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.

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Berta Camps Bisbal

Senior legal analyst
Berta has a law degree from the University of Barcelona and a Juris Doctor degree from Nova Southeastern University (Florida). She has worked as a faculty assistant in legal research in Florida, was a member of the Law Review, and has interned for a magistrate judge of the US District Court for the Southern District of Florida. Berta focuses on US legal analysis, including tracking all federal, state and local regulation. She runs our US interactive regulatory tracker product, following changing regulation on e-cigarettes in all 50 US states.

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