Controversy in promoting e-cigs

Could electronic cigarettes help millions of smokers kick their lethal addiction, saving lives and benefiting all of society?

The U.S. Food and Drug Administration's stated plan to begin regulating e-cigs this summer has renewed debate over tobacco "harm reduction." The idea is that some smokers can't or won't quit, even if they want to. By replacing their cigarettes with e-cigs - which deliver nicotine but eliminate carbon monoxide, tar, and other toxic chemicals found in tobacco smoke - they'll be better off, and so will the public.

"It would be in the same ballpark as being addicted to caffeine," said tobacco-cessation researcher Jonathan Foulds, a professor of public health and psychiatry at Pennsylvania State University. "I'm not saying e-cigs are as harmless as coffee. But the harm isn't such a disaster as death" from smoking.

Just one huge caveat, skeptics say: E-cigs could turn out to be a crutch that reinforces smoking, and also could be a gateway to regular cigarettes for youngsters who wouldn't otherwise get hooked.

To some degree, this is a philosophical debate. Under the proposed FDA rules, e-cigs would be forbidden from making risk-reduction claims without convincing the FDA with scientific evidence - and clear evidence is lacking. (Brands already making unapproved health claims would have to stop.)

Still, experts say, the debate matters. Harm reduction is a basic tenet of public health, underpinning alcohol policies, needle exchanges for drug addicts, methadone clinics.

Alas, some forms of harm reduction are plagued by squishy science or exploited by shrewd marketers, or both. The obesity epidemic that fatty, sugary foods have fed has become a chance to sell "reduced-fat" desserts and snacks.

"The use of misleading product descriptors such as 'low fat' and 'light,' pioneered by the tobacco industry, is more prevalent than ever for foods and beverages," anthropologist Peter Benson at Washington University in St. Louis says in his book Tobacco Capitalism: Growers, Migrant Workers, and the Changing Face of a Global Industry.

E-cigs - battery-powered gizmos that convert liquid nicotine into a vapor inhaled by the smoker, or "vaper" - were invented in China and came to the U.S. in 2007. There are now an estimated 20 million American vapers. Restrictions have been imposed by at least 26 states (including New Jersey, but not Pennsylvania) and many municipalities, including Philadelphia.

In 2009, Congress gave the FDA broad authority to regulate cigarettes and smokeless tobacco, and to bring newer tobacco products under its jurisdiction.

The proposed FDA rules would do just that for e-cigs, as well as cigars, pipe tobacco, and hookahs. Makers would have to add health warnings, disclose ingredients, stop sales to minors, and stop giving free samples.

Makers also would have to retroactively submit costly marketing applications for each of the thousands of existing products - which e-cig industry representatives say would wipe out all but a handful of big companies.

If that happens, "the black market and gray market are going to be ridiculous," said Gregory Conley of Medford, Burlington County, the president of the American Vaping Association.

In the future, the FDA could move to curb online sales, advertising, flavorings, and more.

Taken together, the nation's tobacco-control measures reflect one of the premises of harm reduction - that moral censure and total bans (sought by some tobacco researchers) can backfire.

Consider Prohibition. It reduced alcohol consumption, alcohol-related disease, and arrests for drunkenness. But it also drove drinking underground, spawning illegal enterprises, government corruption, and organized crime.

After the law's repeal in 1933, alcohol's harms were reined in with taxes, age limits, health warnings, education, and drunken-driving laws.

Designating and promoting specific products as risk-reducing is a newer, more controversial tactic.

The influential Institute of Medicine, which advises the government on health policy, endorsed the concept of tobacco harm-reduction products in a 2001 report. While e-cigs didn't yet exist, the institute concluded that cigarettelike reduced-emissions devices and smoking-cessation products such as nicotine patches and gums could potentially be a boon. The institute stressed that evidence was lacking and recommended "scientific research, surveillance, and regulatory tools" to realize "the potential individual and societal benefits."

Many tobacco-control advocates, however, were wary. They pointed to the tobacco industry's history of lying and co-opting the government. Through the 1970s and early 1980s, federal cancer researchers and even the Surgeon General advised smokers to switch to low-tar and "light" cigarettes that manufacturers claimed were safer - even as the companies modified designs and formulas in ways that actually heightened risks.

"The government became a collaborator with industry in certifying that certain cigarettes had less tar and nicotine," recalled Dan Romer, research director at the University of Pennsylvania's Annenberg Public Policy Center.

The California health department's Tobacco Control Program was so opposed to harm-reduction products - and the Institute of Medicine's conclusions - that it held a "Seduction of Harm Reduction Summit" in 2004. It rejected the idea that "there exists an unyielding set of obstinate or hopelessly addicted smokers" and warned that "support of nicotine maintenance undermines tobacco abstinence and cessation."

Despite passionate disagreement among public-health experts, the 2009 law giving the FDA jurisdiction over tobacco includes a way for companies to market a "modified-risk tobacco product."

The way is not easy. The product must be scientifically shown to benefit individual users and the population as a whole.

In April, Swedish Match, maker of a smokeless tobacco called snus, became the first to seek the distinction. The company asked to get rid of required smokeless-tobacco label warnings about mouth cancer, gum disease, and tooth loss. It also asked that the warning that "This product is not a safe alternative to cigarettes" be changed to say, "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."

The company submitted reams of data on what it called the "Swedish Experience." Since the 1970s, when Swedes embraced snus - teabaglike pouches that are tucked under the lip but require no spitting - rates of smoking and related diseases have plunged.

Still, a divided FDA advisory panel voted against softer warnings. The FDA, which usually follows such advice, has yet to rule.

Foulds, at Penn State, fears that if Swedish Match can't get a modified-risk designation, no tobacco firm can.

"They have decades of epidemiology that is absolutely clear," he said. "It's not that snus is harmless, but overall, it's significantly less unsafe. It may be seen as impossible for any other company to get a reduced risk on their label."

Others say time will tell.

"Nobody in the public-health community thinks we should just ban e-cigarettes and ignore the potential," said lawyer Desmond Jenson with the Tobacco Control Legal Consortium in St. Paul, Minn. "But if you want to maximize the public-health benefit and minimize going backward, you have to be careful. There are still so many unknowns."

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