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

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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 [Executive Summary]	EA0004337	FONSI0004337
Philip Morris Products S.A.	Marlboro Bronze HeatSticks	Heated Tobacco Product (HTP)	1/26/2023	PM0004337 [Executive Summary]	EA0004337	FONSI0004337
Philip Morris Products S.A.	Marlboro Amber HeatSticks	Heated Tobacco Product (HTP)	1/26/2023	PM0004691 [Executive Summary]	EA0004691	FONSI0004691

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2022 Premarket Tobacco Product Marketing Granted Orders

Manufacturer	Product Name and Order Letter	Product Category	Date Issued	Decision Summary
NJOY LLC	NJOY DAILY Rich Tobacco 4.5%	ENDS	06/10/2022	PM0000630 [Executive Summary]
NJOY LLC	NJOY DAILY EXTRA Rich Tobacco 6%	ENDS	06/10/2022	PM0000631 [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit	ENDS	05/12/2022	PM0000635  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Tank Original 3.0%	ENDS	05/12/2022	PM0000636  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Vibe Power Unit	ENDS	05/12/2022	PM0004287  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit	ENDS	05/12/2022	PM0000646  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Cartridge Original 1.5%	ENDS	05/12/2022	PM0000712  [Executive Summary]
R.J. Reynolds Vapor Company	Vuse Ciro Power Unit	ENDS	05/12/2022	PM0004293  [Executive Summary]
NJOY LLC	NJOY ACE Device	ENDS	04/26/2022	PM0000613
NJOY LLC	NJOY ACE POD Classic Tobacco 2.4%	ENDS	04/26/2022	PM0000614
NJOY LLC	NJOY ACE POD Classic Tobacco 5%	ENDS	04/26/2022	PM0000615
NJOY LLC	NJOY ACE POD Rich Tobacco 5%	ENDS	04/26/2022	PM0000622
Logic Technology Development LLC	Logic Regular Cartridge/Capsule Package	ENDS	03/24/2022	PM0000529
Logic Technology Development LLC	Logic Vapeleaf Cartridge/Capsule Package	ENDS	03/24/2022	PM0000530
Logic Technology Development LLC	Logic Vapeleaf Tobacco Vapor System	ENDS	03/24/2022	PM0000531
Logic Technology Development LLC	Logic Pro Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000535
Logic Technology Development LLC	Logic Pro Capsule Tank System	ENDS	03/24/2022	PM0000536
Logic Technology Development LLC	Logic Pro Capsule Tank System	ENDS	03/24/2022	PM0000537
Logic Technology Development LLC	Logic Power Tobacco e-Liquid Package	ENDS	03/24/2022	PM0000540
Logic Technology Development LLC	Logic Power Rechargeable Kit	ENDS	03/24/2022	PM0000541

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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