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E-cigarettes: A Legal Conundrum

time2014/10/16

With e-cigarettes becoming increasingly popular among consumers, the electronic cigarette market developing at breakneck speed, and the fast-growing number of companies offering a vast variety of products to answer this snowballing demand in the market,it would not be an exaggeration to say that this explosion in e-cigarette popularity caught nearly everyone by surprise. Industry leaders, public health advocates, researchers, and governments have been struggling to reach a decision whether or not e-cigarettes warrant regulations, and if yes, how best to establish and implement them. What is becoming very apparent, however, is that electronic cigarettes are treated very differently in various parts of the world.


Towards the end of Q2 2014, more than 50 researchers, specialists, and scientists sent a letter to the World Health Organization (WHO) urging it not to regulate e-cigarettes as severely as traditional cigarettes.Their please was based on their research findings, published in the July 2014 issue of Addiction journal, that e-cigarettes help people quit smoking better than several other methods such as the nicotine patch or the nicotine gum, thus making it possible to save millions of lives. Surveying 6,000 smokers who tried to quit smoking in the previous year, the researchers found that the largest number of participants who were able to quit smoking (20%) were those who used e-cigarettes, followed by those who quit without help (15%) and those who quit by using a nicotine patch or gum (10%).


The European Parliament was the first to actually approve regulations on e-cigarettes in February 2014, a move that was both heralded as a benchmark for standards around the world and condemned as a strike against public health. The reason for this could be traced back to the seemingly-simple-yet-so-complicated matter of whether e-cigarettes should be categorized as a tobacco product or a medicinal health product that is effective in helping smokers quit.


Ray Story, c.e.o. of the Tobacco Vapor Electronic Cigarette Association (TVECA), who has worked closely with government offices in the US and Europe on regulating e-cigarettes, said, "I see the e-cigarette, through the process of a few more years, to be considered a risk-reduction or a less harmful product to conventional cigarettes. However, it will fall within the tobacco category due to the fact that nicotine is derived from the stem or leaf of a tobacco plant. Nicotine is an addictive substance just like caffeine is, so therefore there is no other entity that can adequately control, sell, and or bring this product to the public. It will have to fit in the tobacco category due to the fact that age verification and all these other issues pertaining to this adult product have to be enforced and implemented. The consumer category cannot do that and we clearly understand that the medicinal category is completely the wrong category for this product."


"The reason why the vaporizing category and the e-cigarette category has resonated with people so much is because it allows the product to give the individual the one thing they crave which is nicotine and by doing it in a way that is completely comfortable to the habit that they already have which was using conventional cigarettes, by the movement and the physical attachment," said Story. "[It] provides that particular individual with the only thing the body craves which is nicotine,minus all the negatives, so you don't have the tar, the carcinogens, the second-hand smoke, the smell,nor the stains. Nicotine is a natural-occurring alkaloid, which is found in tomatoes, potatoes, green pepper, and broccoli, so the nicotine is clearly not the issue. At the end of the day nicotine in those dosages is basically harmless and there is zero history of harm when it comes to e-cigarettes in general, so that is something that most people are now resonating with."


The EU's Tobacco Products Directive (TPD) will require, starting in mid-2016, that advertising for e-cigarettes be banned in the 28 nations of the European Union, as well as e-cigarettes having graphic health warnings, being childproof, and having no more than 20 milligrams of nicotine per milliliter. What the TPD will not do is regulate e-cigarettes as medicines, as the Parliament voted in October 2013 to keep e-cigarettes regulated as tobacco.


The TPD's new rules will also require that the top 65% of all cigarette packs be covered with health warnings and graphic pictures. All tobacco products specifically targeted at children as well as menthol cigarettes will also be banned.


In the US, the Food and Drug Administration (FDA) recently submitted its proposed regulations to deem e-cigarettes as a tobacco product because their main ingredient, nicotine, is derived from tobacco. The proposed regulations were finally ready four years after Congress passed a major tobacco-control law. The public comment period for the new rules has been extended to August 2014.


The FDA's proposed regulations would also cover pipe tobacco, hookahs, and cigars. They would ban selling e-cigarettes, cigars, hookahs, and pipe tobacco to those under 18 years of age and would require people buying them to show photo identification to verify their age. The proposed law would also require manufacturers of e-cigarettes to register with the FDA, provide the agency with a detailed accounting of their products' ingredients, and disclose their manufacturing processes and scientific data. Companies too would be subject to FDA inspections. Should they have any new products made after 2007, they would need to get FDA approval for them first, but would have two years after the new rules are finalized to do so and can keep their products on the market in the meantime.


The list of rules does not end there. The proposed regulations state that companies would no longer be able to offer free samples, and e-cigarettes would have to come with warning labels saying that they contain nicotine, which is addictive. Companies would also not be able to assert that e-cigarettes were less harmful than real cigarettes unless they got approval from the FDA to do so by submitting scientific information.


However, what the proposed regulations do not cover is any proposal to ban flavors in e-cigarettes nor a move to restrict the marketing of e-cigarettes, as is done for traditional cigarettes.


It would seem that the FDA's proposed rules, while seen by some as not being strict enough, would be a first step to regulate the e-cigarette industry while recognizing that more research is needed to fully understand the implications of e-cigarettes in all aspects. The FDA has approved a budget of US$ 270 million on 48 research projects currently underway to better determine the risks and benefits of e-cigarettes. While leaders of these research projects say final results may not be ready until 2018, non-FDA-funded research may also be a contributing factor in the FDA's regulations coming into effect sooner than that.


Even though there are no federal regulations in place yet, due to the growing popularity of e-cigarettes, many US states have already passed laws that ban e-cigarettes from public places, regulate their sale, ban their sale to minors, and tax them.To date, 38 states have moved to ban e-cigarette sales to minors. Of these 38 states, only Colorado, Nevada, North Carolina, South Dakota, West Virginia, and Wyoming categorize e-cigarettes as tobacco products, 13 states exempt e-cigarettes from being categorized as a tobacco product, and 19 states define e-cigarettes as a separate category altogether.


In Asia, e-cigarette regulation has not received as much attention as e-cigarettes' popularity is not as tremendous as in the US and Europe. In China, for example, traditional tobacco cigarettes are still preferred over e-cigarettes. Yet, even though there is currently low demand domestically, the potential for e-cigarettes in this market, considered to be the world's largest producer and consumer of tobacco products with approximately 350 million smokers, is enormous, particularly with increasingly strict anti-smoking laws.How and when e-cigarettes will be regulated here remains to be seen. Enditem