Federal regulators propose new rules to answer long-burning questions about e-cig
Apr 24, 2014 |By Dina Fine Maron and Larry Greenemeier
Image of NJOY e-cigarette on display at the 2009 International Consumer Electronics Show, courtesy of Larry Greenemeier.
Electronic cigarettes may not generate any smoke, but their very presence in the marketplace gives off no shortage of political heat.
The slim devices that give smokers a nicotine fix devoid of cancer-causing tar have flourished in the U.S. market during the past several years even as the science on their long-term health risks has remained unsettled. Free of the restrictions that impede their tobacco-laden cousins from appearing in television ads or being puffed in public places, electronic cigarettes have become a multibillion-dollar industry that has become a lucrative new product line for Big Tobacco.
Regulators are still wrestling with whether electronic nicotine delivery systems should be treated as a health hazard, like tobacco, or as a tolerable alternative to the mix of poisonous vapors contained in every puff of cigarette smoke. The long-awaited expansion of federal regulations by the U.S. Food and Drug Administration for the electronic devices unveiled April 24 would not allow e-cigarettes free rein, yet neither do much to quell the industry’s growth.
The FDA wants to extend the 2009 Family Smoking Prevention and Tobacco Control Act to give the agency the authority to regulate e-cigarettes as well as cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco and dissolvables not already under the its authority (pdf). “This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” FDA Commissioner Margaret Hamburg said Thursday in an agency-issued statement.
The new rules would reinforce actions that were already being taken by more than 30 states to block minors from buying e-cigarettes. The rules would likewise require health warnings on packaging and prohibit vending machine sales, unless they take place in a facility—such as a bar—that’s off-limits to underage smokers.
The inclusion of e-cigarettes under the 2009 law, however, does not ban TV or radio advertising or online sales of the devices. Nor does it restrict e-cigarette makers from selling kid-friendly flavors such as bubblegum or watermelon—a sticking point for public health advocates who say that such targeted offers are designed to attract youth users. With e-cigarettes covered by the law, the FDA could pursue such restrictions in the future, although they would require separate rule-making and public comment. “FDA is currently assessing available research regarding the impact of flavors on tobacco product use and is funding research on this issue,” according to an agency spokeswoman.
Hamburg touted “science-based” product regulation as a way to protect consumers and reduce the public health burden that tobacco creates. Her statement is regulatory speak for justifying the agency’s decision to give itself the regulatory flexibility to move forward with tougher regulations if studies underway reveal that inhaled e-cigarette vapors pose significant health hazards, but also to tread lightly if these concerns prove unfounded.
Although most public health experts agree that e-cigarettes are a healthier alternative to conventional cigarettes, emerging science is trying to gauge how much better they really are. An article in the May issue of Scientific American notes that researchers attempting to answer questions about the health and safety of the devices are struggling even to accurately measure their ingredients and by-products. That’s due, in part, to the lack of quality control over the devices, which leads to highly variable amounts of nicotine and other ingredients.
Although a typical e-cigarette contains nicotine, flavoring and a syrupy synthetic liquid called propylene glycol, it is the other unknowns—such as the by-products from heating e-cigarettes and the solution inside them—that are sparking the greatest concern. Nicotine acts as a stimulant that can be highly addictive and emerging research also links it to an impaired immune system. Propylene glycol, meanwhile, has FDA approval for use in certain foods and drinks as well as soaps. Yet it is unclear what the health impacts are of inhaling this chemical directly into the lungs. Various studies suggest the vapors from lighting e-cigarette ingredients together contain several cancer-causing substances. And data suggesting that the devices appeal to youths and lead to more instances of nicotine overdoses also raise questions about the long-term impact of “vaping.”
This is the FDA’s second attempt to regulate e-cigarettes. An earlier effort to oversee them as drug-delivery devices was scuttled after a leading e-cigarette company sued the agency saying that the sleek products that vaporize nicotine were not medical devices at all but rather were similar to tobacco products. A federal appeals court agreed, concluding that the devices offered similar recreational benefits to a cigarette.
The FDA’s decision Thursday did little to assuage concerns about their unknown ramifications. Although e-cig companies are not allowed to market their products as smoking-cessation devices (because such claims would mean they lead to being regulated like nicotine patches), many companies do tap dance around the issue, marketing themselves as the direct alternative to harmful cigarettes. The agency’s move puts it in a position of being ready to pounce if new evidence reveals unsuspected harm from e-cigarettes. “The FDA wants additional tools to protect the public health in today’s rapidly evolving tobacco marketplace,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in an agency-issued statement.
The U.S. action comes on the heels of a decision by the European Parliament in February to issue new e-cig regulations that would standardize nicotine levels in e-cigarettes and require child-resistant packaging. (Like FDA’s action, decisions about regulating e-cig flavors was left to its member states, although new health warnings were mandated for all e-cigarettes.)
“Our firm recommendation is people need to get combusted tobacco products [out] of their lives,” Tim McAfee, director of the U.S. Centers for Disease Control’s Office of Smoking and Health, told Scientific American in a recent interview. “We don’t think e-cigs are going away, what we can do is think about what we can do to minimize the danger.”
