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. To date, the FDA has authorized marketing of 45 products, including 34 tobacco- and menthol-flavored e-cigarette products and devices.
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 |
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 | EA0000635 | FONSI0000635 | |
R.J. Reynolds Vapor Company | Vuse Vibe Tank Original 3.0% | ENDS | 05/12/2022 | EA0000636 | FONSI0000636 | |
R.J. Reynolds Vapor Company | Vuse Vibe Power Unit [2] | ENDS | 05/12/2022 | 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 |
ENDS |
04/26/2022 |
EA0000613 | FONSI0000613 | ||
NJOY LLC |
ENDS |
04/26/2022 |
EA0000614 | FONSI0000614 | ||
NJOY LLC |
ENDS |
04/26/2022 |
EA0000615 | FONSI0000615 | ||
NJOY LLC |
NJOY ACE POD Rich Tobacco 5% | ENDS | 04/26/2022 | EA0000622 | FONSI0000622 | |
Logic Technology Development LLC |
Logic Regular Cartridge/Capsule Package | ENDS | 03/24/2022 | EA0000529 | FONSI0000529 | |
Logic Technology Development LLC | Logic Vapeleaf Cartridge/Capsule Package | ENDS | 03/24/2022 | EA0000530 | FONSI0000530 | |
Logic Technology Development LLC | Logic Vapeleaf Tobacco Vapor System | ENDS | 03/24/2022 | EA0000531 | FONSI0000531 | |
Logic Technology Development LLC | Logic Pro Tobacco e-Liquid Package | ENDS | 03/24/2022 | EA0000535 | FONSI0000535 | |
Logic Technology Development LLC | Logic Pro Capsule Tank System [1] | ENDS | 03/24/2022 | EA0000536 | FONSI0000536 | |
Logic Technology Development LLC | Logic Pro Capsule Tank System [2] | ENDS | 03/24/2022 | EA0000537 | FONSI0000537 | |
Logic Technology Development LLC | Logic Power Tobacco e-Liquid Package | ENDS | 03/24/2022 | EA0000540 | FONSI0000540 | |
Logic Technology Development LLC | Logic Power Rechargeable Kit | ENDS | 03/24/2022 | EA0000541 | FONSI0000541 |
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 |
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
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
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 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