FDA Proposes Mandatory GRAS Rule Covering All Market Ingredients, Faces Legal Hurdles

On August 10, 2026, the FDA proposed requiring manufacturers to notify the agency of all ingredients marketed under the GRAS pathway—retroactively and going forward. The rule would yield the first complete inventory of GRAS substances. A 2021 federal ruling affirmed only a voluntary system's legality, signaling likely court challenges if the mandatory rule is finalized.