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          Registration and Product Listing for Owners and Operators of Domestic Tobacco Product EstablishmentsSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
					Guidance for Industry
		
		March 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2009-D-0508
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Tobacco Products


This guidance document is intended to assist owners and operators of domestic tobacco product establishments with the registration and product listing submissions required by section 905 of the Food, Drug, and Cosmetic Act (FD&C Act).  The guidance document explains, among other things:

The statutory requirement to make establishment registration and product listing submissions;
	The definitions of terms used in the statute and this guidance;
	Who should make establishment registration and product listing submissions;
	What information to include in the submissions;
	How to submit the information;
	When to submit the information; and
	FDA’s compliance policies.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-2009-D-0508.



  
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          Contact CTP
				    		    	
		    		    	Center for Tobacco Products
Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
		AskCTP@fda.hhs.gov
		    
		    		    	(9 a.m. - 4 p.m. Eastern) 1-877-CTP-1373 (1-877-287-1373)
		    
		    		    
		    
		    		    			    	

    Twitter: https://twitter.com/FDATobacco
    FDA Tobacco Education Resource Library: https://digitalmedia.hhs.gov/tobacco

                                                                                  Content current as of:
      04/03/2023
         
                  
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