Health advocates such as Keith Ablow are also encouraged that electronic cigarettes not only deliver nicotine in a healthier way than combustible cigarettes, but also address the behavioral aspects of cigarette smoking commonly ignored by traditional nicotine-replacement therapies.
Ablow, a psychiatric expert and TV personality, saw these results firsthand in a clinical study funded by Logic, in which Ablow monitored the habits of traditional tobacco smokers who were given the option of electronic cigarettes.
After three months, 70% of participants were no longer consuming tobacco, and 47% of those stopped using electronic cigarettes as well.
“I’m convinced,” Ablow says, “that electronic cigarettes represent the most powerful way we have to reduce peoples’ use of tobacco—or eliminate it altogether.”
Like Ablow and Carmona, the FDA—specifically Mitch Zeller, the new director of the agency’s Center for Tobacco Products (CTP)—is intrigued by a less harmful, potential cessation device. The potential for harm reduction speaks to Zeller’s vow that any tobacco regulations proposed on his watch must be supported by science and benefit public health.
“In an effort to create lasting regulations, FDA decisions must be based on the strongest possible science,” Zeller said in July. “In doing so, our policies will strengthen the legal precedent and change the tobacco marketplace as we know it.”
While this comment was in response to an advance notice of proposed rulemaking (ANPRM) on menthol, Zeller addressed electronic cigarettes specifically during an appearance at this year’s NATO Show.
“Products like e-cigarettes are very interesting,” Zeller said. “You can look at them in the abstract from a harm perspective and say: If it’s not tobacco, if it’s not combusting, then does it make sense to look at it as something that might be potentially much less harmful than any combustible tobacco product that’s out there?”
But the FDA does not regulate in the abstract. Zeller continued that any regulations would have to look at how the public is using electronic cigarettes. It’s one thing if smokers are using electronic cigarettes as a cessation device or a replacement for cigarettes; it’s another if they are being used as a substitute in places where smokers cannot use tobacco cigarettes.
“These are complicated questions of behavior, complicated questions of public health, and e-cigarettes raise all of these questions,” Zeller surmised.
As complicated as the questions may be, it appears as though enough have been answered to start the regulatory process. It’s been rumored that before the government shutdown, the FDA had provided proposed deeming regulations to the Office of Management—the last step before making a public announcement.
In the Year 2018 …
Though it’s impossible to get a clear picture of the future before these regulations are announced, the entrance of Altria, Reynolds and Lorillard has made it easier to envision what the segment may look like in five years’ time.