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                Premarket Tobacco Product Applications

Premarket Tobacco Product Applications

                        Preparing and Submitting a Premarket Tobacco Product Application
          FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications
          Premarket Tobacco Product Marketing Granted Orders Home
          Tobacco Products
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          Premarket Tobacco Product Applications
          Premarket Tobacco Product Marketing Granted OrdersPremarket Tobacco Product Applications Premarket Tobacco Product Marketing Granted Orders
  
  	
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    PrintTo legally market a new tobacco product in the United States, a company must receive a written marketing order from FDA. Companies may receive marketing authorization through one of the three pathways; the following products have been issued marketing granted orders (MGO) under the PMTA pathway. To date, the FDA has authorized marketing of 45 products, including 23 tobacco-flavored e-cigarette products and devices.

**Note:** Before making documents available to the public, FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary, environmental assessment and finding of no significant impact (FONSI) memo for marketing authorizations may be posted to the website after the order issuance date. In the interim, to provide as much information as possible at the time of order issuance, we are making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.

2023 Premarket Tobacco Product Marketing Granted Orders

***Temporary Compliance Waiver:**The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.*

Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)Philip Morris Products S.A.
			Marlboro Sienna HeatSticks
			Heated Tobacco Product (HTP)
			1/26/2023
			PM0004337.PD1
			EA0004337
			FONSI0004337Philip Morris Products S.A.
			Marlboro Bronze HeatSticks
			Heated Tobacco Product (HTP)
			1/26/2023
			PM0004337.PD2
			EA0004337
			FONSI0004337Philip Morris Products S.A.
			Marlboro Amber HeatSticks
			Heated Tobacco Product (HTP)
			1/26/2023
			PM0004691.PD1
			EA0004691
			FONSI00046912022 Premarket Tobacco Product Marketing Granted Orders

Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)NJOY LLC
			NJOY DAILY Rich Tobacco 4.5%
			ENDS
			06/10/2022
			PM0000630
			EA0000630NJOY LLC
			NJOY DAILY EXTRA Rich Tobacco 6%
			ENDS
			06/10/2022
			PM0000631
			EA0000631R.J. Reynolds Vapor Company
			Vuse Vibe Power Unit [1]
			ENDS
			05/12/2022
			PM0000635R.J. Reynolds Vapor Company
			Vuse Vibe Tank Original 3.0%
			ENDS
			05/12/2022
			PM0000636R.J. Reynolds Vapor Company
			Vuse Vibe Power Unit [2]
			ENDS
			05/12/2022
			PM0004287R.J. Reynolds Vapor Company
			Vuse Ciro Power Unit [1]
			ENDS
			05/12/2022
			PM0000646R.J. Reynolds Vapor Company
			Vuse Ciro Cartridge Original 1.5%
			ENDS
			05/12/2022
			PM0000712R.J. Reynolds Vapor Company
			Vuse Ciro Power Unit [2]
			ENDS
			05/12/2022
			PM0004293NJOY LLC
			NJOY ACE Device
			ENDS
			04/26/2022
			PM0000613
			EA0000613
			FONSI0000613NJOY LLC
			NJOY ACE POD Classic Tobacco 2.4%
			ENDS
			04/26/2022
			PM0000614
			EA0000614
			FONSI0000614NJOY LLC
			NJOY ACE POD Classic Tobacco 5%
			ENDS
			04/26/2022
			PM0000615
			EA0000615
			FONSI0000615NJOY LLC
			NJOY ACE POD Rich Tobacco 5%
			ENDS
			04/26/2022
			PM0000622
			EA0000622
			FONSI0000622Logic Technology Development LLC
			Logic Regular Cartridge/Capsule Package
			ENDS
			03/24/2022
			PM0000529
			EA0000529
			FONSI0000529Logic Technology Development LLC
			Logic Vapeleaf Cartridge/Capsule Package
			ENDS
			03/24/2022
			PM0000530
			EA0000530
			FONSI0000530Logic Technology Development LLC
			Logic Vapeleaf Tobacco Vapor System
			ENDS
			03/24/2022
			PM0000531
			EA0000531
			FONSI0000531Logic Technology Development LLC
			Logic Pro Tobacco e-Liquid Package
			ENDS
			03/24/2022
			PM0000535
			EA0000535
			FONSI0000535Logic Technology Development LLC
			Logic Pro Capsule Tank System [1]
			ENDS
			03/24/2022
			PM0000536
			EA0000536
			FONSI0000536Logic Technology Development LLC
			Logic Pro Capsule Tank System [2]
			ENDS
			03/24/2022
			PM0000537
			EA0000537
			FONSI0000537Logic Technology Development LLC
			Logic Power Tobacco e-Liquid Package
			ENDS
			03/24/2022
			PM0000540
			EA0000540
			FONSI0000540Logic Technology Development LLC
			Logic Power Rechargeable Kit
			ENDS
			03/24/2022
			PM0000541
			EA0000541
			FONSI0000541Expand All



2021 Premarket Tobacco Product Marketing Granted Orders
	Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)U.S. Smokeless Tobacco Company LLC
			VERVE® Discs Blue Mint
			Other
			10/19/2021
			PM0000470
			EA0000470
			FONSI0000470U.S. Smokeless Tobacco Company LLC
			VERVE® Chews Blue Mint
			Other
			10/19/2021
			PM0000471
			EA0000471
			FONSI0000471U.S. Smokeless Tobacco Company LLC
			VERVE® Discs Green Mint
			Other
			10/19/2021
			PM0000472
			EA0000472
			FONSI0000472U.S. Smokeless Tobacco Company LLC
			VERVE® Chews Green Mint
			Other
			10/19/2021
			PM0000473
			EA0000473
			FONSI0000473R.J. Reynolds Vapor Company
			Vuse Solo Power Unit
			ENDS
			10/12/2021
			PM0000551
			EA0000551
			FONSI0000551R.J. Reynolds Vapor Company
			Vuse Replacement Cartridge Original 4.8% G1
			ENDS
			10/12/2021
			PM0000553
			EA0000553
			FONSI0000553R.J. Reynolds Vapor Company
			Vuse Replacement Cartridge Original 4.8% G2
			ENDS
			10/12/2021
			PM0000560
			EA0000560
			FONSI0000560   
2020 Premarket Tobacco Product Marketing Granted Orders
	Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)Philip Morris Products S.A..
			IQOS System Holder and Charger
			Cigarettes*
			12/7/2020
			PM0000634
			EA0000634
			FONSI0000634*Noncombusted cigarettes   
2019 Premarket Tobacco Product Marketing Granted Orders
	Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)22nd Century Group Inc.
			Moonlight ® Menthol
			Cigarettes
			12/17/2019
			PM0000492
			EA0000492
			FONSI000049222nd Century Group Inc.
			Moonlight ®
			Cigarettes
			12/17/2019
			PM0000491
			EA0000491
			FONSI0000491Philip Morris Products S.A.
			Marlboro Heatsticks
			Cigarettes*
			4/30/2019
			PM0000424
			EA0000424
			FONSI0000424Philip Morris Products S.A.
			Marlboro Smooth Menthol Heatsticks
			Cigarettes*
			4/30/2019
			PM0000425
			EA0000425
			FONSI0000425Philip Morris Products S.A.
			Marlboro Fresh Menthol Heatsticks
			Cigarettes*
			4/30/2019
			PM0000426
			EA0000426
			FONSI0000426Philip Morris Products S.A.
			IQOS System Holder and Charger
			Cigarettes*
			4/30/2019
			PM0000479
			EA0000479
			FONSI0000479*Noncombusted cigarettes   
2015 Premarket Tobacco Product Marketing Granted Orders
	Manufacturer
			Product Name and Order Letter
			Product Category
			Date Issued
			Decision Summary
			Environmental Assessment (EA)
			Finding of No Significant Impact (FONSI)Swedish Match North America, Inc.
			General Loose
			Smokeless Tobacco
			11/10/2015
			PM0000010
			EA0000010
			FONSI0000010Swedish Match North America, Inc.
			General Dry Mint Portion Original Mini
			Smokeless Tobacco
			11/10/2015
			PM0000011
			EA0000011
			FONSI0000011Swedish Match North America, Inc.
			General Portion Original Large
			Smokeless Tobacco
			11/10/2015
			PM0000012
			EA0000012
			FONSI0000012Swedish Match North America, Inc.
			General Classic Blend Portion White Large - 12ct
			Smokeless Tobacco
			11/10/2015
			PM0000013
			EA0000013
			FONSI0000013Swedish Match North America, Inc.
			General Mint Portion White Large
			Smokeless Tobacco
			11/10/2015
			PM0000014
			EA0000014
			FONSI0000014Swedish Match North America, Inc.
			General Nordic Mint Portion White Large - 12ct
			Smokeless Tobacco
			11/10/2015
			PM0000015
			EA0000015
			FONSI0000015Swedish Match North America, Inc.
			General Portion White Large
			Smokeless Tobacco
			11/10/2015
			PM0000016
			EA0000016
			FONSI0000016Swedish Match North America, Inc.
			General Wintergreen Portion White Large
			Smokeless Tobacco
			11/10/2015
			PM0000017
			EA0000017
			FONSI0000017

Additional Resources

FDA Authorized E-Cigarette Products
	FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway
	FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product application pathway
	Premarket Tobacco Product Applications
	Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS)
	Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products

                                                                                  Content current as of:
      01/09/2024
              
              
Regulated Product(s)
		 TobaccoPremarket Tobacco Product Applications

          
                        Preparing and Submitting a Premarket Tobacco Product Application
          FDA Tobacco Product Application Tips - Premarket Tobacco Product Applications
          Premarket Tobacco Product Marketing Granted Orders
 
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