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          Applications for Premarket Review of New Tobacco ProductsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Applications for Premarket Review of New Tobacco Products
		 
			Draft Guidance for Industry
		
		September 2011


	Download the  Draft  Guidance Document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	  	    Not for implementation.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-0212
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Tobacco Products


This draft guidance is intended to assist persons submitting applications for new tobacco products under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act; 21 U.S.C. 301 et seq.), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This draft guidance explains, among other things:

Who may submit a new tobacco product application under section 910 of the FD&C Act (21 U.S.C. 387j);
	When to submit a new tobacco product application;
	How to submit a new tobacco product application;
	What information the FD&C Act requires you to submit in a new tobacco product application; and
	What information FDA recommends you submit in a new tobacco product application.Additional Resources

Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)Submit 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-2011-D-0212.



  
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                                                                                  Content current as of:
      02/13/2020
         
                  
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