Micro-comment #6 for FDA Deeming - re: flavors

Docket ID: FDA-2014-N-0189; RIN: 0910-AG38

Electronic cigarettes are not tobacco products and should not be treated as such. Deeming them as tobacco is a grave error with deadly consequences for more than 40 million American smokers who will be denied access to an alternative that is more than 1,000 times safer than combustible tobacco.

The proposed deeming regulations would remove more than 99% of electronic cigarette (ecig) products from the market and deliver the entire ecig business into the hands of Big Tobacco, doing more damage to public health than any cigarette company ever accomplished. This is because many of its premises are constructed on faulty assumptions (http://link.springer.com/article/10.1007/s00204-013-1127-0), junk science (http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html), and unsubstantiated propaganda (http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html) from the tobacco control industry (TCI).

Baseless conjecture spread by TCI and uncritically referenced by the proposed regulation alleges that flavors are solely intended to entice children and falsely claim that they cannot possibly be enjoyed by adults. Common sense dictates that such a claim would fail the straight-face test; but, paradoxically, and in spite of the evidence (Farsalinos et al. 2013) it keeps getting parroted by the media, as well as FDA officials. The study by Farsalinos et al. (2013) surveyed 4618 participants, more than 90% of which were former smokers. Those surveyed overwhelmingly rated flavors as an important element contributing to their continued use and enjoyment of ecigs. This demonstrates beyond contestation that flavors are an important part of e-cigarettes’ success and pleasure perceived by adult users. This study also shows that flavors are marketed because there is a demand by adult users, and not for enticing children. Considering the fact that adoption of ecigs by youth is minimal and restricted to those who are already smokers (ASH England 2014 and ASH Wales 2014), any regulation that would restrict flavor choice would be inappropriate. It would cause harm to vapers, continued harm to smokers who would be denied the opportunity to switch to much safer ecigs, while no public health benefits would be observed in any other population.

The FDA has a mandate and a moral obligation to protect public health by actively seeking and critically reviewing all the available evidence, as well as funding additional research that will further improve our understanding of ecigs. Researchers who are not conflicted by any current or previous association with tobacco control, pharmaceuticals, or Big Tobacco should be supported and encouraged to pursue these studies. Continued improvement and innovation of electronic cigarettes is in the interest of public health, not snubbing them by deeming as tobacco products.

Farsalinos et al. (2013): http://www.mdpi.com/1660-4601/10/12/7272
ASH Wales (2014): http://www.ashwales.org.uk/creo_fil...nd_e-cigarettes_in_wales_final_march_2014.pdf
ASH England (2014): http://www.ash.org.uk/files/documents/ASH_891.pdf

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