Contrary to an email message that the Food and Drug Administration seems to have sent accidentally, the agency did not announce enforcement actions against leading distributors of electronic cigarettes yesterday. Craig Youngblood, CEO of the e-cigarette company inLife, says an FDA official told him the message contained "inaccurate information," but it's not clear whether that means the "extensive rollout" described in the notice has been called off or merely delayed. "Some of the people I know are saying a ban is imminent," says Youngblood, but "we really don't know."
In the meantime, the FDA says it is treating e-cigarettes on a case-by-case basis, which seems to involve looking for health claims that render them unapproved drug delivery devices. The more cautious distributors therefore avoid describing e-cigarettes as a smoking cessation tool or as a way of treating or mitigating disease. It's clear that e-cigarettes, which contain no tobacco and deliver nicotine in water vapor instead of smoke, are far less hazardous than standard cigarettes. But saying so risks attracting unwanted attention from the FDA, which has seized some companies' shipments. (One of them, Smoking Everywhere, has sued the FDA in federal court, arguing that the agency has no jurisdiction over e-cigarettes.) "Safest, safer—those are mitigating claims," says Youngblood. "We need to be careful as an industry in how we depict our product. Without medical evidence, we shouldn't be saying anything is safer."
At the same time, the industry's main argument against FDA interference is that it is providing a safer alternative to cigarettes. In a statement released on Monday, former congressman Matt Salmon, president of the newly formed Electronic Cigarette Association, complains:
The message that is being sent by the FDA to those who cannot stop smoking, or who do not wish to stop smoking, is that it is better to keep smoking tobacco, which kills more than 400,000 people in the US per year….It is time to stop misinformation, to put the needs of consumers ahead of special interests, to put public health ahead of stifling process, and to embrace the first true innovation in a centuries-old space.
The industry's regulatory dilemma is clear when you talk to Youngblood. Even while mentioning testimonials from smokers who "have made a transition," he is careful to say, "We are not a quit-smoking device….We are an alternative nicotine delivery device." (That terminology may be risky too, since that's what former FDA chief David Kessler called cigarettes when he unsuccessfully tried to regulate them during the Clinton administration.) And even while contrasting the myriad toxins and carcinogens in tobacco smoke with the "13 or 14" chemicals in e-cigarette vapor, none of which is a known carcinogen, Youngblood says talking about relative hazards is asking for trouble:
We can't make those statements. We have to make [consumers] draw that conclusion. And quite frankly, that's OK, because people know it….[Regulators] do put you in a bit of a bind. It's hard to communicate openly without putting your foot in your mouth….We're about harm reduction, and that's truly to our core….Except I can't say that.