24-month clinical trial shows no negative health impact on smokers who used vaping products, and no increase in body weight

Amsterdam, Netherlands, 17th January 2018 - A new peer-reviewed clinical trial to be published in the February edition of Regulatory Toxicology and Pharmacology shows that regular use of e-cigarettes does not have any negative health impact on smokers.

The study, "Evaluation of the Safety Profile of an Electronic Vapour Product Used for Two Years by Smokers in a Real-life Setting", examined 209 volunteer smokers who used a typical closed-system e-cigarette for 24 months while researchers monitored for adverse events, as well as lung function, electrocardiogram results, and exposure to nicotine and tobacco constituents.

"This study shows that after two years of continual e-cigarette use, there were no signs of serious health complications in smokers." said Tanvir Walele, Director of Scientific Affairs at Fontem Ventures, the owner of e-cigarette brand blu.

During the trial, no serious safety concerns were recorded among the participants and no clinically relevant findings were observed in all other medically-defined safety criteria. Further, the use of the vaping products was associated with a reduction in nicotine withdrawal symptoms, reduced exposure to cigarette smoke constituents, and no increase in body weight.

"Clinical data over a two-year period gives us a much clearer picture about longer term vaping, and the potential implications for the health of smokers, so they can make an informed decision." said Walele.

A recently updated Cochrane Review1, whilst acknowledging the small number of published clinical studies currently available, reached a similar conclusion to this study: that e-cigarettes with nicotine can help smokers to reduce or replace smoking with no increased health risks associated with short- to mid-term (up to two years) use.

"Governments and policy-makers should ensure that regulatory frameworks reflect this emerging scientific consensus, as more long term research demonstrates the safety profile of e-cigarettes," said Walele. "This research suggests we need e-cigarette regulation that is not modelled on tobacco product regulation, but encourages innovation and compliance with robust product quality, manufacturing and safety standards."

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1 http://www. cochrane. org/ CD010216/ TOBACCO_can-electronic-cigarettes-help-people-stop-smoking-and-are-they-safe-use-purpose

Abstract

The safety profile of Puritane™, a closed system electronic vapour product (EVP), was evaluated when used by smokers of conventional cigarettes (CCs) for 24 months in a real-life setting.

The study was a two-centre ambulatory clinical study with 209 healthy volunteers. Outcome measures included adverse events (AEs), vital signs, electrocardiogram, lung function tests, exposure to nicotine and selected smoke constituents, nicotine withdrawal effects and smoking desire.

No serious AEs related to EVP use were observed. The most frequently reported AEs were headache, nasopharyngitis, sore throat and cough, reported by 28.7%, 28.7%, 19.6% and 16.7% of subjects, respectively, which dissipated over time. Small decreases in lung function were not considered clinically relevant. No clinically relevant findings were observed in the other safety parameters. From Month 2, nicotine withdrawal symptoms decreased. Smoking desire and CC consumption steadily decreased over time in all subjects. EVP use was associated with reduced exposure to cigarette smoke constituents, whereas urinary nicotine levels remained close to baseline. Body weight did not increase in CC subjects switching to the EVP.

In conclusion, the aerosol of the EVP at study was well tolerated and not associated with any clinically relevant health concerns after usage for up to 24 months.

About Fontem Ventures

Fontem Ventures, a division of Imperial Brands PLC, is the owner of the blu e-cigarette brand. Headquartered in Amsterdam, the Netherlands and with a Research & Development centre in Liverpool, UK, Fontem Ventures' purpose is to drive electronic vaping technology forward, and deliver something better to smokers and vapers around the world.