Global Vapour Products Regulation

Vapour legislation: FDA’s release of deeming regulations for e-cigarettes

In May 2016, after years of debate, the US FDA finalised a rule extending itsauthority to all tobacco products, including e-cigarettes. While in somerespects the regulations were neutral, the key aspect was the application ofthe grandfather rule to vapour, which requires companies to submit a pre-markettobacco product application (PMTA) to get a product approved.

FDA’s new nicotine centred plan: Recognition of the continuum of risk and extension for PMT

AsIn July 2017, FDA announced a new plan that places nicotine addiction atthe centre of the agency’s tobacco regulatory efforts. Particularly relevant tothe vapour industry is the recognition that nicotine is delivered throughproducts that represent a continuum of risk and is most harmful whendelivered through combustible cigarettes. Notably, FDA also extended thedeadline to submit PMT. As for newly-regulated non-combustible productsthat were on the market in August 2016 to August 2022.

EU Tobacco Products Directive (EU TPD):Vapour as tobacco

Article 20, the section that affects e-cigarettes in the revised version of the EU TPD, treats e-cigarette products in many respects as tobacco, restricting container sizes, nicotine concentrations and advertising, but leaving the products widely available. Being fully operative since May 2017, the adopted measures were considered as a partial victory for e-cigarette advocates, having blunted more restrictive proposals in the initial draft.

Tobacco Endgame:Vapour products - part of theproblem or part of thesolution?

The “blue sky” measures, introduced by an influential Tobacco Control piecein 2013, aiming to bring the “end of tobacco” are already actively discussedby tobacco controllers worldwide. What part will vapour products play in theendgame context will be a key determinant of the category’s future trajectory.