The US FDA’s PMTA internal review process – a de facto ban on flavours?

The US Food and Drug Administration (FDA)’s internal memos seem to reveal a change in the premarket tobacco product application (PMTA) review process, suggesting the bracketing system has given way to the fatal flaw approach.

When reviewing the cases of companies bringing suits against the FDA for issuing a Marketing Denial Order (MDO) on their product, the courts have started to look at the change in route in the internal review of PMTAs. This report analyses this change in procedure and discusses a number of individual cases where companies have raised it following the issuing of an MDO.