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          Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products
					
		
		September 2016


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2016-D-2335
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


The purpose of this guidance is to advise manufacturers who wish to use the implied nutrient content claim “healthy” to label their food products as provided by our regulations.

More specifically, this guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim “healthy” on their labels which:

(1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or

(2) contain at least ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

This guidance is immediately effective because the agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).

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

Use of the Term Healthy on Food Labeling
	Labeling & Nutrition Guidance Documents & Regulatory InformationSubmit Comments
	   		  			    		Submit Comments Online
					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-2016-D-2335.

                                                                                  Content current as of:
      09/28/2016
         
                  
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