While the FDA seeks data on the “population” impact of vaping (in particular, that e-cigarettes set youth on the path to smoking), it never asks about the impact of its regulations on the estimated 8.34 million established vapers in the U.S., the vast majority of whom are former smokers who have completely switched to non-combustible nicotine products or who are transitioning. What about the public health impact on them?
This question goes to the heart of a recent amicus brief submitted in support of a lawsuit filed in May 2016 the U.S. District Court for the District of Columbia by Nicopure Labs, based in Tampa, Fl., against the FDA (disclosure: I am an amicus signer). The brief, spearheaded by the brilliant Clive Bates, makes the case that reducing the availability of vaping devices via heavy regulation will have the unintended consequence of leading to more people starting smoking, and more former smokers resuming smoking. This likelihood, which the FDA does not acknowledge, would more than offset the benefit that FDA uses to justify its rule.