Wednesday, October 09, 2013

E.U. Decides Not To Interfere With E-Cigarette Sales; Will The FDA Follow Suit?

A man smokes an electronic cigarette in a publ...

 (Image credit: AFP/Getty Images via @daylife)

Yesterday the European Parliament rejected proposed regulations that would have treated electronic cigarettes like pharmaceuticals, sparing manufacturers what The New York Times calls “an onerous and potentially costly certification process.” The E.U. will instead establish a minimum purchase age of 18, along with “tight restrictions on advertising and sponsorship” similar to those for conventional cigarettes. “This is a fantastic result for public health and the millions of smokers around Europe who are switching to e-cigarettes,” said Charles Hamshaw-Thomas, corporate affairs director for E-Lites, the leading British e-cigarette brand. “Common sense has prevailed.”

Whether it will in the United States remains to be seen. The Food and Drug Administration initially tried to ban e-cigarettes as unapproved pharmaceutical products, an effort that was blocked by the courts. More than two years ago, the agency said it would instead regulate e-cigarettes as tobacco products. It is still working on those rules, with a self-imposed deadline set for the end of this month.

Last month 40 state attorneys general wrote the FDA a letter urging it to ban most forms of advertising for e-cigarettes, claiming such messages glamorize smoking and appeal to minors. As evidence that e-cigarette manufacturers are trying to lure children into lifelong nicotine habits, the letter noted that e-cigarette cartridges come in “fruit and candy flavors” and that two companies use “cartoon monkeys” in their ads. By the same logic, Ensure and fiberglass insulation are aimed at children. The attorneys general also noted with alarm survey data indicating that “e-cigarette use among students doubled in the last year.”

As Michael Siegel has pointed out, that increase involves any use in the last month, which may reflect no more than experimentation. Furthermore, nine out of 10 teenagers who reported past-month vaping were smokers, meaning a trend decried as a public health disaster in the making may actually portend successful harm reduction. It is outrageous to suggest censoring truthful, potentially life-saving information about e-cigarettes aimed at adult smokers based on such a flimsy save-the-children rationale.

Such restrictions are unlikely to survive constitutional review in any case. The Supreme Court has overturned less extensive restrictions on outdoor tobacco ads that were likewise defended as a child-protection measure. The cigarette advertising regulations imposed by the Family Smoking Prevention and Tobacco Control Act, which the attorneys general want the FDA to impose on e-cigarettes as well, have been rejected on First Amendment grounds by a federal appeals court. It is hard to see how they could be deemed appropriate for products that are far less hazardous.

Matthew L. Myers, president of Campaign for Tobacco-Free Kids, concedes ”e-cigarettes have potentially positive value” but warns that “we’ve already seen that, if left to their own, e-cigarette manufacturers will reach out to our children, do everything to maximize sales, including re-glamorizing smoking, and that’s where we are today.” Since there is no evidence that teenagers are being lured into smoking by e-cigarettes, this talk of “re-glamorizing smoking” is merely an attempt to put a scientific veneer on activists’ instinctive revulsion at anything that looks like smoking, even when that resemblance may be the key to its succcess in reducing tobacco-related disease.

Another anti-smoking activist, Stanton Glantz, urges a “deliberate” regulatory approach, by which he seems to mean that the FDA should ban first and ask questions later. “We can’t allow e-cigarettes to establish themselves the way cigarettes have,” he tells the Times, ”and then, five years from now when we’ve answered all the open scientific questions, we have to try to stuff the genie back in the bottle.”

Glantz’s idea of caution, not surprsingly, errs on the side of government control, ignoring the health costs of impeding access to, or information about, e-cigarettes for smokers who coulddramatically reduce their chances of disease by switching. We know enough about the differences between these products to say that e-cigarettes, which do not contain tobacco and do not generate combustion products, are much less dangerous than standard cigarettes. Standing in the way of smokers who might want to make the switch, even if the obstruction lasts only “five years,” therefore makes no sense in terms of consumer protection or “public health.” Furthermore, I doubt that that the “open scientific questions” (such as the long-term effects of inhaling propylene glycol vapor) will be resolved to Glantz’s satisfaction as soon as he suggests. If five years of epidemiological data did not reveal any serious cause for concern, would Glantz be happy, or would he then ask for 10 or 20? Meanwhile, current smokers facing well-established health risks would pay the cost of Glantz’s deliberation.

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