From: FDA
By: Ned Sharpless, M.D., Acting Commissioner
***
Under the PMTA pathway, FDA evaluates a new tobacco product based on whether it is appropriate for the protection of the public health. Scientific evaluation considers the risks and benefits of the product for the whole population, including users and non-users. These data should show the increased or decreased likelihood that current tobacco users will stop using certain products, as well as the increased or decreased likelihood that non-users will start using the products.
To provide additional information to manufacturers submitting these applications, FDA has advanced important regulatory documents such as guidance on tobacco product master files, a final rule outlining the minimum threshold for acceptability of an application for review, and a final guidance for companies with recommendations to consider as they prepare to submit PMTAs for ENDS products. In addition, a proposed rule on PMTAs is undergoing OMB review. These types of documents will ultimately help us conduct the product application reviews in a more efficient and transparent manner.