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          Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and LabelingSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling
					
		
		September 2016


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2016-D-2241
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


This guidance document describes the type and quality of evidence that the Food and Drug Administration (FDA or we) recommends infant formula manufacturers and distributors have to substantiate claims about effects on the structure or function of the body (“structure/function claims”) made on the label and in other labeling of nonexempt and exempt infant formulas.

The purpose of this guidance document is to help infant formula manufacturers and distributors making structure/function claims to comply with the statutory requirement that all claims in food labeling must be truthful and not misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(a)(1)).

FDA regulates infant formula under the FD&C Act.  Section 201(z) of the FD&C Act (21 U.S.C. 321(z)) defines “infant formula” as “a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.”  FDA regulations in Title 21 of the *Code of Federal Regulations*(21 CFR) define the term “infant” as “a person not more than 12 months old” (21 CFR 106.3).  Although human milk is the recommended source of nutrition for infants (Ref. 1), infant formula nonetheless provides the sole source of nutrition for many infants during a vulnerable period of life when diet plays a critical role in affecting long-term growth and development.

**Download the Draft Guidance**

Related Information

More Infant Formula Guidance Documents & Regulatory InformationSubmit Comments
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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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						All written comments should be identified with this document's docket number: FDA-2016-D-2241.

                                                                                  Content current as of:
      09/09/2016
         
                  
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Infant Formula & FoodsTopic(s)
			  LabelingSearch for FDA Guidance Documents

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