July 24, 2018

The Vapor Technology Association released a full statement and scientific defense of flavors in eliquids and ENDS (Electronic Nicotine Delivery Systems) as a response to the U.S. Food & Drug Administration's stance on the regulation of flavors, specifically targeted towards electronic cigarettes.  The VTA's official release of this statement comes at a time when the FDA's Advance Notice of Proposed Rulemaking: Regulation of Flavors in Tobacco Products comment period comes to a close.

The Vapor Technology Association is the national non-profit industry trade association whose more than 600 members are dedicated to developing and selling high quality vapor products that provide adult consumers with a safer alternative to traditional combustible cigarettes.  Its member-base includes several small businesses that have created significant employment opportunities in the local communities and contribute substantially to local and state economies.  With the publishing of this statement as a direct response to the FDA's rhetoric, it hopes to use the backing of several internationally recognized academic and public health studies to truly question the rhetoric behind the regulations currently afflicting the vaping industry.

Here is an excerpt:

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.)
It is important to note that all of the foregoing pronouncements included ENDS products of varying flavors, meaning that on balance, the existence or inclusion of flavors in ENDS products was factored into all of these conclusions that e-cigarettes are overwhelmingly safer than smoking.

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."

by Vapor Technology Association Comments Docket No. FDA-2017-N-6565

This excerpt was but a bombshell on top of 74 pages of equally-powerful bombshells directed at the lunacy going on at the FDA.  Massive kudos to the VTA for organizing all of these thoughts into a coherent piece of literature effectively slamming the regulatory agency.  Let's just hope that the FDA is receptive to this; because let's be real, it seems like the FDA is incapable or just flat-out unwilling to listen to the powerful voices of logic.

To read up on the full response, check it out here.


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