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Science of Electronic Cigarettes

Submission to the FDA: Comments on Modified Risk Tobacco Product Applications

Federal Drug Administration

Submission to the FDA by Robert Burton, Director, Corporate & Regulatory Affairs, White Cloud Electronic Cigarettes.
Comments on Modified Risk Tobacco Product Applications:
Applications for 10 Products Submitted by Swedish Match North America Inc. Docket No. FDA-2014-N-1051

Whilst I represent the views of White Cloud Electronic Cigarettes and it’s belief that electronic cigarettes have the opportunity to provide smokers with the first true alternative to combustible cigarettes (whilst maintaining their desire for nicotine), it is impossible to ignore the fact that, for tobacco users, Swedish style Snus has a clear role to play in Tobacco Harm Reduction as part of, what has become commonly referred to as, the Continuum of Risk.

Indeed, it has been determined by several independent researchers that Swedish style Snus represents at least 90% lower risk to tobacco users than traditional combustible cigarettes. The overriding reason is due to the fact that this particular form of Snus is not associated with the major diseases, such as lung cancer and chronic obstructive pulmonary disease (COPD), that account for a large proportion of the morbidity and mortality associated with the smoking of traditional tobacco cigarettes.

Generally speaking, we at White Cloud Electronic Cigarettes support Swedish Match and many others in Public Health who endorse the opportunity of a role for Swedish style Snus in Tobacco Harm Reduction: Specifically, one that embraces a Continuum of Risk approach encompassing, among other things, Snus and Electronic Cigarettes.

However, there are wide variations of Smokeless Tobacco Products, with associated risks. Therefore, any regulation should be science-based and allow for the risk profiles of the various products within this classification. The evidence presented by Swedish Match represents a product with over 100 years of usage history, together with data supporting the “Swedish Experience”. Also, the point made by several about the inability of that experience to transfer to the USA is, quite frankly, irrelevant. Smokers of existing combustible tobacco products, and users of other forms of smokeless tobacco, should have clear communication and labeling around the relative risks of each product and, whilst all tobacco products are addictive and have the potential to cause harm, it is our view that Swedish Match should have the opportunity to communicate the position of Swedish style Snus, based upon the Swedish Experience and a relative risk continuum to the consumers of said tobacco products.

Yours sincerely,

Robert I Burton

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