The US Food and Drug Administration (FDA) released its official list of deemed new tobacco products for which a premarket application was submitted via FDA’s premarket tobacco product application (PMTA) pathway by September 9, 2020.
The agency had posted in February a list of deemed new tobacco products with applications submitted via the substantial equivalent (SE) and exemption from SE request (EX REQ) pathways. At the time the PMTA list was still being compiled.
The process for the PMTA list is now completed, and updates to the SE and EX REQ lists have been made. All three lists will be updated regularly as positive or negative actions are issued on these products through FDA’s deemed new tobacco product applications lists webpage. Reporting and progress of FDA intermediate and final actions taken on all three premarket application pathways across the application review process can be viewed at the agency’s tobacco product applications: metrics and reporting webpage.
The newly-released, 15-part PMTA list includes over six million new tobacco products. Listed products are authorized to remain on the market while applications continue to be reviewed by FDA. Asian companies in the list include Shenzhen First Union Technology, Shenzhen Greensound High-Tech, Shenzhen Innokin Technology, Shenzhen IVPS Technology, Shenzhen Smoore Technology, Shenzhen Vaporesso Technology, and Shenzhen Yibo Technology.