Search Results: PMTA

Some are sanguine, but PMTA fine print causes concern

Written by Freddie Dawson || 12th May 2016 || Regulatory briefing |

Some larger independent e-cigarette companies support the new rules from the U.S. Food and Drug Administration (FDA), despite the debate over them being widely portrayed as an argument between Big Tobacco and health organisations on one side versus...

PMTAs can use many kinds of scientific support, FDA says

Written by Barnaby Page || 10th May 2016 || Regulatory briefing |

The U.S. Food and Drug Administration (FDA) believes most e-cigarette manufacturers will need to conduct fresh scientific research in order to obtain authorisation for their products under the newly-published deeming regulations – but not necessarily full-blown clinical...

PMTAs: the road to FDA approval for e-cigarette products

Written by || 12th November 2015 || Regulatory reports |

Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about the grandfather date • Guidance for industry: information...

In depth: FDA deeming regs – the problems and solutions

Written by Barnaby Page || 19th September 2014 || Market reports |

The proposed regulations • FDA e-cigarette information requests • Analysis of SFATA submission • SFATA’s proposed alternative • Analysis of AEMSA submission and proposals • Analysis of Totally Wicked submission and proposals •...

In depth: potential legal challenges to FDA e-cig rules

Written by ECigIntelligence || 21st June 2014 || Regulatory reports |

Tobacco: precedents for challenge • Potential challenges to the deeming regulations • Challenges to scientific foundation • Challenges to pre-market approval and substantial equivalence • Challenges to health warning labels • Challenges to the deeming of e-cigs as...

ECigIntelligence style guide: specific style points

Written by Aidan Semmens || 1st January 1900 || Resources |

When in doubt, if a particular issue isn’t covered here, it’s worth checking what we’ve done on the site before. Remember, however, that style evolves and some specifics may have changed – notably in such things as capital initials...