The Vapor Technology Association Slams the FDA's Rhetoric on Vaping

B. As a Category, ENDS Products Are At Least 95% Safer than Combustible Cigarettes and Save Lives.

FDA is aware of the significant literature review and evaluations undertaken by the internationally recognized and esteemed Royal College of Physicians in 2014, 2015, and 2016 - evaluations which concluded unequivocally that the potential hazard to health arising from long-term use of ENDS products is five percent (5%), and probably substantially less than that, of the comparable harm resulting from the use of traditional combustible products.  (Royal Collecge Report, 2016.)  This year-over-year conclusion is also shared by the United Kingdom's Department of Health - Public Health England - which reached an identical conclusion after conducting its independent review of the peer reviewed literature in 2015 and 2016.  (McNeill A, et al., 2018.)

Similarly, U.S. researchers recently published a study in Tobacco Control concluding that switching from traditional cigarettes to e-cigarettes would annually prevent between 1.6 million and 6.6 million premature deaths in the United States.  (Levy, et al., 2017.)  This conclusion was further bolstered by the rigorous analysis of the National Academies of Sciences, Engineering, and Medicine ("NASEM") which, in January 2018, published the following material findings regarding e-cigarettes:

• "There is conclusive evidence that completely substituting for combustible tobacco cigarettes reduces users' exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes." (NASEM Report at 604.)  Importantly, the absence of a sound scientific or legal basis for restricting flavors in ENDS products does not mean that the VTA does not endorse continuing the discussions that it has already commenced with FDA to achieve a rational regulatory scheme, as well as the implementation of agreed product standards pertaining to the manufacture and distribution of ENDS and/or e-liquids.  Vapor Technology Association Commends Docket No. FDA-2017-N-6565 Page 9.
• "There is substantial evidence that completely switching from regular use of combustible tobacco cigarettes to e-cigarettes results in short-term adverse health outcomes in several organ systems." (NASEM Report at 617.)
• "The evidence about harm reduction suggests that across a range of studies and outcomes, e-cigarettes pose less risk to an individual than combustible tobacco cigarettes." (NASEM Report at 11, 487.)

Fortunately, adult smokers have been availing themselves of the harm reduction opportunity presented by ENDS products en masse.  The Centers for Disease Control reports that the number of smokers as a percentage of the U.S. population has dropped dramatically from 20.6% in 2009, when ENDS products first gained traction in the United States, to only 15.5% as of 2016.  Unless the FDA can prove that such remarkable advances in the reduction of cigarette smoking have been achieved notwithstanding the dramatic growth and availability of ENDS products to addicted adult smokers, FDA should not take any steps that could reverse this substantial decline in smoking."