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          Guidance for Industry:  Frequently Asked Questions About GRAS for Substances Intended for Use in Human or Animal FoodSearch for FDA Guidance Documents 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 

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    PrintDocket Number:
		    FDA-2020-D-1908
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Center for Food Safety and Applied Nutrition


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**

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More Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory InformationSubmit Comments
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						All written comments should be identified with this document's docket number: FDA-2020-D-1908.

                                                                                  Content current as of:
      07/03/2018
         
                  
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