The Escalating Debate Over E-Cigarettes

Follow the bouncing ping-pong ball.

“E-cigarettes are likely to be gateway devices for nicotine addiction among youth, opening up a whole new market for tobacco.”

—Lauren Dutra, postdoctoral fellow at the UCSF Center for Tobacco Control Research and Education.

“You’ve got two camps here: an abstinence-only camp that thinks anything related to tobacco should be outlawed, and those of us who say abstinence has failed, and that we have to take advantage of every opportunity with a reasonable prospect for harm reduction.”

—Richard Carmona, former U.S. Surgeon General, now board member of e-cigarette maker NJOY. 

“Consumers are led to believe that e-cigarettes are a safe alternative to cigarettes, despite the fact that they are addictive, and there is no regulatory oversight ensuring the safety of the ingredients in e-cigarettes.”

—From a letter to the Food and Drug Administration (FDA) signed by 40 state attorneys general.

“E-cigarettes need more time to develop and to out-compete deadly conventional cigarettes, but they have the potential to end the tobacco epidemic. So if regulators decide to ban them or submit them to stricter regulations than conventional cigarettes, this would be detrimental to public health.”

—Professor Peter Hajek, director of the Tobacco Dependence Research Unit at the Wolfson Institute of Preventive Medicine. 

“There is no scientific evidence that e-cigarettes are a safe substitute for traditional cigarettes or an effective smoking cessation tool. In fact, they may entice young people into trying traditional cigarettes.”

—Russ Sciandra, New York State Director of Advocacy, American Cancer Society.

“I firmly believe that the [New York] City Council’s bill restricting e-cigarettes is a major blow to people who are trying to stop smoking and will end up accomplishing the opposite of advocates’ intended goals of improving people’s health and reducing smoking-related deaths.”

—Tony Newman, director of media relations for the Drug Policy Alliance.

“Once a young person gets acquainted with nicotine, it’s more likely that they’ll try other tobacco products. E-cigarettes are a promising growth area for the tobacco companies, allowing them to diversify their addictive and lethal products with a so-called ‘safe cigarette.’”

—Alexander Prokhorov, head of the Tobacco Outreach Education Program, University of Texas.

“What would constitute a final victory in tobacco control? Must victory entail complete abstinence from e-cigarettes as well as tobacco? To what levels must we reduced the prevalence of smoking? What lessons should be drawn from the histories of alcohol and narcotic-drug prohibition?”

—Amy L. Fairchild, professor of sociomedical sciences, Mailman School of Public Health, Columbia University. 

Photo Credit: St. Paul Pioneer Press (Chris Polydoroff).

Big Tobacco Makes a Move Into E-Cigarettes

“A battery-operated, addiction-based market.”

While the FDA dithered, and health advocates argued, Big Tobacco began placing its bets on the e-cigarette market last year. Tobacco firm Lorillard Inc., the third largest tobacco company in America, bought privately held Blue Ecigs of Charlotte, N.C., for $135 million, driven by what the company says is a market that’s been doubling ever year since e-cigs first arrived from China in 2008.

According to the Wall Street Journal, Blue Ecigs had $30 million in revenues last year, selling through retail outlets like Walgreens, where it competes with e-brands such as NJOY and 21s Century. The FDA has announced vague plans to regulate, and state lawmakers have threatened to ban them outright, or at least place them under the same public smoking bans as cigarettes—bans that some e-smokers love to flout. (E-cigarette manufacturers, based primarily in Asia, quickly changed the electric orange glow at the end of the e-cigarette to a cool shade of blue, to help make clear to bartenders and bouncers that the thing wasn’t a lit cigarette.)

Meanwhile, Reynolds, an industry leader in smokeless products, is developing its own line of e-cigs, and is test-marketing its Vuse and Zonnic brands. “We will be in this category in 2013,” an RJ Reynolds representative said in a CNBC article by Jane Wells. “We have very big plans.”

Altria, the industry giant, is now generating $1.6 billion from smokeless tobacco products, and is expected to make a move into what is viewed as a billion-dollar industry with unlimited growth potential. Last year, the company began testing a new “nicotine-extract product” called Verve, a lozenge that can be sucked or chewed and contains about 1.5 milligrams of nicotine. Late last year, the company reportedly engaged in acquisition talks with e-cig maker Eonsmoke.

Meanwhile, the company that invented the electronic cigarette, Dragonite/Ruyan, is suing practically everybody. And the Argentinean and Venezuelan governments have attempted to ban the use and marketing of electronic cigarettes altogether.

In December, astute American TV viewers may have noticed what looked for all the world like a television commercial for cigarettes—the first since 1971, when Congress banned cigarette ads on TV. It was a commercial for NJOY Kings electronic cigarettes, a brand that currently owns about one-third of the U.S. e-cig market. Patent lawyer Mark Weiss, who founded NJOY, told Time that the company was only competing for the 45 million Americans who are current smokers, not attempting to make new recruits. In the article, Weiss noted three advantages for e-cigarettes: They’re odor free, they don’t burn tobacco, and, at about $8 per e-cigarette, Weiss claims, they’ll last you as long as two regular packs of cigarettes.

When major tobacco companies make moves like this, people notice. “I think they see this as an opportunity to get a seat at the table with opportunities to talk to the FDA about regulation over this growing category,” according to Bonnie Herzog, senior analyst and managing director of tobacco, beverage and consumer research for Wells Fargo Securities. “Lorillard wants to help steer that conversation in the right direction.”

While still a relatively modest market—no more than $500 million, compared to the $100 billion tobacco market in the U.S.—electronic cigarettes have the potential of becoming the most contentious entry in the market for nicotine delivery systems since the advent of the machine-rolled cigarette. “We think e-cigs are to tobacco what energy drinks are to beverages,” Herzog told the media.

Lorillard chairman and CEO Murray Kessler said in an earnings conference call late last year that with e-cigarettes, “you get all of the benefits of not having combustion, but on the other hand you are maintaining the behavior that cigarette smokers enjoyed.” That’s one way of putting it. And according to critics, that’s part of the problem. Anti-smoking activists often view e-cigarettes as gateway products for young adults.

They are cheaper, primarily because of heavy taxes on traditional cigarettes, and produce no second-hand smoke, only steam-like vapor that quickly dissipates. But they have had a rocky start in the U.S. An article in the Winston-Salem Journal in prime tobacco country stated that consumers have “shied away out of safety concerns since most e-cigs are made in China.” Even North Carolina health officials have expressed concerns about “limited regulatory oversight of their contents.” But according to Wells Fargo’s Herzog, Lorillard’s purchase of Blu Ecigs had the effect of “lending credibility and legitimacy to the entire category.”

Brad Rodu, professor of medicine at the University of Louisville, insisted that “tobacco manufacturers have an obligation to smokers to develop, manufacture and sell these vastly safer cigarette substitutes.” In this view, smokers smoke for the nicotine, but it’s the tar that kills them. 

In the same Winston-Salem Journal article, a professor of family and community medicine at Wake Forest School of Medicine said that “many of the carcinogens in tobacco are volatile and would vaporize, and thus be inhaled when heated. I would not recommend that product.”

It seems safe to predict that this “battery-operated, addiction-based market,” as Forbes dubbed it, will be one to watch.

Are E-Cigarettes a Good Idea or a Bad Idea?

A group of nicotine researchers argue for an alternative.

Electronic cigarettes are here to stay. If you're not familiar with them, e-cigarettes are designed to look exactly like conventional cigarettes, but they use batteries to convert liquid nicotine into a fine, heated mist that is absorbed by the lungs. Last summer, even though the FDA insisted on referring to e-cigarettes as “untested drug delivery systems,” Dr. Neal Benowitz of the University of California in San Francisco--a prominent nicotine researcher for many years--called e-cigarettes “an advancement that the field has been waiting for.” And recently, Dr. Michael Siegel of the Boston University School of Public Health wrote: “Few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns.” Furthermore, Dr. Siegel took a swipe at the opposition: “The FDA and major anti-smoking groups keep saying that we don’t know anything about what is in electronic cigarettes. The truth is, we know a lot more about what is in electronic cigarettes than regular cigarettes.”

Harm reduction advocates are ecstatic. But do e-cigarettes simply reduce harm by eliminating combustion by-products--or do they perpetuate nicotine addiction, frustrate the efforts of smoking cessation experts, and give false hope to smokers that they can have their cake and eat it, too?

Dr. Siegel conducted a survey of e-cigarette users and found that 66% reported a reduction in the number of cigarettes smoked at the six-month point. “Of respondents who were not smoking at 6 months, 34.3% were not using e-cigarettes or any nicotine-containing products at the time.” Pretty impressive--although Siegel himself refers to the findings as “suggestive, not definitive”--and seemingly a giant leap forward for harm reduction.

However, even though they have dramatically altered the harm reduction landscape, e-cigarettes will not change anything for smokers who are attempting to completely quit using nicotine. When they inhale their last e-cigarette mist, several hours later they will begin to suffer the same withdrawal pains as regular cigarette smokers: “Irritability, craving, depression, anxiety, cognitive and attention deficits, sleep disturbances, and increased appetite,” as NIDA summarizes it. Current smokers are keenly interested in the new products, partly because of health concerns, and partly, it seems safe to venture, because a new generation of nicotine-based products like e-cigarettes “will enable them to put off the need to quit smoking,” as Dr. Dorothy Hatsukami, director of the Tobacco Use Research Center at the University of Minnesota, has asserted.

Harm reduction advocates for the electronic cigarette often make it sound like once the smoker is only inhaling nicotine, his or her problems are solved. But nicotine, of course, is the addictive part. Nicotinic receptors are present in moderate to high density in the brain areas containing dopamine cell bodies--the ventral tegmental area and the nucleus accumbens—the same pattern as almost every other addictive drug.

Even that part wouldn’t be a problem if addiction to nicotine were utterly benign. But it isn’t--although you wouldn’t know it from the pro-electronic cigarette propaganda. Nicotine in the blood is correlated with increases in arterial vasoconstriction, and is strongly suspected of playing a role in arteriosclerosis and other cardiovascular diseases. Nicotine increases LDL cholesterol, causes brochoconstriction, and has been implicated in the origin of lung tumors. There are also strong suggestions of links between nicotine and low birth weights in newborns.

So, it’s important not to kid ourselves about the hazards of nicotine, even though it may also be a medicine under certain conditions, like many other addictive drugs. Nicotine, you may recall, found industrial use as a farm crop insecticide. A poison, in other words. Nonetheless, what nicotine is NOT linked to certainly matters as well. Nicotine does not cause chronic obstructive pulmonary diseases, like emphysema—a huge plus. Nicotine won’t worsen asthma, as cigarettes do. And in the form of the electronic cigarette, it won’t cause secondhand smoke—another major plus for the e-cig.

There is another approach to regulating the harm caused by cigarettes. A group of scientists has been calling for a major effort at reducing the amount of nicotine in cigarettes so that, over time, a non-addictive level of nicotine would be reached--and cigarettes would no longer be addictive. Study after study has shown that if such were the case, about 80 to 90% of smokers would quit. And teens who experimented with truly low-nicotine cigarettes wouldn’t get hooked—unlike the “light” cigarette scandal, where the supposedly safer cigarettes may actually have turned out to be more dangerous because they forced smokers to smoke more in order to get the desired effect. Dr. Hatsukami and five other prominent nicotine experts contend that extremely low-nicotine cigarettes do not cause smokers to smoke more, “because it is harder to compensate for very low nicotine intake,” according to Hatsukami. Especially if there are no high-nicotine alternatives for sale—legally, at least. Mitch Zeller, who along with Hatsukami, co-chairs the National Cancer Institute’s Tobacco Harm Reduction Network, painted this picture: “Imagine a world where the only cigarettes that kids could experiment with would neither create nor sustain addiction."

Nonsense, counters Dr. Gilbert Ross of the American Council on Science and Health. “Asserting that smokers won’t smoke more cigarettes to get the nicotine they crave is a fairy tale,” he said. “The likely result is a major increase in cigarette-related diseases.”

These are the competing visions of our nicotine-addicted future. In one scenario, smokers stay addicted to nicotine, with its accompanying heath risks and all the other negative aspects of being addicted. But the immediate harm to their health is lessened due to fewer inhaled carcinogens, and they don’t create secondhand smoke. In the opposing scenario, smokers continue to smoke, and society continues to deal with secondhand smoke through no-smoking policies, while medical research agencies, under government mandate, oversee the gradual reduction of nicotine in cigarettes to a level below what is needed for addiction.

The optimistic thought here is that either of these approaches would bring much-needed improvement to the semi-controlled anarchy and hypocrisy of the current situation.

Photo Credit: http://whyquit.com 

Era of the Electronic Cigarette Officially Begins.

Court blocks FDA from prohibiting e-cigarettes.

It’s official: The e-cigarette is here. The right of a distributor of Chinese electronic cigarettes to market the product in the U.S. was solidly affirmed last week by a three-judge ruling in the U.S. Court of Appeals for the District of Columbia. The Food and Drug Administration’s refusal last year to allow importation of e-cigarettes by Sottera Inc. had been the basis for a lower court decision in Sottera’s favor. The earlier court ruled that e-cigarettes did not require FDA approval because they were neither new drugs nor new drug delivery devices. (The FDA is prohibited by an act of Congress from barring the sale of tobacco products outright.)

Last month, under a consent judgement worked out with California state Attorney General Jerry Brown in a related case, Florida-based Smoking Everywhere Co., another distributor of Chinese electronic cigarettes, had agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move came shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices, culminating in the Sottera lawsuit.

The legal argument before the appeals court hinged largely on semantics. The court found that electronic cigarettes are “battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash or carbon monoxide. The liquid nicotine is derived from natural tobacco plants.”

Here is the catch: “The FDA may only approve a product for marketing under the Federal Food, Drug and Cosmetic Act (FDCA) if it is safe and effective for its intended use,” the Appeals Court Justices ruled.  However, the FDA has “exhaustively documented” that tobacco products are unsafe for pharmacological use of any kind. The earlier court had concluded, stealing a page from “Alice in Wonderland”: “If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit” within any conceivable regulatory scheme.

Hence the difficulties in the FDA’s attempt to regulate by agency fiat. E-cigarette manufacturers and distributors, having sensed an opening, are now ready to drive a convoy of semis right through it. This wasn’t a completely straightforward march, as the e-cigarette forces, in the appeals presentation, were required to thread the needle on such conundrums as: Does it matter that e-cigarettes do not, strictly speaking, contain “tobacco products?” Nicotine is a component of, not a product of, tobacco.

You see the problem. The relevant statutes have not been written with pure nicotine delivery devices in mind. In fact, having nicotine--but not the evil substance tobacco--in your product turned out to be a definitional advantage for the e-cigarette marketers: The court pointed out that, unlike products containing tobacco, which the FDA has found to be associated with “cancer, respiratory illnesses, and heart disease,” the FDA has manifestly NOT found that nicotine or tobacco-free products that deliver nicotine are inherently unsafe. And second, the “tobacco-specific legislation” invoked in earlier court cases “simply does not address products that deliver nicotine but contain no tobacco.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a prepared statement: "This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time. We urge the government to appeal this ruling."

Among the many  questions the ruling leaves open is the status of e-cigarettes under existing no-smoking regulations. That litigation has not even gotten underway.

See my earlier post on the e-cigarette question HERE.

For the full court decision, click HERE.

Graphics Credit:  http://thestrobel3.blogspot.com/

Bio Firm Working on New Technology for E-Cigarettes

Key tobacco scientist endorses “going vape.”

Cypress Bioscience of San Diego hopes to enter the controversial and potentially lucrative market for so-called e-cigarettes, which deliver nicotine by heating it to produce an inhalable, smoke-free vapor. The company announced last week that it had acquired a $5 million license for Staccato nicotine technology—“A novel electronic multidose delivery technology designed to help people stop smoking.”

The company claims that the “the electronics embedded within the Staccato delivery system could allow for the programmed, over-time reduction in the overall daily dose of nicotine, and ultimately may lead to the better management of nicotine cravings and eventual sustained smoking cessation”

Critics of e-cigarettes have maintained that the devices were not meant to curb smoking but to enable it, by allowing smokers to circumvent no-smoking regulations. Fears have also been voiced that children might be tempted to make use of them. Makers of electronic cigarettes, primarily in Asia, have maintained that the devices are perfect for the management of nicotine cravings when smokers quit, and may have significant advantages over nicotine gums and patches.

The press release from Cypress Bioscience makes the claim explicitly: “The Staccato technology may be capable of mimicking the pharmacokinetics of smoking cigarettes through the delivery of optimally-sized nicotine particles to the deep lung. Staccato nicotine may also provide some of the psychological aspects of smoking (e.g., hand-to-mouth movement, oral inhalation) and could allow smokers to self-administer and possibly titrate to the dose to treat cravings.”

Up until now, electronic cigarettes have been opposed by the Food and Drug Administration (FDA) on the grounds that e-cigarettes were novel and untested drug delivery systems. Signaling a possible change in official attitudes, Dr. Neal Benowitz, professor of Medicine at the University of California, San Francisco--and a prominent nicotine researcher for many years--said in the Cypress Bioscience press release that a delivery device like Staccato nicotine “may be useful in addressing a pressing pharmacological problem in overcoming nicotine addiction; namely, that acute cravings during quit attempts are inadequately treated by current nicotine replacement therapies.” Dr. Benowitz called the nicotine delivery device “an advancement that the field has been waiting for.”

Cypress Bioscience said it plans to take the technology into Phase 1 clinical trials next year. The company reported a net loss of 5 cents per share in the second quarter, compared to a loss of 23 cents per share during the same period a year ago.

The Centers of Disease Control and Prevention (CDC) estimate that almost 450,000 people die annually in the U.S. from smoking. One in five deaths in the U.S. are due to smoking-related illness, according to the CDC.

Earlier posts:

Leave Cigarettes Along, Judge Tells FDA

E-Cigarettes: Another Look

Graphics Credit: http://www.ecigarettebuyer.co.uk/

E-Cigarettes: Another Look

FDA remains conflicted over safety concerns.

The Food and Drug Administration (FDA) issued a controversial Safety Alert over electronic cigarettes, known as “e-cigarettes,” then held a press conference to explain itself. The agency’s muddled response to the issue has prompted increased advertising and online sales for Asian e-cigarette manufacturers, as well as a countering burst of criticism about the newest nicotine delivery system under the sun.

The FDA conducted a small-scale lab analysis of two different brands of e-cigarettes, and found “carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.” The FDA’s Division of Pharmaceutical Analysis also found evidence of small amounts of cancer-causing nitrosamines. “These products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes,” the agency bulletin said. Therefore, the agency “has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.”

The agency did not seek to ban e-cigarettes, as Canada did in March. However, in a written statement to CNN in March, the FDA admitted it had been detaining or refusing importations of electronic cigarettes for more than a year.

Debate has raged recently over the safety of e-cigarettes, which are battery-operated cigarette substitutes that technically dodge no-smoking bans, since no actual smoke is emitted. When a smoker inhales on the e-cigarette, the battery warms liquid nicotine stored in a plastic filter, producing a smokeless but inhalable form of synthetic nicotine. Upon exhalation, there is a small puff of vapor that quickly evaporates (See my earlier post, "E-Cigarettes and Health").

Michael Levy, director of compliance for the FDA’s division of drug evaluation and research, said he believes the products are illegal. However, “There is pending litigation on the issue of FDA’s jurisdiction over e-cigarettes,” he said.

Proponents of the e-cigarette claim that the devices are self-evidently safer than smoking cigarettes, and can help people stop using tobacco products. Critics respond that the safety of synthetic nicotine drug-delivery devices has not been established. Moreover, the range of fruit and candy flavors offered by e-cigarette manufacturers suggests to Jonathan Inickoff of the American Academy of Pediatrics Tobacco Consortium that the devices seem “tailor-made to appeal to kids,” while addicting them to nicotine and turning them into future cigarette smokers.

With half a million Americans dying prematurely each year from smoking, according to figures from the Centers for Disease Control (CDC), some doctors and tobacco researchers have pointed out that nitrosamines are also found in everything from nicotine patches to bacon. According to one researcher, “FDA should be encouraging, not maligning the manufacture and sale of electronic cigarettes, and working with manufacturers to assure the highest possible quality control.”

For a robust discussion of the e-cigarette question, see www.e-cigarette-forum.com


Photo Credit: www.politech.wordpress.com

addiction drugs smoking nicotine

E-Cigarettes and Health

Smokeless nicotine comes under scrutiny.

You may never have heard of it—but it’s the newest drug in town. It’s called an electronic cigarette, or “e-cigarette.” Electronic cigarettes use batteries to convert liquid nicotine into a fine, heated mist that is absorbed by the lungs. No smoke, but plenty of what makes cigarettes go, if you don’t account for taste—or ashtrays and smoke rings.

In an attempt to work around the world’s growing ban on cigarette smoking in public places, a Hong Kong-based company developed the first e-cigarette in 2004. Since then, other companies have done the same, claiming that e-cigarettes are much healthier than regular smokes.

Last month, that claim was vigorously disputed by the World Health Organization (WHO). In fact, WHO said electronic cigarettes can be deadly. Stressing that the device had not been adequately tested, Douglas Bettcher, the director of WHO’s Tobacco Free Initiative, told the Associated Press that “there’s no experience in pharmacology yet of nicotine replacement therapies which actually inhale nicotine in the lungs.” Replacement therapies such as skin patches and gum have undergone thorough clinical testing, Bettcher said. For these reasons, “the World Health Organization does not consider the electronic cigarette to be a legitimate nicotine replacement therapy.”

The anti-smoking group Action on Smoking and Health (ASH) doesn’t think much of e-cigarettes, either. In the U.K. Times Online, ASH director Deborah Arnott said that “at the moment we don’t know enough about this product. Quality control in China is not the highest, and our advice is it’s best to use nicotine products like gums and patches. The electronic cigarettes fall into a regulatory gap and they haven’t been chemically tested.”

So far, electronic cigarettes are being actively marketed in China, Great Britain, Canada, Brazil, Israel, Sweden, and other countries. The cartridges containing the liquid nicotine are available in several flavors, and battery life is estimated at one to three days for most units. The e-cigarette web site www.e-cig.org offers a list of “best places to use your electronic cigarette,” such as airplanes, in church, at the mall, in a restaurant, bar or hospital, or “at your kid’s school recital.”

According to China View News , a “changeable filter contains a liquid with nicotine and propylene glycol. When the user inhales as he would when smoking, air flow is detected by a sensor and a micro-processor activates an atomizer which injects tiny droplets of the liquid into the flowing air, producing a vapour.”

The unit, which looks like a long cigarette, is powered by a rechargeable battery. Propylene glycol is a commercial product sold as a low-toxicity version of antifreeze, among other applications.

E-cigarettes are readily available for purchase online, and at least one American firm has announced plans to market versions of e-cigarettes domestically. However, none of the manufacturers to date seems to be working through the existing regulatory framework, which in most countries calls for toxicity analyses and clinical studies. Jason Cropper, managing director of the Electronic Cigarettes Company, told BBC News that e-cigarettes “are certainly healthier than smoking cigarettes. Tests have been done on mice in the lab and they have shown they are not harmful.” However, Cropper said, no human trials had been undertaken because they are too expensive.

The World Health Organization became involved in the matter after several e-cigarette manufacturers began using the World Health Organization’s logo on advertisements and product inserts. “It’s 100 percent false to affirm this is a therapy for smokers to quit,” Bettcher said. “There are a number of chemical additives in the product that could be very toxic.”

Meanwhile, The Ruyan e-cigarette, a joint effort by Ruyan Holdings Ltd. of Hong Kong and Ruyan America, Inc., won Most Innovative Product of 2008 at the Tobacco Plus Expo in Las Vegas last May.

addiction drugs smoking nicotine