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    FDA’s Finalized Deeming Regulation Will Not Be End of Rulemaking

    Mitch Zeller reiterates focus on "continuum of nicotine."

    By Melissa Kress, Convenience Store News
    Mitch Zeller is director of the FDA's Center for Tobacco Products.

    LAS VEGAS — One year ago, the Food and Drug Administration (FDA) released its proposed deeming regulation that would give it the authority over electronic cigarettes, cigars, pipe tobacco and certain dissolvable products that are not smokeless tobacco.

    In the intervening 12 months, the agency's Center for Tobacco Products (CTP) received and sifted through more than 135,000 public comments on the proposal. And now, a final rule could be revealed by the end of June, according to Mitch Zeller, director of the CTP.

    Zeller took the stage at the 2015 NATO Show Thursday morning in Las Vegas. It was the second time he addressed the association at its annual show since taking over the director role in March 2013, demonstrating the importance he places on the agency and the tobacco industry working together to responsibly regulate tobacco products.

    He was joined on a panel entitled "Business 'As Usual' Under FDA Regulation" by industry executives Jim Dillard, senior vice president of regulatory affairs at The Altria Group Inc., and Daniel McGee, general counsel at General Cigar Co.

    According to Zeller, there are two key discussions taking place at the FDA. One discussion takes aim at keeping tobacco products out of the hands of minors — a top priority for all stakeholders — while the second conversation centers around looking at nicotine differently. As he noted, the majority of adult cigarette smokers started as minors and by the time they were adults, the addiction had taken hold. Nicotine creates and sustains the addiction, but does not cause death. 

    "It's not the drug, it's the delivery method," Zeller said. "E-cigarettes have become the poster child for this debate, so it's about time to look at nicotine differently. We need to recognize that there is a continuum of nicotine-containing products." On one end of the spectrum are combustible cigarettes and on the other are nicotine replacement therapy products.

    Rules in the Making

    With the June target for a final deeming rule around the corner, the industry waits to see what shape the regulations will take. However, Dillard cautioned that changes can happen between the proposed rule and the final form.

    He is worried the proposal is "a bit overbroad" as there are multiple categories with different characteristics "lumped together."

    Dillard also pointed out the segments covered by the deeming regulation are very diverse, but the agency must apply a level playing field. For example, when it comes to compliance and user fees. 

    On the cigar side of the business, McGee raised concerns with the definition of premium cigars in the deeming regulation and the grandfather date for predicated products, which proposed stands at Feb. 15, 2007 — the same date as tobacco products the FDA already regulates.

    "Premium cigars, in contrast to machine-made cigars, are a very distinct [animal]," McGee said, noting premium cigars are a much smaller segment so the regulations should not be "one size fits all" when it comes to cigars.

    He also hopes the FDA allows sufficient time for compliance once the deeming regulation is finalized.

    By Melissa Kress, Convenience Store News
    • About Melissa Kress Melissa Kress joined EnsembleIQ's Convenience Store News and Convenience Store News for the Single Store Owner in November 2010. Her primary beats include alcoholic beverages and tobacco. Kress has been a professional journalist since 1995. A graduate of West Virginia University, she began her career in community journalism before moving to business-to-business publishing in 2000, covering commercial real estate.

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