FDA moves to regulate e-cigarettes for the first time

The federal government announced Thursday sweeping new rules for electronic cigarettes that will for the first time require the devices and their ingredients to be reviewed, a mandate that could offer some protection for consumers and upend a multibillion-dollar industry that has gone largely unregulated.

Before brands are allowed to stay in the market, regulators would have to check the design, contents and flavor of the devices, which are increasingly popular among teenagers.


"Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical," said Health and Human Services Secretary Sylvia Burwell. "We cannot let the enormous progress we've made toward a tobacco-free generation be undermined by products that impact our health and economy in this way."

The rules issued by the Food and Drug Administration also would extend long-standing restrictions on traditional cigarettes to a host of other products, including e-cigarettes, hookahs, pipe tobacco and nicotine gels. Sale of the products to minors would be prohibited.


E-cigarettes are battery-powered devices that convert a flavored, often nicotine-infused liquid into an inhalable vapor. The vapor lacks the chemicals and tars of burning tobacco, but the devices have not been extensively studied, and there's no scientific consensus on the risks or advantages of "vaping."

More than 15 percent of high school students report using e-cigarettes, an increase of more than 900 percent over the past five years, according to federal figures.

Beginning in August, retailers will be prohibited from selling the tobacco products to anyone under 18, placing them in vending machines or distributing free samples. While nearly all states already ban sales of e-cigarettes to minors, federal officials said they will be able to impose stiffer penalties and deploy more resources to enforcement.

Maryland banned e-cigarette sales to minors in 2012 and expanded the law last year to include all component parts such as the liquid or "juice."

A 2014 survey of teens in the state found that nearly 20 percent of underage high school students — more than 50,000 minors — used electronic products, while 8 percent reported smoking traditional cigarettes and 10 percent smoked cigars. The majority of the teens used flavored products.

Local officials have sought to curtail minors' access to such flavored items. The Maryland Department of Health and Mental Hygiene also asked the FDA ahead of the new rule to ban flavors "such as apple pie, bubble gum and chocolate fudge brownie" and to restrict marketing targeting young people. The FDA did not take action on that matter Thursday, but officials said they continue to study the impacts of flavorings.

For now, the nation's estimated 20 million e-cigarette users likely won't see big changes. Companies have two years to submit their information to the FDA and another year while the agency reviews it. Government officials said this process is critical to taming the "Wild West" marketplace for the products.

"Today's action is a huge step forward for consumer protection," said Dr. Robert Califf, commissioner of the Food and Drug Administration. "With this rule, the FDA will be able to prevent misleading claims and provide consumers with information to help them better understand the risks of using tobacco products."

The FDA action comes five years after the agency first announced its intent to regulate e-cigarettes, and more than two years after it made its initial proposal.

Public health advocates applauded the decision.

"Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products," said Harold Wimmer, president of the American Lung Association.

The vaping industry says lengthy federal reviews would be time-consuming and costly, and could put many smaller companies out of business.


The regulations "will cause a modern-day prohibition of products that are recognized worldwide as far less hazardous than cigarettes," said Gregory Conley, president of the American Vaping Association. "If the FDA's rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years."

The FDA has stumbled before in its efforts to regulate the products. In 2010, a federal appeals court threw out the agency's plan to treat e-cigarettes as drug delivery devices rather than tobacco products.

Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association, who filed one of the initial lawsuits against the agency, vowed to sue the government again.

"We will come out with a vengeance," Story said. "We're certainly not going to allow this industry to get [swept] under the rug."

House Republicans are pushing back already. Last month a House spending committee approved industry-backed legislation that would prohibit the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations.

The legislation's chief author, Republican Rep. Tom Cole of Oklahoma, called the FDA announcement an example of "nanny-state mentality."

Lawmakers on Capitol Hill have long enjoyed a close relationship with the tobacco industry, which has already given more than $1.8 million to members of Congress this election cycle, according to the Center for Responsive Politics.

In Maryland, some industry supporters fear that FDA regulation would mean state lawmakers would again pursue a statewide ban on vaping in public places. Baltimore City and Howard and Montgomery counties ban vaping in public places, but a statewide measure failed recently in the General Assembly, as did legislation to increase e-cigarette taxes.

Such legislation "could have a significant impact in Maryland," said Bruce C. Bereano, a lobbyist representing the Maryland Association of Tobacco & Candy Distributors.

Maryland Vape Professionals, a trade association, also anticipates that such legislation will be introduced again next session. The group's primary concern is to ensure that people who rely on e-cigarettes and other products to reduce or stop their tobacco use still will have access, said Nathan Willner, a Baltimore lawyer who acts as the group's lead counsel.

"We'll be looking for ways to amend the rules or compromise in a way that people in the industry can make a livelihood and continue to help people quit smoking," while considering the rights of nonusers, he said.

It's not clear if the FDA's move will bolster any legislation, but Del. Aruna Miller, a Montgomery County Democrat who has sponsored bills to ban vaping in public spaces, said she planned to work with those opposed to limits before reintroducing any measure.

"I do plan to revisit the legislation," Miller said. "This is a great step the FDA has taken. It's a step toward improving public health."


Some smokers say using e-cigarettes is a good way to quit smoking tobacco or cut down on cigarette use. But there's little scientific evidence about whether such claims are valid.

Sales of e-cigarettes and related vaporizers are projected to reach $4.1 billion in 2016, according to Wells Fargo analyst Bonnie Herzog. After growing rapidly over several years, sales have begun to slow recently due to negative publicity and questions about safety.

Retail sales are dominated by a handful of traditional tobacco companies, including R.J. Reynolds, which sells the Vuse e-cigarette; and Imperial Tobacco, which sells the devices under the brand blu. Those products are sold nationwide at convenience stores and gas stations.

Hundreds of smaller companies sell specialized products — often with refillable "tanks" and customized flavors — at vape shops and over the Internet.

Baltimore Sun reporter Meredith Cohn and the Associated Press contributed to this article.

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