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The Dangers of Regulating E-Cigarettes as Medicinal Products

“The world has gone mad when tobacco is less regulated than products designed to end tobacco use.” This statement belongs to Martin Callanan, a member of the British Parliament, and it was made in reference to the UK’s decision to regulate electronic cigarettes as medicinal products by 2016. Although the FDA has yet to issue a proposal for the regulation of e-cigarettes and other tobacco products, the threat of these devices being regulated the same way in the US still looms.

vapingI’ve personally heard a lot of people say they would actually feel more at ease knowing that the electronic cigarettes and e-liquids they use would have to meet the same strict standards of pharmaceutical products. In today’s completely unregulated e-cigarette market everyone can sell whatever they want without having to present any kind of certificate about the ingredients used in e-liquids and their purity, so I can definitely understand their concerns, but the issue of regulating e-cigs as medicines is a lot more complex than it seems. The truth is, most experts agree this type of strict regulation does a lot more harm than good, and that even adequate consumer product regulation and packaging would solve the issue of questionable products and consumer safety just as efficiently. “For the first time in the history of the tobacco control movement, a realistic possibility is emerging that the tobacco problem might get resolved, and that this could happen with minimal or no government involvement or expenditure. Regulators of medicines should hold their fire,” Peter Hajek, director of the Tobacco Dependence Research Unit at Barts and The London School of Medicine and Dentistry, Queen Mary, said on the matter of medical regulation. Let’s see why this method of control is more dangerous than most people realize:

  • It Makes Electronic Cigarettes Less Effective; Nicotine content in today’s e-liquids ranges from 0mg/ml to 36mg/ml, in order to fit the needs of even the heaviest of smokers, but the UK’s MHRA plans to limit nicotine content of medicinally regulated electronic cigarettes to 4mg/ml. It’s true that e-cigs provide sensory and motor stimuli similar to smoking, making them more comfortable than traditional Nicotine Replacement Therapies, but without the needed does of nicotine, a large number of vapers would be in danger of going back to potentially-deadly tobacco cigarettes. According to a 2012 report by the Harvard School of Public Health “researchers found no difference in relapse rate among those who used NRT for more than six weeks, with or without professional counseling. No difference in quitting success with use of NRT was found for either heavy or light smokers.” Pharmaceutical nicotine sprays have a nicotine content of 10mg/ml, and if that wasn’t enough to keep ex-smokers from relapsing, how does anyone expect less than that to be enough? Another recent study performed by a team of Greek scientists on a group of smokers who quit using electronic cigarettes shows 80% of them needed e-liquid with nicotine levels over 16mg/ml.
  • It Hinders Technological Advancement; Today, vaping technology is improving at a rapid pace, with new and more efficient devices and accessories being invented virtually every day. As Doctor Konstantinos Farsalinos notes in one of his recent studies, “medicinal regulation could reduce technological evolution and development of more efficient products because the cost would be too high to get approval for new products that are developed at a fast rate; this would inevitably restrict the variability of devices and liquids available for consumers.” His recent research showed that “participants were predominantly using modern devices in order to achieve and maintain smoking abstinence”, devices that might not be available if e-cigarettes are regulated as medicinal products. That means we would probably be restricted to a handful of models to choose from, compared to the hundreds if not thousands available right now.
  • It Restricts Access to Electronic Cigarettes; Classifying e-cigs as medicines limits their availability to pharmacies, potentially requiring vapers to get prescriptions from their physicians in order to get the needed dose of nicotine, which will almost certainly be to cumbersome for a large number of e-cigarette users. Electronic cigarettes are already more complex to use than tobacco analogs, and this measure would make them even more impractical for some people. Many health experts agree e-cigarettes have the potential o save millions of lives, but instead of being encouraged as an alternative to smoking, they would be a lot less easily accessible than the already-proven dangerous tobacco cigarettes.
  • It Protects the Tobacco Industry; Electronic cigarettes were designed as an alternative to tobacco cigarettes, but being regulated as medicines, e-cigs would no longer be able to compete with analogs. As Professor Peter Hajek says “Since e-cigarettes are a recreational consumer product that are competing with much more dangerous cigarettes, which are not regulated as medicines, mandatory medicinal regulation is not required for public safety and can harm public health by restricting the ability of e-cigarettes to compete with cigarettes in the marketplace. Excessive regulation of e-cigarettes would protect the market monopoly of cigarettes and have the potential consequences of disease in and death of millions of smokers who were prevented from moving on to the next generation of e-cigarettes.” If we really want e-cigarettes to save millions of lives, we must make sure they are as readily available as analogs.
  • It Wipes Out Most Small E-Cigarette Businesses; Unhindered by high taxes,the vaping industry has proven very lucrative for a lot of people, and hundreds of thousands of jobs around the world now depend on this niche. If e-cigarettes were to be regulated as medicines, their manufacturing and that of e-liquid be limited to those companies which can afford to buy the additional licensing, which would put most small operations out of business.

Everyone agrees that electronic cigarettes must be regulated to some extent in order to ensure their quality and the safety of people using them, but medicinal regulation is much to strict and offers no real advantage over other forms of regulation. Between 2005 and 2012 there hasn’t been a single fatality or serious adverse side effect related to e-cigarettes, which can’t be said about other medicinal smoking-cessation aids, like Chantix (Varenicline), for example. If any such risks emerge in the future, tighter regulation can be implemented at that time.

Sources: Libertas Academica, Queen Mary University of London, The Parliament, The Information Daily

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