NATO Show 2014: To Deem or Not to Deem

Melissa Vonder Haar, Freelance Writer

Some on the panel supported a lengthy rule-making process, saying they would like the FDA take its time and do things right.
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Timing is a funny thing. The rallying cry for the 13th annual NATO Show could have been “Where are our deeming regs?” It was certainly front and center in most—if not every—panel and general session held April 8-10 at the Paris Las Vegas Hotel & Casino.

Though retailers and manufacturers had what has seemed like an endless wait for the announcement of the FDA’s proposed deeming regulations, the answer finally arrived two weeks after the conclusion of the 2014 NATO Show.

It’s easy to speculate that the conversation would have been vastly different had deeming been announced before the show. Yet, as NATO leader Thomas Briant repeatedly stated, the proposed regulations are just the first step toward clarity on the question of how the FDA will ultimately regulate not just e-cigarettes but also cigars and a number of previously unregulated OTP segments.

That rallying cry may have shifted in the aftermath of the FDA’s announcement, but many of the questions and concerns discussed at the nation’s premier tobacco event remain. Read on for some of the most pressing topics facing the tobacco industry today.

Under Pressure

Leading manufacturers discuss the FDA’s rule-making process

It should come as no surprise that retailers, manufacturers and public health advocates all were eager for the U.S. Food and Drug Administration (FDA) to release its long-awaited proposed deeming regulations on electronic cigarettes. And though the proposed regulations were announced shortly after this year’s NATO Show, Carlos Ioos, senior vice president of Glenview, Ill.-based DRL Enterprises (an affiliate of Republic Tobacco and Top Tobacco), warned retailers attending the “Cutting Through the Rhetoric” general session that it may be a while before we get a clear picture of the finalized rules.

Ioos described attending a manufacturer meeting with the FDA’s Center For Tobacco Products (CTP) in 2010, in which then-director Lawrence Deyton was getting called out for when the FDA would release its clerk training protocols.

“Basically, Deyton said, ‘If there’s a time frame in the Tobacco Control Act, you better believe we’re going to follow it,’ ” Loos recalled. “ ‘If there’s no time frame, don’t expect anything soon.’ ”

NATO’s executive director, Thomas Briant agreed, with Loos’ assessment, pointing out that the process has already taken longer than the norm. NATO had recently learned the FDA requested an extension of the proposed regulation review process by the Office of Management and Budget (OMB), leading Briant to believe that the agency has been asked to revise some of its initial proposal.

“Usually, an OMB review doesn’t take six or seven months,” Briant said. “It’s usually about 90 days. We’re now into the seventh month.”

Jack Marshall, senior manager of regulatory affairs for Richmond, Va.-based Altria Client Services Inc., said increased interest in the e-cigarette segment could also have slowed down the process.

“As the OMB reviews proposed regulations, they usually have very little meetings requests or none at all,” he said. “There’s been three dozen publically acknowledged meetings on e-cig regulations. It’s a real indicator in the interest of this across the board.”

This holdup may be somewhat understandable, but that hasn’t stopped the pressure from mounting. FDA commissioner Margaret Hamburg was called out by Congress for how long it was taking to get deeming regulations out. While the FDA’s proposal did come out just weeks later, the reality is it could take another 18 months to four years before the regulations go into effect, given the rulemaking process the FDA is legally obligated to adhere to.

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