Regulatory Stars Aligning for E-Cigs?
Herzog optimistic after attending Food and Drug Law Institute tobacco regulation conference
WASHINGTON -- On Oct. 28, the Food and Drug Law Institute (FDLI) hosted a conference on FDA regulation of tobacco, featuring a number of industry speakers including director of the FDA's Center for Tobacco Products (CTP), Mitch Zeller. According to Wells Fargo Securities analyst Bonnie Herzog, Zeller and other speakers echoed the sentiments famously expressed by Professor Michael Russell that "people smoke for nicotine, but they die from tar."
"The common theme throughout the day was the general agreement among various constituents that it's not the nicotine that harms (or) kills smokers, it's the combustion (and) delivery," Herzog wrote in a research note about the conference. "In fact, combustible cigarettes were demonized and a common goal to migrate smokers from combustible cigarettes to electronic cigarettes was evident."
In terms of the FDA's proposed electronic cigarette deeming regulations--which are currently being reviewed by the Office of Management and Budget (OMB)--Zeller emphasized that the agency needs to consider "population-level impact" as opposed to "individual impact." While there may be some "adverse" effects initially (such as dual-usage), Zeller is looking at the overall picture of improving public health for the long-term by getting the population to move away from combustible cigarettes.
"The key question on e-cigs is how the FDA will deal with pre-market approvals," Herzog said. "In other words, will deeming regulations prevent, limit or restrict rapid innovation of the category? If e-cigarette innovation is stifled, in our view this could dramatically slow down conversion from combustible cigarettes, which would ultimately result in net negative public health impact; clearly, this would be in direct opposition of the agency's goal."
To this goal, Zeller sees a huge opportunity for the FDA to develop a new way of regulating that takes into account the varying degrees of risk from the different ways the general population consumes nicotine. Described as a "comprehensive nicotine regulatory policy," this new way of regulating would recognize the vast difference in harm between products like combustible cigarettes as opposed to nicotine replacement therapy (NRT). This is certainly promising for tar and combustion-free products like electronic cigarettes.
"Overall, we were very encouraged that Mr. Zeller seems to be fully embracing the continuum of risk concept and views the nicotine separately from the delivery, which suggests that electronic cigarettes should ultimately be favorably regulated," Herzog said, noting that this could also be a positive for other non-combustible products like smokeless. "Our bullish e-cig thesis remains intact, and we have further conviction the regulatory stars will ultimately align for e-cigarettes, continuing to propel the category."