On August 11, 2026, the FDA under HHS Secretary Robert F. Kennedy Jr. published a proposed rule, “Substances Generally Recognized as Safe,” whose headline change requires manufacturers to notify the FDA when they conclude that a substance added to food is generally recognized as safe, a change the American Council on Science and Health described as closing the GRAS loophole. Comments are open for 120 days.
The same rule also expands the threshold-of-regulation (TOR) exemption, which until now covered substances that migrate from food-contact materials such as packaging. The Guardian reported that the proposal states that “any substance used in food (both directly or indirectly added) will be exempted from regulation as a food additive” if there is “no appreciable risk to human health.” The rule itself says “TOR submissions to FDA only require minimal data (e.g., identity, dietary exposure)” and “A full safety narrative is not required for a TOR submission.” FDA says the new exposure threshold provides equivalent protection; advocates quoted by the Guardian say some hormone-disrupting chemicals are harmful at levels below the current limit.
The Guardian's headline, that chemicals could be added “without safety review,” overstates the change: TOR is an abbreviated FDA review on request, not no review. The rule is a proposal, not final. Consumer Reports' Brian Ronholm separately called the notification mandate “toothless” because it carries no real consequences, The Center Square reported.