FDA is proposing the biggest change to the GRAS framework in decades. Under a proposed rule published on 11 August 2026, companies would generally be required to notify the agency of new GRAS conclusions rather than deciding whether to do so voluntarily.

If finalised, the proposal would significantly reshape the regulatory pathway for new food and feed ingredients in the US market. If the rule is finalised, this would bring greater transparency, enabling FDA to identify uses that may require food additive approval, detect potentially unsafe substances more quickly, confirm that GRAS conclusions are based on adequate scientific documentation and strengthen public confidence in its oversight of the food supply. The trade-off would be additional compliance cost for industry: preparing and submitting notices and maintaining ongoing notification for new GRAS determinations. On FDA’s side, resource planning will be key as there would be a wave of new mandatory notices to absorb.