Riccardo Polosa - Comment

Document ID: FDA-2012-N-1148-0006
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: December 14 2012, at 12:00 AM Eastern Standard Time
Date Posted: December 27 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: November 28 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: January 2 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jw-82jd-1jh9
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As a Director of the Centre for Tobacco Prevention and Dependence Treatment, at the University of Catania, IItaly, and as a Scientific Director of LIAF Italian NoSmoking Association, I have dedicated many years of my clinical and research activity to fight against tobacco smoking. Current evidence show that available smoking cessation medications do not guarantee high level of efficacy in real life settings and more effective approaches are needed to contrast tobacco smoking. A few years ago, I got involved in the pioneeristic early trials on electronic cigarettes. At that time, a balanced analysis of the risks and benefits of these products was not available and we thought that a rigorous research on e-cig was urgently needed to guide the decision of the regulators, healthcare providers and consumer. It was surprising to see that the findings of this work turned out to be extremely positive; in smokers not willing to quit the use of ecig decreased cigarette's consuption and in some it elicited enduring tobacco abstinenece to a level never achieved by any other device, approach or FDA approved medication. Moreover, no significant side effects were reported and substantial health gains could be achieved by e-cig users. More recently, a number of studies have shown that the risk of second hand vapor from e-cig use is very small in comparison to those associated with second hand tobacco smoke. While secondhand smoke must be eliminated in public places, there are not justification for eliminating ecig use from these. The current evidence is thin and more research is needed, but it is likely that these products will prove useful in the management of tobacco dependence. Therefore, FDA and regulatory bodies in general should carefully consider the public health potential of the ecig. The FDA is strategically poisitioned to provide smokers with truthful health information and legal access to far less hazardous alternative, including e-cig. Prof. Riccardo Polosa

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