New York's Food Safety and Chemical Disclosure Act (SB 1239/AB 1556) has passed both chambers of the legislature and awaits Governor Hochul's signature. If enacted, it would impose a first-of-its-kind state-level mandatory reporting regime for self-affirmed GRAS substances used in food, while also banning Red Dye 3, potassium bromate, and propylparaben. A comprehensive analysis will follow, but here is what companies need to know now.
What the bill requires. Any company that sells, manufactures, or uses a self-affirmed GRAS substance in food sold in New York would be required to submit a detailed safety report to the state—including manufacturing methods, dietary exposure data, and the scientific basis for the GRAS determination—which would be published in a public, searchable database. Substances with an FDA "no questions" letter, those recognized as GRAS in federal regulations, and approved food additives are exempt.
Who is affected. The reporting obligation touches multiple levels of the food supply chain:
- Finished food brands selling products in New York that contain self-affirmed GRAS ingredients must ensure reports are on file for those substances.
- Food ingredient suppliers that have marketed ingredients under self-affirmed GRAS determinations without submitting GRAS notifications to FDA face the obligation directly. Proprietary safety data, manufacturing specifications, and exposure analyses will become publicly accessible. That said, there can be no "general recognition" if the pivotal safety studies are not generally available—this has always been the standard. Thus, suppliers that have built competitive advantages around proprietary GRAS dossiers will need to evaluate the commercial implications of mandatory disclosure to meet what has always been required.
- Contract manufacturers and co-manufacturers (CoMans) face an open question. The bill covers any "person, firm, association, or corporation" that uses a GRAS substance in the manufacturing or processing of food without a report on file. CoMans formulating with non-notified GRAS ingredients should determine where the reporting obligation falls—on them, on the brand client, or on the upstream supplier—and ensure contractual allocations of regulatory responsibility account for this new requirement.
Does it reach dietary supplements? Some advisors have suggested the bill captures dietary supplement ingredients, particularly new dietary ingredients that the FDA has not been notified about. We are not so sure. The bill's obligation is triggered only for "GRAS substances"—defined as substances exempted from the food additive definition because of general recognition of safety. Dietary ingredients in supplements are excluded from the food additive definition under DSHEA, an entirely different statutory mechanism unrelated to GRAS. The concept of GRAS is simply not relevant to the lawful marketing of a dietary supplement ingredient. Our full analysis will set out the textual and structural basis for this conclusion.
What to do now. Companies in the food space—brands, ingredient suppliers, and contract manufacturers—should begin assessing their exposure immediately. Supplement companies receiving advice to begin GRAS reporting preparations should consider whether that advice accounts for how dietary ingredients are actually regulated under federal law. Our comprehensive alert will follow shortly.
Venable's Food and Drug Law team is closely monitoring this developing story and will continue to provide updates as they arise. Please contact a member of the team with any questions.