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FDA Pre-Market Application Databases

FDA's Center for Tobacco Products (CTP) has created two new webpages with key information and data related to pre-market applications filed by the September 9, 2020 deadline for certain deemed tobacco products [cigars, hookah and electronic nicotine delivery systems]:

Deemed New Tobacco Product Applications List: This webpage includes a list of deemed new tobacco products that were on the U.S. market as of Aug. 8, 2016, are currently marketed, and for which a premarket application was submitted via the SE or EX REQ pathways by Sept. 9, 2020. Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time. FDA's Center for Tobacco Products will post information on products submitted through the PMTA pathway as soon as possible. This webpage will also be updated periodically when listed products are the subject of a final action, such as a positive or negative order.

Tobacco Product Applications: Metrics and Reporting: This webpage includes more detailed updates of the agency’s progress on premarket application review than previously available, including metrics broken down by pathway (SE, EX REQ, and PMTA) and by product category type (e.g., cigarette, ENDS, cigars, smokeless). This page will also include updates on intermediate actions such as the number of applications received and accepted, as well as aggregate data on the completion of substantive review and the actions taken. FDA plans to update the metrics on the acceptance and filing phases every other month, and the metrics on the review and action phase once every quarter. The information on this page is replacing the data previously available on the Tobacco Products Marketing Order webpage, which has been updated to house the final marketing orders for each pathway in a more streamlined manner.

Click HERE to read more in CTP Director Mitch Zeller recent perspective piece highlighting FDA’s progress since the September 2020 premarket application deadline for certain deemed new tobacco products.

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