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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Table of contents
- Executive summary
- Introduction – the internal documents
- The “bracketing system”
- The “fatal flaw” review
- A de facto ban on flavours?
- What are the courts saying?
Our research is completely independent and original. It is conducted by ECigIntelligence’s multilingual legal analysis team, all specialists in this sector, and goes through a rigorous review and editing process before publication. Research draws on multiple sources, including: online and offline resources and data, specialist legal software, our own extensive databases and report archives, interviews with key stakeholders and government officials, and collaboration with local legal firms and on-the-ground professionals in the jurisdictions covered.