The federal government on Thursday banned the sale of e-cigarettes to anyone under the age of 18 and required manufacturers to disclose their ingredients and submit their products to the government for approval.
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 on Thursday. “All of this is creating a new generation of Americans who are at risk of addiction."
She said, “As a nation, we have agreed for several years that nicotine does not belong in the hands of children.”
Industry officials reacted angrily to many of the rules, warning that requiring pre-market approval could decimate the many small businesses that produce e-cigarettes and could ultimately 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, so 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 and also 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 then for an additional year while the FDA reviews the submissions.
Zeller told reporters that it would initially 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 of the rules put forward by the agency will endanger the market for products that have the potential to help people move away from traditional tobacco.
"These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers,” Cynthia Cabrera, executive director of the Smoke-Free Alternatives Trade Association, the largest industry trade group, said in a statement .“It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar, job-creating industry, the majority of which are made of small businesses."
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. Officials suggested they might eventually consider banning flavors in cigars and e-cigarettes, but said the topic needs more research.
Thursday’s regulations also bring a range of other products under federal regulation, including hookahs and regular and the more expensive, premium cigars. The International Premium Cigar & Pipe Retailers Association, a trade group, said on its website Thursday that “the FDA’s regulation of premium cigars, if left unchecked, would have a devastating impact on retailers and manufacturers alike.” It added that consumers would “have less choice.” And they said the rule could hurt the thousands of Americans who work in the industry.
But Chris Hansen, president of the American Cancer Society Cancer Action Network, praised the FDA for including a wide range of cigars, including premium cigars, saying "these products pose no less a health risk than other cigars."
In recent weeks, the e-cigarette industry has gotten support from some public health experts. In late April, a group of tobacco-control experts, writing in the journal Addiction, urged the FDA to be "open-minded" about e-cigarettes, saying that the products can result in a reduction in traditional smoking. And recently, the Royal College of Physicians concluded that e-cigarettes were likely to be beneficial to public health in Britain.
But many anti-smoking advocates disagree. They say that e-cigarettes could be harmful, that the long-term health risks are unknown and that companies are marketing their products to younger and younger teens. They say the companies are using the same tactics and themes that the traditional cigarette makers used years ago.
"It’s about time that we stem the tide of these e-cigarettes,” said Roy Herbst, chief of oncology at Yale Cancer Center and Smilow Cancer Hospital. “The momentum has been so much in favor of their use."
The FDA's authority to regulate the products stems from a 2009 law that gave the agency broad power over traditional cigarettes, as well as jurisdiction over other tobacco-related products.
In the years since, states and municipalities have taken it upon themselves to limit the use of e-cigarettes, including banning them in public places and prohibiting sales to minors. Just this week, California Gov. Jerry Brown banned “vaping” in public places such as theaters and restaurants as part of a package of bills that raised the state’s legal smoking age to 21.
This post has been updated and corrected. An earlier version said the FDA banned flavors in cigars. In fact, officials said they would look closely at the issue.
