On September 24-25, the Troutman Sanders tobacco team attended the ECIG USA industry conference in Las Vegas. Bryan Haynes spoke on a panel entitled, “The Deeming Regulations — Expectations vs. Reality.” Panelists also included Cynthia Cabrera of SFATA, Bill Bartkowski of VapAria, and Jim Swauger of Reynolds.
The panelists addressed the actual content of the FDA’s proposed rule governing e-cigarettes relative to their expectations in advance of the rule. The consensus appeared to be that the regulations were not as bad as they could have been, but that some aspects of the regulations failed to account for the fundamental differences between e-cigarettes and the tobacco products that the FDA currently regulates. The proposed regulations did not, for example ban or otherwise regulate flavors. The proposed regulations also did not ban or otherwise regulate Internet sales. However, the regulations’ proposal to subject e-cigarettes to premarket review requirements identifcal to those imposed on cigarettes is a cause for concern. And it is clear that the FDA will be evaluating future controls on both flavors and remote sales.
It was also noted that the deeming regulations did little to address safety and efficacy concerns that have been raised about certain e-cigarettes. Those standards are likely to be adopted under the FDA’s authority to adopt tobacco product standards and/or good manufacturing practices. Panelists also addressed the business uncertainty prompted by the proposed regulations, which could make some less likely to invest and create innovative new products. FDA premarket review is a further disincentive to innovation, seemingly contrary to the FDA’s public health mission to move existing tobacco consumers down the continuum of risk toward less hazardous products.
Panelists were also asked to look into their “crystal balls” and predict the effective date of the proposed regulations. You heard it here first — it will be June 15, 2015. Seriously, there is no way of knowing with any certainty when the FDA will finalize its proposal. Estimates ranged from 1 to 10 years, although some public health advocates are calling for the regulations to be finalized by the end of 2014. Perhaps inevitable litigation challenges could further delay at least some aspects of the regulations. It also always possible (and some might say advisable) that the FDA will consider all of the comments on the proposed regulations, substantially revise its proposal, and then seek additional comments. If it does, this would further delay the process.
Other panelists addressed the growth of the vapor category and its immense potential. The market is currently estimated to be betwen 2.5 and 4 billion dollars, and many believe that vapor products have the potential to surpass traditional cigarettes in the next 10 years.