Submit Tobacco Product Applications for Deemed Tobacco Products | FDA

Submit Tobacco Product Applications for Deemed Tobacco Products | FDA

Premarket Tobacco Product Applications for ENDS

Among many other new deemed tobacco products, applications for the premarket review of e-cigarettes and other electronic nicotine delivery systems (ENDS) on the market as of Aug. 8, 2016 must be submitted to FDA by Sept. 9, 2020. To date, all premarket applications for ENDS products received by FDA have been through the premarket tobacco product applications (PMTA) pathway, and we expect most applications for ENDS products submitted on or before Sept. 9 to be submitted through the PMTA pathway. In June 2019, FDA published a guidance on Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS). This guidance helps clarify the PMTA process for manufacturers and reflects FDA’s current thinking about information that may be helpful to include in a PMTA submission, as well as recommendations to address public health issues such as accidental nicotine exposure and battery failures. The guidance explains, among other things: Products to which the guidance applies When a PMTA is required under the statute and regulations General procedures for review of an ENDS PMTA How to submit a PMTA What information the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires you to submit in a PMTA What information FDA recommends you submit in an ENDS PMTA to show that permitting your new tobacco product to be marketed would be appropriate for the protection of the public health (APPH) Additional considerations for scientific studies and analyses, including bridging information from similar products to the new product, using existing scientific literature or analyses, and referencing tobacco product master files to reduce research burdens on manufacturers and increase efficiency of PMTA preparation and submissions

To view information on products that have already received marketing orders through the PMTA pathway, visit the PMTA marketing orders webpage. For more information and tips, follow @FDATobacco on Twitter and visit FDA’s webpage on preparing and submitting deemed tobacco product applications.

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