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GUIDANCE DOCUMENT

Guidance for Industry: Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal Food October 2016

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-1908
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Human Foods Program

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 the Guidance

Related Information

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1908.

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