One team of researchers assessing the risks of electronic cigarettes is counting the puffs taken by volunteer "vapers." Another will comb Facebook for posts on how people are tinkering with e-cigarettes to make the devices deliver extra nicotine. A third is building a virtual convenience store for 13-to-17-year-olds, measuring how e-cigarette displays and price promotions influence whether minors buy the increasingly popular devices.
The U.S. Food and Drug Administration is spending $270 million on these and 45 other research projects to determine the risks of e-cigarettes before millions more Americans become hooked on the devices.
"They want data and they want it yesterday," said Dr Suchitra Krishnan-Sarin of Yale University, who is leading four projects.
"Yesterday," however, is years away.
Final results may not be available before 2018, researchers leading the FDA-funded projects told Reuters. That timetable, which has not been reported before, underscores how the slow pace of science is contributing to a regulatory vacuum, allowing e-cigarette makers to sell their products virtually unchallenged.
To be sure, studies of e-cigarettes not funded by the FDA are also under way, and the agency can factor those results into any action it takes. But the FDA chose these 48 projects because they address questions central to future regulations.
The e-cigarette industry, which Wells Fargo Securities estimates will make $2 billion in global sales this year, says the FDA must wait for the results of the research before it issues any regulations, or manufacturers risk being driven out of business by unproven fears about their products.
"There shouldn't be regulations akin to those for cigarettes without evidence of similar health impact, especially since the preliminary evidence is positive for the industry" when it comes to comparing the contents of e-cigarette vapor to tobacco smoke, said attorney Bryan Haynes. His Richmond, Virginia-based firm Troutman Sanders represents e-cigarette manufacturers.
Backed by the world's biggest tobacco companies, the industry is aggressively expanding its marketing across the country. More than 14 million U.S. adults and nearly 2 million teens and tweens have used e-cigarettes, and the rate of use among high-schoolers doubled from 2011 to 2012, the latest data available.
The FDA "will always make regulatory decisions based on the best available science," said an agency spokeswoman. "With regard to e-cigarettes, the agency does not believe it will take many years to create the regulatory framework" once the FDA has the basic authority to regulate the products, which could happen next year.
The missing science includes basic questions such as what compounds are in the vapor produced by e-cigarettes. It also includes complicated ones like whether flavors such as butterscotch and bubble gum entice children to vape, how e-cigarette displays in online stores affect teenagers' desire to buy vaping liquid, and, perhaps most crucial, whether e-cigarettes will reduce the number of smokers or produce millions of new nicotine addicts.
The Yale team, for instance, will study whether menthol and flavors such as chocolate and cherry increase the appeal of e-cigarettes, especially to 16-to-18-year-old smokers or "dual users" who both smoke and vape. If that turns out to be the case, the FDA would have scientific support for regulating.
"We'll have the first results within two years" and complete ones in four to five, Krishnan-Sarin said.
As an uncontrolled experiment in public health, the use of electronic cigarettes is rivaled only by conventional tobacco smoking, a habit adopted by half of American men and one-third of women during its peak in the 1960s. The first Surgeon General's report on the health dangers of cigarettes was released in 1964, when more than 40 percent of American adults were already hooked. To date, more than 10 million Americans have died