Amid FDA Regulation Plans, E-Cigarettes are Subject of Debate

The debate over electronic cigarettes as a smoking-cessation tool is heating up. In April 2014, the U.S. Food and Drug Administration (FDA) made a bid to regulate the sale of the devices. If regulation occurs, will “e-cigarettes” remain as plentiful, and in what form? And will they be helpful to smokers diagnosed with cancer who are trying to quit tobacco?

E-cigarettes can be found in convenience stories as battery-operated “cig-alikes,” which physically resemble tobacco cigarettes, or in “vape shops” and online as “e-liquids” inhaled through vaporizers, according to Bill Godshall, executive director of Smokefree Pennsylvania.

While e-cigarettes contain tobacco-derived nicotine and a heating element, they do not burn, and produce aerosol rather than smoke. Some studies have found that, in comparison to their tobacco-containing counterparts, e-cigarettes are less likely to cause disease in users, and that they reduce the dangers associated with secondhand smoke. A small 2014 Flemish study found them “immediately and highly effective” in reducing tobacco cigarette cravings, with 44 percent of the 48 participants smoking less, or no, tobacco after eight months. Still, no large studies have looked at the long-term effects of e-cigarettes.

The United Kingdom’s chapter of the global organization Action on Smoking and Health (ASH UK) recommends e-cigarettes as a smoking- cessation tool, but pulmonologist Frank Leone, director of the smoking-cessation program at the Perelman School of Medicine at the University of Pennsylvania, supports regulation in America first, saying that ingredients in the devices can vary in potency and quality. Instead, Leone favors FDA-approved tools like nicotine gum, skin patches, lozenges, or the drug Chantix (varenicline)—preferably in combination, and under professional guidance.

“It’s hard for me to imagine a health care professional simply trying something unproven and hoping for the best,” Leone says. The FDA proposed in April that e-cigarettes become subject to the agency’s review, specifying that it has the authority to take that action under the Family Smoking Prevention and Tobacco Control Act of 2009. Having heard public comments, the FDA could now publish a final rule allowing it to prohibit e-cigarette sales to minors, require that the products carry a health warning, and issue new regulations of the devices, potentially including those intended to reduce harmfulness, says agency spokesperson Jenny Haliski.

The American Medical Association (AMA) has supported regulation, citing government findings that e-cigarette use by students in the nation’s middle and high schools more than doubled from 3.3 percent in 2011 to 6.8 percent in 2012.

Godshall calls those numbers misleading, saying that study didn’t distinguish between occasional and frequent use—important, since dabblers are unlikely to become regular “vapers.” According to recent ASH UK research, most teens who use e-cigarettes do so only after becoming smokers of tobacco cigarettes.

But a study by the National Institute on Drug Abuse found that more teens used e-cigarettes than tobacco products in 2014, and Leone cautions that teenagers, whose brains are still developing, are especially vulnerable to the addictive properties of nicotine.

If the regulations went into effect, e-cigarette companies would have to register each product and its ingredients with the FDA—at a cost of $334,000 per product, the agency estimates.

Godshall guesses that the expense of registration will push several thousand e-cigarette companies out of business—all except the country’s three largest tobacco companies, which have greater financial resources.

Republicans in the U.S. House of Representatives, including Speaker John Boehner, agreed in a Nov. 24 letter to the U.S. Department of Health and Human Services, asking that e-cigarettes currently on the market remain available without FDA review.

“The cost and barriers surrounding a new product submission would largely prevent new entries (into the marketplace), posing an unwarranted regulatory barrier to innovation,” they wrote.

Leone would be fine with companies closing if it meant that patients would know what was in their e-cigarettes. He also isn’t concerned where e-cigarette profits land, including in the hands of the companies that have fed America’s tobacco smoking habit.

“My responsibility as a physician is to do for my patients what I believe is in their best interest, regardless of its impact on Phillip Morris or mom-and-pop businesses or John Boehner,” Leone says. “Marketplace concerns should be meaningless to us when it comes to a person with cancer who needs to stop smoking.”

He recommends that smokers read the clinical guideline for the treatment of tobacco use in lung cancer available through the American College of Chest Physicians (http://journal.publications.chestnet. org/article.aspx?articleID=1685800).

“Ask your oncology nurse or your primary-care physician for help, or call a quit line,” he adds. “Look for information that is well-reasoned, cuts through the noise and nonsense, and offers solid data.”