A mandatory GRAS notice still lets a company sell first and file later. The payoff industry wants sits in the preemption clauses of laws Texas and Louisiana already passed.
Robert F. Kennedy Jr. announced a proposed rule on Monday requiring food companies to tell the FDA when they decide an ingredient is safe. The rule creates a public database. It does not create a gate: a company can put a substance on shelves before it files, and keep selling while the agency reviews. Six days earlier, 269 food and agriculture trade groups wrote to Congress asking for a federal ingredient standard that sets both the floor and the ceiling. That second word is the whole trade. A ceiling means states cannot go further, and nine states have already passed laws that go much further.
Kyle Diamantas, the acting FDA commissioner, said the notifications are mandatory. Asked how the government would enforce that against a company already selling the ingredient, he confirmed suppliers can still go to market before notifying anyone. Advocates who spent a decade attacking the self-certification system called the proposal a first step. The Food Industry Association called it an important step and then pivoted, in the same statement, to what it wants next: a nationally uniform framework that avoids a fragmented state-by-state patchwork.
Read those two reactions together and the rule stops looking like a crackdown.
What Happened
The FDA proposed amending 21 CFR parts 170 and 570 to require anyone introducing a substance into interstate commerce under the Generally Recognized as Safe provision to notify the agency of the basis for that conclusion. The requirement covers ingredients added to food and substances that migrate out of packaging. Companies with substances already on the market get a time-limited streamlined pathway: submit the substance identity, intended uses, use levels, and evidence it was already in commerce. The FDA publishes that on a list.
The agency was explicit that appearing on the list does not mean it reviewed or agreed with anything.
The mechanics run long. Comments stay open 120 days from the August 11 Federal Register publication. The FDA gets 45 days to decide whether to file a submission as a notice, then 180 days to respond, extendable by two further 90-day periods. Once a final rule publishes, it takes effect after 60 days, and companies get 18 months after that to comply. Practitioners tracking the docket expect a binding final rule no earlier than late 2028, given the comment volume and the litigation that follows any FDA chemical rulemaking.
Kennedy also said the federal definition of ultraprocessed food is under final review. He promised that definition by April. It did not arrive Monday either, and HHS gave no date.
The Backstory
Congress wrote the GRAS exemption into the Food, Drug, and Cosmetic Act in 1958 for ingredients everyone already trusted, things like vinegar and salt. In 1997 the FDA stopped policing determinations directly and opened a voluntary notification channel. Companies could file a dossier and receive a letter saying the agency had no questions, or they could convene their own expert panel, reach their own conclusion, and sell.
Most chose the second route. EWG’s 2022 analysis found industry, not the FDA, greenlit close to 99% of new food chemicals since 2000. The FDA’s Human Foods Program had filed more than 1,200 GRAS notices as of March 2025, across 29 years of the voluntary program. In the proposed rule the agency cited a 2011 estimate of roughly 1,000 human food substances circulating on independent conclusions it never saw. Pew put the broader number at 10,000 additives permitted in food, about 3,000 of which the FDA has never assessed.
Kennedy directed the FDA in March 2025 to explore eliminating self-affirmation outright. Monday’s proposal does not do that.
While the federal process ground forward, legislators in the states moved. MultiState counted more than 140 food additive bills across 38 states in 2025. Nine states have now enacted school or retail restrictions on color additives. California’s AB 418 and the Texas warning-label statute both bite on January 1, 2027. West Virginia’s retail ban is already running. In April 2026 the New York legislature passed the Food Safety and Chemical Disclosure Act, 106 to 32 in the Assembly and unanimously in the Senate, and sent it to Governor Hochul.
New York’s bill does what the federal proposal declines to do. It bars the sale of any GRAS substance that has not been reported to state regulators and entered in a public database. No listing, no sale. The weaker rule is the federal one.
The Plan
Three months ago the industry stopped fighting disclosure and started buying uniformity.
Americans for Ingredient Transparency, a coalition running the campaign, commissioned Policy Navigation Group to price the alternative. That February 2026 analysis put the combined cost of the Louisiana, Texas and West Virginia laws at $12.2 billion a year against a single federal framework, and translated it into a 12% grocery increase. A separate study for Job Creators Network estimated label update costs at $14.8 million under one national standard versus $381 million under fifty, a ratio of about 26 to 1. On July 28 the coalition sent Congress a letter signed by 269 organizations. Senator Bill Cassidy, who chairs the Senate HELP Committee, has said he will keep working on a national uniform standard.
The asks in that letter are specific. A single national standard for ingredient review, use and labeling. A modernized GRAS framework implemented uniformly across all states. And the FDA reaffirmed as the authority setting both the floor and the ceiling of ingredient regulation.
Texas wrote the escape hatch into its own statute. SB 25 switches off its warning requirement for any ingredient the FDA or USDA prohibits, requires a warning for, determines safe for human consumption, or covers with an ultraprocessed labeling rule. Louisiana’s SB 14 contains a similar clause keyed to federal action that is equivalent or more restrictive. Texas health regulators then read their own preemption provision to reach existing FDA rules, not only new ones, which would exempt most of the 44 listed ingredients before the law ever takes effect. A federal court has enjoined the Texas warning requirement on First Amendment grounds, and the state appealed to the Fifth Circuit in March.
Every route out of the patchwork runs through Washington. The industry noticed.
The Business Model Angle
Compliance is a fixed cost, and fixed costs are how incumbents win.
A GRAS dossier requires the same evidentiary standard whether a company files it or keeps it in a drawer. The safety data obligation does not change under the proposed rule. What changes is that someone has to assemble the paperwork, pay the regulatory affairs staff, and manage a filing that the FDA may question. Nestlé absorbs that against $100 billion in revenue. A specialty enzyme house with eleven employees absorbs it against a product line. The rule raises the price of introducing a new ingredient without raising the price of selling an old one, which protects the ingredients already in the pantry.
Notice who signs the filing. The obligation attaches to the party introducing the substance into interstate commerce, which in practice means the flavor, color and functional ingredient supplier rather than the brand on the box. Givaudan and Kerry carry the compliance load. General Mills and Kraft Heinz collect the preemption benefit. The brands lobbying hardest for this framework are asking their suppliers to fund it.
The reformulation concession costs even less than the filing. Nestlé USA finished removing FD&C colors from its entire US portfolio on June 15, 2026, and had cleared more than 90% of that portfolio before it ever made the pledge. General Mills and Kraft Heinz both aim at the end of 2027, and both told investors the large majority of their products already carried no certified colors. The industry handed over something it had mostly spent a decade paying for, and asked for a federal ceiling in return.
That is a good trade in any category, and packaged food needs one. Procter & Gamble closed fiscal 2026 with volume contributing nothing to growth, a pricing engine that ran out of room after four years. Regulatory uniformity does not sell a single extra unit, but it removes a line from the cost structure that scales with the number of jurisdictions rather than the number of customers. Fifty rulebooks means fifty label SKUs, fifty legal reviews, and fifty enforcement exposures on a product designed to run one national formula through one national plant network.
The Risk
The industry’s own numbers deserve scrutiny before anyone repeats them.
Louisiana, Texas and West Virginia hold about 37 million people, roughly 11% of the country. Scale the $12.2 billion figure nationally and you get something above $100 billion a year against US food-at-home spending in the neighborhood of $1.1 trillion. Reaching a 12% grocery increase requires believing that swapping colorants and printing warning text moves the checkout total by more than a tenth. Synthetic dyes cost a fraction of a cent per unit, and the same companies told shareholders their portfolios were already 85% to 90% clear of them. Treat the number as a statement of what industry will pay for preemption, not as a price forecast.
The second risk cuts against the deal. The FDA’s streamlined listing pathway says outright that publication implies no agency review or agreement. A substance sitting on a public list has not been determined safe for human consumption, which is the trigger Texas SB 25 actually names. Industry may find the registry generates transparency without generating the preemption findings it wants, in which case the rule delivers the cost and not the benefit.
Then there is arithmetic. HHS says the FDA evaluates about 75 GRAS notices a year. Against the agency’s own cited estimate of 1,000 substances already circulating on independent conclusions, clearing that stock as full notices runs past thirteen years. The streamlined pathway exists because the review capacity does not, which is the honest reason this proposal builds a filing cabinet instead of a gate.
And the clock is the thing nobody at Monday’s event mentioned. State requirements bind manufacturers in five months. On a best case that assumes a final rule in late 2028, the federal notification requirement binds them in forty-eight. Whatever Congress does, companies spend the next four years complying with the states.
Quick Questions
Does the rule stop a company from selling a new ingredient? No. A supplier can market a substance before notifying the FDA and keep selling while the agency reviews the notice.
When does it actually apply? Comments close 120 days after August 11. A final rule takes effect 60 days after publication, with an 18-month compliance window after that. Practitioners expect nothing binding before 2030.
Why would food companies want more regulation? One federal rulebook costs less than fifty state ones, and several state statutes turn themselves off once the federal government acts on a listed ingredient.
What happened to the ultraprocessed food definition? Kennedy said it is under final review. HHS gave no release date. A federal labeling rule for ultraprocessed food is one of the four triggers that would void the Texas warning requirement.
Who pays for the filings? The ingredient supplier that introduces the substance, not the brand that puts it in a product.
The Business Model Analyst Take
Monday produced a registry and a lobbying position, in that order.
The registry is worth having. Regulators and the public will learn which substances are circulating, and that information has been missing since 1997. Peter Lurie at the Center for Science in the Public Interest is right that the change works slowly, because the backlog of substances that entered quietly is large and the FDA’s review capacity is not.
The lobbying position is the part with money attached. Every serious constraint on food ingredients in this country now comes from state legislatures, and the packaged food industry has priced that exposure at $12.2 billion a year from three states. A federal framework that sets a ceiling ends the exposure permanently. Disclosure paperwork is a cheap price, especially when the reformulation half of the bargain was already paid and the filing half lands on suppliers.
Watch the strength of what gets preempted. New York passed a law that bans the sale of unreported GRAS substances. The federal proposal permits the sale of unreported GRAS substances while the FDA reads the file. If Congress converts the weaker standard into a national ceiling, industry will have traded a filing cabinet for the right to overwrite every state that built a gate. Supply chains work the same way. Concentration turned one lettuce processor into a single point of failure for the entire fast food category, and when that failed, Taco Bell bought its traffic back with dollar promotions rather than absorbing the reputational hit. Companies that operate at national scale, including Nestlé, optimize for one standard applied everywhere. Kennedy just offered them the mechanism to get it.
