Why E-Cigs Need (Sensible) Regulation
So far, proposed regulations have not been a good thing for the vaping industry. In the U.S., the FDA’s draft proposal consisted of little more than bureaucratic requirements to submit paperwork, placing an undue burden on the primarily small businesses that make up the industry while including none of the many suggestions that could actually help protect consumers from inferior products. In Europe, things aren’t much better, with arbitrary limits on nicotine levels and the size of bottles being among the many absurd things in the proposed regulations.
However, none of this means that regulations are inherently a bad thing. In fact, some well-designed and proportionate regulations could minimize any risks associated with vaping and ensure companies put out consistent products. The challenge is providing that quality assurance without demolishing the innovation that makes the industry what it is today.
The Goal of E-Cigarette Regulations
Determining the actual intention of e-cigarette regulation is the first problem, and there are two main things to take into account: minimizing risk while still encouraging switching among smokers. Regulations should undoubtedly aim to remove any unnecessary health risks and keep any unavoidable risks to a minimum. However, the true scope of regulation is broader than that: the aim should be to improve public health. When you’re considering e-cigarettes, which are almost entirely used by smokers and ex-smokers, this raises the vital comparison with cigarettes.
Cigarettes are widely-available, addictive and undeniably deadly. They offer a quick and easy hit of nicotine, and despite firm restrictions on advertising, are still used by about 18 percent of American adults. Smoking is widely identified as the leading preventable cause of death in the U.S., so reducing the number of adults that smoke should be a priority.
For e-cigarette regulation, the implication of this is clear: to benefit public health, e-cigarettes need to have a substantial chance of attracting smokers to make the switch. If regulations designed to reduce the already miniscule risks likely associated with vaping end up reducing their ability to compete with cigarettes, the marginal benefit in the safety of e-cigarettes will be dwarfed by the harm coming from fewer smokers making the switch.
The core goal of e-cigarette regulation, then, should be to provide quality assurance but not at the expense of the appeal of e-cigarettes to existing smokers. Of course, it makes sense to have some restrictions to ensure that people aren’t harmed in other ways, or that non-smoking adults or youths aren’t encouraged to start vaping, but every decision risks making available products less appealing to smokers and vapers, which could in turn lead to increases in (or smaller decreases in) the smoking rate.
The Regulations We Need
To keep the regulation proportional to the risks of the product, it’s clear that e-cigarettes only really need a “light-touch” approach, much like that used in Sweden to regulate snus. However, we shouldn’t let that mislead us into thinking that no regulation is acceptable: at present, companies do things like claim their e-liquids are diacetyl-free despite not actually being diacetyl-free, and while we don’t think this is a huge problem, there are cases of no-nicotine e-liquids actually containing traces of nicotine. Clearly, there needs to be some accountability for things like this, because we ultimately inhale what these people produce.
There are many possible requirements that don’t place undue burdens on small businesses but would still serve to provide protection for consumers, such as setting minimum purity levels for e-liquids (including making them free from known hazards like diactyl), ensuring that e-liquids are produced in a clean and sterile environment, and many other reasonable standards, such as those suggested by the American E-Liquid Manufacturing Standards Association, including mandating the use of child-proof caps for e-liquid. Similarly, obvious risks such as the use of lead-based solder in devices should be removed. These requirements would offer consumers much-needed protection and would provide some additional confidence in the quality of the products we purchase.
Although limiting marketing is arguably not justified – since this could reduce their chance of convincing adult smokers to make the switch and thereby cause harm – it would obviously make sense that, alongside a ban on sales to minors, some steps should be taken to ensure that companies don’t do anything to deliberately market to youths or non-smokers. What precisely would need to be restricted is a difficult question, but things like ensuring that ads for e-cigs can’t appear in places primarily seen by youths and making sure campaigns are focused on encouraging smokers to make the switch (rather than positioning vaping as a new hobby for anybody to take up) could accomplish this.
In addition to existing consumer protection rules covering things like electrical components, such regulations are reasonable and would actually be good for vaping on the whole.
The Regulations We Don’t Need
Sadly, the regulations as currently proposed in many places primarily focus on other things and do very little to accomplish these core goals. The FDA’s proposal offers very little aside from bureaucratic burdens, and the “substantial equivalence” requirement threatens to effectively ban most products currently on the market. A new bill may help prevent this pointless decimation of the industry, but it’s a perfect example of the type of regulation that comes with a lot of harm (by basically protecting the cigarette market from competition) with no clear benefit (to vapers or anybody else) in terms of establishing product standards.
Similarly, the EU’s proposal includes a virtually total ban on advertising, a limit of 2.0 % nicotine in ecig liquid (despite many smokers needing to use 2.4 % nicotine e-liquids to switch), e-liquid bottles being limited to 10 ml containers (in a misguided attempt to quell fears of accidental poisonings) and many more borderline useless requirements such as “leak-free” filling. Totally Wicked has challenged this legislation in court, but whether their argument that the regulations are a “disproportionate impediment” to the free movement of goods in Europe will be upheld by the Court of Justice of the European Union remains to be seen.
The basic lesson is that anything else – particularly if it risks jeopardizing the appeal or availability of e-cigarettes to adult smokers and vapers – is unnecessary, disproportionate to the potential risks of vaping and ultimately damaging. Drawing arbitrary lines in the sand (like “grandfather dates” or irrational nicotine limits) doesn’t help anybody, and could reduce the ability of e-cigarettes to reduce the number of smokers around the world.
Conclusion – Regulations Could Benefit the Industry, If Done Right
The case for regulation of e-cigarettes is pretty strong, overall: it provides customers with some much-needed assurance that they aren’t being lied to or otherwise misled, and that their e-liquids and devices are compliant with reasonable standards. However, all around the world, this reasonable argument is being twisted to support thoughtless regulations that offer no benefits and a lot of potential downsides. As vapers and businesses, we should oppose such irrational moves in any way we can, but we should keep in mind that some “light touch” regulation to buy e-juice and devices would still be a good thing for the industry.
- The Counterfactual: Regulation of E-Cigarettes – General Ideas
- The Counterfactual: What is Wrong with the Tobacco Products Directive for Vapor Products?
- CASAA: The FDA & Deeming Regulations of E-Cigarettes
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