Fda proposes first e-cigarette rules — nbc news

Supporters and some researchers say they may be useful in helping people quit smoking what they call combustible cigarettes, but the research is limited. Hamburg says it’s important to find out just how people really are using them whether as an aid to kicking the habit or as a crutch to get them past no smoking zones.

And most health advocates are suspicious of the motives of e cigarette makers.

«The tobacco industry are very vigorously looking at alternative products to smoking tobacco and are betting a lot that this will be a product for them that will be viable in the future,» said American Heart Association president Dr. Mariell jessup.

«It s being marketed a lot that the smoke is harmless and we don t know that. We shouldn’t be fooled by the promises that these devices, these nicotine delivery systems, are safe.»

Jessup is disappointed the new rules don’t limit advertising and flavors.

We will be very disappointed if the regulations don t address the marketing of these products. In particular, e cigarettes have been intensively advertised and really focused on youth, she added.

The Campaign for Tobacco Free Kids was more blunt.

«It is inexcusable that it has taken the FDA and the Administration so long to act. This delay has had serious public health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids, and their use has skyrocketed,» the group said in a statement.

E cigarettes contain at the least nicotine and compounds such as propylene glycol, as well as water, to make a flavored mist that looks like smoke and that users can inhale like they would a cigarette.

But Hamburg says no one really knows what else is in them or what the effects are of inhaling the heated up mixture. We don t know as much about the safety and risks of e cigarettes and that is why we want to be able to regulate them, Hamburg told NBC News.

The current situation is of great concern to us, she added. It is an unregulated environment with respect to these products.

They are an easy way for kids to take up a nicotine habit and then go on to cigarettes and other tobacco products.»

Flavors such as strawberry and thin mint make it clear the products are being aimed at children, teens and young adults, Hamburg said.

They are an easy way for kids to take up a nicotine habit and then go on to cigarettes and other tobacco products that we know carry very serious risks, she said.

Thursday s proposals are just the start of a cumbersome process. FDA will publish the suggested regulations and then the public and industry may weigh in. FDA must consider the comments before it enacts a final rule something that can take months or even years.

We want to move as quickly as we can but it is a process and it will take time, Hamburg said. We think the fact that we are beginning the process is important.

Advocates are not happy about this.

I do feel impatient because you cannot watch television or listen to the radio without hearing about these e cigarettes,» Jessup told NBC News. This is a full court press from the tobacco industry. They used to be available only in small kiosks in malls and now they are available on the internet. They are ubiquitous now. All of these legislative things move very slowly but the marketing of these products is now moving slowly.

The FDA banned fruit and candy flavored cigarettes soon after the agency was given regulatory power over tobacco in 2009. Hamburg noted that tobacco companies then started making flavored cigars and she said that worries her.

Last year, the FDA found that menthol cigarettes were more dangerous than non flavored cigarettes, but did nothing to limit their sale.

NBC’s Tom Costello and Jay Blackman contributed to this report

E-cigarettes face first regulations

The battery powered devices that turn nicotine laced water into vapor are a fast growing alternative to smoking, with sales expected to approach $2 billion this year, compared with the overall U.S. tobacco market of about $100 billion. The gadgets have drawn huge investor interest while sparking debate over whether they attract new users or mostly divert cigarette buyers, and whether they lure children into nicotine addiction.

E cigarettes are taxed less than regular cigarettes and typically cost less.

Under its new rules, the FDA will require manufacturers to provide scientific evidence to substantiate any claims they make that e cigarettes are safer than standard ones.

The FDA plans a 75 day comment period before the regulations become final. Some provisions, such as requiring evidence of health benefits, will go into effect at that point. The agency then will allow two years for all other provisions to be effective.

One of the biggest new requirements is that e cigarette makers will need to apply to the FDA within two years to keep existing products on the market. The agency then will rule on applications roughly as it does on other tobacco products.

The rules come as some studies suggest the devices help traditional smokers kick the habit. A randomized trial of 657 people in New Zealand published last year in the medical journal Lancet found e cigarettes were «modestly effective» in smoking cessation, with a 7.3% abstinence rate after six months.

«We have not seen anything like this in 100 years that could make the combustible cigarette obsolete,» said David Abrams, a professor at Johns Hopkins School of Public Health and research director at Legacy, an anti tobacco group. He believes the devices could wean people from traditional cigarettes.

Smoking remains the leading cause of preventable death, killing 480,000 Americans annually, government estimates show.

FDA Commissioner Margaret A. Hamburg said the regulations mark «an historic day for the FDA and for public health.» She said the agency was stepping in to prevent children from smoking and suffering «a lifetime of nicotine addiction.» The new rules, she said, «will make a real and enduring difference.»

FDA officials stressed the new rules are just a first step, and that regulations over added flavors remain a strong possibility.

But the rules fall short of what some critics have sought.

«I am concerned about e cigarettes because manufacturers are targeting children and using promotions with celebrities, as well as using colors and flavors that are appealing to children,» said Sen. Richard Blumenthal (D., Conn.)

E cigarette makers say they don’t target youth in their marketing.

Most researchers believe e cigarettes are less harmful than regular ones, which release carbon monoxide and thousands of chemicals, including known carcinogens, through combustion.

The financial stakes are huge. Big Tobacco is plunging into e cigarettes to try to offset sliding sales, rising taxes and widening bans on traditional smokes.

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Reynolds American Inc., RAI 2.93% Reynolds American Inc. U.S. NYSE $53.40 1.61 2.93% April 23, 2014 4 02 pm Volume (Delayed 15m) 3.61M AFTER HOURS $53.40 0.00 0.00% April 23, 2014 6 32 pm Volume (Delayed 15m) 45,075 P/E Ratio 18.41 Market Cap $29.51 Billion Dividend Yield 5.02% Rev. per Employee $1,556,900 04/24/14 E Cigarettes Face First Regula… 04/23/14 Reynolds American Revenue Grow… 04/22/14 AHEAD OF THE TAPE Tobacco&#39 s V… More quote details and news RAI in Your Value Your Change Short position maker of Camel cigarettes and the No. 2 tobacco player, plans to roll out its Vuse e cigarette nationally by midyear.

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