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          Modified Risk Tobacco Product ApplicationsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Modified Risk Tobacco Product Applications
		 
			Draft Guidance for Industry
		
		April 2012


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2012-D-0071
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Tobacco Products


The draft guidance provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through postmarket surveillance and studies.

Additional Resources

Modified Risk Tobacco ProductsSubmit 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-2012-D-0071.



  
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                                                                                  Content current as of:
      02/13/2020
         
                  
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