Premarket Tobacco Product Marketing Granted Orders

NOTE: This page will not be updated after March 28, 2024. For the latest information on tobacco products that may be legally marketed in the United States, view the “Searchable Tobacco Products Database,” which now serves as the new location for this information. 

To 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.

_{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

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	FONSI0004337
Philip Morris Products S.A.	Marlboro Bronze HeatSticks	Heated Tobacco Product (HTP)	1/26/2023	PM0004337.PD2	EA0004337	FONSI0004337
Philip Morris Products S.A.	Marlboro Amber HeatSticks	Heated Tobacco Product (HTP)	1/26/2023	PM0004691.PD1	EA0004691	FONSI0004691

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2022 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	EA0000630	FONSI0000630
NJOY LLC	NJOY DAILY EXTRA Rich Tobacco 6%	ENDS	06/10/2022	PM0000631	EA0000631	FONSI0000631
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit [1]	ENDS	05/12/2022	PM0000635	EA0000635	FONSI0000635
R.J. Reynolds Vapor Company	Vuse Vibe Tank Original 3.0%	ENDS	05/12/2022	PM0000636	EA0000636	FONSI0000636
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit [2]	ENDS	05/12/2022	PM0004287	EA0004287	FONSI0004287
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit [1]	ENDS	05/12/2022	PM0000646	EA0000646	FONSI0000646
R.J. Reynolds Vapor Company	Vuse Ciro Cartridge Original 1.5%	ENDS	05/12/2022	PM0000712	EA0000712	FONSI0000712
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit [2]	ENDS	05/12/2022	PM0004293	EA0004293	FONSI0004293
NJOY LLC	NJOY ACE Device	ENDS	04/26/2022	PM0000613	EA0000613	FONSI0000613
NJOY LLC	NJOY ACE POD Classic Tobacco 2.4%	ENDS	04/26/2022	PM0000614	EA0000614	FONSI0000614
NJOY LLC	NJOY ACE POD Classic Tobacco 5%	ENDS	04/26/2022	PM0000615	EA0000615	FONSI0000615
NJOY LLC	NJOY ACE POD Rich Tobacco 5%	ENDS	04/26/2022	PM0000622	EA0000622	FONSI0000622
Logic Technology Development LLC	Logic Regular Cartridge/Capsule Package	ENDS	03/24/2022	PM0000529	EA0000529	FONSI0000529
Logic Technology Development LLC	Logic Vapeleaf Cartridge/Capsule Package	ENDS	03/24/2022	PM0000530	EA0000530	FONSI0000530
Logic Technology Development LLC	Logic Vapeleaf Tobacco Vapor System	ENDS	03/24/2022	PM0000531	EA0000531	FONSI0000531
Logic Technology Development LLC	Logic Pro Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000535	EA0000535	FONSI0000535
Logic Technology Development LLC	Logic Pro Capsule Tank System [1]	ENDS	03/24/2022	PM0000536	EA0000536	FONSI0000536
Logic Technology Development LLC	Logic Pro Capsule Tank System [2]	ENDS	03/24/2022	PM0000537	EA0000537	FONSI0000537
Logic Technology Development LLC	Logic Power Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000540	EA0000540	FONSI0000540
Logic Technology Development LLC	Logic Power Rechargeable Kit	ENDS	03/24/2022	PM0000541	EA0000541	FONSI0000541

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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	FONSI0000470
U.S. Smokeless Tobacco Company LLC	VERVE® Chews Blue Mint	Other	10/19/2021	PM0000471	EA0000471	FONSI0000471
U.S. Smokeless Tobacco Company LLC	VERVE® Discs Green Mint	Other	10/19/2021	PM0000472	EA0000472	FONSI0000472
U.S. Smokeless Tobacco Company LLC	VERVE® Chews Green Mint	Other	10/19/2021	PM0000473	EA0000473	FONSI0000473
R.J. Reynolds Vapor Company	Vuse Solo Power Unit	ENDS	10/12/2021	PM0000551	EA0000551	FONSI0000551
R.J. Reynolds Vapor Company	Vuse Replacement Cartridge Original 4.8% G1	ENDS	10/12/2021	PM0000553	EA0000553	FONSI0000553
R.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	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}

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	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 Authorized E-Cigarette Products
• 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