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The Regulation of E-Cigarettes: Trying to Fit a Square Peg Into a Round Hole?

As with many new things, the apparent widespread use of e-cigarettes is raising a number of questions: Are they making smoking "cool" again, and if so, will they lead to a new generation of smokers? Are they safe? And my personal favourite: how should they be regulated?
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Electronic cigarettes (or e-cigarettes) have been making big news lately. It seems many of our favourite celebs are making the switch from traditional cigarettes to the less-stinky alternative, and "e-cigarette" lounges, or "vaporiums", are all the rage in New York and other U.S. cities.

Indeed, e-cigarettes may just be the catalyst for the largest public health debate of 2014.

As reported in the New York Times, the e-cigarette market has grown to around $1.7 billion in sales in the United States alone, and some are projecting that e-cigarette sales will beat out sales of regular cigarettes in the next decade.

As with many new things, the apparent widespread use of e-cigarettes is raising a number of questions: Are they making smoking "cool" again, and if so, will they lead to a new generation of smokers? Are they safe? And my personal favourite: how should they be regulated?

The issue as I see it: e-cigarettes do not fit neatly within any existing regulatory scheme (square peg, round hole). This has resulted in a significant gray area, or as some are calling it, the 'wild west'.

And to be clear, living in the "wild west" is not necessarily a good thing.

It is estimated that there are over 250 different e-cigarette brands available in the United States today. Undoubtedly, there is a wide range in the quality of these products, and the chemicals that each contains. Without regulation of this industry, consumers are essentially putting blind faith in manufacturers, and the reputation of the industry as a whole is tied to its weakest link.

Governments around the world are grappling with how to regulate e-cigarettes (just this week, the European Union announced it would regulate the industry) and manufacturers and consumers are awaiting the results with bated breath.

The Current Rules in Canada and the United States

Health Canada has made its position on e-cigarettes clear: e-cigarettes containing nicotine cannot be sold or advertised in Canada without Health Canada approval.

Depending on the amount of nicotine delivered "per dosage unit", e-cigarettes are regulated as either drugs or natural health products. In either case, Health Canada requires pre-marketing evidence of safety, quality and efficacy in connection with intended use.

(Note that e-cigarettes that do not contain nicotine and are not marketed with health claims are not subject to pre-approval and can be -- and indeed are being -- marketed in Canada.)

Like Health Canada, the FDA regulates e-cigarettes that are marketed for therapeutic purposes as drugs and/or devices. Unlike Health Canada, however, the FDA has not yet claimed jurisdiction over e-cigarettes that contain nicotine, as long as they do not claim a health-related use.

As a result, e-cigarettes containing nicotine are being widely marketed and sold throughout the United States, with no rules or regulation about their manufacture or sale - talk about the wild west!

Separately, the FDA regulates tobacco, which currently includes cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. The agency has announced it has a proposed rule which will allow it to regulate "additional categories of tobacco products". It is widely suspected that this will bring e-cigarettes under the umbrella by which the sale and advertising of tobacco is controlled.

The FDA's proposed rule is currently before the Office of Management and Budget for review. It was believed that the proposed rule would be released for public comment back in October but still, we wait.

The Path Forward?

If the FDA regulates e-cigarettes as tobacco, advertising would likely be tightly regulated (if not outright banned) and we may see a prohibition on flavoured juice. In addition, we could see taxes levied, restrictions on where e-cigarettes can be sold and to who, and the requirement to include warnings on labels.

Regulation in this way may alleviate concerns about e-cigarettes becoming the gateway for new (teenaged) smokers (assuming the requisite links can be established).

However, regulation of e-cigarettes as tobacco products may do nothing to ensure the safety of the product. For example, who will control how and where the liquid in e-cigarettes is made?

Drugs and similar products must be manufactured and sold in accordance with strict good manufacturing practices. These requirements ensure (among other things), the quality of products, that they are produced in sanitary conditions with appropriate materials, and that there are processes in place for recalls if needed. Essentially, production and quality are controlled. These controls would likely need to be more stringent in the case of e-cigarettes, in comparison to traditional tobacco products.

Health Canada has provided no indication of how it will regulate e-cigarettes in the future. It may follow the FDA's (assumed) lead and pull them under the umbrella of tobacco regulation, or it may continue to regulate them under the Food and Drugs Act as either drugs or natural health products.

While regulating e-cigarettes as tobacco may not make sense, it may be equally nonsensical to regulate them as drugs or natural health products.

In particular, it may be difficult for a health-related regulatory body to fold a 'smoking product' into its mandate of promoting health and safety, even if e-cigarettes are safe and contribute to getting folks off cancer-causing traditional cigarettes. This is particularly so, given the industry's apparent lack of interest in marketing e-cigarettes as nicotine replacement therapies (like the Nicorette inhaler, patch or gum).

And so, as I see it, the real issue with the regulation of e-cigarettes is that the product does not fit neatly into an existing regulatory category -- square peg, round hole.

It may make the most sense to take the relevant elements of the two existing regimes (drug and tobacco) and create a category-specific regulatory regime specifically designed for what looks to be one of the biggest up-and-coming products of the next decade. Health Canada has done this before, most notably, with the introduction of the Natural Health Product Regulations to govern "herbal remedies" in 2004.

Whichever way you slice it, there is no question that the e-cigarette industry is innovative and that nicotine is big business (just think of all the upcoming New Year's resolutions!). There will continue to be demand for this product, and industry will figure out a way to get it into the hands (and mouths) of consumers.

But they too want to make sure it's done smartly. The reputable e-cigarette manufacturers want regulation to ensure that fly-by-night operations do not kill the industry.

The key is making sure regulation ensures the safety of the product and imposes the most appropriate rules around its marketing and advertising. In order to accomplish this, lawmakers will need to acknowledge that e-cigarettes are neither drugs nor tobacco products is necessary. Simply put: there is no way to reasonably fit a square peg into a round hole.

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