New CTP director less clear on menthol, deeming, substantial equivalents
LAS VEGAS — Tobacco retailers, suppliers and other NATO Show attendees made up a standing-room only crowd at the general session, The FDA’s Vantage Point & NATO’s Viewpoint, eager to hear whether Mitch Zeller, the U.S. Food & Drug Administration’s newly appointed director of the Center for Tobacco Products (CTP), would provide any insights on if and when the agency would issue its stance on menthol.
Those expecting a clue to whether the FDA will regulate the segment would be disappointed.
“You don’t actually expect me to make an announcement on menthol today, do you?” Zeller joked, when asked.
“All I can say is when I started, there were a series of very critical, urgent issues and menthol was one of them,” he continued. “The first four to five weeks of my return to the FDA were fully occupied by dealing with menthol, deeming [regulations] and substantial equivalency. There’s nothing I can say publically about any of those topics.”
Zeller did say the FDA was close to being able to announce its plans for menthol, deeming and substantial equivalents, noting that he understands that clarity on these topics is very important to retailers and manufacturers alike.
“As we begin to rule on the decisions on what is substantial equivalent, what isn’t substantial equivalent, they’ll be a lot more clarity and transparency to the process,” he said. “Menthol and deeming, when we eventually announce what we’re going to do, will be more straightforward because it’s more policy focused than individual applications, like with substantial equivalents.”
While such discretion might be expected from the FDA, Zeller was more open to discussion when Ray Cross, category manager for the Springfield, Mass.-based F.L. Roberts & Co. Inc., brought up the issue of electronic cigarettes.
Zeller gave the “stock lawyerly answer” that he is required to give on such issues, stating that electronic cigarettes relate to deeming regulations, which the FDA has yet to announce. But he also expressed a growing interest in the nascent segment and its potential to affect public health.
“Products like e-cigarettes are very interesting,” he 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 is as something that might be potentially much less harmful than any combustible tobacco product that’s out there?”
The issue Zeller has is that the FDA would not be regulating electronic cigarettes based on their abstract potential, but how real consumers are actually using such products and how such products affect public health.
“Any of the newer products that in the abstract might pose less risk, all comes down to how the product is being used,” said Zeller. “Who is using the product? What is impact on initiation, what is the impact on cessation?”
For example, if smokers are merely using e-cigarettes as a nicotine substitute in situations where smoking bans prevent them from smoking a traditional cigarette, e-cigarettes would not actually be improving public health.
“These are complicated questions of behavior, complicated questions of public health and e-cigarettes raise all of these questions,” he said.
Ultimately, Zeller believes that tobacco retailers could provide invaluable insight into these complication questions.
“My question is, what are the retailers seeing–especially with e-cigarettes–in terms of who’s buying them, why are they buying them, how has their use of the product (if there are repeat purchases) changed over time?” he asked. “We’re very interested in hearing the front-line perspective of what’s going on with this particular product.”