Five Fresh Insights into Tobacco Regulation

FDA director Zeller on deeming, modified risk and policy moving forward

By 
Melissa Vonder Haar, Freelance Writer

Mitch Zeller director of the FDA's Center for Tobacco Products

Mitch Zeller

LAS VEGAS -- When the man in charge of regulating tobacco for the U.S. Food and Drug Administration (FDA) appears in front of a group of tobacco retailers and manufacturers, nobody's expecting him to share any groundbreaking news on issues like deeming regulations or future policies. And the NATO Show panel featuring Mitch Zeller, director of the FDA's Center for Tobacco Products (CTP), was no exception. There was a bevy of "no comment" and "I can't say" responses.

However, as with the director's previous NATO Show appearance in 2013, there were a number of clues buried in the Zeller's presentation. Here are five key points CSP observed:

1. A final deeming rule is imminent, but more regulations are on the way.

The agency announced its proposed deeming regulations for cigars, electronic cigarettes and a number of previously undeemed tobacco products last April and has been reviewing the 135,000 comments submitted on the proposal since last August. Though Zeller would not give any indication on how close the agency was to finalizing the rule (or what changes might be made to it), he referenced that the FDA's unified agenda states a goal of having deeming finalized by June of 2015.

"I can't reveal non-public information on where we are in the rulemaking process," he said. "But June is still our goal, and we're working very hard to meet that goal."

That said, deeming will hardly be the FDA's final regulations of cigars and e-vapor.

"Deeming is primarily a jurisdictional step," Zeller said. "We should all expect further rulemaking to come once deeming has been finalized."

2. Substantial equivalence (SE) is still a work in progress.

At his first appearance at the NATO Show, Zeller listed substantial equivalence as one of his top three priorities. The CTP made its first-ever SE rulings shortly after, but it's been somewhat slow-going ever since. In fact, the Government Accountability Office (GAO) issued a rather scathing report on the FDA's lack of movement on SE, instructing the agency to set up performance measures for how it processes SE applications.

Zeller was proud to report that the agency has since set up these performance measures and reviews, telling the audience “as of March, we have no backlog. When a new application comes in, it's reviewed immediately.”

Which is only partially true. By Zeller's own admission, the CTP has set up performance measures and caught up with what's classified as "regular" SE applications: applications filed after March 2011. Unfortunately, only 1,100 of the 4,700 SE applications filed are considered "regular."

The CTP claims it hasn't had enough experience with "provisional" SE applications (those filed before a March 2011 deadline, which allows these products to remain on the market while the FDA considers the application) and thus hasn't set up performance measures or ruled on the majority of the 3,600 "provisional" applications.

3. TPSAC remains a hot-button topic.

The director only briefly addressed a Swedish Match application to market snus as a modified-risk tobacco product (MRTP), all-together avoiding the fact that a TPSAC (Tobacco Products Scientific Advisory Committee) panel recently voted against granting modified-risk status.

Zeller did, however, want to clarify two points on TPSAC. "Federal committees like TPSAC serve an advisory function: They are not the decision makers," he said, going on to clarify that the panel ruling on snus was not made up of the same individuals advising on menthol, which a 2014 federal court ruled as having a conflict of interest.

4. It's not an e-cig debate; it's a nicotine debate.

Zeller has often cited his position that the public health problem isn't nicotine, it's the delivery mechanism for the drug. During his panel, the director elaborated further on this notion.

"It shouldn't be a debate about e-cigs," he said. "It should be a debate about nicotine with e-cigs as the poster child of that debate."

Which isn't to say Zeller is fully on-board with nicotine being considered a low-risk drug.

"People have said we should treat nicotine like caffeine," said Zeller. "I'm not there yet, but I do agree we have to think about it differently."

5. Nicotine policy at forefront of things to come.

Perhaps the biggest clues Zeller dropped as to future priorities for the agency both centered on the continuum of risk: namely a discussion across multiple FDA centers on defining which nicotine-derived products should be regulated as tobacco and which should be regulated as therapeutic and an easier application process for products on the safer end of the risk continuum.

"Armed with more science, yes, future regulations should take into consideration a products' place on the continuum of risk," Zeller promised.