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    Print**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**U.S. Smokeless Tobacco Company
			Copenhagen Classic Snuff
			Smokeless Tobacco
			3/16/2023
			MR0000108
			EA0000108
			FONSI0000108Philip Morris Products S.A.
			IQOS 3 System Holder and Charger*
			Heated Tobacco Product
			3/11/2022
			MR000019222nd Century Group, Inc.
			VLN® King
			Cigarettes
			12/23/2021
			MR000015922nd Century Group, Inc.
			VLN® Menthol King
			Cigarettes
			12/23/2021
			MR0000160Philip Morris Products S.A.
			IQOS System Holder and Charger
			Cigarettes
			07/07/2020
			MR0000133Philip Morris Products S.A.
			Marlboro Heatsticks
			Cigarettes
			07/07/2020
			MR0000059Philip Morris Products S.A.
			Marlboro Smooth Menthol Heatsticks
			Cigarettes
			07/07/2020
			MR0000060Philip Morris Products S.A.
			Marlboro Fresh Menthol Heatsticks
			Cigarettes
			07/07/2020
			MR0000061Swedish Match USA, Inc.
			General Loose
			Smokeless tobacco
			10/22/2019
			MR0000020Swedish Match USA, Inc.
			General Dry Mint Portion Original Mini
			Smokeless tobacco
			10/22/2019
			MR0000021Swedish Match USA, Inc.
			General Portion Original Large
			Smokeless tobacco
			10/22/2019
			MR0000022Swedish Match USA, Inc.
			General Classic Blend Portion White Large - 12ct
			Smokeless tobacco
			10/22/2019
			MR0000024Swedish Match USA, Inc.
			General Mint Portion White Large
			Smokeless tobacco
			10/22/2019
			MR0000025Swedish Match USA, Inc.
			General Nordic Mint Portion White Large - 12ct
			Smokeless tobacco
			10/22/2019
			MR0000027Swedish Match USA, Inc.
			General Portion White Large
			Smokeless tobacco
			10/22/2019
			MR0000028Swedish 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.

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                                                                                  Content current as of:
      03/16/2023
              
              
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