U.S. flag An official website of the United States government
  1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Market and Distribute a Tobacco Product
  5. Premarket Tobacco Product Applications
  6. Premarket Tobacco Product Marketing Granted Orders
  1. Premarket Tobacco Product Applications

Premarket Tobacco Product Marketing Granted Orders

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 23 tobacco-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

Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email [email protected] or call 1-877-287-1373.

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  
NJOY LLC NJOY DAILY EXTRA Rich Tobacco 6% ENDS 06/10/2022 PM0000631 EA0000631  
R.J. Reynolds Vapor Company Vuse Vibe Power Unit [1] ENDS 05/12/2022

PM0000635

   
R.J. Reynolds Vapor Company Vuse Vibe Tank Original 3.0% ENDS 05/12/2022

PM0000636

   
R.J. Reynolds Vapor Company Vuse Vibe Power Unit [2] ENDS 05/12/2022

PM0004287

   
R.J. Reynolds Vapor Company Vuse Ciro Power Unit [1] ENDS 05/12/2022 PM0000646    
R.J. Reynolds Vapor Company Vuse Ciro Cartridge Original 1.5% ENDS 05/12/2022 PM0000712    
R.J. Reynolds Vapor Company Vuse Ciro Power Unit [2] ENDS 05/12/2022 PM0004293    

NJOY LLC

NJOY ACE Device

ENDS

04/26/2022

PM0000613

EA0000613 FONSI0000613

NJOY LLC

NJOY ACE POD Classic Tobacco 2.4%

ENDS

04/26/2022

PM0000614

EA0000614 FONSI0000614

NJOY LLC

NJOY ACE POD Classic Tobacco 5%

ENDS

04/26/2022

PM0000615

EA0000615 FONSI0000615

NJOY LLC

NJOY ACE POD Rich Tobacco 5% ENDS 04/26/2022

PM0000622

EA0000622 FONSI0000622

Logic Technology Development LLC 

Logic Regular Cartridge/Capsule Package ENDS 03/24/2022

PM0000529 

EA0000529 FONSI0000529
Logic Technology Development LLC  Logic Vapeleaf Cartridge/Capsule Package ENDS 03/24/2022

PM0000530

EA0000530 FONSI0000530
Logic Technology Development LLC Logic Vapeleaf Tobacco Vapor System ENDS 03/24/2022

PM0000531

EA0000531 FONSI0000531
Logic Technology Development LLC  Logic Pro Tobacco e-Liquid Package ENDS 03/24/2022

PM0000535

EA0000535 FONSI0000535
Logic Technology Development LLC  Logic Pro Capsule Tank System [1] ENDS 03/24/2022

PM0000536

EA0000536 FONSI0000536
Logic Technology Development LLC Logic Pro Capsule Tank System [2] ENDS 03/24/2022

PM0000537

EA0000537 FONSI0000537
Logic Technology Development LLC  Logic Power Tobacco e-Liquid Package ENDS 03/24/2022

PM0000540

EA0000540 FONSI0000540
Logic Technology Development LLC  Logic Power Rechargeable Kit ENDS 03/24/2022

PM0000541

EA0000541 FONSI0000541

 


Additional Resources

 

 

 
Back to Top