Substantial Moves

Are Zeller’s announcements on substantial equivalence and menthol historic—or more of the same from the FDA?

Melissa Vonder Haar, Freelance Writer

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Just weeks into his new position as the U.S. Food & Drug Administration’s (FDA’s) director of the Center for Tobacco Products (CTP), Mitch Zeller faced a firing squad of questions from tobacco retailers and suppliers attending the 2013 NATO Show in April. Not surprisingly, those questions centered around long-awaited decisions on hot-button issues such as menthol.

“You don’t actually expect me to make an announcement on menthol today, do you?” Zeller joked at the April event.

But that doesn’t mean Zeller wasn’t feeling political pressure to move on such important tobacco-related concerns.

“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 publicly about any of those topics.”

Many in the industry were understandably skeptical about Zeller’s ability to make any headway on these priorities. After all, Zeller’s CTP predecessor, Lawrence Deyton, failed to even propose rules on any of these major issues during his more than three-year tenure.

Yet it took Zeller only until June 25 to tackle the first of those critical issues he outlined at The NATO Show, granting the agency’s first-ever substantial equivalence (SE) approvals. Fast-forward a month, when Zeller issued an advance notice of proposed rulemaking (ANPRM) on menthol. And though the April deadline for a notice of proposed rulemaking (NPRM) on OTP deeming regulations came and went, an announcement on Zeller’s third-named priority is now expected in October.

Making progress on not just one but three major issues within the first six months of his tenure has impressed industry experts such as Bonnie Herzog, Wells Fargo’s managing director of beverage, tobacco and convenience-store research.

“I’m optimistic that [Zeller] can get action,” she says. “We are starting to see things happen.”

But even Herzog acknowledges the substantial-equivalence announcement wasn’t quite as “historic” as Zeller described. Yes, the agency approved two products and rejected four, but there is still a backlog of thousands of applications awaiting a decision.

Similarly, while Zeller has at least set up a timetable for menthol, any actual decisions are a ways off.

“The regulatory process is very long,” says Greg Wilson, director of regulatory affairs, engagement and information for Richmond, Va.-based Altria Group Inc. “If the FDA was to propose to do anything on menthol, I think that they would first put out a proposed regulation and take public comments. Then they’d have to review those public comments, react to those public comments and ultimately arrive at what they would propose to be a final rule and put that out for public comment. It’s a very lengthy process.”


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