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  1. Premarket Tobacco Product Applications

Premarket Tobacco Product Marketing Granted Orders

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.

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

Temporary Compliance Waiver

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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

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


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


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

Additional Resources

 

 

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