December 3rd, 2015
From: The Hill
By Lydia Wheeler
Industry and health groups are flocking to the White House in hopes of winning last-minute changes to sweeping new regulations for electronic cigarettes and conventional cigars.
A hotly contested rule that would for the first time put both types of products under the Food and Drug Administration’s supervision is undergoing final review at the White House’s Office of Management and Budget (OMB).
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November 27th, 2015
From: R Street
by Joel Nitzkin
Two recent public comment letters from Stanton Glantz of the University of California at San Francisco finally lay bare the myth that underlies the public-health crusade against e-cigarettes – that no non-pharmaceutical nicotine-delivery product could possibly have any personal or public health benefits.
If not licensed as a drug, the argument goes, all such products (other than cigarettes) should be summarily removed from the market.
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November 20th, 2015
Can any independent electronic cigarette afford the application process?
By Melissa Vonder Haar, Tobacco Editor, CSP
BOSTON — Last week, for the first time ever, the U.S. Food and Drug Administration (FDA) authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The decision, which applied to eight new Swedish Match snus products, was lauded as a landmark in tobacco regulation.
“Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.
November 11th, 2015
From: TobaccoAnalysis
Yesterday, based on my analysis of the FDA draft guidance that will accompany the electronic cigarette deeming regulations, I explained that the requirements for a pre-market tobacco product application (PMTA) are so cumbersome and expensive that only a few of the largest e-cigarette manufacturers would be able to keep their products on the market.
Today, I add a few clarifications and expansions on my commentary, which I didn’t have time to discuss yesterday because I wanted to present a general overview of the regulations and their likely impact.
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November 5th, 2015
From: CSPnet.com
Only OMB review, publication in the Federal Register remain
Published in Tobacco E-News
By Thomas A. Briant, NATO Executive Director
MINNEAPOLIS — On October 19th of this year, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products submitted to the Office of Management and Budget (OMB) the final deeming regulations on cigars, pipe tobacco, and e-cigarettes.
