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.
Manufacturer Product Name and Order Letter Product Category Date Issued Decision Summary Environmental Assessment FONSI Swedish Match USA, Inc. ZYN Chill (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Chill (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Cinnamon (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Cinnamon (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Citrus (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Citrus (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Coffee (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Coffee (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Cool Mint (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Cool Mint (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Menthol (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Menthol (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Peppermint (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Peppermint (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Smooth (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Smooth (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Spearmint (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Spearmint (6 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Wintergreen (3 milligram) Other 6/30/2026 Swedish Match USA, Inc. ZYN Wintergreen (6 milligram) Other 6/30/2026 Philip Morris Products S.A. IQOS 3 System Holder and Charger* Heated Tobacco Product 4/17/2026 Renewal MR0000254.PD3 EA0000254.PD3 FONSI0000254.PD3 Philip Morris Products S.A. IQOS System Holder and Charger Cigarettes 4/17/2026 Renewal MR0000254.PD1 EA0000254.PD1 FONSI0000254.PD1 Philip Morris Products S.A. Marlboro Amber Heatsticks Cigarettes 4/17/2026 Renewal MR0000254.PD5 EA0000254.PD5 FONSI0000254.PD5 Philip Morris Products S.A. Marlboro Green Menthol Heatsticks Cigarettes 4/17/2026 Renewal MR0000254.PD6 EA0000254.PD6 FONSI0000254.PD6 Philip Morris Products S.A. Marlboro Blue Menthol Heatsticks Cigarettes 4/17/2026 Renewal MR0000254.PD7 EA0000254.PD7 FONSI0000254.PD7 Swedish Match USA, Inc. General Loose Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD1 EA0000256.PD1 FONSI0000256.PD1 Swedish Match USA, Inc. General Dry Mint Portion Original Mini Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD2 EA0000256.PD2 FONSI0000256.PD2 Swedish Match USA, Inc. General Portion Original Large Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD3 EA0000256.PD3 FONSI0000256.PD3 Swedish Match USA, Inc. General Classic Blend Portion White Large - 12ct Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD4 EA0000256.PD4 FONSI0000256.PD4 Swedish Match USA, Inc. General Mint Portion White Large Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD5 EA0000256.PD5 FONSI0000256.PD5 Swedish Match USA, Inc. General Nordic Mint Portion White Large - 12ct Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD7 EA0000256.PD7 FONSI0000256.PD7 Swedish Match USA, Inc. General Portion White Large Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD8 EA0000256.PD8 FONSI0000256.PD8 Swedish Match USA, Inc. General Wintergreen Portion White Large Smokeless Tobacco 11/07/2024 Renewal MR0000256.PD9 EA0000256.PD9 FONSI0000256.PD9 U.S. Smokeless Tobacco Company Copenhagen Classic Snuff Smokeless Tobacco 3/16/2023 MR0000108 EA0000108 FONSI0000108 Philip Morris Products S.A. IQOS 3 System Holder and Charger* Heated Tobacco Product 3/11/2022 MR0000192 [Expired; Renewal Granted 4/17/26] 22nd Century Group, Inc. VLN® King Cigarettes 12/23/2021 MR0000159 22nd Century Group, Inc. VLN® Menthol King Cigarettes 12/23/2021 MR0000160 Philip Morris Products S.A. IQOS System Holder and Charger Cigarettes 07/07/2020 MR0000133 [Expired; Renewal Granted 4/17/26] Philip Morris Products S.A. Marlboro Heatsticks Cigarettes 07/07/2020 MR0000059 [Expired; Renewal Granted 4/17/26] Philip Morris Products S.A. Marlboro Smooth Menthol Heatsticks Cigarettes 07/07/2020 MR0000060 [Expired; Renewal Granted 4/17/26] Philip Morris Products S.A. Marlboro Fresh Menthol Heatsticks Cigarettes 07/07/2020 MR0000061 [Expired; Renewal Granted 4/17/26] Swedish Match USA, Inc. General Loose Smokeless tobacco 10/22/2019 MR0000020 Swedish Match USA, Inc. General Dry Mint Portion Original Mini Smokeless tobacco 10/22/2019 MR0000021 Swedish Match USA, Inc. General Portion Original Large Smokeless tobacco 10/22/2019 MR0000022 Swedish Match USA, Inc. General Classic Blend Portion White Large - 12ct Smokeless tobacco 10/22/2019 MR0000024 Swedish Match USA, Inc. General Mint Portion White Large Smokeless tobacco 10/22/2019 MR0000025 Swedish Match USA, Inc. General Nordic Mint Portion White Large - 12ct Smokeless tobacco 10/22/2019 MR0000027 Swedish Match USA, Inc. General Portion White Large Smokeless tobacco 10/22/2019 MR0000028 Swedish Match USA, Inc. General Wintergreen Portion White Large Smokeless tobacco 10/22/2019 MR0000029
*The product categories listed in this chart only reflect FDA’s categorization for the purposes of premarket review. Some products may fit in one category for the purposes of premarket review but may come under different product category definitions by statute and regulation, and thus may be subject to different or additional requirements than the category indicated in the chart.
Additional Resources
Content current as of:
06/30/2026
