Premarket Tobacco Product Applications | FDA
A Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under . A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers (per section 910(c)(4)), among other things:
In 2021, . For FDA to complete a substantive review of a PMTA, the application must include the information described in the final rule.
FDA regulations require individual environmental assessments to be submitted for each individual tobacco product.
Importantly, each product in a grouped submission is still treated as an individual product application. FDA regulations still require individual environmental assessments to be submitted for each individual tobacco product.