Actions on Tobacco Product Marketing Applications From CY 2013 to FY 2020
Below are FDA actions taken on premarket tobacco product applications, substantial equivalence reports and requests for exemption from substantial equivalence prior to the current fiscal year.
Note: FDA changed from calendar year (CY) reporting to fiscal year (FY) reporting at the end of CY2016.
| PMTA Actions | CY 2014 | CY 2015 | CY 2016 | FY 2017 | FY 2018 | FY 2019 | FY 2020 | Total through FY2020 |
|---|---|---|---|---|---|---|---|---|
| Marketing Granted Orders | 0 | 8 | 0 | 0 | 0 | 4 | 2 | 14 |
| Marketing Denial Orders | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 6 |
| Refuse-to-File (RTF) | 4 | 0 | 0 | 1 | 0 | 2 | 219 | 226 |
| Refuse-to-Accept (RTA) | 0 | 0 | 362 | 5 | 0 | 1 | 150 | 518 |
| Withdrawn by Applicant | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 3 |
Actions on Substantial Equivalence (SE) Reports CY 2013 through FY 2020
| SE Actions | CY 2013 | CY 2014 | CY 2015* | CY 2016** | FY 2017 | FY 2018 | FY 2019 | FY 2020 | Total through FY2020 |
|---|---|---|---|---|---|---|---|---|---|
| Substantial Equivalence (SE) Orders | 17 | 78 | 460 | 47 | 79 | 255 | 296 | 213 | 1419 |
| Not Substantially Equivalent (NSE) Orders | 13 | 25 | 114 | 30 | 63 | 87 | 84 | 17 | 409 |
| Refuse-to-Accept (RTA) | 0 | 16 | 16 | **672 | 15 | 0 | 10 | 66 | 378 |
| Withdrawn by Applicant | 207 | 301 | 473 | 409 | 339 | 227 | 236 | 89 | 2184 |
| Total Applications Received | -- | -- | -- | -- | 132 | 104 | 302 | 7071 | 13759 |
*In CY 2015, FDA also issued 23 SE order rescissions.
** In CY 2016, there were 267 Full Report RTAs and 405 Same Characteristic Report Cancellations.
-- Denotes that the metric wasn’t measured during that time period.
Actions on Exemption from Substantial Equivalence Requests CY 2013 through FY 2020
| EX Actions | CY 2013 | CY 2014 | CY 2015 | CY 2016 | FY 2017 | FY 2018 | FY 2019 | FY 2020 | Total through FY2020 |
|---|---|---|---|---|---|---|---|---|---|
| Exempt (EX) Orders | -- | -- | 1 | 0 | 26 | 58 | 244 | 219 | 546 |
| Not Exempt (NEX) Orders | -- | -- | -- | -- | 0 | 2 | 14 | 70 | 92 |
| Refusal-To-Accept (RTA) | 22 | 14 | 14 | 5 | 25 | 0 | 21 | 23 | 99 |
| Withdrawn | -- | -- | -- | 9 | 0 | 2 | 20 | 4 | 59 |
| Total Applications Received | -- | -- | -- | -- | -- | -- | 366 | 546 | 1115 |
-- Denotes that there was no data to report during that time period or that the metric wasn’t measured during that time period.