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  1. Premarket Tobacco Product Applications

Premarket Tobacco Product Marketing Granted Orders

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

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 [email protected] or call 1-877-287-1373.

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.

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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