GRAS Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require notification to the Food and Drug Administration (FDA) before using substances as generally recognized as safe (GRAS), mandates reassessments of certain GRAS substances, and provides resources for these reviews. Sec. 2, Removal of GRAS exemption: The bill removes the exemption for GRAS substances from the definition of a food additive, meaning they are now included in the definition, and defines 'generally recognized as safe' as recognition by qualified experts based on scientific procedures or common use before 1958. Sec. 3, GRAS notifications: Any person intending to treat a new use of a substance or a substance not marketed in the US before enactment as GRAS must submit a notice to the FDA with supporting data on identity, composition, safety, and other factors. The FDA must issue a statement not objecting or objecting within 180 days (extendable by 90 days), and the notice and statement are made public with a 60-day comment period. Sec. 4, Reassessments: The FDA must reassess the safety of at least 10 substances (including food additives, GRAS substances, color additives, prior-sanctioned substances, and food contact substances) every 3 years, starting within 3 years of enactment. The FDA can require safety evaluations from manufacturers and revoke a statement not objecting if safety concerns arise, with civil penalties for violations. Sec. 5, Definitions: The bill defines key terms like 'carcinogenic', 'class', 'conflict of interest', 'cumulative effects', 'developmental toxicity', 'food contact substance', 'new use', and 'reproductive toxicity' for the purposes of the section. Sec. 6, Fees: The bill authorizes the FDA to collect fees from persons filing petitions or notices for food additives and from those subject to reassessments, with fees set to cover 100% of the costs for these activities, and updates the base fiscal years for fee calculations.