From: NASDAQ
By Rich Duprey, Motley Fool
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Batting 0-for-35
So far, it’s been impossible to get a modified risk label for tobacco. Since 2011, 35 applications have been submitted to the FDA, and not a single one has been approved. Eight received a response that essentially denied the application, but said they could be resubmitted with some modifications.
| Action Taken | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | Total |
| Refuse to accept | 2 | 0 | 0 | 0 | 0 | 8 | 0 | 10 |
| Refuse to file | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 4 |
| Denial (in whole/part) | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 8 |
| Response (in whole/part) | 0 | 0 | 0 | 0 | 0 | 8 | 0 | 8 |
| Withdrawn by applicant | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 5 |
| Modified risk order | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Total | 3 | 4 | 0 | 0 | 2 | 24 | 2 | 35 |
Data source: FDA.