E-cig industry on tenterhooks ahead of U.S. regulation

(Reuters) - Lobbyists for electronic cigarette companies have been beating a path to the White House, hoping to prevent the administration from imposing strict, and possibly costly, rules on the burgeoning $2 billion industry.

In November and December, more than 35 organizations including e-cigarette companies, cigar and tobacco makers, trade associations, physician groups, lawyers, lobbyists and public health advocates trooped through the doors of the White House's Office of Management and Budget.

OMB has been reviewing a rule proposed by the Food and Drug Administration that would bring e-cigarettes under its jurisdiction and could potentially require companies to register and pay fees, list the ingredients in their products, obtain prior approval for new products and restrict online sales and marketing to children.

The OMB, which reviews proposed regulations to assess, among other things, their economic impact, has not given a date for when it will be finished with its review, but officials have not had a meeting with outsiders since January 17 according to public records, suggesting they have heard all they need, or are willing, to hear.

At stake is the future of an industry that some analysts believe will eventually overtake the $80 billion-a-year tobacco business. Advocates of e-cigarettes, which are battery-powered cartridges filled with nicotine liquid that when heated creates an inhalable vapor, say they are less dangerous than tobacco products and can help smokers quit. Public health experts fear they may act as a gateway to smoking for the uninitiated.

Mitch Zeller, head of the FDA's tobacco division, said in an interview that there is a "continuum of risk" among nicotine products currently on the market, with cigarettes on one end and medicinal nicotine on the other. He declined to say where on the spectrum he expects e-cigarettes to fall or what is contained in the FDA's proposals. In general, he said, people smoke for the nicotine and die from the tar.

"I'm not saying nicotine is benign, but when compared to the risk associated with regular tobacco, it pales," he said.

Some, therefore, expect the FDA to exercise flexibility in regulating  electronic-cigarette

"It's not just a matter of a blanket dropping in of the current regulations over additional products," said Diane Canova, vice president of government affairs at the anti-tobacco American Legacy Foundation, "Some of the current restrictions may not fit."

TOBACCO CONTROL ACT

A law passed in 2009 gave the FDA the authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco. It also gave the agency the power to deem other tobacco products to be within its jurisdiction but it must first issue a rule to that effect. E-cigarette companies believe they should be exempt from the full spectrum of regulations, saying they would stifle innovation, damage small business and hurt consumers trying to quit smoking.

Tobacco company Lorillard Inc, owner of the blu e-cigarette brand, is the dominant player in the field, followed by privately-held NJOY and LOGIC Technology. The three account for an estimated 80 percent of the market.

In a November 7 presentation to OMB, representatives for NJOY said that while the company supports product registration and minimum age requirements, it opposes restrictions on TV advertising and sponsorship and any regulation that would subject e-cigarettes to the pre-market approval requirements that traditional tobacco products face.

"The concern is that a product that is constantly changing could be tied up in a very time-consuming process before the products could be legally marketed," said Bryan Haynes, a lawyer for the Electronic Cigarette Industry Group (ECIG).

The FDA is already working its way through a backlog of nearly 4,000 applications for new or modified tobacco products.

E-cigarettes are sold online and at a variety of retail locations including some gas stations, convenience stores, grocery stores and drug stores.

"We think the proposals will include a potential ban on internet sales because you can't age verify," said Vivien Azer, an analyst at Citigroup. The FDA is expected to place age restrictions on who can buy e-cigarettes.

Restricting internet sales would be "devastating to the companies that have built successful businesses online," said Cynthia Cabrera, executive director of the Smoke Free Alternatives Trade Association (SFATA). "About quarter of the revenue from e-cigarettes come from online sales," she added.

Another contested area is the use of flavorings. Banned in traditional cigarettes they are used widely in e-cigarettes to produce tastes ranging from pear and passion fruit to butterscotch and banana cream.

Public health advocates say flavorings attract children and threaten to create a new generation of nicotine addicts even the government is trying to create a generation that is tobacco free.

Adult smoking rates have fallen to 18 percent from 43 percent in 1965. Even so, more than 3,200 young people a day under the age of 18 try their first cigarette, a recent government report found. The use of e-cigarettes by young people doubled between 2011 to 2012, according to the Centers for Disease Control and Prevention.

ADVERTISING RESTRICTIONS

Once the proposed rule is announced there will be a period for public comment, after which the FDA will develop final regulation. The process could take a year or more. In the meantime, critics say e-cigarette companies are using the same promotional techniques that were used for decades by cigarette manufacturers to attract teenagers to their products.

On February 12, two Democratic U.S. representatives, Henry Waxman and Peter Welch, and one senator, Tom Harkin, wrote to the attorneys general in their states to bring electronic cigarettes under the terms of a settlement reached in 1998 with top tobacco companies that prohibited any advertising targeting youth.

"Youth use of these products is particularly troubling since the full extent of e-cigarette harms is not yet understood," they wrote.

Some e-cigarette companies are already positioning themselves for a more restrictive environment. LOGIC Technology, for one, expects advertising, flavors and online sales to be banned or severely restricted.

"I think what is important is retail locations," Miguel Martin, LOGIC's president, said in an interview. "In retail locations, there is age verification. I believe that is where the industry is going and where regulation is going. If you are relying on the internet and TV, I think those vehicles are going to be taken away from you."

LOGIC's products taste either of tobacco or menthol only, the flavors allowed with traditional cigarettes.

But Martin, like other e-cigarette companies, wants his industry to be exempt from the requirement that new or modified products be reviewed by the FDA before hitting the market.

In the meantime, OMB officials have mostly kept their thoughts to themselves.

"I've been in some of these meetings," said Eric Criss, president of ECIG. "It's mostly a one-way conversation."

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So it would have happened if all smokers switched to e cig counterparts - the researchers said. But the truth is that there is currently no research on their long-term effects and impact on health
Scientists , politicians, health professionals , physicians , manufacturers of e-cigarettes from around the world met this week in the London headquarters of the Royal Society , to discuss the future of e-cigarettes . The current knowledge about their health , their effectiveness in parting with addiction and the legal regulations . About how governments and ordinary people should approach the phenomenon that has become a mass e - smoking .

Its scale has grown tremendously and very fast - the sale of these products for four years at the doubles. At the moment it is estimated that in Europe alone is already 7 million smokers electronically . In Poland, more than 500 thousand . Why ? What are better than other nicotine therapy , such as patches or gum ?- Apparently they have what is missing tablets , plastrom , gumom or inhalatorom nicotine . In addition to supplying the substance from which it is dependent , gives the impression of a puff of smoke , the whole ritual of smoking - said in an interview for " Gazeta " prof. Andrzej Sobczak from the Institute of Occupational Medicine and Environmental Health in Sosnowiec , which conducts research on e - cigarettes in Poland.

Some support only electronic smoking and switched to others not at all. We recently demonstrated that e- cigarettes are just as effective in quitting smoking as nicotine patches.

In the UK , where he held the current debate , about 100 thousand . people die each year because of tobacco dependence . The world with over 5 million . Some scholars who took part in the meeting , they hope that the growing interest in electronic cigarette change these statistics, I pull into the lungs instead of the toxic substances contained in tobacco , users of e - cigarettes inhale only dissolved in a liquid nicotine.

Robert West , professor of medical psychology at University College London , did not hesitate to even say that " thanks to e - cigarettes can be saved millions of people ."

It is their absolute supporter .

But there are those who believe that e- smoking causes a nicotine addiction as something normal . Habit , which should not be fighting.

The World Health Organization (WHO ) in case issued a statement that the person wishing to make use of e - cigarettes should halt until you finally proven that they are safe. WHO indicates that there is a potential " unspecified risk" for their use.

But this means years of waiting . For those heavily addicted to nicotine is often too long. After smoking can harm them at that time more than any consequences of the use of e-cigarettes . And what are the associated risks ?

E - cigarettes are new to the market , so there was no opportunity to carry out long-term research into their effects on health . To get the hard scientific evidence , the need for a large group of users followed for many years.

For now, the results of short-term studies that show that electronic cigarettes are healthier than traditional .

- We looked under investigation by us e - cigarettes * for example, the presence of formaldehyde , acetaldehyde , acrolein . Also volatile organic compounds - including benzene, toluene, xylene - told "Gazeta " prof. Sobczak . I named : - We checked whether there are nitrosamines , polycyclic aromatic hydrocarbons , heavy metals . Most of these compounds are carcinogenic . We compared our results to having always the same composition of the reference cigarette produced for research by the University of Kentucky, Lexington , USA. Tested by us e - cigarettes do not contain harmful carcinogens, which we were looking for , or their concentration is below the level of quantification - he explained.

What, then, is the nicotine fluids ? - Nicotine - from 0.4 percent . up to 3.6 percent . glycol, propylene glycol , glycerin , water, flavoring compounds . The tobacco smoke is more than 5.6 thousand . chemical compounds. In the case of e-cigarette is their award- less , so much easier to explore what exactly inhales the e - smoker - explained Professor . Sobczak .

There are also studies in rats , which show that after two years of inhaling nicotine aerosol in animals did not show any negative effects. - These tests were performed in 1996, before any electronic cigarette was on the market , so there could be no question of pressure from the companies producing and selling out e - cigarettes - explained Dr. Jacques Le Houezec , the doctor who studies the effects of nicotine and tobacco on human health.

Nevertheless, there are doubts . British Medical Association has called for the same smoking bans e - cigarettes in public places such as traditional. It's mainly for the protection of young people and non-smokers - people using e - cigarettes wherever they want , could encourage these people to start smoking and nicotine addiction present as harmless.

But Lynne Dawkins , of the University of East London, believes that it kills the positive message of e- smoking, which shows addicted to tobacco , however, that there is a way to get out of addiction and hope for the improvement of health. - I do not want to waste this great opportunity offered by addicts e - cigarettes. We must of course be cautious in their raptures , but at the same time we can not stifle the initiative in the bud. I have not had a chance - she said. The scientist also argued that electronic cigarettes are " really safe alternative " for people addicted to tobacco.

He supported her in this thesis , Dr. Le Houezec : - We should not impose too stringent regulations on e - cigarettes. Be afraid of them. We are located on the battlefield for a long time . And despite the different treatment of nicotine lose. For us, e - cigarettes are a revolution .

And he added firmly in the revolutionary tone : - Every teenager is trying something new, forbidden . I prefer to try e-cigarettes than traditional.

- In 1997-2007, the number of smokers has fallen in Poland, with 37 percent . to 31 percent . society . But since then , little has changed . You have to look for something new - says the professor . Sobczak .

Undoubtedly, you need to finally settle the issue of e - smoking . Disappeared proposal of the European Union to legalize e - cigarettes as medical devices available only in pharmacies. However, the UK is in such a form has to be approved in 2016.

Konstantinos Farsalinos from the university hospital Gathuisberga in Belgium is of the opinion that the regulations must be introduced as soon as possible . - Many companies hide behind their lack of legal solutions to this issue and has no obligation to provide any research of their products. This is a big problem.

Counterfeit products afraid to prof. Sobczak - I'm worried about the presence on the market of products of unknown origin . In them can be anything .



* Tests on an fluid-containing nicotine cigarettes Mild Black ( 14 mg / ml) and Volish Platinum High ( 18 mg / ml).