Micro-comment #8 for FDA Deeming - re: appropriate regulation

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 [1], junk science [2a, 2b], and unsubstantiated propaganda [3a, 3b] from the tobacco control industry (TCI).

The cost-benefit analysis forwarded by the FDA in regards to the deeming regulations is particularly egregious, because it overweighs hypothetical risks, while discounting real benefits. In a recent commentary, Clive Bates [4] itemizes the risks associated with misguided regulations and quantifies that for every hypothetical risk from vaping, there is a more plausible benefit. These benefits are eloquently quantified by Joel Nitzkin [5] in a policy study regarding ecigs, which proposes sensible approaches to ecig regulations. Another excellent summary of the risk-benefit proposition of regulating ecigs is presented by Saitta et al. (2014)[6], who also discuss the enormous opportunity for appropriate, fact-based regulations to prevent “much misery and suffering” and save millions of lives.

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 and impacts of regulations. Researchers who are not conflicted by any current or previous association with tobacco control, Big Pharma, 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.

[1] http://link.springer.com/article/10.1007/s00204-013-1127-0
[2a] http://tobaccoanalysis.blogspot.com/2014/05/glantz-review-article-is-little-more.html
[2b] http://www.bernd-mayer.com/pseudoscience-electronic-cigarette-policy/
[3a] http://tobaccoanalysis.blogspot.com/2014/03/new-study-on-electronic-cigarettes-by.html
[3b] http://www.ecigarette-research.com/web/index.php/2013-04-07-09-50-07/2014/166-glantz-response-cvd
[4] http://www.clivebates.com/?p=2257#more-2257
[5] http://www.rstreet.org/wp-content/uploads/2014/06/RSTREET25.pdf
[6] http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3926346/

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