Contains Nonbinding Recommendations

October 2016

This list of frequently asked questions (FAQ) is intended to be a convenient place to find answers to common questions about the food substance classification known as "generally recognized as safe" or "GRAS."

This FAQ addresses common questions about the regulatory process and regulatory considerations regarding whether the use of a substance in human or animal food is GRAS.

Our Center for Food Safety and Applied Nutrition (CFSAN) provides additional information about GRAS substances intended for use in human food on CFSAN’s Web site entitled “Generally Recognized as Safe (GRAS).” Our Center for Veterinary Medicine (CVM) provides additional information about GRAS substances intended for use in animal food on CVM’s Web site entitled “Generally Recognized as Safe (GRAS) Notification Program.” To contact CFSAN or CVM to obtain more information about whether the intended use of a substance in human food or animal food is GRAS, see section III.

This guidance updates and replaces a previous guidance, entitled “Frequently Asked Questions About GRAS,” that CFSAN issued in December 2004. This updated guidance refers to the provisions of a final rule that we published on August 17, 2016 (81 Fed. Reg. 54960) and addresses substances used in human food as well as substances used in animal food.

This guidance also includes an editorial change, relative to the guidance issued on October 17, 2016, to clarify the response to Question 14.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

Download Guidance for Industry:
Frequently Asked Questions About GRAS
(PDF 117KB)

This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.

This guidance has been jointly prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition and the Division of Animal Feeds in the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. Food and Drug Administration.

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm061846.htm