This report outlines the main regulatory pathways that must be followed when
launching tobacco products in the US. Companies need to have their premarket tobacco
product applications (PMTA) approved by the Food and Drug Administration (FDA) or take
the substantial equivalence (SE) route, if certain requirements can be met. Further to the
PMTA, firms may also submit a modified risk tobacco product application (MRTPA), which
allows them to make claims about the modified risks of their approved products.
And what could happen to new tobacco products that do not follow any of these routes?
Reasons to buy
If you are considering launching a tobacco product on the US
market then this report will show you which legal routes you need to take. It covers the
processes for PMTAs and both types of MRTP, with important information about what the
FDA considers when reviewing applications and how many have been granted or denied. It
also explores the different routes to obtaining substantial equivalence, including the
characteristics of each one and what kind of data an applicant needs to submit. Plus, what are
the penalties for new tobacco products that do not follow the paths covered in this report?
Table of contents
- Executive summary
- The PMTA
- The MRTPA
- Differences between a PMTA and an MRTP
- The substantial equivalence route: an alternative to PMTAs
The research is completely original and conducted by ECigIntelligence’s
multilingual legal analysis team using several sources, including: online and offline resources
and data, specialist legal software, interviews with key stakeholders and government officials,
and via the collaboration with local lawyers and on-the-ground professionals.