News analysis / Americas

West Virginia politician is latest to contest deeming rule in court

19th June 2016 | News analysis |

The U.S. Food and Drug Administration (FDA) is facing another legal challenge to its new deeming regulation on e-cigarettes. Filed in the Southern District of West Virginia on 10th June, the action was taken by Larry W. Faircloth, a Republican member of West Virginia’s House of Delegates who is described as a user of e-cigarette devices and liquid nicotine.

Opinion: how big is the risk of diacetyl litigation?

26th May 2016 | News analysis |

Plaintiffs’ attorneys in the U.S. are always on the hunt for a new target to sue. And, having had some success suing diacetyl manufacturers over workers’ exposure to the chemical in microwave popcorn plants, attorneys are now beginning to target coffee roasters and the e-cigarette industry as well.

Cessation evidence unclear, but second-gen devices may help

24th May 2016 | News analysis |

A new systematic review of e-cigarettes and smoking cessation is claimed to be the most comprehensive so far as it covers not only published, peer-reviewed studies – including observational research as well as RCTs – but also so-called “grey literature”, material published outside of peer review.

Some are sanguine, but PMTA fine print causes concern

12th May 2016 | News analysis |

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 indie e-cig firms on the other.

PMTAs can use many kinds of scientific support, FDA says

10th May 2016 | News analysis |

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 studies.

Deeming regulations: no more store-branded e-liquids?

6th May 2016 | News analysis |

The era of vape stores producing their own e-liquids is likely to come to an end after the introduction of the deeming regulations in the U.S., the agency responsible for them predicts. The Food and Drug Administration (FDA) says it “expects that most vape shops will stop mixing e-liquids“ because if they continue to do so they will fall under » Continue Reading.

Washington reaction: “mystery chemicals” and “over-reach”

6th May 2016 | News analysis |

Several members of Congress welcomed what they view as a long-overdue rule by the U.S. Food and Drug Administration (FDA) to regulate e-cigarettes, but the initial responses also provided another opportunity for Democrats and Republicans to show how divided they are when it comes to adding new federal oversight.

FDA faced hard decisions, criticism in crafting regulations

5th May 2016 | News analysis |

Striving for science-based policy-making in the deeming regulations, the FDA faced a tough task in attempting to corral the rapidly-developing and often contradictory data on e-cigarettes at the same time as it was dealing with pleas and criticisms from the industry and pressure groups.