The Food and Drug Administration on Thursday proposed new regulations on electronic cigarettes—setting off a new, furious debate over what’s become the most controversial subject related to tobacco control. E-cigarettes are the rechargeable devices that allow you to inhale nicotine in a propylene glycol vapor, which can be blown out with the look and feel of real smoke. Companies market them as a safer alternative to smoking, while their advocates say they can help people quit. The sales pitch seems to be working. From 2008 to 2012, sales jumped from 50,000 units to 5 million.
The new FDA regulations would ban the sale of e-cigarettes to minors and regulate how much nicotine the devices can contain. Analysts warned that restrictions could slow the industry’s growth, retarding innovation. But the announcement drew some expressions of relief from manufacturers, which feared more aggressive restrictions. “I like the overall tone,” Jason Healey, president of blue e-Cigs, told USA Today. Miguel Martin, president of LOGIC, the second-largest seller, said “I’m encouraged by it.”
Anti-tobacco activists seemed a bit more anxious. Under the proposed regulations, e-cigarette companies could continue offering flavored versions, advertising the products on television, and selling them online. “It’s very disappointing,” said Stanton Glantz, a professor at the Center of Tobacco Control Research and Education at the University of California, San Francisco. E-cigarettes raise real some safety concerns: Nicotine itself can be highly toxic in large doses and, already, several thousand poisonings from e-cig refills have been reported. But the big worry for public health advocates, including the major medical societies, is what e-cigarettes would mean for the use of regular cigarettes and other forms of smoking.
Rather than help people to quit, public health advocates fear, e-cigarettes might encourage more people to start.
Tobacco use remains the nation’s leading preventable cause of death. It leads to a half-million causalities and costs $100 billion in health care each year, killing far more people than high blood pressure, obesity, violence, or alcohol abuse. Tobacco’s harms include numerous diseases, including preterm births, cancer, heart disease, diabetes, residential fires, and sudden infant death syndrome.
Today cigarettes are subject to extensive regulation—they cannot be flavored, sold to minors, advertised, or be promoted as having any health benefits (for example, for weight loss). Meanwhile, local and state governments have banned smoking in many public areas. As a result of these restrictions and many other public health actions—higher cigarette taxes, advertising restriction, minimal-age purchasing laws, systematic efforts to de-emphasize smoking in movies and TV shows, and other campaigns—there had been a remarkable reduction in smoking rates, as documented by the Centers for Disease Control.
But it’s important to understand exactly how this reduction took place. It is almost entirely the result of fewer and fewer people smoking in the first place. According to the American Lung Association, the percentage of “never smokers” increased from 48 to 72 percent of the population over the past 50 years, accounting for almost the entire decline. In contrast, the number of former smokers—that is, people who quit—has remained stagnant. The key to tobacco control, it turns out, is cutting off the supply of smokers in the first place. Despite years of research, tons of spending on everything from nicotine patches to nicotine gum, and admonitions from physicians, no one has figured out a great way to help smokers quit.
E-cigarette advocates insist their products can work better—and the companies have marketed them that way. The campaign may be working. One survey of North Carolina doctors found that 35 percent recommend them to their patients as quit aides, and 13 percent erroneously believe the FDA already approved them for this purpose. But for all the anecdotal evidence that e-cigarettes help people quit smoking actual cigarettes, the best studies today find little to no evidence e-cigs help much.
Some supporters defend e-cigarettes as a form of "harm reduction"—similar to needle-exchange programs for HIV prevention in injectable drug users, or methadone clinics for heroin addicts. E-cigarettes, after all, don't contain tar and other cigarette additives that cause so many health problems.Read More: You have to smoke e-cigarettes for this many days before saving money over tobacco
But public health experts worry that e-cigarettes pose a new, distinct danger. Most smokers start the habit as children. Tobacco control advocates worry that any effort to “normalize” even the rituals of smoking, as with e-cigs, could undermine hard-won battles to ban public smoking, re-establish smoking as cool, and lead to youth-directed marketing. Already, between 2011 and 2012, the number of children experimenting with “vaping” e-cigs doubled. Little data on the long term impact of e-cigs on youth smoking exists, but many health advocates believe the FDA proposed regulations have not gone far enough, since they leave the door open to advertising and flavoring e-cigs.
Thursday’s announcement isn’t the end of the story. Rather, it represents the beginning of a public comment period, during which all the interested parties—including the companies and public health advocates—can register their opinions. It will likely be years before final regulations take effect. That means e-cigarettes will continue to be available without anything like the new restrictions—continuing a vast, unregulated experiment in the nation’s public health.
Darshak Sanghavi, a pediatric cardiologist, is the Merkin Fellow and Managing Director of the Engelberg Center for Health Care Reform at the Brookings Institution. Follow him on Twitter at @darshaksanghavi.