LAS VEGAS --It should come as no surprise that retailers, manufacturers and public health advocates alike are eager for the U.S. Food and Drug Administration (FDA) to release its long awaited proposed deeming regulations on electronic cigarettes; however, Carl Ioos, senior vice president of the Glenview, Ill.-based DRL Enterprises (an affiliate of Republic Tobacco and Top Tobacco), warned retailers attending the "Cutting Through the Rhetoric" general session at last week's NATO Show that it may be a while.
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 timeframe in the Tobacco Control Act, you better believe we're going to follow it'," Ioos recalled. "'If there's no timeframe, don't expect anything soon'."
Although the FDA has promised that these proposed deeming regulations will be announced as soon as the Office of Management and Budget (OMB) complete its review (which has been going on since October), NATO's executive director Thomas Briant agreed with Ioos assessment. In fact NATO recently learned that the FDA requested an extension of the review process, leading Briant to believe that the agency has been asked to revise some of the proposed regulations.
"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 the Richmond, Va.-based Altria Client Services Inc., added that increased interest in the electronic cigarette segment could also be slowing down the process.
"Usually as the OMB reviews proposed regulations, they 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. Most recently, FDA commissioner Margaret Hamburg was called out by Congress for how long it's taking to get these deeming regulations out. Though Hamburg promised these regulations will be announced soon, the reality is it could take another 18 months to four years before these regulations go into effect, given the rulemaking process the FDA is legally obligated to adhere to.
"Folks on the hill are certainly watching this very closely," Marshall said. "Every day there's a letter from a public health group, from a senator or someone in the House of Representatives, to get deeming out. I think everybody sees this open white space right now and the critical need to get regulations. The pressure is certainly on from a political perspective."
And from a manufacturing perspective as well. 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 rulemaking 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 this 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."
Though this process is only beneficial to the industry 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," added Marshall.
This opportunity to engage, combined with the strength of the industry, has Shannon hopefully optimistic about the future.
"Yes, we have our challenges, but what a team that this industry has as resources to accomplish and deal with those challenges," he said, citing the retailers, distributors, manufacturers and industry associations in attendance. "We have a great team that really is focused on these issues. The FDA presents new challenges, but it's a new attitude, a time to reset and maybe find that opportunity to align our business interests with the FDA and public health interests."
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