GRAS Oversight and Transparency Act

This bill directs the Secretary of Health and Human Services, through the FDA Commissioner, to establish a board to review certain pre-2000 manufacturer designations that a food substance is generally recognized as safe (GRAS), and allows for revocation of those designations if safety is not shown.

Sec. 2, GRAS Review Board; Revocation of Certain GRAS Designations: The Secretary must establish a board to review the validity of covered GRAS designations. The board includes voting members from HHS, USDA, FDA, and other agencies, plus non-voting academic and industry representatives, all serving five-year terms without compensation.

The board's duties are to identify covered GRAS designations by requiring food manufacturers to submit notices, categorize each into tier 1, 2, or 3 review categories (tier 1 highest priority), review each designation to determine validity, and report results. If the board finds a substance not shown to be safe, it must notify the Secretary and Congress within 90 days and recommend revocation.

Food manufacturers must provide a notice identifying each covered GRAS designation within 90 days of enactment. Failure to comply can result in civil penalties or the substance being treated as an unapproved food additive.

Upon receiving a board recommendation, the Secretary may revoke a covered GRAS designation after notifying the manufacturer, providing 180 days for the manufacturer to submit safety evidence, reviewing that evidence, and notifying the manufacturer of the outcome. The Secretary must establish procedures for compliance, including timelines for ceasing distribution and recalling the substance.

The board must submit reports to the Secretary and Congress, made public on the FDA website, with recommendations. Reports for tier 1 designations are due within 2 years of enactment, tier 2 within 4 years, and tier 3 within 10 years.

A covered GRAS designation is a manufacturer's pre-2000 designation that a food substance is generally recognized as safe, for which no FDA petition or notification was filed. The board terminates 10 years after enactment.