Regulating E-cigarettes Right: Tobacco Product, Not Medicinal

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E-cigarettes continue to grow in popularity with users around the world. While the popularity of e-cigarettes in Asia has not reached levels as high as in the US or in Europe, there has been a definite upswing with more users turning from conventional cigarettes to electronic ones, even in countries like China and Indonesia that have been recognized as having some of the largest populations of cigarette smokers.

By Nattira Medvedeva

The exponential growth of e-cigarettes’ popularity and the explosive growth in the number of manufacturers supplying hardware and e-liquids to answer this demand has led to countries scrambling to try to regulate e-cigarettes.  The European Union now has the revised Tobacco Products Directive (TPD). Starting in mid-2016, TPD requires 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 TPD will not do is regulate e-cigarettes as medicines, as the parliament voted in October 2013 to keep e-cigarettes regulated as tobacco.

In the US, the Food and Drug Administration (FDA) submitted its final rule for e-cigarettes to the White House’s Office of Management and Budget (OMB) for review in October 2015. The initial review timeframe is 90 days but this can be extended, meaning it might still be a while before we find out the extent of the new e-cigarette regulations.

At present, FDA regulates only e-cigarettes that are marketed for therapeutic purposes. FDA’s new regulations will change that by redefining e-cigarettes as tobacco products. The new 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. The proposed law would also require manufacturers of e-cigarettes to register with FDA, provide the agency with a detailed accounting of their products’ ingredients, and disclose their manufacturing processes and scientific data. Companies would also 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.  In June 2014, the White House’s OMB weakened some of the language that could have been used to prevent the online sale of e-cigs, as well as removed language that detailed FDA’s concerns regarding the safety of e-cigs.

While both Europe and the US are redefining e-cigarettes as tobacco products, it is not necessarily the case in Asia. For example, Brunei, Singapore, and Thailand have banned e-cigarettes outright. In Hong Kong, the sale and possession of nicotine-based e-cigarettes is not authorized and both are considered punishable with a fine of up to HK$100,000 and/or a prison term of two years. However, the law does not cover any non-nicotine inhalers. The governments of Hong Kong and Macau, however, are pushing to ban e-cigarettes entirely. 

The problem, it can be argued, lies in how e-cigarettes are categorized or defined. Ray Story, founder and c.e.o. of the Tobacco Vapor Electronic Cigarette Association (TVECA) and the United Tobacco Vapor Group (UTVG), who has worked closely and successfully with government offices in the US and Europe on categorizing and regulating e-cigarettes correctly and is now working with governments in Asian countries, strongly believes that the first step that needs to be taken is defining the correct category for e-cigarettes as a tobacco product.

“To change [the definition of tobacco products], that is not a definition that you can just change,”said Story. “It’s a global definition of what a tobacco product is. The same thing goes for medicinal products, because [there is] a global definition of what a medicinal product is. So those are two categories, and then you’ve got the consumer products. As a consumer product you can’t sell a product that is focused only on the adult population and that is also addictive like nicotine is. There’s no category that allows for that in the way we have our structure, whether it’s in the US, Europe, or Asia. So that has to change first, but you’re not going to change that category because no one’s going to assist you with that, not government, not Big Tobacco, not Big Pharma, because that would disrupt everything they know today, so that would never happen,” he said.

“So, then you have to work with the definitions that are there, which is on tobacco products. Any product that’s derived from the stem or leaf of a tobacco plant is therefore a tobacco product. Then you have to create a category within that tobacco category that’s obviously less restrictive for a product that is obviously less harmful. Most people don’t see it like that. They’ll say, ‘well, we don’t want it to be a tobacco product, there’s no tobacco in it’. Well, if you read the definition, any product that’s derived from the stem or leaf of a tobacco plant – and nicotine is from a tobacco plant – you’re going to fall in that category.”

China, the largest exporter of e-cigarettes and e-liquids and one of the countries with the largest number of smokers, is also currently in the process of trying to establish e-cigarette regulations with members of the industry working closely with the Chinese government. Ray believes that China will also need to categorize e-cigarettes as a tobacco product.  “They have to because at the end of the day you have to understand, if they don’t harmonize themselves with Europe and the US, they’re out of business. If a product is not categorized as a tobacco product in China, then they will never be able to sell it to Europe or the US. They can’t get it in. It has to be a tobacco product when it leaves the manufacturer, so that it can be harmonized as a tobacco product and then come to Europe or the US.” 

Despite e-cigarettes’ growing popularity and the progress made with the EU and the US recognizing e-cigarettes as a tobacco product and regulating them thusly instead of banning them completely, the debate on whether e-cigarettes are safer than conventional cigarettes remains highly divisive. A recent example is the report released by Public Health England (PHE) in August 2015, announcing that e-cigarettes were 95% less harmful than conventional cigarettes and suggesting they could one day be offered alongside nicotine patches as a smoking cessation aid. Less than a week later, PHE and the team of researchers in this study were under fire with critics accusing the research as being methodologically weak and having conflicts of interest surrounding its funding and members of the research team with links to the tobacco industry, thus concluding that the research findings were questionable.

However, it seems that this could very likely be a case of the pot calling the kettle black. “Well, you have to understand, whenever we get these reports from WHO and from the FDA and from the CDC, those people are 100% paid by the ministry of health and Big Pharma. 100%. There is nobody from the tobacco category or an impartial person on that particular panel when they write these reports,” said Story. “So, certainly, if there are people out there who are going to be writing about e-cigarettes, it is going to be pro e-cigarettes. But to sit there and say that this particular story was skewed because it only had people from the category or only some people from the category is not a fair assessment because those who oppose this are only from Big Pharma and they have their opinion, so they don’t even allow anybody – even [one who] is probably not biased but could potentially be impartial – they don’t allow anybody. It’s only from Big Pharma and from the ministry of health in each and every country and they’re extremely biased towards Big Pharma and their cessation devices.

“You have to understand, e-cigarettes, until I changed the law in the US and in Europe, were considered a medicinal device. We took that away from them. But, it was a medicinal product; it was a drug delivery device. How this product got to be a drug delivery device, where somebody signed it into law, nobody can tell me, but it ended up there. Big Tobacco has an image problem but at the end of the day they have to fight for every inch, whereas Big Pharma intertwined with the ministry of health of each government can do basically whatever they want and they do”.

“If you look, for instance, at Chantix [a smoking cessation prescription medicine], over 3,000 violent acts have been committed while people were on Chantix. I think there’s 500+ people who have committed suicide on Chantix. Do you hear anything about it? FDA put a special page on its website warning you against that drug. Yet, one little battery, after millions and millions have been sold, blows up because the user uses it incorrectly, and it is headline news around the world. That’s the problem. They do not want this product because ultimately if we provide a product to the consumer that would lower the mortality rate, it goes directly against the business model of Big Pharma who makes their money off of sick people. So, they certainly don’t want to cut their cash cow and fighting cancer from long-term tobacco use is their number one money-maker”.

Describing his efforts working with governments to categorize e-cigarettes as tobacco products and regulate them correctly, Story said, “It’s not trying to beat them, it’s trying to show them that they have misinterpreted and miscategorized the product and that doing so goes against everything that would support public health.  Conventional tobacco cannot be outlawed, so they need to put a product up against it that has the ability to compete against that product and potentially defeat and eliminate it over time. And if you have a product that’s manufactured with 6,000 chemicals and over 65 different carcinogens and you then take that product and create the exact same euphoria with 5 ingredients without the history of harm and without all the carcinogens you would find in a conventional tobacco product, that is doing something for public health, which is of course in the interest of the public, and that’s the message we have to bring.”