Zeller Chimes In on FDA Proposals

WASHINGTON -- With Scott Gottlieb, commissioner of the U.S. Food and Drug Administration (FDA), publicly targeting flavored tobacco products in new proposals issued in fall, Mitch Zeller, director of the FDA’s Center for Tobacco Products, took a moment with CSP to further elaborate on the agency’s intent and what it means for c-store retailers.

Here’s that discussion …

Q: What are the FDA and CTP’s current views on tobacco regulation?

A: We can’t look at a product or technology in isolation. We have to bring in the human dimension and consider behavior. What is the risk of a product beyond chemistry or toxicity? Who is using these products and how are they used? The 2018 Youth Risk Behavior Survey from the CDC (Centers for Disease Control and Prevention) showed an unbelievable surge in high school and middle school kids using e-cigarettes. But we are also concerned about how adults were using them and getting answers on potential dual use, where adults are using e-cigarettes but continue to smoke.

Q: What about flavors in e-cigarettes and cigars, and menthol cigarettes and cigars?

A: We are very concerned about flavors as they relate to kids. If a retailer wants to sell bubble gum- and cotton candy-flavored vaping pods, then they’ll have to do it in age-restricted areas. But it’s a balancing act. We’re getting grief from tobacco-control groups because we’re looking at mint and menthol in e-cigarettes differently from other flavors.

Q: What’s your response to retailers’ concerns about their businesses?

A: Our open and participatory process obligates us to lay bare what we think about the economic and regulatory impact, assessing both the costs and benefits. The rulemaking process is open and available to all interested parties, and we carefully consider every comment. If there’s new information, we have to seriously consider that. We take those responsibilities seriously.

Q: You’ve given Juul, the San Francisco-based e-cigarette maker, a lot of attention in recent months. Why?

A: The interaction we’ve had with the company covers things that are both public and nonpublic. But generally, there has been a remarkable one-year rise in e-cigarette use among youth that might have been fueled by the popularity of Juul and products like it. They’re similar in form, taking the shape of a USB flash drive, and their use of nicotine salts. But understand our perspective. The technology may help addicted adults switch to a less-harmful form of nicotine delivery, but we’re not going to allow a new generation of kids to get addicted. We have a concern that the category is wildly popular with kids, so we have to consider the characteristics of the products, including flavors.