Plumes of Praise Rise From FDA Proposal
E-cigarette makers, analysts largely praise tobacco regulation moves
Published in Tobacco E-News
That said, today’s actions deliver an important roadmap as to the kind of oversight it intends to adopt. The strictures proposed very much echo the tone assumed by Mitch Zeller since he assumed the top position more than a year ago at FDA’s Center for Tobacco Products. That is, he is intrigued by electronic nicotine devices and will allow the science to ultimately determine whether further limits are justified, but that his chief concern is underage consumption of tobacco.
To that end, the FDA’s deeming regulations aim to impose fences against the sale of all tobacco products to minor. Thus, it proposes bans of online e-cig sales to minors, and for retailers, minimum age and ID restrictions to prevent sales to underage youth.
That said, the FDA’s proposal seems to give e-cigs greater latitude than its combustible counterparts. Companies, for instance, would be permitted to continue marketing electronic nicotine devices via television and other traditional media and would continue to roll out the increasingly expanding repertoire of flavors.
That, of course, means not everyone is breathing easily about the agency’s news, especially as it relates to e-cigarettes.
“All in all, the deeming regulations are a disaster,” blogged Dr. Michael Siegel, a professor at Boston University’s School of Health. Siegel previously worked at the Office on Smoking and Health at the Centers for Disease Control. A longtime smoking critic, Siegel has embraced electronic-cigarette devices as an effective lure to convert cigarette smokers.
While he praised the FDA for not banning internet sale of e-cigs to adults or restricting flavors, Siegel lambasted the call mandating pre-approval (or substantial equivalence determination) for all new e-cig products.
Ronald Tully, vice president of new projects/public affairs at National Tobacco Co. L.P., also saw holes in the proposed regulations.
"Our company was pleased to see youth-access limitations on other tobacco products," he told CSP's Tobacco E-News, "but we have concerns with the direction of some elements of the proposed regulations and their impact on small companies. We sincerely hope that the agency will carefully review the comments of industry stakeholders, and that FDA ultimately recognizes the need for an alternative regulatory regime for many of the transformative and progressively innovative products that came, and will continue to come to the market, post Feb. 15, 2007."
“At the end of the day, while there are some positive aspects to these regulations, it is clear that science is not playing much of a role in the process,” Siegel wrote. “That does not bode well for the potential of electronic cigarettes to seriously challenge the combustible tobacco market, and thus to save hundreds of thousands of lives.”