WASHINGTON — The federal government on Thursday banned the sale of e-cigarettes to anyone under age 18 and required manufacturers to disclose their ingredients and submit their products to the government for approval.
The Food and Drug Administration’s action, which represents the first time the government has regulated the booming market of e-cigarettes, seeks to clamp down on devices that have become increasingly popular, especially among young people, even as they have been subject to almost no oversight.
The agency, which first said it intended to regulate e-cigarettes in 2014, also imposed the regulations on cigars, hookahs and pipe tobacco.
The effort is a response to long-standing concerns about what health experts call a “Wild West” atmosphere involving the multibillion-dollar e-cigarette industry. The battery-powered devices heat up flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.”
Easily carried and offering flavors from bubble gum to mocha to margarita, the devices are used by many Americans, but most notably by middle- and high-schoolers.
The number of young people using e-cigarettes now exceeds the number who smoke traditional cigarettes, according to the Centers for Disease Control and Prevention. About 5.3 percent of middle school students reported in 2015 that they had used e-cigarettes in the previous 30 days. For high-schoolers, the figure has risen to 16 percent. In 2015, 3 million middle and high school students reported using e-cigarettes, according to the FDA and the CDC.
“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” said Sylvia Mathews Burwell, secretary of health and human services, in announcing the rules Thursday. “All of this is creating a new generation of Americans who are at risk of addiction.”
Industry officials reacted angrily, predicting the new regulations could decimate the many small businesses that produce e-cigarettes and ultimately could deprive consumers of what they say is a less harmful alternative to conventional cigarettes.
Public health experts largely welcomed the rules, saying they were long overdue. Some said the FDA should have gone much further, banning the use of e-cigarette flavors and placing curbs on advertising.
“FDA passed up critical opportunities in this rule by failing to prohibit the sale of tobacco products coming in flavors like cotton candy,” said Benard Dreyer, president of the American Academy of Pediatrics.
But despite the landmark nature of the effort, the FDA action is unlikely to settle an intensifying debate over whether e-cigarettes are a gateway to traditional tar-laden, chemical-filled cigarettes or an effective way to help the long-addicted quit smoking.
David Levy, a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center, argued there is “strong evidence” that e-cigarettes could help people stop smoking and that the agency should be cautious about derailing the industry.
But many experts, including the FDA’s top tobacco official, Mitch Zeller, said there isn’t enough scientific evidence about the long-term health effects of e-cigarettes or about whether they are effective as smoke-cessation tools.
The new regulations generally require manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and for an additional year while the FDA reviews the submissions.
Zeller told reporters it initially would cost companies “several hundred thousand dollars” to apply for FDA approval, but that could change over time.
Representatives of the e-cigarette industry have supported bans on sales to minors but argued Thursday that some rules put forward by the agency will endanger the market for products that have the potential to help people move away from traditional tobacco.
The FDA’s new youth-access restrictions, which take effect in 90 days, compel retailers to verify the age of purchasers by photo identification, to put health warnings on their labels and to bar sales of the products in vending machines that are accessible to minors. Many states have such restrictions, but federal officials said enforcement wasn’t always consistent.
The rules also ban the distribution of free samples and the use of flavors in cigars.
Thursday’s regulations also bring a range of other products under federal regulation, including hookahs, regular cigars and the more expensive, premium cigars.
