2022 Premarket Tobacco Product Marketing Granted Orders 

Manufacturer	Product Name and Order Letter	Product Category	Date Issued	Decision Summary
NJOY LLC	NJOY DAILY Rich Tobacco 4.5%	ENDS	06/10/2022	PM0000630 [Executive Summary]
NJOY LLC	NJOY DAILY EXTRA Rich Tobacco 6%	ENDS	06/10/2022	PM0000631 [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit	ENDS	05/12/2022	PM0000635  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Tank Original 3.0%	ENDS	05/12/2022	PM0000636  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit	ENDS	05/12/2022	PM0004287  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit	ENDS	05/12/2022	PM0000646  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Cartridge Original 1.5%	ENDS	05/12/2022	PM0000712  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit	ENDS	05/12/2022	PM0004293  [Executive Summary]
NJOY LLC	NJOY ACE Device	ENDS	04/26/2022	PM0000613  [Executive Summary]
NJOY LLC	NJOY ACE POD Classic Tobacco 2.4%	ENDS	04/26/2022	PM0000614  [Executive Summary]
NJOY LLC	NJOY ACE POD Classic Tobacco 5%	ENDS	04/26/2022	PM0000615  [Executive Summary]
NJOY LLC	NJOY ACE POD Rich Tobacco 5%	ENDS	04/26/2022	PM0000622  [Executive Summary]
Logic Technology Development LLC	Logic Regular Cartridge/Capsule Package	ENDS	03/24/2022	PM0000529
Logic Technology Development LLC	Logic Vapeleaf Cartridge/Capsule Package	ENDS	03/24/2022	PM0000530
Logic Technology Development LLC	Logic Vapeleaf Tobacco Vapor System	ENDS	03/24/2022	PM0000531
Logic Technology Development LLC	Logic Pro Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000535
Logic Technology Development LLC	Logic Pro Capsule Tank System	ENDS	03/24/2022	PM0000536
Logic Technology Development LLC	Logic Pro Capsule Tank System	ENDS	03/24/2022	PM0000537
Logic Technology Development LLC	Logic Power Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000540
Logic Technology Development LLC	Logic Power Rechargeable Kit	ENDS	03/24/2022	PM0000541

^{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 for marketing authorizations may not be posted to the website until 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.}

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2021 Premarket Tobacco Product Marketing Granted Orders 

Manufacturer	Product Name and Order Letter	Product Category	Date Issued	Decision Summary
U.S. Smokeless Tobacco Company LLC	VERVE® Discs Blue Mint	Other	10/19/2021	PM0000470
U.S. Smokeless Tobacco Company LLC	VERVE® Chews Blue Mint	Other	10/19/2021	PM0000471
U.S. Smokeless Tobacco Company LLC	VERVE® Discs Green Mint	Other	10/19/2021	PM0000472
U.S. Smokeless Tobacco Company LLC	VERVE® Chews Green Mint	Other	10/19/2021	PM0000473
R.J. Reynolds Vapor Company	Vuse Solo Power Unit	ENDS	10/12/2021	PM0000551
R.J. Reynolds Vapor Company	Vuse Replacement Cartridge Original 4.8% G1	ENDS	10/12/2021	PM0000553
R.J. Reynolds Vapor Company	Vuse Replacement Cartridge Original 4.8% G2	ENDS	10/12/2021	PM0000560

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^{To prioritize resources and provide the public with the most helpful information in a timely manner, starting FY 2021 FDA will be posting only order letters and decision summaries related to marketing orders on the FDA website. However, other documents, such as the environmental assessment (EA) and finding of no significant impact (FONSI), will remain available to the public upon request. To request records related to a recently issued marketing order please submit a FOIA request. For general tobacco-related questions and information please contact CTP.}

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2020 Premarket Tobacco Product Marketing 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}

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2019 Premarket Tobacco Product Marketing 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	FONSI0000492
22nd Century Group Inc.	Moonlight ®	Cigarettes	12/17/2019	PM0000491	EA0000491	FONSI0000491
Philip Morris Products S.A.	Marlboro Heatsticks	Cigarettes*	4/30/2019	PM0000424	EA0000424	FONSI0000424
Philip Morris Products S.A.	Marlboro Smooth Menthol Heatsticks	Cigarettes*	4/30/2019	PM0000425	EA0000425	FONSI0000425
Philip Morris Products S.A.	Marlboro Fresh Menthol Heatsticks	Cigarettes*	4/30/2019	PM0000426	EA0000426	FONSI0000426
Philip Morris Products S.A.	IQOS System Holder and Charger	Cigarettes*	4/30/2019	PM0000479	EA0000479	FONSI0000479

_{*Noncombusted cigarettes}

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2015 Premarket Tobacco Product Marketing 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	FONSI0000010
Swedish Match North America, Inc.	General Dry Mint Portion Original Mini	Smokeless Tobacco	11/10/2015	PM0000011	EA0000011	FONSI0000011
Swedish Match North America, Inc.	General Portion Original Large	Smokeless Tobacco	11/10/2015	PM0000012	EA0000012	FONSI0000012
Swedish Match North America, Inc.	General Classic Blend Portion White Large - 12ct	Smokeless Tobacco	11/10/2015	PM0000013	EA0000013	FONSI0000013
Swedish Match North America, Inc.	General Mint Portion White Large	Smokeless Tobacco	11/10/2015	PM0000014	EA0000014	FONSI0000014
Swedish Match North America, Inc.	General Nordic Mint Portion White Large - 12ct	Smokeless Tobacco	11/10/2015	PM0000015	EA0000015	FONSI0000015
Swedish Match North America, Inc.	General Portion White Large	Smokeless Tobacco	11/10/2015	PM0000016	EA0000016	FONSI0000016
Swedish Match North America, Inc.	General Wintergreen Portion White Large	Smokeless Tobacco	11/10/2015	PM0000017	EA0000017	FONSI0000017

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Additional Resources

• 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