chemicals used as preservatives and plasticizers in food and food packaging for decades.
Congressional action is advancing in tandem. The Better Food Disclosure Act (S. 3122) would mandate notification for all GRAS substances — including those already on the market — and establish a post-market review process. The bill’s sponsors have framed it as complementary to, rather than a replacement for, the FDA’s rulemaking effort.
Synthetic Dyes: A Voluntary Phase-Out With an Uncertain Enforcement Mechanism
The second prong of the overhaul targets the nine petroleum-based synthetic dyes currently authorized for use in American food. In April 2025, HHS and the FDA announced a plan to phase out all synthetic food dyes and replace them with natural alternatives. The FDA immediately initiated revocation proceedings for two rarely used dyes — Citrus Red No. 2 and Orange B — and set a target of eliminating the remaining six widely used dyes (FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3) by the end of 2026.
The agency simultaneously authorized four new natural color additives — calcium phosphate, galdieria extract blue, gardenia blue, and butterfly pea flower extract — to provide manufacturers with alternatives. HHS Secretary Kennedy stated that synthetic dyes “offer no nutritional benefit and pose real, measurable dangers to our children’s health.”
But the enforcement mechanism remains voluntary. The phase-out relies on what the FDA has described as an “understanding” with major food companies rather than a formal ban backed by regulatory authority. While manufacturers including Nestlé, Kraft Heinz, and J.M. Smucker have committed to reformulation timelines, the transition to natural alternatives has proven more technically complex than anticipated. Natural dyes behave differently under heat, light, and acidity, and the FDA’s new working definition of “natural” — which includes dyes manufactured via fermentation from yeast, algae, or fungi, or extracted from plants bred to maximize color production — has raised questions about whether the replacements represent a meaningful improvement.
The separate ban on FD&C Red No. 3, ordered by the FDA in January 2025 under the Delaney Clause after the dye was found to induce cancer in laboratory animals, carries mandatory compliance deadlines of January 2027 for food and January 2028 for ingested drugs. The FDA has requested that companies remove Red No. 3 ahead of those deadlines.
At the state level, the regulatory pressure is intensifying. Nearly 350 PFAS- and food-additive bills were introduced across 39 states in 2025. West Virginia passed a law prohibiting all seven major synthetic dyes effective January 2028, though a preliminary injunction has partially blocked enforcement. Texas enacted a law requiring warning labels on foods containing 44 specified ingredients, though its scope was narrowed by regulatory interpretation and a First Amendment challenge in February 2026.
PFAS in the Food Supply: From Packaging to Produce
The third front involves per- and polyfluoroalkyl substances, the class of synthetic chemicals known as “forever chemicals” for their environmental persistence. While PFAS contamination in food packaging has been a regulatory target for several years — the European Union’s Packaging and Packaging Waste Regulation imposes strict PFAS limits on food-contact packaging beginning August 12, 2026 — recent research has exposed a more fundamental pathway: PFAS-containing pesticides applied directly to crops.
An Environmental Working Group analysis of California Department of Pesticide Regulation data, published in March 2026, found that 37 percent of nearly 1,000 conventionally grown produce samples contained PFAS pesticide residues. Researchers identified 17 different PFAS pesticides on 40 types of fruits and vegetables. The highest concentrations of fludioxonil — classified as an endocrine disruptor by the European Food Safety Authority — appeared on lemons at more than one part per million, followed by peaches, nectarines, pears, plums, blueberries, and apricots. More than 90 percent of nectarines, plums, and peaches tested positive for fludioxonil. California produces nearly half of the nation’s vegetables and more than 75 percent of its fruits and nuts, giving the findings national significance.
A separate study of Long Island farmland found PFAS in every produce sample tested, pointing to soil and water contamination from the historical application of sewage sludge as fertilizer. Researchers at the University at Albany are investigating how PFAS from sludge-spreading migrates into food crops through root uptake.
The health implications continue to sharpen. A study published in Frontiers in Aging in February 2026 found that two PFAS compounds — perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA) — detected in 95 percent of participants in a nationally representative sample, were strongly linked to accelerated biological aging in men between 50 and 64, as measured by DNA methylation patterns across 12 established epigenetic clocks. The EPA is currently reviewing emergency exemption requests from Arkansas and Missouri to use tetflupyrolimet, an unregistered PFAS pesticide, on a combined 646,000 acres of rice.
The Structural Challenge
The convergence of these three initiatives exposes a structural tension at the heart of US food regulation. The GRAS reform seeks to impose pre-market scrutiny on new ingredients, but thousands of substances already circulate through the food supply under the old voluntary framework. The dye phase-out targets a visible and politically salient category of additives, but its voluntary enforcement mechanism raises questions about whether the same approach can scale to less conspicuous chemicals. And the PFAS findings suggest that contamination pathways extend well beyond the ingredients and packaging the FDA directly regulates, reaching into agricultural inputs governed by the EPA.
The FDA’s 2026 Priority Deliverables also include launching the Better Regulatory Inspections for Dynamic Government Efficiency initiative, which delegates routine food safety inspections to state partners while maintaining federal standards, and releasing an updated Food Code to modernize state-level regulatory frameworks.
Whether these reforms amount to a durable restructuring of food chemical oversight or a politically driven sprint that outpaces the agency’s enforcement capacity will depend on several factors still in motion: the scope of the final GRAS rule, industry compliance with the voluntary dye phase-out deadline, and whether Congress provides the FDA with the resources and statutory authority to sustain post-market surveillance at scale. The proposed GRAS rule’s public comment period, expected this summer, will be the first concrete test of how far the food industry is willing to let the pendulum swing.