The GRAS Act (Grocery Reform And Safety Act) makes significant changes to how food additives that are "generally recognized as safe" (GRAS) are regulated in the United States. Currently, companies can use certain food additives without FDA approval if they determine the substances are safe based on scientific evidence. This bill changes that system by requiring companies to notify the FDA before using any new GRAS substances or substances not previously used in food, and the FDA must approve these uses before they can be marketed.

Under the new rules, companies must submit detailed safety information to the FDA, including data on how much people will be exposed to the substance, whether it causes cancer or reproductive harm, and how safe it actually is. The FDA then has 180 days (extendable to 270 days) to review this information and decide whether to object. The FDA must also make all this information public and allow the public 60 days to comment before making a final decision. This is a major shift from the current system where companies can use GRAS substances without FDA approval.

The bill also requires the FDA to regularly review substances already on the market that were previously considered GRAS, starting within three years and continuing every three years after that. If the FDA finds safety concerns during these reviews, it can revoke its previous approval. Additionally, the bill establishes fees that companies must pay when submitting GRAS notifications or undergoing these safety reassessments, which helps fund the FDA's review process. Violations of these new requirements can result in civil penalties.