FDA bans e-cigarette sales to minors: Why now?

The US Food and Drug Administration began banning sales of electronic cigarettes to minors on Monday, apparently ending a contentious debate about whether e-cigarettes should be considered separately from other tobacco products.

In addition to barring the sale of e-cigarettes and other tobacco products to people under 18, the rules also require a photo ID to purchase them, stop retailers from handing out free samples, and require all e-cigarettes on the market since February 2007 to undergo a federal review.

The battery-operated devices, which vaporize a flavored fluid that typically includes nicotine, have often been marketed as a way for smokers to wean themselves from regular cigarettes. But with studies showing that e-cigarettes can lead young people to traditional tobacco products, the regulator is particularly aiming to crack down on the industry.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” Sylvia Burwell, secretary of the US Department of Health & Human Services, in a statement released by the FDA in May. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction.”

One study by researchers at the University of Southern California found that teens who use e-cigarettes – often known as vaping – are six times more likely to try regular cigarettes than those whose have never vaped.

But some caution that the study, released in June, didn’t necessarily prove that vaping causes teens to begin smoking cigarettes, since the survey didn’t track how many times the teens had vaped before they tried cigarettes.

“What's probably happening is these kids did not become regular vapers, (and) they turned to smoking,” Michael Siegel, a professor at the Boston University School of Public Health and a proponent of e-cigarettes as a way to reduce combustible cigarette use, told Reuters.

The industry’s lobbying group makes a similar argument in favor of e-cigarettes, noting the health care costs for Americans who smoke cigarettes.

“These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers,” harming a ”multi-billion job-creating industry,” the Smoke-Free Alternatives Trade Association said in May.

The group also notes scientific evidence showing that e-cigarettes, which don't offer the tar and chemicals of burning tobacco, are "more than 95 percent less harmful than combustible cigarettes."

But proponents say e-cigarettes have a variety of harmful effects, including that e-cigarettes may flout clean air laws, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said during a media briefing in May, when the rules were announced, US News reports.

The rules aim to rein in the industry as regulators have found that marketing efforts, particularly directed at teens, have increased.

“E-cigarette companies spent $115 million on advertising in 2014, compared to $6.4 million in 2011, the [Center for Disease Control’s] National Youth Tobacco Survey found. And they feature familiar images of sex, rebellion, and gritty independence that got yesterday's teens smoking regular cigarettes,” The Christian Science Monitor’s Lucy Schouten reported in January.

Under the FDA’s rules, companies won’t be allowed to promote vaping as a healthy alternative to smoking unless they provide strong scientific evidence to support that claim, Mr. Zeller said. The rules also apply to other tobacco products, including cigars, hookahs, and pipes.

The Smoke-Free Alternatives Trade Association estimated that the rules will mean that 99 percent of all e-cigarette products on the market will have to be submitted to the FDA’s review.

The regulator says existing brands will have at least three more years on the market before the regulations are enforced – two years while the companies prepare their applications and another year of FDA review, USNews reports.

But while the companies have condemned the rules, medical associations and health experts say they are needed to avoid putting young people on the road to smoking.

“The use of e-cigarettes in kids appears increasingly likely to result in an increased risk of using regular cigarettes, CDC Director Tom Frieden said at a press briefing in January. “They are not harmless.”