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In 2009, Congress gave the Food and Drug Administration wide authority to oversee tobacco products. The agency has moved cautiously in flexing that power. On Thursday, for the first time, the FDA “deemed” several tobacco products to be under its watch, including cigars, pipe tobacco, nicotine gels, hookahs and e cigarettes. This move is welcome, if overdue. The FDA now has to conduct the tricky work of figuring out when further restrictions, particularly on e cigarettes, help and when they might actually harm public health.
As long as the FDA steers clear of direct regulation of products other than cigarettes, smokeless tobacco and roll your own tobacco, public health advocates rightly worry that potential smokers — particularly children and teenagers — will find it easier or more appealing to use unregulated products with varying or unknown public health effects. The agency says that expanding its oversight, which Congress gave it the power to do, is the first, “foundational” step toward broad regulation of these alternatives to cigarettes.
The FDA is demanding some concrete steps of manufacturers upfront. They will have to register their products with the agency and reveal their ingredients. They will have to attach warning labels. Many vending machines will become off limits. And the federal government will ban e cigarette sales to minors. Once regulators gather more information on the harm various products can cause and on how people are obtaining and using them, they can do more in the interest of public health, such as consider bans on Internet sales, candy like flavorings or certain kinds of marketing.
The FDA is also accepting feedback on whether to exempt “premium” cigars from regulation, since people often do not smoke them habitually. That strikes us as unnecessary, because cigars, too, can do harm. If regulators determine that premium cigars do not pose the same public health risks as other products, they can keep the demands on their manufacturers relatively light.
But for one product there is good reason for caution. E cigarettes, which deliver a nicotine laced vapor that presumably contains many fewer harmful ingredients than tobacco smoke, could help addicted, lifetime smokers to reduce their consumption or quit. On the other hand, e cigarette use among young people is soaring, and there is concern that it might be a gateway to conventional smoking.
Unlike with many other nicotine containing products, the FDA has to determine how to keep e cigarettes available to those who might benefit from them while minimizing their capacity to hook young people or encourage continued smoking. Thursday&apos s announcement is just the beginning of that process.
Feds propose first regulations on e-cigarettes
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WASHINGTON (TheBlaze/AP) The federal government wants take up the same stance that many cities have already adopted to ban sales of electronic cigarettes to minors and require approval for new products and health warning labels.
While the proposed regulations being issued by the Food and Drug Administration Thursday won t immediately mean changes for the popular devices, the move is aimed at eventually taming the fast growing e cigarette industry.
Daryl Cura demonstrates an e cigarette at Vape store in Chicago. 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. (AP/Nam Y. Huh)
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.
Watch WPTV TV s report about the proposed regulations
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.
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.
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.
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E cigarette makers believe e cigarettes present an opportunity to offer smokers an alternative and, as NJOY Inc. CEO Craig Weiss says, make cigarettes obsolete.
FDA can t just say no to electronic cigarettes anymore. I think they also understand it s the lesser of the two evils, said James Xu, owner of several Avail Vapor shops.
Some though raise 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.
Some cities have already taken bans against e cigarettes as far as to prohibit them in establishments or areas where smoking regular tobacco products was already not allowed.
Watch KTLA TV s report about such a ban