Premarket Tobacco Product Marketing Orders
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