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FDA Proposes First Regulations For E-Cigarettes

NEW YORK (CBSNewYork/AP) – The federal government wants to prohibit sales of electronic cigarettes to minors and require approval for new products and health warning labels under regulations being proposed by the Food and Drug Administration.

While the proposal being issued Thursday won’t immediately mean changes for the popular devices, the move is aimed at eventually taming the fast-growing e-cigarette industry.

The agency said the proposal sets a foundation for regulating the products but the rules don’t immediately ban the wide array of flavors of e-cigarettes, curb marketing on places like TV or set product standards.

Any further rules “will have to be grounded in our growing body of knowledge and understanding about the use of e-cigarettes and their potential health risks or public health benefits,” Commissioner Dr. Margaret Hamburg said.

The move comes as members of Congress and public health groups have raised concerns over e-cigarettes and questioned their marketing tactics.

“When finalized (the proposal) would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products.

Also on Thursday, the FDA proposed extending its authority to regulate cigars, hookah, nicotine gels, pipe tobacco and dissolvable tobacco products.

Public health advocates said the FDA proposal is a critical step in reining in marketing of the new products.

But they also said it comes after an “inexcusably long delay,” pointing out that the FDA first announced its plans to regulate e-cigarettes in April 2011.

New Jersey Congressman Frank Pallone, Jr. called the proposed regulations “long overdue.”

“After months of waiting, I am pleased that the FDA has finally issued proposed regulations regarding the manufacture and sale of e-cigarettes and other tobacco products,” he said in a statement. “The FDA must have a role in examining the science behind e-cigarettes in order to protect the public health.”

Once finalized, the agency could propose additional restrictions on e-cigarettes. Officials didn’t provide a timetable for that action.

The FDA said the public, members of the industry and others will have 75 days to comment on the proposal. The agency will evaluate those comments before issuing a final rule but there’s no timetable for when that will happen.

The regulations will be a step in a long process that many believe will ultimately end up being challenged in court.

E-cigarettes are plastic or metal tubes, usually the size of a cigarette, that heat a liquid nicotine solution instead of burning tobacco. That creates vapor that users inhale.

Smokers like e-cigarettes because the nicotine-infused vapor looks like smoke but doesn’t contain the thousands of chemicals, tar or odor of regular cigarettes.

Some smokers use e-cigarettes as a way to quit smoking tobacco, or to cut down. However, there’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.

The industry started on the Internet and at shopping-mall kiosks and has rocketed from thousands of users in 2006 to several million worldwide who can choose from more than 200 brands.

Sales are estimated to have reached nearly $2 billion in 2013. Tobacco company executives have noted that they are eating into traditional cigarette sales, and their companies have jumped into the business.

Some believe lightly regulating electronic cigarettes might actually be better for public health overall, if smokers switch and e-cigarettes really are safer.

Others are raising alarms about the hazards of the products and a litany of questions about whether e-cigarettes will keep smokers addicted or encourage others to start using e-cigarettes, and even eventually tobacco products.

“Right now for something like e-cigarettes, there are far more questions than answers,” Zeller said, adding that the agency is conducting research to better understand the safety of the devices and who is using them.

“It seems to be a responsible approach — and shows the FDA’s commitment to look at particular e-cigarettes in a science-based way rather than just conjecture,” said Jason Healy, president of Blu e-cigs, which is owned by Lorillard Inc. and holds more than 45 percent of the market. “Obviously we’ve got a long way to go. This may be just some calm before the storm.”

Healy noted that the e-cigarette landscape and the products themselves will continue to evolve and grow before the regulations take effect, and they will likely spur a consolidation of companies in the market.

In addition to prohibiting sales to minors and requiring health labels that warn users that nicotine is an addictive chemical, e-cigarette makers also would be required to register their products with the agency and disclose ingredients. They also would not be allowed to claim their products are safer than other tobacco products.

They also couldn’t use words such as “light” or “mild” to describe their products, give out free samples or sell their products in vending machines unless they are in a place open only to adults, such as a bar.

Last month, Sen. Charles Schumer said he is co-sponsoring a Senate bill that would ban e-cigarette marketing campaigns targeted at children.

“Instead of being harmless, e-cigarettes are actually a gateway to conventional smoking, particularly for kids,” Schumer said. “That’s the problem.”

New York City became the first large city in the country to ban sales of tobacco products to anyone under 21 years old when former Mayor Michael Bloomberg signed the bill last November.

The measure, which includes the sale of cigarettes, cigars and other tobacco products, also applies to e-cigarettes.

In December of last year, the New York City Council approved legislation to ban the use of e-cigarettes from indoor public spaces where smoking is already prohibited. It was signed into law during Bloomberg’s last month in office.

The Metropolitan Transportation Authority has also added e-cigarettes to its smoking ban on Long Island Rail Road and Metro-North trains.

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