The FDA gained the ability to regulate and control tobacco products in 2009. In 2011 it launch a comprehensive 5-year-long study of tobacco use that will be completed in the blink of an eye (at least when speaking in FDA time). The study in question is called the Population Assessment of Tobacco and Health (PATH) and it has been following some 46,000 people.
The results of that study are intended to shape the future of tobacco products regulation to come. But despite some expectations that this study will shed light in places previously dark, the advent of electronic cigarettes and vaping in the last few years may have changed things so dramatically as to make the study virtually useless.
The problem lies two-fold.
First, at absolute best, the study’s methodology and perimeters were conceived based only the 2011 version of electronic cigarettes, vaping products, and the vaping industry at large. Though the study focuses on tobacco, the vaping industry has shaped the tobacco industry in ways we never could have imagined even in 2011. At worst though, the study’s methodology took the vaping industry as the FDA understood it in 2011… meaning closer to as it was in 2008 and 2009 or (more likely) not at all. No matter what anyone says, a comprehensive look at tobacco use can no more ignore electronic cigarettes and vaping product than it can nicotine gum, the patch, and all variety of tobacco cessation products.
Second, even if the study was up to date on electronic cigarettes and managed to evolve at least a little as the industry did, the study’s results will be based on tobacco use at the cusp of one of the most significant changes to the industry to date. What we’re seeing happen to tobacco now is similar to what the introduction of the automobile did to the horse and buggy in the late 1800’s. In short, the study isn’t going to provide meaningful information on the product that will be the focal point of most future debate, discussion, and regulation.
That just about exactly what this recent article from Reuters is suggesting.
Perhaps this quote says it all best: “While all this data that is being accumulated through the PATH study is great, it is unclear to me how much is going to be useful for setting the policy and regulations of the future.” That comes from a health policy consultant based in Washington, D.C. If even now, the value of the information appears dubious, it seems unlikely to get any better.
The problem I foresee is that the FDA will likely use the results of this study to both praise its tobacco control efforts and raise alarms that those victories are now being lost to the new smoking — e-cigs. The results will likely provide the FDA a few powerful (but misleading) tidbits that it can use to convince the world of two things — vaping needs to be fought, and the FDA should be the organization in charge of fighting it.
Fortunately, it seems even a good year before the results hit, some experts and media are questioning whether it should actually be a meaningful part of future debates.