PMTA
PDA
WHAT IS PMTA?
The Premarket Tobacco Product Application (PMTA) is the regulatory pathway required by the U.S. Food and Drug Administration (FDA) for manufacturers seeking authorization to market new tobacco products, including electronic nicotine delivery systems (ENDS) such as e-cigarettes, vape devices, and e-liquids, in the United States. A PMTA can be submitted by any person for any new tobacco product seeking an FDA marketing order, and must provide scientific data that demonstrates a product is appropriate for the protection of public health.
PMTA’S MEANING FOR THE INDUSTRY
High Investment
Regulated Industry
Quality Assured
PMTA REVIEW PROCESS
OUR COMMITMENT TO PMTA
The electronic nicotine delivery system (ENDS) products that we sell or distribute in the United States have been submitted to FDA through PMTA process. We have devoted substantial resources to the preparation and submission of these applications and remain committed to ongoing regulatory compliance and appropriate cooperation with FDA. We will continue to manage our products and related activities in accordance with applicable legal and regulatory requirements while FDA review is ongoing.