Plumes of vapor from e-cigarette users can be seen all around Hawaii, on the beach, at the bus stop and even in restaurants.

E-cigarettes are pervasive, sometimes controversial and, for now at least, unregulated.

What started as an ingenuous way to help people stop smoking tobacco is raising concerns:

• The health effects of these devices are largely unknown with scientific research in its infancy, and yet e-cigarette can be used anywhere, including indoor spaces.

• There are no regulations on how these devices are marketed and to whom, which has some people concerned that e-cigarette advertisements are targeting minors.

• Manufacturers are not required to label what ingredients are in their cocktail of liquid nicotine (e-juice), or the level of nicotine concentration. The cartridges might contain a myriad of liquid substances: nicotine, flavoring and even illegal drugs.

An e-cigarette-user exhales in downtown Honolulu.

PF Bentley/Civil Beat

“We seem to have very high usage, you can’t go a day in our state and not see someone using them,” said Jessica Yamauchi, executive director for the Coalition for a Tobacco-Free Hawaii.

The coalition and the Department of Health would like to rein in the growing industry. Three bills were proposed to the Hawaii Legislature, but none has passed.

SB 2572 attempted to establish additional taxes on e-cigarettes, similar to those imposed on tobacco products. SB 2029 sought to bump up the legal age to purchase tobacco products — and include e-cigarettes — to 21. And SB 2495 attempted to limit the areas where the devices could be used.

The federal Food and Drug Administration has yet to establish national e-cigarette regulations.

“They’re completely unregulated at this time. People can create e-juice in their home, you can buy it by the gallon online,” Yamauchi said.

‘Vapers’ Go Where Smokers Cannot

E-cigarettes hit the market in 2007, and manufacturers contend that they are giving smokers their freedom back by providing them with a product that allows them to enjoy nicotine in a country where smoking is no longer accepted in public. They also don’t leave users with the lingering smell of cigarette smoke.

Big tobacco companies see e-cigarettes as a way to re-vitalize their industry which has been heavily regulated.

A battery operated vaporizer heats up the “e-juice” — usually a mixture of liquid nicotine and propylene glycol — within a chamber to create a vapor inhaled by the user.

When the vapor is exhaled it has the look of smoke, an intentional semblance designed to give the user the sensation of smoking.

“I don’t smoke, but I have friends who do and I’d rather them smoke e-cigarettes than cigarettes.” — Mo Bay, sales associate at Hawaiian Holy Smokes

Cartridges carry varying amounts of nicotine and other ingredients and come in a variety of flavors such as Dr. Pepper, chocolate, pina colada and peach Schnapps.

There is no legal requirement to detail how much nicotine is in a cartridge or what other ingredients may be in the e-juice, so what exactly is in the vapor can be as much a mystery to e-cigarette users as to other people nearby.

Some companies do make a point to report how much nicotine is in their cartridges.

Blu, for example, a brand that defines itself as having “an intense passion and one goal — to help adult smokers take back their freedom,” advertises four levels of cartridges: high containing 13-16 mg of nicotine; medium, 9-12 mg; low, 6-8mg; and non-nicotine.

The products are sold on line with the simple click of a button that says, “I’m over 18.”

At Hawaiian Holy Smokes on Waialae Avenue in Honolulu, e-juice is available in 15 ml, 30 ml and much-larger 12-ounce containers with concentrations that range from non-nicotine to 24 mg of nicotine.

A shelf is jammed with rainbow-colored liquids, each with a unique flavor.

E-cigarettes contains fewer chemicals than tobacco. They’re rechargeable and most are refillable.

“It’s way cheaper than buying cigarettes,” said sales associate Mo Bay at Hawaiian Holy Smokes. “I don’t smoke, but I have friends who do and I’d rather them smoke e-cigarettes than cigarettes.”

Addictive in Their Own Right?

Originally designed to simulate the look and feel of a cigarette and help smokers quit, the devices have evolved into various sizes, shapes and capacities.

“There’s so many options,” Bay said, plucking some products from the display case.

One was not much bigger than a tube of lip gloss, another was bulky, like a big Sharpie.

Bay said most of her e-cigarette customers are trying to quit smoking and many return to restock on e-juice.

 “It appears that people who are able to quit cigarette smoking with e-cigarettes continue using e-cigarettes.” — Pallav Pokhrel, University of Hawaii Cancer Center

The devices can give users the nicotine without the added chemicals found in traditional cigarettes. The idea is that users can eventually wean themselves off nicotine by decreasing dosages.

But  the variety of flavors and concentrations, not to mention the freedom to vape anywhere, has some users able to quit tobacco but not able to kick their nicotine addiction.

There is no conclusive evidence that e-cigarettes actually help existing smokers quit.

In 2013, researchers and professors Pallav Pokhrel and Thaddeus Herzog of the University of Hawaii Cancer Center surveyed 1,567 adult smokers (people who smoked at least three cigarettes a day or more than 100 cigarettes in their lifetime) who were using e-cigarettes to quit smoking.

Pokhrel and Herzog found e-cigarette users tended to be younger and they rated higher in motivation to want to quit smoking. But whether or not e-cigarettes are actually resulting in users giving up traditional cigarettes and eventually kicking their nicotine addiction is still uncertain.

“Currently, it is unclear how e-cigarette affects nicotine addiction. It appears that people who are able to quit cigarette smoking with e-cigarettes continue using e-cigarettes,” Pokhrel said.

Pokhrel says that he and his research team will be following up with the study subjects to see if they have, in fact, quit smoking.

“It is not clear what proportion of them quit e-cigarettes eventually. It is also unclear what percentage of them switch back to smoking cigarettes or end up using both e-cigarettes and cigarettes,” Pokhrel said.

What’s All the Fuss About?

Lack of regulation presents several issues.

There are no laws that prohibit how manufacturers market their products or who they target. Much of the controversy concerns marketing e-cigarettes to minors and to non-smokers by offering a variety of flavors — some that sound more like candy than liquid nicotine.

“I think they are preying on youth and re-normalizing smoking,” Yamauchi said.

“Until we have more evidence to go on, I would urge you to be cautious when lumping these devices in the same category as cigarettes. They are as much a cigarette as a bicycle is a car.” — Tim Michel, e-cigarette user, in testimony to the Legislature

Pokhrel said when he surveyed college students on Oahu for one of his studies, some said e-cigarettes made them feel sophisticated and that other people didn’t mind them vaping because the vapor didn’t smell bad.

“It’s a novel, innovative product and people are curious about it. It has advantages for kids; you can use it in your room and people don‘t know you’re using it. You can take it in the library.  You can take it all these different places and you don’t get busted,” Pokhrel said.

Some people may be smoking substances besides liquid nicotine in e-cigarettes.

When asked whether people use the devices to vape drugs such as marijuana, Yamauchi of the Coalition for a Tobacco-Free Hawaii said, “people get creative.”

The Honolulu Police Department said using e-cigarette devices for illegal drug consumption is something it has encountered, though such abuses are not prolific.

Prompted by an increase in calls to the Hawaii Poison Control Center regarding young children ingesting e-juice, concerns over the lack of regulation of these sweet smelling, candy-flavored liquids intensified.

The FDA has suggested, in its proposed regulations, to impose child safety caps similar to those found on cough syrup bottles.

One of the biggest concerns with the lack of regulation is that health effects are widely unknown for users and those impacted by second-hand vapor.

“Currently not much is known about the long- and short-term health consequences of e-cigarettes,” Pokhrel said.

‘They Want Data and They Want it Yesterday’

Pokhrel has only conducted a handful of studies on the impacts of e-cigarettes and most of those have been behavioral studies, where he investigates how the device may or may not impact the users’ motivation to quit smoking and eventually kick their addiction to nicotine.

Within the next month, Pokhrel and UH Cancer Center will be conducting two new studies focusing on impacts on consumer behavior as well as investigating possible changes in the brain.

In one study, Pokhrel and his team will look at how media advertisements for e-cigarettes impact behaviors of Hawaii’s young adult smokers and non-smokers. One question is whether advertisements influence people to try the product.

“This study is being funded by the FDA because there is a lot of interest in the young adult age group,” Pokhrel said, noting tobacco use is greatest in people ages 18-35.

The FDA has approximately 45 research projects costing an estimated $270 million to study the effects of e-cigarettes on users and bystanders.

Pokhrel says he’ll be working with approximately 400 randomly chosen subjects and he expects to release the results within a year.

The other effort is a small pilot study internally funded by the UH Cancer Center in which the center will partner with the MRI lab at the UH John A. Burns School of Medicine to see if the brain of a smoker differs from the brain of an e-cigarette vaper.

The MRI study will look at 2o individuals — chronic, exclusive tobacco smokers and e-cigarette vapers — and investigate whether there are differences in how the brain registers addiction.

Pohkrel said that study will most likely start before the end of the year.

Research has found that e-cigarettes, while having less chemicals than a traditional tobacco cigarette, still contain toxins and carcinogens.

“Some toxins and carcinogens found in cigarette smoke have been found in e-liquid or e-cigarette cartridges but usually in very small amounts compared to cigarette smoke,” Pokhrel said.

Researchers at Virginia Commonwealth University found that e-liquids that are vaporized at high heat can release the byproduct formaldehyde, found in embalming fluid and a known carcinogen.

According to an article from Reuters news service, the FDA has approximately 45 research projects costing an estimated $270 million to study the effects of e-cigarettes on users and bystanders.

“They want data and they want it yesterday,” Dr. Suchitra Krishnan-Sarin of Yale University, leader of four projects, said in the Reuters article.

The results of these research studies aren’t expected to be available until 2018 as scientists seek evidence to catalyze regulatory action.

One study looks into the exact chemical make-up of vapor from various e-cigarette manufacturers. It also exposes mice to the vapor for up to six months to check for the effect on their lungs and other cells.

The results should be ready in 2015, but making the research leap to effects on humans could take an additional five years.

Other studies will employ social media to look at who is vaping and perceptions of e-cigarettes across a multitude of factors, including age, ethnicity and location.

Scientists at Georgia State University School of Public Health will be conducting online surveys of 6,000 people to ascertain how they feel about e-cigarettes, whether they think they are less harmful than traditional cigarettes.

“This is the kind of research that is going to be informing the FDA’s regulatory process,” said Michael Eriksen, dean of the School of Public Health and leader of three FDA-funded projects on tobacco said in the Reuters article.

There is no shortage of complaints being posted by users and people who are consistently near users.

The Food and Drug Administration has been taking comments from people who want to report “adverse affects” they experienced when being in contact with e-cigarettes.

In the self-reported statements on the FDA website, people complained about anxiety, difficulty sleeping, coughing, chest pains, loss of appetite, canker sores, rashes, blisters, swelling, swollen lips and itchy arms.

A 25-year-old man said of concerns he had about consuming too much of the vapor, “It is my opinion that the effect would feel almost like drowning.  Breathing in too much water, very, very, slowly.”

He said he developed a cough unlike anything he felt when he used to smoke cigarettes.  “It’s like my lungs are lined with too much moisture,” he wrote.  The man reported using the e-cigarette for six to 12 months.

The Attempts to Regulate

The Hawaii Department of Health and the Coalition for a Tobacco-Free Hawaii, among others, are advocating for legislation that would impose regulations on e-cigarette retailers.

SB2495 was one of three the proposed bills that would have regulated e-cigarettes in Hawaii, but the bill did not advance. E-cigarettes and liquids would have been subject to additional taxes just like tobacco products. Currently, they are only subject to the General Excise Tax. Also, e-cigarette retailers would have been required to obtain licenses and permits.

Retailers were not happy about the proposed requirements and testified to that effect.

“We want to encourage companies to pass their own policies to ban use of e-cigarettes on their premises until we can get something through at the state level.” — Jessica Yamauchi, executive director, Coalition for a Tobacco-Free Hawaii

Cory Smith, CEO and owner of Volcano Fine Electronic Cigarettes in Honolulu, submitted testimony opposing the bill.

“To date, there is no evidence that electronic cigarette usage has harmed anyone, which is logical since the product emits a tiny amount of vaporized nicotine and flavorings,” Smith said.

Retailers weren’t the only ones to oppose SB2495 and the other bills. E-cigarette users also criticized attempts to equate the product with tobacco.

Tim Michel, who said he had been smoking up to two packs a day for over 35 years before he switched to e-cigarette, wrote that he’d been smoke-free for six months.

“Until we have more evidence to go on, I would urge you to be cautious when lumping these devices in the same category as cigarettes,” he wrote. “They are as much a cigarette as a bicycle is a car.”

The bill also included a proposed amendment to Hawaii’s anti-smoking statute that would make it illegal to use e-cigarettes in work spaces and in public places.

Smith argued that was not practical.

“It is also impossible to enforce an e-cigarette usage ban, since the products can be used discreetly without anyone else knowing,” he said. “Enacting unwarranted and unenforceable regulations carries the risk of unintended consequences like sending former smokers back to combustible tobacco products; harming their health and undermining the mandate of the state to promote viable alternatives to known killers.”

Because SB 2495 did not pass, Hawaii has no ban on where e-cigarettes can be used, leaving some non-vapers complaining of the unsightly vapor clouds, especially in indoor locations.

“I think the problem is the vapor,” Mo Bay of Hawaiian Holy Smokes said. “Seeing the big puff of smoke is a distraction, especially if you’re in a restaurant eating dinner.”

Some restaurants have banned e-cigarettes, a decision that, for now, is up to individual establishments.

The Hawaii state Department of Health has banned the use of e-cigarettes on all of its premises.  The Honolulu city buses and Consolidated Theatres have done the same.

“We want to encourage companies to pass their own policies to ban use of e-cigarettes on their premises until we can get something through at the state level,” Yamauchi said.

SB 2495 failed in part because it did not have the scientific evidence to back up the general premise that e-cigarettes and tobacco products are comparable and should be regulated in the same manner.

SB2572 attempted to address establishment of an excise tax for e-cigarettes but also did not pass. SB2029 attempted to increase the legal age to purchase tobacco products and e-cigarettes from 18 to 21, but only passed in Hawaii County under county ordinance 13-124.

At the federal level, in 2010, the Federal Drug Administration attempted to regulate e-cigarettes as a “drug” and effectively broaden its definition of “medical device” under the Federal Food, Drug and Cosmetic Act. But that attempt was challenged in court.

Since then, the FDA has made moves to treat e-cigarettes as “new tobacco products.” Under Chapter IX of FDCA, e-cigarettes, like tobacco products, would be “subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions.”

The FDA is taking public comments regarding possible e-cigarette regulation until Aug. 8.