UNITED STATES
Experts say leaked FDA vaping guidance signals over-regulation

Leaked guidance on forthcoming e-cigarette regulation show the Food and Drug Administration’s (FDA) proposed final rule would decimate the US vaping industry, say experts who have seen the documents.

“This is an insane way to craft a regulatory strategy for the range of nicotine containing products on the market,” commented Boston University Prof. Michael Siegel in his tobacco issues blog, The Rest of the Story. "The most toxic products – combustible cigarettes – are being given a free ride. The safest products on the market – electronic cigarettes – are being forced to complete complex, burdensome, expensive, and unruly applications for which in most cases it is technically impossible to make the demonstrations that are required by the deeming regulations.”
The Tobacco Vapor Electronic Cigarette Association (TVECA) posted for download the FDA’s proposed industry guidance for pre-market tobacco product approval (PMTA) for electronic nicotine delivery systems and the final draft regulation table of contents at http://www.tveca.com/. TVECA reportedly withheld publication of the final draft at the FDA's request.
Industry livelihoods are threatened, “in this desperate time,” TVECA said. A “long and cumbersome” legal battle looms, the advocacy group said.
University of California Dr Stanton Glantz, the American Legacy Foundation distinguished professor of tobacco control, called on the Obama Administration to release the proposed final deeming rule to the public. The rule currently is under review at the White House Office of Management and Budget.

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