FDA proposes regulations for e-cigarettes

The Food and Drug Administration (FDA) announced Thursday that it plans to regulate the booming business of electronic cigarettes by requiring new health warnings and banning sales to children.

The FDA already regulates most tobacco products, but is extending its authority to e-cigarettes and hookah tobacco for the first time after coming under pressure from members of Congress.

“With FDA having no authority to regulate these products, it is a little bit of the wild, wild west,” FDA Commissioner Margaret A. Hamburg said in a press call.

E-cigarettes have come under fire from health advocates, state legislatures and Democrats who warn the product could carry health risks. Lawmakers also say the industry is targeting children, as the devices can now be purchased by people of any age in many states.

Senate Health Committee Chairman Tom Harkin (D-Iowa) and other members have Congress have been calling for the FDA to regulate the devices, which contain nicotine.

“It’s past time for the FDA to take action on e-cigarettes and to treat these products as what they are — addictive tobacco products,” Harkin said in a statement to The Hill. “I welcome FDA action and look forward to closely examining this proposal once it comes out.”

The FDA is trying to determine whether e-cigarettes are more likely to ween smokers off traditional cigarettes, or simply convince them not to quit, because they think these products are safer.

“If somebody is a pack-a-day smoker, and that hypothetical smoker substituted cigarettes for e-cigarettes, we would concede that person is likely to be reducing their risk,” Zeller said.

But regulators are wary that e-cigarettes could also attract new smokers who see them as a safer alternative to traditional cigarettes. The FDA’s rule would not allow e-cigarette manufacturers to claim their products are safer than traditional cigarettes unless there is scientific evidence to prove it.

“If a kid starts with e-cigarettes, nicotine being addictive, it creates a heightened vulnerability that they will go on to use other tobacco products as well,” Hamburg said.

The FDA’s proposed rule would ban sales of electronic cigarettes to people under the age of 18.

The e-cigarette industry’s trade group says it supports the FDA’s goal of keeping these products out of the hands of minors.

“We are completely aligned with FDA and other groups who believe that electronic cigarettes and vaporizing products should not be accessible to children or teens, and we welcome a ban on access to anyone under 18,” the Smoke Free Alternatives Trade Association said in a press release.

The rules would also require health warnings on the products and prohibit manufacturers from distributing free samples or selling them in vending machines that are located in buildings where children have access.

Under the rules, e-cigarette manufacturers would be required to register with the FDA. They would only be allowed to market e-cigarettes after going through an extensive FDA review process, so the agency can examine the ingredients of their products.

E-cigarette manufacturers would have two years to submit applications for review to the FDA. In the meantime, they could continue selling their products until the FDA issues a decision. But new e-cigarettes would not allowed to come to market until they receive FDA approval.

But the FDA’s rule would not ban companies from selling flavored e-cigarettes, something Harkin would like to see before the agency moves forward with the rule.

“I urge the agency to keep their foot on the gas and take strong action towards ensuring that they are kept out of the hands of young people — in particular, by including in the finalized rule a prohibition against candy flavors used to entice kids to become addicted to their products,” Harkin said.

The public has 75 days to comment on the proposed rule.

— This story was updated at 4:25 p.m.