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Description
This report examines the challenge brought to court by Wages and White Lion Investments – doing business as Triton Distribution (“Triton”) – and a second company, Vapetasia, against the marketing denial orders (MDOs) issued by the US Food and Drug Administration (FDA) in response to both companies’ premarket tobacco product applications (PMTAs). The two cases were consolidated for appeal due to the reasons for PMTA denial being the same.
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An ECigIntelligence regulatory report will provide you with:
- A clear and detailed understanding of current regulatory requirements affecting this sector in a specific jurisdiction, enabling you to be confident your business and your products are compliant.
- The ability to plan ahead for specific regulatory changes.
- Strategic understanding of the policy climate within the jurisdiction, enabling you to forecast how it might affect business development.
- Sources of further information, for example links to full texts of legislation and contact details for relevant government offices.
Table of contents
- Executive summary
- Background
- Timeline
- Arguments by petitioners
- Arguments by the FDA
- Amicus curiae: public participation
- US Court of Appeals for the Fifth Circuit Decision
- En banc rehearing
Methodology
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.
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