E-Cig Regulation: Thoughts from Vapers and Experts
With the FDA on the cusp of announcing deeming regulations for e-cigs, many vapers, researchers and advocates have been pondering the question of how best to regulate e-cigs of late. Even amongst the community, the question is divisive; it’s a problem which pits idealism against realism. Most readily agree that things are fine as they are (given that the alternative is equivalent in terms of risk to playing Russian roulette with three bullets in the chamber), but it’s unrealistic to pretend that this will continue.
So, what should regulation be like? Should we be as worried about children and non-smokers taking up vaping as much as ideological anti-smoking groups, prohibitionist politicians and sensationalist media outlets allege? Are marketing restrictions justified? Should e-cigs really be considered as tobacco products in the eyes of the Federal Government? We put these – and other – questions to ordinary vapers, bloggers and reviewers, scientists and researchers, and prominent advocates to get a picture of where the community falls on the issues.
#1. What do you think e-cig regulation should look like? Do we need it at all?
I think it’s important to remember what the job of government is really supposed to be. Yes, I believe we need some regulation, but not much. What we need is more enforcement in the “truth in advertising” laws. That’s not to say we don’t need regulations to make sure that quality parts are used in the construction of e-cigarettes, they are batteries after all. Cartomizers should be filled with quality materials, safe for human consumption. E-liquids should be regulated more, with emphasis on purity of the ingredients, handling, mixing, bottling, storage, and shipping. Like foodstuffs. Local laws should take precedence for local sales of local e-liquids, federal level laws when products are sold over the internet, out of state, etc. Inspections of facilities, like they do with restaurants, is sensible. Random checks on bottled e-liquids to check nicotine levels and purity. If companies are selling 100% VG then it should be 100% VG, 18mg should be 18mg, and so on. Some regulation is needed, but keep it to a minimum. The government should also come down hard on any e-cig brand making statements that are untrue, or hiding information like auto-shipment, “risk free” scams, and so forth. Don’t outlaw them, just make them play straight and they will simply disappear.
I don't think there is one specific element that could be made safer through government regulation. One thing that I think needs to be in place for all liquid manufacturing (and what AEMSA is trying to accomplish) is some good manufacturing practices. My background is in manufacturing, so I understand things like sterile, clean work areas, safe handling, HACCP, Food Safety, etc. These things just make sense in liquid manufacturing. The days of Joe Shmoe's kitchen mixed e-liquid need to go away.
Why the intense concern on quality of ingredients, or manufacturing standards? For me this is replacing cigarette smoking, where I am inhaling a large number of chemicals which are known to be dangerous. Is the FDA going to certify that tobacco processing (at all stages, from the farm to the shelf) doesn't add anything extra, and is performed under sterile conditions?
There is currently a lot of competition between juice vendors, and those that do not make a quality product will not stay in business. If a juice company wants to certify their production environment and do spectrographic analyses of their juices (as some are now doing!) then a customer can decide to use them.
The “safety” of e-juice is a red herring, plain and simple. The FDA is not effective in protecting our produce from salmonella, e-coli, listeria and other deadly contaminants, and always points to outbreaks as “We just don't have the manpower to inspect and test everything.” So somehow e-juice is such a dangerous threat that it merits pulling the few inspectors off of food and drug inspections so they can inspect e-juice factories? Personally I see a much greater potential for danger in the food I eat than in the liquids I vape. Food production provides numerous opportunities for contamination, whereas the manufacture of e-juice only requires simple precautions to provide an “as advertised” product.
To compound the issue, the FDA has shown a complete lack of understanding of basic science when it conducted the one-and-only test it has ever done on e-juice. Before we start handing over more funds to the FDA to do any kind of certification, I would like to see one example of a competent analysis of e-juice conducted by the FDA, with their findings reviewed and published in a respectable scientific publication.
Dr. Konstantinos Farsalinos, Researcher, Onassis Cardiac Surgery Center, and Blogger at E-Cigarette Research:
Currently-proposed regulations by organizations such as the MHRA are unlikely to promote any kind of benefits in terms of e-cigarette products safety. The amount of bureaucracy, extensive testing and tight restrictions will limit accessibility, reduce variability and destroy innovation and development of new and more efficient products. Undoubtedly some regulation should be implemented. The e-cigarette industry should become more responsible and provide proof rather than just words about the quality and safety of their products. E-cigarette users deserve to make informed decisions based on evidence, and regulation will force companies to test their products. This can be achieved without having an adverse impact on the main characteristics that determine the success of e-cigarettes. It is easy, rational and cost-effective to implement rules to provide proof that pharma-grade ingredients are used in e-liquids. Additionally, targeted but limited testing on liquids and vapor should be requested, which will ensure that consumers make informed decisions about their choices. Standards in the production process, such as those released by American E-liquid Manufacturing Standards Association (AEMSA), are a major step forward in promoting sensible but substantial regulation which ensures product quality and safety.
Personally, we'd like to see the type of testing that we undertake being made mandatory. We have all imported e-liquid tested by SGS and then additional batch testing by a UK government approved lab to test for nicotine accuracy and impurities.
As far as I'm concerned, the only reason I'd want to see the FDA regulate regarding ingredients is because it will help shut up the anti-smoking zealots and their “we don't know what's in them” propaganda. And, let's face it, they're going to keep beating that dead horse because of one cartridge from China — the same country that seems to think putting toxic ingredients in milk and baby formula and pet foods is A-OK — and thanks, FDA, for that one.
It may be useful to look at the existing regulations – in the EU, but the US has similar provisions – to answer this question, since there is very good provision for consumer protection, particularly concerning the safety risks with both ecig hardware and eliquid. In the interests of brevity, ecig hardware must not contain any of the restricted hazardous substances identified in the RoHS Directive, i.e. no lead in the solder, etc. Perhaps more importantly, in terms of the functioning of electrical and/or electronic equipment, ecig hardware must be tested for electro-magnetic compatibility (part of CE) to ensure it does not interfere with the functioning of other equipment, and vice versa, and anything which plugs into the mains electricity must be tested under the Low Voltage Directive, to prevent house fires, electric shocks, etc. There is also, of course, a raft of regulations concerning battery safety, including requirements concerning battery disposal (along with waste electrical and electronic equipment (WEEE) requirements), so all in all, if the existing regulations are complied with, there need be no concerns regarding the safety of the ecig hardware. The main problem is that, at the moment, there is not enough compliance, and not enough enforcement – considerably exacerbated by the fact that policy-makers continue to describe ecigs in the media as ‘unregulated’. This is untrue, and a dangerous suggestion to ‘cowboy’ vendors who would like nothing more than to operate with no rules at all!
As for eliquid, again there is great regulation already in place: the various Directives and Acts require regular testing for contaminants and nicotine levels; there is a raft of requirements for appropriate packaging and labelling, to ensure that consumers are informed about the potential risks and how to avoid coming to harm; and any and all eliquid products containing nicotine – whether bottled or in prefilled carts – are required to be supplied in child-proof packaging.
What’s not to like, and what’s missing? Well, the only thing missing, as far as we can see, is a mandated restriction on sales to minors. ECITA has been asking for this for four years. We remain hopeful that this may come – one day!
It’s important to stress that protecting consumers includes creating access to e-cigarettes to smokers. Limiting access, that is, in any way making e-cigs less available than cigarettes, endangers consumers since it makes the purchase of the more dangerous product easier. Other than that applying current product safety standards should be sufficient. These do a good enough job of protecting consumers.
Pamdis, ECF user and vaper:
If they must be regulated, I think it should be regulated the same way as my TV dinner is, and not an inch more. […]
This of course would apply only to the e-liquids, as they are ingested. […] On second thought, it's not really ingested, so food regulations may be too stiff. How are fog machine liquids regulated? Cleaning product fumes, candle scents, perfumes?
I think there are some elements of vaping which will improve under legislation. For instance, juice makers should absolutely be using at least food grade components. I think that’s just common sense, and as long as the regulations are reasonable, they shouldn’t result in significant barriers to entry. I suspect that at some point, mods will likely require the same vetting as the surge protector on the computer I’m using.
What concerns me, however, is that “deeming regulations” that treat our products like tobacco are inherently burdensome. The testing, packaging, warnings, and increased liability exposure will kill many business while prevent others from getting started. Big Tobacco doesn’t have to worry about these issues. They have the money, resources and Washington DC contacts to control the debate. However, if vaping isn’t deemed to be tobacco, then Lorillard, RJ Reynolds and the others have to compete with us like any other vape business.
An electrical consumer product designed to deliver a material for inhalation by placement directly in front of the face will need to comply with multiple regulations. If a product is reported to fail in this usage mode, with a risk of injury to the user, it would be quickly removed from the market and the manufacturer or importer and the vendor would face court proceedings.
In the case of a leisure product designed to be inhaled, in significant quantity, over a timescale of decades, it is reasonable to expect that additional regulations should apply in order that consumers can be assured that products they are inhaling are of merchantable quality. This is mostly what the current debate is about in the UK / EU: sufficient protections already apply in the form of labeling, packaging, and electrical safety; what is under discussion, essentially, is how to ensure quality and purity in the refills for inhalation.
To recap, a complete consumer protection system appears to require:
Labeling regulations that dictate exactly how the product is labeled
Packaging regulations that dictate how a potentially-toxic product is packaged (child-proof caps, shrink-wrap cover, Braille marker for toxic products)
Electrical safety rules and compliant product markings
In some cases, specific manufacturing guidelines
Local inspectors who visit, check, inspect, test and analyze all consumer products everywhere for safety and compliance with statutes
If some of these factors are missing then perhaps it could be asked how those protections could be enabled, before other measures are taken.
Additional protections for e-liquid that perform the same task as the extra regulations for cosmetics or nutritional products seem a reasonable suggestion. In Europe, it would be impossible to envisage a situation where a product was inhaled in large quantities for decades without there being some form of additional oversight; no sensible consumer would argue against this.
The question is not, “E-cigs are orders of magnitude safer than tobacco cigarettes, why worry?”; it is, “How can we make sure incompetents and fraudsters do not supply our inhalation products?”
The situation in the USA is probably no different in that some form of oversight needs to be in place for the refills. The problem is how to make it as light-touch as possible.
I was the first person to call for trade associations to rapidly form and self-regulate. Some of the most successful product regulation schemes in existence are trade regulatory models – they have lasted without issue for centuries in some cases. Unfortunately the e-cigarette trade never wanted any form of regulation, and thought the good times would last forever. So, to a certain extent, we can thank the trade for the problems and restrictions that we inevitably face. They absolutely cannot complain about the situation, when it arrives.
People like Aaron Frazier, Lou Ritter, Linc Williams and Greg Connelly have had to do their job for them; a thankless task with zero reward and multiple brickbats instead of the huge debt of gratitude the trade owes them.
#2. Should the FDA limit the maximum amount of nicotine permissible per ml?
Dr. Konstantinos Farsalinos:
Nicotine should be limited because of the hazards of handling highly-concentrated nicotine solutions. However, since nicotine delivery has a major role in e-cigarettes’ acceptance and success as a substitute to smoking, the limit should be high enough to promote effective delivery to the consumer. In any case, it is extremely important that consumers are educated about proper handling of nicotine.
If you want to apply a reasonable set of safety regulations to the product, together with allowing maximum market development to take place, then a maximum strength of 75mg/ml (7.5%) for nicotine in solution has proved safe and effective in the UK for several decades. It allows people to mix as needed, though without huge savings; it ensures that nothing too toxic can be sold at retail.
The issue of high strength liquids for DIY mixing is a different one.
You'll always be able to get 200mg base on the black market. Unfortunately you won't know what's in it, though, because it will be outside the legal product sales system.
I do NOT think that there should be limitations on nicotine strength, for several reasons.
First, many vapers like to make their own juices because then they are much more in control of what goes into them and how they taste. In order to do this, higher-concentrated juice is needed, since it will get diluted by the addition of flavorings and PG or VG.
Second, one of the strongest advantages of e-cigarettes over something like the patch is that the e-cig user can control his nicotine dosage (much like with smoking cigarettes). The “continuous dosage” of the patch does NOT simulate nicotine intake in the same manner as cigarette smoking. Many vapers who used to be heavy smokers find that lower-strength nicotine does not work for them, particularly if their opportunities to vape (for example at work) are restricted to times when they could be smoking instead
[Nicotine content should be regulated] only if the amount exceeds an amount dangerous to humans. How much caffeine is allowed in energy drinks? Products should be properly labeled, then allow adults to make their own decisions.
Nick “GrimmGreen” Green:
All limiting nicotine will do is help vaping fail. Vaping worked for me because I could get 18mg juice in order to keep my cigarette cravings to a minimum. People can step down if they feel the need. We need to stress that this is not a “quit smoking aid' But rather a harm reduction process.
I believe that at least some of the key to their success is the option to be able to start on a higher nicotine strength and then gradually over time lower the nicotine level to that which suits the user, often resulting in people reaching a level where nicotine dependency is zero and vaping is no longer required.
#3. Should the FDA be looking to “Protect the Children” with the coming regulations? Would restrictions on flavors be justified?
Restricting flavors has little relevance to youth uptake, as 50-year-olds need the flavors but kids prefer harsh tobacco flavor as it makes them feel tough and cool. Flavors have no relevance to health because that implies you want to restrict PV sales; instead, for best impact on public health, obviously you want to sell as many e-cigs as possible. Arguing about flavors is inverse logic: the reverse of the real situation; it only applies if you want to remove e-cigs from the market. Regulating the flavors is a good way to cripple e-cigs, if that is what is intended – otherwise leave well alone.
Limiting flavors will do nothing to curb the appeal to youth. Youth are attracted to the gadget nature of the product plus the fact that they can use it without the harm and smell.
Clearly, the FDA and all the other policy-makers looking at e-cigs at the moment must consider the protection of children and young people as a high priority. However, to do so at the expense of the millions of adult smokers, who will die if they get this wrong, would be counter-intuitive at best, and murderous at worst. The flavorings in e-cigs are the key to their appeal to the adult smoking population, and crucially important in helping those adult smokers stay switched; once one has moved away from the tobacco flavor of smoldering compost heap, onto something fruity, sweet or savory, it is very difficult to return to smoking. So a balance must be struck. This is why at ECITA, we have been calling for a mandated age restriction for over four years now: these are adult products for adult smokers, and very definitely not for children.
The research we have seen in the UK is that e-cigarettes do not appeal to non-smoking children – the very, very small minority of children here who use e-cigarettes are those who were already using tobacco cigarettes. Adults also enjoy flavors, and when they use a non-tobacco flavor they move further away from smoking tobacco cigarettes. So even before we start to take into account freedom of choice, flavors are important.
Shopan, vaper and ECF user:
As for flavors, DO NOT TOUCH THEM!! That is half the reason I have fallen in love with vaping and there is NO argument that can stand on its own that there is a reason to limit the amazing variety that is possible.
As far as I am concerned, once you establish a no minors restriction, then any other restrictions based on appeal to children is absurd. If they cannot legally obtain it then whether they like it or not is irrelevant. Kids might like candy colored cars but because they cannot legally drive them it is not a sufficient reason to ban adults who like bright colors from purchasing neon orange autos. It borders on the criminal to remove an element that might be the deciding factor in someone switching from smoking on the basis of the possible preferences of someone who is barred from using the product.
The issue of kids getting hold of vaping products is an enforcement issue, not a legislative one. Cops, ABC, etc. will keep vaping away from kids. In Pierce County, where I live, we cannot sell vaping supplies to anyone under 18 years of age.
I think most people understand that we don’t want kids to drink, but they do. We don’t want them experimenting with drugs but they do. FDA is simply tasked with ensuring that a product is safe for consumption (including tobacco), and that it performs as advertised. Still, I think FDA will create age restrictions.
As for flavors, there is a lot of concern in the anti-vaping community that kids like sweet flavors, vaping flavors are sweet, therefore, kids will vape. It’s also true that adults want products that taste good. It’s much easier for an adult smoker to transition to juice that tastes good. In fact, that’s one of the benefits of vaping: great flavors. Nobody started smoking because tobacco tasted good. Nobody’s gonna quit if there isn’t something all the way around better. Vaping is cheaper, doesn’t produce ash, doesn’t smell bad, doesn’t have all the bad stuff in tobacco, and has great flavors. Eliminating flavor choices probably just creates a flavored juice grey-market, or lures fewer people from smoking, or both.
Gayhalo, Vaper and ECF user:
I do not think an age ban is productive. If children started by vaping INSTEAD of smoking it's a winner. There is no evidence of vaping being a gateway to smoking; in fact the latest survey says it is not. Some children may vape that would not have smoked but it will not kill them and may not even make them dependant on nicotine.
Dr. Konstantinos Farsalinos:
Currently there is no problem with e-cigarette use in youngsters. Additionally, there is no evidence that e-cigarette is a gateway to smoking. Regulation should implement age restrictions. Concerning flavors, there is a big myth that flavors are promoted to attract youngsters. Data from a survey of 4,500 e-cigarette users we recently performed showed that flavors are a major reason for e-cigarettes’ success in substituting smoking.
I have no problem with preventing minors from obtaining e-cigarettes. As far as flavors go, limiting flavors would make no difference whatsoever. If an ex-smoker wishes to take up vaping what difference does it make? Vaping is basically harmless and I don’t believe anyone would be silly enough to move back to tobacco cigarettes once they start vaping.
Nick “GrimmGreen” Green:
My least favorite argument out of all of them. “SAVE THE CHILDREN!” It's ridiculous to limit e-liquid flavors; while we still have gummy worm and birthday cake flavored vodka on the market.
The vast amount of flavors available give people a wide range of options to choose from which is a key in helping to find something that suits the individual personally and ultimately aid them in switching away from harmful tobacco.
If restrictions are allowed that limit the nicotine strength and range of flavors available, I believe it will have a very negative affect and the success of the electronic cigarette will be thwarted. Of course it is vitally important to restrict sales to minors as I'm sure no one would want a child to start using vaping products, but I do not believe that restricting flavors will aid that whatsoever especially when there is already a vast array of flavored alcohol freely available which surely must fall under the same scrutiny!
Responsible selling, responsible information and responsible policing is more likely to be the correct way of ensuring vaping products remain out of the reach of minors.
#4. Should e-cigs be subject to tobacco-like advertising restrictions?
Some form of marketing regulations are inevitable, whether we want them or not. It remains to be seen exactly how such regulations could be framed. For example, it is inevitable that young, pretty, popular celebs are used – because that is the basis for all marketing: you can't sell anything if you picture it used by real-world consumers. The buying public are old, ugly, and unknown: the opposite of a successful formula. That's why there are no mirrors in casinos.
So, normal and everyday marketing will be called ‘marketing to children' by opponents, even though it is how everything is sold.
As regards the major issue of ‘unintended consequences' – ex-smokers starting up again and so on – we already have a market model to look at. Smoking is dying out in Sweden: by 2016 male smoking prevalence will be 5% and it falls by 1% per year. So, apparently, it doesn't matter about the details: if you offer a good, unrestricted alternative, people give up smoking, and the national health statistics exactly reflect the number of smokers; other tobacco or nicotine users are invisible in terms of public health impact.
It depends what you want: maximum drive to switch away from smoking, which in turn eliminates smoking disease and death; or some kind of perfect fantasy world where you can ignore the fact that smoking prevalence has been about the same for 5 years and will stay that way. Sweden won't have a smoking problem, very soon; is that what you want or not? It seems to me that any other solution is simply protecting tax revenues together with cigarette and pharmaceutical sales. If that's what the country wants, fine – but don't call it ‘public health', because restricting THR products is absolutely the worst possible thing for public health.
THR products need maximum promotion with maximum drive. Forget the unintended consequences, the Swedish data tells us smoking disappears; and either you want that or you don't.
Dr. Konstantinos Farsalinos:
Obviously there is no reason to apply the same regulations as in tobacco concerning advertising. However, we must make sure that e-cigarettes are not marketed as a new habit for the general population. Any kind of marketing or advertising should focus on the use of e-cigarettes by smokers only, as a smoking substitute.
The advertising and marketing practices of the electronic cigarette industry need robust regulation, and we are delighted that the UK’s Advertising Standards Agency is currently working on guidelines specifically for this sector, but Tobacco Regulations, including advertising restrictions, should be for Tobacco products – with their specific, known harms. As an industry body specifically concerned with standards, we suggested some further restrictions to the ASA, and trust that there will be a robust standard forthcoming which specifically restricts marketing to children, and does not glamorize an activity which still looks like smoking. That said, it is vitally important that this industry can market its products to smokers, since smokers must have access to the truth about their options, and must know that these products are available to them. After decades of pitiful success rates with NRT products (less than 5% success, over the longer term, according to the academic literature), smokers need to see vaping for what it is: a gateway out of smoking.
I believe there does need to be regulation on where they can be advertised to avoid unscrupulous advertising directed at anyone under the legal smoking age.
It seems logical that if electronic cigarettes are vastly safer than tobacco cigarettes, sellers should be allowed every avenue to promote the safer alternative. That said, we are not great believers in advertising – e-cigarettes are spreading fine by word of mouth, and if advertising is allowed it will essentially see sellers competing with their advertising budgets to win greater market share – perhaps it will ultimately be better for the industry if that money goes into improving product quality. Perhaps it’s also a case in point that tobacco industry profits have not been harmed by bans on advertising!
I cannot see the need for advertising restrictions when the product is as safe as it is. The rare never having used or planning to use individual is not incurring enough risk to worry about and paramount above all is making sure that all smokers realize this safer alternative exists and there is no better way of getting the word out than advertising. And in regards to smokers who have already quit, the risk level is low enough that it is no tragedy if they take up vaping and it may in fact preempt them from returning to cigarettes.
#5. Should e-cigs be deemed “Tobacco Products” for regulatory purposes?
Dr. Konstantinos Farsalinos:
It seems paradoxical that a product which does not contain tobacco is classified as a tobacco product. Perhaps this is the only way from a legislative perspective, however I believe the category of tobacco harm reduction products should be regulated separately, in a way that promotes their use instead of combustible tobacco products.
Electronic cigarettes are not medicinal products, but they are also not tobacco products. They are consumer products, and a lifestyle choice for an increasing number of adults around the world. The tobacco product regulations have developed over the years with a very clear spirit and intent: to minimise and mitigate the risks from smoking. Tobacco products cause a unique problem for regulators: they remain legally available even though it is generally accepted knowledge that smoking kills half of its users. This means that policy-makers can make particularly free with very restrictive regulation, without much opposition. The same cannot possibly be said for ecigs, which demonstrably massively reduce the harms caused by smoking and are very much part of the solution, and not a new ‘trick’ as part of the problem.
The vaping revolution is now simply too big to be crushed out of existence, but over-burdensome legislation would force it into a grey/black market, with NO standards for consumer protection, NO standards for safety of the products, and NO controls over who uses them. Concomitantly, it would inevitably lead to fewer smokers making the switch, with half of those dying as a consequence.
Regulatory policy-makers need to be very, very careful how they approach this, so that they do not make costly mistakes – both in monetary terms, and in lives lost.
[The] FDA now seeks to give itself authority by finding that vaping is the same as tobacco. If they make that finding, then vaping supplies will be subject to the same taxes, insurance risk analysis, government oversight, and advertising restrictions as Big Tobacco. Big Tobacco really wants this because it makes life much more expensive and complicated for any business that wants to get into vaping.
Big Tobacco is feeling pretty good about life, because they have been working with our legislators for the last ten years, and they have a lot of money to throw around. If FDA and Big Tobacco deem vaping to be tobacco, the overwhelming majority of small businesses will go away. The ones that can afford lawyers to navigate the new laws will see their prices undercut by Big Tobacco. Vaping businesses will go the way of the corner store after a Walmart pops up across the street.
#6. Is there a trade-off between protecting consumers and allowing new business to thrive?
Absolutely not! The regulation of e-cigs offers a unique opportunity to policy-makers to END the tobacco problem once and for all! The difficulty, if they get these crucial decisions wrong, is that they wipe out the independent businesses and hand it all over to Big Tobacco and Big Pharma (if the latter can even be bothered to get involved) and virtually wipe out all the products that actually work for people. Having a thriving independent industry, made up of mostly SMEs, encourages competition, drives innovation, and ensures that consumers are kept at the very heart of the whole process – rather than having it controlled by huge, faceless conglomerates.
How we end up regulating vaping is a trade-off between a perfect tobacco-free world, and the one we actually live in. Many people look at both smokers and vapers and think “those people should just quit.” The fact of the matter is that many, many people will not quit smoking. They don’t want to quit. You, the government, their loved ones, etc. are not going to make them quit. To then the question becomes, is there an alternative, with fewer chemicals, carcinogens, etc. that these non-quitters can switch to? Of course, the answer is Vaping.
The icing on this particular cake is that brick and mortar vaping stores are sprouting up everywhere. They are employing people with fair wages, paying taxes, and providing a better alternative to smoking cigarettes.
It’s ironic that so many people in government want condoms and syringes handed out as harm reduction tools, but they see vaping and think, “oh, we can’t encourage nicotine use” with e-cigarettes. It’s absurd, but that’s kind of government.
While I feel that any government regulation is going to create barriers to starting and running a profitable vaping business, I also recognize that we are going to be regulated whether we like it or not, so we had better start getting involved now. Reasonable regulations will ensure that business are selling safe products, which may encourage skeptical smokers to give up the analog habit and try vaping.
I think regulation that improves the safety and quality of e-cigarettes without raising the barriers to entry too high would be good. The problem is the balance. Too little regulation and you’ll have the cowboys entering the industry looking to make a quick buck without due attention to the safety and the quality of the product they are offering. Too much regulation and you will block innovation, strangle the smaller companies and prepare the field for the large tobacco companies to dominate the market with lookalike cigarettes which will not provide a satisfactory alternative to cigarette for many vapers, especially those who have grown used to more advanced devices.
I fear that the tobacco companies will push for a stringent regulatory regime which they can afford to comply with but smaller companies can’t. This won’t destroy the industry as such, but it will change it to one dominated by large tobacco companies producing cigarette lookalikes, while smaller innovative companies will be forced out of the market.
There is no conflict when regulations are framed by uninterested independents, and enforced by the normal processes that enforce other consumer product statutes. No one in the UK has ever suggested that electrical safety regulations are anti-trade or anti-consumer, or that the additional cosmetic regulations excluding some materials from use are unduly restrictive; people are generally quite happy they didn't get electrocuted or their face melted. The problem comes when opponents frame the laws, not when they are independently and justly framed and enforced.
The problem with any set of regulations, though, is who sets them up and who operates them. It's not much use if those are the people who want to see the product heavily and unjustly restricted or even removed from the market. It's why I am so deeply annoyed with the e-cig trade, since for several years they had the opportunity to set up a regulatory system and then say: “We already did what was necessary – job done”.
#7. In the worst case scenario of an effective ban, do you think the move would impact on smokers looking to make the switch more so than experienced vapers?
Nick “GrimmGreen” Green:
I think history has proven that prohibition does not work. I don't think that vaping will become some sort of mobster driven underground world, but I do think that people will continue to find a way to vape, and without having good clean labs and access to pharma grade PG and VG it will just make our liquid more dangerous. Honestly though. How is the FDA going to ban a battery? or a tube? I don't believe that the FDA wants to ban vaping, but they do want to make it as unappealing and difficult as possible.
Kaerie Peterson, via We Are CASAA Facebook:
It would be impossible for them to effectively regulate the devices. The hardware is pretty easy to come by and could be fairly simply assembled by most people who have been around vaping for any length of time.
I mean, look at how well they've regulated the production of meth, and putting together an e-cig is unlikely to kill you and your family.
So, they could try, but I think they would be foolish in the extreme to even attempt it.
Dr. Konstantinos Farsalinos:
Potential consumers (smokers) represent a much larger population compared to current users. Regulation should be oriented towards making e-cigarettes more accessible and appealing to smokers. “Strangulating” them by applying strict rules gives unwanted advantages to tobacco cigarettes, which are already very easy to access and to use.
All regulation of any kind will first hit new customers. That's the way it is. Therefore, by definition, regulation cuts the number of people switching away from smoking. A realist would say that is what it is designed to do.
The FDA's agenda is, first and foremost, to protect the pharmaceutical industry. If you need to know what they will do, then just ask: “What will benefit pharma most? What is the most they can get away with, without facing legal challenge?” Then, you'll know what the FDA will do – simple as that.
The key word is experienced vapers – so yes. It would stop inexperienced vapers from finding the solution that suits them best. You’d also see an increase in illegal e-liquid sold on the black market, with a corresponding decrease in safety.
Once criminal gangs get in on the act, I’d think you see deaths from e-liquid which hasn’t been properly tested.
This is one of the biggest concerns, yes. All those millions of current vapers are fine! We all know how to get hold of the products we want to use, and will continue to be able to source them. However, generations of smokers to come will not have the same opportunity that we have had – and that would be a travesty of justice and a human tragedy on an enormous scale.
Canada is an interesting case because many smokers are interested in e-cigarettes but do not seek them out because they believe them to be illegal and unobtainable in this country. Neither case is true but the impression is enough to keep people smoking. Those that do seek out e-cigarettes tend to use cross border or black market sources and with the former often have shipments confiscated at the border. The annoyance is enough that many of those who would have switched don’t.
Harsh regulations would slow the conversion to the less harmful product while supporting if not boosting tobacco sales. Not as many will home brew liquids and would simply go the easy route back to cigarettes.
There must be just cause for restrictions and laws. Simply restricting because of ideology or morality is not a sufficient reason
#8. A frequently heard refrain is that e-cigs “haven’t been proven to be safe” yet – do you think restrictions should be imposed based on insufficient evidence of safety, or should rules only be instituted when there is sufficient evidence of harm?
Dr. Konstantinos Farsalinos:
There is no reason to prove that e-cigarettes are absolutely safe. In that case, it would be proposed as a new healthy habit for everyone to adopt. Although we still have a lot to learn about e-cigarettes, no-one can deny the fact that all studies have shown that it is by far less harmful compared to tobacco cigarettes. Based on current evidence, we can use common sense to draw the conclusion that, even after long-term use, any adverse effects would be substantially milder compared to long-term smoking. Of course, this does not mean that we should not research for the best quality and least harmful products, as long as product variability and evolution are maintained.
What we don’t know is the long term effects of inhaling vapour over decades, but we have studies into short term health benefits, studies into the effect on the heart, studies into the effects on respiratory function and many more. All these studies have shown that e-cigarettes are vastly better than tobacco cigarettes. In addition, scientific opinion – which hasn’t been influenced by pharma grants – is that e-cigarettes ARE vastly safer than tobacco cigarettes, a fact which the UK government agrees with.
This speaks directly to the ‘Battle of the Principles’, if you will: on the one hand, you have the Precautionary Principle, which dictates that nothing should be allowed until you know all the risks and can resolve them; on the other, you have the Principle of Proportionality, which suggests that rules should be proportionate to the potential for risks, measured against the potential for benefits. Much is made of the fact that this is a ‘new’ technology, so we don’t know anything yet, but as the years go by, this becomes less and less true. The electronic cigarette industry has been dynamically growing across the world for 7 years now, with a frankly astonishing lack or harm being caused – even in the global climate of regulatory uncertainty. Furthermore, we most definitely do know what is in them, and that they are orders of magnitude safer than smoking, and that they pose a negligible risk in and of themselves, so in my view, we have more than enough information to err on the side of proportionality rather than precaution. Another significant factor in this debate ought to be the fact that every day that passes without vaping being recognized for what it is, is another day when more smokers will die prematurely from smoking-related diseases who might have been saved if they had been told the truth about their options. Enough with the ‘quit or die’ mantra: there is a better way – SWITCH!
#9. How could the FDA best protect public health through the coming e-cig regulation?
Enforce trade association membership on all vendors, importers and manufacturers.
Allow traders to set up their own suitable trade associations. Compile a list of approved associations.
Require trade associations to implement best-practice rules for their members.
Allow trade associations to eject those who do not comply.
Make sales by non-members of a trade association illegal.
Since that is not going to happen now as it is too late, then:
Apply normal consumer product regulations to e-cigarette products.
In addition, set up a similar scheme to that which oversees cosmetics or nutrition consumer products.
Establish an oversight system that regulates e-liquid quality by setting a minimum purity level* and preventing certain materials being deliberately used**.Nothing else is needed.* Actually, this is already in place in some respects, since a max inclusion of 2% DEG is allowed in US consumer products; however this could be framed better, and probably more tightly. A DEG level no higher than 0.25% is acceptable in e-liquid. We have reason to believe that this would not be measurable in the vapor.** Such as diacetyl.
Create a framework of regulation which ensures quality and safety while allowing room for smaller companies to continue to innovate. I don’t think that’s likely to happen, though!
The FDA would best protect public health by acknowledging that ecigs are neither medicinal nor tobacco products, but consumer products, and regulating them appropriately. There is no reason why the existing US regulations for, for example oven cleaner, or household bleach – products which contain potentially dangerous chemicals, but which are commonly used in households across the developed world (and notably, NOT by children) – should not be applied to ecigs too. If the FDA were to commission a State-wide education program about the products, that would be a real victory for public health, because then US smokers could be informed properly about their options, and many more could be saved from a horrible, drawn out premature death.
Electronic cigarette regulation presents some unique challenges, and it’s clear that the likely approach of using tobacco regulations for e-cigarettes is like trying to force a square block through a triangular hole. If the FDA takes into account their relative safety, tobacco regulations are cripplingly excessive and could impact on the wide variability of e-liquids and devices available today. It might not be as easy for them, but the only way to fairly regulate e-cigarettes is to create a unique regulatory category; one that takes into account the massively reduced harm, primarily focusing on establishing reasonable manufacturing standards, but nothing so stringent as to kill off the small, independent businesses which make vaping what it is today. If there was a consensus viewpoint from the vapers, advocates, researchers and bloggers we contacted, that would be it. Whether you believe the FDA will take this route is another matter, but anything else is undeniably excessive.
We’d like to wholeheartedly thank everybody who shared their insight, opinions and knowledge with us and helped us get this collection together! Additionally, if you want to send in your responses to any of the questions, feel free to share your thoughts in the comments section or send us an email, and if you don’t want to write anything, you can also respond the poll below!