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Ifs, Ands, or Butts

By Kari Santos | Mar. 2, 2015
News

Law Office Management

Mar. 2, 2015

Ifs, Ands, or Butts

E-cigarettes could be a pathway for smokers to quit, or the next big thing for Big Tobacco.

One morning last December I walked past the no-smoking signs at the gas pumps outside an Oakland 7-Eleven, and entered through a door beneath the green and orange façade.

Behind the counter, near pints of Jack Daniels and Jagermeister, were rows of cigarette packages: Marlboros, Camels, Newports. Next to them was something else: electronic cigarettes. They generate vapor - not smoke - produced when the user inhales from a nicotine-laced solution superheated by lithium batteries that atomize the liquid into a mist. Inhaling that mist is called vaping.

Less than a decade after e-cigarettes hit world markets, vaping has become so popular that the Oxford Dictionaries named it 2014's word of the year.

I went to the 7-Eleven because I wanted to try vaping. "Do you have Njoy singles?" I asked the clerk, referring to a brand that controls about 40 percent of the U.S. market.

"Kings or menthol?"

"Kings."

He passed me a small, rectangular package, wrapped in red plastic. The package contained a single e-cigarette and cost $7.99.

I walked half a block away, stopping in front of a closed antique store. Along the sidewalk, a couple with a toddler approached. Even though it's widely believed that inhaling nicotine vapor has fewer health risks than smoking tobacco, vaping didn't seem like something that I should do around a kid.

As I let the family pass, I glanced at the back of my Njoy's packaging. The label read: WARNING: Njoy products are not smoking cessation products and have not been tested as such. Njoy products are intended for use by adults of legal smoking age (18 or older in California) and not by children, women who are pregnant or breastfeeding, or persons with, or at risk of, heart disease, high blood pressure, diabetes or taking medicine for depression or asthma.

That language was part of a deal then-state Attorney General Jerry Brown reached with distributors in 2010. Sottera Inc., doing business as Njoy, agreed not to market its products to minors, and to pull from California retail shelves e-cigarettes with flavors attractive to kids - such as strawberry, chocolate, cookies-and-cream, and mint. (People v. Sottera, Inc., No. RG10528622 (Alameda Super. Ct.).)

I looked up again. The toddler was down the block. I flipped open the spring-loaded lid of the case with my thumb, exposing what looked like the filter end of a traditional cigarette. I pulled it out.

There were no instructions. At the colored filter end was a small hole. I brought it to my lips and inhaled sharply, which triggered the superheating process. The vapor smelled and tasted like the tobacco in cigarettes I had flirted with as a teenager. I exhaled what looked like smoke. The vapor quickly dissipated. I repeated this twice more.

The nicotine buzz came quickly. I don't smoke. My drug of choice is a different stimulant - caffeine. But what the Njoy delivered was far different from the effects of black coffee. A slight sensation rippled in my chest. My throat felt hot. The smell of tobacco clung to me well after the vapor had vanished.

Outside a coffee shop nearby, a homeless man who looked about 60 years old was begging for money. He's a neighborhood character and a heavy smoker who coughs and hacks chronically. Sometimes I see him scouring the gutter for cigarette butts, desperate to salvage a drag or two. I asked if he wanted my Njoy.

"It's supposed to be less harmful than cigarettes," I said, feeling a scraping in the back of my throat and what seemed like sharp prickles in my chest. I held the Njoy out to him.

He looked at me through yellowing eyes, slowly shaking his head. "Naah," he said. "I ain't trusting nothing ain't real. That ain't no cigarette."

Here was a piece of street-corner wisdom that touched on the gist of the controversy: Do e-cigarettes reduce harm by delivering nicotine in a safer form, or do they simply encourage smoking tobacco?

Let's say this fellow took my Njoy and turned from smoking to vaping. Without daily exposure to the deadly tar in cigarettes, his health might improve - maybe delaying medical problems that will undoubtedly be society's burden. And while passersby or others who sit near him might be exposed to secondhand vapor, research suggests it is less harmful than secondhand tobacco smoke.

But suppose that instead of giving away my Njoys, I kept them and got hooked on nicotine. I'd be inhaling whatever toxins are in the nicotine liquid, and emitting secondhand vapor. I'd be harming myself and perhaps the people around me.

The concept of harm reduction is elusive and difficult to quantify. More safe does not mean safe. Less risk than smoking tobacco does not mean no risk from vaping. E-cigarettes still contain unknown and potentially harmful substances. My homeless neighbor seemed to grasp this in an instant.

What is known about vaping is that it's the new cool: sleek, techy, and edgy enough to be outlawed in many venues. It is rapidly attracting young adults, who, according to the state Department of Public Health, are three times more likely to be vapers than people over 30. And last year for the first time, teens consumed more e-cigarettes than traditional smokes.

That makes vaping a pressing legal and public health concern. The U.S. Food and Drug Administration, in fact, is gearing up to issue national e-cigarette regulations later this year.

Quitting Claims
My father smoked. At the height of his addiction he was up to around four packs a day, so much tobacco that though he'd quit more than 25 years before he died, his death certificate listed smoking as the cause for the cancer that ravaged him.

To cut costs, he bought cigarette-makings in bulk. Every evening he'd sit on the floor, watch Walter Cronkite report the news, and load tobacco, filters, and paper into a Laredo rolling machine. He'd slide a handle and pop out smokes - about 80 cigarettes a night, enough to get him through the next day.

Nothing, it seemed, could slake his craving for nicotine. Then in the early 1970s a bad cold forced him to bed, and never-ending coughs rang through the house as he hacked up blackened phlegm. He thought he already had cancer. He didn't, but it scared him enough to endure miserable weeks of withdrawal. No nicotine gum, no patch. Cold turkey. Black coffee. Hands that shook. Objects hitting walls as his temper erupted at the slightest provocation.

Could vaping have brought him down more humanely? Perhaps. But my father never had the chance to see if vaping could have helped him quit. Neither did the father of Hon Lik, a pharmacist in the People's Republic of China. But when Lik's father died of lung cancer, Lik - who also smoked heavily - began experiments in harm reduction. He released a version of e-cigarettes in 2003.

By April 2006 the devices were being sold in Europe; they hit American markets the next year. Today, the fastest growing share of the market is vaping pens - tank systems with a cartridge of flavored nicotine liquid and a larger battery that can produce more heat.

In September 2008 two shipments of e-cigarettes from China were detained on arrival at Los Angeles International Airport. The FDA claimed the cargo qualified as a drug-device combination, defined under the Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 321(g)(1)(C)) as an article "intended to affect the structure or any function of the body."

Smoking Everywhere, a Florida-based distributor that was to receive the shipments, challenged that authority in federal court, and was soon joined by Sottera. The companies argued that the Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (529 U.S. 120 (2000)) held that Congress never intended the FDCA to grant the agency jurisdiction to regulate cigarettes or other tobacco products. They contended e-cigarettes weren't meant "for any therapeutic purpose, as a smoking cessation aid," but rather were "marketed, labeled, and sold solely to provide adult consumers with alternative 'smoking' pleasure, without the inconveniences of traditional tobacco smoking." (Smoking Everywhere, Inc. v. FDA, No. 09-CV-00771 (D.D.C. filed Apr. 28, 2009).)

A year later, U.S. District Judge Richard J. Leon agreed and issued a preliminary injunction. "This case appears to be yet another example of FDA's aggressive efforts to regulate recreation tobacco products as drugs or devices under the FDCA," he wrote. (Smoking Everywhere, Inc., v. FDA, 680 F. Supp. 2d 62, 78 (D.D.C. 2010).) Leon's ruling was upheld on appeal, and the FDA declined to seek Supreme Court review. (Sottera, Inc. v. FDA, 627 F.3d 891 (D.C. Cir. 2010).)

Leon was particularly annoyed that the federal agency had apparently blocked e-cigarette imports in anticipation of the Family Smoking Prevention and Tobacco Control Act (Pub. L. No. 111-31), enacted shortly after the plaintiffs filed suit. The 2009 act granted the FDA new authority to regulate "any product made or derived from tobacco that is intended for human consumption" - including e-cigarettes. (21 U.S.C. § 321(rr)(1).)

"[N]otwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred," Leon wrote.

Before the agency could propose new federal rules, however, California Attorney General Brown sued Smoking Everywhere under the state's Health and Safety Code - and prepared a complaint against Sottera - alleging that the two distributors targeted minors and misled consumers. The companies quickly settled, paying fines and promising not to market e-cigarettes to minors or to claim that their products are safer than traditional cigarettes. (See People v. Smoking Everywhere, Inc., No. RG10493637 (Alameda Super. Ct. stipulated judgment filed Nov. 2, 2010); and People v. Sottera, Inc., No. RG10528622 (Alameda Super. Ct. consent judgment filed Sept. 10, 2010).)

Since then, at least seven states and more than 100 cities and counties in California have enacted e-cigarette regulations.

Finally, last April, the FDA proposed a new rule "deeming" certain tobacco products to be subject to regulation: e-cigarettes, cigars, pipe tobacco, nicotine gels, water pipe or hookah tobacco, and "dissolvables not already under the FDA's authority."

FDA Commissioner Margaret A. Hamburg, in a May letter to the New York Times, called the rule a critical first step that "will bring an end to the completely unregulated e-cigarette marketplace." Noting that the agency had financed four studies of nicotine vapor, Dr. Hamburg wrote that it is "committed to the science-based regulation of these products to better protect public health."

The deeming rule would ban e-cigarette sales to minors nationwide, require proof of age to buy the devices, and require producers to register with the FDA and provide details on ingredients, manufacturing processes, and other scientific data. But the proposal doesn't address flavored liquids, including those that critics say are aimed at youth. As Mitchell Zeller, director of the FDA's Center for Tobacco Products, explained to the Times, that would require a proving of harm, which isn't possible until regulatory control over the products is established.

Sending a Message
In California, Brown's 2010 consent judgments address many of the perceived hazards of e-cigarettes. Among other provisions, Smoking Everywhere and Sottera agreed to audit manufacturing to ensure product safety and not to advertise e-cigarettes as smoking-cessation devices or claim that the devices are safer than cigarettes or will improve a user's health.

Still, the settlements permit the two distributors to market e-cigarettes as an alternative to smoking traditional cigarettes, provided the ad "states conspicuously that e-cigarettes are sold for purely recreational purposes and not for treating nicotine addiction, and that nicotine causes addiction."

Rival distributors were under no such restrictions, permitting them to market e-cigarettes and vaporizers extensively. According to a study by the Centers for Disease Control and Prevention, as of 2013 more than 36 percent of smokers in the United States had tried electronic cigarettes, and 8.5 percent of all adults had tried them.

Two putative class actions brought last year in California have challenged the legality of some advertising messages. The first, filed in federal court in Los Angeles, alleges that Njoy uses unfair and deceptive practices in its e-cigarette marketing campaign, violating the state's Consumers Legal Remedies Act (Civil Code §§ 1750-1784) and Unfair Competition Law (Bus. & Prof. Code § 17200). (In re Njoy, Inc. Consumer Class Action Litigation, No. CV-14-00428 (C.D. Cal. filed Jan. 17, 2014).) At issue are slogans such as "All the pleasures of smoking without all the problems"; "Everything you like about smoking without the things you don't"; "Finally, smokers have a real alternative"; and "Cigarettes, you've met your match."

U.S. District Court Judge Margaret M. Morrow, presiding in the consolidated cases, was full of questions about e-cigarettes at a hearing last May. "How big a market is this, and what is the sense of the plaintiffs as to the potential recovery here?" she asked Janine L. Pollack, a class action specialist and partner in the New York office of Wolf Haldenstein Adler Freeman & Herz.

"The e-cigarette market is growing at leaps and bounds," Pollack replied. "I think it's half a billion to a billion [dollars]. ... There's an expectation that it will grow exponentially in the next few years."

Paul L. Gale, Njoy's lawyer and a partner in the Irvine office of Troutman Sanders, told Judge Morrow that the 2010 consent judgment would be the cornerstone of Njoy's defense. That agreement, he said, "covered everything that [the plaintiffs are] complaining about. We've been in full compliance with that consent decree since then."

At the hearing Gale also said that deeming regulations pending at the FDA could affect his defense. He affirmed that he anticipated raising "some preemption issues," but did not elaborate. The consent judgment expressly permits modification of the agreement should it "become preempted by federal law or regulation."

The litigators declined to be interviewed, and Njoy's CEO, Craig Weiss, did not respond to multiple messages.

In October, Morrow dismissed the complaint, ruling that plaintiffs had failed to show they relied on Njoy's ads. Even a "somewhat relaxed" reading of the "particularity" requirement under rule 9(b) of the Federal Rules of Civil Procedure, she wrote, wouldn't permit the case to proceed.

"Plaintiffs offer no information regarding when, or even if, each of the named Plaintiffs viewed the [Njoy] website and/or operating instructions," Morrow stated. "Without such facts, these conclusory allegations do not come within a country mile of satisfying Rule 9(b)."

After another failed attempt, the plaintiffs filed a third amended complaint in November, and Gale moved to dismiss with prejudice. "Njoy was under no duty to disclose either the ingredients on its label, or the fact that a few hand-picked, publicly available studies that looked at different products found that more study is needed regarding long-term health effects of e-cigarette usage," he argued. Gale also disputed allegations that Njoy promotes its products as "generally safe or safer than traditional cigarettes." Morrow has scheduled a hearing on the motion later this month.

The second lawsuit, this one in Los Angeles Superior Court, makes similar claims against Fumizer LLC, a Glendale-based distributor of e-cigarettes. The plaintiffs assert that in what they describe as an owner's manual, Fumizer boasts its "very good quality" e-cigarettes are "healthy" and "can help you quit smoking." The lead plaintiff also alleges that one of Fumizer's e-cigarettes exploded in his home, starting a fire that destroyed personal property. (Sheppard v. Fumizer, LLC, No. BC 558403 (L.A. Super. Ct. filed Sept. 22, 2014).)

The complaint calls the marketing claims at issue "contradictory and hypocritical" since the labels on Fumizer's e-cigarette packaging warn that the product is not a smoking-cessation device. "This is a 60-year-old flashback to Big Tobacco telling us that 'Four out of five doctors prefer Camels,' " says attorney Jerusalem Beligan, who works with lead counsel John P. Bisnar, a principal at Bisnar Chase in Newport Beach. The suit seeks unspecified damages for "deceptive, false and misleading" representations and advertisements. Fumizer had not replied to the complaint by press time.

Doing Less Harm
Both of the Los Angeles suits allege that the distributors of e-cigarettes imply through their marketing that the devices reduce harm associated with using tobacco - despite abundant studies showing that e-cigarettes themselves are not harmless. A study of e-cigarette cartridges by the FDA's Division of Pharmaceutical Analysis found "detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed."

"There have been claims that the secondhand vapor is just water vapor that's not harmful," says Andy Tan, an assistant professor of social and behavioral sciences at Harvard's School of Public Health. "That's not true. The health concerns are still unknown."

Nicotine vapors contain propylene glycol, for instance, a synthetic liquid that absorbs water and is used to make polyester compounds, de-icing solutions, and fake smoke for theatrical productions. When eaten as a food additive, the FDA considers propylene glycol "generally recognized as safe."

But what happens when vaporized and sucked deeply into the lungs? There isn't enough scientific evidence to know if the compound is also safe to inhale - though researchers are skeptical.

Another additive is diacetyl, commonly used to give butter flavoring to microwave popcorn and some e-cigarettes. When inhaled, it has been found to cause irreversible lung scarring - or "popcorn lung disease," nicknamed after the food-plant workers exposed to diacetyl.

Did my Njoy King contain diacetyl? Probably not - it wasn't butter-flavored. But how could I know? E-cigarettes don't come with a complete list of ingredients.

Other toxins sometimes found in e-cigarette vapor include nitrosamines - a class of carcinogenic compounds - and diethylene glycol, an ingredient in antifreeze.

Currently there are no rules governing the contents of nicotine liquids, and thousands of flavors are available. "If you want cat-piss or camel-dung flavor, it's not illegal," says Robert Proctor, a history professor at Stanford University who studies the tobacco industry.

With few exceptions, Proctor says, e-cigarette marketers are cautious about claiming their products can cure smoking addictions, and he adds that their goal is to sell as many of the new devices as possible. "They are very careful with their word magic," he says.

Proctor sees great irony in the spread of e-cigarettes. The fact that they are trumpeted as a lesser evil "could cause more harm and prolong the [tobacco] epidemic" by actually increasing nicotine consumption.

Dr. Robert Jackler, a professor at Stanford Medical School's Research into the Impact of Tobacco Advertising program, seems even more skeptical. "Do e-cigarettes help established smokers to quit?" Jackler asks. The devices "may have a role, but the success rate is disappointing." And if smokers can vape in places where smoking isn't allowed, it may even boost their nicotine consumption. "These are nicotine-continuity products," Jackler adds. "They may very well damage the lungs ... with very unnatural things. There's no reason to think they're safe."

Dr. Prue Talbot, a professor of cell biology at UC Riverside, used a smoking machine that mimics a human dragging on e-cigarettes to determine how much suction it takes to produce aerosol and get a hit of nicotine. "Some of [the products] required quite hard puffs to activate and get vapor," she told me.

Of course, free-market proponents of e-cigarettes argue that there is no reason to think they are unsafe until proven otherwise. Sally L. Satel, a resident scholar at the American Enterprise Institute, urged in a January op-ed article in the New York Times that the FDA hold off issuing final regulations, citing more than 135,000 public comments sent to the agency after its deeming-rule announcement last year. Her concern: the "hugely burdensome regulatory framework" in the 2009 Tobacco Control Act for any new product. This includes "pre-market review," forcing companies to demonstrate "not only that each specific product was beneficial to intended users (adult smokers), but [also] the consequences to teens and nonsmokers. Gathering these data would be vastly time consuming and expensive."

Satel recommended that the FDA issue interim safety guidelines "that would not carry the force of law" but could "bolster smokers' confidence that a safer way to inhale nicotine exists."

Meanwhile, warning cries over the apparent dangers of vaping are growing louder, including cautions from public health advocates such as the World Health Organization and the American College of Chest Physicians.

In October, a tobacco specialist for the Paris-based International Union Against Tuberculosis and Lung Disease called for a ban on e-cigarettes until they're proven safe. "Of course, more research is needed to establish the degree of danger, but until this research is done, the e-cigarettes should be banned," Tara Singh Bam told a conference in Moscow.

In January, the New England Journal of Medicine published a peer-reviewed study by five scientists at Portland State University who found that vaping at a high voltage causes formaldehyde-releasing agents to develop - exposing users to a carcinogen. That same month, the California Department of Public Health issued a 21-page report concluding that "e-cigarettes do not emit a harmless water vapor, but a concoction of chemicals toxic to human cells in the form of an aerosol." At least ten of the chemicals found in the aerosol are on the state's Proposition 65 list of substances known to cause cancer, birth defects, or other reproductive harm.

This year, state Sen. Mark Leno (D-San Francisco) introduced SB 140, which would allow state regulation of e-cigarettes by defining them as tobacco products, thus barring their use at work, in schools, on public transportation, and in restaurants and bars. "Addiction is what is really being sold," says Leno. Last year SB 648, sponsored by state Sen. Ellen Corbett (D-San Leandro) to ban e-cigarette sales from vending machines, was defeated in an Assembly committee.

California's retiring U.S. Senator Barbara Boxer was one of six Democratic senators who recently wrote to FDA Commissioner Hamburg asking for "standardized [e-cigarette] consumer protections that are strictly based on scientific evidence." Citing the FDA's proposal to require a label warning that reads, "This product contains nicotine derived from tobacco. Nicotine is an addictive chemical," the senators urged the agency to go further and "address health risks that e-cigarettes pose."

UC Riverside's professor Talbot reminded me that some 20 years after the United States began mass-producing cigarettes in the early 1900s, lung cancer rates began to rise. And yet, another half century would elapse before the dangers of smoking became known and health warnings appeared on cigarette packaging.

Until similar definitive research results on vaping's health effects are available, it may be premature to file personal injury claims. Still, "[w]e have a history in the United States of filing cases quickly after there's some notice that a product is said to be hazardous," says Deborah R. Hensler, an expert on class action litigation at Stanford Law School. For example, lawsuits alleging harm from silicone breast implants were filed under pressure from women's groups before the health dangers of implants were fully researched.

"It's difficult if there aren't regulations that are being violated," Hensler adds. "But one of the roles of private litigation is to incentivize regulation."

Michael F. Ram, a partner who specializes in consumer-safety cases at Ram, Olson, Cereghino & Kopczynski in San Francisco, agrees. "I don't see a downside, societally, to [litigating] now," he says. "Even if there's need for further study, [we have concerns] based on findings that there are toxins in nicotine vapor. [B]ut the industry's clear message is that e-cigarettes are entirely safe. Under the consumer protection laws of California, you're going to have a cause of action if companies are advertising in a misleading fashion."

Protecting Public Health
In August, 29 state attorneys general urged the FDA to extend its deeming rule to limit e-cigarette flavors and Internet sales, and to bring applicable marketing rules in line with those for traditional cigarettes.

But tougher rules could have unintended consequences, says Stephen D. Sugarman, a law professor at UC Berkeley and the author of two books on tobacco regulation. When smokers switch to vaping it's "a plus for public health," he contends. The same goes when people take up vaping instead of starting to smoke. "The FDA is in a tough spot: What if [e-cigarettes] turn out to be safe and helpful?"

Even so, one of tobacco-control advocates' biggest fears is that vaping will help "re-normalize" tobacco use. "There is a whole generation of young people that has no television exposure to tobacco products," notes Harvard's Tan. If vaping commercials are introduced on TV, he fears, using e-cigarettes could become the norm, or at least "acceptable."

Still, Tan concedes that harm reduction remains "the crux of the debate - not just between the industry and regulators, but also within the public health community."

One of the most passionate debates over harm reduction took place in Los Angeles last year, when the City Council unanimously passed an ordinance to ban vaping wherever smoking is already prohibited. But there was a separate vote on a proposal to exempt bars and nightclubs from the ban.

The exemption was defeated, but only after City Council President Herb J. Wesson Jr. made a personal appeal. Wesson, who has smoked heavily since his early twenties, said he's failed in numerous attempts to quit. He fears kids will start out vaping and then transition to smoking. "I will not support anything - anything - that might attract one new smoker," he told the council.

Wesson said he began smoking one summer while working in a factory. After shifts, the older men took him to bars. "They'd order a Budweiser and they'd smoke and talk. It was just so cool. One guy leans over to me and says, 'Young blood, you want a cigarette?' "

Opposing testimony came from Jeff Stier, a senior fellow at the National Center for Public Policy Research, a conservative think tank in Washington, D.C., focused on free-market policies. "Vaping isn't smoking," he reminded the council members. E-cigarettes "don't normalize smoking - they normalize nonsmoking."

Forcing people who might quit cigarettes through vaping to "go outside with the smokers" is nonsense, Stier argued. "If you put them outside with the smokers, they're going to go back to smoking."

Wesson countered that allowing vaping in bars and clubs would only spread its popularity. "I can't sit in silence," he said. "[Smoking] kills, and it will probably kill me."

As the debate over harm reduction swirls, the FDA isn't likely to wait decades for definitive scientific evidence on vaping's long-term health effects. "[Medical] studies are being done much quicker now," says professor Talbot. "It shouldn't take 40 years.

"People are watching."

Thomas Peele is an investigative reporter for the Bay Area News Group.

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Kari Santos

Daily Journal Staff Writer

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