FDA Deeming Regulations On E-Cigarettes Postponed: What That Means

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People trying to quit smoking won a major battle last week when the FDA announced it would delay implementation of regulations that would have deemed a number of e-cigarette products illegal. So why are some anti-nicotine advocates calling foul?

Commissioner Dr. Scott Gottlieb made the announcement on July 28th as part of a larger initiative aimed at reducing nicotine-related deaths in the US. Without this policy change, the e-cigarette industry was facing a deadline of next year to seek approval to sell any product that entered the market after Feb. 15, 2007. The new rules grant companies until Aug. 8, 2022. Gottlieb also stated that the FDA will force cigarette companies to reduce the amount of nicotine in traditional cigarettes.

The position signals a change of position on e-cigarettes for the FDA. Previously, the agency treated these products as a gateway to combustible cigarette smoking. But Gottlieb sees potential in these products to work as a smoking cessation tool, telling reporters, “We do think there’s a potential opportunity for e-cigarettes to be a lower-risk alternative to smokers who want to quit combustible cigarettes.”

Gottlieb encouraged e-cigarette manufacturers to reach out and work with the FDA to gain approve for their products as smoking cessation aids. However, he did note some concern over the use of these products by children and left the door open to regulating flavored e-cigarettes that he feels are marketed to underage users.

The evidence supports the reversal. For example just a few weeks ago, a paper in BMJ showed again that e-cigarette use leads to fewer people smoking far more harmful traditional cigarettes.

Yet the anti-tobacco community, primarily academics and ad agencies who have been living off of The Tobacco Master Settlement Agreement (MSA) since 1998, are upset. That's because as smoking has declined they have switched to being anti-corporation rather than anti-smoking. Which is no longer a public health agenda. Like caffeine, nicotine is addictive and like caffeine, it can be harmful, so by providing the stimulant without the carcinogens, public health will be improved. Smokers can quit.

Yet people who claim to care about public health are instead adopting a "quit or die" approach, even though if you asked them if abstinence-only sex education should be federal policy they would deny it vehemently. 

Their argument against e-cigarettes? They haven't been studied long enough. If that sounds like the tired anti-science rhetoric behind groups opposed to things like vaccines, genetically engineered plants and energy technology (and they are often the same groups) it certainly is. It made some sense that the former administration (1) would clamp down on e-cigarettes, given their political beliefs about government controlling health outcomes, and it makes equal sense that a physician like Gottlieb, who is more free market and also has private sector experience, would not want to make thousands of products illegal arbitrarily.

NOTE:

(1) As was shown, the Obama administration was doing worse than invoking the precautionary principle; they had an ideological goal in mind, made a determination in advance, and then hand-picked selected journalists to act as public relations conduits to make it seem as if everyone was cheering about their decision.

As you can imagine, our scientists and doctors were not among the groups FDA chose to include in its secret plan to change America from being in a war on smoking. But we should have been, even if we refused to play along. As we have long told officials, smoking is a pediatric disease. Almost all adult smokers started before the age of 18;