This bill limits the circumstances in which a food additive may be considered generally recognized as safe (GRAS) and requires the Food and Drug Administration (FDA) to review the safety of all such additives.
Under current law, food additives generally require pre-market FDA approval unless they are considered GRAS (generally recognized among qualified experts as safe for their intended use). When a manufacturer determines that an additive is GRAS, it may, but is not required to, notify the FDA of that determination. Under the bill, before an additive may be used in food, it must be (1) approved by the FDA, or (2) the subject of a GRAS notification submitted up to two years after the bill’s enactment to which the FDA has not objected.
GRAS notifications submitted after enactment must include specified supporting information. The FDA must publish and seek public comment on such notifications. The FDA must ultimately publish a written determination stating whether it objects to the GRAS determination along with its reasoning.
The FDA may also reassess GRAS notifications submitted before the bill’s enactment and require a manufacturer to submit the same supporting information required of post-enactment notifications.
The FDA must annually review or reassess at least 50 GRAS notifications until all notifications have been reviewed or reassessed. Separately, the FDA must regularly reassess the safety of approved food additives and those considered GRAS.
Finally, the bill makes toxic and carcinogenic substances ineligible to be considered GRAS.