The debate raging over electronic cigarettes largely comes down to the fate of people like Dylan Johnson, a 21-year-old from LaPine who started smoking when he was 14.
“I was pretty young,” he admits.
After seven years of smoking — all but three below the legal age to buy tobacco cigarettes — he had developed a pack-and-a-half-per-day habit.
Living in a house where most of his family smokes, without some sort of assistance Johnson might never be able to quit smoking. Only half of smokers do. He faced a lifelong risk of disease and disability, and could expect to cut 10 years off his life expectancy if he smoked past the age of 35.
But in January, Johnson decided on his own he needed to make a change and began to wean himself off smoking using e-cigarettes. Almost immediately, he was able to cut his cigarette use, stretching each pack of 20 cigarettes to last a full day, then two. He experimented with preloaded, disposable e-cigarettes, but they didn’t work well for him. He soon switched to using an atomizer with a refillable tank system, often called vaping. By September, he was down to just five cigarettes a day.
“I smoke about the same number of times each day but more towards the vaping side,” he said. “I don’t cough up any black tar or anything.”
He’s been ratcheting down the nicotine levels in his e-cigarettes as well, from a potent 24 mg/ml when he started vaping, down to about 6 mg/ml by September.
His ultimate goal is to stop smoking tobacco cigarettes, but he has no immediate plans to stop using e-cigarettes.
“I think I’ll still be vaping regularly but I want to be at a much lower level (of nicotine) than what I started,” he said.
Cases like his leave public health officials with a conundrum. On the one hand, e-cigarettes could significantly reduce the harm for smokers, taking away the tar and other carcinogens that cause myriad health problems, saving millions of lives and billions in health care costs. On the other hand, e-cigarettes carry the risk of addicting a new generation of nicotine users and potentially undoing much of what health officials have accomplished in stigmatizing smoking.
After eight years on the U.S. market, there is widespread agreement by both proponents and critics of e-cigarettes that regulation is needed. But how that regulation is put into place could ultimately determine whether these products become the best chance of moving to a tobacco-free society or whether the progress of five decades of tobacco control efforts will go up in smoke.
No standards, little data
E-cigarettes exploded onto the U.S. market in 2006. By 2014, there were 2.5 million e-cigarettes users nationwide. While initial products looked much like traditional cigarettes, a long cylindrical tube with a glowing tip, over the past year in particular the market has moved toward refillable tank systems that bear little resemblance to tobacco cigarettes.
While there are multiple different designs, most use the same basic concept: a battery-powered heating element that heats a nicotine-containing liquid until it turns into a vapor to be inhaled just like cigarette smoke.
While smoke is produced by burning tobacco, the vapor is produced only by heating the liquid, much like steam from a kettle. For most users, a disposable e-cigarette will last about as long as two packs of tobacco cigarettes. Tank systems or atomizers, on the other hand, can be refilled as often as needed.
The liquid, often called juice by vapers, is even more varied. The juice consists mainly of water, propylene glycol and glycerin mixed with varying amounts of nicotine and flavoring. The liquid may be manufactured by large multinational companies with millions in sales or by small mom-and-pop vape shops that produce their own juice for their local customers.
One analysis earlier this year identified 466 brands and 7,764 unique flavors of e-cigarettes. But with no regulations or even manufacturing standards in place, it is almost impossible to make any definitive statement about e-cigarettes. What applies to one product, may not apply to another.
“There really is a Wild West in the e-cigarette market out there,” said Vince Willmore, communications director for Tobacco-Free Kids. “There isn’t one e-cigarette. There are probably hundreds of types of e-cigarettes, which really makes it hard to get a handle on the health impact of these products.”
The industry is so new and changing so rapidly, there is little conclusive evidence upon which public health experts, regulators or even industry proponents can rely. So decisions on regulations are being made in a vacuum, which each side of this polarized debate is exploiting to further its own agenda.
“People are actually being very one-sided in this debate. The main issue here is the whole discussion is ahead of the evidence,” said Dr. Wasim Maziak, a professor of epidemiology at Florida International University. “There are two very disconnected parties and they’re feeding off of each other without really influencing one another.”
Proponents of e-cigarettes have adopted the harm-reduction argument, arguing that what’s in the vapor from e-cigarettes is much safer than the witch’s brew of poisons and carcinogens in tobacco cigarettes. It’s a low hurdle to clear.
“There’s no question that electronic cigarettes are much safer than cigarettes,” said Dr. Michael Siegel, a professor of community health sciences at the Boston University School of Public Health. “There’s just no comparison between these two products.”
Nonetheless, opponents argue it’s still unclear whether the vapor is less harmful. They point to studies that have found toxins and metal particles in e-cigarettes as proof these are far from the safe products many make them out to be.
Researchers at the University of Southern California recently looked at vapor from the Elips Serie C e-cig, one of the more popular brands in Europe. The researchers found a 10-fold decrease in exposure to harmful particles compared with tobacco cigarettes, with close-to-zero levels of organic carcinogens. But they also found particles of chromium, which is not found in traditional cigarettes, and nickel at levels four times higher than in tobacco cigarettes. They found traces of lead and zinc, but in concentrations lower than in traditional cigarettes.
Not just nicotine
Vaping is starting to make inroads into the medical marijuana market as well. A marijuana vape pen eliminates the need to burn the marijuana leaf — a key issue for bedridden patients. Additionally, cannabis e-cigarette juice can be formulated to maximize the content of cannabidiol, the compound in marijuana thought to be responsible for its analgesic, anti-inflammatory and anti-anxiety properties, while minimizing the psychoactive effect that leads to feeling “high” or “stoned.” It does, however, raise concerns that individuals could start using e-cigarettes to vape marijuana surreptitiously in states where marijuana is still illegal or limited to those with medical conditions.
“The metal particles likely come from the cartridge of the e-cigarette devices themselves, which opens up the possibility that better manufacturing standards for the devices could reduce the quantity of metals in the smoke,” said Arian Saffari, the lead author of the paper.
But it’s unclear how many brands of e-cigarettes or tank atomizers would have similar problems, or whether the problem could be solved with manufacturing standards.
Another study raised concerns that some e-cigarettes run too hot, heating the liquids to temperatures sufficient to create cancer-causing chemicals such as formaldehyde or acetaldehyde. But again, those concerns are limited to only some e-cigarettes and might also be addressed with better standards.
Other safety concerns might not be as easily avoided. Researchers at Boston University recently reported that human bronchial cells exposed in a lab to e-cigarette vapor showed changes in gene expression similar to those caused by tobacco smoke. Still, that’s a long way from proving e-cigarettes can cause lung cancer, and the researcher acknowledged that e-cigarettes, although not completely benign, might indeed be safer than traditional cigarettes.
And nicotine itself is not a particularly benign product. It’s one of the more poisonous and addictive compounds found in nature. While there’s little research available on the impact of long term nicotine use outside of smoking, there are major concerns. There is evidence that nicotine has adverse effects on adolescent brain development that could result in lasting deficits in cognitive function. And recent studies suggest that nicotine may prime the brain for illicit drug use and addiction.
There’s even less data on what second-hand exposure to e-cigarette vapor might be. The Centers for Disease Control and Prevention estimates that 50,000 non-smokers die each year in the U.S. from exposure to second-hand tobacco smoke. But most of that risk comes from the smoke that curls off the end of a tobacco cigarette. When inhaled, most of the dangerous compounds in cigarette smoke are absorbed in the throat and lungs and released in much lower quantities in the smoke that’s exhaled.
E-cigarettes, on the other hand, don’t release any vapor unless the user is inhaling, and again any of the exhaled vapor contains little of concern. A study by the Roswell Park Cancer Institute in Buffalo, N.Y., testing three models of e-cigarettes found that indoor use does leave nicotine residue on the surroundings, although not to the extent that tobacco cigarettes do. And e-cigarette users can also resort to what’s known as discreet vaping, preventing any of the vapor from being exhaled.
“If you just hold your breath for several seconds when you’re inhaling, there’s no visible exhalant,” said Julie Woessner, president of the Consumer Advocates for Smoke-free Alternatives Association, a consumer-run nonprofit advocacy group. “We do not claim that e-cigarette use is safe. We’re estimating based on the fact that this a smoke-free alternative and it’s the smoke that does the damage, that it’s 99 percent less harmful than smoking.”
One of the few proven harms associated with e-cigarettes is the nicotine liquid itself. Nicotine is highly toxic and some users have had to go to the emergency room after spilling the liquid on their skin where it can be quickly absorbed. And because there are no requirements for child-proof packaging, there has been a slate of poisonings involving young children.
The CDC recently reported that from September 2010 through February 2014, poison control centers fielded 2,405 calls involving e-cigarettes and 16,248 involving tobacco cigarettes. E-cigarette calls per month rose from a single call in September 2010, to 215 in February. More than half of those calls were for kids under the age of 5.
Meanwhile, the evidence that e-cigarettes can be used as a smoking cessation aid is limited and with mixed results. One study conducted in the U.S., U.K., Canada and Australia found that e-cigarettes do not help with quitting. Another found smokers were much more effective at quitting using e-cigarettes than with a nicotine patch or going cold-turkey.
A randomized controlled trial found nicotine-containing e-cigarettes were marginally better for quitting smoking, resulting in a 7.3 percent quit rate after six months, compared to 5.8 percent with the patch and 4.1 percent with nicotine-free e-cigarettes. E-cigarette users were able to cut the number of cigarettes consumed by nearly 10 per day, compared to nearly eight fewer for those using the patch.
Undoing anti-smoking work
What has public health officials most concerned is the potential erosion of many of their strategies for combating tobacco use.
Tobacco control efforts have relied on three main approaches: prevent kids for taking up smoking in the first place, making it more difficult for smokers to continue their habits, and to stigmatize smoking to make it less attractive. Over the past four decades, tobacco control has put in place dozens of laws and regulations designed to further these goals, and keep tobacco companies from gaining new ground. These laws have been remarkably effective, cutting the smoking rate from 42 percent of Americans in 1965 to just over 19 percent in 2011.
Cigarette taxes and minimum pack size are designed to price cigarettes out of reach of children. Manufacturers are banned from marketing flavored cigarettes which could be more appealing to kids, and cannot advertise their products on televisions or in print.
But the advertising bans don’t apply to e-cigarette companies who have taken to the airwaves to market their products. E-cigarette advertising has grown from $6.4 million in 2011 to $60 million in 2013, reviving much of the messaging used by cigarette companies in the 1950s and 1960s.
“The marketing of e-cigarettes comes out of the same playbook tobacco companies have used to market regular cigarettes to kids,” Willmore said. “We have seen the new slick magazine and TV ads that make e-cigarettes look glamorous just like the Marlboro man and the Virginia Slims woman.”
They’ve hired celebrity spokespeople, including TV personality Jenny McCarthy, who in one TV spot talks about taking her freedom back and being able to smoke anywhere. They’ve sponsored sporting events and concerts, and plastered their logos on bikini-clad models. In 2013 and 2014, e-cigarette maker EJoy ran commercials during the Super Bowl.
E-cigarette companies are offering free samples and selling single products that lower the entry costs for young users. And so far, no state has implemented a tax on e-cigarettes to make them just as expensive as tobacco cigarettes.
While clear air laws have forced smokers outdoors, few states or localities have addressed vaping or e-cigarette use in public places. Many individual offices, restaurants and bars where smoking is illegal now permit vaping.
And nothing has characterized the e-cigarette industry more than the variety of flavored juices, like Cherry Kool-aid or SweetTarts, that seem to be targeting children.
“This is part of the campaign called deceit with sweet,” said Penny Pritchard, tobacco prevention coordinator for Deschutes County Health Services. “Without these restrictions on flavor bans or age bans for electronic cigarettes in Oregon, we’ve seen an increase in kids who want to try e-cigarettes, but they don’t want to try conventional cigarettes.”
It’s doubly concerning because the county already has higher smoking rates among 11th graders (20 percent) than adults (14 percent).
“In fact its the second highest rate in Oregon,” Pritchard said. “A lot of people don’t think it’s an issue, because of our low adult smoking rate, but there’s a huge gap in our perception.”
Pritchard attributes that teen smoking rate to Oregon’s high rate of illegal sales to minors, the worst in the nation according to a 2012 report.
“This is a huge issue in our community, convenience stores and grocery stores not carding,” she said. “Especially in rural communities, that’s an issue.”
And while many stores and vape shops say they voluntarily refrain from selling e-cigarette and juice to minors, with so many shops selling cigarettes illegally, a voluntary ban seems unlikely to have much effect.
Public health officials also worry that people don’t consider e-cigarettes or vaping risky, and are willing to give it a pass in social situations.
“If you’re at dinner, you’re not going to smoke in front of your friends, but if you have a vape pen, you might,” Pritchard said.
Parents might be more willing to vape indoors or in cars with children. And many workplaces that can’t allow smoking tolerate vaping.
“It has the potential to be exposing people to the vapor that other people are using, but also that it does model for kids to have smoking happen anytime, anywhere,” said Dr. Bruce Gutelius, deputy state epidemiologist with the Oregon Public Health Division. “There’s this potential for them to be a bridge product, so they can use them where they can’t smoke, and then go back to smoking when they are somewhere where they can smoke.”
Certainly, adults also buy candy and enjoy candy flavors. And many e-cigarette flavors, such as coffee or black walnut, seem to be geared more toward adults. But the fear among anti-smoking advocates is that kids will be attracted to e-cigarettes, become addicted to nicotine and then transition into smoking. While it’s not yet clear whether that is happening, there is data showing that youth are at least trying e-cigarettes in increasing numbers.
According to a CDC survey released in August, more than a quarter million middle and high school students who had never smoked a cigarette used electronic cigarettes in 2013, a three-fold increase from 79,000 in 2011 to 263,000 in 2013.
Those who used e-cigarettes reported being twice as likely to smoke conventional cigarettes (44 percent) compared with those who did not (22 percent.) Past surveys have shown that a stated intention to smoke is predictive of future cigarette use.
“Eighty percent of established adult users establish before the age of 18, so it requires an upstream approach,” said Shanta Dube, associate professor of epidemiology at Georgia State University, who was involved with the CDC survey. “Primary prevention is about making sure you do not begin or initiate or experiment.”
According to the CDC, every day 3,200 kids try their first tobacco cigarette, more than 700 of them go on to become daily smokers. Even at the current reduced levels of smoking, an estimated 5.6 million children in the U.S. alive today will die prematurely from a smoking-related illness.
“The other side of the coin is that there are smokers, and smoking is a difficult thing to change because of the issue around the nicotine dependence,” Dube said. “But in terms of e-cigarettes and the potential for harm reduction, I can’t be completely positive about that, until there is more evidence about the safety of the product. The jury is still out. I think in the spectrum, it’s safer than cigarettes but we don’t know how safe because we don’t have any evidence.”
Even in states which have implemented a ban in the sales to minors, e-cigarettes use among teens continues to rise. In Utah, for example, teen use of e-cigarettes tripled to nearly 6 percent between 2011 and 2013, and nearly one-third of users said they had never smoked a traditional cigarette.
“This whole area of e-cigarettes is new, it’s changed our landscape of tobacco control,” Dube said.
Proponents of e-cigarettes counter that none of that data shows that kids are becoming regular users of e-cigarettes, much less traditional cigarettes.
“We now have established a pretty good body of literature showing that e-cigarettes do not attract non-smokers. They simply don’t. Virtually every e-cigarette user is a smoker who switched,” said Dr. Joel Nitzkin, a public health physician who now consults for R Street, a conservative think tank in Washingon, D.C. “There are lots of non-smokers, especially kids, who are tempted to try e-cigarettes, to sample them. But it’s hard to find even a single kid who is started off as a non-smoker, sampled them and continued its use.”
He points to two studies conducted by public health groups as proof. A U.S. survey of 3,240 adults found only six nonsmokers who had ever used an e-cigarette, and a 2013 UK survey of more than 12,000 adults and 2,000 children was not able to identify a single nonsmoker who used e-cigarettes regularly.
CDC data, he said, could be interpreted in the same way, showing a rapid increase in teens trying e-cigarette use, but a continued decline in teen smoking rates.
“The best path from where we are to a tobacco-free society is to adopt tobacco harm reduction elements in the public health programs and have people switch to products that are a whole lot easier to quit,” Nitzkin said. “Not only are they easier to quit, they cut the risk of potentially fatal tobacco related illness by 99 percent or more. I think we have good solid scientific evidence to point that out.”
Many public health experts agree. In May, more than 50 researchers and public health officials sent a letter to the World Health Organization urging the group to not suppress the e-cigarette industry.
“If the WHO gets its way and extinguishes e-cigarettes, it will not only have passed up what is clearly one of the biggest public health innovations of the last three decades that could potentially save millions of lives, but it will have abrogated its own responsibility under its own charter to empower consumers to take control of their own health, something which they are already doing themselves in the millions,” said Professor Gerry Stimson, emeritus professor at the Imperial College in London and one of the signatories in the letter.
A review of available research by academics at Queen Mary University of London found that although long-term health effects of e-cigarettes are unknown, compared with conventional cigarettes they are likely to be much less harmful. The reviewers said the evidence does not justify regulating them as strictly as conventional cigarettes.
“The evidence we currently have is clear: E-cigarettes should be allowed to compete against conventional cigarettes in the marketplace,” said Peter Hajek, a professor who led the analysis. “Healthcare professionals may advise smokers who are unwilling to cease nicotine use to switch to e-cigarettes. Smokers who have not managed to stop with current treatments may also benefit from switching to e-cigarettes.”
In June, however, more than 129 public health doctors wrote to the WHO refuting the claims of the May letter, and urging tighter controls on e-cigarettes.
“Their response is the known science is only suggestive, it’s not conclusive. But you know, proof, like beauty, is often in the eye of the beholder,” Nitzkin said. “We know how toxic cigarette smoke is, we know how addictive the cigarette is. We also know that nicotine-only delivery products are substantially less addictive. That means they are easier to quit than cigarettes. So all of the science is in favor of the e-cigarettes.”
In some ways, the difference between the two groups come down to a matter of perspective. Those opposed to e-cigarettes see the harm that can come to people who don’t currently smoke but could start. Those supporting e-cigarettes focus on the reduction in harm that come for people already addicted to smoking.
“It is only in comparison to cigarettes,” Nitzkin said, “that they can be considered very low risk.”
Many e-cigarette proponents see a continuum of nicotine-related harm, with smoking cigarettes on end and nicotine-replacement products like gum and the patch on the other. As people move across the continuum away from smoking, they not only reduce their harm but it becomes easier to quit tobacco smoking altogether. E-cigarettes, they argue, would fall somewhere in the middle.
But Maziak, the Florida International professor, believes that sort of approach could result in a major public health blunder.
“To me we do not benchmark on the worst practice,” he said. “When cigarettes were first introduced to the market, they were thought to be beneficial, and then they became very strong economically. It’s a very unique history that we don’t want to repeat or actually use as an excuse for going really blind on e-cigarettes.”
Maziak acknowledges that among the best arguments in favor of e-cigarettes is there is little else to offer smokers, so those opposed are basically advocating a quit or die policy for smokers.
“With e-cigarettes we finally have a product that looks like cigarettes, works like cigarettes, is popular among smokers but poses less harm than conventional cigarettes,” he said.
That alone gives them an advantage over nicotine replacement products. Clamping down on e-cigarettes might end up throwing some smokers under the bus, but might still be the right call.
“There will be some price to pay,” he said, “If we get some evidence that there is really minor uptake among non-smokers then that changes the whole thing. But we don’t have that now. We don’t have any evidence that it really does work as people claim it does.”
Big Tobacco and more
The debate may come down to a gruesome accounting of harm, whether e-cigarettes will save more lives by reducing death and disease in current smokers or increase the death rates by creating new smokers.
“The bottom line is to reduce the death and disease caused by tobacco use,” Willmore said. “But the evidence is still very limited and inconclusive whether e-cigarettes can play that kind of roll. We’re seeing a lot of trial, but not a lot of switching.”
It’s possible, he said, that e-cigarettes could prove less harmful for smokers, but still not benefit the population as a whole. And many anti-smoking advocates simply don’t buy the hype about e-cigarettes.
“I empathize with smokers who do think they’re going to quit by using e-cigarettes, but they lose me when they tell me they quit smoking but they’re still smoking e-cigarettes,” said Anne Palmer, a smoking cessation counselor and owner of Customize Your Quit in Bend. “They’re still smoking the nicotine. They have not quit smoking. They’ve simply changed the delivery method.”
Palmer said she hasn’t had one client who’s actually quit smoking traditional cigarettes by using e-cigarettes. She says that’s because vaping continues the nicotine addiction and mimics the hand-to-mouth action of smoking.
“I understand that people are very passionate. ‘Oh yeah, I switched to e-cigs. I feel so much better.’ That’s great but these people are masters of delusion, they smoked all of those years and the only way you can continue to do that is by lying to yourself about the fact that you’re poisoning yourself 20, 30 times a day.”
Nor does she buy the harm reduction model.
“We’ve been down this road before. We’ve gone through it with menthol, we went through it with light cigarettes and then low-tar. It was all nonsense,” she said. “I think it’s wishful thinking for people to say that all of a sudden the tobacco industry has come up with a safe smoke. They’ve shown a wanton disregard for their clients and I don’t see that changing with e-cigarettes.”
The distrust of tobacco companies has played a large role in the reaction to e-cigarettes, with public health experts wary of repeating the difficult history with smoking. The big tobacco companies, however, have only recently entered the e-cigarette marketplace. Most of the growth in the industry has come from independent companies, some of which are now being bought out by the large cigarette makers.
In 2012, Lorillard paid $135 million for blu eCigs, and in 2013, Reynolds American started marketing Vuse. This year, Altria, parent company of Philip Morris USA, purchased e-cigarette maker Green Smoke for $110 million and last year began marketing its own e-cigarette, the MarkTen.
Nonetheless the tobacco companies’ entry to the market complicates the discussion as anti-smoking advocates have been quick to transfer the sins of the tobacco industry to e-cigarettes makers.
“Their whole strategy is based on addicting our children and if you care about the quality of life of our children and you care about the health care costs in our system you would do everything you possibly could to block these efforts to lure our children into a life of addiction,” said Sen. Jeff Merkley (D-Ore.).
Merkley became concerned about tobacco marketing to kids when he was first elected to Congress in 2009. He had learned about efforts to test market in Oregon three new products that formulated finely ground tobacco into mint orbs, toothpicks or breath strips. The orbs were packaged in hourglass-shaped containers that when slipped into a back pocket looked like the profile of the flip phones popular at the time.
“It was pretty diabolical. Actually jaws would drop. It’s unbelievable that once again the tobacco industry is targeting our children.” Merkley said. “Now I think they’ve found what has been a far more successful strategy of selling nicotine extracted from tobacco, and once again we see this massive effort to target children. I don’t think we were trying to get 30-year-old people to buy gummy bear and Scooby snack (products).”
Merkley has been pushing the FDA to regulate e-cigarettes since Congress passed the Tobacco Control Act in 2009, and was one of a handful of Democrats in Congress to issue a scathing report on the e-cigarettes industry and the lack of regulation in April. The FDA proposed regulations a week later.
“They have been dragging their feet unacceptably,” Merkley said. “They finally came out with a draft of (e-cigarette) regulations that largely simply says, ‘Yes the law gives us the power to regulate this.’ Well we knew that when we passed the law in 2009. But I do not know why or how they could possibly justify stretching this out over these five years.”
The FDA first tried to regulate e-cigarettes in 2009 as drug delivery devices, a move many saw as an attempt to devastate the industry. Had they succeeded, it would have required manufacturers to meet the same strict standards that medical device manufacturers must meet to gain FDA approval. The cost of the types of studies required would likely have been beyond the reach of most e-cigarette makers at the time.
But one e-cigarette maker sued the FDA and won. The court ruled that as long as e-cigarette makers weren’t making health claims, such as that e-cigarettes were healthier than smoking tobacco or that they were an effective cessation aid, they could only be regulated as a tobacco product.
So this year, FDA issued proposed so-called “deeming regulations” that would establish its authority to regulate e-cigarettes as a new tobacco product. Those regulations would ban free samples and sales to minors, require a warning label, force companies to submit a list of ingredients to the agency, and prohibit them from using any risk modifiers, such as the words light, low or mild, in their marketing.
Critics immediately decried the lack of ban on flavorings, although an FDA spokesman indicated the agency must first gain legal jurisdiction before applying any possible future restrictions on flavorings.
The proposed regulations, however, would decimate the e-cigarette industry, reducing it only a handful of large players by requiring extensive paperwork to be filed for each e-cigarette product. The FDA has estimated that each application would require on average 5,000 hours of work.
“Most e-cigarette companies are pretty small. In fact the majority of them are not even companies, they are little shops,” said Siegel, the Boston University School of Public Health professor. “Some guy sets up a store and starts selling these things. How is he going to spend 5,000 hours putting together a report on a new product?”
A vape shop that makes its own juice would have to submit a new product application for each flavor.
“It’s basically going to put most of these businesses out of business,” Seigel said. “And basically the only ones that are going to remain are the really huge companies. And unfortunately those happen to be the big tobacco companies. So it’s basically going to give the market to Big Tobacco.”
Some argue Big Tobacco, with its deep pockets and large marketing budget, is likely to dominate the market anyway. But there’s evidence that Big Tobacco is looking at e-cigarettes much differently than independent firms. In its comments on the proposed deeming regulations, Reynolds urged the FDA to ban refillable tank atomizers, arguing they pose a safety risk. That would leave only disposable e-cigarettes, which require a more sophisticated and expensive production system but look much more like traditional cigarettes.
“There’s no real reason for that. If you’re just trying to deliver nicotine you can do it anyway you want. And in fact there’s probably more practical ways to contain the liquid, said Chris Bostic, deputy director of the advocacy group Action on Smoking and Health. “But they go out of their way to make it look like cigarettes because they’re marketing cigarettes to people.”
Skeptics say it’s further proof that Big Tobacco wants to use e-cigarettes as a gateway to attract more cigarette smokers. And banning refillable tank systems would kill off the mom-and-pop vape shops.
“If the only way to regulate us under the Tobacco Control Act is to decimate the industry,” Woessner said. “Then no, that’s not good for consumers and that’s not what we want.”
Spencer Knowles, owner of High Mountain Mist, a vape shop in Bend, said he would like to see some regulation, but is concerned it could price him out of the market.
“Of course, I want regulation, but as the little guy, how am I going to keep this business going if they say, just arbitrarily, it’s $30,000 to test this?” he said. “And the reason they do that is to put mom and pop out of business.”
Knowles said most of his clients are smokers who are looking for a safer alternative to cigarettes or hookah smoking. He discounts the notion that e-cigarettes are going to lead to new smokers.
“From what I’ve experienced is, those people who gravitate to vaping first would have been smokers anyway,” he said. “Most kids start smoking because of the psychological thing. They’re pissed off at society or their parents, and they want to rebel. This is a way of saying, ‘I know this is bad for me, but I do it anyway.’ Those are the same kids who are starting to vape.”
He believes that opposition to vaping has less to do with facts or evidence, and more with emotional reactions.
“People have friends and family that they’ve lost to smoking. There’s a deep emotional rift in their heart and their soul against smoking,” he said. “We have bans in public for smoking, because second hand smoke is terrible, and we have bans for children, and these are all very good things. And now they walk in and they see people smoking in those areas, and they’re so emotionally traumatized by losing dad, or grandma, or seeing a friend dying of emphysema, they do not have the capability in their brain to say, ‘Oh that’s something absolutely different.’”
Siegel agrees that it’s ideology that’s driving policy instead of evidence.
“The ideology is so strong that tobacco control practitioners have become against the act of smoking, not against the harm done by smoking,” he said. “So they see a product that looks like a cigarette and acts like a cigarette, to them it’s just a cigarette. The fact that the scientific data actually show that it’s much safer — they’re not able to see that. They can’t condone it even though that may be the way to save someone’s life.”
Seigel maintains that even without regulation, there is a net public health benefit to e-cigarettes. Putting in common sense regulations could further improve the risk-to-benefit ratio. To maximize the benefit, he said, it must be as easy as possible for adult smokers to get these products.
“The proposed deeming regulations may actually do the opposite,” Seigel said. “They make it as difficult as possible for electronic cigarette companies to remain viable.”
He argues the FDA should instead focus on reducing the identified harms, most of which could be prevented by setting manufacturing standards.
“I would say here are the standards that everybody must follow. The battery safety must look like this. The maximum temperature is this. Here is the quality of the chemicals you can put in there. Here are the chemicals you can and cannot put in there. Here’s the childproof packaging that you can have. Here is how you have to prevent leaks,” he said. “And any product that meets the standards can go on the market.”
By adding restrictions on marketing and sales to minors, the agency could address most of the more pressing concerns.
“If they do this right and they allow this market to thrive and put in reasonable controls, these have the potential to take up as much as 30 to 50 percent of the combustible market,” Siegel said. “If that happens it would be the greatest public-health victory of our lifetime.”
The comment period for the proposed regulations closed in August and it will take some time for FDA to review the nearly 80,000 comments they received. The agency projected a release of the final regulations in June 2015, followed by another 90-day comment period. But it may be much longer before regulations impact the e-cigarette market.
“They’re being as careful as possible because they’re pretty certain no matter what they come up with they are going to get sued,” said Bostic, of Action on Smoking & Health. “They want to make sure they have all their ducks in a row. You want to do the right thing but they want have it stick and not have it overturned in court.”
Several companies are already moving production to the U.S. from China to prepare for the standardization and quality control that could be required by the FDA. The e-cigarette industry has issued an extensive set of quality standards for e-cigarette fluid, but those remain voluntary. And in the absence of regulation, no one is inspecting the contents of vape juice or the production facilities. Knowles said his juice is created in a high-quality lab in Arizona with the strictest of standards.
But as Pritchard points out, shops can make claims about their manufacturing process, but “without regulatory oversight of the county looking at that, we really don’t know what’s in these products.”
There remain no standards for nicotine levels in the juice. And while some juice makers disclose the amount, there is no way to know that it’s accurate. Some analyses showed even juice listed as zero nicotine contained some.
“Thankfully more and more vape stores are investing in proper clean rooms,” said Greg Conley, president of the American Vaping Association. “The good news for consumers is that making a liquid is extremely cheap. Often the bottles and the labels will end up costing more than what’s actually in there. So there are no cost benefits to cheapening health when you only have four ingredients.”
Other countries have taken markedly different approaches. E-cigarettes are already prohibited in Australia, Brazil, Canada, Mexico, Panama, Singapore, and Switzerland. Starting in 2016, the European Union will ban advertising in 28 nations, require childproof packaging and graphic warning labels, and limit nicotine content to 20 mg/ml.
The U.K. on the other hand has been more open, and its National Health Services allows its tobacco cessation counselors to advise smokers trying to quit on how to use e-cigarettes.
With the FDA regulatory process dragging on, states and localities have been filling the void.
At least 22 states have explicitly banned sales of e-cigarettes to minors, another six have language banning sale of nicotine products to minors, without using the term e-cigarette.
The Oregon legislature in 2014 considered two e-cigarette bills that would ban sales to minors, but those were ultimately handed over to a work group to craft a compromise bill.
Anti-smoking groups like the American Cancer Society and the American Lung Association believe industry representatives are lobbying for bills that would provide some minimal restrictions but exempt e-cigarettes from the much tougher regulations facing tobacco sales.
“The e-cigarette companies are supporting Trojan horse bills in states that look like they’re solving the problem but in fact they are in exempting e-cigarettes from tobacco regulations,” Willmore said. “In a lot of states e-cigarette manufacturers are looking to create new definitions. So it wouldn’t be clear what penalties will apply, what licensing would apply. We think the most effective and the most strict form is to regulate them as tobacco products.”
That would raise a host of new issues, including whether insurance companies could treat e-cigarette users as tobacco smokers and charge them higher premiums. While many employers offer discounts or incentives to employees who don’t smoke, the blood and urine tests used to detect nicotine would also be triggered by e-cigarette use.
The Federal Aviation Administration has already ruled that vaping and using e-cigarettes are banned on airline flights just as cigarettes are. And the CVS drug store chain included e-cigarettes in its recent ban on tobacco products, although it does continue to sell nicotine replacement products such patches, lozenges and gum.
The American Heart Association recently released its guidance on e-cigarettes and while it called for greater regulation and more studies, it did not close the door on the products altogether.
“We’ve been through this before the low-tar cigarettes, so we are very cautious not make the same mistakes,” said Dr. Aruni Bhatnagar, chair of cardiovascular medicine at the University of Louisville, who chaired the committee that penned the guidance. “In case of the individuals who could not quit, we would not discourage them from trying e-cigarettes. We don’t want to be completely averse to the whole position.”
The group also called for differential taxation of e-cigarettes, high enough to price them out of reach of young people, but not so high as to make them as expensive as cigarettes.
“Although we don’t know whether there is harm reduction when you switch from cigarettes to e-cigarettes, it’s reasoned that they couldn’t be worse than traditional cigarettes,” Bhatnagar said. “So in that vein I think we need to wait for the right evidence to emerge.”
In a survey of North Carolina physicians, two-thirds said they believed e-cigarettes could help patients stop smoking and 36 percent recommended them to their patients even though no e-cigarette product has been approved as a smoking cessation tool.
“When a 30-year-old smoker is hacking up their lungs, they’re beginning to say ‘Well if you tried the gum and the patch and didn’t work, you need to go down the street and get yourself an e-cigarette,’” Conley said.
But many are waiting for more definitive evidence.
“When I talk to patients who are trying to quit smoking, who are considering using e-cigarettes to try to stop smoking, I really caution them against the use of e-cigarettes,” said Dr. Emily Speelmon, a pulmonologist with St. Charles Bend.
But Speelmon said even with approved products quit rates are rather low.
“It can be from 5 to 15 percent, so we caution people on average this takes nine tries,” she said. “If you’ve failed, try again. You just need to hit your number.”
On the other hand, e-cigarettes have already gained an acceptance among smokers that makers of the patch or gum could only dream of, and restricting access to e-cigarettes could mean rejecting the best alternative smoking the market has ever devised.
“The patch and the gum are not very sexy. The whole vaping thing is a big thing right now and it’s very cool to be doing it,” said Wendy Bjornson, co-director of Oregon Health & Science University’s Smoking Cessation Center. “If we get some good public health benefit out of it then I say more power to it. But we just have to wait and see.”
FDA is currently funding more than three dozen studies about e-cigarettes, looking at things from contents of e-cigarettes to smokers’ behavior to the way such products are marketing. Bjornson said that the industry is far ahead of the science, and it will take a while to catch up.
“They are just very trendy right now,” she said. “We’ll see what happens once the wild enthusiasm dies off, what the ongoing role will be of such a product. And frankly, I hope that it does turn out to be a good option that we can actually use. But again we’re very cautious.” •