E-cig Regulations
By Nattira Medvedeva
As those in the industry are aware, e-cigarettes are gaining in popularity with some predicting they will take over traditional tobacco cigarettes perhaps as soon as 10 years from now. Due to the fact that e-cigarettes are a relatively recent innovation that only gained prominence in the past decade, the fast-growing e-cigarette industry has been largely unregulated until recently, when the European Products Directive comes into force in 2016, and the US FDA currently in the process of coming up with regulations, possibly in late 2015 or in 2016.
Beginning of Story
At the CECMOL Second Chinese E-cig Forum (the Forum) held in Shenzhen on April 9, 2015, a common topic visited time and time again was e-cigarette regulations. While a lot of the discussions touched on the European Commission’s Tobacco Products Directive (TPD) and the US Food and Drug Administration’s (FDA) regulations, Dr. Konstantinos Farsalinos, a cardiovascular specialist and internationally-acclaimed researcher at the Onassis Cardiac Surgery Center in Athens, Greece and the University of Patra, Greece, renown for his work on e-cigarettes and their effects, drew attention to a very valid point often overlooked by governments: regulations must be based on scientific evidence, not ideology.
In his presentation, Dr. Farsalinos shared findings from different research studies he and his team have conducted that provides such evidence showing that e-cigarettes present fewer health risks than conventional tobacco cigarettes, addressing many of the concerns that have been brought up by regulators. The scientific research findings could also be used to help set regulations and standards for manufacturers of e-cigarettes and e-liquids to ensure quality products are delivered to the end consumer.
E-cig Regulations
Nitrosamines are a main carcinogen found in tobacco cigarette smoke. A study says conventional cigarettes deliver 1,800 times more nitrosamines than e-cigarettes.
Nitrosamines
One of the findings Dr. Farsalinos presented at the Forum was about nitrosamines, a main carcinogen found in tobacco cigarette smoke. An analysis he and Prof. Ricardo Pollosa did of previous studies measuring nitrosamines in e-cigarettes and in tobacco cigarettes showed that the average e-cigarette user gets about 52 nanograms (ng) of nitrosamines per day, which is almost the same as the amount found in pharmaceutical nicotine gum. However, tobacco cigarette smokers get 50,000-94,000 ng of nitrosamines per day, approximately 1,800 times more than e-cigarettes. Or, as Dr. Farsalinos said, “With one day of smoking you get what you would get from six years of vaping. So it’s a huge, huge benefit for switching from tobacco cigarettes to e-cigarettes in terms of nitrosamines, one of the most important carcinogens in cigarette smoke.”
Research findings by Dr. Farsalinos and his team that were published as recently as March 2015 focused on nitrates and phenols, two other carcinogenic compounds. In this latest study, they tested 21 e-liquid samples and found that the levels of nitrate and phenols were 150-1,500 times lower in e-cigarettes compared to tobacco cigarettes.
“Why do e-cigarettes exist? Basically because medicine has failed,” said Dr. Farsalinos. “The NRTs, the nicotine replacement therapies, the gums and patches that we all know, have a success rate of 6% or even less than that. The only medications that have been approved for use as smoking cessation medications, they also have very low success rates, less than 20%. I think that e-cigarettes have a role to play as a substitute for smoking.”
E-cig Regulations
Dr. Farsalinos' study counters the findings of another recent study claiming that e-cigarettes contain up to 15 times higher levels of formaldehyde than conventional cigarettes.
Formaldehyde
Countering the findings of a recent study that said e-cigarettes contained 15 times higher levels of formaldehyde than conventional cigarettes, Dr. Farsalinos shared some details of one of his latest studies that show very different results.
Test participants in this study tested two atomizers, one with a single wick and the other with a double wick. They then were asked to test the atomizers at different wattage levels, the levels being 6.5, 7.5, 9, and 10 watts and inform the researchers when dry puffs, an unpleasant burning taste that happens when e-liquids get overheated, started. Participants reported that the single wick atomizer produced dry puffs at 9 and 10 watts, while the double wick atomizer was normal at all wattage levels. The researchers also found that in the double wick atomizer there were minimal levels of aldehydes at all wattage levels. For the single wick atomizer, there were minimal levels of aldehydes at 6.5 and 7.5 watts but higher levels of aldehydes at 9 and 10 watts. In other words, it was found that aldehydes are produced at high levels only under dry puff conditions. According to Dr. Farsalinos, this in itself serves as a defense mechanism that protects the vaper from exposure to high levels of aldehyde as vapers usually avoid dry puffs anyway. The study also showed that if vapers use better atomizers, such as double wick rather than single wick, wattage levels are not an issue and vapers can vape at higher wattage without the problem of exposure to the production of aldehydes.
Passive Vaping
Another issue that regulators are concerned about is the effects of passive vaping – what happens to a non-vaping person who is near a vaper. A study by Dr. Farsalinos and team presented in 2012 had five vapers and five smokers vape or smoke in a hotel room on different days. The study found that after a five-hour period, the level of organic carbons found in the room from e-cigarettes was 0.73 milligrams per cubic meter (mg/m3) and 6.66 mg/m3 from tobacco cigarettes. Or, in simpler terms, as Dr. Farsalinos mentioned, “You got the same amount of organic carbon in 11 minutes of smoking as you would get from 5 hours of vaping. That’s a huge gap and it shows that the level of chemicals that are released in the environment inside the room when someone [is] vaping are extremely low compared to smoking.
“Chemical studies have found that exposure to toxic chemicals from electronic cigarettes is by far lower compared to tobacco cigarettes. There’s no doubt about it. However, besides comparing the level of specific chemicals, we have to understand that most of the 6,000 chemicals that are present in tobacco cigarette smoke are totally absent from e-cigarettes. So, you don’t get exposed to all these chemicals.”
Glycerin
Other research findings Dr. Farsalinos presented included toxicological results showing that live cells exposed to e-cigarette vapor have a survival rate of up to 1,500% higher than in cells exposed to tobacco cigarettes, results from a study of cardiovascular function in which it was shown that there are no adverse effects in heart function and no effects on oxygen delivery to the heart after using e-cigarettes, as well as debunking the claims of a previous study that said e-cigarette vapor causes lipoid pneumonia because of the glycerin in e-liquids, which, as Dr. Farsalinos explained, is not possible as glycerin or glycerol is an alcohol and lipoid pneumonia can only be caused by the presence of lipid substances in the lungs.
Throughout his presentation at the Forum Dr. Farsalinos stressed that e-cigarettes should be for smokers who are looking to quit smoking. “We don’t recommend to start using e-cigarettes to a non-smoker,” he said. “Basically it should be marketed as a smoking substitute for smokers only and that’s how studies should be performed. This is the information that we need – how would a smoker react if he switched from tobacco to electronic cigarettes?”
The safety of using e-cigarettes is also a major concern for regulators; however, as Dr. Farsalinos pointed out, long-term studies on safety cannot be performed because, in contrast to smoking, which is known to cause diseases after 15 or 20 years of exposure, there currently are no e-cigarette users who have been vaping for that long who can be studied.
“Vapers will eventually look for safety and quality and will choose the products which have been tested,” said Dr. Farsalinos. “So, it’s not only that the regulators are asking for proof of safety but the vapers are going to start asking for proof of safety and quality of the products. To do all this we need the industry to participate actively. The industry needs to recruit experts and fund studies, consult experts, develop well-designed protocols.
“The e-cigarette is a public health revolution,” concluded Dr. Farsalinos. “There is no doubt that they are less harmful by big margins compared to tobacco cigarettes. Of course we need more evidence and proof about the safety and quality in order to convince [not only] the regulators but also the scientists and the doctors.”