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          Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts LabelsSearch for FDA Guidance Documents SMALL ENTITY COMPLIANCE GUIDE
	Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels
					
		
		February 2020


	Download the  Final Small Entity Compliance Guide
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2012-N-1210
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


In the *Federal Register* of May 27, 2016 (81 FR 33742), FDA (we) published a final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (“the final rule”). The final rule amends the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices and set a compliance date of July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales. We subsequently extended the compliance dates to January 1, 2020, and January 1, 2021, respectively (83 FR 19619). We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the revisions made in the final rule and is intended to help small entities comply with the requirements established in 21 CFR 101.9, 101.30, and 101.36.

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 our guidances means that something is suggested or recommended, but not required.

In the remainder of this guidance, “you” and “I” refer to food manufacturers that are subject to the rule. Many answers in this guidance are followed by citations to show where a specific requirement can be found in either the Federal Food, Drug, and Cosmetic Act (FD&C Act) or Title 21 of the *Code of Federal Regulations*.

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Labeling & Nutrition Guidance Documents & Regulatory InformationSubmit Comments
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						All written comments should be identified with this document's docket number: FDA-2012-N-1210.

                                                                                  Content current as of:
      02/03/2020
         
                  
Regulated Product(s)
		 Dietary Supplements
			  			     			  			     Food & BeveragesTopic(s)
			  Nutrition Label
				  				     				  				  
				  
				   
				  
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