At 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).
Reasons to buy
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
- Companies that have petitioned for review of their MDO
- The arguments
- Challenges to the FDA’s approach to review
- Outcomes – what are the judges deciding?
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.