LAS VEGAS -- Contrary to many predictions, the U.S. Food and Drug Administration (FDA) did not release its final deeming regulations during last week’s NATO Show, nor did the FDA’s Center for Tobacco Products (CTP) director, Mitch Zeller, provide further clarity on when that announcement would be made.
“I guess I’m past the expiration date of being able to say, ‘It’s close',” Zeller joked during his general session. “Obviously, the No. 1 thing we have to do at the FDA is finalize deeming. It will happen under [the Obama] administration.”
Though Zeller said he could not provide further comment on the deeming regulations and a number of other potential regulatory issues (including menthol), here are four points he could publicly talk about:
Electronic Cigarettes Have a Place on the Spectrum of Risk
Zeller has repeatedly commented on the need to acknowledge and establish a spectrum of risk when it comes to nicotine.
“It gets complicated because nicotine is not a completely safe compound,” he said. “Nicotine in cigarettes is deadly—yet in gum/patches/lozenges, it’s so safe and effective it doesn’t even require a prescription. There’s a public health opportunity to move someone at the highest end of the spectrum of risk (cigarettes) to the lower end.”
For now, that “lower end” means nicotine-replacement therapies. But, Zeller said, “Once electronic cigarettes are deemed, they too have a place on that spectrum.”
The E-Cig Debate Has Been Detrimental to Harm Reduction
Zeller went on to discuss the all-too-familiar argument about the potential pros and cons of e-cigs and vaping, wondering if tobacco-control groups and vaping advocates were “having the wrong debate.”
“The e-cig debate has been emotional, divisive and is not advancing common ground on harm reduction,” he said. “Where and how can we apply the principle of harm reduction to this debate and find common ground? It’s been horribly ineffective to date.
“Part of the challenge with tobacco-control groups and public-health advocates is a historic distrust of the tobacco industry,” he continued. “Every sector has a role to play (in finding common ground).”
Social Sources Are a Problem
Initial data from the FDA’s long-term Population Assessment of Tobacco and Health (PATH) study suggest the vast majority of minors are not accessing tobacco from retailers, but from “social sources” (older siblings, friends, parents or even strangers). Specifically, 86% of 15- to 17-year olds obtained cigarettes from social sources, while 89% of 15- to 17-year-olds obtained e-cigs from social sources.
“Social sources are a very important issue to reduce youth access to tobacco,” said NATO executive director Thomas Briant. “We look forward to FDA stepping in to educate adults about not being a source of tobacco (for minors).”
Though Zeller agreed that social sources are a big problem, he didn’t quite have an answer on how the FDA would go about addressing it.
“Youth access is not just about retail,” he said. “What we’re going to do about social sources is a very good question, and we are open to suggestions.”
The FDA Is Looking at POS
Zeller went through several studies the agency is conducting in an effort to enact science-based regulations. Perhaps the most retail-centric example came from research the FDA recently completed on point-of-sale (POS) marketing.
“This is one of those examples where we really need to know more than we currently do about the relationship between point-of-sale marketing and adult attitudes toward quitting,” he said.
While Zeller did not provide additional information on when that data would be made public or how the FDA might regulate POS based on the findings, he said the agency can regulate these kinds of marketing materials.
“I understand there are First Amendment issues," he said, "but we do have broad authority to look at appropriate restrictions on advertising and promotional practices.”