List of Heated Tobacco Products Granted Marketing Authorization in the U.S. Tobacco Market in 2023
To legally market a new tobacco product in the United States, a company must obtain a written marketing authorization order from the FDA. A company can receive marketing authorization through one of three pathways; the products below have received Marketing Granted Orders (MGOs) under the PMTA (Premarket Tobacco Product Application) pathway. To date, the FDA has authorized the marketing of 45 products, including 23 tobacco-flavored e-cigarette products and devices.
Official temporary compliance exemption statement: For readers using assistive technology, the linked files may not be accessible. We regret any inconvenience this may cause. If you are unable to read these documents or portions of them, please email AskCTP@fda.hhs.gov or call 1-877-287-1373.
2023 Premarket Tobacco Product Marketing Granted Orders
| Manufacturer | Product Name and Order Letter | Product Category | Issue Date | 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 |



