The FDA is set to release proposed regulations on electronic cigarettes by the end of this month. Confused local governments could sure use them.
The Food and Drug Administration is set to release proposed regulations on electronic cigarettes by the end of this month, a long awaited move that's been delayed in part by struggles to better understand their potential health risks and benefits. In the meantime, state and local governments have been left to their own devices in regulating just where e-cigarettes can be used and to whom they can be sold, leading to a vast and at times confusing array of outcomes.
A total of 24 states and a growing number of counties, cities and towns currently have laws on the books restricting e-cigarette sales, many of which are aimed at keeping the products away from people under the age of 18. Electronic "vaping" may be a gateway to traditional smoking, the argument goes. A recent study from the Centers for Disease Control and Prevention showed that e-cigarette use also doubled among teens from 2011 and 2012.
In New York, where the city council has just approved raising the legal age for tobacco sales (including e-cigarettes) to 21, outgoing Mayor Michael Bloomberg is reportedly also mulling a near ban on the electronic products that would make most "flavored" versions available only at a handful of grandfathered cigar bars.
New Jersey was the first state to specifically ban electronic vaping in public places, including bars and restaurants, in 2010. Since then, Utah, North Dakota and cities including Seattle, Indianapolis, Savannah, Georgia, and Petaluma, California, have followed suit. In New York, a state law prohibits e-smoking within 100 feet of schools, while Boston has banned e-cigarettes from workplaces.
Yet in most areas — like New York City for the time being — it's up to the individual bar, restaurant, or property owner to decide whether to permit customers to vaporize inside, a situation that can lead to confusion and awkward moments between those who use them and those who may mistake e-cigarette vapor for actual smoke.
The arguments against indoor e-cigarette use are similar to those in favor of smoking bans: While many of the harmful ingredients often found in traditional smokes may not be present in e-cigs, some experts worry that secondhand vapors are potentially harmful.
“We don’t yet understand the long-term effects of these novel tobacco products,” Mitch Zeller, director of FDA’s Center for Tobacco Products, said in a Sept. 15 statement after an agency study found that e-cigarette usage had more more than doubled among adults between 2011 to 2012. Roughly 3.5 million Americans now regularly puff on the battery operated devices, which allow users to get their nicotine fix by heating a certain amount of the drug along with other liquid ingredients into an inhalable water vapor.
Some of the additional statewide e-cigarette limitations include those on the use of displays (Indiana) and samples and discounts (Washington), as well as where the devices can be sold. Hawaii and many municipalities in Massachusetts require that all electronic cigarette purchases be made face-to-face, a hurdle intended to remove small, relatively unknown internet merchants from the marketplace. Meanwhile, Seal Beach, California, recently enacted a 10-month moratorium on business licenses for e-cigarette retailers, in order to give lawmakers more time to come up with suitable land-use restrictions.
So there's a strong sense within many local governments that we ought to be doing something to restrict the use of e-cigarettes. But if so, what, exactly? And what happens in the cities where no decision is made?
"It's pretty clear to me that e-cigarettes have helped more people quit smoking than the 2009 Tobacco Control Act, all the FDA-approved smoking cessation drugs and all the government anti-tobacco propaganda programs combined," says Bill Godshall, executive director of Smokefree Pennsylvania, a non-profit organization that's advocated for strict restrictions on traditional cigarettes since 1990. "When a cigarette company says 'I would like to market a less hazardous alternative to smokers,' public health officials should be thanking them."
Godshall, who supports bans on e-cigarettes for users under the age of 18, points out that the vast majority of kids (80 percent of middle schoolers) who admitted trying e-cigarettes in the recent CDC study had already tried traditional cigarettes. He also says that much of the push for other restrictions is being funded by pharmaceutical companies who see the electronic products as competition for more expensive, highly regulated nicotine replacement therapies and smoking cessation drugs.
"Really high use by minors along with really aggressive marketing campaigns are some of the primary reasons why these products need to be regulated," says Jordan K. Paradise, a Seton Hall law professor who specializes in food and drug issues. "There is very much a place for these products, but the concerns relate to how they're marketed and who's actually using them."
"We really have no idea about the variations in these products," Paradise says. "There are a lot of questions about how safe these things are because there's really no control whatsoever before they hit the market."
These same concerns have prompted efforts by Bloomberg and other local officials to push for near bans on e-cigarettes. In Oregon, the state attorney general's office seems to be moving toward complete prohibition on a piece by piece basis. The state has banned at least two of the country's e-cig manufacturers — Sottera, the maker of NJOY products, and Smoking Everywhere — from selling their wares in the state. Oregon has also blocked two national travel store chains from carrying electronic cigarettes on their shelves.
But Godshall argues the rush to limit or even outlaw e-cigarettes is misguided. "There's no evidence that anyone has ever been harmed by using an e-cigarette," he says. "If you're going to ban any tobacco product, ban the most hazardous one, not the least hazardous one."
Godshall's organization has helped successfully resist complete bans on e-cigarettes in eight states over the last four years, including in Illinois, Tennessee, and California, where then-Governor Arnold Schwarzenegger vetoed a ban in 2009. Elsewhere in the state, the Laguna Beach city council voted down a measure in August that would have subjected e-cigarettes to tobacco restrictions already in place. City council members cited a dearth of information about secondhand vapor effects and the potential benefits of e-cigs as smoking cessation devices. Lawmakers in Boise shot down an effort last year to include e-cigs in the city's indoor smoking ban.
Meanwhile, no one knows exactly what the FDA's proposed regulations will look like when they come down later this month. Industry players, health officials and other interested parties will get a chance to weigh in on the proposals before they go into effect, a process that may take up to two years.
Paradise and Godshall both say the biggest question is whether the agency will deem e-cigs a "tobacco product," given that they contain nicotine. In a recent letter to the FDA, 41 state attorneys general urged precisely this action. That would bring them under the Tobacco Control Act's wide ranging restrictions. It would probably also mean that Stephen Dorff's run as the industry's version of the Marlboro Man is over.
Another question remains as to what will become of internet sales, much of which cater to aficionados who use higher-end devices that they refill with liquids purchased online. In what Godshall calls a "cannibalization" of the industry, disposable e-cig makers who sell their wares in physical smoke shops and convenience stores have supported bans on internet retailers, who may represent up to half of e-cigarette product sales.
In the increasingly likely event of widespread electronic cigarette regulation, Godshall says the real winner won't be these relative newcomers, however. Instead, it's the tobacco industry's oldest and best funded players who are best positioned to take the electronic market by storm, given their expertise in the regulatory environment, deep pockets and contractually mandated convenience store shelf space.
"What it will do is effectively give the entire industry to big tobacco," Godshall says.