The FDA on Its New Rules for E-Cigs: What We Don't Know Could Hurt Us

Courtesy Campaign for Tobacco-Free Kids

The number of kids in grades 6 to 12 who’ve tried electronic cigarettes doubled from 2011 to 2012, according to the Centers for Disease Control. While the long-term health effects of inhaling nicotine vapor are unknown, U.S. regulators want to keep e-cigs out of kids’ hands with new rules to prevent sales to people under 18.

“We have far more questions than answers about who is using e-cigarettes and how they’re being used,” Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products told reporters today.

Electronic cigarettes have been on the market for less than a decade in the U.S. We don’t yet know whether using e-cigs, which mimic old-fashioned smokes with heated cartridges that deliver nicotine vapor, has long-term health consequences. We don’t know whether they help longtime smokers quit, and we don’t know whether kids who try e-cigs are more likely to start smoking tobacco cigarettes. We don’t even fully know what’s in them, because e-cigarette manufacturers haven’t been required to disclose ingredients.

The lack of evidence about e-cigs poses a challenge for public health advocates and regulators watching the industry, which may have sales as high as $1.5 billion in the U.S. this year. The FDA notes how big the unknowns are in its new proposed rules (pdf) for e-cigs: “We do not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health.” (The new rules would also apply to other tobacco products, including cigars, pipe tobacco, and cigarillos.)

The agency acknowledges that if new products offer ways for nicotine addicts to get their fix that are less harmful than cigarettes, “they could help reduce the overall death and disease toll from tobacco product use.” But the FDA also notes that nicotine’s addictive properties are well established. It would eventually require warning labels, although the language is less scary than what’s currently on cigarette packages: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.”

That’s also why it plans to prohibit the sale of e-cigs to kids under 18. Keeping adolescents from buying e-cigs—as well as “combustible” tobacco products such as cigars—is intended to prevent them from smoking cigarettes, a habit known to be both addictive and potentially deadly. By stepping in with regulation, the agency wants to keep people from assuming that e-cigs are harmless before the evidence is in. “There is the risk that failure to act will reinforce consumers’ existing confusion and misinformation about these products’ safety or lack of harmfulness.”

The rule will also require e-cig makers, as well as manufacturers of cigars and other tobacco products, to disclose ingredients to the FDA—though not to the public. Cigarette makers have had to do this under the 2009 tobacco control act.

The FDA didn’t go as far as it could have. E-cig makers would still be able to sell cartridges that taste like candy or other flavors that might appeal to children. And the rule doesn’t impose any restrictions on marketing—so a billboard advertisement of Santa Claus vaping would still be fair game.

A statement by Lorillard, the tobacco company that owns the Blu e-cig brand, said the company “has long-supported reasonable science-based regulation of electronic cigarettes such as establishing minimum age-of-purchase requirements, setting product quality and safety standards, and listing of ingredients and other relevant consumer information.”

Congress empowered the FDA to regulate tobacco products such as e-cigs and cigars in 2009. John Seffrin, chief executive of the American Cancer Society, said the FDA took too long to write rules. “Certainly the tobacco industry has taken full advantage of the delay to skirt regulations,” he said on a call with reporters.

Here’s the dilemma for regulators: Research into the public health consequences of e-cigs will take years. If it turns out they lead young people to other tobacco products known to be dangerous, the FDA risks standing by while a new generation of smokers picks up the habit.

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