Fda proposes ban on e-cigarettes for young americans

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.

Fda proposes new rules to regulate e-cigs like cigarettes

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The FDA yesterday proposed a new rule that would permit it to regulate e cigarettes in the same way the agency regulates other tobacco products.

E cig advocates were reportedly pretty happy with the proposed regulations, as they take a much lighter touch than was expected. While they would ban the sale of e cigarettes to children, they would not limit advertising.

The FDA regs also, interestingly, call for the regulation of cigars and hookahs, among other tobacco delivery devices. From the FDA’s press release

Products that would be deemed to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e cigarettes), cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco, and dissolvables not already under the FDA s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco.

The basic structure of an e cigarette, courtesy of the FDA.

Our own Dr. Mark Thoma penned an E Cig 101 post for us, explaining the basics of how e cigarettes work, and summarizing some of the health and safety concerns surrounding them

E cigarettes have been around for about 10 years. First developed and marketed in China (not known as a bastion of consumer safety), they were designed to offer a convenient way to enjoy smoking. The e cigarette is designed to vaporize a liquid (that contains nicotine, flavorants and other substances) and allow it to be inhaled. The liquid can have varying amounts of nicotine. It can also have other substances (flavorants) added (mint, fruit flavors and others.) These flavorants are seen by some as a marketing ploy to get children to start smoking. The liquid may contain other chemicals or impurities, as well.

As Mark reported earlier, because e cigarettes are not currently regulated, companies can make them any way they want, with no standards whatsoever as to safety or quality.

What studies have found to date is that even nictotine free e cigarettes can contain nicotine, the amount of nicotine that e cigs deliver can vary by as much as 60% from puff to puff, and that some e cigs tested positive for nitrosamines, which may increase the risk of cancer in humans.

Mark noted that there are also concerns about refillable e cigs, in which you buy pure nicotine that you use to refill the delivery system. The NYT noted the potential problems with refillable e cigs

These e liquids, the key ingredients in e cigarettes, are powerful neurotoxins. Tiny amounts, whether ingested or absorbed through the skin, can cause vomiting and seizures and even be lethal. A teaspoon of even highly diluted e liquid can kill a small child.

But, like e cigarettes, e liquids are not regulated by federal authorities. They are mixed on factory floors and in the back rooms of shops, and sold legally in stores and online in small bottles that are kept casually around the house for regular refilling of e cigarettes.

E cig advocates argue that e cigs are still safer than cigarettes, since cigarettes contain such a long list of carcinogens. From the American Lung Association

There are approximately 600 ingredients in cigarettes. When burned, they create more than 7,000 chemicals. At least 69 of these chemicals are known to cause cancer, and many are poisonous.

The problem, experts say, is that we just don’t know enough about e cigs, because they’re not regulated, and because there aren’t enough health and safety studies, so while we think they may be safer than cigarettes, we simply don’t know for sure. From WebMD

So far, evidence suggests that e cigarettes may be safer than regular cigarettes. The biggest danger from tobacco is the smoke, and e cigarettes don’t burn. Tests show the levels of dangerous chemicals they give off are a fraction of what you’d get from a real cigarette. But they aren t regulated by the FDA, so what’s in them can vary.

«E cigarettes may be less harmful than cigarettes,» Drummond says. «But we still don’t know enough about their long term risks or the effects of secondhand exposure.»

I for one am glad to see the regulation. This is something you ingest. We ought to at the very least have standards for how it’s made, to ensure it’s safe.

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