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.
NEXT PAGE: “Kiddie-Flavored” E-Cigs
A Lengthy Engagement
Many manufacturers are eager for these deeming regulations both to legitimize the category and to get a clearer picture of the future. And yet Michael Shannon, vice president of external affairs and associate general counsel for Greensboro, N.C.’s Lorillard Inc., argued against a speedy rule-making process.
“The FDA is like any organization: It does respond to criticism and to pressures,” he said. “But I’d rather the FDA, or any lawmaking organization, take its time and get it right rather than push something out.”
Multiple panelists referenced the menthol debate as an example of how beneficial a lengthy rulemaking process can be. The FDA has been looking at menthol since 2010, reviewing hundreds of thousands of comments from manufacturers, retailers and scientists on the issue.
“It can take a good bit of time,” Marshall said. “The key takeaway is there is a process—and that process can be very important.”
However, this process is beneficial to the industry only if people take the time to share their insights with the FDA.
“We have to find the time to engage, because otherwise there’s only one story; the FDA doesn’t see the other side of it,” said Shannon. “That’s the critical part we have to fill in, and the FDA has been very good about seeking out that information so they can make the right decision.”
“While people can get frustrated at the time and the length, the process is set up there to allow for people to engage and drive the evidence and science-based decision making process,” Marshall said. “We manufacturers certainly have things we can chime in on, but so do you. You’re out in the real world. What you’re seeing and experiencing every day is critical input for the agency.”
A real-world perspective will be essential as the FDA attempts to regulate electronic cigarettes and where they might fall on the continuum of risk. Regulations could either foster or stifle the segment’s growth potential.
“For us, the key really is that [regulations] are science- and evidence-based,” Marshall said. “We want the regulations to foster innovation in the space and allow manufacturers the opportunity—through regulations—to develop new products that can have a positive impact on public health.”
‘Kiddie’ Land?
Part of the problem is that anti-tobacco voices are pushing a lot of rhetoric based on public opinion, not public health. Perhaps nowhere is this more clear than the outcry over “kiddie-flavored” e-cigs.
“Adults like flavors,” said Shannon, pointing out that he’d enjoyed an Absolut Citron the previous night. “If you go to a bar, there’s a lot of flavored alcohol. I don’t hear those referred to as ‘kiddie flavors.’ Whoever’s using that term is not using any scientific base; they’re just throwing out a term to try and generate some kind of shock and push through unfair legislation and regulations.”
The initial proposed regulations did not include a flavor ban but left the door open for future regulations to limit or outright outlaw characterizing flavors. However, in order to do so, the FDA would be legally required to consider all consequences such actions might have. It’s something the agency has already dealt with during the scientific advisory meetings on menthol, where concerns over black-market threats were prominent.
“Congress realized that whatever regulations do occur, you’re going to have unintended consequences,” Shannon said. “Sometimes you can have a good purpose with your legislation but could actually cause more damage to public health.”
So while it may be exhaustingly slow, the FDA’s rulemaking process is one that can be beneficial to manufacturers and retailers hoping for science-based regulations.
“This theme of fostering innovation in the industry so that products can be developed that through the FDA regulatory process can get us to perhaps a positive public health impact,” Marshall said. “Reduced harm certainly plays a role in that.”
“We’ve got to keep that foot on the gas pedals,” Shannon agreed. “I think we have a great opportunity to try and change the dynamics and change the rhetoric that has, for such a long time, made it very difficult for our industry.”
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