Irresponsible E-Cigarette Theatrics from Federal Officials

The anti-tobacco movement continues to ignore evidence that millions worldwide have switched from smoke to vapor.  Witness today’s press release (here) from the Centers for Disease Control and Prevention (CDC): “There is no conclusive scientific evidence that e-cigarettes promote successful long-term quitting.”  Yet in the absence of proof, extremists insist that e-cigarettes are a gateway to smoking for teenagers.  A new CDC report adds fuel to that gateway fire in the nation’s media. 

The report (available here) uses information from the 2011 and 2012 National Youth Tobacco Surveys (NYTS).  In 2012, 2.8% of high school students used an e-cigarette in the past 30 days, compared with 1.5% of students in 2011.  Over 80% of e-cigarette users also had smoked cigarettes in the past 30 days. 

There is no information in the CDC report or in the NYTS relating to gateway.  The NYTS asks teenagers at what age they first smoked a cigarette.  However, since the teens were not asked at what age they first used e-cigarettes, gateway analysis is impossible.  Still, that didn’t stop CDC Director Tom Frieden from speculating: “Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes.”

The report’s findings are hardly surprising.  The market for e-cigarettes is rapidly expanding, and youths who smoke cigarettes will also experiment with vapor products.  Yet federal officials’ headline-ready comments put the findings in apocalyptic terms.  Dr. Tim McAfee, director of the CDC Office of Smoking and Health, said, “These dramatic increases suggest that developing strategies to prevent marketing, sales, and use of e-cigarettes among youth is critical.” 

The report is an unabashed pitch for FDA e-cigarette regulation, which is likely coming in October.  Mitch Zeller, director of the FDA’s Center for Tobacco Products, also exaggerated the findings to justify FDA action: “These data show a dramatic rise in usage of e-cigarettes by youth, and this is cause for great concern as we don’t yet understand the long-term effects of these novel tobacco products…These findings reinforce why the FDA intends to expand its authority

over all tobacco products and establish a comprehensive and appropriate regulatory framework to reduce disease and death from tobacco use.”

Zeller, a respected authority on tobacco use, knows that cigarettes cause 99% of “disease and death from tobacco use.”  Here, he deliberately conflates the risks of smoke-free and combustible tobacco products in the context of teenage use.

Federal authorities should restrict youth access to all tobacco products, but it is unacceptable for them to characterize e-cigarettes as gateway products when they are, in fact, helping to eliminate the smoking plague.

Federal Officials Endorse Impossibly High Standard for E-Cigarettes

NPR host Diane Rehm on August 5 discussed “Smoking in America Today” with Dr. Tim McAfee, Director of Office of Smoking and Health at the Centers for Disease Control and Prevention; Mitch Zeller, Director of Center for Tobacco Products at the FDA; Dr. Thomas Glynn, Director of Cancer Science and Trends at the American Cancer Society; Michael Felberbaum, journalist covering tobacco for the Associated Press; and Craig Weiss, President and CEO of e-cigarette maker NJOY (program available here).

The federal officials and Dr. Glynn held essentially identical views on e-cigarettes, providing a strong signal that FDA regulation is likely to be burdensome or even punitive.

Early in the program, Rehm asked about relative risk: “Is there any evidence whatsoever from the public health community regarding electronic cigarettes and whether they are in fact safer than tobacco products?”

The CDC’s McAfee gave an extended answer, starting with: “Well, there’s several different ways that we’re thinking about this, we think it’s an incredibly important question.”  Important, but unanswered, as Dr. McAfee shifted to the familiar cigarette mantra: “… we need to focus on the harm that’s caused by cigarette smoking, and ways to get smokers to quit and to prevent nonsmokers from starting.”  As for e-cigarettes, “.. the challenge is that we don’t yet know how e-cigarettes are going to completely fit into that.  The availability of a cigarette alternative that does deliver nicotine without also delivering harmful by-products of combustion… could this play a beneficial role in reducing tobacco-related death and disease?  This would be especially true if a large number of smokers successfully switched completely to e-cigarettes, either permanently or as a transition phase to nicotine abstinence.”

Dr. McAfee expressed concern that alternative tobacco products might foster dual use, prevent smoking cessation and serve as a gateway to smoking for new users and former smokers. “… The other alternative is that the availability of e-cigarettes could result in harm by increasing the initiation of cigarette use among youth and young adults or by delaying quitting among smokers who, rather than switching, engage in dual use, which currently looks like that’s the majority situation.  People are using them in situations where it’s hard to smoke cigarettes.  And we see ex-smokers think ‘Hey, maybe I can go back to e-cigarettes,’ and that re-kindles their nicotine addiction.  And they actually start smoking cigarettes themselves.”    

Regulator Zeller returned to these themes later in the program.  He alluded to, but never quite acknowledged, the vast difference in risk between traditional and electronic cigarettes: “The thing that’s most interesting about e-cigarette is that we look at individual-level risk, what is the risk, say, to a current smoker who would be otherwise unable or unwilling to quit, if that person completely substituted all of their conventional cigarettes for an e-cigarette, that’s individual-level risk.”

However, he made clear that FDA regulation isn’t about individual smokers: “… Policy is going to be made here at the population level, and there’s population-level harm.  Who is actually using these products?  And how are they being used?  Tim [McAfee] talked about this earlier.  Are current smokers going to be less inclined to quit, and more likely to engage in what we call dual use of both the combustible version and the electronic version?  Are kids going to start using e-cigarettes?  These are the kinds of questions that we have that ultimately comes down to behavior, and right now we have far more questions than answers.”

I discussed in 2010 scientific evidence documenting that a population-level evidentiary standard was “unattainable” (here).  I also said that the standard was unprecedented.  The FDA has regulatory authority over other consumer items – food, cosmetics, drugs, medical devices and vaccines.  FDA regulations assure that drugs, medical devices and vaccines provide the intended medical benefit.  Far more importantly, they assure that all of these products are safe to consume.  The FDA does not traditionally compromise individual safety with a population standard.

Today, the FDA also regulates tobacco products.  One of these (the cigarette) is highly toxic, killing over 400,000 Americans every year.  When the FDA asserts regulatory authority over e-cigarettes, it would be criminal to use an arbitrary population standard to deny American smokers access to these products.