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E-cigarettes: effective cessation tools or public health threat?

Jan 1st, 2016
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L. Clancy1 and K. Babineau1
From the 1TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Kevin Street, Dublin 8, Ireland
Address correspondence to Prof Luke Clancy, TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Kevin Street, Dublin 8, Ireland.
email: lclancy@tri.ie

In a short time, electronic cigarettes have become a multi-billion dollar industry. Since their introduction to the market, prevalence of ever-use among smokers in the USA appears to have increased from 2% in 2010 to >30% in 2012, and the rate of increase appears to be similar in the United Kingdom, Ireland and other Western countries according to a special Eurobarometer survey in 2014.1 The e-cigarette market is estimated to be worth over $3 billion. However, there is no consensus on the role of e-cigarettes and their contribution to the provision of smoking cessation (SC) services, nor to global tobacco control.

At the Conference of the Parties to the WHO Framework Convention on Tobacco Control in September 2014, the secretariat presented a report outlining the current facts concerning ecigarettes, put forth an opinion on these devices, and offered considerations on options for regulation.2 This was on the tail of two contrasting letters to Margaret Chan, Director General of the WHO, submitted by scientists from many disciplines including tobacco control, public health, epidemiology, pharmacology and the clinical sciences (Letters to Dr Chan; June 2014). One letter stated that e-cigarettes offer huge prospective gains by reducing the prevalence of cigarette smoking and subsequently, the harm done by smoking. Those in favour of this position therefore requested support for the introduction and widespread availability of e-cigarettes. The other letter cautioned restraint, citing the possible damage that e-cigarettes could have on tobacco control.

For those favouring the widespread proliferation of ecigarettes, the main considerations appear to be the efficacy and safety of e-cigarettes with regards to SC and potential for harm reduction. For those cautioning restraint the main consideration seems to be the possible effects these products may have on broad tobacco control measures such as smoking prevalence among children and young people, the possibility of relapse among ex-smokers, the impact on smokefree laws, the effects on advertising and sponsorship and the feared influence of the tobacco industry. Although both groups are, of course, concerned about all these issues, the discourse suggests that priorities may be somewhat different for different scientists.

So what does the evidence say? On the whole, it remains inconclusive.

With regard to the potential efficacy of e-cigarettes as a smoking cessation tool, two randomized controlled trial (RCT) studies suggest that e-cigarettes may be helpful. One study found that e-cigarettes containing nicotine are as effective as nicotine patches for smoking cessation when used as directed.3

In this study [n¼657], one group of participants received vouchers for nicotine patches by post and were encouraged to use them, while the other groups were given e-cigarettes—one with and one without nicotine. In another RCT [n¼300], smokers were randomized to three groups (patches, e-cigarettes with nicotine, e-cigarettes without nicotine). This study found that at 2, 4 and 12 weeks, there was a statistically significant difference between the two groups with e-cigarettes containing nicotine and the group with non-nicotine containing devices. However, there was no difference between the groups with regard to the overall reduction in the number cigarettes smoked at 24 or 52 weeks.4 In addition to these, there are many other small-scale trials, some of which show positive and some of which have negative results which may be considered inconclusive. These studies often address particular aspects of efficacy which are of concern (e.g. efficacy in key sub-populations), but they do not resolve the overall question of the efficacy of e-cigarettes for cessation. An interesting ‘real world’ study which was part of the continuing English Smoking Toolkit Study found that ecigarette users had a better quit rate than those who used ‘over the counter’ nicotine replacement products, or than those who succeeded in quitting without any form of nicotine.5 The survey reports high e-cigarette use among ex-smokers, which raises questions regarding the role of e-cigarettes in maintaining abstinence or as a gateway to relapse.

The approach to establishing safety has included demands for accurate information on e-cigarette contents and basic ingredients, which was initially very limited but is now increasing thanks to labelling by makers and analysis by independent scientists.

However, the wide range of available devices (some estimates exceed 500 variants) reduces confidence that the contents are reliably known. For the purpose of this article, only nicotine containing devices are relevant to this discussion.

Within these products, the main constituents are reported to be nicotine, propylene glycol, glycerine and flavours which of course when vaporized are released as particles of varying sizes which have not been well characterized. Particle size may be a consideration in itself, distinct from the actual composition of the particles. All of these substances have toxicity and when vaporized are inhaled into the lungs and released into the atmosphere.

The relevance of animal studies showing potential toxicity from e-cigarettes are uncertain but to date, they are thought to be low.6 At least two human-based studies show acute but mild toxicity on lung function: one demonstrates an increase in airway resistance with active e-cigarette usage7 and one indicates a decrease in FEV1/FVC ratio, but only in passive exposure to e-cigarettes.8 It is too soon to be confident about long-term toxicity. A knowledge of the constituents indicates that the effects may not be severe, with one estimate suggesting that in comparative terms it may be as little as 5% that due to cigarette smoking.9 However, this estimate is based on a modelling study where the inputs for the effects of e-cigarettes are reported to be largely unknown for these relatively new devices.

The possible long-term effects on tobacco control are also largely unknown. Prevalence studies referred to earlier suggest that adolescences and young adults are using e-cigarettes in increasing numbers.10 Most studies find that young people who use e-cigarettes also use tobacco products, though there are instances where young people try e-cigarettes without having tried tobacco.11 The possible gateway effect to cigarette smoking is not resolved. Studies conducted in the UK have not shown a link to date but research from the USA is starting to indicate that e-cigarettes may serve as a gateway in some circumstances. 12, 13

The effects that e-cigarette use may have on smokefree laws are no less complex. Many purport that the vapour released from e-cigarettes is harmless and therefore should not be banned in indoor/public places. However, the possibility that the vapour may be confused with smoke has led some authorities to ban ‘vaping’ where smoking is banned with the aim of ensuring continued support for Article 8 of the WHO FCTC and avoiding the confusion that e-cigarette use in public may affect attitudes and implementation of smokefree laws. Countries contemplating policies towards the tobacco ‘endgame’ (e.g. Ireland, Finland, Scotland, New Zealand and Singapore) are also grappling with the policy implications that e-cigarettes may have on smokefree legislation.14

Perhaps the greatest challenge that e-cigarettes may pose for tobacco control would be the actions and reactions of the tobacco industry. With the e-cigarette market, we see a revival of the difficulties that marketing, advertising, sponsorship and promotion of cigarettes posed for tobacco control and that were subsequently reflected in WHO FCTC Article 13. Perhaps even more concerning is the threat posed by the consequences of ownership of a large and seemingly increasing proportion of the e-cigarette industry by the tobacco industry, which directly challenges implementation of WHO Article 5.3, requiring governments to refuse the tobacco industry access to policy formation in public health and is regarded among the most important of tobacco control measures. It seems possible that the proposed provisions of the Transatlantic Trade and Investment Partnership (TTIP) may also be used to threaten TC. In the European Union, multinational corporations may try to use TTIP to challenge the EU Tobacco Products Directive regulations on e-cigarettes, further muddling the already unclear circumstances surrounding the right of Member States to legislate for public health of their citizens.

Data to support or refute these growing hopes for, or concerns regarding, e-cigarettes are yet not available and will likely not become available during this rapidly evolving situation.

History, however, suggests caution. Both in Europe and the USA, efforts by scientists to collaborate with the tobacco industry in the 1950s, 1960s and 1970s to find safer nicotine delivery devices had the net effect of only delaying the inevitable conclusion that the tobacco industry’s aims are incompatible with public health.15, 16 Will history repeat itself with this new, sophisticated, less toxic device or will public health learn the lessons from history and reject the extravagant hopes placed in a technology which, at its most benign can be seen as another nicotine replacement therapy with unpredictable prospects of success?

Funding

The authors, Prof Luke Clancy and Dr Kate Babineau are employed and funded by Tobacco Free Research Institute Ireland (TFRI), Dublin.
Conflict of interest: None declared.

References

1. TNS Opinion & Social. Special Eurobarometer 429. Attitudes of Europeans towards tobacco and electronic cigarettes. 2015 [Online]. http://www.thehealthwell.info/node/870442.
2. Conference of the parties to the WHO Framework Convention on Tobacco Control. Electronic nicotine delivery systems, including electronic cigarettes, Moscow. http://apps.who.int/gb/fctc/PDF/cop6/FCTC_COP6_Report-en.pdf (13–18 October 2012, date last accessed).
3. Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet 2013; 382:1629–37.
4. Caponnetto P, Campgna D, Cibella F, Morjaria JB, Caruso M, Russo C, et al. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One 2013; 8: e66317.
5. Brown J, Beard E, Kotz D, Michie S, West R. Real-world effectiveness of e-cigarettes when used to aid smoking cessation: a cross-sectional population study. Addiction 2014; 109: 1531–40.
6. Hajek P. Electronic cigarettes: review of use, content, safety, effects on smokers and potential for harm and benefit. Addiction 2014; 109: 1801–10.
7. Chorti M, Poulianti K, Jamurtas A, et al. Effects of active and passive electronic and tobacco cigarette smoking on lung function. Abstracts/Toxicol Lett 2012; 21: 64.
8. Vansickel AR, Cobb CO, Weaver MF. A clinical laboratory model for evaluating the acute effects of electronic cigarettes: nicotine delivery profile and cardiovascular and subjective effects. Cancer Epidemiol Biomark 2010; 19: 1945–53.
9. Grana R, Benowitz N, Glantz SAE-. cigarettes a scientific review. Circulation 2014; 129: 1972–86.
10.Cooper M, Case KR, Loukas A. Ecigarette use among Texas youth: results from the 2014 Texas Youth Tobacco Survey. Addict Behav 2015; 50:173–7.
11.Babineau K, Taylor K, Clancy L. Electronic cigarette use among Irish youth: a cross sectional study of prevalence and associated factors. PloS One 2015; 10: e0126419.
12.Dutra LM, Glantz SA. Electronic cigarettes and conventional cigarette use among US adolescents: a cross-sectional study. JAMA Pediatr 2014; 168: 610–7.
13.ASH. Electronic cigarettes (also known as vapourisers). A Briefing. 2014. http://www.ash.org.uk/files/documents/ASH_715.pdf
14.Beaglehole R, Bonita R, Yach D, Mackay J, Reddy KS. A tobacco-free world: a call to action to phase out the sale of tobacco products by 2040. Lancet 2015; 385: 1011–8.
15.Berridge V. Marketing Health. Smoking and the discourse of public health in Britain, 1945-2000. Oxford University Press, Oxford, 2007.
16.Parascandola M. Lessons from the history of tobacco harm reduction: the National Cancer Institute’s Smoking and Health Program and the “less hazardous cigarette”. Nicotine Tob Res 2005; 7: 779–89.

Electronic Cigarette Executives Get Schooled in Senate Hearing

Jun 18th, 2014
by Editor.
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“I think we have seen this movie before,” Senator Richard Blumenthal said. “It is called big nicotine comes to children near you and you are using the same kinds of tactics and promotions and ads that were used by big tobacco and proved so effective”

http://time.com/2896962/electronic-cigarette-executives-get-schooled-in-senate-hearing/

In a hearing Wednesday afternoon that harkened back to the famous congressional Big Tobacco hearings two decades ago, Senators on the Commerce, Science and Transportation Committee eviscerated electronic cigarette executives Jason Healy, CEO of blue eCigs (owned by tobacco company Lorillard), and Craig Weiss, CEO of NJOY, leaders of the two leading e-cig brands.

The hearing was on the marketing practices by the electronic cigarette industry, which the Senators said appeals directly to kids, a lift straight from the tobacco industry’s playbook, when it began in the 1950s to try and hook young people early to addictive nicotine. Though nicotine is not the carcinogenic ingredient in tobacco cigarettes, it is the culprit behind why so many continue to smoke, and it’s hardly a benign substance either. Nicotine is highly toxic on its own, and there has recently been an increase in calls to poison control centers after contact with electronic cigarette liquid containing nicotine. Nor is the substance good for the developing teen brain.
The Senators and those offering testimony at the hearing, which included electronic cigarette executives and representatives from public health organizations, were in agreement that electronic cigarettes should not be sold to kids under the age of 18. At issue was whether the marketing practices employed by electronic cigarette makers, which are currently unregulated by the federal government, were designed to appeal to kids.

At the hearing, the e-cigarette executives were skewered by the Senators who had the facts on their side. A recent CDC report showed that the use of electronic cigarettes by middle school and high school students doubled from 2011 to 2012. The same survey showed that more than 1.78 million middle and high school students nationwide have tried electronic cigarettes. A recent American Legacy Foundation report found that last year 14 million kids saw ads for electronic cigarettes on TV, 9.5 million saw them in print.

A study from RTI International and the Florida Department of Public Health published in the Journal of Pediatrics showed that exposure to electronic cigarette advertising jumped 256% from 2011 to 2013 among adolescents aged 12 to 17. Mr. Healy’s company, blu eCigs was found responsible for almost 82% of the ads that reached that age group.

Slumped in their chairs, the beleaguered executives, Mr. Weiss and Mr. Healy, argued that their marketing was not directed at kids, but adults. Electronic cigarettes, both men argued, are designed to entice those who already smoke to use the product, claiming they are a valuable public health tool to help wean the 40 million adult smokers off of deadly cigarettes. “It is our corporate mission to [make] obsolete the combustion cigarette,” Weiss testified.

“Every time I use an e-cigarette instead of a combustible cigarette, that’s a good decision,” said Mr. Healy, a smoker who “vapes” (inhales through the e-cigarette vaporizer).

Healy and Weiss aren’t wrong that electronic cigarettes hold promise to improve the nation’s well-being if they can get America’s smokers off of combustible cigarettes–a view held by many in public health. Scientific research has not yet determined how or whether electronic cigarettes can really get people to quit smoking, but it is a technology we should embrace to see if it can. As Mitch Zeller, head of the FDA’s Center for Tobacco Control has said: “We have to have an open mind on the potential for these emerging technologies to benefit public health.”

But Senators including Richard Blumenthal (D-Connecticut) and Amy Klobuchar (D-Minnesota), both former prosecutors, undermined those health promotion claims during cross-examination, calling into question the brands’ use of celebrities, social media, free cigarettes, and TV and print advertisements in major television markets (NJOY advertised during the Super Bowl), and flavors that appeal to kids.

“The only difference between your testimony today and testimony of the tobacco executives is that you are not under oath,” said Senator Blumenthal. “I find in your testimony a sense of denial that I cannot credibly accept because it is defied by the numbers. 18 million teens were exposed to blu’s print TV ads in 6 months and NJOY’s ads reached 3 million teens [these statistics come from the American Legacy Foundation report]. There is a legal principle that people are responsible for the natural and logical effects of what you do, and you know that you are reaching children.”

“I think we have seen this movie before,” he continued. “It is called big nicotine comes to children near you and you are using the same kinds of tactics and promotions and ads that were used by big tobacco and proved so effective.”

Holding up a picture of Robert Pattinson, the star of the popular Twilight films, vaping an NJOY, Blumenthal asked Weiss, “Do you deny he is designed to appeal to teens?”

“He’s a 28 year old adult smoker,” Weiss replied. “Are you saying if they are older than 18, they have no impact on people under 18?”

“Our target is to reach adult smokers,” said Weiss.

Senator Klobuchar took over the same line of questioning. “Have you gone to the Twilight movies, Mr. Weiss? I’ve been to those movies with my daughter, who is 16, and I can tell you, in those theaters, the people in there are kids…[Pattinson] is an adult smoker that appears in movies that appeal to kids. That’s what matters to me.”

Klobuchar continued, “I’ve got to tell you that most people over fifty are not going to know Robert Pattinson. Justin Bieber is over 18, someone put him out there, I don’t think anyone is going to think [he is being] marketed to adults. This is my exhibit D, that heavy duty marketing [efforts] go on to youth.”

Another tense moment occurred between Senator Barbara Boxer from California, who grilled Weiss and Healy about flavored e-cigarettes.

Weiss and Healy both contended that having different flavors available appeals to adults, too. Some Senators referred to a website sponsored by blu’s parent company, Lorillard, stating that flavors like “cherry” and “vanilla” make children vulnerable to electronic cigarettes. Healy responded that the average age of a consumer using blu’s cherry flavor is in the high 40s. The average overall consumer of blu eCigs is 51, said Healy.

Responding to questions from Senator Boxer (D-California) about the flavors NJOY plans to introduce, Weiss made a slip, saying “for adults, we have single malt scotch.”

“Adult flavors?” said Boxer. “As opposed to those for children.” Weiss continued nervously, attempting to remember the new flavors off the top of his head: “In addition, there’s vanilla bean, there’s also peach tea, there’s also, um…”

At the end of her time to question, Boxer said: “Mr. Healy and Mr. Weiss, you can con yourself. But we don’t know if this product gets people off cigarettes yet, so don’t think you are doing some great mission. Don’t say you care about kids,” said Senator Boxer. “Don’t be a part of this, because you’ll regret it.”

But the harshest words came from Senator Jay Rockefeller (D- West Virginia), who said to the executives: “I’m ashamed of you. I don’t know how you go to sleep at night. I don’t know what gets you to work in the morning except the color green of dollars. You are what is wrong with this country.”

New e-cig ad pushes the line: Friends don’t let friends smoke but vaping is OK

Jan 3rd, 2014
by Editor.
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2014 is expected to be the Year of the E-cig, as manufacturers race regulators to the wire

https://www.consumeraffairs.com/e-cigarette-warnings-and-lawsuits?page=2

Friends don’t let friends drive drunk. And now, a new ad campaign tells us they don’t let them smoke either. Ah, but there’s a catch, as the NJoy ad has it: Friends do let friends vape.

“For everything friends do for each other,” a voiceover says. “This new year return the favor. Friends don’t let friends smoke. Give them the only electronic cigarette worth switching to: the NJoy King.” It concludes with the tagline: “Cigarettes, you’ve met your match.”

Marketers are expecting 2014 to be the Year of the E-cig, as Big Tobacco moves into the business in a big way. And the NJoy ad takes more than a few leaves from Big Tobacco’s playbook.

Most obviously, it glorifies vaping, just as the Marlboro Man, before he succumbed to lung cancer, epitomized the rugged outdoorsish qualities of Marlboros.

It also comes tantalizingly close to making health claims for e-cigs, which could get a not-so-pleasant reaction from the Food and Drug Administration (FDA) and other agencies that regulate advertising, since the clear implication of the NJoy ad is that puffing away on an e-cig is healthier than smoking a traditional tobacco cigarette.

It’s illegal to make health claims that are not substantiated by scientifically sound evidence, which so far is somewhat scant in the case of electronic cigarettes. The NJoy ad is playing the same game Big Tobacco played for years, before broadcast tobacco advertising was finally banned altogether — surrounding its products with happy, healthy, spirited young people.

“We do not advertise e-cigs as a smoking cessation device,” a company spokesman said in a statement to AdAge, an advertising trade journal. “However, a unique aspect of the NJOY video is that we are appealing to the friends & loved ones of smokers — asking them to leverage the fundamental connection and emotional bond of love that bring us all together and strengthens our trust/intimacy. Everyone can identify with the desire to help our friends & loved ones become the best versions of themselves, and goal (especially in the new year!) to strive to be better versions of ourselves.”

Whether that statement cuts much ice with regulators remains to be seen. Probably the exclamation mark won’t help too much.

Big bucks

Just to be clear, the e-cig industry is not in this for its health, or anyone else’s. Big bucks are at stake. E-cig sales are expected to hit $1.7 billion this year, assuming the FDA doesn’t shut the market down or severely curtail it.

The agency has said for more than a year that it is considering new e-cig marketing regulations, possibly including new rules on television advertising, although an outright ad ban may not be in the cards without Congressional action.

Tobacco TV commercials have been banned for 40 years but the tobacco companies worked to build their brand identities before the ban took effect, and most of the major brands have survived to this day on the basis of history, habit and other forms of advertising and promotion.

Big Tobacco — Altria, Reynolds American and Lorillard — have waded into the e-cig market in a big way and are expected to use the same technique to build their electronic brands before the government bestirs itself.

Tired of waiting for the feds, New Jersey, North Dakota and Utah, among others, have already banned vaping indoors. As one of his final acts, former New York City mayor Michael Bloomberg signed a similar measure. But the states and cities have no effective way to control national advertising, so the indoor vaping bans are, at the most, petty annoyances to the e-cig industry.

Electronic Cigarette Maker To Stop Deceptive Marketing and Sales To Minors

Aug 5th, 2010
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Company claimed product that includes nicotine contained no carcinogens

https://www.consumeraffairs.com/e-cigarette-warnings-and-lawsuits?page=2

Sottera, one of the country’s largest electronic cigarette producers has agreed to stop targeting minors and claiming that electronic cigarettes are a safe alternative to smoking.

“Electronic cigarette companies have targeted minors with fruit-flavored products and misleading claims that their products are safe,” said California Attorney General Edmund G. Brown Jr. “This settlement will stop Sottera from marketing these dangerous and addictive products to kids.”

Brown and Sottera reached the settlement without litigation based on Sottera’s willingness to adopt measures that address Brown’s concerns about the dangers of its electronic cigarettes. In January this year, Brown filed suit against the nation’s other leading e-cigarette retailer, Smoking Everywhere. That lawsuit is proceeding in Alameda County Superior Court.

E-smokes

Electronic cigarettes, or e-cigarettes, are battery-operated devices with nicotine cartridges designed to look and feel like conventional cigarettes. Instead of actual smoke, e-cigarettes produce a vapor from the nicotine cartridge that is inhaled by the user. Sottera and other electronic cigarette makers have claimed in advertisements and other marketing materials that the e-cigarettes have no carcinogens, no tar, no second-hand smoke, and are therefore safe.

However, the U.S. Food and Drug Administration (FDA) has determined that electronic cigarettes contain a variety of dangerous chemicals, including nicotine, carcinogens such as nitrosamines and, in at least one case, diethylene glycol, commonly known as antifreeze.

The products are often marketed with advertisements, and flavors like strawberry, chocolate, mint, banana and cookies-and-cream, that are designed to appeal to a youthful target audience.

Ending phony claims

The settlement prohibits Sottera from marketing to minors and from making false or misleading claims about electronic cigarettes. Specifically, the company has agreed that it will not:

• Sell electronic cigarettes to minors. Its website will be age-restricted, and a customer will need to provide a government ID before making a purchase. Retail products will be behind a counter. Any advertising will note the age restriction.

• Sell flavored electronic cigarette cartridges, such as strawberry, mint or bubblegum, that could appeal to minors.

• Advertise its product as a smoking cessation device unless the FDA approves it as such.

• Sell cartridges that contain vitamins unless the company obtains competent and reliable scientific evidence to support an implied health claim.

• Claim that the product is safer than cigarettes, contains no tobacco, no tar, no carcinogens or no second-hand smoke unless there is competent reliable scientific evidence to support the claims.

Sottera also agreed to adopt and implement quality control standards for its products to preclude the presence of harmful substances. The company will regularly be subject to independent audits.

In addition, the company will provide a Proposition 65 warning that its products contain nicotine, a chemical known by the State of California to cause birth defects or reproductive harm. The warning will include additional information about risks associated with nicotine, including that it is addictive and toxic if swallowed. The warning will appear on product packaging, Sottera’s website and at retail sites.

Finally, Sottera will pay $85,000 in penalties and fees.

Oregon Sues Electronic Cigarette Maker

Aug 26th, 2009
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Charges firm is targeting kids

https://www.consumeraffairs.com/e-cigarette-warnings-and-lawsuits?page=2

Weeks after reaching a settlement with three retailers to block sale of the electronic cigarette NJOY, the state of Oregon is taking another e-cigarette maker to court.

Oregon Attorney General John Kroger is suing Smoking Everywhere, alleging that the Florida-based e-cigarette company made false health claims about its nicotine delivery device and targeted children with sweet flavors such as bubblegum, chocolate and cookies ‘n’ cream.

Electronic cigarettes are not approved by the U.S. Food and Drug Administration (FDA) and some contain known carcinogens. Even so, they are advertised on radio and television, where tobacco cigarettes have been banned from the airwaves for three decades.

Thus far, Oregon remains the only state that has taken legal action against e-cigarette importers and retailers. In addition to the recent settlement with retailers, the state reached agreement with Sottera, Inc.,distributor of NJOY, prohibiting it from doing business in Oregon until local and national standards are met.

Kroger said he offered to settle with Smoking Everywhere, but the company rebuffed his offer. The result was the attorney general’s lawsuit.

As a general rule, nicotine products other than traditional tobacco products used to get a nicotine “buzz” or to quit smoking are considered by the FDA to be drugs and must be submitted for pre-approval. Prior to approval, the FDA requires manufacturers to submit reliable scientific evidence that proves the product is safe and effective for its intended use.

Kroger said Smoking Everywhere did not seek FDA pre-approval under the theory that a regulatory loophole allowed the sale of the devices as long as they were not marketed for smoking cessation. E-cigarettes are not approved by the FDA for any purpose. The FDA has rejected the defendants’ arguments and has seized e-cigarette shipments from China.

Smoking Everywhere responded by suing the FDA. Sottera, Inc., whose electronic cigarettes were also seized by the FDA, later joined the suit.

The FDA has never declared e-cigarettes safe for public consumption, but they remain easily available throughout the country – except in Oregon, where the Department of Justice in July reached agreements with retailers to temporarily stop selling them while DOJ continued its investigation.

Electronic cigarettes are designed to mimic the look and experience of smoking a conventional cigarette. Smoking Everywhere e-cigarettes contain a battery-operated heating element and a replaceable plastic cartridge that contains various chemicals, including liquid nicotine. The heating element vaporizes the liquid, which is inhaled by the user.

Oregon’s lawsuit alleges that Smoking Everywhere has marketed e-cigarettes as safe in general and safer than conventional cigarettes, yet the company possesses no scientific evidence to support such claims.

Smoking Everywhere claims that e-cigarettes contain “no harmful carcinogenic ingredients” and are “free of tar & other chemical substances” that are “produced in traditional cigarettes.” In fact, lab testing by the FDA found tobacco-specific nitrosamines, which are known carcinogens in humans. FDA testing also found diethylene glycol, an ingredient used in antifreeze that is known to be highly toxic in humans.

Some electronic cigarette cartridges have been sold as containing no nicotine, but FDA testing found detectable levels of nicotine.

Oregon’s lawsuit also alleges that Smoking Everywhere’s promotional efforts target adolescents and youths who may not already be addicted to nicotine. Although Smoking Everywhere claims e-cigarettes are “intended for use by adult smokers,” the lawsuit alleges that advertisements are designed to attract young people.

For example, advertisements use young female models who look like teenagers. The use of sweet flavored cartridges such as bubblegum and cookies ‘n’ cream also appeals to young people. Further, as part of its advertising campaign, Smoking Everywhere staged a promotional event on the Howard Stern radio show that told listeners: “For kids out there, you still look cool ’cause, like, it still looks like a cigarette…”

“We’re fighting to make sure kids are protected from unapproved gimmicks like e-cigarettes that get them hooked on nicotine,” Kroger said.

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