Now is not the time to tax e-cigarette liquid

We know that there is a vast differential in risk depending on how nicotine is consumed

Employees check electronic cigarettes at a production line in a factory in Shenzhen, southern Chinese province of Guangdong. Photograph: Tyrone Siu/Reuters

e Government has been urged to add a tax to the liquid used in e-cigarettes (vapour) products. But it is a recommendation that, in the interest of both health and economics, should not be implemented.

Though it should go without saying, it is still worth reiterating that smoking is an extraordinarily huge and unnecessary cause of death and disease. Cigarettes claim the lives of roughly half of long-term users. Policy measures to reduce smoking continue to be one of the most effective, and cost effective, measures we have to improve global health. And to date no other intervention has had nearly the impact of cigarette tax increases, which result in fewer smokers consuming fewer cigarettes.

But no policy intervention is without unintended consequences and, as important as tax policy has been in reducing smoking rates, there are issues worth addressing. An obvious one is that since obtaining nicotine through inhalation of smoke is so addictive, taxes sometimes create incentives for those unable to quit to turn to contraband product.

They can also place already- disadvantaged people who cannot forgo nicotine at an ever greater overall economic disadvantage which further impacts their health.

Recognising, as did General George Patton, that “there is no such thing as an obstacle, only a new opportunity”, both health knowledge and economic policy can help us overcome these unintended consequences. In fact, they can help us achieve much greater public health gains in the process.

Severe consequences

From the standpoint of health, we know that there is a vast differential in risk depending on how nicotine is consumed. Simply put, people smoke cigarettes for the nicotine but die from smoke. Our bodies are not designed to inhale it without severe consequences. If we could simply move smokers to far less hazardous but consumer acceptable non-combustion alternatives we would see an enormous improvement in health.

Until recently the cigarette trade has had a virtual “nicotine maintenance monopoly” – anyone who wanted nicotine on an ongoing basis had little choice but cigarettes. But that changed with the introduction of disruptive technology that allows nicotine to be delivered in a vapour rather than via smoke. How much less hazardous are e-cigarettes?


According to a comprehensive look at the evidence by the UK’s Royal College of Physicians: it is not possible to precisely quantify the long- term risks, but the available data suggests they are unlikely to exceed 5 per cent of those associated with smoked tobacco products, and may well be substantially lower.

So, the potential gains from vaping are tremendous. But how might we get smokers to switch? This is where economics comes in. People respond to price signals; not just absolute price, but relative prices. Tax policies that ensure cigarettes are at a marketplace disadvantage compared to vaping facilitate more switching.

The advent of products like e-cigarettes means smokers are finally being offered a viable alternative to total abstinence, or indeed are given a more viable route to becoming nicotine free. To date, though simply increasing taxes reduces total smoking, the overwhelming majority of those motivated to try to quit are unsuccessful. That is because the cessation of cigarettes has also meant abstinence from the nicotine to which they have a dependence. Alternative nicotine products help solve this by giving many smokers an acceptable way to de-link the nicotine and inhalation of the toxic smoke.

So, we should say yes to health-focused cigarette taxation. But yes, too, to giving smokers a viable alternative. Then, maybe, when vaping products have replaced cigarettes there will be a basis for taxing them. Especially if even less hazardous products are then competing.

David Sweanor is with the faculty of law and the centre for health law, policy and ethics at the University of Ottawa. He co-authored a commentary in theNew England Journal of Medicine in 2015 entitled Differential Taxes for Differential Risks – Toward Reduced Harm from Nicotine-Yielding Products. He has worked on tobacco tax policies since the 1980s.


Roswell Park study finds e-cigarettes ‘safer, less toxic’

Inhaling vapor from electronic cigarettes is safer than smoking traditional tobacco cigarettes, according to a new research study out of Roswell Park Cancer Institute.

It’s one of the first studies to confirm that switching to e-cigarettes can reduce the risk of cancer for smokers, and researchers say it will bolster efforts at the local and national level to help smokers quit the habit.

That’s according to Maciej Goniewicz, lead author of the study and assistant professor of oncology in Roswell Park’s department of health behavior, whose work will be published in the journal Nicotine Tobacco Research.

While nicotine exposure remains the same, individuals who switch from tobacco cigarettes to e-cigarettes saw the levels of specific carcinogens and toxins reduced significantly. The study also found that switching did not cause study participants to crave higher levels of nicotine.

“They are safer, less toxic,” he said. “It’s the first time we have very strong evidence that we will be able now to give (smokers) that the answer is, yes , this you should consider a transition, a substitute for your tobacco cigarette that will save your life.”

Researchers focused on transitioning existing smokers to e-cigarettes, recruiting 20 individuals who reported smoking an average of 16 cigarettes per day and who had previously tried, unsuccessfully, to quit using different medicines and smoking cessation methods.

“We focused on this transition because we thought and still think this is the potential transition that can have a huge impact on public health,” Goniewicz said.

The study is believed to be the first on smokers to demonstrate that substituting e-cigarettes for tobacco cigarettes may reduce exposure to toxins and carcinogens that can cause cancer. That’s an important finding for a cancer institute that focuses on reducing exposure and causes of cancer, he said. Roswell Park also holds the contract to run New York’s statewide smoker’s quitline.

“Toxins and carcinogens we measure in the body almost disappeared – the body cleared the 17 different chemicals we were looking for,” Goniewicz said.


The Latest In The Never-Ending Assaults On Our Freedoms. One Of These Is Lethal

TYRANNY IS about control. Even in democracies the natural tendency of government, unless stopped, is to expand its powers and extend its tentacles into every facet of its citizens’ lives–always in the name of helping them. Control means curtailing people’s opportunities to make choices and restricting the scope of their freedom of action. Left to their own devices bureaucracies would bar you from doing anything without first receiving a permission slip from them. Our Founders understood that it’s the steady accumulation of petty, tyrannical restrictions that leads to the ultimate loss of freedom.

An example of tyranny by small steps is the FDA’s recent decree concerning small manufacturers of premium cigars and the makers of e-cigarette devices. Several years ago Congress gave the FDA extensive powers to regulate the tobacco industry, ostensibly to fight teenage cigarette smoking.

The FDA’s massive list of rules was released in May and took effect in August. All the chatter about protecting health to the contrary, the net effect will benefit large companies by crushing their smaller competitors under the weight of complying with expensive new rules. Most egregiously, the regs will harm public health by crippling the most effective alternative to traditional cigarettes: tobacco-free “vapers,” or e-cigarettes.

–E-cigarettes. Vapers have been a godsend to millions of smokers who had previously had no success in quitting. Essentially, e-cigarettes allow users to inhale nicotine–the ingredient that gives a smoker pleasure–but without the carcinogens that make traditional cigarettes so deadly. In the same manner they keep millions of young people who would normally take up cigarette smoking from doing so. There’s no credible evidence whatsoever that vapers are a gateway to cigarettes. If anything, they’re a prophylactic. Yet the FDA has hit this lifesaving industry in the solar plexus.

All devices made after Feb. 15, 2007 are now subject to FDA approval, an enormously expensive and time-consuming process. Given the agency’s bias, makers may still not get approval. Meanwhile, for those who want to quit smoking–well, too bad.

Why that 2007 date? It’s arbitrary. It’s when Congress took up legislation to give the FDA new powers over the tobacco industry.

Vaping is a fairly new technology. The few products available in early 2007 were vastly inferior in convenience and safety compared with those available today. Competition has given consumers better and better offerings.

Perversely, the FDA will, in effect, be junking today’s good stuff in favor of the relatively low-quality products made nearly a decade ago.

–Premium cigars. Each year a number of artisan cigar manufacturers bring out a variety of new-blend stogies. They are usually handmade or made from vintage machines that date back to the 1930s. Such cigars aren’t cheap–each costs $10 or more. These manufacturers are the cigar equivalent to microbrewers, who have so enriched the quality–not to mention the fantastic array of choices–of today’s beers.

The FDA’s new regs will put most of these cigar companies out of business by subjecting each new blend to a costly, complicated approval process that involves some 5,000 hours of testing and could take years to complete. Makers must prove that each new cigar is “substantially equivalent to” (whatever that means) the blends sold before.

Traditional beermakers must be dreaming up ways to get the FDA to level similar regulations on those pesky microbrewers.


Vaping Opponents Continue to Just Make Up the “Facts”

In apparent desperation because the actual facts do not support their vigorous opposition to vaping, anti-vaping advocates continue to simply make up the “facts” as they go along.

Just last week, a professor at Eastern Tennessee State University was quoted in an article in the Johnson City Press as stating that the increase in youth e-cigarette use means that vaping is bringing in new smokers.

According to the article: “Dr. Hadii Mamudu, an East Tennessee State University assistant professor in the school’s College of Public Health, is a world-wide recognized expert on this topic. One of his biggest evidence-based concerns, which have been somewhat addressed in the new regulations, pertain to the unsettling trend that more youth are taking to e-cigarette use, whereas they might not have come into tobacco use otherwise. “A North Carolina survey suggests that youth use rates increased from 1.1 percent to about 8 percent between just 2011 and 2013,” Mamudu said. “It’s very, very quick. And that’s troubling that it’s bringing in new smokers.” … It’s partly generational, Mamudu said, and it’s frustrating that when tobacco experts were making progress against tobacco use in recent decades, e-cigarettes came along to cut into their gains.”

The Rest of the Story

I am aware of no evidence that vaping is bringing in new smokers. What it is doing is bringing in new vapers. But there is no evidence that vaping is easing the transition to becoming a smoker. If anything, the evidence suggests the opposite. While e-cigarette use skyrockets, youth smoking has plummeted to its lowest historical level.

It is not even conceptually reasonable to suggest that e-cigarette use brings in new smokers. The e-cigarettes that youth are using are heavily flavored products and after getting used to the sweet and tasty flavorings, it is difficult to imagine that a youth would then find a Marlboro attractive. The truth is that youth who really do take up vaping are likely going to find it much more difficult to transition to smoking.

But the lack of evidence – either empirical or conceptual – is not stopping vaping opponents from simply making up the facts as they go along. Apparently, the truth is not enough to support their vigorous opposition to vaping. When the truth is not on your side, your only resort is to manufacture, make up, or distort the facts to support your position.

There is another possibility as well. It is possible that when he says that e-cigarettes are bringing in new smokers, the professor means that vapers are smokers – in other words, that vaping is a form of smoking. But that is obviously false, as vaping involves no combustion, produces no smoke, and does not even involve the use of tobacco.

Either way, anti-vaping advocates continue to intentionally mislead and deceive the public. It is unfortunate that vapers cannot trust tobacco control and health groups to provide accurate information. They can’t even trust national health agencies like the CDC and FDA. The only place they can turn for accurate information is to the vaping community itself.


New Study Of E-Cigarette Users Finds Implementation Of FDA Deeming Rule Could Create A Black Market For Vaping Products And Drive Users Back To Tobacco

A new study released today by the UK-based Center for Substance Use Research (CSUR) has identified the potential for serious adverse health effects to arise from recently implemented regulations governing e-cigarettes. These include the very high likelihood that current e-cigarette users will continue to use vapor products by circumventing regulations in a number of ways or, if they are unable to legally purchase e-cigarettes and vapor products, will increase their consumption of conventional tobacco cigarettes.

The FDA Deeming Rule imposes much tighter regulations on the manufacture and sale of e-cigarettes and e-liquids with the likely result that the vast majority of e-cigarettes and e-liquids being sold within the US today will cease to be legally available. All devices developed after the February 15, 2007 predicate date will be required to undergo lengthy and costly assessment before receiving the necessary approval for their continued availability.

In this study, 9,040 US-based current users of electronic cigarettes (8,451 current e-cigarette users who were former smokers, 282 current e-cigarette users who were also current smokers, and 307 current e-cigarette users who had never smoked) were asked what they would do if, as a consequence of the Deeming Rule, the e-cigarette products they use right now were taken off the market. Approximately 75 percent of those questioned said that in advance of the rules being implemented, they would stock up on their preferred e-cigarettes; nearly 70 percent said that they would buy their e-cigarettes and e-liquid from a non-licensed vendor (i.e. the creation of an unregulated “black market”); 66 percent said they would import e-cigarette products from overseas; and 65 percent said that they would make and mix their own e-liquid on their own premises. In stark contrast to these high percentages, less than 20 percent of e-cigarette users said they would switch to a FDA approved e-cigarette in the event that their current preferred product was no longer available.

Worryingly, 15 percent of the former smokers questioned said that they would likely go back to smoking tobacco cigarettes if the e-cigarettes they are currently using were no longer being sold. In addition, 33 percent of current smokers said they would likely smoke more tobacco, and 10 percent of non-smokers who currently use e-cigarettes said they would be more likely to start smoking, if they find themselves in a situation where they cannot buy their preferred e-cigarette products.

Dr. Christopher Russell from the Centre for Substance Use Research who led the research, commented that, “This research shows there is an enormous gulf between the expressed intentions of the FDA and what many e-cigarette users see as being the likely impact of the regulations. The regulators’ aims of improving the quality standards in e-cigarette production, improving the accuracy of labeling, ensuring the safety of e-cigarettes, and to reducing young people’s access to e-cigarettes are all laudable aims in themselves. However, if in the wake of these regulations, significant numbers of e-cigarette users turn to the black-market to source their preferred products, then the positive impact of the regulations will have been diminished and significant harm could be caused to those users. It is vitally important that FDA and policy makers recognise the harms that would potentially be caused if, after August 8th 2018, the majority of current e-cigarette users sampled, who may represent many millions more, act on their expressed intentions to pursue ways to continue to using e-cigarette products that are taken off the licit market by the FDA’s Deeming Rule.”

“There is a clear need for the FDA to monitor the impact of these rules to identify whether these adverse effects are occurring and, if they are, to consider reconfiguring the regulations,” Dr. Russell continued. “Clearly it is not in anybody’s interests to drive the population of current e-cigarette users towards the black-market. One way of avoiding these adverse unintended consequences would be for the FDA to allow current e-cigarettes and e-liquids to continue to be the subject of a lighter form of regulatory assessment whilst imposing much stricter regulatory controls on any future products being developed by the industry.”

There are currently an estimated 8.34 million e-cigarette users in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). The CSUR’s survey contained 12 questions that assessed participant demographics, actions intended to be taken when the FDA Deeming Rule comes into effect, and perceptions of the likely impact of the Deeming Rule on various stakeholders, among other questions. Of the survey respondents, the majority (91.6 percent) were current e-cigarette users and former smokers, with 3.1 percent current e-cigarette users and current smokers (dual users), 3.3 percent current e-cigarette users and never smokers. The remaining two percent of respondents either identified themselves as “something else” or did not answer the question. Survey respondents represented all 50 states and four of six territories.

Additional key findings:

  • 72 percent of respondents indicated they would bulk-buy in large quantities before the Rule takes effect, raising serious concerns about product degradation and consumer safety.
  • 69 percent of respondents indicated they would buy products on the black market from local non-authorized vendors.
  • 65 percent of respondents indicated they would make their own e-liquids at home.
  • 66 percent of respondents indicated they would purchase devices, products, and liquids from online vendors not subject to domestic regulations, tax regimes, or electronic product standards.
  • Only 6 percent of current e-cigarette users who described themselves as former smokers (no cigarette smoking, not even a puff, within the past 30 days) indicated an intention to stop using e-cigarettes after the regulations come into effect, and even fewer (1 percent) indicated an intention to stop using e-cigarettes before the regulations come into effect.
  • There was little indication that respondents intend to replace e-cigarettes with other nicotine products post-regulations; 3 percent said they would start using snus/smokeless tobacco, and 12 percent said they would start using or use one or more Nicotine Replacement Therapy (NRT) products, like patches, gum, or lozenges.
  • 15 percent of former smokers said they would likely go back to smoking tobacco once they are no longer able to legally buy the e-cigarette products they currently use.
  • 69 percent of respondents who were former smokers, 57 percent of dual users, and 64 percent of never smokers who currently use e-cigarettes indicated they would continue to use e-cigarettes by buying products and supplies on an unregulated black market.


Nicotine vaping should be legal

This month, the New Zealand government agreed in principle to allowing the sale of nicotine e-cigarettes as a consumer product. Evidence for the safety and effectiveness of nicotine e-cigarettes for helping smokers quit is now compelling and Australia should make similar changes.

New Zealand authorities are satisfied that nicotine e-cigarettes can help smokers quit and can substantially reduce smoking-related disease. Similarly, in Britain, the prestigious UK Royal College of Physicians recently recommended that they be promoted as widely as possible as a substitute for smoking in the interests of public health.

Colin Mendelsohn: E-cigarettes provide smokers with an alternative way of getting the nicotine to which they are ...

However, in Australia it is illegal to sell, possess or use nicotine without an authority, such as a prescription. Nicotine is classified as a Schedule 7 “dangerous poison” in the Poisons Standard, the national medicines and poisons register. How have we got it so wrong?

Last week, the New Nicotine Alliance made a submission to the Australian drug regulator, the Therapeutics Goods Administration to remove low concentrations of nicotine from the Poisons Standard. This would allow legal access to nicotine for use in e-cigarettes as a less harmful alternative to smoking tobacco. The alliance is a not-for-profit consumer organisation representing ex-smokers who now vape instead of smoking. Under the current laws, their members are being criminalised for quitting smoking “the wrong way”.

Is nicotine really the villain? The classification of nicotine as a “dangerous poison” is a historical anomaly and was established prior to the emergence of e-cigarettes. Although it is the main addictive chemical in tobacco, we now know that nicotine has relatively minor health effects except in pregnancy. It is not a carcinogen, does not cause respiratory disease and has only minor cardiovascular effects. Long-term use of nicotine is regarded as low risk, based on long-term studies of snus (moist, oral tobacco used in Sweden) and nicotine replacement therapy, such as nicotine patches.

Recent research has found that nicotine’s fearsome reputation as a lethal poison has been greatly exaggerated. The risk of poisoning from ingestion of nicotine e-liquids is similar to other potentially poisonous household substances. Even in overdose, the risk of harm from nicotine e-liquids is small. Most cases result in prompt vomiting and serious outcomes are rare.

Paradoxically, the current Australian laws ban a less harmful form of nicotine intake (e-cigarettes) while allowing the sale of the most lethal form of nicotine intake (tobacco cigarettes).

The rationale of tobacco harm reduction is to provide smokers with an alternative way of getting the nicotine to which they are addicted without the smoke that causes almost all of the adverse health effectsof smoking. Switching to an e-cigarette can effectively satisfy the smoker’s need for nicotine as well as providing “a smoking experience” which many smokers miss after quitting and which often leads to relapse.

Nicotine dependence is a powerful addiction. Most smokers want to quit and try but fail repeatedly to do so. For those who are unable or unwilling to quit smoking, switching to an e-cigarette is a much safer alternative.

There is a general scientific consensus that the long-term health risks to vapers is “unlikely to exceed 5 per cent of the harm from smoking”. On the other hand, two out of three smokers will die prematurely from a smoking-related disease if they continue to smoke.

Despite the intuitive common sense of harm reduction, the introduction of harm reduction strategies over the years has struggled against relentless hostility in Australia. Proposals such as car seat belts, needle exchange for injecting drug users and methadone substitution for heroin users have been strongly opposed, but ultimately turn out to be significantly more successful than expected.

The resistance to e-cigarettes appears to be following the same inexorable pattern. Federal and state governments and health organisations in Australia have taken a prohibitionist, risk-averse view on nicotine and e-cigarettes without considering the substantial health benefits.

Exempting “low concentrations of nicotine for use in e-cigarettes” from Schedule 7 would bring it within the jurisdiction of the Australian Consumer and Competition Commission under The Australian Consumer Law. This would ensure product safety (accurate labelling, restricted sales to minors, child resistant containers) and quality (high-quality manufacturing practice, pharmaceutical grade ingredients). Unregulated black market products would disappear.

The TGA should review the evidence and approve the NNA’s submission to exempt low-concentrations of nicotine from the Poisons Schedule for tobacco harm reduction as soon as possible. Electronic cigarettes with nicotine are proving to be a valuable aid for helping smokers quit and Australian smokers should not be denied this technology.

With appropriate controls, the widespread availability e-cigarettes containing nicotine has the potential to save the lives of hundreds of thousands of Australian smokers.

Colin Mendelsohn is an Associate Professor in the School of Public Health and Community Medicine at the University of NSW and a tobacco treatment specialist.

He has no commercial relationship with any e-cigarette or tobacco company. He has received payments for teaching, consulting and conference expenses from Pfizer Australia, GlaxoSmithKline Australia and Johnson and Johnson Pacific. None has commercial interests in e-cigarettes.


FDA Assigns Zero Value To Smokers Who Die Because Of Its E-Cigarette Regulations

The Food and Drug Administration’s e-cigarette regulations, which took effect this week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use.

The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety.

All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results.

Although preventing fraud is the official intent of the FDA’s speech restrictions, the agency’s rules prohibit statements that are accurate and highly relevant to consumers choosing between smoking and vaping. Nicopure, one of the companies that is challenging the FDA’s regulations in federal court, used to tell consumers that in vaping “nothing is burned,” “no smoke is released,” and “no ash” is generated. It also noted that the aerosol produced by e-cigarettes contains “no tar” and only “a fraction of the 4000 chemicals currently found in standard tobacco cigarettes.” Although all of these statements are indisputably true, they are illegal under the FDA’s reading of the Family Smoking Prevention and Tobacco Control Act.

That law gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. The Tobacco Control Act prohibits unapproved “modified risk” claims, including any “explicit or implicit representation that [a] tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke.” According to the FDA, that means e-cigarette companies are not allowed to advertise the main advantage of their products. Even describing an e-cigarette as “smokeless” or “smoke-free” is asking for trouble, since “the Agency will evaluate an [e-cigarette] manufacturer’s use of ‘smokeless’ or ‘smoke-free’ (and similar descriptive terms) on a case-by-case basis.”


A Federal Judge from the District Court in Washington D.C. has finally set a date of October 19, 2016 for the landmark lawsuit filed by Nicopure Labs against the legality of the FDA e-cig regulations. Judge Amy Berman Jackson also demanded that the legal action filed by the Tampa-based retailer be joined by another lawsuit filed just last month by eleven vaping advocacy groups, including the Consumer Advocates for Smoke-free Alternatives Association (CASAA), the Smoke-Free Alternatives Trade Association (SFATA),, and The Shenzhen E-Vapor Industry Association USA (SEVIA-USA).

While several other lawsuits with similar allegations against the FDA have also been filed throughout the country, Judge Jackson wants to consolidate these two cases because they were filed in the same Federal Court. Rather than hearing two cases at different times, Jackson appears to be trying to streamline the judicial process and perhaps save the taxpayers a bit of time and money. If the FDA does not respond to Jackson’s demands for consolidation by August 16, then the October court date stands.

Another case filed by Lost Arts Liquids over the FDA e-cig regulations will not be included in the newly consolidated lawsuit because it was originally filed in the Central District of California, which is not in Jackson’s jurisdiction. But because the Nicopure-combined case takes place in federal court rather than state court, most political pundits agree that its outcome could set a legal precedent that will significantly influence all future court decisions, state or federal, for years to come. In short, a lot is riding on this one. Among the many points of argument include the following:


Does the FDA have the authority to institute a backdated predicated date of February 15, 2007 on all e-cig and vaping merchandise?
Does the FDA have the authority to require e-cig and vaping retailers to undergo the million-dollar Pre-Market Tobacco Application (PMTA) process that is typically reserved for traditional cigarettes, cigars, and other tobacco products?
Does the FDA have the authority to regulate e-cigs as “tobacco products” when they are 100% tobacco-free?
Does the FDA have the authority to essentially tax an entire industry out of business?
Is a federal ban on free e-juice samples legally constitutional?
Strangely, within hours of the Jackson announcement, several Cigar Associations banded together to file another lawsuit in the same Federal Court making very similar claims against the FDA. The Cigar Rights of America, the Cigar Association of America, and the International Premium Cigar and Pipe Retailers Association filed for a declaratory injunction to “vacate, set aside and enjoin the enforcement of the final (FDA e-cig regulations).” It looks like Judge Amy Berman Jackson is going to be a major player in the War on Vaping.


How many Americans will die because of the FDA’s vaping rule?

E-cigarettes could lead to a 21 percent decline in deaths from smoking-related diseases for people born after 1997,  according to a study published in Nicotine & Tobacco Research. Even accounting for harms people might suffer from vaping who would have otherwise not smoked at all, the researchers found a net public health gain from the presence of e-cigarettes. So why is the U.S. Food and Drug Administration putting up big regulatory barriers for e-cigarettes starting in August?

The reason is simple: regulator over-caution. The FDA isn’t publicly blamed for the people who suffer and die because a drug, product or service wasn’t available due to their slow and prohibitively expensive approval process. It is, however, blamed for products that cause harm 20 or 30 years down the line. So, regulators err on the side of caution.

In the case of electronic cigarettes, they are sacrificing the millions of people who will certainly die because of their tobacco addiction for the unknown number of people who might be harmed by the long-term effects of nicotine found in vaping products.

The risks of smoking traditional cigarettes far outweigh the risks of vaping. Both contain nicotine, which is an addictive substance, but itself may be no more harmful that caffeine and might even have some benefits. But cigarettes kill 50 percent or more  of its users. Vaping, though a relatively new product category, is estimated to be 95 percent less harmful than traditional tobacco products.

Equally as important, smokers seem willing to make the switch to vaping. A survey of nearly 30,000 European Union residents, published last month in the Journal Addiction, concluded that of the 7.5 million daily vapers, 35 percent had completely switched from traditional tobacco cigarettes. For simplicity’s sake, I ignored the 2 percent of vapers who, according to the study, were not tobacco smokers prior to vaping.

Applying these rates to American vapers (though there are certainly differences in culture and regulation), a conservative estimate is that of the 9 million regular papers in the United States, 2,970,000 of them have quit smoking traditional cigarettes by using e-cigarettes.

Of course, some people don’t entirely quit smoking, but refuse their use of traditional cigarettes. According to the E.U. study, 32 percent of the current vapors fell into this category.

Yet, beginning on August 8, the FDA will treat these two very different products in functionally the same way. Manufacturers and importers will have two years to gain FDA approval for every device, component and e-liquid formula; a process that takes hundreds to thousands of man-hours and can cost up to $1 million per application. By the FDA’s own estimate, 99 percent of the current products on the market will not receive approval from the FDA and will disappear from the market.

The purpose of the Tobacco Control Act — which gave the FDA power to regulate tobacco — was to “provide new and flexible enforcement authority” and to aid the industry’s attempts to “develop, introduce and promote less harmful tobacco products.”

Yet, with this new rule the FDA is doing is exactly the opposite. As my organization’s founder Fred Smith once quipped, perhaps it’s the FDA that should come with a warning label, not e-cigarettes.

American health advocates should be raising a stink about the damage these new rules will do to public health. But instead they worry about vaping “re-normalizing” cigarette smoking, which they worked so hard to make taboo.

It’s too bad they aren’t following the lead of British health professionals, who embraced the scientific evidence that e-cigarettes are relatively safe and an effective way to quit smoking. They have even advised doctors to encourage their smoking patients to switch to vaping.

So, what can be done to stop the FDA for perpetrating this harm?

First, Congress should enact legislation that would change the “grandfather date” within the Tobacco Control Act to 2016. The grandfather or “predicate” date, which allowed tobacco products on the market before February 2007 (or similar to such products) to bypass the agency’s pre-market approval process, is set at February 2007.  Because e-cigarettes didn’t really exist before this date no products would qualify for this exemption. Though TCA explicitly gives FDA “flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce and promote less harmful tobacco products,” the FDA indicated that it doesn’t have the authority to change the grandfather date.

To address the problem, Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., introduced an amendment to the Agriculture Appropriations bill that would change the predicate date to August 2016. While not a perfect solution, grandfathering in most of the products on the market now would just bring innovation to a screeching halt, rather than throwing it back nine years.

In the long term, lawmakers should enact legislation directing the FDA to issue rules that account for the relative harm of products and make it easier and cheaper for less harmful products to get approval.

FDA’s fears about vaping products are certainly not baseless. Though they’ve been around for about a decade and are safer than cigarettes, the long-term effects of vaping aren’t known. What is known, however, is that millions of people will die because of their addiction to traditional cigarettes unless they quit or switch to another product and the FDA’s new rules will make switching more expensive, less attractive and less likely.

Even if bureaucrats at the FDA don’t get the blame, their failure to enact rules that preserve the electronic cigarette market will result in deaths that could have been prevented.


New Zealand to make nicotine e-cigarettes legal

End Smoking NZ applauds the Government on its decision to make nicotine for vaping (using electronic cigarettes) legally available in New Zealand. The Government has agreed in principle that nicotine for e-cigarettes should be legally available for sale with appropriate controls. Currently it can only be imported for personal use creating often insurmountable barriers preventing smokers from switching to vaping.

“The Associate Minister of Health, Peseta Sam Lotu-Iiga has made the right decision.” Said End Smoking’s Chairperson Associate Professor Marewa Glover. “He has listened with compassion to smokers and vapers. We are so relieved that our pragmatic nature as a country has triumphed over the negative misinformation and unfounded fears that have dominated the debate for too long.”

Long-time advocate of nicotine e-cigarettes and founding Board member, Dr Murray Laugesen started work on e-cigarettes in 2007. “I’m absolutely delighted.” He said. “This will be a turning point that will have a significant impact on reducing the death and disease caused by smoking. It also gives us a real shot at achieving Smokefree 2025.” He said.

“This announcement by the Minister gives health professionals a clear message that smokers who choose to use vaping to help them quit can be supported to do so.” Said Board member Dr George Laking.

The Ministry of Health is calling for submissions on how to legislate electronic cigarette products and what regulations or controls need to be in place.

“Vaping nicotine has been estimated to be 95% safer than smoking tobacco, thus End Smoking doesn’t believe we need overly restrictive or costly regulation and controls of e-cigarette products.

However, some concerns such as restricting sales to minors will be wise to prevent retailers who currently sell tobacco to minors pushing e-cigarette products on to kids.” Dr Glover said.

Some public health researchers and advocates in New Zealand and around the world have concerns that vaping will re-normalise smoking, be a gateway to smoking, and establish nicotine addiction among new users. However, there is no evidence that this is occurring in countries where vaping is established.

Whilst there is still some way to go before nicotine for vaping will be legally available in New Zealand, End Smoking says the first steps are positive.