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Six Key Steps to Follow During the PMTA Application Process
Jun 20,2022

What is PMTA? 

Premarket Tobacco Application (PMTA) is an application that must be submitted for review and approval by the Food and Drug Administration (FDA) before a new tobacco product can be legally marketed in the United States. 

The application process overview 

The process is lengthy - it can take a year or more for the FDA to approve every application. Therefore, it is essential that any company wishing to launch new products follows the process correctly. Here we outline the six steps to ensure every e-cig company goes through the application process smoothly.



The vital points that the FDA focuses on during the acceptance process 

1. All new products have to be proven to present no harm to public health 

All e-cig companies must submit documents that illustrate all components of the products are compliant and present no harm to public health. Notably, once the regulatory department has checked the records, it will arrange its test procedure to verify that the use of the product will not negatively affect the health of users and non-users. Eventually, the products that pass the tests are determined to flow into the market legally.


2. The demonstration of potential health risks

In general, preparing complete reports of all information about safety examinations plays an essential role during the PMTA application. The FDA will check the risk of new products and is free to select which studies to base its decision on. In other words, there is a risk if the FDA adopts anti-vaping research, as this could mean that all the efforts made by e-cig enterprises would have been wasted. 

3. The likelihood that non-tobacco users will start using such products. 

Proving that the tobacco product submitted for approval will not cause non-users—especially juveniles who are the primary concern of the FDA—to take up nicotine use is tricky. Furthermore, demonstrating that the product is likely to promote cessation of all tobacco products asks for extensive and expensive scientific research. Hence, e-cig manufacturers must make arrangements to design surveys and studies of large groups to show that their products do not appeal to adolescents and non-users.


From this review of the process, it is evident that the FDA's key concerns are security and harm reduction. E-cigarette products should be developed in such a way as not to attract non-users to try them out, especially adolescents. In other words, understanding the FDA's requirements and submitting the complete documents is an essential process for companies to follow, to avoid the financial and time-loss implications of receiving RTA or RTF letters.
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E-cigarette product contains nicotine. Nicotine is an addictive chemical.