The e-cigarette news keeps on coming waiting for the FDA s ruling

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FDA Stamp of Approval

The chief of the FDA s Center for Tobacco Products, Mitch Zeller, has again almost-promised that he will, this month, render a decision on how the agency will handle the controversial subject of e-cigarettes. Of course, the Big Shutdown may further delay that plan it wouldn t be too surprising, given that in the 4-years-plus existence of the CTP, they have basically done nothing of significance to reduce the toll of smoking in our country.

Two new contributions to the burgeoning media and literature discussion of e-cigs have appeared over the weekend: an editorial in Lancet Oncology has decided that it s Time for e-cigarette regulation; and an article in The Washington Post shows some insights into E-cigarette makers lobbying hard to shape rules for fast-growing industry. (The media interest seems to be growing almost as fast as the industry).

The Lancet piece basically toes the now-expected party line which all the official public health groups, journals and governmental regulators have signed on to in lock-step. Which is, we just don t know what the long-term effects of e-cigarettes might be, and we must protect our children from them, so stick with the FDA-approved methods. The particular bones they have to pick include:

...new evidence released by the US Centers for Disease Control and Prevention (CDC) on Sept 6, 2013, shows that use of e-cigarettes by children and teenagers has more than doubled in the past 2 years. There is a real danger of the devices becoming a gateway product, attracting more young people to begin smoking ¦ and ...they are not being advertised as smoking cessation devices. Instead they are being marketed aggressively as lifestyle-choice consumables. Their conclusion: E-cigarettes should be regulated as medical devices, and their promotion should come under the ordinance of the WHO Framework Convention on Tobacco Control. This approach would effectively ban e-cigarettes from the marketplace.

As is universally the case, this position ignores these salient facts: the 45 million Americans who smoke; the 450,000 or so who die each year of smoking; the fact that the FDA-endorsed products to help smokers quit, don t; and that the CDC report was bogus, ignoring the evidence that the few teens who tried e-cigarettes did not become hooked. The fact that the hundreds of e-cigarette marketers don t advertise them as smoking cessation devices is only because the law specifically forbids them from doing that.

The Washington Post piece was a more even discussion, mostly absent of a clear agenda. It did take pains to point out that the FDA decision on the regulatory framework for e-cigs will be of huge importance, for smokers trying to quit, for the fledgling industry, and yes, even for the big tobacco companies. But mostly, for America s (and the world s) public health. As CASAA s Greg Conley put it, FDA is in the position to either foster a new market that s helping smokers to quit, or decimate it and drive much of it underground. He added, We re cautiously optimistic.

ACSH s Dr. Gilbert Ross said, I wish I could be optimistic. But the monolithic opposition to what seems to be, clearly, a nascent public health miracle is so frustrating and dismaying to me that I m just going to wait and see. But if the FDA does deem c-cigarettes as requiring regulation similar to real cigarettes, millions will die from smoking who might have been saved by switching, and the e-cigarette industry itself will cleave into those swallowed by Big Tobacco, and those who will become black marketeers. This would be a real tragedy and a travesty.