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          Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)
					Guidance for Industry
		
		March 2023


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
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    PrintDocket Number:
		    FDA-2015-D-2496
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Tobacco Products


The final rule “Premarket Tobacco Product Applications and Recordkeeping Requirements” (the final PMTA rule) published in the *Federal Register* of October 5, 2021 (86 FR 55300), and on November 4, 2021, it became effective. The final PMTA rule sets forth content and format requirements for PMTAs and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. FDA intends to update this guidance to ensure the recommendations on preparing and submitting PMTAs for electronic nicotine delivery systems (ENDS) are consistent with the requirements of the final PMTA rule.

This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j). This guidance communicates FDA’s current thinking on these applications to improve the efficiency of application submission and review; however, the recommendations in this guidance are non-binding. When FDA reviews PMTAs for ENDS, it will base decisions on the obligations that arise from the FD&C Act and its implementing regulations. FDA anticipates that the experience gained through the publication of this guidance and review of PMTAs may contribute to future rulemaking and guidances.

The guidance explains, among other things:

Products to which this guidance applies;
	When a PMTA is required under the statute and regulations;
	General procedures for review of an ENDS PMTA;
	What information the FD&C Act requires you to submit in a PMTA; and
	What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH).Additional Resources

Applications for Premarket Review of New 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-2015-D-2496.



  
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		    		    	(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:
      03/17/2023
         
                  
Regulated Product(s)
		 Tobacco
			  			     			  						              
			
			
			
			
			
			
			
			
						  Electronic Nicotine Delivery Systems (ENDS)Topic(s)
			  Product Application and ReviewSearch for FDA Guidance Documents

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