Sponsors (5)
Official title: Amend the Federal Food, Drug, and Cosmetic Act to impose requirements for substances generally recognized as safe, to require the Commissioner of Food and Drugs to reassess the safety of chemicals added to food, and for other purposes.
Introduced July 17, 2025 by Edward John Markey · Last progress July 17, 2025
The bill strengthens consumer protections and transparency around GRAS determinations and creates regular reassessments to catch unsafe additives, but does so at the cost of higher compliance burdens for manufacturers, increased FDA workload, and potential market disruption or reduced availability of some food ingredients.
General public (including low-income individuals) will see at least 10 food substances reassessed every 3 years, increasing the chance unsafe additives are identified and restricted.
Consumers gain clearer statutory safety criteria (e.g., definitions for carcinogenicity, cumulative effects, developmental/reproductive toxicity) and formal reliance on authoritative assessments (NTP, IARC, EPA), improving the rigor of safety determinations.
Consumers benefit from clearer, more transparent GRAS rules, including consistent FDA review and public posting of GRAS notices, making regulatory decisions easier to track.
FDA must complete frequent reassessments (≥10 every 3 years), which could strain agency resources, delay other reviews, and require additional funding—affecting taxpayers and slowing some regulatory actions.
Manufacturers and small businesses will face higher compliance costs to prepare more detailed GRAS notices and to generate data or studies when selected for reassessment.
Producers face greater regulatory exposure: the new statutory reassessment/withdrawal pathway increases the risk that products may be restricted or removed—even after prior FDA non‑objection—creating business uncertainty.
Based on analysis of 3 sections of legislative text.
Adds a statutory GRAS standard to the FD&C Act and requires the FDA to reassess at least 10 substances every 3 years, with new evidentiary requirements for GRAS notices.
Creates a statutory framework in the Federal Food, Drug, and Cosmetic Act for when a substance that becomes or affects a component of food is treated as a safe (GRAS) substance versus an unsafe food additive, and requires the FDA to reassess the safety of at least 10 substances or substance classes every three years. It ties exemptions from the unsafe-additive standard to either existing food additive approval, prior GRAS notices with non-objection, or GRAS notices submitted during a specified pre-effective window with specified supporting evidence, and gives the FDA authority to require data from manufacturers during periodic reassessments.