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          Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live MicrobialsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials
					
		
		September 2018


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2011-D-0376
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


The purpose of this guidance is to advise firms that manufacture, market, or distribute dietary supplements of our intent to exercise enforcement discretion with respect to the declaration of live microbial quantity in colony forming units (CFUs), in addition to the quantitative amount by weight declaration required by regulation, within the Supplement Facts label of dietary supplements containing live microbials, provided that certain conditions are met.

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

Dietary Supplements 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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						Dockets Management
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2011-D-0376.

                                                                                  Content current as of:
      09/15/2018
         
                  
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