New York's Food Safety and Chemical Disclosure Act: A State-Level Overhaul of GRAS Regulation

New York has passed sweeping food additive legislation that, if signed by Governor Kathy Hochul, will fundamentally reshape how food manufacturers and suppliers operate in the state. The Food Safety and Chemical Disclosure Act (S1239F) would establish the first state-level disclosure and database regime for substances that companies have independently determined to be "Generally Recognized as Safe" (GRAS). The bill represents a significant escalation in state-level food safety regulation with far-reaching consequences for food manufacturers, ingredient suppliers, and consumer products companies operating in the New York market.

Under the federal Food, Drug, and Cosmetic Act (FDCA), substances that are "generally recognized as safe" are exempt from the premarket approval process required for food additives. Since 1997, the FDA has permitted companies to make these GRAS determinations independently—or "self-affirmed"—without notifying the agency or the public. A manufacturer may simply rely on a qualified expert's opinion and begin using the substance in food products, with no disclosure obligation whatsoever. The Act directly targets this gap by making the self-affirmation process visible for the first time.

Outright Bans on Three Substances

Section 2 of the Act amends New York's Agriculture and Markets Law § 199-a to prohibit the manufacture, sale, distribution, or use in food of three specific substances. FD&C Red No. 3 (搜索)搜索该药品, a synthetic dye long used in maraschino cherries, candies, and certain medications, was banned by the FDA from cosmetics in 1990 but was not pulled from food until January 2025 under federal law. Potassium bromate (搜索)搜索该药品, a flour treatment agent, is already banned in the European Union, United Kingdom, Canada, and elsewhere but remains permitted federally in the United States. Propylparaben查看药品详情, a preservative with alleged endocrine-disrupting properties, is already banned in food in the EU.

Retailers with existing stock would receive a transition period, allowing continued sale until the earlier of the product's expiration or "sell by" date, or three years after enactment. The New York Commissioner of Agriculture and Markets must amend the state exemption list at least 180 days before the ban's effective date.

The GRAS Disclosure Regime

The Act creates a new Agriculture and Markets Law § 199-h, establishing a mandatory reporting and public database system for GRAS substances used in food sold in New York. Unless a compliant GRAS report has been submitted to the Commissioner and is publicly available in a state-maintained database, it will be unlawful to sell or use any GRAS substance in or on food, make any new use of a GRAS substance in food, or sell any food product containing a GRAS substance. This sweeping prohibition could apply to virtually every processed food product on the market, because the overwhelming majority of food additives, flavoring agents, processing aids, and preservatives used today rely on GRAS status.

The required GRAS report is detailed and must include: identity information including chemical name, CAS or EC registry number, empirical and structural formula composition, and for biological-source substances, full taxonomic identification including any known toxicants in the source material; manufacturing process and description sufficient to evaluate safety as manufactured; dietary exposure estimates covering the intended use, metabolites or reaction products, contaminants or by-products, all sources in the diet, and the assumptions underlying the estimates; a narrative explaining why the substance is safe under its intended conditions of use and how it is generally recognized among qualified experts; any prior GRAS notices submitted to FDA and FDA's responses; and certifications from a responsible official that the report is complete, representative, and balanced.

Critically, trade secret data cannot be the basis for a GRAS conclusion. The Act provides that data establishing general recognition of safety must be based on publicly available information. The Commissioner may redact trade secret information from public-facing reports but cannot redact data that forms the basis for the GRAS safety conclusion.

Exemptions and Limitations

Not every GRAS substance would require a new state report. Exemptions include: substances already reviewed by FDA for which FDA has issued a "no questions" GRAS letter; substances formally approved for use in food or food packaging by the FDA or the U.S. Department of Agriculture prior to January 1, 1958, and recognized as such in federal regulations; food contact substances with effective premarket notifications; substances approved by federal regulation for their intended food use; ingredients widely consumed in the U.S. prior to January 1, 1958, subject only to conventional processing and without known safety hazards; new dietary ingredients for which FDA has acknowledged a notification without objection; and substances the Commissioner determines are safe through rulemaking.

Retailers are protected from liability if they have a valid written contract with their manufacturer, producer, distributor, or supplier certifying that the food product is compliant. Liability flows upstream to manufacturers and suppliers. Small businesses that are independently owned and operated with 100 or fewer employees are entirely exempt from the GRAS reporting requirements. No labeling obligations are created beyond what existing law already requires.

Implementation and Broader Regulatory Context

The Act takes effect one year after becoming law, except that the Commissioner's authority to begin rulemaking is effective immediately upon enactment. The one-year timeline is tight: building and deploying a searchable public database, establishing a filing process, and processing what could be a significant volume of GRAS reports for thousands of substances currently in commercial use will require substantial administrative infrastructure.

The Act complements recent efforts occurring at the federal level to reform the GRAS oversight process. In March 2025, the Secretary of Health and Human Services directed the FDA to explore rulemaking to eliminate the pathway for companies to self-affirm food ingredients are GRAS. On December 1, 2025, the FDA submitted a proposed rule concerning GRAS substances to the Office of Management and Budget for review, which remains pending. A federal bill called The Better Food Disclosure Act of 2025 would amend the FDCA to require notifications to the FDA regarding food substances generally recognized as safe.

The Act is also part of a broader, accelerating state-level movement to fill perceived gaps in federal food safety regulation. California, Illinois, and other states have enacted or are considering similar measures. This trend reflects growing skepticism among state legislators about the adequacy of federal food safety regulation, particularly in light of the FDA's limited resources for reviewing the thousands of substances currently in the food supply.

The practical impact of the Act would be substantial. Companies that have relied on self-affirmed GRAS determinations would need to prepare and submit detailed reports or risk being unable to lawfully sell their products in New York. The Governor's signature and the subsequent administrative rulemaking process will be critical to watch, as the Act signals that the era of truly "self-affirmed" GRAS determinations—made and maintained entirely outside the public view—is drawing to a close, at least in New York.