The first team of scientists is evaluating the risks of e-cigarettes by counting the puffs taken by volunteer ‘vapers.’ The second team is scanning the popular social network platform Facebook for posts on how people are fiddling with ecigs to make the devices deliver extra nicotine. The third team is building a virtual general store for children between 13 and 17 years of age, measuring how electronic cigarette displays and price promotions impact on whether underage people buy the increasingly popular devices.The FDA seems like it is finally getting seriously involved in the much needed e-cigarette research. Over the next few years, it has planned on spending about $270 million on dozens of ecig studies, trying to answer some fundamental questions, like ‘what dangers do they have to human health?’, ‘do they represent a gateway to combustible tobacco smoking?’ and ‘will they decrease the total number of American smokers?’
‘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. In an interview to Reuters, the scientists leading the Food and Drug Administration funded study said the conclusive results might not be available before 2018.The calendar, which has not been reported before, highlights how the slow pace of science is contributing to a regulatory system, allowing for the time being only a few rules on e-cig manufacturers.
To be certain, studies of electronic cigarettes not funded by the FDA are also taking place as we speak, and the agency can factor those results into any future action it takes. However, the FDA chose these 48 researches because they address questions central to imminent regulations.
The e-cigarette market, which Wells Fargo analysts estimate will make $2 billion in global sales in 2014 alone, believes the Food and Drug Administration has to wait for the conclusive results before it issues any regulations or manufacturers face being driven out of business by questionable 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 analyze the contents of ecig vapor to tobacco smoke, believes attorney Bryan Haynes. His Richmond, Virginia-based firm Troutman Sanders represents a couple of electronic cigarette manufacturers.
However, the FDA ‘will always make regulatory decisions based on the best available science’, and ’the agency does not believe it will take many years to create the regulatory framework’ for e-cigarettes, said a spokesperson. For example, the team at Yale University will study if menthol and flavors such as vanilla or berries increase the appeal of electronic cigarettes to minors or dual users of tobacco and ecigs.‘We’ll have the first results within two years’ and complete ones in four to five, Krishnan-Sarin said. If that turns out to be true, the agency will have scientific support for regulating.