GRAS Oversight and Transparency Act

GRAS Oversight and Transparency Act

This bill requires the Food and Drug Administration (FDA) to establish a board to review determinations made by food manufacturers prior to the year 2000 that certain substances are safe for use in food.

Under current law, substances added to food must generally be approved by the FDA. However, substances that are generally recognized as safe (GRAS) by qualified experts are exempt from the FDA's premarket review. Manufacturers are not required to notify the FDA when they designate a substance as GRAS.

Under the bill, each food manufacturer must provide the board with a list of pre-2000 GRAS designations attributable to the manufacturer. Manufacturers who do not comply may be subject to specified penalties. The board must review each designation and notify Congress and the FDA of (1) a determination that a substance has not been shown to be safe, and (2) a recommendation that the FDA revoke a GRAS designation.

After receiving such a notification, if the FDA decides to revoke the GRAS designation, it must notify the manufacturer and provide them an opportunity to offer evidence of the substance’s safety. The FDA must review its revocation decision using such evidence. The FDA must also establish procedures to ensure compliance with a revocation, including a timeline for recalling and ceasing distribution of substances.

The board must report to the FDA and Congress with information about reviews carried out under the bill.

The bill terminates 10 years after enactment.