FDA proposes first regulations for e-cigarettes

AP Tobacco WriterApril 23, 2014 

  • Diary of the e-cigarette

    Late 2006: Electronic cigarettes first marketed in U.S. via kiosks in shopping malls and online.

    Early 2009: E-cigarette sellers sue the Food and Drug Administration after the agency told customs officials to refuse entry of shipments into U.S.

    June 2009: The Food and Drug Administration said testing of products from two leading electronic cigarette makers turned up several toxic chemicals, including a key ingredient in antifreeze.

    January 2010: Federal judge rules that the FDA can’t stop those shipments, saying the agency had overstepped its authority.

    December 2010: Federal appeals court rules e-cigarettes should be regulated as tobacco products by the FDA rather than as drug-delivery devices.

    February 2011: U.S. Department of Transportation prohibits use of e-cigarettes on commercial airlines.

    April 2011: FDA announces plans to regulate electronic cigarettes as tobacco products.

    July 2011: FDA announces intent to have e-cigarette regulations proposed by October 2011.

    April 2012: Lorillard Inc., the nation’s third-biggest tobacco company, buys Blu Ecigs.

    Summer 2012: No. 2 tobacco company Reynolds American Inc. begins limited distribution of first electronic cigarette under Vuse brand.

    February 2013: The Centers for Disease Control and Prevention releases study showing increased awareness and use of electronic cigarettes in the U.S.

    March 2013: Former U.S. surgeon general Dr. Richard Carmona joins board of directors for e-cigarette maker NJOY Inc.

    July 2013: Reynolds American launches test market of revamped version of Vuse e-cigarette.

    August 2013: Subsidiary of Altria Group Inc., owner of the nation’s biggest tobacco company, Philip Morris USA, launches test market first e-cigarette under MarkTen brand name.

    September 2013: CDC releases study showing growing use of e-cigarettes by middle and high school students.

    End of 2013: Sales of e-cigarettes reach nearly $2 billion with more than 200 brands.

    April 24, 2014: FDA issues proposed regulations for electronic cigarettes.

    -The Associated Press

— The federal government wants to ban 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.

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

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.

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.

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.

Companies also will be required to submit applications for premarket review within two years. As long as an e-cigarette maker has submitted the application, the FDA said it will allow the products to stay on the market while they are being reviewed. That would mean companies would have to submit an application for all e-cigarettes now being sold.

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Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum .

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