By Rich Duprey, Motley Fool
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.
|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|Withdrawn by applicant||1||0||0||0||2||0||2||5|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|
Data source: FDA.