Why the CDC Director Hates E-Cigarettes

The pros and cons of getting your vape on.

Last month, the Food and Drug Administration (FDA) began a new era—regulating e-cigarettes. With a non-controversial first step, the FDA banned the sale of e-cigarettes to minors, required health warnings, prohibited health claims, and outlined a plan to register and license all electronic nicotine products at some future date. The FDA’s proposed rules would also give the agency the power to regulate the currently unregulated mixture of chemicals and flavorings that are heated during e-cigarette use.  Whatever regulations the FDA promulgates for electronic cigarettes will also apply to nicotine gels, water pipe tobacco, and hookahs.

Perhaps what rankles e-cigarette activists the most is the FDA’s insistence that companies will have to provide scientific evidence before making any implied claims about risk reduction for their product, compared with cigarettes. The FDA did not restrict advertising or prohibit flavorings (bubble gum, apple-blueberry, gummi bear, and cappuccino are popular).

Within a few days after the FDA’s announcement, Chicago, New York City, and other major cities placed e-cigarettes under the same municipal smoking bans as cigarettes. 

The battle over e-cigarettes is both a public health issue and a private enterprise war for market share. Corporate giants Altria and Lorillard, which dominate the corporate tobacco landscape in the U.S., are fighting for a piece of what has become nearly a $2 billion market in a few short years. (Altria recently boosted  its growth forecast to 6-9% growth for 2014). Lorillard has been making heavy acquisitions of its own, and commands more than half the present market with its Blu brand. Altria has made its own vapor acquisitions, and is launching its own brand, MarkTen.

So far, the moves being contemplated by the FDA do not have these companies shaking in their boots. They anticipated the ban on sales to minors, a system of formal FDA approval, a disclosure of ingredients, and health warnings about the addictive nature of nicotine. And Congress gave the FDA legal authority to draft a set of rules for e-cigarettes five years ago, so the FDA’s reluctance to step in on liquid nicotine delivery systems has been evident.

In an interview with the Los Angeles Times, Tom Frieden, director of the Center for Disease Control and Prevention (CDC), listed the reasons for his opposition to electronic cigarettes:

—E-cigarettes are an additional means of hooking another generation of kids on nicotine, making them more likely to become adult smokers.

—Smokers who might have quit smoking will maintain their nicotine addiction, remaining highly vulnerable to tobacco craving.

—Ex-smokers might make themselves more vulnerable to relapse if they take up vaping.

—Smokers might forego medications that could help them quit, in favor of the unproven promise of tobacco abstention via e-cigarette.

—E-cigarettes might have the cultural effect of “re-glamorizing” smoking.

—E-cigarette users might be exposing children and pregnant women to nicotine via secondhand smoke mechanisms.

—E-cigarette users can refill cartridges with liquid cannabis products and other drugs.

Dr. Michael Siegel, a tobacco expert at the Boston University School of Public Health, worries that smaller players will be squeezed out due to costs associated with the FDA approval process, driving sales toward the traditional cigarette industry leaders. Go-go analysts have predicted market penetration of as much as 50% for e-cigarettes, but Siegel is more pessimistic, and believes the e-cigarette share could top out at 10% if FDA regulations set back efforts by vaping proponents to position their product as a safer and healthier alternative to tobacco cigarettes. And that, says Siegel, would be a shame. He told the Boston Globe: “There simply is no product on the market that’s more dangerous than tobacco cigarettes, and nobody in their right mind would argue that cigarette smoking is less hazardous or even equally hazardous to vaping.”

Frieden at the CDC is sympathetic to the fact that many smokers have indeed quit smoking tobacco with the aid of e-cigarettes. “Stick to stick, they’re almost certainly less toxic than cigarettes.” But like many tobacco experts, he sees the possibility of a new generation of nicotine addicts. Almost two million high school kids have tried e-cigarettes, Frieden told the LA Times, “and a lot of them are using them regularly…. That’s like watching someone harm hundreds of thousands of children.”  The CDC reported that the percentage of high school students who have used an e-cigarette jumped from 4.7% in 2011 to 10% in 2012. Calls to poison control centers involving children and e-cigarettes have increased sharply as well.

Frieden views the Food and Drug Administration as David under siege by Goliath. The FDA, he said, “tried to regulate e-cigarettes earlier, and they lost to the tobacco industry…. So the FDA has to balance moving quickly with moving in a way that’s going to be able to survive the tobacco industry’s highly paid legal challenge.” If E-cigarette makers really want to market to people trying to quit smoking, Frieden told the LA Times, “then do the clinical trials and apply to the FDA. But they don’t want to do that.” (See my post on Big Tobacco’s move into the e-cigarette market).

“It’s really the wild, wild West out there,” a beleaguered FDA commissioner Margaret Hamburg told the press.   “They’re coming in different sizes, shapes and flavors in terms of the nicotine in them.”

On May 4, the New York Times published a report by Matt Richtel, based on an upcoming paper in the journal Nicotine and Tobacco Research. Nicotine researchers discovered that high-end electronic cigarette systems with refillable tanks produce formaldehyde, a known carcinogen, as a component of the exhaled nicotine vapor. Moreover, unlike disposable e-cigarettes, tank systems require users to refill them with liquid nicotine, itself a potent toxin. “Nicotine is a pesticide, fundamentally,” Michael Eriksen, dean of the School of Public Health at Georgia Statue University, told CNN. “We take so many precautions about pesticides for our lawns and how to wear gloves. But what precautions do consumers take when they put the nicotine vials in?”

This was not good news for harm reductionists, who view the advantages of e-cigarettes as self-evident. The New York Times report says that the toxin is formed “when liquid nicotine and other e-cigarette ingredients are subjected to high temperatures,” according to the research. “A second study that is being prepared for submission to the same journal points to similar findings.” In addition, a new study by researchers RTI International documents the release of tiny metal particles, including tin, chromium and nickel, which may worsen asthma and bronchitis.

Eric Moskowitz at the Boston Globe  reported that “thousands of gas stations and convenience stores statewide carry e-cigarettes, usually stocking disposable or cartridge-based versions that resemble traditional cigarettes.”

In U.S. News, Gregory Conley, president of the trade group American Vaping Association, predicted “a huge influx of anti-e-cigarette legislation in the last half of 2014 and especially in 2015 when the legislative sessions get going again.” 

According to Carl Tobias, a law professor at the University of Richmond, “it may be years before  regulations are imposed. The lobbying at FDA and Congress will be intense.”

Effectively regulated, e-cigarettes have the potential to drastically reduce deaths from tobacco-related diseases among cigarette smokers. In an editorial for the journal Addiction, Sara Hitchman, Ann McNeill, and Leonie Brose of King’s College, London, wrote: “E-cigarettes may offer a way out of the smoking epidemic or a way of perpetuating it; robustly designed, implemented and accurately reported scientific evidence will be the best tool we have to help us predict and shape which of these realities transpires.”

Photo credit: http://ecigarettereviewed.com

Built-In Advantages Give Big Tobacco an Edge in E-Cigs

The Big Three are now in it to win it. 

If there was ever any doubt that major tobacco companies have designs on the emerging electronic cigarette market, a recent roundup in the Wall Street Journal makes the case with ease, something that eager acolytes of e-cigs are anxious to avoid. No doubt about it, Big Tobacco wants in.

Results from intensive test marketing in Colorado have, like a political primary, provided an early indication of where the popularity lies. Reynolds American, the nation’s 2nd largest tobacco company (Camel), led the, uh, pack with its offering, the Vuse e-cigarette, introduced in July. Vuse racked up a 55% market share in that state. Next in line, with 25%, was Blu, owned by the 3rd largest cigarette maker, Lorillard (Newport). NJOY, an independent company, came in third.  The elephant in the room, Altria Group, the largest U.S. tobacco firm (Marlboro), is still in the test marketing stage with its e-cigarette entry, the MarkTen. Altria began testing the MarkTen in Indiana and Arizona in late summer.

It took Reynolds less than 16 weeks to achieve market dominance in Colorado, and the company made sure that investors heard about it. With 1,800 retail outlets in Colorado, and a database of 12 million tobacco consumers, Reynolds is perfectly poised to benefit from the inherent advantages of being Big Tobacco. The Big Three have three major head starts, the Wall Street Journal reported: “extensive distribution networks, existing customer relationships numbering in the millions, and deep pockets.”

The market for electronic cigarettes has broken a billion dollars, say stock watchers. This magic number seems to have energized the Big Three to take a heavy step into a market that has been around in nascent form since 2006, even though it’s still small change compared to the $100 billion U.S. tobacco market. It was not clear, in the beginning, whether Reynolds, Lorillard, and Altria would attempt to, pardon me, snuff out the competition, or dominate it. That decision now appears to have been made, and the game is on.

Stephanie Cordisco, president of R.J. Reynolds Vapor Company, which markets Vuse, said the marketing tagline in Colorado was: “A perfect puff. First time, every time.” 

So far, e-cigarettes, which heat nicotine-based liquid to create a vaporized mist, have benefitted from the fact that they are not, at present, savagely taxed like regular cigarettes. And e-cigs come in flavors, cherry and pina colada being among the favorites.

In April of 2012, Lorillard broke the e-cig barrier when it acquired Blu Ecigs for $135 million. At the Wall Street Journal, Mike Esterl suggested that the move came “as the Food and Drug Administration weighs a possible crackdown on menthol-flavored cigarettes, which represent about 90% of revenue at Greensboro, N.C.-based Lorillard, owner of the popular Newport brand. The FDA already has banned all other cigarette flavors.”

Reynolds followed Lorillard into the market early in 2013 with Vuse. And the giant Altria Group announced in October that it planned to expand sales of the MarkTen after successful “lead market” sales. It’s too early too say how it will go for the MarkTen, but Altria CEO Marty Barrington said in a conference call reported by the Richmond Times-Dispatch that the company is not overly worried about cannibalizing Marlboro sales: “I can tell you that with respect to who is trying the products in e-vapor generally,” he said, “ we do know that there is dual use. As adult smokers try e-vapor products, we know that some of them are satisfied and others are not. Some of them use [e-cigarettes] situationally.”

That does not sound like an executive rolling out a stop-smoking therapy tool.

Graphics Credit: http://seekingalpha.com

New Warning Labels for U.S. Cigarettes; Big Tobacco on the Rampage

Philip Morris Intl. sues Uruguay and Brazil.

Lots of developments on the nicotine front these days. On opposite ends of the news spectrum, so to speak, the Food and Drug Administration (FDA) announced plans to slap new and much more graphic warning stickers on cigarette packs--while elsewhere in the world, the world’s major tobacco companies got busy fighting tougher regulations on cigarette marketing. Meanwhile, the state of California has set limits on the marketing of e-cigarettes, disallowing companies from promoting the nicotine inhalers as “smoking-cessation devices.”

So let’s get busy. In the first significant change for cigarette advertising in 25 years, the FDA, freed by Congress last year to regulate tobacco products, will select nine new designs from among 36 contenders for new, far more graphic warning labels on cigarette packages. The new warning labels will begin appearing in about a year. To view the contenders, go to www.fda.gov/cigarettewarnings.

But will new, grisly images of dying smokers and rotted lungs really make a difference to the roughly one-quarter of adult Americans who still smoke?  “I am pleasantly shocked that [they are] doing this,” Stanton A. Glantz, a tobacco researcher at UC San Francisco, told the Los Angeles Times.  “There is no question but that strong graphic warning labels work,” he said. “Right now we have the weakest warning labels in the world. Now we will be right up there tied for the strongest.”

No so fast, counters John F.  Banzhaf, the executive director of Action on Smoking and Health and a George Washington University law professor. In the same L.A. Times article, Banzhaf said he was “quite disappointed,” stating that the agency “has done nothing more than exactly what Congress told them to do, and not one iota more.” So far, the FDA has banned advertising in magazines for young people, nixed the marketing ploy of handing out free samples on the street, and forbidden tobacco companies from marketing cigarettes by using the words “light” or “low-tar.”

Perhaps a more important result of Congressional approval of FDA oversight is that Medicare has now changed its rules to include smoking cessation products for covered beneficiaries. Previously, only people dying of lung disease were approved for smoking cessation products—a bit late in the disease cycle to do anybody much good.

According to a variety of estimates from government and research agencies, as many as half a million Americans die prematurely from smoking-related diseases. The Department of Health and Human Services has lately been stymied by a smoking rate of about 20%, basically unchanged since 2004. In 1965, about 42% of Americans smoked. The Department of Health and Human Services (HHS) has a stated goal of bringing smoking levels down to 12% by 2020.

That will not be an easy target to hit. And neither Congress nor the FDA nor HHS can count on anything amounting to cooperation from the cigarette giants. The New York Times, in an article by Duff Wilson, notes that worldwide cigarette sales rose 2% last year, as cigarette companies increasingly shift their marketing efforts toward a hunt for new customers in developing countries.  The aggressive nature of the worldwide cigarette marketing push was underscored this year when Philip Morris International sued the governments of Uruguay and Brazil, claiming that those countries had enacted tobacco regulations that were excessive and a threat to the company’s trademark and property rights.

Dr. Douglas Bettcher of the World Health Organization’s Tobacco Free Initiative accused the company of “using litigation to threaten low- and middle-income countries.” Philip Morris subsidiaries are also filing suits in Ireland and Norway over display advertising prohibitions. (Philip Morris USA, a separate division, is not involved in these lawsuits, and did not join with R.J. Reynolds and other tobacco companies in filing suit against the FDA last year.)

In the New York Times article, Wilson writes:

Companies like Philip Morris International and British American Tobacco are contesting limits on ads in Britain, bigger health warnings in South America and higher cigarette taxes in the Philippines and Mexico. They are also spending billions on lobbying and marketing campaigns in Africa and Asia, and in one case provided undisclosed financing for TV commercials in Australia.

As tobacco expert Dr. Cynthia Pomerleau points out on her blog, low smoking rates among women in the developing world make them a particularly tempting marketing target for the tobacco industry. Pomerleau, research professor emerita in the University of Michigan’s Department of Psychiatry, also reminds us that “the real goal here is not to remove health warnings altogether—health warnings have actually worked well for them by legitimizing the claim that if people choose to smoke, it’s not their fault—just to prevent them from dominating the package and actually becoming salient.”

It is important for the industry, says Pomerleau, to publicize “effects that can be achieved or problems that can be addressed by smoking.” In this respect, Pomerleau is concerned about the likelihood that the tobacco industry will seize upon the relationship between smoking and thinness as the wedge for sales campaigns aimed at women. “If it worked in the U.S., why not in Africa or Asia or South America?”

And finally, under a consent judgment worked out with California state Attorney General Jerry Brown, the Florida-based Smoking Everywhere company, a distributor of electronic cigarettes, has agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move comes shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices. Smoking Everywhere distributes e-cigarettes manufactured in China. The consent judgment also bars the company from selling its products in vending machines, and requires the products to contain warning labels about the dangers of nicotine.

And don’t forget: Thursday, November 18 marks the 35th annual Great American Smokeout.