The Japanese government said yesterday that it planned to restrict tobacco smoking in indoor public places but that it would not impose a ban, according to a story in The Japan Times.
Under the plan drawn up by the health ministry, restrictions on the use of heat-not-burn products would be less stringent than those on combustible cigarettes.
Smoking would be banned in hospitals, schools, universities and government offices, and minors would be prohibited from entering smoking areas.
Smoking would be permitted in restaurants and bars only within special rooms set aside for the exclusive use of smokers. The serving of food or drink would not be allowed within these rooms.
However, discussions are taking place about whether some restaurants and bars might be exempted from the requirement to establish separate smoking areas.
The use of heat-not-burn products too will be restricted to specially-designated rooms within restaurants, though in this case it will be permissible for customers to eat and drink.
Currently, facility operators are required only to ‘make efforts’ to prevent passive smoking.
The ministry plans to submit its tobacco-control bill to the Diet in March, and implement the legislation in stages in advance of the 2020 Tokyo Olympic and Paralympic Games.
The ministry originally planned to introduce a tougher ban, but was said by the Times to have backed down in the face of opposition from the Liberal Democratic Party (LDP) and ‘industries’.
A senior ministry official was quoted as saying that it would be difficult to introduce restrictions that disregarded smokers. “We need to take a first step,” the official said.
Category: Regulation
Japan inches toward ban
E-cig rules challenged
US Food and Drug Administration rules threatening the survival of the US’ independent electronic-cigarette industry could be overturned if a new lawsuit filed by the non-profit Pacific Legal Foundation proves successful, according to an op-ed piece by Guy Bentley for the Washington Examiner.
Bentley said that the FDA’s ‘deeming rule’, which was issued in 2016, brought e-cigarettes under the agency’s regulatory control, subjecting them to the same kinds of marketing restrictions as those governing tobacco cigarettes.
Even to get approval for sale, vapor products would have to be taken through a prohibitively expensive pre-market approval process, and Bentley predicted that most e-cigarettes would disappear from the market by 2022, when product applications were due.
And the manufacturers of those products that did get through the application process would face an even greater battle to be allowed to make straightforwardly factual statements about their products to consumers.
‘Thanks to this regulatory mess, by 2022 we could face the bizarre situation where cigarettes, which kill half of their lifelong users, remain abundant and new cigarettes can come to market with ease but products that are safer and help people quit smoking will be regulated out of existence,’ said Bentley.
‘But this outcome is not inevitable, with the deeming rule’s facing a fresh legal challenge.
PLF’s lawsuit against the FDA argues the deeming rule is unconstitutional and threatens individual liberty.’
Bentley (@gbentley1) is a contributor to the Washington Examiner’s Beltway Confidential blog. He is a consumer freedom research associate at the Reason Foundation and was previously a reporter for the Daily Caller.
His piece, which includes details about the PLF’s key arguments, is at: http://www.washingtonexaminer.com/fda-sued-over-unconstitutional-rule-that-threatens-e-cigarette-businesses/article/2647532.PMI: review continuing
Philip Morris International has made the point that the ‘careful review’ by the US Food and Drug Administration of the Modified Risk Tobacco Product (MRTP) applications for PMI’s heated tobacco device IQOS is continuing.
On January 24 and 25, the Tobacco Products Scientific Advisory Committee (TPSAC) carried out, at the request of the FDA, an investigation into the scientific issues related to these MRTP applications and broadly recommended that they be rejected.
On a note posted on its website yesterday, PMI said that experts from PMI and Philip Morris USA Inc. had presented to the TPSAC meeting.
‘The meeting was part of the FDA’s review of PMI’s request to commercialize IQOS in the US as a “Modified Risk Tobacco Product”,’ the note said. ‘US law and policy recognize product innovation as important to the 40 million American men and women who smoke.
‘To advise the agency on PMI’s applications, the committee covered a wide range of scientific, technical, and consumer-communications topics. It raised questions and probed the likelihood and magnitude of potential benefits as well as how best to address possible unintended use.
‘Although the Committee did not agree with some of the specific language of proposed risk and harm consumer communications, it confirmed that the evidence supported the statement that switching completely to IQOS significantly reduces exposure to harmful chemicals.’
Meanwhile, PMI’s CEO, André Calantzopoulos (pictured), described the committee’s two-day discussion as a milestone event. “We thank the agency and the committee for their interest in our scientific dossier and our determination to enable adults who smoke to have access to and information about better alternatives,” he was quoted as saying. “I am deeply grateful to my colleagues for their exceptional work on our application to the FDA and for the presentations last week. Our science and the commitment of our people give me confidence that we will realize our vision of a smoke-free future.”
The PMI note said that the company believed the committee’s interactions with presenters and its discussion reflected respect for PMI’s scientific data and commitment to bring IQOS to the US.
‘The Committee delved into such areas as inferences about long-term health outcomes, quantification and comparison of risk, the best way to formulate consumer information, and areas for post-market surveillance,’ the note said. ‘At the end of the meeting, the members of the committee discussed and voted on particular questions on which the agency requested the committee’s views. TPSAC recommendations and votes are not binding on the FDA.’
Calantzopoulos said that as a next step, PMI looked forward to working with the FDA to clarify outstanding points so as to best assist in the agency’s ongoing decision-making process, which inherently entailed a certain degree of scientific uncertainty pre-market. “As the FDA routinely does with regard to the many products it regulates, I believe the agency will ultimately address that uncertainty in the best interest of people who smoke,” he said.
PMI has submitted also a Pre-Market Tobacco Application (PMTA) to the FDA which, if granted, will permit the commercialization of IQOS in the US without modified risk messages. This application was not before the committee because it follows a separate regulatory pathway.
Under agreements with PMI, PM USA is licensed to sell IQOS in the US should PMI receive a PMTA marketing order from the FDATrading rights under threat
The Indian government is asking the Supreme Court to apply a rarely-used classification to the tobacco industry that would strip it of its legal right to trade, according to a Reuters story.
The move is said to be aimed at deterring tobacco companies from challenging new regulations.
But the government reportedly is not seeking to ban tobacco.
According to a Reuters review of a previously-unreported court filing by the Health Ministry on January 8, India’s top court is being asked to classify tobacco as res extra commercium, or a thing outside commerce.
If applied, the classification would have far reaching implications in denying the industry’s legal standing to trade and in giving authorities more leeway to impose restrictions.
The Supreme Court’s application of the classification to the alcohol industry during the 1970s paved the way for at least two Indian states to ban alcohol completely and provided for stricter regulations.
R. Balasubramanian, a government lawyer who is acting on behalf of the Ministry of Health in pursuing the classification implied that the effects on the tobacco industry would be greater than they were on the alcohol industry. “It will be a fillip to this drive against tobacco,” he said.
Balasubramanian said, however, that the government was not discussing banning tobacco and the goal of invoking the classification was only to curtail the industry’s legal rights.Graduated smoking fines
Tobacco smoking will be banned in public places in Armenia under a bill proposed by the Ministry of Health, according to a story in The Jam News, Yerevan.
However, it wasn’t clear whether or not the ban would spill over into private spheres as well. The story described fines for smoking in cars, as distinct from smoking in public transport vehicles, though it was possible these ‘cars’ referred to work vehicles.
The ban is part of a new anti-smoking strategy adopted by the government in August. The strategy is aimed at reducing ‘smoking rates by 30-40 percent’.
“Over 55 percent of adult men and three percent of women in Armenia are regular smokers,” said the Minister of Health, Levon Altunyan. “Therefore, we propose a ban on smoking in public places.
“There won’t be separate smoking areas in restaurants because the aim of this anti-smoking measure is to ensure that nobody smokes at all rather than just to prevent smoking in the presence of non-smokers.”
Nevertheless, special outdoor facilities will be made available for smoking.
Under the bill, smokers would be fined an amount based on the place where they were found smoking; so those found smoking in a car would face a fine of AMD50,000 (US$104), while those found smoking on public transport or in a taxi would be liable to a fine of AMD100,000 (US$208), and those found smoking in an elevator, café or office would face a fine of AMD250,000 (US$520).
Meanwhile, cigarette retailers who sell loose cigarettes will face a fine of AMD300,000 (USD 624), while those who sell cigarettes within 100-meters of schools would be liable to a fine of AMD500,000 (US$1,040).
Employers who fail to display a ‘no smoking’ sign in their workplaces will face a fine of AMD100,000, while those who fail to ban smoking will be liable to a fine of AMD500,000.Ban has a silver lining
Kenya’s ban on shisha has opened up further opportunities for sales of electronic cigarettes, according to a story in Citizen Digital.
Now more than ever, electronic cigarettes and vaping are being popularized in Kenya as netizens share their vaping videos on social media.
Speaking to Citizen Digital, a Kenyan vape retailer reportedly said that e-cigarettes had always been available locally, but that the banning of shisha had opened new opportunities. Retailers were importing more vapes as a preferable alternative for a hungry smoking market.
“The vapes are now on a higher demand because with it you can smoke anything you want, from soft drinks, beverages, tobacco, liquid shisha and even liquid marijuana; it is a safer option compared to smoking shisha from a pot,” said the retailer.E-cig ban coming
From February 1, it will be illegal in Singapore to buy, use or possess ’emerging and imitation tobacco products’, according to a story in The Straits Times.
The definition of emerging and imitation tobacco products apparently takes in any device or article that resembles a tobacco product, including vaporisers such as electronic cigarettes, electronic pipes and electronic cigars.
And it takes in too smokeless tobacco products and shisha.
Under amendments to the Tobacco (Control of Advertisements and Sale) Act, anyone caught buying, possessing or using such products can be fined up to S$2,000, the Ministry of Health (MOH) said in a statement today.
Currently, only the importation, sale and distribution of such products are illegal, with those found guilty of such activities liable to be jailed for up to six months and/or fined up to $$10,000. Repeat offenders risk being hit with double those penalties.
In addition, the amended act will gradually raise the minimum legal age for the purchase, use, possession, sale and supply of tobacco products from 18 to 21.
The age limit will be raised from 18 to 19 on January 1; to 20 on January 1, 2020, and to 21 on January 1, 2021.
The ministry of health said it remained committed to lowering the prevalence of smoking in Singapore ‘through a comprehensive, multi-pronged approach.
This approach included imposing restrictions on tobacco advertising and promotions, offering smoking cessation services, using fiscal policies such as taxes, and providing public education on the harms of tobacco use.An unusual case
A court in China’s Henan Province on Tuesday overruled an appeal filed by the family of a smoker who died of a heart attack after an argument with a man who had asked him to stop smoking in a lift, according to a Xinhua Newswire story.
The Intermediate People’s Court of Zhengzhou found that the behavior of the defendant Yang Jun was lawful and was aimed at safeguarding the public interest.
The court overruled earlier findings, rejected the plaintiff’s compensation claim, and asked the plaintiff to pay litigation costs of more than 14,000 yuan (about US$2,180).
The family of the elderly smoker had claimed more than 400,000 yuan from Yang following the incident in May, alleging that the argument had played a role in triggering the heart attack.
In September, the People’s Court of Jinshui District ruled that Yang’s behavior had not led to the death of the smoker but ordered Yang to pay compensation of 15,000 yuan to the family.
The family appealed against the court’s decision to the Intermediate People’s Court of Zhengzhou City. The court heard the appeal in November but pronounced the final judgement on Tuesday.
The Xinhua Newswire story said the case had attracted nationwide attention with many people criticizing the initial ruling against Yang and welcoming the final judgement.
Although there is no national law on indoor smoking in China, a 2011 regulation banned smoking in indoor public spaces including lifts.
But as of 2016, 18 cities, including Beijing, Shanghai and Shenzhen, had imposed smoking bans.
“Everyone, smoker or non-smoker, has the right to ask smokers to stop smoking in public venues,” said Jiang Yuan, an officer with the Tobacco Control Office, which operates under the Chinese Center For Disease Control and Prevention.
“The final ruling is support for national tobacco control and for those who get up the courage to say no to second-hand smoke.”New approach suggested
Imperial Tobacco Canada has said it believes that Health Canada can achieve the goal of reducing Canada’s smoking rate to less than five percent ahead of the target date of 2035.
It could do this, it added, by embracing the principles of harm reduction: by allowing smokers to choose alternatives to cigarettes, such as vaping and tobacco-heating products.
Imperial yesterday issued a statement to mark National Non-Smoking Week.
‘Tobacco Heating Products (THPs) and vaping products are battery-powered devices that do not use combustion to deliver nicotine, with the consumer instead inhaling vapor, not smoke,’ the statement said. ‘The vast majority of toxicants in cigarette emissions are the product of combustion, and with no combustion, the result is far fewer toxicants.
‘A report by the UK Royal College of Physicians states that because “most of the harm caused by smoking arises not from nicotine but from other components of tobacco smoke, the health and life expectancy of today’s smokers could be radically improved by encouraging as many as possible to switch to a smoke-free source of nicotine”.’
“In order to provide smokers with options between cigarettes and other alternatives – with no combustion and therefore potentially less risk – it is essential that Canada introduces regulations that can communicate their harm reduction potential,” Eric Gagnon, head of corporate and regulatory affairs, was quoted as saying. “With a reasonable and sustainable regulatory framework that supports harm reduction and next generation products, the federal government can reduce the public health impact of tobacco.”
Imperial said that the sale of nicotine-containing vaping products was currently illegal in Canada unless they had been approved by Health Canada. And since none of the products currently on the Canadian market had been approved, they were all illicit.
‘Bill S-5, which is currently before the House of Commons, seeks to legalize and introduce a regulatory framework for vaping products,’ Imperial said in its statement. ‘The Bill’s resulting regulations will have a significant impact on smokers who may choose to migrate from traditional cigarettes to smoke-free products.
‘Some governments, including that of the UK, have already taken a pragmatic approach to some of these new products and are actively providing smokers with proper information.’
“As part of the world’s largest and most international tobacco and nicotine company, we understand the complex needs of smokers, and this is why our company has invested more than US$2.5 billion since 2012 to develop a range of next generation products (NGPs) such as vapor and tobacco heating products,” said Gagnon. “It is crucial that the federal government changes its current approach toward NGPs to allow adult smokers to choose potentially less harmful products if they wish.”
Imperial said that the expiry of the Federal Tobacco Control Strategy in March 2018 would present an additional opportunity for the federal government to recognize how embracing harm-reduction principles could achieve its five percent goal, rather than adding more radical and ineffective control measures on tobacco products that only served to fuel the further growth of illicit tobacco.
“To lower the smoking rate, Canada should focus its efforts on building consumer awareness of less-risky alternatives to smoking, and crack down on the illegal tobacco industry that continues to grow and supplies more than 20 percent of the market with unregulated and untaxed cigarettes,” said Gagnon.E-cig, HNB excise opposed
The EU Commission believes that excise tax should not be applied to electronic cigarettes or heat-not-burn (HNB) products, according to a story by Sarantis Michalopoulos for euractiv.com.
Given the tobacco market’s shift away from traditional tobacco and toward new generation products such as e-cigarettes and HNB devices, and in the light of new developments in the illegal tobacco trade, the EU Council asked the Commission in March 2016 to come up with a proposal on the revision of the Tobacco Excise Directive.
This legislation sets out harmonised rules on the rates of excise duty applied to manufactured tobacco across the EU.
E-cigarettes and other novel products are not covered by the directive and the member states asked the Commission to conduct a study to explore the possibility of imposing excise taxes on them.
But, due to the availability of only limited data on these products, the Commission decided not to propose a harmonised approach until further information was available.
The Commission said that it would re-examine the situation in the next regular report on tobacco taxation, which is due in 2019.
