FDA clamps down on e-cigarettes

Rules require warnings and ban free samples, sales to minors

Health and Human Services Secretary Sylvia Burwell, accompanied by Food and Drug Administration Commissioner Robert Califf, on Thursday announces new regulations for electronic cigarettes.
Health and Human Services Secretary Sylvia Burwell, accompanied by Food and Drug Administration Commissioner Robert Califf, on Thursday announces new regulations for electronic cigarettes.

WASHINGTON -- The federal government Thursday announced new rules for electronic cigarettes that will for the first time require the devices and their ingredients to be reviewed, a mandate that's designed to offer some protection for consumers and to regulate a multibillion-dollar industry that has gone largely unchecked.

The rules prohibit sales of e-cigarettes to minors, ban free samples, require package warning labels and call for makers of products released after 2007 to seek Food and Drug Administration permission to remain on store shelves, the FDA said Thursday in a statement.

"Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical," Health and Human Services Secretary Sylvia Burwell said. "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 will affect big companies -- such as Reynolds American Inc. and Altria Group Inc. -- that also make traditional cigarettes, as well as smaller players in the e-cigarette and vapor industry, which was worth about $5.2 billion in 2015. Congress gave the FDA authority to oversee tobacco products in 2009, but until now the agency had not finalized rules to regulate e-cigarettes and cigars.

Regulation was needed as the use of e-cigarettes and vapor products grows among young people in contrast to declining rates of smoking traditional cigarettes, health officials said.

E-cigarettes are battery-powered devices that turn liquid nicotine into an inhalable vapor. They lack the chemicals and tars of burning tobacco, but they have not been extensively studied, and there's no scientific consensus on the risks or advantages of "vaping."

"As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap," Burwell said. "All of this is creating a new generation of Americans who are at risk of addiction."

While the regulations are a move in the right direction, additional action is needed from the FDA to reduce the lure of tobacco products to young people, the American Cancer Society Cancer Action Network said.

"The FDA should immediately take action to address flavorings attractive to youth in all products and the egregious industry marketing practices," Chris Hansen, president of the group, said in a statement. "The tobacco industry has taken full advantage to exploit the lack of regulations on these issues."

Companies will have 24 months to file pre-market applications for their products, according to the rule. The FDA then has a year to review the submission, during which the products can remain on shelves.

Manufacturers "were looking for that compromise," said Kenneth Shea, a Bloomberg Intelligence analyst. "The critical question that no one really knows right now is, will the FDA conclude that these new products are unsafe or not?"

E-cigarette use among high school students rose 900 percent between 2010 and 2015, the FDA said Thursday, citing an earlier study done with the Centers for Disease Control and Prevention. About 16 percent of that group now use the products, according to the study.

Altria and Reynolds representatives didn't immediately respond to telephone and emailed requests for comment.

The FDA said in 2014 that it would create rules whereby electronic cigarettes would have to pass a review to stay on the market. When he was named to lead the FDA this year, Robert Califf, a cardiologist, said the rules were needed and forthcoming.

"We're thinking of this as a first step versus a last step in lots of work that needs to be done," said Robin Koval, chief executive officer of the Truth Initiative, a nonprofit dedicated to ending tobacco use. "The wild west is finally coming to an end, and that's good for everyone."

The vaping industry says the lengthy federal reviews will 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, who filed one of the initial lawsuits against the agency, vowed to sue the government again.

"We will come out with a vengeance," said Story, chief executive officer of the Tobacco Vapor Electronic Cigarette Association. "We're certainly not going to allow this industry to get swiped under the rug."

House Republicans already are pushing back. A House spending committee last month 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."

Information for this article was contributed by Matthew Perrone, Mary Clare Jalonick and Tom Murphy of The Associated Press and by Jennifer Kaplan of Bloomberg News.

A Section on 05/06/2016

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