Tobacco retailers, suppliers, and other NATO Show attendees crowded the general session, 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 were disappointed. However, 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 and what isn’t substantial equivalent, there will be a lot more clarity and transparency to the process,” he said. “Menthol and deeming will be more straightforward because it’s more policy-focused than individual applications like substantial equivalents.”
While such discretion might be expected from the FDA, Zeller was more open to discussion of electronic cigarettes. He gave the stock lawyerly answer required 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 it 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. “With any of the newer products that in the abstract might pose less risk, it comes down to how the product is being used,” said Zeller. “Who is using the product? What is the 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. Ultimately, Zeller believes that tobacco retailers could provide invaluable insight into these questions. “What are the retailers seeing 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.” (Melissa Vonder Haar – Tobacco E-News)