Makers of electronic cigarettes such as Lorillard Inc. (LO) and Altria Group Inc. will for the first time face regulatory oversight, including passing a review to stay on the market, under a U.S. plan that doesn t ban TV ads or flavored versions of the new products.

The Food and Drug Administration today said it planned to extend its reach over the tobacco industry to include the $3 billion market for e cigarettes such as NJOY and blu, as well as cigars. The rules, if finalized, will limit sales to minors, ban free samples and require nicotine addiction warnings.

Consumer groups have said e cigarette companies use candy flavors, TV ads and music festival sponsorships to target youth, who doubled their use of the products in 2012 from a year earlier. Agency officials called today s proposal a foundation that may lead to tighter control in the future.

For the first time there will be a science based, independent regulatory agency providing gatekeeping, Mitch Zeller, director of the FDA s Center for Tobacco Products, said in a briefing. The regulator will finally be doing its job.

The FDA gained the authority in 2009 to regulate e cigarettes and cigars. The latest plan, open to public comment for 75 days, would require e cigarette and cigar manufacturers to give the agency ingredient lists as well. The rules also will apply to pipe tobacco and hookah tobacco.

The agency is assessing available research on flavors in e cigarettes, FDA Commissioner Margaret Hamburg said.

We re prepared for responsible regulation, Andries Verleur, chief executive officer and co founder of Miami based V2 Cigs, said in an interview before the proposal was made public. Anything that would stifle innovation or accessibility we ll stand firmly against. I can say with certainty the electronic cigarette is not going anywhere.

Massive Impact

While Verleur said regulatory review requirements could have a massive impact financially, he favors prohibiting sales to those younger than 18.

Most e cigarettes deliver nicotine while leaving out the tars, arsenic and other chemicals common in tobacco products. The tubular devices, which produce an inhalable vapor to mimic smoking, were added at the end of last year to a New York ban on smoking in restaurants, bars, offices and parks. Chicago and Los Angeles followed with similar prohibitions.

Graham Hubert, a 29 year old set builder in New York, used traditional smokes for 10 years before switching to e cigarettes. He views them as an alternative that may have fewer side effects.

I m concerned about the little bit, that we don t know much about the long term side effects, Hubert said. But I do know the long term side effects of smoking, so I rather be smoking an e cigarette.

He said e cigarettes should be regulated similarly to regular cigarettes, especially in banning sales to minors.

Limit Addiction

When you re a young person there should be a way to limit the amount of addiction you have, Hubert said. I didn t smoke when I was a teenager. Why make something available to a kid that they don t need.

Cigarettes already must meet FDA review standards, maintain minimum age requirements and display warnings. Traditional smokes, though, are also banned from online sales, TV advertising, sponsorship and the use of flavors. Menthol is permitted while the ingredient is under FDA review.

The industry may choose to sue the FDA to fight the proposal. Zeller said he s confident the agency would be able to back up their regulatory attempt with science.

Regulatory Power

While companies such as Altria and Reynolds American Inc. (RAI) have been under the FDA s authority since Congress gave the agency power over the $90 billion tobacco industry in 2009, e cigarettes and cigars haven t been subject to the same oversight. The industry has flourished with sales tripling last year to $1.5 billion, according to Bloomberg Industries.

The law passed about five years ago and a lot has happened on a lot of different tobacco products without any regulatory activity by the FDA, Gregg Haifley, associate director of federal relations with the American Cancer Society s Cancer Action Network, said before the proposal was released. We re disappointed that it has taken this long.

Industry sales may reach $5 billion in 2015, according to Bloomberg Industries, which had previously predicted $6 billion in sales but lowered the figure to reflect growing bans on where they can be smoked.

High sales potential has lured the traditional tobacco companies into the market, with Lorillard, the largest seller of menthol cigarettes in the U.S., buying blu eCigs in 2012 and Altria (MO) testing its MarkTen brand in certain regions last year.

Smaller Companies

Verleur of V2 Cigs said he anticipates the new regulation will push smaller companies that haven t invested in quality controls out of the market and lead to consolidation.

New products and those that want to stay on the market will be subject to FDA review, according to the proposal. New cigarettes that have gained FDA clearance have used a pathway that allows companies to compare them with products that were for sale before Feb. 15, 2007.

E cigarettes, an industry that only took off a few years ago, may not be able to identify products marketed before the date. Zeller said the comment period will help the agency determine if anything is comparable or whether e cigarette makers might be put through a more arduous clearance process. Once the regulation is final, manufacturers will have two years to submit an application for FDA review and will be allowed to continue sales while the agency makes a determination.

The FDA also is asking for comment on whether premium cigars should be included in the agency s regulation, Zeller said. He wouldn t say when the proposal might become final.

Enticing Children

Advocacy groups that fight cancer are concerned flavored e cigarettes and cigars as well as stylish advertising is attracting children to use the products as a gateway to cigarettes, Haifley said in an interview. The share of U.S. students in middle school and high school who used e cigarettes in 2012 doubled to 10 percent, according to the Centers for Disease Control and Prevention s National Youth Tobacco Survey released in September.

It presents serious problems in the smoke free context and it is potentially undercutting the whole social norm, Haifley said. All the sudden having people behaving like they re smoking, what kind of social message does that send to kids?

Executives at e cigarette companies argue their products are aimed at current smokers as a cigarette alternative. Though most don t say the products can help traditional smokers quit which would require stricter FDA regulation as a drug product.

The potential for removing combustion from the smoking process can have such an impact on public health and also the economics of public health because of the number of people who suffer from smoking complications, Verleur said.

To contact the reporter on this story Anna Edney in Washington at aedney

To contact the editors responsible for this story Reg Gale at rgale5 Andrew Pollack

Young using e-cigarettes smoke too, study finds –

Djarum – wikipedia, the free encyclopedia

Middle and high school students who used electronic cigarettes were more likely to smoke real cigarettes and less likely to quit than students who did not use the devices, a new study has found. They were also more likely to smoke heavily. But experts are divided about what the findings mean.

The study s lead author, Stanton Glantz, a professor of medicine at the University of California, San Francisco, who has been critical of the devices, said the results suggested that the use of e cigarettes was leading to less quitting, not more.

The use of e cigarettes does not discourage, and may encourage, conventional cigarette use among U.S. adolescents, the study concluded. It was published online in the journal JAMA Pediatrics on Thursday.

But other experts said the data did not support that interpretation. They said that just because e cigarettes are being used by youths who smoke more and have a harder time quitting does not mean that the devices themselves are the cause of those problems. It is just as possible, they said, that young people who use the devices were heavier smokers to begin with, or would have become heavy smokers anyway.

The data in this study do not allow many of the broad conclusions that it draws, said Thomas J. Glynn, a researcher at the American Cancer Society.

The study is likely to stir the debate further over what electronic cigarettes mean for the nation s 45 million smokers, about three million of whom are middle and high school students. Some experts worry that e cigarettes are a gateway to smoking real cigarettes for young people, though most say the data is too skimpy to settle the issue. Others hope the devices could be a path to quitting.

So far, the overwhelming majority of young people who use e cigarettes also smoke real cigarettes, a large federal survey published last year found.

Still, while e cigarette use among youths doubled from 2011 to 2012, regular cigarette smoking for youths has continued to decline. The rate hit a record low in 2013 of 9.6 percent, down by two thirds from its peak in 1997.

The new study drew on broad federal survey data from more than 17,000 middle school and high school students in 2011 and more than 22,000 in 2012. But instead of following the same students over time which many experts say is crucial to determine whether there has been a progression from e cigarettes to actual smoking the study examined two different groups of students, essentially creating two snapshots.

Dr. Glantz says that his findings show that use of e cigarettes can predict who will go on to become an established smoker. Students who said they had experimented with cigarettes that is, taken at least one puff were much more likely to become established smokers if they also used e cigarettes, he said.

One of the arguments that people make for e cigarettes is that they are a way to cut down on the smoking of cigarettes, but the actual use pattern is just the opposite, he said.

But David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Legacy Foundation, an antismoking research group, said the study s data do not support that conclusion.

I am quite certain that a survey would find that people who have used nicotine gum are much more likely to be smokers and to have trouble quitting, but that does not mean that gum is a gateway to smoking or makes it harder to quit, he said.

He argued that there were many possible reasons that students who experimented with e cigarettes were also heavier smokers for example, living in a home where people smoke, belonging to a social circle where smoking is more common, or abusing drugs or alcohol.

The study did have a bright spot Youths who used e cigarettes were more likely to plan to quit smoking. Dr. Abrams highlighted that finding, but said it was impossible to tell whether students who planned to quit actually did, because the data did not track this.