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 AskCTP@fda.hhs.gov 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
- 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