Three years after first announcing plans to do so, the Food and Drug Administration (FDA) indicated on April 24 that it would use the authority provided by the 2009 Family Smoking Prevention and Tobacco Control Act to regulate electronic cigarettes. The agency already regulates normal cigarettes but proposed rules would allow the FDA to regulate the rapidly growing $1.5 billion e-cigarette industry for the first time.
Did you say electronic cigarettes?
Essentially, e-cigarettes are plastic or metal tubes often made to look a lot like normal cigarettes. A battery inside the device heats and vaporizes nicotine fluid when the user inhales. E-cigarette supporters have suggested that they are safer. The idea: users receive nicotine (the highly addictive substance in cigarettes) without inhaling the smoke or thousands of harmful chemicals contained in normal cigarettes.
That doesn't sound terribly far-fetched, so what's the problem?
The problem is that there is virtually no federal oversight or protections for American consumers. In a radio interview with NPR on April 24, Mitch Zeller, the director of the FDA's Center for Tobacco Products called the current marketplace for e-cigarettes "the wild, wild West." Manufactures aren't required to disclose ingredients or submit anything at all to the FDA, so how do we know if e-cigarettes are actually a safe option? As Zeller pointed out, "There is no independent regulatory review of any of the claims that might be made for the product."
Some e-cigarette supporters have suggested that the products could be helpful in getting smokers to quit regular tobacco products, similar to nicotine patches. However, some public health experts fear that the popularization of e-cigarettes as "cool" and the use of flavored tobacco will serve to entice and addict young new smokers.
The FDA's proposal also provides an option that would exempt "premium cigars" from oversight, a loophole that has already garnered opposition from public health groups such as the American Lung Association.
Extending FDA authority
Once the proposed rule becomes final, the FDA will be able to do a number of things to increase consumer safety. The agency announced that among other restrictions, producers would be required to register with the FDA, disclose ingredients and manufacturing process, and place health warning labels on their products. Further, manufacturers would be banned from making health-related claims without scientific evidence.
The New York Times reports that while some industry advocates worry that new federal regulations will impact small businesses, "some of the larger players in the e-cigarette market praised FDA for committing to a science-based regulatory process, which they hope will allow them to make a strong case that e-cigarettes have the potential to reduce tobacco-related harm and be an overall positive for public health."
Not far enough
While industry welcomed the FDA's proposal, many tobacco-control advocates criticized the plan for what it did not contain. The Campaign for Tobacco-Free Kids highlighted that e-cigarettes' aggressive advertising is the same type that made cigarettes so appealing to young people decades ago. Today, most of the smokeless devices have sleek designs and even LED lights on the ends. Celebrities tout the benefits of e-cigarettes in national television ads.
Another criticism concerns the FDA's lack of action concerning the sweetly flavored nicotine options. "Shame on the FDA," Sen. Dick Durbin (D-IL) said in a statement. "Prohibiting sales to kids but doing nothing to protect children from candy flavored marketing in children's venues is an awful outcome."
Whether or not the FDA's restrictions go far enough, the move toward federal regulation is inarguably a critical first step. E-cigarettes may prove to offer a real lifesaving alternative to a deadly habit, or they may have risks of their own. What we do know is this: moving forward in the debate over e-cigarettes, hard evidence and reliable scientific research will play a key role.
Image by Flickr user EverExplore, used under a Creative Commons license
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