Posts 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.


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.

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

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.

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.”

NY Times Opinion: Clashing Views on E-Cigarettes

A British government agency has issued a bullish assessment of the value of electronic cigarettes in helping people to quit smoking. It found that e-cigarettes can reduce the health risks of smoking by 95 percent because they deliver nicotine to satisfy an addiction, but far fewer harmful chemicals than regular cigarettes. It also found little evidence that large numbers of consumers who had never smoked were taking up e-cigarettes. That seemed to challenge the notion that e-cigarettes would be a gateway to more dangerous products.

But the study is hardly definitive; experts in America have drawn different conclusions on usage and on the gateway issue.

The British assessment, commissioned by Public Health England and conducted by academic experts, was cautious in its claims. It noted that the best results are obtained when e-cigarettes are used in combination with professional counseling and smoking-cessation medication.

In the United States, according to the Campaign for Tobacco-Free Kids, e-cigarette use by young people has grown more rapidly than in Britain. The user population includes many children who have never smoked and thus may be vulnerable to being hooked by nicotine and later moving to traditional cigarettes.

By coincidence, a day before the British study was issued, a study tracking more than 2,500 students at 10 Los Angeles schools who had never smoked tobacco, published in the Journal of the American Medical Association, came to the opposite conclusion. It said ninth graders who had tried e-cigarettes were far more likely than other students to start smoking “combustible tobacco” (cigarettes, cigars, hookahs) within a year.

Strong regulation is needed in Europe and the United States to protect young people from advertising and promotions designed to lure them into trying e-cigarettes and perhaps getting hooked on them. America’s Food and Drug Administration needs to issue rules it proposed last year and make them even stronger by banning flavors that appeal to youngsters.

Opinion: Chamber's tobacco tax stance flawed

I used to believe smoking was just a part of life. My parents, grandparents, uncles, aunts, cousins, neighbors, doctors, nurses, teachers, etc. all smoked around me as I was growing up.
For years, I worked in bars and restaurants where people smoked. The more they smoked, the more they drank. The more they drank, the more they spent. The more they spent, the more I made. Simple.
I even participated in a public service announcement urging people to vote against banning smoking in bars in restaurants many years ago. I would be a hypocrite if I did not disclose that information.
I was dead wrong.
State Chamber executive Andy Peterson’s opinion piece in The Forum (Sunday, July 12) offering a rationale that it’s “free enterprise” for the Greater ND Chamber of Commerce’s stance on lobbying against a cigarette tax increase prompted me to research what this stance may be costing his members.
North Dakota has the sixth-lowest cigarette tax per pack in the United States, $0.44 per pack. Montana, $1.70 per pack. South Dakota, $1.53 per pack. Minnesota, $2.90 per pack. Canada, $2.80 per pack.
Statistically, there are more than 440,000 workers in North Dakota (Bureau of Labor Statistics, U.S. Department of Labor).
I couldn’t find exact numbers but let’s say, conservatively, half of those workers, 220,000, work for the 1,037 member businesses listed on the Chamber’s website. Four of the top five largest employers in the state are also members of the Greater ND Chamber of Commerce. The fifth employer was not disclosed.
The average cost to a business per employee who smokes is $5,816 a year, per a 2013 Ohio State University study. A Gallup poll from 2013, “estimates that 19 percent of workers still smoke and that workers who smoke cost the U.S. economy $278 billion annually in lost productivity due to absenteeism and extra health care costs. This figure is based on an analysis of the cost of extra missed workdays due to poor health, partial absenteeism due to smoke breaks, and additional health care costs compared with workers who do not smoke.”
So let’s say, conservatively, 41,800 workers (220,000 x 19 percent) employed by the Greater ND Chamber businesses still smoke. That is potentially costing these member businesses $243,108,800 ($5,816 x 41,800).
The most recent revenue numbers I could find from cigarette sales in North Dakota was $68,951,521 for 2009.
Now I’m just beginning my graduate studies in business, but it appears it would be in the Greater ND Chamber’s best interest to encourage a cigarette tax increase.
Not only would an increase in the cigarette tax raise revenue for some of Peterson’s members, it would decrease the amount of money most if not all of his member businesses are losing out on paying for smoking- related costs.

Opinion: Does the ND State Chamber side with the U.S. Chamber on Opposing Tobacco Prevention?

By: Dr. Eric Johnson, Grand Forks
President, Tobacco Free North Dakota
If you have not read the June 30, 2015 New York Times article titled, “U.S. Chamber of Commerce Works Globally to Fight Antismoking Measures”, please do so. While we acknowledge there is, at times, a disconnect between national, state and local organizations such as the Chambers of Commerce organizations, I couldn’t help but recognize some similarities between Chamber international efforts as detailed in the article referenced above and the actions of the Greater North Dakota Chamber here in our state.
Even as an active member of the Healthy North Dakota Summit, a public health initiative established by then-Governor John Hoeven and whose statewide plan identifies strategies to “support North Dakotans who make healthy choices – in schools, workplaces, senior centers, homes and anywhere people live, learn, work and play,” the GNDC has not only been absent in supporting tobacco prevention efforts in our state, it has actively opposed them.
With the goal to “reduce tobacco use in North Dakota” on paper in their statewide plan and in mind, we are troubled to see efforts of the Chambers of Commerce – whether internationally or here at the state level – combat proven prevention strategies that save both lives and money.
We call on North Dakotans to demand better and challenge the GNDC to accept what the numbers have long confirmed – that comprehensive tobacco prevention practices are fiscally responsible to taxpayers, health care systems, and ultimately, our workforce and employers in the business community.
Click here to read Mr. Andy Peterson’s letter to the editor in response.
And click here to read Dr. Eric Johnson’s corrections to the inaccuracies of Mr. Peterson’s letter.

Reuters: States target e-cigarette sales to minors amid slow federal action

NEW YORK – Frustrated by the slow pace of federal action, state attorneys general are waging their own campaigns against the sale and advertising of e-cigarettes to minors.

More than a dozen AGs, including those in New York, California, Indiana and Ohio, are using new state and local laws – some of which they helped craft – to put pressure on the industry at all levels, from neighborhood vape shops to big tobacco companies like Altria Group and Reynolds American Inc.

Much of the campaign so far has involved threats to sue violators or appeals to a company’s sense of responsibility, though some lawsuits have been filed, too.

State actions have accelerated in the wake of government data released in April, which showed that teen use of e-cigarettes tripled in 2014 alone, making them more common for youngsters than tobacco.

North Dakota passed its own bill to combat e-cigarettes this legislative session. House Bill 1186, which was signed by Gov. Jack Dalrymple on April 9, outlaws the sale of e-cigarettes to minors in the state. Minors are not allowed to buy, possess or use electronic smoking devices, and those who sell or give e-cigarettes to anyone under 18 is guilty of an infraction.

“The key is to avoid another generation being addicted to nicotine,” Indiana Attorney General Greg Zoeller said in an interview.

State attorneys general played a pivotal role during the 1990s in battling tobacco companies over conventional cigarettes.

The Master Settlement Agreement (MSA), an accord reached in November 1998 between the state attorneys general of 46 states, five U.S. territories, the District of Columbia and the five largest tobacco companies, resulted in significant changes to cigarette marketing and required the tobacco industry to pay the states about $10 billion annually for the indefinite future.

Nearly a year ago, a group of AGs asked the U.S. Food and Drug Administration to take a tougher line on e-cigarettes, the risks and benefits of which are still being studied.

In April of 2014, the agency proposed banning the sale of e-cigarettes to people under the age of 18, but did not recommend prohibiting advertising, flavored products or online sales – all of which help make the devices attractive to youngsters, according to public health advocates.

The FDA proposal has been under review ever since, which has meant that vaping remains legal for youths in states that haven’t passed laws banning it. The agency is likely to finalize its new e-cigarette regulations later this summer, though it could be several years before the federal rules go into effect.

Federal regulations and the 1998 Master Settlement prohibit makers of conventional cigarettes from targeting youth and from advertising on television, billboards and mass transit, but the rules don’t apply to e-cigarettes.

So far, however, 46 states have passed laws banning their sale to minors. Twelve of those states have also passed laws requiring child-proof packaging for e-liquids and e-cigarettes, according to the Campaign for Tobacco-Free Kids.

AGs are using these laws, as well as others not directly tied to e-cigarettes, to force companies to drop ads appealing to teens, switch to child-proof packaging and spend thousands of dollars on more vigilant age verification systems for their websites and online deliveries.

In June, New York Attorney General Eric Schneiderman announced settlements with four companies that were not complying with the state’s rule about child resistant packaging for nicotine liquids.

Reuters spoke with more than 10 e-cigarette and vaping companies – including Reynolds American, which sells Vuse, and Altria Group, which sells MarkTen and Green Smoke – that acknowledged they have been contacted by state law enforcers or by the National Associations of Attorneys General. Reynolds and Altria say their brands were not in violation of local laws.

Some of the AGs have coordinated their efforts. One group is pressuring certain e-cigarette manufacturers and vendors to limit ads that appeal to teens, especially on company websites and places like YouTube.

Ohio Attorney General Mike DeWine, along with colleagues from several other states, sent a letter in April to privately-held manufacturer NJOY, asking it to “immediately instruct YouTube to restrict” access to its advertisements to adults.

NJOY said in an April letter to DeWine that more than 90 percent of the U.S. viewers who have watched its hosted YouTube videos are at least 18, and the company said it would suspend videos if that figure fell to 85 percent or less.

NJOY, which previously settled a case with California over allegations of targeting minors and deceptive marketing, would not comment further.

California has sent letters to more than 150 e-cigarette and vaping companies in recent years “to encourage voluntary compliance with applicable state and federal laws,” including a ban on sales to youth, according to documents reviewed by Reuters.

The state is also pursuing companies that sell fruit-flavored vaping liquids that appeal to teens and those that make false or misleading statements in their advertisements. One letter sent by the state asked a manufacturer to quit claiming that “electronic cigarettes are one of the safest forms of nicotine available” and that “when you exhale, you are exhaling harmless water vapor.”

“Many companies have taken some or all of our recommended steps,” said Kristin Ford, a spokeswoman for Attorney General Kamala Harris.

AGs are paying particular attention to sales on websites, a popular source of vaping materials for teens, who trade information about which ones require little proof of age.

Jan Verleur, CEO and co-founder of electronic cigarette company VMR Products, said his company changed its age verification system in some states after being contacted by a state AG. He estimated the cost per order would increase by about 50 cents, but would not say if VMR would absorb any of that. The company makes about half its sales online.

“This is bad news for the smaller players and good news for the tobacco companies, whose business model relied on mass manufacturing, not personalized products,” said Philip Gorham, an equity analyst at Morningstar who covers consumer products.

New York Times: U.S. Chamber of Commerce Works Globally to Fight Antismoking Measures


KIEV, Ukraine — A parliamentary hearing was convened here in March to consider an odd remnant of Ukraine’s corrupt, pre-revolutionary government.

Three years ago, Ukraine filed an international legal challenge against Australia, over Australia’s right to enact antismoking laws on its own soil. To a number of lawmakers, the case seemed absurd, and they wanted to investigate why it was even being pursued.

When it came time to defend the tobacco industry, a man named Taras Kachka spoke up. He argued that several “fantastic tobacco companies” had bought up Soviet-era factories and modernized them, and now they were exporting tobacco to many other countries. It was in Ukraine’s national interest, he said, to support investors in the country, even though they do not sell tobacco to Australia.

Mr. Kachka was not a tobacco lobbyist or farmer or factory owner. He was the head of a Ukrainian affiliate of the U.S. Chamber of Commerce, America’s largest trade group.

From Ukraine to Uruguay, Moldova to the Philippines, the U.S. Chamber of Commerce and its foreign affiliates have become the hammer for the tobacco industry, engaging in a worldwide effort to fight antismoking laws of all kinds, according to interviews with government ministers, lobbyists, lawmakers and public health groups in Asia, Europe, Latin America and the United States.

The U.S. Chamber’s work in support of the tobacco industry in recent years has emerged as a priority at the same time the industry has faced one of the most serious threats in its history. A global treaty, negotiated through the World Health Organization, mandates anti-smoking measures and also seeks to curb the influence of the tobacco industry in policy making. The treaty, which took effect in 2005, has been ratified by 179 countries; holdouts include Cuba, Haiti and the United States.

Facing a wave of new legislation around the world, the tobacco lobby has turned for help to the U.S. Chamber of Commerce, with the weight of American business behind it. While the chamber’s global tobacco lobbying has been largely hidden from public view, its influence has been widely felt.

Letters, emails and other documents from foreign governments, the chamber’s affiliates and antismoking groups, which were reviewed by The New York Times, show how the chamber has embraced the challenge, undertaking a three-pronged strategy in its global campaign to advance the interests of the tobacco industry.

In the capitals of far-flung nations, the chamber lobbies alongside its foreign affiliates to beat back antismoking laws.

In trade forums, the chamber pits countries against one another. The Ukrainian prime minister, Arseniy Yatsenyuk, recently revealed that his country’s case against Australia was prompted by a complaint from the U.S. Chamber.

And in Washington, Thomas J. Donohue, the chief executive of the chamber, has personally taken part in lobbying to defend the ability of the tobacco industry to sue under future international treaties, notably the Trans-Pacific Partnership, a trade agreement being negotiated between the United States and several Pacific Rim nations.

“They represent the interests of the tobacco industry,” said Dr. Vera Luiza da Costa e Silva, the head of the Secretariat that oversees the W.H.O treaty, called the Framework Convention on Tobacco Control. “They are putting their feet everywhere where there are stronger regulations coming up.”

The increasing global advocacy highlights the chamber’s enduring ties to the tobacco industry, which in years past centered on American regulation of cigarettes. A top executive at the tobacco giant Altria Group serves on the chamber’s board. Philip Morris International plays a leading role in the global campaign; one executive drafted a position paper used by a chamber affiliate in Brussels, while another accompanied a chamber executive to a meeting with the Philippine ambassador in Washington to lobby against a cigarette-tax increase. The cigarette makers’ payments to the chamber are not disclosed.

It is not clear how the chamber’s campaign reflects the interests of its broader membership, which includes technology companies like Google, pharmaceutical giants like Pfizer and health insurers like Anthem. And the chamber’s record in its tobacco fight is mixed, often leaving American business as the face of a losing cause, pushing a well-known toxin on poor populations whose leaders are determined to curb smoking.

The U.S. Chamber issued brief statements in response to inquiries. “The Chamber regularly reaches out to governments around the world to urge them to avoid measures that discriminate against particular companies or industries, undermine their trademarks or brands, or destroy their intellectual property,” the statement said, adding, “we’ve worked with a broad array of business organizations at home and abroad to defend these principles.”

The chamber declined to say if it supported any measures to curb smoking.

The chamber, a private nonprofit that has more than three million members and annual revenue of $165 million, spends more on lobbying than any other interest group in America. For decades, it has taken positions aimed at bolstering its members’ fortunes.

While the chamber has local outposts across the United States, it also has more than 100 affiliates around the world. Foreign branches pay dues and typically hew to the U.S. Chamber’s strategy, often advancing it on the ground. Members include both American and foreign businesses, a symbiotic relationship that magnifies the chamber’s clout.

For foreign companies, membership comes with “access to the U.S. Embassy” according to the Cambodian branch, and entree to “the U.S. government,” according to the Azerbaijan branch. Members in Hanoi get an invitation to an annual trip to “lobby Congress and the administration” in Washington.

Since Mr. Donohue took over in 1997, he has steered the chamber into positions that have alienated some members. In 2009, the chamber threatened to sue if the Environmental Protection Agency regulated greenhouse gas emissions, disputing its authority to act on climate change. That led Nike to step down from the chamber’s board, and to Apple’s departure from the group. In 2013, the American arm of the Swedish construction giant Skanska resigned, protesting the chamber’s support for what Skanska called a “chemical industry-led initiative” to lobby against green building codes.

The chamber’s tobacco lobbying has led to confusion for many countries, Dr. da Costa e Silva said, adding “there is a misconception that the American chamber of commerce represents the government of the U.S.” In some places like Estonia, the lines are blurred. The United States ambassador there, Jeffrey Levine, serves as honorary president of the chamber’s local affiliate; the affiliate quoted Philip Morris in a publication outlining its priorities.

The tobacco industry has increasingly turned to international courts to challenge antismoking laws that countries have enacted after the passage of the W.H.O. treaty. Early this year, Michael R. Bloomberg and Bill Gates set up an international fund to fight such suits. Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, an advocacy group that administers the fund, called the chamber “the tobacco industry’s most formidable front group,” adding, “it pops up everywhere.”

In Ukraine, the chamber’s involvement was no surprise to Hanna Hopko, the lawmaker who led the hearing in Parliament. She said the chamber there had fought against antismoking laws for years.

“They were against the tobacco tax increase, they were against placing warning labels on cigarettes,” she said. “This is just business as usual for them.”

Country-by-Country Strategy

More than 3,000 miles away, in Nepal, the health ministry proposed a law last year to increase the size of graphic warning labels from covering three-fourths of a cigarette pack to 90 percent. Countries like Nepal that have ratified the W.H.O. treaty are supposed to take steps to make cigarette packs less appealing.

Not long afterward, one of Nepal’s top officials, Lilamani Poudel, said he received an email from a representative of the chamber’s local affiliate in the country, warning that the proposal “would negate foreign investment” and “invite instability.”

In January, the U.S. Chamber itself weighed in. In a letter to Nepal’s deputy prime minister, a senior vice president at the chamber, Tami Overby, wrote that she was “not aware of any science-based evidence” that larger warning labels “will have any discernible impact on reducing or discouraging tobacco use.”

A 2013 Harvard study found that graphic warning labels “play a lifesaving role in highlighting the dangers of smoking and encouraging smokers to quit.”

While Nepal eventually mandated the change in warning labels, cigarette companies filed for an extension and compliance has stalled.

“Since we have to focus on responding to the devastating earthquake, we have not been able to monitor the state of law enforcement effectively,” said Shanta Bahadur Shrestha, a senior health ministry official.

The episode reflects the chamber’s country-by-country lobbying strategy. A pattern emerged in letters to seven nations: Written by either the chamber’s top international executive, Myron Brilliant, or his deputies, they introduced the chamber as “the world’s largest business federation.”

Then the letters mention a matter “of concern.” In Jamaica and Nepal, it was graphic health warnings on packages. In Uruguay, it was a plan to bar cigarettes from being displayed by retailers. The Moldovan president was warned against “extreme measures” in his country, though they included common steps like restricting smoking in public places and banning advertising where cigarettes are sold.

A proposal to raise cigarette taxes in the Philippines would open the floodgates to smugglers, the government there was told. Tax revenue has increased since the proposal became law.

“We are not cowed by them,” said Jeremias Paul, the country’s under secretary of finance. “We meet with these guys when we’re trying to encourage investment in the Philippines, so clearly they are very influential, but that doesn’t mean they will dictate their ways.”

Protecting tobacco companies is portrayed by the chamber as vital for a nation’s economic health. Uruguay’s president is warned that antismoking laws will “have a disruptive effect on the formal economy.” El Salvador’s vice president is told that “arbitrary actions” like requiring graphic health warnings in advertisements undermine “investment and economic growth.”

On the ground, the chamber’s local affiliates use hands-on tactics.

After Moldova’s health ministry proposed measures in 2013, Serghei Toncu, the head of the American Chamber of Commerce in Moldova, laid out his objections in a series of meetings held by a regulatory review panel.

“The consumption of alcohol and cigarettes is at the discretion of each person,” Mr. Toncu said at one meeting, adding that the discussion should not be about “whether smoking is harmful.”

“You do not respect us,” he told the health ministry at another.

At a third, he called the ministry’s research “flawed from the start.”

His objections were not merely plaintive cries. The American chamber has a seat on Moldova’s regulatory review panel giving it direct influence over policy making in the small country.

“The American Chamber of Commerce is a very powerful and active organization,” said Oleg Chelaru, a team leader on the staff that assists the review panel. “They played a very crucial role in analyzing and giving an opinion on this initiative.”

Mr. Toncu, who has since left the chamber, declined to comment. Mila Malairau, the chamber’s executive director, said its main objective was to make sure the industry “was consulted” in “a transparent and predictable manner.”

After recently passing in Parliament, the long-stalled measures were subject to fresh objections from the chamber and others, and have not yet been enacted.

Fighting a Trade Exception

In Washington, the U.S. Chamber’s tobacco lobbying has been visible in the negotiations over the Trans-Pacific Partnership, a priority of the Obama administration that recently received critical backing in Congress.

One of the more controversial proposals would expand the power of companies to sue countries if they violate trade rules. The U.S. Chamber has openly opposed plans to withhold such powers from tobacco companies, curbing their ability to challenge national antismoking laws. The chamber says on its website that “singling out tobacco” will “open a Pandora’s box as other governments go after their particular bêtes noires.”

The issue is still unresolved. A spokesman for the United States trade representative said negotiators would ensure that governments “can implement regulations to protect public health” while also “ensuring that our farmers are not discriminated against.”

Email traffic shows that Mr. Donohue, the chamber’s head, sought to raise the issue in 2012 directly with Ron Kirk, who was then the United States trade representative. In email exchanges between staff members of the two, Mr. Donohue specifically sought to discuss the role of tobacco in the trade agreement.

“Tom had a couple of things to raise, including urging that the tobacco text not be submitted at this round,” one of Mr. Donohue’s staff members wrote to Mr. Kirk’s staff. The emails were produced in response to a Freedom of Information request filed by the Campaign for Tobacco-Free Kids, which provided them to The Times.

Mr. Kirk is now a senior lawyer at Gibson, Dunn, a firm that counts the tobacco industry as a client. He said in an interview that during his tenure as trade representative, he met periodically with Mr. Donohue but could not recall a specific conversation on tobacco.

He said trade groups were generally concerned about “treating one industry different than you would treat anyone else, more so than doing tobacco’s bidding.”

The chamber declined to make Mr. Donohue available for an interview.

A Face-Saving Measure

In Ukraine, it was Valeriy Pyatnytskiy who signed off on the complaint against Australia in 2012, which was filed with the World Trade Organization. At the time, he was Ukraine’s chief negotiator to the W.T.O. His political career has survived the revolution and he is now an adviser to the Ukrainian prime minister, Mr. Yatsenyuk.

In a recent interview, he said that for Ukraine, the case was a matter of principle. It was about respecting the rules.

He offered a hypothetical: If Ukraine allowed Australia to use plain packaging on cigarettes, what would stop Ukraine from introducing plain packaging for wine? Then Ukrainian winemakers could better compete with French wines, because they would all be in plain bags marked red or white.

“We had this in the Soviet times,” he said. “It was absolutely plain packaging everywhere.”

Some Ukrainian officials have long been troubled by the case.

“It has nothing to do with trade laws,” said Pavlo Sheremeta, who briefly served as Ukraine’s economic minister after the revolution. “We have zero exports of tobacco to Australia, so what do we have to do with this?”

Last year, he urged the American Chamber in Kiev to reconsider.

“I wrote a formal letter, asking them, ‘Do you still keep the same position?’ ” Mr. Sheremeta said. “Basically I was suggesting a face-saving way out of this.” But when he met with chamber officials, the plain packaging case was outlined as a top priority.

They refused to back down. After Mr. Pyatnytskiy, a tobacco ally, was installed as his deputy, Mr. Sheremeta resigned.

“The world was laughing at us,” he said of the case.

Shortly after The Times discussed the case with Ukrainian government officials, there were new protests from activists. Mr. Yatsenyuk called for a review of the matter. Ukraine has since suspended its involvement, but other countries including Cuba and Honduras are continuing to pursue the case against Australia.

Andy Hunder, who took over as president of the American Chamber of Commerce in Kiev in April, said the organization was moving on, adding, “We are looking forward now.”

Sofiia Kochmar contributed reporting from Kiev, Bhadra Sharma from Kathmandu and Palko Karasz from London.®ion=top-news&WT.nav=top-news&_r=1

Upon reading this article, TFND communicated its disappointment with the Greater North Dakota Chamber’s work in our state alongside Big Tobacco. In doing so, we sent this letter: TFND Letter to GNDC – 7.1.15.

GNDC responded: GNDC – TFND Letter – 7.2.15

And our final communication back to GNDC: TFND response to GNDC – 7.2.15