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Major cancer groups call for e-cigarette research, regulation

By John Nielsen, ScienceInsider

One telling sign of the popularity of electronic cigarettes, or e-cigarettes, which allow users to inhale nicotine vapors without other harmful chemicals, arrived late last year: The editors of the Oxford Dictionaries declared “vape” their Word of the Year for 2014.

Today, e-cigarettes earned another kind of notice: Two of the largest cancer science and treatment groups in the United States called on the government to start regulating “electronic nicotine delivery systems” and step up research on the health effects of vaping.

“While e-cigarettes may reduce smoking rates and attendant adverse health risks, we will not know for sure until these products are researched and regulated,” said Peter Paul Yu, president of the 35,000-member American Society of Clinical Oncology, in a statement. “We are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop nicotine addiction.” His group was joined by the American Association for Cancer Research, which has more than 33,000 members.

The joint statement endorsed the urgent need for new research into the health effects of e-cigarettes and using tobacco tax revenues to help fund studies. It also included a long list of recommended actions by state and federal government agencies. They include requiring makers of e-cigarettes to register their products with the Food and Drug Administration (FDA), to identify the chemicals and levels of nicotine in various brands, and to agree to help stop teenagers from vaping.

In April 2014, FDA issued a proposal to start regulating e-cigarettes. The proposal would require FDA reviews of e-cigarette products and force makers to stop claiming health benefits until the science is in. The rule would also ban the distribution of free samples of e-cigarettes and vending machine sales. Health warnings would be mandatory. FDA has not finalized the rules, however, and researchers and health professionals say they hope today’s statement will highlight the need to move quickly.

“As someone who runs a treatment program for tobacco addicts, I would love to be able to endorse the use of e-cigarettes as an alternative,” says Michael Steinberg of the Robert Wood Johnson Medical School at Rutgers University, New Brunswick, in New Jersey. “But I cannot do that because we don’t know the risks involved, nor can we be sure that moving to e-cigarettes really helps people stop smoking.” Steinberg says it could turn out that smokers who start vaping tend to end up using both e-cigarettes and flammable ones or that the nicotine produced by e-cigarettes is unexpectedly toxic.

Some researchers worry that any new rules won’t go far enough, soon enough. Neither the FDA proposal nor today’s joint statement calls for a ban on television advertising by e-cigarette makers, for example, notes Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco. (Glantz, a frequent critic of the health claims made by makers of e-cigarettes, says he supports such a ban.) There’s also no mention of regulating e-cigarette “flavorings,” such as minty or fruity flavors, which were banned from cigarettes after they were linked to elevated smoking rates among teenagers.

Glantz also worries that it could be years before FDA fully regulates the devices. “It’s an especially torturous political and legal process at the federal level,” he says. Regulations may be easier to finalize on the state and local level, he adds, noting that several states and cities have already imposed restrictions. “I would look for progress at the local level,” Glantz says. “I expect that in this case the most important changes will start at the bottom, not the top.”

In the meantime, e-cigarettes are becoming increasingly mainstream. The small, battery-powered devices first became readily available in the United States in 2006, and sales rose to about $2 billion in 2014 alone. “Vaping” bars where people speak of “vapers’ rights” are popping up in towns and cities. Movie stars have advertised their vaping skills on late-night television talk shows.

This past December, a survey released by the National Institute on Drug Abuse reported that 17% of high school seniors said they’d vaped at least once a month, compared with 14% percent who admitted to smoking. Vaping among 10 graders, at 16%, was more than twice the rate of smoking. Antismoking activists found these reports alarming, arguing that vaping could become a “gateway habit” that could draw nonsmokers toward cigarette use.

http://news.sciencemag.org/health/2015/01/major-cancer-groups-call-e-cigarette-research-regulation

USA Today – Our View: E-cigarettes cloud progress on teen smoking

USA Today Editorial Board

E-cigarettes, once seen as a harmless alternative to tobacco smoking, are beginning to look more like a new gateway to addiction.

This year, for the first time, more teens used electronic cigarettes than traditional ones: 17% of high school seniors used the devices, vs. 14% who smoked cigarettes. Kids in eighth and 10th grades favored them 2-to-1 over traditional smokes, according to an eye-opening University of Michigan survey released Tuesday.

In one sense, there is good news. Teen smoking hit a record low last year after a steady decline since the late 1990s, leaving fewer teens vulnerable to the risk of cancer, heart disease and emphysema that comes with tobacco use. But e-cigarettes are a troubling alternative.

Just as scientists didn’t grasp the danger of tobacco when the nation was becoming addicted, they don’t fully understand the risks posed by e-cigarettes now.

One is obvious: addiction.

E-cigs, battery-powered nicotine inhalers that produce a vapor cloud, could be every bit as addictive as tobacco. With sales skyrocketing to $754 million, 30 times five-year-ago levels, and tobacco giants Altria and Reynolds entering the business, millions of people are getting hooked.

This is particularly a problem during the teen years because that is when nearly all smokers pick up their habit.

For manufacturers, the logic is inescapable: Addict a teenager and you could have a customer for life; miss the moment and you have no customer at all. So in ways subtle and not so subtle, e-cigarette makers have applied Big Tobacco’s advertising and marketing practices.

One prominent tactic is their use of celebrities — including former Playboy centerfold Jenny McCarthy, singer Courtney Love, actor Stephen Dorff and teen heartthrob Robert Pattinson of Twilight fame — to make “vaping” look sexy and rebellious.

No one knows how dangerous this is because with federal oversight missing, no one knows exactly what’s in the devices, some made in China. A Japanese study found hazardous substances in the vapor at higher levels than in cigarette smoke.

There are obvious ways to address the problem, starting with attention from the newly confirmed surgeon general, Vivek Murthy, and analysis by the Food and Drug Administration of e-cigarette content. Both worked with tobacco but could be thwarted by a Congress rigidly opposed to regulation.

Alternatively, states could fill the breach. Nearly a dozen still allow e-cigarette sales to minors when they plainly should not. They could also use the 1998 tobacco settlement negotiated with the industry long before e-cigarettes existed. The accord defines covered products in a way that includes e-cigarettes, because nicotine is derived from tobacco.

By invoking the settlement, state attorneys general would be able to clamp down on marketing that’s targeted at youth, including certain celebrity promotions, concert sponsorships and access to free samples.

After a decades-long battle against youth smoking, it would be tragic to see a new generation of teens hooked on a different but potentially dangerous substitute.

USA TODAY’s editorial opinions are decided by its Editorial Board, separate from the news staff. Most editorials are coupled with an opposing view — a unique USA TODAY feature.

http://www.usatoday.com/story/opinion/2014/12/16/e-cigarettes-teen-smoking-university-of-michigan-editorials-debates/20485297/

New CDC Youth Tobacco Survey Should Spur FDA to Finalize Rule Regulating All Tobacco Products, Including E-Cigarettes and Cigars

New CDC Youth Tobacco Survey Should Spur FDA to Finalize Rule Regulating All Tobacco Products, Including E-Cigarettes and Cigars

Teen E-Cigarette Use Triples, Cigar Use Stays Steady Even While Cigarette Smoking Continues to Drop 

WASHINGTON, DC – The 2013 National Youth Tobacco Survey released today by the CDC shows that while youth cigarette smoking continues to decline, electronic cigarette use among high school students tripled from 2011 to 2013 and there has been no progress in reducing youth cigar smoking.

These findings underscore the urgent need for the Food and Drug Administration to finalize its proposed rule to regulate all tobacco products, including e-cigarettes and cigars, in order to prevent youth use of these products.  We again call on the FDA to issue a final rule by April 25, 2015 – one year after the FDA issued a proposed rule – and to close gaps in the rule by cracking down on marketing and flavors that appeal to kids.  The FDA first announced in early 2011 that it planned to regulate e-cigarettes, cigars and other unregulated tobacco products, so these important public health protections are long overdue.  We cannot afford more delays that allow the tobacco industry to continue targeting our kids with a new generation of unregulated tobacco products.

The FDA currently regulates cigarettes, smokeless tobacco and roll-your-own tobacco under a landmark 2009 law, the Family Smoking Prevention and Tobacco Control Act.  But the FDA must assert jurisdiction over other tobacco products, including e-cigarettes and cigars, before it can regulate them, which is what the proposed rule would do.

Key findings of the new survey include:

·        Youth cigarette smoking continues a steady, long-term decline, again reaching a record low.  In 2013, the cigarette smoking rate among high school students was 12.7 percent, down from 14 percent in 2012 and 15.8 percent in 2011 (the CDC last year published results of the 2011 and 2012 National Youth Tobacco Surveys). Since 2000, cigarette smoking among high school students has been cut by more than half (from 28 to 12.7 percent), while middle school smoking has fallen by 74 percent (from 11 to 2.9 percent).

·        In 2013, 4.5 percent of high school students reported using e-cigarettes in the past 30 days. That is triple the 1.5 percent who reported doing so in 2011 and up from 2.8 percent in 2012. This increase comes as e-cigarette makers have marketed their products with the same tactics long used to market regular cigarettes to kids, including celebrity endorsements, slick TV and magazine ads, sponsorships of race cars and concerts, and sweet flavors such as gummi bear and cotton candy.

·        There has been no progress in reducing youth cigar smoking in recent years.  In 2013, 11.9 percent of high school students were cigar smokers, compared to 11.6 percent in 2011.  In 2013, high school boys smoked cigars at higher rates than cigarettes – 15.4 percent vs. 14.1 percent, while African-American high school students smoked cigars at much higher rates than cigarettes – 14.7 percent vs. 9 percent.  Because cigars are unregulated, often taxed at lower rates than cigarettes and can be sold individually, tobacco companies have been able to market an array of cheap, sweet cigars that appeal to kids.

As the CDC noted in its report on the survey results, nicotine use by youths in any form is unsafe and can harm adolescent brain development.  It is critical that the FDA act to regulate all tobacco products and prevent youth use of any tobacco product.

The big drops in cigarette smoking demonstrate that we know how to win the fight against tobacco by implementing scientifically proven strategies. These include higher tobacco taxes, strong smoke-free laws, well-funded tobacco prevention and cessation programs that include mass media campaigns, and effective FDA regulation of all tobacco products.

Tobacco use is the number one cause of preventable death in our country, killing 480,000 people and costing at least $289 billion in health care bills and economic losses each year.  It is within our reach to win this fight and make the next generation tobacco-free, but only if we have the political will to fully implement what we know works.

The National Youth Tobacco Survey results were published in the CDC’s Morbidity and Mortality Weekly Report.

NOTE: In addition to the increase in youth use of e-cigarettes, poison control centers across the country continue to report soaring numbers of accidental poisonings related to e-cigarettes and the  nicotine liquids used in them.  The American Association of Poison Control Centers reports that, through October 31, there have been 3,353 calls so far this year involving exposures to e-cigarette devices and nicotine liquids.  This is more than double the 1,543 calls in all of 2013 and more than 12 times the 271 calls in 2011. The huge increase in poisoning incidents related to e-cigarettes is one more reason why the FDA must quickly finalize its rule, including requiring child-resistant packaging of nicotine liquids.

Tobacco companies have made cigarettes deadlier than ever

Updated by 

Over the last five decades, the tobacco industry has engineered cigarettes to be more addictive — and has also made them more dangerous.

Smokers suffer from higher risk of lung cancer and chronic obstructive pulmonary disease (COPD) todaycompared to 1964, when the very first Surgeon General’s report on cigarettes was issued. This infographic, from The Campaign for Tobacco-Free Kids, lays out exactly how cigarettes have changed in the last 50 years.

Screen_Shot_2014-06-23_at_1.50.55_PMCompared to cigarettes in Australia and Canada, tobacco blends used in U.S. cigarettes have higher levels of tobacco-specific nitrosamines (TSNAs), chemicals known to cause cancer. TSNA levels have increased since 1964.

Cigarette companies also introduced ventilation holes in cigarette filters so that cigarettes would look healthier on paper. The ventilation holes cause machines to report lower levels of tar and nicotine when testing cigarettes. However, it’s been documented that these ventilation holes actually change how people smoke cigarettes. Smokers inhale more frequently and more deeply, drawing cancer-causing chemicals farther into the lungs.
The ill effects of these design changes are compacted by efforts to make cigarettes more attractive and more addictive.
Tobacco companies have introduced flavorings to make the taste of cigarettes more appealing, while also introducing chemicals that reduce discomfort and irritation in the lungs. Higher levels of nicotine, ammonia, and sugars have increased the addictiveness of cigarettes over time.
The smoking rate in the United States has hit an historic low — but tobacco use remains the greatest source of preventable death in the United States. According to the Surgeon General, smoking kills 480,000 Americans each year. It’s estimated that half of today’s smokers will die prematurely, losing, on average, ten years of life. It takes a toll on the nation’s economy, too: $289 billion is spent on health care and other financial losses associated with cigarettes annually.
The Tobacco Free Kids report calls for more aggressive oversight of the tobacco industry by the Food and Drug Administration. This is somewhat new terrain for the FDA; the agency wasn’t able to regulate tobacco much until 2009, when Congress enacted the Tobacco Control Act. Early efforts to stretch this regulatory muscle haven’t always been successful — the FDA wasn’t able to require cigarette manufacturers to totally overhaul their labeling to make health hazards more obvious, for example.
http://www.vox.com/2014/6/23/5835158/tobacco-companies-have-made-cigarettes-deadlier-than-ever?utm_medium=social&utm_source=facebook&utm_campaign=ezraklein&utm_content=sunday

FDA extending comment period on e-cigarette rules

MICHAEL FELBERBAUM, AP Tobacco Writer

RICHMOND, Va. (AP) — The public will have more time to weigh in on a federal proposal to regulate electronic cigarettes and other tobacco products.

The Food and Drug Administration said Friday the public comment period slated to end July 9 is being extended until Aug. 8.

In April, the agency proposed banning sales of e-cigarettes to anyone under 18, adding warning labels and requiring product approval. But it didn’t immediately restrict marketing or ban fruit or candy flavors, measures that some anti-smoking groups and members of Congress are demanding.

The FDA also proposed extending its authority to regulate cigars, hookahs, nicotine gels and pipe tobacco.

The agency has received more than 33,700 comments on the proposal. By comparison, it received around 176,000 comments on potential menthol cigarette regulations during a 120-day comment period.

Electronic Cigarettes Makers Under Fire in Senate

By JENNIFER C. KERR Associated Press

E-cigarettes with fruity flavors like “cherry crush” ignited an intense Senate debate Wednesday about whether manufacturers are trying to appeal to youngsters similar to the way that Big Tobacco used Joe Camel decades ago.

“The last thing anyone should want to do is encourage young people to start using a new nicotine delivery product,” Senate Commerce Committee Chairman Jay Rockefeller, D-W.Va., said as he opened a hearing on the battery-powered devices and worries that e-cigarette makers aim to tempt young people to take up something that could prove addictive.

Jason Healy, president of blu eCigs, and Craig Weiss, president of NJoy, were challenged for more than two hours about industry marketing practices that include running TV commercials and sponsoring race cars and other events. Both men insisted they aren’t trying to glamorize smoking and don’t target young people and that their products are a critical alternative for people desperate to quit traditional smokes.

Electronic cigarettes heat a liquid nicotine solution, creating vapor that users inhale. E-cigarette users say the devices address both the addictive and behavioral aspects of smoking without the thousands of chemicals found in regular paper-and-tobacco cigarettes. But there’s not much research on any health risks of e-cigarettes, and the studies that have been done have been inconclusive.

As the Food and Drug Administration considers regulating e-cigarettes, critics wonder whether e-cigs keep smokers addicted or hook new users and encourage them to move on to tobacco.

Healy of blu eCigs, which is owned by the tobacco company Lorillard Inc., testified that his company has voluntary restrictions in place, such as limiting advertising placements to media and events where the target audience is at least 85 percent adults.

Sen. Barbara Boxer, D-Calif., questioned the youthful-sounding flavors for e-cigarettes. Healy’s company, for example, sells electronic cigarettes that come in flavors like Cherry Crush, Peach Schnapps and Pina Colada. Healy countered that the average age for consumers of his e-cigarettes is 51.

Rockefeller was not swayed, bluntly admonishing both men and telling them: “I am ashamed of you. I don’t know how you sleep at night.”

About 2 percent of U.S. teenagers said they’d used an e-cigarette in the previous month, according to a survey done in 2012 and released by the Centers for Disease Control and Prevention. And about 7 percent said they’d tried an e-cigarette at least once in 2012, which translates to nearly 1.8 million.

In April, the FDA proposed regulating e-cigarettes, banning sales to anyone under 18, adding warning labels and requiring agency approval for new products. But the FDA didn’t immediately place marketing restrictions on e-cigarette makers or a ban on fruit or candy flavors, which are barred for use in regular cigarettes. The agency has left the door open to further regulations, but says it wants more evidence before it rushes into more restrictions.

————

AP Tobacco Writer Michael Felberbaum in Richmond, Virginia, contributed to this report.

http://abcnews.go.com/Health/wireStory/electronic-cigarettes-makers-fire-senate-24202582

Dr. Nancy Snyderman: E-cigarette issue ‘is a big fight’

Today Show:  NBC News’ chief medical editor discusses what new FDA regulations could mean for e-cigarette consumers.

To view video:  http://www.today.com/video/today/55025322#55025308

Proposal would ban e-cigarette sales to minors, allow advertising

By: Reuters, INFORUM
WASHINGTON – The U.S. Food and Drug Administration proposed rules on Thursday that would ban the sale of e-cigarettes to anyone under 18, but would not restrict flavored products, online sales or advertising, which public health advocates say attract children.
The long-awaited proposal, which would subject the $2 billion industry to federal regulation for the first time, is not as restrictive as some companies had feared and will likely take years to become fully effective.
Bonnie Herzog, an analyst at Wells Fargo, said the proposal is “positive for industry.”
But public health advocates lamented the fact that the proposal does not take aim at e-cigarette advertising or sweetly-flavored products, which they say risk introducing a new generation of young people to conventional cigarettes when little is known about the long-term health impact of the electronic devices.
“It’s very disappointing because they don’t do anything to rein in the wild-west marketing that is targeting kids,” said Stanton Glantz, a professor at the Center of Tobacco Control Research and Education at the University of California, San Francisco.
FDA Commissioner Margaret Hamburg said at a briefing on Wednesday that the proposal represented the first “foundational” step toward broader restrictions if scientific evidence shows they are needed to protect public health.
That declaration worries some companies.
“The window is still open for a more draconian approach,” said Jason Healy, president of Lorillard Inc’s blu eCigs unit, which holds roughly 48 percent of the market. “I think the proposal shows a good science-based reaction here from the FDA, but there is a lot we have to go through during the public comment period.”
Lorillard, together with privately-held NJOY and Logic Technology account for an estimated 80 percent of the market. Other big tobacco companies, including Altria Group Inc and Reynolds American Inc, are also entering the market.
E-cigarette advocates welcomed the FDA’s light touch.
Dr. Michael Siegel, a professor of community health sciences at Boston University, said a ban on flavorings would have “devastated the industry, as the flavors are a key aspect of what makes these products competitive with tobacco cigarettes.”
Similarly, a ban on all e-cigarette advertising “would have given tobacco cigarettes an unfair advantage in the marketplace,” he said.
NO FREE SAMPLES
A law passed in 2009 gave the FDA authority to regulate cigarettes, smokeless tobacco and roll-your-own tobacco and stipulated the agency could extend its jurisdiction to other nicotine products after issuing a rule to that effect. E-cigarettes use battery-powered cartridges to produce a nicotine-laced inhalable vapor.
In the short term, the new rules would prohibit companies from distributing free e-cigarette samples, forbid vending machine sales except in adult-only venues and prohibit sales to minors.
Companies would also be required to warn consumers that nicotine is addictive, but no other health warnings would be required. The addiction warning would have to be added no later than two years after the rule is set and the e-cigarette companies would not be allowed to make health claims in any advertising.
The proposal is subject to a public-comment period of 75 days.
Vince Willmore, a spokesman for the Campaign for Tobacco Free Kids, said the proposal “by no means does everything we think needs to be done, but it starts the process. What is critical now is that they finalize this rule and then move quickly to fill the gaps.”
He said the FDA should aim to establish the rule within a year, but many are skeptical the agency will act that quickly.
“The reality of these things is that every step takes years,” said UCSF’s Glantz. “By not addressing the youth-directed marketing it means it won’t be addressed for a very long time.”
Some e-cigarette companies that sell primarily through convenience stores were surprised at the lack of restrictions on online sales, since it can be difficult to verify a customer’s age over the Internet.
“The Internet thing is very surprising to me,” said Miguel Martin, president of Logic Technology. “It reduces the visibility of the sales of the products and the type of products that the government has awareness of.”
The new rules would also require companies to submit new and existing products to the FDA for approval. They would have two years to submit applications from the time the rule goes into effect. Companies may continue selling their products and introducing new products pending the FDA’s review.
In the meantime, e-cigarette companies would be required to register with the FDA and list the ingredients in their products. They would not be required to adhere immediately to specific product or quality control standards. That could come later, Hamburg said.
THE “VAPING” INDUSTRY
E-cigarettes and other “vaping” devices generate roughly $2 billion a year in the United States, and some industry analysts expect their sales to outpace the $85 billion conventional-cigarette industry within a decade.
Advocates of e-cigarettes claim they are a safer alternative to conventional cigarettes, since they do not produce lung-destroying tar, though long-term safety data is thin.
The FDA’s proposal leaves many questions unanswered about how new products would be regulated over the long run. One key question relates to how products are approved.
Under current law, new tobacco products can be approved if they are “substantially equivalent” to a product that was on the market before Feb. 15, 2007. It is unclear whether any e-cigarettes were on sale before then, to be used as a benchmark.
Mitch Zeller, head of the FDA’s tobacco division, said at a briefing that the agency would be seeking more information during the public-comment period on whether the “substantial equivalence” pathway is even valid for e-cigarettes.
If it is not, e-cigarette companies would have to use a different process, which would require them to prove their products are appropriate for public health, a higher hurdle to clear.
Also up in the air is the regulatory fate of some cigars. The current proposal would include e-vaping products and other tobacco products, but premium cigars may be excluded.
The FDA said it would seek public comment on whether all cigars should be regulated equally. One option proposed by the agency is to regulate them all. The other is to define a category of premium cigars that would not be subject to the FDA’s authority.
Physicians said the possible exemption of premium cigars from regulation was troubling.
“Any exemption for any kind of tobacco product proven to cause lung and heart disease and cancer is unacceptable,” said Harold Wimmer, chief executive of the American Lung Association.
Cigar companies, backed by some members of Congress, had lobbied heavily for a regulatory carve-out for premium cigars. In a December 2013 letter to Hamburg and Sylvia Mathews Burwell, director of the White House’s Office of Management and Budget, 24 Republican lawmakers asked that premium cigars be exempt.
“As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”
Under the proposed rule, premium cigars are considered those wrapped in whole tobacco leaf, made manually by combining the wrapper, filler and binder, have no characterizing flavor, have no filter, tip or non-tobacco mouthpiece and are relatively expensive.
http://www.inforum.com/event/article/id/432967/group/homepage/

FDA Moves to Regulate E-Cigarettes

By Krista Harju, KFYR-TV

FDA E-cig Regulations

The American Lung Association is calling it an important step forward for public health. The Food and Drug Administration’s Center for Tobacco Products issued a long-awaited proposal to regulate electronic cigarettes and other tobacco products.
Many tobacco smokers are making the switch to e-cigarettes. For some it’s about kicking the habit.
“After the first couple weeks, I don’t crave them as much. I still do, but I don’t think that will ever go away,” says smoker Shawn Deanna Barnes.
Some believe the smoking alternative is safer than traditional cigarettes. But the FDA isn’t ready to make that claim.
“They’ve analyzed three different e-cigarette cartridges and all three tested differently,” says Alison Harrington a respiratory therapist and certified tobacco treatment specialist.”With each puff there was one that had 26 micrograms of nicotine, and the other one had 43 micrograms of nicotine. And they were all labeled the same.”
Harrington says other carcinogens that weren’t mentioned on labels have been found, including diethylene glycol which is toxic to humans.
The proposed regulation would require manufacturers to register all products and ingredients with the FDA. And new products could only be marketed after an FDA review.
Barnes says she thinks it’s important to know what she’s ingesting.
“I don’t know if I’ll smoke them after I read whatever else is in them. We’ll see,” says Barnes.
The proposed rules also call for regulation of cigars, pipe tobacco, nicotine gels, water pipe tobacco and hookahs. Right now, only cigarettes and smokeless tobacco fall under the FDA’s regulatory authority.
The proposed regulation would also establish a nationwide minimum age for the legal purchase of tobacco. The age limit is expected to be at least 18, but individual states could choose to set it higher.
http://www.kfyrtv.com/story/25333937/fda-moves-to-regulate-e-cigarettes#.U1mtEbb4Lo8.facebook

Federal regulations loom for e-cigarette industry

By MICHAEL FELBERBAUM  The Associated Press
RICHMOND, Va. – Smokers are increasingly turning to battery-powered electronic cigarettes to get their nicotine fix. They’re about to find out what federal regulators have to say about the popular devices.
The Food and Drug Administration will propose rules for e-cigarettes as early as this month. The rules will have big implications for a fast-growing, largely unregulated industry and its legions of customers.
Regulators aim to answer the burning question posed by Kenneth Warner, a professor at the University of Michigan School of Public Health: “Is this going to be the disruptive technology that finally takes us in the direction of getting rid of cigarettes?”
The FDA faces a balancing act. If the regulations are too strict, they could kill an industry that offers a hope of being safer than cigarettes and potentially helping smokers quit them. But the agency also has to be sure e-cigarettes really are safer and aren’t hooking children on an addictive drug.
Members of Congress and several public health groups have raised safety concerns over e-cigarettes, questioned their marketing tactics and called on regulators to address those worries quickly.
Here’s a primer on e-cigarettes and their future:
WHAT ARE E-CIGARETTES?
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.
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. Their companies have jumped into the business.
There’s not much scientific evidence showing e-cigarettes help smokers quit or smoke less, and it’s unclear how safe they are.
WHAT IS THE FDA LIKELY TO DO?
The FDA is likely to propose restrictions that mirror those on regular cigarettes.
The most likely of the FDA’s actions will be to ban the sale of e-cigarettes to people under 18. Many companies already restrict sales to minors, and more than two dozen states already have banned selling them to young people.
Federal regulators also are expected to set product standards and require companies to disclose their ingredients and place health warning labels on packages and other advertising.
Where the real questions remain is how the agency will treat the thousands of flavors available for e-cigarettes. While some companies are limiting offerings to tobacco and menthol flavors, others are selling candy-like flavors like cherry and strawberry.
Flavors other than menthol are banned for regular cigarettes over concerns that flavored tobacco targets children.
Regulators also must determine if they’ll treat various designs for electronic cigarettes differently.
Some, known as “cig-a-likes,” look like traditional cigarettes and use sealed cartridges that hold liquid nicotine. Others have empty compartments or tanks that users can fill their own liquid. The latter has raised safety concerns because ingesting the liquid or absorbing it through the skin could lead to nicotine poisoning. To prevent that, the FDA could mandate child-resistant packaging.
The FDA also will decide the grandfather date that would allow electronic cigarette products to remain on the market without getting prior approval from regulators — a ruling that could force some, if not all, e-cigarettes to be pulled from store shelves while they are evaluated by the agency.
The regulations will be a step in a long process that many believe will ultimately end up being challenged in court.
WHAT ABOUT MARKETING?
There are a few limitations on marketing. Companies can’t tout e-cigarettes as stop-smoking aids, unless they want to be regulated by the FDA under stricter rules for drug-delivery devices. But many are sold as “cigarette alternatives.”
The FDA’s proposals could curb advertising on TV, radio and billboards, ban sponsorship of concerts and sporting events, and prohibit branded items such as shirts and hats. The agency also could limit sales over the Internet and require retailers to move e-cigarettes behind the counter.
WHAT DOES THE INDUSTRY THINK?
The industry expects regulations, but hopes they won’t force products off shelves and will keep the business viable.
E-cigarette makers especially want the FDA to allow them to continue marketing and catering to adult smokers — some of whom want flavors other than tobacco. They 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, whose wooden shelves are lined with vials of liquid nicotine flavor, such as Gold Rush, Cowboy Cut and Forbidden Fruit.
WHAT DO PUBLIC HEALTH OFFICIALS THINK?
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.
“This is a very complicated issue and we must be quite careful how we proceed,” said David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the American Legacy Foundation, in a recent panel discussion. “I call this sort of the Goldilocks approach. The regulation must be just right. The porridge can’t be too hot, and it can’t be too cold.”
http://www.newsday.com/business/federal-regulations-loom-for-e-cigarette-industry-1.7794606