Fda proposes first regulations for e-cigarettes – wire technology – the sacramento bee
WASHINGTON 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.
Michael Felberbaum can be reached at .
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In October, Ms. Saunders convened a student advisory board to discuss how to approach e cigs. They said What s an e cig? Ms. Saunders recalled, and she showed what she meant. They said That s a vape pen.
Health officials worry that such views will lead to increased nicotine use and, possibly, prompt some people to graduate to cigarettes. The Food and Drug Administration is preparing to issue regulations that would give the agency control over e cigarettes, which have grown explosively virtually free of any federal oversight. Sales of e cigarettes more than doubled last year from 2012, to $1.7 billion, according to Wells Fargo Securities, and in the next decade, consumption of e cigarettes could outstrip that of conventional cigarettes. The number of stores that sell them has quadrupled in just the last year, according to the Smoke Free Alternatives Trade Association, an e cigarette industry trade group.
The emergence of hookah pens and other products and nicknames seems to suggest the market is growing well beyond smokers. Ms. Zacks was among more than 300 Bay Area high school students who attended a conference focused on health issues last month on the campus of the University of California, Berkeley. Many students talked about wide use of e hookahs or vaping pens saying as many as half of their classmates had tried one but said that there was little use of e cigarettes.
Ms. Zacks said the devices were popular at her high school here. E cigarettes are for people trying to quit smoking, she said, explaining her understanding of the distinction. Hookah pens are for people doing tricks, like blowing smoke rings.
James Hennessey, a sophomore at Drake High School in San Anselmo, Calif., who has tried a hookah pen several times, said e hookahs were less dangerous than e cigarettes. He and several Drake students estimated that 60 percent of their classmates had tried the devices, that they could be purchased easily in local stores, and that they often were present at parties or when people were hanging out.
E cigarettes have nicotine and hookah pens just have water vapor and flavor, said Andrew Hamilton, a senior from Drake.
Actually, it is possible for e cigarettes or e hookah devices to vary in nicotine content, and even to have no nicotine. Mr. Querbach at Romman said that 75 percent of the demand initially was for liquids with no nicotine, but that makers of the liquids were expanding their nicotine offerings. Often, nicotine is precisely the point, along with flavor.
Take, for example, the offerings of a store in San Francisco called King Kush Clothing Plus, where high school students say they sometimes buy their electronic inhalers. On a counter near the back, where tobacco products are sold, are several racks of flavored liquids that can be used to refill e cigarettes or hookah pens. The flavors include cinnamon apple, banana nut bread, vanilla cupcake, chocolate candy bar and coconut bomb. They range in nicotine concentration from zero to 24 milligrams about as much as a pack of 20 ordinary cigarettes but most of the products have some nicotine. To use the refills, it is necessary to buy a hookah pen, which vary widely in price around $20 and upward.
It is also possible to buy disposable versions, whether e cigarettes or hookah pens, that vary in nicotine content and flavor. At King Kush, the Atmos ice lemonade flavored disposable electronic portable hookah promises 0.6 percent nicotine and 600 puffs before it expires.
Emily Anne McDonald, an anthropologist at the University of California, San Francisco who is studying e cigarette use among young people, said the lack of public education about the breadth of nicotine vapor products was creating a vacuum so that young adults are getting information from marketing and from each other.
We need to understand what people are calling these before we send out large surveys, Dr. McDonald said. Otherwise the responses do not reflect reality, and then you re back to the beginning.