Updated on March 11, 2025

Introduction

“GRAS” is an acronym for Generally Recognized As Safe, which is an important food regulatory category in the United States. Simply speaking, if a substance is GRAS under the conditions of its intended use among qualified experts, it is excluded from the definition of a food additive and is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act.

This means that a substance that has been concluded GRAS may be marketed for its intended use in food without FDA review or approval. It is, however, important to note that it is the use of a substance, rather than the substance itself, that is eligible for GRAS status.

Boasting widespread recognition internationally, GRAS has become a gateway for enterprises to access global markets.

Brief History of GRAS

Types of GRAS Conclusions

The intended use of a substance in food may be GRAS through:

GRAS through common use prior to January 1, 1958, requires generally available evidence of substantial history of consumption by significant numbers of consumers. It is rare for such documentation to exist.

GRAS through scientific procedures requires the same quantity and quality of scientific evidence as required to obtain approval of a food additive and that the scientific evidence is generally available to, and generally accepted by, qualified experts throughout the scientific community.

Independent Conclusion of GRAS Status

Independent Conclusions of GRAS status may be made by a “proponent” (i.e., an individual, partnership, corporation, association, or other legal entity) based on the views of experts qualified by training and experience to evaluate the safety of the substances directly or indirectly added to food that publicly available data, information, and methods establish that there is reasonable certainty that the substance is not harmful under the conditions of its intended use. A GRAS substance may be marketed based on an independent conclusion of GRAS status that remains with the proponent. The proponent may also choose to submit their GRAS conclusion to the FDA as a GRAS notice.

* Note: FDA will issue one of three potential response letters: 1) FDA has no questions regarding the notifier’s GRAS conclusion, 2) FDA concludes the notice does not provide a sufficient basis for a GRAS conclusion, or 3) at the notifier’s request, FDA ceased evaluation of the GRAS notice.