Tobacco Products Scientific Advisory Committee; Notice of Meeting

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.Show citation box
Name of Committee: Tobacco Products Scientific Advisory Committee (TPSAC).Show citation box
General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues.Show citation box
Date and Time: The meeting will be held on November 2, 2011, from 9 a.m. to 5 p.m., and on November 3, 2011, from 8 a.m. to 5 p.m.Show citation box
Location: Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd. rm. 020B, Rockville, MD 20850, 1-877-287-1373.Show citation box
Contact Person: Caryn Cohen, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1-877-287-1373 (choose option 4), e-mail: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.Show citation box
Agenda: The committee will continue the discussions of issues related to the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children, as part of TPSAC’s required report to the Secretary of Health and Human Services. Discussion will include such topics as the composition and characteristics of dissolvable tobacco products, product use, potential health effects, and marketing.Show citation box
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.Show citation box
Procedure: On November 2, 2011, from 1 p.m. to 5 p.m., and on November 3, from 8 a.m. to 5 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 19, 2011. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on November 3, 2011. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 11, 2011. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 12, 2011.Show citation box
Closed Committee Deliberations: On November 2, 2011, from 9 a.m. to 12 noon, the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). This portion of the meeting must be closed because the committee will be discussing trade secret and/or confidential data provided by the tobacco companies regarding dissolvable tobacco products.Show citation box
Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.Show citation box
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting.Show citation box
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.Show citation box
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Show citation box
Dated: September 13, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.

China Endorsing Tobacco in Schools Adds to $10 Trillion Cost

In dozens of rural villages in China’s western provinces, one of the first things primary school kids learn is what made their education possible: tobacco.
“On the gates of these schools, you’ll see slogans that say ‘Genius comes from hard work — Tobacco helps you become talented,’” said Xu Guihua, secretary general of the privately funded lobby group Chinese Association on Tobacco Control. The schools are sponsored by local units of China’s government-owned monopoly cigarette maker. “They are pinning their hopes on young people taking up smoking.”
Anti-tobacco groups say efforts to reduce sales in the world’s largest cigarette consumer, such as a ban on smoking in public places introduced in May, have been hampered by light penalties, a lack of education about the dangers of smoking and the fact that the regulator, the State Tobacco Monopoly Administration, also runs the world’s biggest cigarette maker, China National Tobacco Corp.
China has more than 320 million smokers, a third of the world’s total, and about 1 million Chinese die from tobacco- related illnesses every year. Reducing mortality in the country from cardiovascular diseases, for which smoking is a main risk factor, by 1 percent a year over the three decades to 2040 could generate economic value equal to 68 percent of China’s 2010 real gross domestic product, or $10.7 trillion, according to a World Bank report published in July.
“Despite the strong will of the government to implement smoking control policies,” the volume of cigarettes sold in China is expected to keep rising from 2011 to 2015, London-based researcher Euromonitor International said in a July report. It forecasts China’s tobacco market will grow at an average 14 percent a year to hit 1.8 trillion yuan in retail sales in 2015.
Sales Rising
The tobacco industry grew at an average annual rate of 19 percent from 2006 to 2010, according to State Tobacco. Last year, earnings rose 17 percent to 605 billion yuan ($95 billion), including 499 billion yuan in taxes. About 53 percent of Chinese men and 2.4 percent of women smoke, according to a 2010 survey by the Chinese Center for Disease Control and Prevention.
While China’s laws ban tobacco advertising on radio, television and in newspapers, they “do not have clear restrictions on sales and sponsorship activities,” according to a report published in January by Yang Gonghuan, a former deputy director of China’s Center for Disease Control, and Tsinghua University professor Hu Angang. The report, titled “Tobacco Control and China’s Future”, cited the example of a Chinese cigarette brand that sponsored a TV series, ensuring that the name appeared during the closing credits.
The European Union banned all tobacco advertising in its member states in 2005. Last year, new U.S. rules ended the industry’s backing of sports like Nascar racing.
‘Healthy Mothers’
Other tobacco sponsorship in China includes funding for 42 primary school libraries in Xinjiang and 40 in Tibet in September 2010, and a 10 million yuan donation in Nov 2010 to a Chinese women’s development fund for a “Healthy Mothers’ Express” campaign, the report said. China National Tobacco, lists charitable activities on its website, including a 5 million yuan donation this month for drought-hit Yunnan province.
In a survey of more than 2,000 adults conducted in 2009 by the Chinese Association on Tobacco Control, 7 percent had a good impression of the tobacco industry because of its charity work, while 18 percent said they would pick a cigarette brand based on involvement in such activities.
State Tobacco’s press office didn’t respond to requests for interviews or a faxed list of questions about sponsorship.
China decided to create a tobacco monopoly in the 1980s when the industry supplied more than 10 percent of government revenue, said Wang Shiyong, the World Bank’s senior health specialist in Beijing. Today, tobacco contributes 6.7 percent, according to figures from Yang and Hu’s report.
Internal Lobbying
“Especially in tobacco-growing provinces like Yunnan and Guizhou, the tobacco industry is a very important part of local government income,” said Wang. “There is a lot of internal government lobbying to make sure the health consequences of smoking are not addressed.”
The lack of awareness is an issue lung surgeon Liu Deruo is trying to address, starting in his own hospital. Liu lit his first cigarette in 1974 while forced to work in a tobacco field in northeast China during the Cultural Revolution.
“All the farmers I worked with smoked, so I also smoked,” said the 55-year-old head of thoracic surgery at Beijing’s China-Japan Friendship Hospital, who quit after going to medical college. He persuaded the 15 surgeons who work for him also to kick the habit. “Now I tell my doctors they are allowed to smoke only in my office, and nobody dares to do so.”
Liu’s campaign is part of an effort to get doctors to lead reforms in people’s lifestyles.
‘Role Models’
“Doctors’ smoking behavior is of particular importance,” said Sarah England, technical officer at the Tobacco Free Initiative of the World Health Organization in China. “They are role models for their patients and for the general public.”
A government survey found that two in five male doctors light up every day in China. When Liu took over his department in 2001, 94 percent of the doctors smoked, he said.
Pfizer Inc., whose Champix is the main prescription anti- smoking drug sold in China, funded a three-year program from 2008 to set up 60 smoke-free hospitals in Beijing, Shanghai and Guangzhou to help doctors quit. Smoking among the hospitals’ leadership more than halved to 8.4 percent from 19.1 percent, while overall rates for doctors fell to 6.8 percent from 10.7 percent, said Neena Moorjani, a spokeswoman for the New York- based drugmaker in an e-mail.
Western Images
The education drive has a way to go. Only one in four adults in China believe exposure to tobacco smoke causes heart diseases and lung cancer, and the percentage for smokers is even lower — 22 percent — according to the 2010 Global Adult Tobacco Survey for China.
“Socially, smoking is still part of everyday life in China and images, many from the West, still glamorize smoking,” said Linda Sarna, a professor at the University of California, Los Angeles’ School of Nursing, in an e-mail. “Quitting smoking is still not the norm,” said Sarna, who is recruiting 1,000 nurses at four Beijing hospitals for a new smoking intervention program.
China National Tobacco is one of the country’s biggest employers, with 510,000 staff and its monopoly on production has meant international rivals have made little progress in the country. The state cigarette maker controlled 97.9 percent of the market in 2010, followed by British American Tobacco Plc with 0.6 percent, Philip Morris International Inc. with 0.3 percent, and Japan Tobacco Inc. with 0.1 percent, according to Euromonitor.
Closed Market
Philip Morris, the world’s second-biggest tobacco company, entered the market in 2008 after signing a license for China National Tobacco to produce Marlboros at two factories.
“For now, the Chinese market is pretty much closed,” Chief Financial Officer Herman Waldemer said at a conference on Sept. 7. “There is a complete monopoly on it. We are developing our relationships.”
In addition to State Tobacco’s control of the industry, it is also part of the Ministry of Industry and Information Technology, which chairs the eight-member body tasked with implementing the WHO’s Framework Convention on Tobacco Control in China, said Xu, a former deputy director at the Chinese Center for Disease Control and Prevention.
“The government and the industry are in the same body — the regulator is also the enterprise,” she said.
Judith Mackay, a senior policy adviser to the World Health Organization, said the power of the tobacco industry in China made it more difficult to address the problem.

Health Warnings

“An amazing number of things in China come under the jurisdiction of the tobacco industry,” she said. “The health warnings on cigarettes for example. It’s not under the Health Ministry. There’s clearly a set of conflict of interests.”
Mackay was attending a United Nations meeting on Sept. 19- 20 at which global leaders backed a plan to fight non- communicable diseases such as lung cancer, including proposals to curb tobacco use.
Regional units of China’s tobacco monopoly fund more than 100 primary schools throughout the country, such as the Sichuan Tobacco Hope Primary School, the official Xinhua News Agency reported in May. Some are named after top-selling brands like Hongta, which means red pagoda, or Zhongnanhai, named after the compound next to the Forbidden City where China’s top leaders live and work.
“We’ve been trying to get the Ministry of Education to stop the tobacco companies from sponsoring these schools,” said Xu. “But the ministry wants us to show them proof that this is causing harm.”
–Daryl Loo. Editors: Adam Majendie, Bret Okeson.

Health groups weigh in on graphic cigarette label suit

RICHMOND, Va. — Several public health groups are weighing in on a lawsuit over graphic cigarette warning labels that include the

cigarette labels fda
New warning labels cigarette makers will have to use by the fall of 2012. Four of the five largest U.S. tobacco companies sued the federal government Tuesday, Aug. 16, 2011, over the new graphic cigarette labels, saying the warnings violate their free speech rights and will cost millions of dollars to print.

sewn-up corpse of a smoker, saying the federal government has a strong interest in more effectively informing people about the effects of tobacco and current warnings aren’t sufficient.
The groups filed a friend of the court brief with the U.S. District Court in Washington, D.C., ahead of a Wednesday hearing in which some of the nation’s largest tobacco companies will ask a judge to stop the labels, set to appear on packs next year. A decision on a preliminary injunction could come as soon as October.
The companies, led by R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., sued the Food and Drug Administration last month to block the labels, saying they violate free speech laws, unfairly urge adults to shun their legal products and will cost millions to produce.
Tobacco companies are increasingly relying on their packaging to build brand loyalty and grab consumers. It’s one of few advertising levers left to pull since the government has curbed their presence in magazines, billboards and TV.
But the health groups wrote: “It is difficult to imagine any product for which the government has a stronger interest in ensuring effective warnings to consumers. … Tobacco products are unique among consumer goods: They kill up to one-half of the people who use them as they are intended to be used.”
The groups include the American Academy of Pediatrics, the American Cancer Society, the American Heart Association, the American Legacy Foundation, the American Lung Association, the American Medical Association, the American Public Health Association, the Campaign for Tobacco-Free Kids, and Public Citizen.
“In addition to failing to inform consumers about the risks of tobacco use, the current warnings fail to change consumers’ decisionmaking or behavior,” they added.
In opposition to the lawsuit, the FDA similarly said that the public interest in conveying the dangers of smoking outweighs the companies’ free speech rights. And it said the cost to the companies to incorporate the new graphics is not sufficient to halt the labels.
The federal agency also argued that Congress gave it the authority to require the new labels because existing warnings dating to 1984 were going unnoticed. It says it drew on the advice of various experts to create the labels, which the FDA said are similar to those used in other countries, including Canada.
The companies responded that while the government has authority to mandate them to accurately warn consumers about the dangers of their products plainly and legibly, it “lacks authority to compel manufacturers to replace their product labels and logos with emotionally-charged photographs and messages demanding that adult customers stop using their lawful products.”
In June, the FDA approved nine new warning labels that companies are to print on the entire top half of cigarette packs, front and back. The new warnings, each of which includes a number for a stop-smoking hotline, must constitute 20 percent of cigarette advertising, and marketers are to rotate use of the images.
One label depicts a corpse with its chest sewn up and the words “Smoking can kill you.” Another shows a healthy pair of lungs beside a yellow and black pair with a warning that smoking causes fatal lung disease.
Joining R.J. Reynolds and Lorillard in the suit are Commonwealth Brands Inc., Liggett Group LLC and Santa Fe Natural Tobacco Company Inc.
Altria Group Inc., parent company of the nation’s largest cigarette maker, cigs4us.biz/marlboro-cigarette maker Philip Morris USA, is not a part of the lawsuit.
The tobacco industry’s legal challenge could delay the new warning labels for years. That is likely to save cigarette makers millions of dollars in lost sales and increased packaging costs.

Cigarette mailing ban on Senecas is upheld


A federal appeals court upheld a ban on the mailing of cigarettes by Seneca Nation businesses Tuesday but left intact an injunction against the collection of taxes on those cigarettes.
The court, in siding with U.S. District Judge Richard J. Arcara, upheld most of a sweeping new federal law prohibiting the U.S. Postal Service from delivering commercial cigarette shipments.
The one aspect of the law, known as the Prevent All Cigarette Trafficking Act, or PACT Act, that the appeals court rejected, at least for now, is the requirement that companies that engage in out-of-state tobacco sales pay sales taxes on those products.
“This is a positive decision,” Seneca President Robert Odawi Porter said in a statement. “While restrictions on mailing remain in place, the method currently used by Seneca Nation merchants to send product — private shippers other than the major delivery companies — is back open.”
A year ago, Seneca officials decried the law and suggested that it would cripple their mail-order operations and result in hundreds of lost jobs.
One of the exceptions to that doom-and-gloom scenario was the Seneca Smokeshop and owner Aaron J. Pierce, who has been able to find new ways of distributing his tax-free cigarettes.
“He’s still shipping to customers out of state through means other than the U.S. Postal Service,” said Lisa A. Coppola, a lawyer for the company.
Coppola said Pierce, the lead plaintiff, is more concerned about the collection of taxes than the loss of mail service.
Signed into law by President Obama last year, the PACT Act is designed to end a practice that cost governments billions of dollars a year in lost taxes. It also is intended to prevent underage smokers from obtaining cigarettes through the mail.
“We’re happy,” said Michael Seilback, vice president of public policy for the American Lung Association in New York State. “The fact that the law will prevent the shipping of these products through the mail is certainly a win for public health.”
The PACT Act is viewed by both critics and supporters as landmark legislation with billions of dollars in tax revenue and thousands of jobs at stake.
Shortly after the law took effect, Seneca business owners challenged it in federal court, contending that it was unconstitutional and discriminatory.
In July of last year, Arcara upheld the federal government’s right to ban the mailing of cigarettes by Seneca Nation businesses but rejected for the time being the collection of taxes on those cigarettes.
The law also requires cigarette businesses to register with the state where they are headquartered and make periodic reports to state tax departments. It also requires that they check the age and identification of customers who buy tobacco products.
The judge ruled that the collection of taxes may violate the Senecas’ right to due process, or the principle that government must respect the legal rights of individuals.
It is not yet clear whether either side will challenge the U.S. Court of Appeals decision. They have 90 days to appeal to the U.S. Supreme Court.
U.S. Attorney William J. Hochul Jr. had no immediate comment on the ruling.
By Phil Fairbanks
pfairbanks@buffnews.com

Alcohol, Tobacco Taxes to Go Up

New York — CONCERNED by the high prevalence of non-communicable diseases, the Government is considering raising alcohol and tobacco taxes to finance the prevention and treatment of such conditions.
The move will push retail prices of the products upwards.
Speaking ahead of the United Nations High-Level Meeting on NCDs, which begins here today, Health and Child Welfare Minister Dr Henry Madzorera said he would present the proposals to Cabinet after the Summit.
Although statistics were not readily available, he said alcohol and tobacco were responsible for a good number of NCDs.
A non-communicable disease is a medical condition that is non-infectious, for instance, cancer and diabetes.
“We are going to propose taxes on tobacco and alcohol; Government will look into the issue. Taxes reduce consumption (of the two products) and the money raised will go towards improving programmes related to the diseases they cause,” he said.
“There are more deaths caused by NCDs than HIV and Aids, malaria and tuberculosis combined. A total of 80 percent of premature deaths caused by NCDs are in developing countries.
“Initially, people thought NCDs were for the affluent and had not realised they are the causes of high mortality. However, we have woken up to the reality.”
Dr Madzorera said the proposal is in line with the World Health Organisation’s Zero Draft of the UN Summit Outcomes Statement, which, among other issues, urges member states to set up domestic financing mechanisms and utilise available resources efficiently to fight NCDs.
He said the Government was working diligently to combat this group of diseases, but continued to experience financial challenges.
He said specific policies and regulations should be refined to leverage ongoing efforts.
Such an initiative includes enforcing public smoking regulations and curtailing tobacco and alcohol advertising.
“When we look at regulations, there are conventions such as the Framework Convention on Tobacco Control. We, as Zimbabwe, have not yet signed that convention. The convention seeks to limit advertisements of tobacco and to ensure such advertisements inform the public about the hazards of tobacco. It also seeks to ban public smoking to eliminate passive smoking.
“Furthermore, the convention promotes the production of alternative crops.
“This is voluntary, and those that do switch to different crops will be funded for the transition.
“The convention will not affect our tobacco revenues, as 98 percent of this revenue is generated outside the country. It is the 2 percent that we want to look at.”
The minister said the Summit marks a turning point in the fight against the diseases.
“The most important aspect is that the Summit is the second the UN has convened to look at a (global) health issue.
“We learnt from the last Summit that better results – in terms of financing of disease prevention and treatment – are attained when there is commitment at the highest level of Heads of State and Government.
“We want to ride on the 2001 meeting to deal with NCDs and hope that financing improves. We also hope this will mobilise the global community as the last Summit did.”
The high-level meeting seeks to formulate a co-ordinated global strategy to deal with NCDs, which cause 60 percent of deaths across the world. Cancers, cardiovascular ailments, chronic respiratory disorders and diabetes will feature prominently.
The President of the General Assembly will today chair plenary meetings where UN Secretary-General Mr Ban Ki-moon, WHO Director-General Dr Margaret Chan and a civil society representative are scheduled to make presentations.
Three roundtable discussions are expected to tackle the rising incidence and socio-economic impact of NCDs and their risk factors. Also to come under the spotlight will be methods of strengthening the national capacities and policies of member states to address their prevention and control.
The meeting will finally adopt an action-oriented outcome document.
The Non-Communicable Diseases Alliance is pushing for more aggressive approaches in dealing with NCDs. The alliance – consisting of the International Diabetes Federation; Union for International Cancer Control; World Heart Federation and International Union against Tuberculosis and Lung Disease -represents 880 societies in 170 countries.
The grouping and the Lancet NCD Action Group have since published a Summit paper proposing priority action points that include leadership, prevention, treatment, international co-operation as well as monitoring and accountability.
They also proposed interventions such as tobacco control, salt reduction, improved diets and physical activity, reduction in hazardous alcohol intake, and essential drugs and technologies.
Published by the government of Zimbabwe

What would happen if Americans stopped smoking?

The number of New Yorkers who smoke dropped to an all-time low of 14 percent this year, Mayor Mike Bloomberg announced late last NY smoking banweek. That’s down from 22 percent in 2002 and translates into 450,000 fewer adult New Yorkers who smoke than did a decade ago.
The New York drop mirrors a nationwide decline, where smoking rates have fallen by over half since the 1950s. But that still leaves 46 million American smokers — what if they all kicked the habit, too? That’s the world “After Tobacco,” a new book from economic researchers Peter Bearman, Kathryn Neckerman and Leslie Wright, tries to imagine.
The authors estimate that if all smoking ceased in 2006, 2.8 million premature deaths would be avoided between then and 2025. Health spending would decrease by $211 billion, or 1.52 percent, in that same time period.
The economic effect on public programs, however, would be more of a mixed bag. States’ Medicaid costs would noticeably decrease: lower-income populations have higher rates of smoking and the negative health outcomes that follow. But states would also lose revenue from cigarette excise taxes, which amounted to $13.75 billion in 2006. If Americans stopped smoking altogether, states could see a 1.4 percent decrease in revenue, according to a chapter from Hunter College’s Howard Chernick.
A similar, spilt-effect would be true for Social Security. With Americans living longer, Social Security would bear the increased cost of supporting people for a longer time. But those costs are slightly offset from an increase in healthy workers, who “tend to earn more and retire later,” leading to higher contributions. On balance, “After Tobacco” estimates the end of smoking means a slight, 1.58 percent increase in Social Security outlays.
The end of smoking would even ripple as far as corporate philanthropy. Between 1997 and 2005, the tobacco industry made over $143 million in charitable donations, 42 percent of which went to public health and community development programs. Much, if not all, of that giving would presumably dry up with tobacco manufacturers making smaller profits. Nationally, the impact wouldn’t be giant, with tobacco only currently making up about 3 percent of corporate giving. But the authors speculate that in cities where tobacco giants are headquartered, like Winston-Salem or Richmond, nonprofits would notice the decline.
This is by no means to say that lost tax revenue or higher Social Security outlays is a reason to rethink anti-smoking campaigns; the end of tobacco use would be a huge public health victory, one that stands to prevent millions of premature deaths. Rather “After Tobacco” illustrates how entrenched tobacco has become, and remains, in the American economy. Despite huge reductions in smoking over the past 50 years or so, a complete halt to tobacco use would touch just about every public program and private sector in many, varied ways.
By Sarah Kliff

Japan Tobacco can rise Cigarette Prices 75%

Japan Tobacco Inc. (2914), the world’s third-biggest publicly traded cigarette maker, climbed to the highest in almost three years on japan women smokingspeculation it can lift prices more than the tax increases proposed by the health minister.
Japan Tobacco rallied 6 percent to 370,000 yen, the highest intraday level since October 2008, as of 2:01 p.m. in Tokyo trading while the broader Topix index fell 1.8 percent.
Tobacco taxes in Japan should be raised until the average price of a pack of cigarettes is about 700 yen ($9.15), or 75 percent higher than the current level, to cut medical costs, Health MinisterYoko Komiyama said. Smoking in Japan was responsible for at least 4.3 trillion yen in medical costs and economic losses in 2005, according to the Institute for Health Economics and Policy.
“Tax increases will lead to Japan Tobacco’s profit growth,” said Mikihiko Yamato, a research partner at Japan Invest KK who recommends buying the stock. “If the price is over 500 yen, it will damage the sales of tobacco, but cigarette companies can still raise profit when their price increases reflect the higher costs.”
The ministry, which is participating in a tax panel session, will push for increasing tobacco levies by 100 yen annually for three years, Komiyama said in a Sept. 16 interview. Most panel members agreed with the idea last year, she said.
Underage Smoking
“At that level, we can expect people who want to quit smoking to stop, while maintaining the level of tax revenue,” said Komiyama, 63, who became minister on Sept. 2. “It’s also the best way to prevent underage smoking.”
Almost 10 percent of Japanese under 20 years old had smoked at least once, with 1.2 percent of them smoking every day, according to a study funded by the health ministry in 2007.
Efforts to raise duties have been complicated by government ownership of a controlling stake in Japan Tobacco and concerns that tax revenue may decline for a country facing the world’s largest public debt.
The tax panel, led by Finance Minister Jun Azumi, proposes reducing the government’s stake in Japan Tobacco to a third from about half, he said Sept. 16. The maker of Mild Seven and Camel cigarettes has gained 23 percent this year in Tokyo trading, giving it a market value of 3.7 trillion yen, or $48 billion.
Ruling Party’s Manifesto
“It is almost clear that the government will sell a certain amount of Japan Tobacco shares, which will make it easier for the company to do business,” Japan Invest KK’s Yamato said.
The average price of a pack of 20 cigarettes increased by 33 percent last October to 400 yen, or about $5.20. That compares with the average price of $10.80 in New York City, where taxes were raised in July 2010.
Japan Tobacco forecast an 11 percent increase in profit this fiscal year after raising prices in Russia and other overseas markets. Net income in the year ended March rose 4.7 percent to 145 billion yen, beating analysts’ estimates.
Cigarette sales volume fell after a tax increase in October pushed up prices, Japan Tobacco has said.
The proposal to increase taxes is in accordance with the manifesto of the ruling Democratic Party of Japan, Komiyama said. The manifesto calls for abolishing a law that the government own more than half of Japan Tobacco’s outstanding shares and says tobacco-related issues should be included in the “health agenda,” she said.
Children’s Fund
The cigarette maker said Sept. 6 it wants the government to sell its shares and use the funds to finance reconstruction after a March 11 earthquake and tsunami left more than 20,000 people dead or missing.
The Children’s Investment Fund Management UK LLP, the London hedge fund founded by Christopher Cooper-Hohn, has been lobbying for Japan Tobacco to buy back at least 17 percent of its stock and raise dividends.
Central and regional governments raise about 2 trillion yen in tax revenue each year from tobacco, according to the finance ministry.
One of every four adults in Japan smoked in 2009, according to Japan Tobacco. That’s down from one in three in 2000.
“You have to have political will to bring down smoking rates,” said Judith McKay, a Hong Kong-based senior adviser to the World Lung Foundation who has campaigned for stricter tobacco control. “Japan is the one exception.”
6 Million Deaths
In the U.S., one of every five adults smokes cigarettes, according to the U.S. Centers for Disease Control and Prevention. Smoking was estimated to be responsible for $193 billion in annual health-related economic losses in the U.S. between 2000 and 2004, according to the CDC.
Tobacco-related illnesses comprise one of the biggest public-health threats and kill almost 6 million people, including 600,000 non-smokers, a year, according to the World Health Organization. Almost 80 percent of the world’s 1 billion smokers live in low- and middle-income countries, the Geneva- based agency said on its website.
Japan’s health ministry also will submit legislation at the session requiring businesses to ban smoking or provide separate smoking sections, Komiyama said. The ministry probably will give exceptions to restaurants and hotels for a few years and subsidize the purchase of ventilation equipment, she said.
“It may be extreme to say this, but I’m not stopping people from shortening their lives themselves,” Komiyama said. “But I don’t want to let them cause trouble for others.”
Komiyama began advocating anti-smoking measures when she became a lawmaker in 1998 and found other legislators smoked in the parliament buildings and at meetings. She said she had been careful about protecting her throat when she worked as an anchorwoman for public broadcaster NHK for more than 20 years.
“I walked around with a sign that said ‘no smoking at my table’ to every meeting I attended,” Komiyama said. “Then many lawmakers who didn’t enjoy the smoke began sitting near me. That’s how this started.”
To contact the reporters on this story: Kanoko Matsuyama in Tokyo at kmatsuyama2@bloomberg.net; Shunichi Ozasa in Tokyo at sozasa@bloomberg.net
By Kanoko Matsuyama and Shunichi Ozasa

The War on E-Cigarettes

Earlier this month, the Centers for Disease Control (CDC) reported that from 2005 to 2010, the nation’s smoking rate experienced a measly decline, from 20.9 percent to 19.3 percent. This, despite hundreds of millions of dollars in government anti-smoking campaigns and higher cigarette taxes. The CDC now estimates that the smoking rate will be 17 percent in 2020, far short of the sub–12 percent goal set by the 2009 Family Smoking Prevention and Tobacco Control Act.
If there’s any chance of reaching the goal, influential anti-tobacco activist groups should quit stubbornly relying on the government to solve the problem, especially when the private sector is coming up with innovative approaches to reduce the risks related to tobacco use.
The Campaign for Tobacco Free Kids, perhaps the most prominent anti-tobacco group, wrote in a press release that the decline in smoking rates was “nothing to cheer” about and that the news “underscores the need for elected officials at all levels to more aggressively implement proven measures to reduce tobacco use.” Except by their own admission, the only thing proven about the current government approach is that it isn’t working.
In fact, groups like Campaign for Tobacco Free Kids have remained steadfast in their adamant opposition to many commonsense strategies for making tobacco less deadly. The most egregious example is their continued prohibitionist stance towards electronic cigarettes. E-cigarettes, which deliver nicotine to the user in a water-like vapor that does not contain the deadly amalgamation of particles found in tobacco smoke, have caught on over the last half-decade with smokers looking for less risky ways to get nicotine, or even trying to quit entirely. Published surveys suggest that e-cigarettes have helped a significant number of people remain abstinent from traditional cigarettes. Furthermore, despite fear-mongering by activist groups, tests performed on e-cigarette liquid and vapor demonstrate that the product is no more toxic than other nicotine-replacement therapy products such as the nicotine patch, gum, and inhaler.
Apparently, the city of Boston hasn’t gotten the memo. Earlier this month, the Boston Public Health Commission took the first step toward banning the use of e-cigarettes in workplaces, restaurant patios and decks, and loading docks. If passed by the Health Commission, Boston will join a small but growing list of communities — one of the most significant being King County, Wash., (which includes the city of Seattle) — that have voted to force e-cigarette users, many of whom are ex-smokers, back into the smoking section based on nothing but pure hype and conjecture. There is no evidence whatsoever that e-cigarette vapors contain anything more harmful than small amounts of nicotine, which is not a carcinogen.
Unfortunately, these are not isolated examples of local governments’ interfering with effective private-sector solutions. In fact, these campaigns have been bankrolled by the CDC, the very same federal bureaucracy that’s spending recklessly — and ineffectively — to fight smoking.
When Congress passed the Patient Protection and Affordable Care Act, it created a CDC slush fund called Communities Putting Prevention to Work. Initially created as part of the 2009 stimulus package to distribute $400 million in grants to state departments of health and local governments, the CPPW program, like most big spending programs, refused to die. Its funding now stands at $750 million a year, and will rise to $2 billion a year beginning in 2015. The cash handouts are supposed to be targeted at “reducing chronic disease morbidity and mortality associated with obesity and tobacco use . . . through implementing evidence- and practice-based approaches.”
What is the “evidence” supporting a CDC-funded campaign to restrict the use of e-cigarettes? The Boston Public Health Commission declined to share with us a report issued by their CPPW advisory council to Mayor Thomas Menino on the topic. And the CDC dismissed any notion of accountability and transparency by referring our questions back to the (non-responsive) grant recipient.
Whether achieved by national or local policy change, governmental micromanagement of health behaviors not only restricts freedom, but is failed policy. Boston’s proposed law is undoubtedly a waste of money and resources. But by creating obstacles for smokers to switch to e-cigarettes, it will actually do far more harm than good.
Most important, it again illustrates what the few rational voices in the tobacco-control movement have been saying for years: The so-called public-health community simply strives for more control over our lives, even at the expense of shortening them.
By Jeff Stier

Battle Against Smoking Goes Back Centuries

cityroom-smoking
A 19th-century painting depicting a 1639 smoke-in by citizens of New Amsterdam against a tobacco ban. It is not clear whether the protest, described by Washington Irving in a largely satirical work, ever occurred.

Mayor Michael R. Bloomberg has snuffed out smoking more audaciously than any of his recent predecessors, as the latest figures attest: only 14 percent of New Yorkers now smoke, the city reported Thursday, discouraged in large part by the ever-cresting wave of Bloomberg-driven taxes and bans.
But Mr. Bloomberg is hardly the first New York official to battle tobacco use. Efforts to restrict smoking can be traced back at least as far as an edict in 1639, which happened to coincide with the start of New Amsterdam’s first tobacco plantation.
William Kieft, the Dutch colony’s hapless director general, tried to ban pipe-smoking altogether, the journalist Eric Burns writes in “The Smoke of the Gods: A Social History of Tobacco.”
The episode inspired a chapter in Washington Irving’s fact-and-fiction-mixing 1809 opus “A History of New-York from the Beginning of the World to the End of the Dutch Dynasty, by Diedrich Knickerbocker” in which Kieft meets his match in Manhattan’s burghers. The citizens stage a smoke-in at his house to protest the ban, forcing him to compromise and permit short pipes that “would not be in the way of business.” (It is not known whether such a protest occurred, and the short-pipe compromise did not, but attempts to curb the Dutch smoking habit were widespread in the colonies, said Elisabeth Funk, a historian.)
By the early 19th century, cigar-smoking had replaced pipes as a protest target. In 1817, a visitor from abroad wrote that among the sights that struck strangers most was “the custom of smoking segars in the streets (even followed by some of the children).”
In 1839, The Evening Post complained that “the nuisance of smoking in the streets has much increased lately” and the atmosphere in parts of Broadway “is almost as narcotic and sickening with tobacco smoke as the air of the traveler’s room in a High Dutch tavern.”
“No doubt,” the newspaper continued, “many of those persons who indulge in their favorite habit in the public streets, do it thoughtlessly without thinking how offensive it is to others, and would be surprised at hearing that they are guilty of a blackguard practice.”
The New York Times weighed in in 1853, two years after it began publishing, with an editorial asking: “What right has any man to become a perambulating nuisance — a moving smoke-house — a traveling volcano — leaving his trail of nauseous vapor on the air, which his neighbor cannot avoid, but must, perforce, respire?”
Smoking indoors was considered even more offensive. A news article in 1853 reported that a passenger caught smoking on a Sixth Avenue streetcar was ordered by a conductor to stop, “but the ladies and gentlemen who were so unfortunate as to be in the car at the time, found their clothes so thoroughly besmoked that the disagreeable odor of smoke at second hand, remained with them till the following day.”
Later, the antismoking crusade was embraced by temperance leaders, who reasoned that the habit left smokers parched and craving drink, most likely alcohol. In 1907, the Woman’s Christian Temperance Union in Manhattan began inspecting library books to eliminate smoking heroes and heroines from modern novels.
“In 95 percent of the reading matter published the cigarettes and tobacco are represented as indispensable,” said Mrs. Emile D. Martin, the W.C.T.U.’s New York County superintendent. “In stories in all classes of literature the hero, although he may be an about-to-be-translated saint, Christian, evangelist or philanthropist is surrounded by a halo of ‘white curling wreaths of priceless Havanas.’”
The following year, word that some restaurateurs would allow women customers to smoke prompted Timothy P. Sullivan, known as Little Time, the majority leader of the Board of Aldermen, to introduce legislation that would impose penalties on hotels, restaurants and places of public entertainment that permitted women to smoke.
His bill, which became effective immediately, passed just two weeks later. It was on the books for only two weeks when it was vetoed by the mayor, but not before Katie Mulcahey, 29, was arrested on the Bowery for lighting up. “No man shall dictate to me,” she said, before being jailed because she was too poor to pay the $5 fine.
In vetoing the bill, Mayor George B. McClellan Jr. maintained that the aldermen were not empowered to ban smoking. “While the conduct of individuals or of the owners of private property can be regulated by legislation, to a certain extent, for the protection of the public morals, health or safety,” he said, “I do not believe that this general power, which is technically known as the police power of a government, can be invoked to sustain an ordinance of this kind.”
Others thought the aldermen had not gone far enough. Dr. Charles J. Pease, president of the Non-Smokers’ Protective League, argued for a ban against anyone smoking in a public place where women were present “who ought not be forced to inhale tobacco fumes.” He also pressed for a ban on smoking at park concerts.
A 1909, an editorial in The Times condemned smoking in subway stations, which was subsequently banned by the Board of Health — a ban that the United States Tobacco Journal branded as “obtuse and reactionary paternalism.” The editorial further railed against even extinguished cigars, complaining that “the odor of one partly burned cigar, disagreeable anywhere, is positively nauseating in a subway car.”
In 1911, The Times urged: “Anything that may be done to restrict the general and indiscriminate use of tobacco in public places, hotels, restaurants, railroad cars, will receive the approval of everybody whose approval is worth having.”
A year later, following the Triangle Waist Company fire, the Fire Department distributed 35,000 placards in English, Italian and Yiddish advising that smoking in factory workrooms and department stores was illegal “under such circumstances as renders the act ‘dangerous to human life’ or ‘endangers the safety of a considerable number of persons’ or ‘renders a considerable number of persons insecure in life or in the use of property.’ ”
In 1920, the Fifth Avenue Coach Company limited smoking to only the rear seats on the upper deck of its buses.
A 1988 law passed under the administration of Mayor Edward I. Koch and amended in 1995, prohibited smoking in most restaurants and offices, with some exceptions. A much stricter ban covering bars and other public places was imposed effective 2003 and was extended to hospital grounds in 2009. In May, it was further applied to parks, pools, beaches and other outdoor areas.
As for Governor Kieft, who was known as William the Testy, the smoking ban was far from his only miscalculation. He was fired by the Dutch West India Company after massacring scores of Indians. He drowned in 1647 when his ship sank as he was returning to the Netherlands to defend himself.

Nestle Fight Behind Scenes at UN Threatens Campaign on Deadliest Diseases

Nestle SA (NESN), GlaxoSmithKline Plc (GSK) and SAB Miller SA face health lobbyists next week in New York as the first United Nations General Assembly on disease since the 2001 AIDS summit tries to combat the world’s biggest killers.
Company officials join political leaders and health groups to produce a plan to reverse the rising tide of non-communicable diseases like cancer, diabetes, and heart and lung disease that the World Health Organization says a study found will cost the global economy more than $30 trillion over the next 20 years.
On the table are proposals to fight obesity, cut tobacco and alcohol use and expand access to lifesaving drugs in an effort to tackle unhealthy diets and lifestyles that drive three of every five deaths worldwide. At stake for the makers of snacks, drinks, cigarettes and drugs is a market with combined sales of more than $2 trillion worldwide last year.
“It’s kind of like letting Dracula advise on blood bank security,” said Jorge Alday, associate director of policy with World Lung Foundation, which lobbies for tobacco control. “There’s important expertise there, but you have to question the motive.”
The two-day summit starting Monday aims to produce a resolution for government action against physical inactivity and use of harmful food ingredients, tobacco and alcohol. The only other time the General Assembly met solely on a health topic was the AIDS meeting that led to a global fund and a 10-fold increase in financial backing for HIV, tuberculosis and malaria programs.
Channeling AIDS
The International Diabetes Federation wants similar support from governments to stop a disease it estimates costs $465 billion annually to treat. In two years, the global estimate of people with diabetes — a disease mostly associated with obesity — jumped 28 percent to 366 million, researchers said this week.
“Left unchecked, these costly diseases have the power to devour the benefits of economic gains, sending millions of people below the poverty line,” WHO Director-General Margaret Chan told health officials in Baku, Azerbaijan, on Sept. 13. “When a problem like obesity is so widespread throughout a population, the cause is not a failure of individual willpower, but a failure of political will at the highest level.”
The issue has divided political leaders, according to earlier versions of the 12-page declaration drafted Sept. 7 for debate in New York that were obtained by Bloomberg News. On one side stands the U.S. and Western Europe, home to many of the companies that make the food, alcohol and cigarettes. On the other are emerging economies such as India and Brazil that have surging rates of diabetes and heart disease attributed to the consumption and marketing of some of these companies’ products.
Kill or Change
“Companies are going to have to either kill this or change what they’re doing,” said Shiriki Kumanyika, a researcher at the University of Pennsylvania School of Medicine who will represent the International Association for the Study of Obesity at the summit. “It’s a direct affront to the current way of doing business.”
Health advocacy groups spearheaded by the NCD Alliance, an umbrella group of about 900 organizations, said the U.S. and other wealthy nations watered down the resolution language and guidelines pertaining to alcohol and tobacco use, salt intake and access to medicines. The countries also stymied efforts to describe the disease burden as an “epidemic” in case it gave nations more leverage in circumventing drug patents.
Less Salt
“We believe it was because of lobbying from the food, beverage and alcohol industry in particular,” said Ann Keeling, the International Diabetes Federation’s chief executive officer and NCD Alliance chair. “We were looking for some time-bound measures on food content — salt in particular. At one point they were in the document and now they’re not.”
Keeling’s NCD Alliance and Kumanyika’s obesity research group are among about 270 members of organizations, academia, companies and industry groups — which the UN refers to collectively as “civil society” — invited to participate in next week’s meeting, while being excluded from decision making.
Included on that list are representatives from distiller Diageo Plc (DGE) and drugmakers Sanofi, Roche Holding AG (ROG), Bayer AG (BAYN) and Novo Nordisk A/S.
“I am not averse to them lobbying,” said Robert Beaglehole, chairman of New Zealand’s Smokefree Coalition and a former director of chronic disease and health promotion at the WHO in Geneva. “I am averse to governments taking them seriously.”
Europe’s Debt
The talks have been hampered by concern from donor governments they would be asked for more aid money amid Europe’s debt crisis and a faltering U.S. economic recovery, Keeling said. Those governments favor spending on treatments for chronic diseases over policies that tackle their causes, said Boyd Swinburn, director of the WHO Collaborating Centre for Obesity Prevention at Melbourne’s Deakin University.
“They promote consumption — that’s how we get economic growth,” Swinburn said. “They have been very slow to act, abdicating the responsibility largely to individuals.”
Companies have acted faster, proposing self-regulation through “powerful lobbying activities that have been a major part of blocking good prevention policies,” Swinburn said.
The International Food & Beverage Alliance, formed in May 2008 by Kraft Foods Inc. (KFT), Coca-Cola Co., General Mills Inc. (GIS) and five other multinational companies with combined 2010 revenue of more than $350 billion, said that isn’t true. The group has made commitments to WHO’s Chan to improve diets, promote good nutrition and healthy lifestyles, and advertise products to children responsibly.
‘Collaborative Approach’
“What I’m looking for is a collaborative approach which has been pioneered in other parts of the United Nations and needs to be applied here,” said Janet Voute, co-chair of the producers’ alliance. Voute, vice president of public affairs at Vevey, Switzerland-based Nestle, is a former WHO staffer and onetime chief executive officer of the World Heart Foundation.
“An adversarial, finger-pointing, they’re-evil-we’re-good approach is outdated,” she said. “We have to tap the know-how, the core capabilities of each stakeholder.”
The NCD Alliance supported a goal proposed by a WHO panel this year to reduce deaths from cardiovascular disease, cancer, diabetes and chronic respiratory disease by 25 percent by 2025 from last year’s levels. Those targets weren’t included in a final draft of the resolution completed last week. Nor was a proposal by Norway to agree on a limit for a person’s daily salt consumption after opposition from the EU, U.S. and Canada.
‘Just Words’
“If there are no goals and targets with a date on it, there’s not going to be any accountability,” said Peter Piot, director of the London School of Hygiene & Tropical Medicine and former executive director of the Joint United Nations Programme on HIV/AIDS. “It will be just words in a UN resolution.”
Targets won’t bring about change unless they are achievable, said Jean-Luc Butel, executive vice president and group president for the international business at Medtronic Inc. (MDT), the world’s biggest maker of heart-rhythm devices.
“If it’s not realistic then nothing will be done,” Butel said. “I am also very realistic about how hard it is to have an agreement when you have so many people around the table.”
Unilever, the world’s second-biggest maker of consumer goods, supports “collaborative initiatives that encourage industry to reduce levels of salt in their products,” said Anne Heughan, external affairs director at the London- and Rotterdam- based company. “Unilever has been at the forefront of salt reduction from an industry perspective, and we continue to encourage others stakeholders to work with us in reducing salt intake.”
British Reception
The British Consul General will host a reception in New York on Sept. 19 for the International Federation of Pharmaceutical Manufacturers & Associations, a Geneva-based lobby representing research-based drugmakers. Its president, David Brennan, who also is chief executive officer at AstraZeneca Plc (AZN), will explain to guests where he believes the focus should lie in improving access to NCD medicines.
PepsiCo Inc. and the International Food & Beverage Alliance are also holding events in New York.
“By the time you’ve got the tobacco, food and pharmaceutical industries swimming around this meeting, you have a recipe for major influence because those boys come with serious checkbooks, power, organizational ability and persuasion,” Deakin University’s Swinburn said.
Alday’s New York-based World Lung Foundation is one of 135 organizations that petitioned the President of the General Assembly and the summit’s coordinators for a code of conduct on how the UN should engage with companies. The Bloomberg Family Foundation is the main donor to World Lung Foundation and supports health programs around the world. The Bloomberg foundation was set up by New York Mayor Michael Bloomberg, founder and majority owner of Bloomberg News parent Bloomberg LP.
Forced Licenses
One of the chief issues in the talks is a proposal backed by G77 countries about allowing drugs still under patent to be made by other suppliers to reduce costs for treatment of epidemics. The U.S. and EU argued for the references to be deleted because it would establish a new interpretation of a 2001 World Trade Organization declaration on Trade-Related Aspects of Intellectual Property Rights.
The EU and U.S. pushed to remove references to “epidemic” to avoid making an implicit link between the declaration and non-communicable diseases. Instead, the revised draft document describes the diseases as “a challenge of epidemic proportions.”
Asked what concern the U.S. has with the word “epidemic,” Andy Laine, a spokesman for the State Department in Washington, said he couldn’t “go into specifics” about ongoing talks.
U.S. Engagement
“The United States remains closely engaged in the negotiations and we look forward to concluding a political declaration that reflects the strong commitment of the international community to pursue the range of actions that will reduce the impact of non-communicable diseases in countries around the world,” Laine said in an e-mail.
The U.S. and EU are trying to put pressure on other governments not to issue compulsory drug licenses, said Frederick M. Abbott, a professor of international law at Florida State University College of Law in Tallahassee.
U.S. and EU drugmakers face slower revenue growth in their home markets as patents expire, allowing competitors to make cheaper versions of their best-selling medicines. They’re looking to emerging markets to expand sales, Abbott said.
“Any compromise on the issue of patents would from their standpoint begin an erosion of their earnings potential,” said Abbott, who advised South Africa when it was sued by 39 drugmakers for making cheaper AIDS medicines available for its people. Compulsory licenses pose a “significant threat to their prospects for long-term profitability on a significant scale,” he said.
To contact the reporters on this story: Jason Gale in Singapore at j.gale@bloomberg.net; Duane D. Stanford in Atlanta at dstanford2@bloomberg.net
By Bret Okeson
bokeson@bloomberg.net