On this page:
- Premarket Tobacco Product Applications (PMTA)
- Substantial Equivalence (SE) Reports
- Exemption from Substantial Equivalence Requests (EX REQ)
- Tobacco Product Applications Metrics Glossary
On June 11, 2021, from 1:00 to 3:30 p.m. EDT, join the Center for Tobacco Products (CTP) for a live, virtual meeting about the scientific review of applications received by Sept. 9, 2020. The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question and answer session with Director Holman and additional Office of Science staff. The meeting is intended to improve public understanding of the policies and processes for tobacco product application review. The meeting is free of charge, but prior registration is required.
In order to provide the most current information, FDA will be regularly updating this page with reporting and progress of FDA intermediate and final actions taken on premarket applications– PMTA, SE Report and EX REQ – across the application review process. The information included in these PDF charts replaces the information previously posted on the Tobacco Product Marketing Orders page (which has now been updated to more clearly present the order letters, decision summaries and other documents associated with tobacco products that FDA has authorized). Those who were familiar with the previous monthly aggregate numbers posted on that page will note that the new PDF charts include data on many more categories and milestones in the review process.
FDA intends to provide these metrics and data on a regular and reliable basis and in an easy-to-understand format, typically within a month of the closing of the reporting period.
Note: Information on this page is current as of April 1, 2021. Due to the large volume of applications received in September in advance of the September 9 premarket application deadline, the exact total number of products within the applications is still being processed. This information will be updated in the tables when available.
FDA may periodically reassess and change the categories or amount of data provided on this website. This data is produced on an ongoing basis and is subject to change due to updates, corrections, or other reasons. Some metrics can also change as FDA is processing an extremely large number of applications that move through many steps during the review process. The data reported here is generally accurate to within 10%.
Most of the metrics reported reflect the number of tobacco products that are at each stage. Descriptions of each of the metrics are provided within the Tobacco Product Applications Metrics Glossary.
View the complete set of PMTA Metrics for Acceptance, Filing and Review/Action Phases
View the complete set of SE Report Metrics for Acceptance and Review/Action Phases
View the complete set of EX REQ Metrics for Acceptance and Review/Action Phases
Actions on PMTA, SE Report and EX REQs taken by FDA before FY 2021 can be found in the Archive.
|Accepted||Number of products for which CTP performed an administrative review, accepted the application for further review, and issued an Acceptance letter to the applicant|
|Refuse to Accept||Number of products for which CTP did not accept a marketing application because a preliminary administrative review concludes that it has not met a minimum threshold for acceptability for FDA review|
|Total Applications Received||Number of products for which an application was received through one of the three submission types [SE Report, EX REQ or PMTA]|
|Filed||Number of products for which CTP performed a preliminary scientific review of a PMTA, did not identify significant data or information missing, and issued a Filing letter to the applicant informing them that they will be entering substantive review|
|Refuse to File||Number of products for which CTP will not file a marketing application because a preliminary scientific review concludes that necessary information is not included in the application|
|Number of Discipline Reviews Completed||Number of discipline reviews conducted by CTP for evaluation of the scientific information and data in a marketing application. Review disciplines may include engineering, chemistry, microbiology, toxicology, social science, behavioral and clinical pharmacology, medical, epidemiology, regulatory, and compliance|
|Deficiency Letters Issued||Number of products for which CTP issued deficiency letters requesting additional information from the applicant to make a marketing decision|
|Environmental Information Request Letters Issued||Number of products for which CTP made a scientific decision to support a marketing order; however, applicant still is required to provide information for environmental considerations before a marketing order can be issued|
|Marketing Granted Order||Number of products for which CTP concluded that marketing a new tobacco product is appropriate for the protection of public health and CTP issued an order indicating that the new product can be marketed|
|Marketing Denial Order||Number of products for which CTP concluded that marketing a new tobacco product is not appropriate for the protection of public health and CTP issued an order denying marketing of the new product|
|Substantial Equivalence Order||Number of products for which CTP concluded that a new product is substantially equivalent to a predicate product and CTP issued an order indicating that the new product can be marketed|
|Not Substantially Equivalent Order||Number of products for which CTP concluded that a new product is not substantially equivalent to a predicate product and CTP issued an order denying the marketing of a new product|
|Found Exempt Order||Number of products for which CTP concluded that a new product is exempt from the requirements of substantial equivalence and CTP issued an order indicating that the new product can be marketed|
|Not Exempt Order||Number of products for which CTP concluded that a new product is not exempt from demonstrating substantial equivalence to the original product and CTP issued an order denying marketing of the new product|
|Withdrawn by Applicant||Number of products for which CTP acknowledged and complied with the applicant’s request to remove its marketing application from consideration for a marketing order|
|Closure||Number of products for which CTP did not make a decision on an application because there was an error and the marketing application should not have been opened|