SHARE

Vaping Post: Now in 2017, what do you retain from the year 2016?

“Only 10 days before the EU revised Tobacco Products Directive compliance deadline an important milestone was achieved across the Atlantic, in the United States”
Patricia Kovacevic: The year 2016 marked the most impactful regulatory developments to date in both Europe and the United States. Only 10 days before the EU revised Tobacco Products Directive compliance deadline an important milestone was achieved across the Atlantic, in the United States.

Namely, on May 10 the Food and Drug Administration, the U.S. government agency overseeing, among other, tobacco products, issued its “deeming rule”, which brought as of August 8, 2016 all vaping products under the rather inadequate regulatory framework of the 2009 Family Smoking Prevention and Tobacco Control Act.

It is quite symbolic that in May of 2016 both sides of the Atlantic entered a new era for the industry, moving from complete lack of industry-specific regulation to rather complex premarket and reporting requirements.

Vaping Post: Can you briefly summarize what characterize the regulatory approaches on both sides of the Atlantic?

Patricia Kovacevic: The two regulatory regimes – EU and USA – could be considered divergent in terms of industry impact. While generally inadequate, the EU TPD implementation suffers primarily from inconsistent implementation among member states and going too far in limiting access to product through remote sale restrictions in some EU member states and severe limitations on product advertising.

The US regulation gets it all wrong – it has a disproportionate impact on the US vaping industry versus the US conventional tobacco products industry; it punishes novel and clearly substantially reduced risk products with an unforgiving regulatory regime intended to really punish Big (Old) Tobacco, and it accomplishes precisely nothing in terms of tobacco harm reduction, product safety, consumer information and product improvement. 

“2016 was also the year of the least predictable – or maybe most intuitive – presidential election outcome”
In the US, 2016 also marked the development of a new and impactful trade association, the Vapor Technology Association, which established itself as a credible and effective voice of the industry and has grown to a few hundred members within less than a year.

The association, as well as other engagement agents in the United States political realm have positioned the industry very well for engagement with the new administration. Because, let us not forget, 2016 was also the year of the least predictable – or maybe most intuitive – presidential election outcome. Never before has America seen such a wave of economic optimism lead by the most controversial candidate.

The election outcome is cautiously optimistic for the vaping industry, as the democratic (now) minority is inexplicably unfriendly to vaping – let’s attribute it to lack of understanding of harm reduction opportunities – and now, well, in minority.

Patricia I. Kovacevic, General Counsel and Chief Compliance Officer, Nicopure Labs LLC (USA)

The industry itself has probably seen less direct monetary impact in the US in 2016 and more economic impact coming out of the EU TPD implementation with respect to premarket notification efforts and mandatory packaging changes against a backdrop of uncertain interpretation of the law.

Like with any new set of laws, they need to be tested to understand their true boundaries, and that takes time, usually years.

“An alien observer would think the US and UK are not even on the same planet”
2016 was also a year of contradictory public announcements: on the one hand, the UK takes a more constructive approach towards communicating the relative benefits of vaping vs smoking through the Royal College of Physicians Report and other government-endorsed communications, while stopping short of full transparency.

The US bodies – FDA, CDC and the Surgeon General in particular – appear to cherry-pick scaremongering messages about vaping products for the public at large, and it did not help that California opted for an ill-informed, full blown campaign against vaping. An alien observer would think the US and UK are not even on the same planet, or maybe are populated by completely different species of humans.

Vaping Post: What are your expectations for 2017?

“(…) a fighting chance due to the dedication of individuals and organizations that understand harm reduction and the risk cliff”
Patricia Kovacevic: 2017 will likely bring major developments in the US. My prediction is that certain FDA deadlines are likely to be extended, the new administration will demand more transparency, accountability and reasonableness of the FDA, and vaping will stand a fighting chance due to the dedication of individuals and organizations that understand harm reduction and the risk cliff. Should the current regulatory regime be somewhat mitigated, we can expect to see more consolidation in the vaping industry.

“2017 is a year of hope and continued promise”
In Europe there will be the inevitable trials and tribulations brought about by the inconsistent TPD application among 28 member states – some still lagging with TPD implementation.

While many look at heat-not-burn as a competitor to vaping, personally I believe it is just another product in the spectrum of consumer preferences, like hookahs or pipe tobacco, that has its place on the  market,  but is not competing with the much better established vaping industry.

Altogether, 2017 is a year of hope and continued promise, and a year when many more smokers will have quit smoking for good, most of them because they have an acceptable alternative. And that is what matters most.