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FDA.gov: FDA takes significant steps to protect Americans from dangers of tobacco through new regulation

For Immediate Release: May 5, 2016

Today, the U.S. Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction,” said HHS Secretary Sylvia Burwell. “Today’s announcement is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

Tobacco use is a significant public health threat. In fact, smoking is the leading cause of preventable disease and death in the United States and responsible for 480,000 deaths per year. While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) and hookah use has risen significantly. In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes. Additionally, a joint study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors consistently cited as a reason for use.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

The actions being taken today will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

Today’s rule also requires manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit – and an additional year while the FDA reviews – a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

For decades, the federal government and the public health community have fought to protect people from the dangers of tobacco use. Since the first Surgeon General’s report on Smoking and Health in 1964, which warned Americans about the risks associated with smoking, significant progress has been made to reduce smoking rates among Americans. In fact, tobacco prevention and control efforts have saved at least 8 million lives in the last 50 years, according to the 2014 Surgeon General’s Report on the Health Consequences of Smoking. In 2009, Congress took a historic step in the fight for public health by passing the bipartisan Family Smoking Prevention and Tobacco Control Act (TCA) giving the FDA authority to regulate the manufacturing, distribution and marketing of tobacco products to protect the public health.

Today’s action marks a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection.

“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”

Today’s actions will subject all manufacturers, importers and/or retailers of newly- regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

These requirements include:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients, and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements; and
  • Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

To assist the newly-regulated tobacco industry in complying with the requirements being announced today, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The Washington Post: New, sweeping federal rules bar e-cigarette sales to teens younger than 18

By Laurie McGinley and Brady Dennis

The Obama administration on Thursday announced controversial new rules for electronic cigarettes, cigars, hookahs and pipe tobacco, including barring the sales of the products to teens under 18 years old.

The new requirements, which go into effect in 90 days, mark the first time the Food and Drug Administration has regulated any of the items.

The rules compel retailers to verify the age of purchasers by photo identification and bar sales of the products in vending machines that are accessible to minors. They also ban the distribution of free samples.

In addition, the FDA is generally requiring manufacturers whose products went on sale after Feb. 15, 2007, to get approval from the agency to continue selling their products. These product reviews will allow the FDA to scrutinize ingredients, product design and health risks, the agency said. It added that it will allow the companies to keep selling their products for two years while they submit their applications and then for an additional year while the FDA reviews the submissions.

The requirements, which have been the focus of intense lobbying from the industry on one side and tobacco-control advocates on the other, are likely to only intensify the debate over whether the devices are a dangerous gateway to traditional tar-laden, chemical-filled cigarettes or a helpful smoking-cessation tool.

“As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap,” said Sylvia Mathews Burwell, secretary of health and human services, in announcing the new rules. “All of this is creating a new generation of Americans who are at risk of addiction.”

She said the new regulations were an “important step in the fight for a tobacco-free generation — it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

E-cigarettes are battery-powered devices that heat flavored, nicotine-laced liquid, turning it into a vapor that the user inhales, or “vapes.” The flavors can come in a wide range, from mango to margarita to mocha.

The FDA’s authority to regulate the products stems from a 2009 law that gave the agency broad power over traditional cigarettes, as well as jurisdiction over other tobacco-related products.

In recent weeks, the e-cigarette industry has gotten support from some public health experts. In late April, a group of tobacco-control experts, writing in the journal Addiction, urged the FDA to be “open-minded” about e-cigarettes, saying that the products are more beneficial than harmful and can result in a reduction in traditional smoking.

“We’re concerned the FDA, which has asserted its right to regulate e-cigarettes, will focus solely on the possibility that e-cigarettes and other vapor nicotine products might act as a gateway to cigarette use,” David Levy, the lead author and a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center, said at the time.

He added that the “big picture tells us that these products appear to be used mostly by people who already are or who are likely to become cigarette smokers.”

And recently, the Royal College of Physicians concluded that e-cigarettes were likely to be beneficial to public health in Britain.

But many anti-smoking advocates disagree. They say that e-cigarettes could be harmful, that the long-term health risks are unknown and that companies are marketing their products to younger and younger teens. They say the companies are using the same tactics and themes that the traditional cigarette makers used years ago.

The number of middle and high school students using electronic cigarettes tripled between 2013 and 2014, according to a study by the Centers for Disease Control and Prevention.

https://www.washingtonpost.com/news/to-your-health/wp/2016/05/05/obama-administration-announces-controversial-new-rules-for-e-cigarettes/

WebMD News from HealthDay: FDA Launches Ad Campaign Against Chewing Tobacco

By Dennis Thompson

HealthDay Reporter

TUESDAY, April 19, 2016 (HealthDay News) — U.S. health officials said Tuesday that they are targeting rural teenagers with a new $36 million ad campaign that highlights the health risks associated with chewing tobacco.

The campaign’s message — “smokeless doesn’t mean harmless” — will challenge a habit that has become a tradition in the rural United States, said Mitch Zeller, director of the Center for Tobacco Products at the U.S. Food and Drug Administration.

“It is culturally ingrained in many rural communities, and can be seen as a rite of passage and an acceptable societal norm,” Zeller said during a Tuesday morning news conference. He noted that smokeless tobacco use is more than twice as common in rural areas as it is in urban settings.

Chewing tobacco, snuff and other smokeless tobacco products have been linked to multiple kinds of cancer, gum disease, tooth loss and nicotine addiction, Zeller said.

Nevertheless, smokeless tobacco use has become increasingly popular among rural male teenagers, according to FDA research.

Every day in the United States, nearly 1,000 males younger than 18 try smokeless tobacco for the first time, outpacing those who take their first puff on a cigarette, Zeller said. About one-third of rural white males aged 12 to 17 have tried or are at risk of trying smokeless tobacco, totaling approximately 629,000 male youth nationwide.

Rural teens are used to seeing role models use smokeless tobacco, including fathers, grandfathers, older brothers and community leaders, Zeller explained.

“When people who these teens most trust and admire openly use and share smokeless tobacco, the product is seen as acceptable, and even as an expected part of growing up and belonging,” Zeller said.

This is the first time the FDA has focused on smokeless tobacco in an ad campaign, said Kathy Crosby, director of the FDA’s Office of Health Communication and Education.

Crosby said the campaign will focus on 35 rural markets across the United States, including: Albany, Ga.; Billings, Mont.; Flint, Mich.; Medford, Ore.; Monroe, La.; Sioux Falls, S.D.; Little Rock, Ark.; and Tri-Cities, Tenn.

Ads linked to the campaign show young men with ugly lip sores and horrific facial scars caused by mouth cancer, and a football player being tossed around by a nicotine addiction “monster.” The ads will run on local television and in print, while others appear on local radio and through social media.

The new campaign will also collaborate with select Minor League Baseball teams to help combat the link between baseball and smokeless tobacco use among the campaign’s target audience, Crosby said.

This summer, stadiums across the country will display campaign advertising and provide opportunities for fans to meet players who support the campaign’s public health message, she said.

The FDA also is in ongoing talks with Major League Baseball about joining the campaign, and Zeller said he is “optimistic” that a partnership will be announced sometime this season.

Major cities such as Boston, Los Angeles, New York City and San Francisco have banned smokeless tobacco products at ballparks and other sports venues. Major League Baseball has warned that players caught violating the ban in these cities will be subject to discipline from the commissioner.

The smokeless tobacco campaign is an offshoot of the FDA’s award-winning “The Real Cost” campaign, which since 2014 has been warning teenagers about the health effects of smoking.

http://www.webmd.com/smoking-cessation/news/20160419/fda-launches-ad-campaign-against-chewing-tobacco

ADA News: ADA, others "concerned" about tobacco products

By Jennifer Garvin, American Dental Association News

Silver Spring, Md. — The ADA and 35 other health organizations have asked the Food and Drug Administration to be more diligent about requiring tobacco companies to obtain approval before introducing new tobacco products to market.

In a Feb. 26 letter to Mitchell Zeller, director, Center for Tobacco Products, the organizations shared that they are “increasingly concerned” that tobacco companies are introducing new tobacco products into the marketplace without proper regulatory review.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA unprecedented authority to regulate the manufacturing, distribution and marketing of tobacco products. It also requires tobacco companies to seek FDA approval before introducing new tobacco products to the market.

“The premarket review provisions of the Tobacco Control Act are intended to prevent the tobacco industry from continuing to introduce new tobacco products that are more harmful, more addictive and more appealing, particularly to young people,” stated the letter.

The letter also points out that the Tobacco Control Act prohibits commercial marketing of a new tobacco product unless FDA has issued an order finding the product “appropriate for the protection of the public health.” It singles out several new products it claims are non-compliant with the act. These products include:

  • Marlboro Midnight, a menthol cigarette;
  • Grizzly Wintergreen, a new snuff;
  • Three new brands of snus from Kretek International Inc: Thunder Xtreme, Offroad and Oden’s Extreme;
  • Marlboro Black NXT, a crushable menthol capsule.

“FDA’s failure to take the actions necessary to remove these products from the market represents a serious failure to protect the public health,” the letter stated.

“Given that the avoidance of premarket review seriously undercuts the public health protections of the Tobacco Control Act, please explain why no enforcement actions have been taken by FDA against these products and indicate what the agency plans to do to prevent additional products from entering the market without the required regulatory review.”

Read the entire letter here.

http://www.ada.org/en/publications/ada-news/2016-archive/march/ada-35-health-organizations-concerned?nav=news

Medical News Today: Graphic warnings on cigarette packets 'help smokers consider health risks'

Written by
With 2016 just around the corner, many individuals will be gearing up to take on one of the most challenging New Year’s resolutions: to quit smoking. But a new study suggests this challenge could be made easier if graphic warning labels were put on cigarette packets, after finding such warnings trigger more negative feelings toward smoking than text warnings alone.
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Lead study author Abigail Evans, a postdoctoral researcher at Ohio State University, and colleagues publish their findings in the journal PLOS One.
In 2011, the Food and Drug Administration (FDA) published a final rule that required tobacco companies to include color graphics on cigarette packets that depict the negative health implications of smoking.
In 2012, however, a US federal appeals court overturned the ruling, claiming the images put forward by the FDA were “unconstitutional” and were “unabashed attempts to evoke emotion […] and browbeat consumers into quitting.”
According to Evans and colleagues, their findings suggest the decision to overturn the FDA’s rule based on these grounds was wrong; the team says the graphic images do not “browbeat” consumers, and though they do evoke emotion in smokers, the researchers say these emotions make people think more carefully about the health risks of smoking.
“What the court is missing is that without emotions, we can’t make decisions,” says study coauthor Ellen Peters, professor of psychology at Ohio State. “We require having feelings about information we collect in order to feel motivated to act. These graphic warnings helped people to think more carefully about the risks and to consider them more.”

Feelings produced by graphic images ‘acted as a spotlight’

The team reached their conclusion by assessing 244 adults of an average age of 34 who smoked between 5-40 cigarettes a day.
For 4 weeks, smokers were given their preferred brand of cigarettes in packaging that had been modified; some packets contained warning text only – such as “cigarettes cause fatal lung disease” – some contained warning text plus one of nine graphics depicting the dangers of smoking, while others consisted of warning text, graphics plus additional text detailing the risk of every cigarette smoked.
The warning graphics used were developed by the FDA and contained disturbing images, such as a man smoking through a hole in his throat, depicting a surgical procedure known as a tracheostomy that is a result of some smoking-related cancers.
Each week for the 4-week period, smokers collected their cigarettes from the lab and completed surveys detailing how the new packaging made them feel about smoking.
Compared with participants who received text-only packaging, those who received packaging with graphic warnings were more likely to read or look closely at the information, were more likely to remember the information, and were more likely to report that the packaging made them feel worse about smoking.
“The feelings produced by the graphic images acted as a spotlight,” notes Peters. “Smokers looked more carefully at the packages and, as a result, the health risks fell into the spotlight and led to more consideration of those risks.”
In addition, smokers who received packaging with graphic warnings were also more likely to view the information as more “credible” than those who received text-only packaging, and they were also slightly more likely to say they planned to quit smoking.
“For a health issue like smoking, which causes about a half-million deaths a year in the United States, even small effects can have a large impact in the population,” says Peters. “The effect was small, but it was not unimportant.”
Overall, the researchers say their findings show graphic warnings are more effective than text-only warnings for getting consumers to consider the health risks of smoking. They add: “Policies requiring such labels have the potential to reduce the number of Americans who smoke. The effect induced by graphic warning labels appears to have utility in communicating more and more credible information, useful to promoting risk perceptions and quit intentions among smokers in the US and around the world.”
This research supports another study reported by Medical News Today earlier this year, which found a combination of health warning graphics and text on cigarette packets increased knowledge about the dangers of smoking among young adults, compared with text-only warnings.

http://www.medicalnewstoday.com/articles/304495.php

Wahpeton Daily News: Study: More nicotine found in smokeless tobacco

By Carrie McDermott • Daily News

Users of smokeless tobacco are exposed to equal or higher levels of nicotine and NNK, a cancer-causing chemical in tobacco products, than cigarette smokers, according to a study from the federal government.
Researchers from the Food and Drug Administration and the Centers for Disease Control and Prevention say more data is needed on the toxic components of smokeless tobacco products and the health of those who use them.
In the study, researchers analyzed information from more than 23,000 participants in national health surveys between 1999 and 2012. They looked for markers used to measure the addictive stimulant nicotine and cancer-causing NNK from blood and urine samples. They found the level of cotinine, the marker for nicotine exposure, to be .043 nanograms/milliliter in nonsmokers compared to 180 ng/ml among smokeless tobacco users, about 131 ng/ml in cigarette users and 184 ng/ml among people who used both smokeless tobacco and cigarettes.

Jason McCoy, tobacco prevention coordinator at PartnerSHIP 4 Health in Moorhead, Minnesota, said he’s eager to get this surprising information out to the public.
“We know that in rural parts of the state, one in 10 young white men, basically high school boys, are using Snus and chewing tobacco, thinking it’s less dangerous than smoking,” he said.
He said the only difference is when they use chewing tobacco, they aren’t affecting others with secondhand smoke.
“The individual is potentially damaging themselves more,” he said. “It’s surprising.”
And many young smokeless tobacco users are choosing flavored products, which make it more attractive.
“This ties into other research we have that shows flavored tobacco is viewed, in self reports by teens, as less addictive than regular tobacco,” McCoy said. “On the other end, we know the flavoring makes it more addictive. The part of the brain that ties into the flavor of the product, similar to why you may like Coke over Pepsi, it’s the same triggering mechanism that happens. The flavor gets assigned in your brain along with the nicotine.”
McCoy works with four counties — Becker, Clay, Otter Tail and Wilkin — and gets reports showing that often high school athletes know they don’t want to smoke because of the smell, so they choose smokeless tobacco, also thinking it won’t affect their athletic performance.
“We know that short term, it’s going to cause gum disease and tooth decay, long term, possible mouth, throat and stomach cancers,” he said. “It’s every bit as dangerous as cigarettes.”
He said he’s been told by teachers that students are taking the Ice Breakers mints and filling those containers with Snus, so they can surreptitiously carry the smokeless tobacco around with them.
“When they open it up, it just looks like they’re getting a mint,” he said.
About 3.6 percent of Minnesotans regularly use smokeless tobacco, according to the latest Minnesota Adult Tobacco survey.
For those wanting to quit their nicotine use, the state of Minnesota offers QUITPLAN which provides proven methods of quitting successfully. The program offers phone counseling and nicotine replacement tools at no cost. To find out more, visit www.quitplan.com or call 1-888-354-7526.
http://www.wahpetondailynews.com/news/study-more-nicotine-found-in-smokeless-tobacco/article_a81d5b36-9a9f-11e5-9849-3facbacf33f9.html

STAT: E-cigarettes widely seen as harmful in STAT-Harvard poll

By DAVID NATHER And SHEILA KAPLAN
WASHINGTON — Most Americans believe electronic cigarettes are harmful to people’s health, according to a new national poll — even though scientists have not reached a consensus on the risks of the increasingly popular products.
The results of the poll, by STAT and the Harvard T.H. Chan School of Public Health, could bolster the Food and Drug Administration as it moves to regulate e-cigarettes for the first time. There is solid support for a broad range of government restrictions among both Democrats and Republicans, with virtually no partisan differences to be found.
E-cigarettes have been around only since 2004 — too little time for researchers to have completed definitive studies on their health effects — but already they are more popular among teenagers than conventional cigarettes.
Manufacturers market the products as safer than tobacco cigarettes and as an effective way to help people stop smoking. The poll results, however, suggest that the public isn’t buying this pitch.

Read the full poll results here

E-cigarette users don’t inhale cancer-causing tobacco smoke. Instead, the devices produce a vapor from heated liquid nicotine. For many public health experts, though, the concern is that they still contain nicotine — which is addictive — and may expose users to various toxic chemicals.
Americans do think they’re less dangerous than tobacco cigarettes, but that doesn’t mean they think the products are safe. The survey found that 65 percent of adults believe e-cigarettes are harmful to the people who use them. That’s less than the 96 percent who say tobacco cigarettes are harmful, but more than the 58 percent who say the same thing about marijuana.
Those results appear to be the main reason the public is ready to embrace regulations that would treat e-cigarettes largely like tobacco cigarettes, including rules that go beyond what are actively being considered at the federal level.
“They believe it’s less harmful than tobacco, but they do think it is harmful, and that sets off all the other answers,” said Robert Blendon, a professor of health policy and political analysis at Harvard who directed the poll.

Roughly 9 out of 10 Americans support banning the sale of e-cigarettes to minors under age 18 — a law already passed in most states. A similar number favor requiring warning labels stating that e-cigarettes contain nicotine.
About 7 out of 10 say people shouldn’t be allowed to use e-cigarettes indoors in public places like restaurants and workplaces, and 6 out of 10 say the government should ban e-cigarette ads on TV, just as it bans ads for tobacco cigarettes.
Even the biggest partisan differences are slight. The warning labels on e-cigarette packages are supported by 98 percent of Democrats and 87 percent of Republicans.
And on taxes — a subject that usually sets off food fights in Washington — there is solid support from both parties: 63 percent of Republicans and 72 percent of Democrats say they support taxing e-cigarettes in the same way that tobacco cigarettes are taxed.
The results suggest that Americans have largely made up their minds on how e-cigarettes should be treated, and that they’re using tobacco cigarettes as their frame of reference — even as scientists are still trying to determine what the health consequences of e-cigarettes are.
“For a new product … you wouldn’t have expected that people would have reached as firm a judgment about this as they have,” said Blendon. On the proposed policies the poll asked about, he added, “their responses are nearly identical to what you find asking about tobacco cigarettes.”
That’s how Anna Glasscock, a Republican retiree who lives near Springfield, Ill., decided her views on e-cigarettes. She’s a former smoker who knows the health risks of tobacco and said e-cigarettes “shouldn’t even exist” because “any addictions are not good.”
Glasscock, one of the people in the poll who agreed to a follow-up interview, said e-cigarettes should be regulated and taxed — she considers it a “sin tax.” Even though e-cigarettes are different from tobacco cigarettes, she said, “I don’t see that replacing one with the other makes any difference.”
Gregory Conley, president of the American Vaping Association, the main advocacy group for e-cigarette makers, blamed the poll results on “unethical propaganda campaigns” against e-cigarettes that have led to “a confused populace.”
“This poll is not measuring public opinion, but the effectiveness of a well-funded corporate strategy to destroy a category that is eroding a cash cow for Big Pharma,” he said.
But Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, said it was “not surprising that the public wants to apply common-sense regulations to e-cigarettes” and urged the Obama administration to issue the FDA’s e-cigarette regulations as soon as possible.
The one issue the public is split on is whether to ban the sale of flavored nicotine cartridges — an issue that doesn’t have any parallel with tobacco cigarettes. Fewer than half of Americans think that’s a good idea.
Supporters argue that flavored cartridges attract young people to start using e-cigarettes, and that they will later move on to tobacco cigarettes.
The telephone poll of 1,014 adults was conducted Oct. 7-11 and has a margin of error of 3.7 percentage points.
John Dunn of Garland, Texas, a suburb of Dallas, said he has used e-cigarettes to quit smoking tobacco cigarettes. But a friend who tried the same thing got hooked on e-cigarettes.
“I think they’re pretty different, but also I’ve seen people get on the vapors and not be able to stop,” said Dunn, 33, a Democrat. He’s in favor of some regulation, including warning labels: “They should know they might get addicted.”
E-cigarette makers say that e-cigarettes help smokers quit, and there is some evidence from a small number of studies that they do — although scientists say more research is needed. The survey found that 38 percent of Americans believe e-cigarettes can help people quit smoking, but that 47 percent don’t think they’re effective.
At the same time, public health advocates — and government regulators such as the FDA and the Centers for Disease Control and Prevention — have strong concerns that e-cigarettes serve as a “gateway” for non-smokers to start using tobacco products. More than half of Americans — 56 percent — believe e-cigarettes make teenagers more likely to try tobacco cigarettes, according to the poll.
At a panel discussion on e-cigarettes last month, CDC Director Tom Frieden declared that e-cigarettes are “highly addictive” and that the goal should be to “keep kids away from all forms of nicotine.” The CDC reported earlier this year that e-cigarette use tripled among high-school and middle-school students from 2013 to 2014.
The FDA is preparing to issue a final version of a rule that would extend the agency’s authority to regulate e-cigarettes. The proposal, recently submitted to the White House Office of Management and Budget for final revisions, would likely require pre-market reviews of e-cigarettes — a process that is used to prove whether potentially risky products are safe. The FDA is also expected to ban e-cigarette sales to minors under age 18 and require warning labels stating that the products contain nicotine. The regulation drew 135,000 comments from the public when the original proposal was published.
The agency is also considering a separate proposal that could require broader warnings about the dangers of nicotine — especially accidental exposure to infants and children — and possibly require child-resistant packages for e-liquids, which are liquid nicotine combined with colorings and flavorings.
Some in Congress, however, are trying to prevent the FDA from taking action that might damage the industry. A House spending bill includes a provision by Representative Robert Aderholt (R-Ala.) that would keep the FDA from requiring premarket review for e-cigarettes that are already being sold in stores. Aderholt’s office did not respond to requests for comment.
Even if much of the public is ready to regulate e-cigarettes, Aderholt will find at least some support from those who don’t think they are dangerous enough to need new rules.
“They’re not a cigarette. The only thing you’re inhaling is vapor,” said Chris Grieser, a Republican from Cheyenne, Wyo. who participated in the survey. “That’s no different from standing over a pot of boiling water.”
Researchers aren’t so sure about that, though. One study earlier this year found that e-cigarette vapor can contain cancer-causing formaldehyde at levels far higher than those found in tobacco cigarettes.
The original e-cigarettes were manufactured by small companies, but when it became clear that they were catching on, the more established tobacco companies such as RJ Reynolds and British American Tobacco bought out or partnered with some of these smaller businesses, or launched their own divisions. This has given more clout to industry groups such as the American Vaping Association.
This is the first of a series of monthly polls being conducted by STAT and the Harvard T.H. Chan School of Public Health.
http://www.statnews.com/2015/11/09/e-cigarettes-widely-seen-as-harmful-in-stat-harvard-poll/

NPR: Poll: Most Americans Support FDA Regulation Of E-Cigarettes

Poll: "Do you believe e-cigarettes should be regulated by the FDA like tobacco products?"
A majority of Americans say electronic cigarettes should be regulated by the Food and Drug Administration the same way the agency handles cigarettes containing tobacco, according to results from the latest NPR-Truven Health Analytics Health Poll.
Overall, 57 percent of people said the FDA should regulate e-cigarettes like tobacco products. The proportion of people in favor of regulation rose with age and education. Nearly, two-thirds of people with college degrees or graduate degrees supported regulation compared with 48 percent with high school diplomas or less.
The Food and Drug Administration proposed regulations for e-cigarettes in April 2014. Since then the agency has collected comments and held workshops on the public health issues raised by the products.
The agency sent its e-cigarette regulations to the White House on Oct. 19 for a required review, agency spokesman Michael Felberbaum tells Shots. The Office of Management and Budget has to pore over major regulations before they can be into effect.
Some of the key parts of the proposal included a ban on the sale of e-cigarettes to minors, a requirement that the products carry warnings they contain nicotine and disclosure of ingredients by manufacturers.
How much the FDA may have changed the regulations since they were first proposed isn’t clear because the agency doesn’t publicly release what it sends to the White House for sign-off. The White House can further tweak the rules, too.
We may find out fairly soon, though. There is a 90-day timetable for OMB review. The White House can extend the review to allow for more back and forth on the rules.
In the meantime, plenty of Americans have tried e-cigarettes. The NPR-Truven Health poll found that a quarter of respondents had vaped at least once. About a quarter of the respondents said they are current tobacco users.
E-Cigarette Use vs. Tobacco Use
What’s drawing people to e-cigarettes? The most common reasons given from those who have tried them were: to help stop smoking cigarettes (27 percent), as a healthier alternative to tobacco (26 percent) and curiosity (24 percent).
Among people who have tried e-cigarettes, half continue to use them. But 40 percent of current vapers said they have concerns about the health effects.
What was your primary reason for trying e-cigarettes?
“Electronic cigarettes have exploded in popularity in just a few short years, but we still know very little about the health risks associated with the technology,” said Dr. Michael Taylor, chief medical officer at Truven Health Analytics. “With our data showing a 50 percent adoption rate among those who have tried e-cigarettes, it’s reasonable to expect that usage will continue to grow, even as traditional cigarette smoking declines. This is clearly an area that will require a great deal more research.”
More than 3,000 people were surveyed about e-cigarettes during the first half of August. The responses came from households contacted by cellphone, land line and the Internet. The margin of error is plus or minus 1.8 percentage points.
You can find the questions and full results of the latest poll here. For previous polls, click here.
http://www.npr.org/sections/health-shots/2015/10/27/452244929/poll-most-americans-support-fda-regulation-of-e-cigarettes

LA Times: First-time tobacco users lured by flavorings, report says

Melissa Healy, Contact Reporter
A majority of adolescents who are puffing, vaping or chewing a tobacco product for the first time prefer one with flavor, suggesting that fruity, tangy, spicy or minty flavorings add a powerful allure to the uninitiated.
In a nationwide survey of U.S. children ages 12 to 17, the Food and Drug Administration’s Center for Tobacco Products has found that among those trying a hookah, electronic cigarette, cigar or regular cigarette for the first time, 89%, 81%, 65% and 50%, respectively, chose to try their tobacco product with an added flavoring.
In the United States, the marketing of flavored cigarettes — with the exception of menthol — is prohibited. But a wide range of flavorings is used in tobacco that is vaped, smoked in hookahs, chewed or dissolved in the mouth.
When adolescents were asked about their use of a tobacco product over the last 30 days, large majorities underscored that flavorings continued to play a role in their enjoyment of tobacco products. Asked about their tobacco use in the preceding month, 89% among hookah users said they had used flavored tobacco, compared with 85% of e-cigarette users, 72% of  users of any cigar type, and 60% of cigarette smokers.
The results were published Monday in the Journal of the American Medical Assn.
The study offers new insights into what factors pave the way for an estimated 3,200 American kids each day to try tobacco for the first time. A lifetime tobacco habit is overwhelmingly started in the teen and young adult years, and federal regulators have been keen to blunt smoking’s appeal to first-time users.
Since 2009, the FDA has had sweeping powers to regulate tobacco products in the interest of the public’s health. New evidence that flavorings play a key role in easing a would-be tobacco user’s introduction to the product is sure to spark renewed debate over outlawing flavorings.
“Consistent with national school-based estimates, this study confirms widespread appeal of flavored products among youth tobacco users,” the authors write. “In addition to continued proven tobacco control and prevention strategies, efforts to decrease use of flavored tobacco products among youth should be considered.”
http://www.latimes.com/science/sciencenow/la-sci-sn-first-time-tobacco-flavorings-20151026-story.html

The Hill: FDA sends e-cigarette regs to White House for review

By Lydia Wheeler
The Food and Drug Administration (FDA) has sent its final rule to regulate additional tobacco products, including electronic cigarettes and cigars, for White House review.
The rule, which was first proposed more than a year ago, was sent to the White House Office of Management and Budget’s Office of Information and Regulatory Affairs on Monday, but it could be weeks before the rule is actually released.
FDA spokesman Michael Felberbaum said the Office of Management and Budget is required to review all significant regulatory actions and has 90 calendar days to do so.
“However, this timeframe can be extended to allow for additional interagency discussion,” he said. “At this time, the FDA cannot provide any further comment until the final rule is published.”
The American Lung Association is hoping for an expedited review.
“We remain deeply troubled that it’s taken 18 months from the time the proposal was released to now,” said Erika Sward, the group’s assistant vice president of national advocacy. “We need to move forward in protecting kids and public heath.”
Sward said the lung association is hoping the final rule will give FDA the authority to truly regulate all tobacco products. Under the proposed rule, she said, there was a loophole for certain “premium” cigars.
“There’s no such thing as a safe tobacco product and certainly not a safe cigar,” she said. “FDA needs to have the basic authority over all tobacco products to make sure kids aren’t buying them and warning labels are required.”
http://thehill.com/regulation/pending-regs/257920-fdas-tobacco-deeming-rule-under-final-review