LATEST ALERTSAt least 41 companies have petitioned the courts for review of their Marketing Denial Orders (MDO). Many companies filed two types of proceedings with the courts: one to review their MDO and another petitioning a stay of their MDO while pending review.
This report tracks and analyses the challenges brought to court by vape companies against their MDO of their premarket tobacco product applications (PMTA).
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Table of contents
- Executive summary
- Introduction
- Companies that have petitioned for review of their MDO
- The arguments
- Standard of review of the FDA – the “fatal flaw” approach
- Outcome – what are the judges deciding?
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