A heated debate is redrawing alliances in the tobacco control movement as federal officials wrestle with how to regulate the growing e-cigarette market.
The players include researchers, smoking-cessation advocates, and “vaping” connoisseurs.
“It’s become very divisive in a community that was largely united against Big Tobacco,” said Samir Soneji, an associate professor at the Dartmouth Institute for Health Policy and Clinical Practice, who researches tobacco control policy.
The comment period, which so far has generated more than 16,000 statements, will close on June 19. But many bureaucratic hurdles remain before a final rule will be issued.
One school of thought is that e-cigarettes, specifically ones that taste good, help people quit tobacco.
But opponents maintain there is little evidence from studies done on large groups of people to support this idea.
The limited data makes regulation tricky, FDA Commissioner Scott Gottlieb told Kaiser Health News. The agency may end up commissioning new research before developing policy.
“There’s a lot of interest in this subject,” he said. “The question is how much of that will be scientific, that can inform our rulemaking.”
Further complicating the picture, skeptics argue, is Big Tobacco’s looming presence.
Already, companies such as Altria, Reynolds American, and Japan Tobacco International (JTI) are marketing e-cig products and flexing their political muscle.
When contacted, JTI and Altria opted not to comment on e-cig regulations until their complete responses were filed with the FDA.
Reynolds declined to comment.
Meanwhile, Tony Abboud, executive director of the Vapor Technology Association (VTA), a trade organization, said the landscape has changed.
The Debate
E-cigarettes are electronic, handheld devices that deliver a vapor made of nicotine and other chemicals. Since entering the U.S. market in 2007, they have amassed a substantial following.Mark Anton, executive director of the Smoke-Free Alternatives Trade Association, another industry group, dismissed these concerns.
“The evidence [of harm to teens] … is highly anecdotal,” he said.
And, at least in testimonials, there’s increasing traction for vapes’ smoking-cessation potential.
The tobacco industry has a history of leveraging customer loyalty, and mobilizing a vocal support base, said Pamela Ling, a professor of medicine at the University of California-San Francisco, who studies tobacco and its marketing.
Negotiating Trade-Offs
Testimonials aside, it’s unclear whether e-cigarettes are more effective tools to quit smoking than the nicotine patch or drugs like Wellbutrin. It’s also unclear whether flavors help.“The evidence is really limited,” Ling said.
Many adults smokers don’t actually quit tobacco but use vapes in places where cigarettes are banned, said John Pierce, a professor for cancer research at the University of California-San Diego.
In fact, e-cigarettes are not an FDA-certified smoking cessation therapy. The industry has not sought this label, and the VTA doesn’t intend to change that, Abboud said. Certification requires rigorously demonstrating e-cigs’ effectiveness, and showing that the benefits outweigh risks.
“It’s a double-edged sword in some ways,” Gottlieb said. “Flavors in this context could do both harm and good.”
That underscores this debate’s central question: Are potential benefits for adults worth the risks for children?
Tobacco researchers such as Stanton Glantz, at the University of California-San Francisco, say the risks—and limited favorable evidence—support keeping flavored vapes off the market until science clearly supports their use for smoking cessation.
But analysts such as Kenneth Warner, a public health professor and economist at the University of Michigan, focus on how vaping could lower adult tobacco use.
“The FDA is … asking for a level of proof about its public health effects that’s probably unattainable,” he added. “I’m sympathetic about worrying about the impact on kids. I just don’t want to throw out the baby with the bathwater.”
The ideal standard, Gottlieb said, would ban flavors that appeal to kids while permitting adult-friendly ones. That’s easier said than done.
That last point is essential, Gottlieb suggested.
“That rulemaking we do needs to be informed by data,” he said. “We’re a science-based organization. We want to get it right.”