FDA's Zeller: Let's Reframe Debate to Focus on Nicotine


LAS VEGAS — As director of the Food and Drug Administration's (FDA) Center for Tobacco Products (CTP), Mitch Zeller understands the importance of dialogue, debate and policy.

As he explained to attendees of the 2016 NATO Show in Las Vegas on Thursday, one policy "near and dear" to him is addressing nicotine.

"It's something I spend a lot of time thinking about," Zeller noted. "It's time to start looking at nicotine differently."

Explaining this in more depth, the CTP director said "looking at nicotine differently" starts with addressing a few key points:

  • Recognize there is a continuum of nicotine-containing products;
  • Understand people smoke for the nicotine but die from the tar; and
  • Acknowledge the public health opportunity to move tobacco users down the risk spectrum. 

Zeller acknowledges that it's a complicated concept because nicotine is not a completely "safe" compound; it is never safe for non-users or for youth. However, he said there are safe delivery systems for nicotine, like gums, patches and lozenges.

He believes there is room for dialogue and debate, but said right now the industry is holding the wrong debate.

"Are we having the wrong debate? For me, yes. The debate has been about e-cigarettes. It should be about nicotine," he said, adding that "someone needs to step up to the plate" and reframe the debate.

Once that is successfully done, the nicotine debate needs to center on some critical questions, according to Zeller. These include: What is the longer-term use for those who need it? Is there a potential need for a period of dual use and, if so, for how long? What are the unintended consequences? Where does the principle of harm reduction come in?

Reframing of the debate away from electronic cigarettes comes as the industry awaits the FDA's final deeming rule, which would impact e-cigarettes, cigars, pipe tobacco and other tobacco products not currently under the FDA's authority.

On that front, Zeller said he could not comment on when the final deeming rule — which was first proposed in April 2014 — will be published or what the rule will contain. However, he did say "it is really close and it will happen in this administration." 

The 2016 NATO Show took place April 19-21 at Paris Las Vegas. 

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