Regulations loom over Wild West freedom of E-cigarette industry

July 18, 2015

BY JULIA HOROWITZ / THE ASSOCIATED PRESS

SACRAMENTO – The Vapor Spot doesn’t immediately conjure images of the Wild West. There’s a curved, neon-backed bar and full-length windows at the downtown Sacramento shop. The high exposed ceilings are decked with orbed light fixtures to give the expansive space a warm glow. Patrons gather in the “vape shop” to smoke electronic cigarettes, inhaling nicotine through a flavored vapor solution, known as “juice.”

It may appear laid back. But there is real muscle beneath the specialty e-cigarette retailer’s trendy skin: a booming billion-dollar industry that has operated largely free of government regulations, ruled almost entirely by small business vigilantes who are making hefty profits.

If it’s not a Wild West, it’s close. But with anti-smoking groups demanding change, government regulations are all but imminent. One California state lawmaker backs legislation that would regulate e-cigarettes as tobacco.

In 2014, there were roughly 25,000 e-cigarette retailers in the U.S., the Stanford Prevention Research Center estimated. But with 1,400 vape shops in California alone, proponents consider it the epicenter of the movement.

“Over the past five years you’ve seen my business grow from zero to hero,” said John “JJ” Jenkins, who left his job as an animator to open The Vapor Spot in Los Angeles in 2010. He now owns four locations.

With a Wells Fargo analysis forecasting the industry will top $10 billion annually by 2017, and big tobacco companies angling to take three-quarters of the market, calls for regulation are growing louder.

R.J. Reynolds announced in February that its Vuse e-cigarette is sold at 100,000 retailers nationwide, and Altria is pushing its MarkTen e-cigarettes while spending millions to buy vapor companies. Altria announced Thursday that it will be working with Philip Morris International to research and develop e-cigarette products.

Anti-smoking groups are outraged that e-cigarettes skirt virtually all oversight.

The industry says e-cigarettes are a new technology that differs from traditional cigarettes and shouldn’t be forced to follow tobacco laws or pay tobacco taxes. E-cigarettes are battery-powered devices that heat liquid nicotine into an inhalable vapor.

The U.S. Food and Drug Administration is weighing regulations that would subject e-cigarette products to federal review and require health warnings on packages.

“Irrespective of the fact that there are small independent players, Big Tobacco is buying up this industry faster than I am speaking,” said California Sen. Mark Leno, D-San Francisco. Leno is pushing legislation that calls for e-cigarettes and its paraphernalia to be regulated as a tobacco product.

Leno said the coveted market for the industry is young people and he points to vapor solutions in flavors like bubblegum that target them. The California Department of Public Health says people 18 to 29 are three times as likely to use e-cigarettes as those 30 and older; the Centers for Disease Control says e-cigarette use tripled among middle and high school students from 2013 to 2014.

California’s only state law regulating e-cigarettes forbids selling them to minors.

Proprietors say they do not target minors, instead focusing on claims that vaping helps smokers quit traditional cigarettes.

James Uy, 30, who manages Planet of the Vapes in Sacramento, said vaping has helped him reduce his nicotine use after having smoked a pack a day since childhood.

“Vaping gave me a little hope,” he said, standing near a display touting peanut butter crunch juice as the “flavor of the day.”

Blogs are filled with testimonials from longtime smokers who say they’ve kicked the habit. Adherents also tout the social environment of vapor bars, which serve as informal support groups. Some even use e-cigarettes in place of marijuana.

“Instead of always smoking weed I needed to have some flavor in my life, so I decided, OK, I’ll hit up vapes,” said Fallon Ferguson, 18, who said she has been vaping for about a year.

The industry offers a textbook case for studying the effects of government regulation.

On one hand, vaping is seeing unfettered innovation without the burden of bureaucracy. New products hit stores almost weekly. Proponents say vaping is experiencing a “technology boom,” and is much more Silicon Valley than hippy Haight-Ashbury.

“Products that we had two years ago are pretty much considered dinosaurs compared to what’s out right now,” said Scot Taylor, 26, who manages The Vapor Spot’s Sacramento location.

But self-regulation only goes so far. Supporters pride themselves on vigilante justice that calls out shady operators on message boards but acknowledge the rumors about unclean products made in bathtubs and garages.

“I wouldn’t be mad if they’re going to regulate the juices,” Uy said.

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Vaping etiquette: where can you legally vape?

Vape — it may be Oxford Dictionary’s word of the year, but you’d need a paralegal to parse the law on where it’s OK, illegal, or just plain rude to use an e-cigarette or other vaporizer.

These small, battery-powered devices create an inhaled mist of usually liquid nicotine, flavoring, or sometimes medical and recreational marijuana. And they’ve rapidly grown in popularity over the last five years, even as tobacco smoking rates have decreased.

Meanwhile, social norms and the law have failed to keep pace with folks blowing vapor clouds in city hall, airports, airplanes and elevators.

“I’ve seen it happen in crowded restaurants,” said Dale Gieringer, vaporizer researcher and longtime cannabis advocate for California NORML. “I have sneaked tokes all sorts of places where you know it might have been prohibited.”

Consequently, there’s a new legal trend in restricting or banning vaping. It started with small organizations — transit agencies, colleges — and has since percolated up to major cities like San Francisco and Los Angeles. This year, a ban on vaping wherever tobacco smoking is prohibited may become California law under San Francisco Senator Mark Leno’s pending SB 140.

Right now, only one statewide law covers vaping — a restriction on sales of e-cigarettes to children.

SB 140 would radically alter the vape landscape, a Senate analysis finds, broadening the definition of “tobacco product” to include “e-cigarettes” and “other electronic devices that deliver nicotine or other substances.”

San Francisco passed a similar law in 2014. Vaping defenders call the trend a case of policymakers getting ahead of the science. For one, vaping is not smoking, and the scientific evidence for equating all vape activity to smoking doesn’t exist, they say.

“This gives the wrong message that vaping is comparable in danger to smoking and there’s just no solid scientific basis for that at all,” Gieringer said.

Even so, kids are trying e-cigarettes at alarming rates, health officials say. “[E-cigarettes] have the potential to re-normalize smoking behavior and tempt a new generation of youth and young adults into the cycle of nicotine addiction,” writes Corey Egel in the California Department of Public Health’s office of public affairs.

Public Health plans to spend $18 million in tobacco taxes over the next two years discouraging youth e-cigarette use, Egel stated.

Leno’s SB 140 is up for debate in the legislature this month, along with at least three other vape-related bills. The law is also quickly changing at the county and city level. Below, we do our best to provide what the law says and then a dose of common sense.

Can I vape nicotine alone in my house that I own?
‘Yes’, state officials say. Unless your house shares a wall with another residence, in which case, ‘maybe’ — local anti-smoking laws may apply to vaping and prohibit it in apartment complexes and condos. That’s the case in Berkeley, said Northern California Smoke-Free Alternatives Trade Association spokesperson Stefan Didak.

Can I vape nicotine in my apartment?
Maybe. The state says it’s ok, but local laws bout shared walls as well as landlord rules may apply.

Can I vape on the sidewalk?
Generally yes. But El Cerrito, CA. is considering a bill to ban vaping on sidewalks, Didak said.

Can I vape while driving a car?
Yes, it’s legal, but Didak said vapers have reported being pulled over on suspicion of drugged driving.

Can I vape in the business that I own?
At the state level, it’s legal. But local laws may apply. Not in San Francisco, L.A. and elsewhere.

Can I vape in the business that I work at or patronize?
At the state level, it’s legal. But local laws may ban it, or the business owner may refuse it.

“I would not recommend vaping in a restaurant — it has the same effect as wearing heavy perfume. It’s just bad form,” Didak said.

“The general rule is to be discreet and if you’re not going to be discrete, then make an arrangement with the owner,” said Gieringer.

Can I vape in public buildings like City Hall or a Rec Center?
At the state level, it’s legal. But local laws may ban it, and Didak recommends not doing it.

Can I vape in the airport?
At the state level, it’s legal. But local laws may ban it. The airport may ban it. Interestingly, the FAA recommends no vaping on planes but it’s up to the individual airline, Egel stated. Vaping rules alsovary by state.

Can I vape on the bus/train/cab?
Not in San Francisco and many other cities. BART banned vaping in February, and the SFMTA did it in March. Vaping in a San Francisco taxi can result in an $85 fine.

Can I vape in public parks?
At the state level, it’s legal. But local laws may ban it. The ban is subject to enforcement, however, and vaping is very discreet. Again, don’t bother people.

Can I vape in a church?
At the state level, it’s legal. But local laws or the pastor and common sense can ban it. Depends on the church.

Can I vape in a daycare?
At the state level, it’s shockingly legal. But local laws or the day care provider may ban it. Under state law, adults may not furnish e-cigarettes to children.

Can I vape at a public school or a university?
Legal at a state level, but likely against the rules of the school district or university.

What about all of the above vape questions as they pertain to medical cannabis vaping?
All medical cannabis vaping is federally illegal, quasi-legal at the state level, but subject to local restrictions or immunity. It really depends. Call a lawyer.

Sen. Leno wrote us saying that SB 140: “does not affect any current laws or regulations regarding medical cannabis. In fact, the bill includes language, which is identical to San Francisco’s e-cigarettes ordinance, explicitly clarifying that there is no impact on the existing state restrictions that already apply to medical marijuana.”

Bottom line: “Do not try and be obnoxious on purpose,” said Didak. “Do not excessively blow clouds in areas where there are a lot of people who might not have seen it before or be wondering whether it’s toxic or might have been influenced by what’s going on in the media and might run and hide,” said Didak. “Ask for permission first and if they say ‘No’, that’s the rules. Private property rights should be respected.

It’s all about context. Are you at a dab bar in Venice Beach, or an antique store in Pleasanton?

“California not only has the most non-smokers but a majority of anti-smokers,” Didak said.

“Just be polite,” said Gieringer. “‘Use common sense’ is always the rule for anything. We don’t need a law about that.”

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E-cig business surveys customers on why they vape

By JOHN REID BLACKWELL Richmond Times-Dispatch

While the public health community continues to debate the pros and cons of electronic cigarettes, one Richmond-area e-cig company has surveyed its customers to shed light on why they use the devices.

Avail Vapor LLC, a fast-growing Chesterfield County-based retailer of e-cigs, said it conducted a two-week survey that drew 8,500 responses, about half of them its own customers.

James Xu, the co-founder and co-owner of Avail, said the survey results shed light on some of the key questions about e-cigs in the ongoing public health debate, such as whether the devices are a “gateway” to using conventional tobacco products, and whether e-cig users — known as “vapers” — typically use them exclusively or in combination with conventional tobacco products.

Avail said 94 percent of the survey respondents already used tobacco products before starting e-cigs, with the length of time they used conventional products varying widely from less than one year to more than 30 years.

Only 5.8 percent of survey respondents said they started using e-cigs without using traditional tobacco products first.

Almost 80 percent of the survey respondents said they started using e-cigs as a way to quit using conventional tobacco products, and 85 percent said they did quit using conventional tobacco products, with 69 percent quitting within a month.

About 13 percent said they had reduced their consumption of conventional products.

The company’s survey indicates that e-cigs are “not a gateway to traditional smoking,” Xu said. “The data shows it is a one-way street.”

“We don’t see much dual use,” of both e-cigs and conventional products, he said.

Avail plans to submit the survey results to the U.S. Food and Drug Administration, which is considering how it should regulate e-cigs and may issue rules in June. The agency is planning a public meeting on June 1 and June 2 to collect more information and “stimulate discussion among scientists about electronic cigarettes.”

The FDA has published a list of about 50 questions that it wants to have answered about e-cig use. Avail said it adapted its survey questions from the FDA’s list.

“We decided we would like our customers to voice their opinions,” said Maggie M. Gowen, director of communications for Avail, which has 43 e-cig shops in the Southeast and is planning to open more stores. Avail has seven stores in the Richmond area.

“We felt like it was important that we take some sample data and present it to the FDA,” Xu said. “How they use it, or not, we have no control over.”

The Avail survey was divided about evenly between respondents from the company’s database of store customers, and other respondents from social media sites where a link to the survey was posted.

Because the survey was limited to people over the age of 18, it did not address questions about youth e-cig use — a major concern for the FDA. Instead, the survey focused on why adults use the products.

In regulating e-cigs, the FDA has to consider not only how the products might affect individual users, but what impact they might have on the whole population, such as encouraging more nicotine use, for example.

E-cigs have been controversial in part because the nicotine solutions that are used in the devices are sold with variety of added, artificial flavorings, including sweet and fruity flavors. Critics of the industry say that makes vaping more attractive to children and that flavors should be restricted or banned.

The Avail survey indicates that flavors are important to adult vapers. More than 70 percent said they consider it “very important” to have a variety of flavors to choose from.

Xu said the survey also indicates that most e-cig users gradually reduce nicotine consumption. Almost 76 percent said they started vaping with higher levels of nicotine in their e-cig devices but cut back over time. Only 2 percent said they increased nicotine intake.

Avail said the largest age group of people who responded to the survey were ages 30 to 39 (28.8 percent), followed by ages 21 to 29 (27.9 percent). Less than 10 percent of those surveyed were 18 to 20.

E-cigs are still relatively new products, and the long-term health effects and quit rates associated with them is unknown. More research such as the Avail survey is needed, said Scott Ballin, an independent health policy consultant who works on tobacco regulation issues.

“Things are changing so rapidly these days,” he said. “No one anticipated this explosion of e-cigarettes. It was a fad for a while and now all of sudden the market is being flooded with them.”

“There needs to be more information and more data,” he said.

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Task Force Recommendations Address E-Cigs — And Their Role In Quitting Smoking

Jenna Birch May 7, 2015

E-cigs: More helpful than harmful, or the other way around? 

Tobacco use causes 480,000 deaths each year in the U.S., consistently topping causes of preventable death. To that end, it’s no surprise experts say quitting smoking is one of the best things you can do for your health. So, the real question is: How do you do so effectively?

Apparently, the U.S. Preventive Services Task Force‘s updated recommendations on tobacco cessation interventions are a good place to start. This week, the American Lung Association tipped its hat to the new recommendations, which involved having doctors ask patients about their smoking habits and providing resources for helping them quit. And, for the first time ever, the USPSTF also reviewed the influx of recent scientific studies on usage of e-cigarette usage, otherwise known as electronic nicotine delivery systems (ENDS). 

For now, the USPSTF concluded there is not enough evidence to determine whether e-cigs are more helpful or harmful for smokers trying to quit, and prompted doctors to stick with proven smoking cessation techniques.

“E-cigarette companies have been making claims that they can help smokers quit,”Erika Sward, assistant vice president of National Advocacy for The American Lung Association, tells Yahoo Health.“The FDA has not found any e-cigarette is safe and effective to help smokers quit. We’re seeing a lot of dual use, smokers using e-cigarettes when they can’t use other tobacco products.”

Sward says roughly 77 percent of recent e-cigarette users also use traditional tobacco cigarettes. The Lung Association is also concerned with the number of teens dabbling in e-cigarettes. For this demographic, trying these devices out has tripled in one year’s time.

Even though e-cigs are consistently in the news, there’s still a lot of misinformation about what they are and what they do. With nearly 500 brands, it’s impossible to make generalizations about safety — or even tell exactly what’s in a solution, since it varies across devices. As for the “vapor” that supposedly comes from e-cigarettes? “The Lung Association is very careful never to use the word ‘vapor,’”Sward says. “We use aerosol. Vapor implies water, and the substance is not water.”

Much of the confusion surrounding e-cigarettes is due to the lack of regulation, leading to an overwhelming amount of emerging research and lots of opinions on safety. “It’s been compared to the Wild, Wild West out there,”Sward says. E-cig worries range from inhaling substances like metals and propylene glycol; vaping at higher voltages, which increases toxins released; and the effects of secondhand carcinogen emissions, like formaldehyde.

Ultimately, Sward says the confusion will likely continue until the President pushes through the Deeming regulationthat allows the FDA to step in and start overseeing additional tobacco products besides cigarettes.

There have been numerous delays in that legislation, but finally allowing the FDA authority over these products may provide needed clarity. In January, U.S. Surgeon General Dr. Vivek Murthy remained open to the possibility of using e-cigarettes for specific, special cases. Some research, like this 2013 JAMA study, showed certain e-cigs may be as effective as the patch at helping smokers quit.

“There’ve been theories and ideas around the fact that e-cigarettes may be helpful from a harm-reduction perspective in helping people who are already on cigarettes (that) have had trouble quitting actually get off cigarettes,”he said. “If the data indeed bears that out, then I think we should absolutely embrace that and use e-cigarettes in targeted ways.”

While it’s tough to make a final judgment about which ENDS products may or may not be effective for cessation, Sward does say research is indicating they’re not a fully safe solution — even if they might be safer than traditional smoking.

“Using cigarettes is kind of like jumping off a 50-story building,”she says. “E-cigarettes are not a no-risk product. We just don’t know what story [those users] are jumping off.”

While e-cigarettes are not currently recommended to cut out smoking altogether, there are other accepted, science-backed routes to quitting, says Sward —although not one-size-fits-all. A smoking cessation plan begins in the doctor’s office, so talk to your primary-care physician about how you can drop the habit.

“The Lung Association was pleased to see evidence-based tobacco interventions,” Sward says. “Those were affirmed again. People have to have access to all seven FDA-approved medications, combined with counseling. We also need to eliminate the hurdles to helping smokers quit, like copays and step therapies.”

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Nicotine Levels and Presence of Selected Tobacco-Derived Toxins in Tobacco Flavoured Electronic Cigarette Refill Liquids

Published: 24 March 2015

Abstract

Background: Some electronic cigarette (EC) liquids of tobacco flavour contain extracts of cured tobacco leaves produced by a process of solvent extraction and steeping. These are commonly called Natural Extract of Tobacco (NET) liquids. The purpose of the study was to evaluate nicotine levels and the presence of tobacco-derived toxins in tobacco-flavoured conventional and NET liquids. Methods. Twenty-one samples (10 conventional and 11 NET liquids) were obtained from the US and Greek market. Nicotine levels were measured and compared with labelled values. The levels of tobacco-derived chemicals were compared with literature data on tobacco products. 

Results: Twelve samples had nicotine levels within 10% of the labelled value. Inconsistency ranged from −21% to 22.1%, with no difference observed between conventional and NET liquids. Tobacco-specific nitrosamines (TSNAs) were present in all samples at ng/mL levels. Nitrates were present almost exclusively in NET liquids. Acetaldehyde was present predominantly in conventional liquids while formaldehyde was detected in almost all EC liquids at trace levels. Phenols were present in trace amounts, mostly in NET liquids. Total TSNAs and nitrate, which are derived from the tobacco plant, were present at levels 200–300 times lower in 1 mL of NET liquids compared to 1 gram of tobacco products.

Conclusions: NET liquids contained higher levels of phenols and nitrates, but lower levels of acetaldehyde compared to conventional EC liquids. The lower levels of tobacco-derived toxins found in NET liquids compared to tobacco products indicate that the extraction process used to make these products did not transfer a significant amount of toxins to the NET.

**** Overall, all EC liquids contained far lower (by 2–3 orders of magnitude) levels of the tobacco-derived toxins compared to tobacco products.

Keywords: electronic cigarette; tobacco; nitrosamines; aldehydes; nitrates; phenols; nicotine

(View the full research article HERE)

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