Category: Regulation

Airy approach to holes
The EU Commission is keeping a watching brief on the question of ventilation holes in cigarette filters; so, as things stand, nothing will happen before 2021 at the earliest.
In May, an article in the Journal of the National Cancer Institute suggested that the US Food and Drug Administration should consider regulating cigarette filter ventilation, up to and including a ban.
It further suggested a research agenda to support such an effort.
A short background to the article said that filter ventilation was adopted in the mid-1960s and was initially equated with making cigarettes safer. But since then, lung adenocarcinoma rates had paradoxically increased relative to other lung cancer subtypes.
Filter ventilation was said to alter tobacco consumption in such a way as to increase smoke toxicants. It was said to allow for elasticity of use so that smokers inhaled more smoke to maintain their nicotine intake. And it was said to cause a false perception of lower health risk from ‘lighter’ smoke.
This led to questions being raised in the EU parliament.
In a preamble to their questions, the Dutch MEP, Gerben-Jan Gerbrandy, and the Belgian MEP, Frédérique Ries, said that, on May 29, the Dutch national newspaper ‘de Volkskrant’ had reported that ventilation holes in cigarettes contributed to an increasing risk of ‘adenocarcinoma’, the most common form of lung cancer.
‘Research from the National Cancer Institute in the US shows a connection between the perforated filter and an increase in this specific type of cancer,’ they said.
‘Based on the findings of the research institute, the ventilation holes in cigarettes could pose a new threat to public health.
‘Moreover, these ventilation holes mislead the measuring equipment that is developed to detect harmful substances in cigarettes.
‘Experts have therefore requested a strict ban on ventilation holes.’
Gerbrandy and Ries went on to ask whether the Commission was aware of the potential health risk of ventilation holes in cigarettes and whether the Commission had taken any action or investigated the issue at an earlier stage?
‘Based on the research findings, does the Commission believe that the European standards for cigarette components and the measurement methods, which are developed to detect harmful substances in cigarettes, should be adapted?,’ they asked.
‘Has the Commission envisaged other steps to further investigate the issue and does the Commission intend to update the current Tobacco Products Directive (2014/40/EU) based on the findings of this research?’
In its written answer, the Commission said it was aware of the risk of the use of ventilation holes by tobacco manufacturers to lower measured values of tar, nicotine and CO emissions (TNCO), such as in so-called “light cigarettes”.
‘Branding such cigarettes as “light, “mild” or “ultra-light” had been shown to mislead consumers since they do not have health benefits for smokers. As a result, the Commission banned such descriptors on cigarette packages in 20011. Instead, TNCO were required to be indicated,’ the Commission said.
‘However, as these values were found not to reflect the actual emissions during intended use, the revised Tobacco Products Directive 2014/40/EU2 discontinued TNCO labelling on cigarette packs.
‘In absence of a gold standard and for the purpose of regulatory continuity, the International Organization for Standardization methodology continues to be used for emission measurement. However, Article 4 of the Tobacco Products Directive gives the Commission delegated power to adapt the measurement methods, based on scientific and technical developments or internationally agreed standards.
‘The Commission and the member states have discussed measurement methods in the Expert Group on Tobacco Policy on several occasions. By 2021, the Commission will report on the application of the Tobacco Products Directive. If appropriate and based on the findings of the report, proposals for amending the directive may be foreseen.’
August 2, 2017
Red-letter day
A US public health expert has described Friday, July 28, as ‘truly a great day for public health’.
This was the day that the Food and Drug Administration announced its Comprehensive Plan for Tobacco and Nicotine Regulation.
‘On Friday, the new FDA Commissioner – Dr. Scott Gottlieb – saved the day for the public’s health by officially embracing a harm reduction approach to tobacco control,’ Dr. Michael Siegel, who is a professor in the Department of Community Health Sciences, Boston University School of Public Health, wrote on his tobacco analysis blog.
‘Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA’s previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.’
Siegel said that, previously, the FDA had lumped e-cigarettes into the same category as tobacco cigarettes and, in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all traditional tobacco cigarettes were exempted.
The old approach, Siegel said, would have destroyed about 99 percent of the existing vaping product market, leading to a major reduction in smoking cessation in the US and with that, an increase in smoking-related morbidity and mortality.
‘Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process,’ he said.
‘At the same time, the FDA will – for the first time – actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms.
‘And, to top it all off, the agency will consider – also for the first time – actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.’
Siegel, in fact, foresaw the possibility of Friday’s announcement by the FDA. Writing on his blog in November, he said that, from a public health perspective, there were many reasons to be concerned about the outcome of the US presidential election. ‘However, there is one reason to potentially be encouraged,’ he said. ‘With a Trump presidency, and with Republican control of the Senate, we ironically have a tremendous opportunity to once and for all craft a sensible regulatory strategy for electronic cigarettes and vaping products.’
Siegel’s blog is at: http://tobaccoanalysis.blogspot.co.uk/.
August 2, 2017
Earnings hit in Indonesia
The earnings of Indonesia’s listed cigarette producers are expected to remain under pressure for the remainder of this year, according to a story in Indonesia Investments.
The companies, the story said, would face big challenges this year from fierce competition for market share, from rising taxes and from anti-tobacco regulations.
Of the four publicly-listed cigarette manufacturers in Indonesia, only Gudang Garam had reported growing net sales and profit during the first half of the year. HM Sampoerna and Wismilak Inti Makmur had seen their sales and net profits decline, while Bentoel was yet to release its results.
A finance ministry regulation from January 1 pushed the value-added tax on cigarettes up to 9.1 percent. And later that month cigarette excise tax was increased by an average of 10.54 percent.
August 2, 2017
Qualified support for FDA
A US senator has decried the electronic-cigarette provisions of the Food and Drug Administration’s Comprehensive Plan for Tobacco and Nicotine Regulation, which was announced on Friday.
“The tobacco industry produces products that kill thousands of Americans each year, and sustains itself by recruiting ‘replacement smokers’ by marketing to young adults,” Oregon’s Senator Jeff Merkley, the top Democrat on the Senate Appropriations Subcommittee overseeing the FDA, said in a statement posted on his website. “That’s why we were hoping to hear a strong plan from the FDA today [Friday].
“Unfortunately, the FDA instead announced that it will allow e-cigarette products, largely aimed at children, to remain on the market for five more years with very little regulation.
“According to the CDC’s [Center for Disease Control and Prevention] latest data, 20 percent of high school students, and seven percent of middle school students – 12 and 13 year old kids – use e-cigarettes. And they use it [sic] because they have names like ‘cotton candy’, ‘froot loops’ and ‘gummy bear’. These are not products targeted towards adults. “While the FDA’s goal of reducing the level of nicotine in traditional cigarettes is an important and admirable goal, it does nothing to address the growing threat of e-cigarette usage. Thousands more children will become addicted during this time, and everyone who cares about America’s youth should be deeply concerned by this decision.”
Meanwhile, the American Heart Association (AHA) has said that while the FDA’s move to lower nicotine and examine flavoring comprise a promising step, the Deeming Rule delay is disappointing. It is concerned, also, that the FDA has raised the possibility of exempting premium cigars in the future.
“FDA’s move today to lower nicotine levels and take a harder look at how flavored tobacco products attract the young is to be commended,” said AHA CEO Nancy Brown.
“However, the Association is disappointed with the agency’s decision to delay certain e-cigarette and cigar compliance deadlines. Altering the deadline for FDA review of e-cigarettes and cigars is a troubling step and one that we will closely monitor.
“We are also concerned that the FDA has raised the possibility of exempting premium cigars in the future. Tobacco in any form presents risk. That’s why we have advocated for – and will continue to insist – that FDA oversight of all tobacco products is absolutely essential. Premium cigars are no different. Cigars are a concern because high school-aged males now smoke them at a higher rate than [they smoke] cigarettes. As we have seen in recent Senate legislation, often the definition for ‘premium cigars’ creates a loophole that allows the flavored and cheap cigars that attract youth to qualify as ‘premium’. Weakening the deeming rule in any way could lead to an increasing number of Americans at risk for heart disease, stroke or even an early death due to tobacco use.
“As the FDA carries out its new nicotine and tobacco plan, we urge the agency to remember that protecting public health, particularly the health of young people in this country, should be at the very top of its priority list. While we look forward to agency actions that can lower the number of Americans exposed to the harms of combustible tobacco, the FDA must advance all tobacco regulation. We must not take two steps forward and then one step back.”
The 22nd Century Group welcomed the FDA’s announcement. The group said that it was ‘uniquely positioned to deliver on the new product standards’ given that its proprietary “Very Low Nicotine” cigarettes contained less than 0.6 mg nicotine per piece and yielded less than 0.05 mg nicotine per piece. These levels represented a nicotine reduction of at least 95 percent relative to the levels of other cigarette brands.
The group said its tobacco was grown on ‘independently-owned farms in US, and was not subjected to any ‘artificial extraction or chemical processes’.
It was the only company globally that was capable of growing tobacco with non-addictive levels of nicotine.
The cigarettes produced from this tobacco, it added, had the ‘taste and sensory characteristics of conventional cigarettes’.
August 1, 2017
HNB status unclear
Two months after a smoking ban came into effect in pubs and restaurants in the Czech Republic, smokers are getting acquainted with heat-not-burn (HNB) products that they might be able to use in public places, according to a Radio Prague story.
The Czech authorities have yet to classify heat-not-burn products, which contain but do not burn tobacco, and that deliver nicotine in a vapor rather than in smoke.
“What is important is that the tobacco does not burn –it is merely heated to 300 degrees Celsius which means that there is no smoke and no ash, and you cannot smell it as much as normal cigarettes,” Philip Morris’ Klára Jirovcová Pospíšilová was quoted as saying.
Radio Prague said that HNBs first appeared on the Czech market in 1988, but that they were not a commercial success.
‘At the time, they were no match for the classic cigarette, but with tough anti-smoking laws in force around Europe, tobacco companies are hoping HNBs will see new opportunities opening up,’ Radio Prague reported.
‘Some countries in Europe, such as Poland, Hungary and Spain, have already issued a tough ban on HNBs, putting them on par with regular cigarettes, but others like the Czech Republic have yet to lay down the rules for these products.’
The Czech Health Ministry says the smoking ban should apply to HNBs, but others claim that under Czech law they would fall into the same category as electronic cigarettes, which are not banned in pubs and restaurants.
Meanwhile, it has not been decided at the EU level how to tax HNB tobacco products and the Czech Finance Ministry has yet to address the issue.
For the time being, HNBs are exempted from consumer tax in the Czech Republic, which gives them an enormous advantage over traditional cigarettes.
An amendment to Czech law is expected to clarify the status of HNBs by 2019.
August 1, 2017
Illegal trade targeted
The trade association representing the UK tobacco industry yesterday launched a campaign targeting the illegal tobacco trade across some of the busiest transport hubs in the UK, key transports routes in and out of the country and online.
‘The campaign which builds on previous TMA [UK] activities seeks to challenge the flows of non-UK duty paid tobacco from known high-risk routes into the UK which is then sold on illegally in a variety of ways,’ said a TMA press note.
‘Research shows that this ranges from simply selling on to friends and family or by more sophisticated means such as through the use of retailers, social media and community websites.
‘The TMA is therefore extending its campaign activities to focus on such online platforms used for the sale of illegal tobacco as well as known transport routes used to bring non-UK duty paid tobacco into the UK.’
The campaign, which will run during the summer, will target, for instance, airports, ports, international coaches, websites and social media platforms.
The TMA said it was advising adult consumers to adhere to the government guidelines and only bring tobacco into the UK for personal use, because the consequences for doing otherwise could be severe.
And it said it was advising smokers not to buy illicit tobacco products from online sources because in doing so they could be aiding organised crime.
“As people travel to and from the continent over the summer holidays, we are taking this opportunity to remind them with this new campaign that it is illegal to bring back tobacco from overseas and then sell it on in the UK,” said Giles Roca, director general of the TMA.
“Reselling tobacco bought overseas is not a victimless crime. This practice affects many hard-working independent shopkeepers who are deprived of legitimate tobacco sales and related footfall.”
August 1, 2017
Nicotine takes Center stage
Altria on Friday described the US Food and Drug Administration’s Comprehensive Plan for Tobacco and Nicotine Regulation as an important evolution in the Agency’s approach to regulating tobacco products and a meaningful step forward in developing a comprehensive regulatory policy that acknowledges the continuum of risk.
‘We supported FDA regulation because, among other things, it created a framework for communication about reduced harm products,’ the company said in a note posted on its website. ‘Reconsideration of the rules and timelines for newly deemed products is an important and timely step in this effort.
‘The process outlined by the [FDA] commissioner today will allow all stakeholders the opportunity to participate in a science and evidence based regulatory framework which is “transparent, predictable, and sustainable”.
‘It’s important to understand that any proposed rule such as a nicotine product standard must be based on science and evidence, must not lead to unintended consequences and must be technically achievable. Establishing a standard of any sort is a deliberative process, with multiple opportunities for interested parties to provide perspectives. We intend to be fully engaged throughout this process.’
In announcing its plan, the FDA said it would serve as a multi-year roadmap to better protect young people and significantly reduce tobacco-related disease and death.
The approach placed nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts, the FDA’s Center for Tobacco Products (CTP) said in a press note. The goal was to ensure that the FDA had the proper scientific and regulatory foundation efficiently and effectively to implement the Family Smoking Prevention and Tobacco Control Act.’
“Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground,” said FDA Commissioner Dr. Scott Gottlieb.
Among other aspects of the comprehensive approach, the FDA plans to:
- ‘Issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. This will help begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.’
- ‘Extend timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of Aug. 8, 2016. This will allow the agency to further examine how existing regulatory science can encourage innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. Under the expected revised timeline, the application deadlines for newly-regulated products would be as follows: combustible products, such as cigars and hookah tobacco, Aug. 8, 2021; non-combustible products, such as ENDS or e-cigarettes, Aug. 8, 2022.’
- ‘Further explore how best to protect public health in the evolving tobacco marketplace by issuing two ANPRMs to seek input from the public on a variety of significant topics, including: ‘The role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery’; and ‘The patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule’.
The FDA’s announcement was generally positively received, though it was acknowledged that some devils could lie lurking in the details.
The R Street Institute welcome the FDA announcement saying it would postpone a regulation, previously set to take effect this fall, that would have forced manufacturers to get agency approval for tobacco and nicotine products introduced to the market after February 2007. This costly process would, in practice, have resulted in the near-complete elimination of harm-reduction tools such as electronic cigarettes from the market.
R Street’s harm reduction policy director Carrie Wade said the FDA’s plans should be considered an important first step to reorient FDA regulation of tobacco products from a process designed to protect the sales and profits of the major cigarette makers to one designed to reduce tobacco-related addiction, illness and death.
“R Street has been one of the leading proponents of a harm-reduction approach to cigarette addiction, so to read today’s [Friday’s] announcement feels like vindication that someone is listening,” Wade said. “It’s taken a little while, but it seems the FDA is beginning to realize something the scientific community woke up to years ago: policies aimed at destroying the e-cigarette market actually would result in the unintended consequence of more smokers sticking with traditional combustible cigarettes.”
Jeff Stier, the director of the Risk Analysis Division of the National Center for Public Policy Research, said he applauded Gottlieb and the CTP for making sweeping changes to the Obama-era approach to tobacco regulation that would have effectively banned almost all e-cigarettes on the market today.
“The most significant change is that the FDA’s regulatory approach will now seek to implement a ‘tobacco harm reduction’ approach, recognizing that there’s a continuum of risk among different nicotine products,” he said.
“In other words, it will not impose onerous deadlines and ill-defined requirements for so-called pre-market tobacco applications.
“The FDA will first develop clear, science-based product standards before manufacturers would be required to submit applications.
“The FDA will now begin to develop new rules which will recognize that non-combustible lower-risk products such as e-cigarettes and next generation ‘heat not burn’ products should no longer be treated solely as public health threats. The FDA will instead embark on a rule-making process whereby the products will be regulated based on their risk profile. This approach, if implemented properly, will foster a robust market offering a range of options to smokers who wish to reduce the risk from smoking.”
Alex Clark, the CEO of the Consumer Advocates for Smoke-free Alternatives Association (CASAA) described the FDA plan as a positive step forward in preserving consumer access to low-risk vapor products. Most importantly, it said, the forthcoming guidance from the FDA would play a vital role in reducing harm for millions of Americans who continued to smoke and would benefit from honest information about low-risk alternatives to combustible tobacco.
“Delaying the deadline for pre-market tobacco applications from vapor product manufacturers is an important first-step.” said Alex Clark, CASAA’s CEO.
“CASAA and our membership have been asking for this delay since March as it allows science, genuine public health, and consumer needs – rather than ideology – to contribute to developing reasonable and achievable regulation of low-risk nicotine products.
“Too much of the current legislative and regulatory efforts are born out of fear and misinformation. As a result, policymakers and regulators are losing sight of the most important goal – reducing the harm from traditional combustible tobacco products.”
The Vapor Technology Association focused on the FDA’s granting of a four-year extension of the deadline for Premarket Tobacco Applications for electronic nicotine delivery systems (ENDS) until August 8, 2022. “This decision is a victory for science-based regulation and for public health,” said Tony Abboud, VTA’s executive director.
“By recognizing that US policies need to evolve to the current state of science which demonstrates that ENDS products are at least 95 percent safer than combustible cigarettes, FDA is taking a big step forward in protecting public health by acknowledging for the first time that ENDS are a harm reduction product and need to be regulated as such.
“By delaying the deadline for compliance for electronic nicotine delivery systems, FDA has also recognized that the current regulations have halted the kind of technological innovation that is key to ending this country’s reliance on combustible cigarettes, and that we need to implement clear and meaningful regulations that strike the right balance between consumer protection and fostering innovation.”
But not everyone agreed. Matthew L. Myers, resident of the Campaign for Tobacco-Free Kids, said the sweeping tobacco regulatory agenda proposed by Gottlieb represented a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and the death and disease it caused in the US. “Critical to his vision is his recognition that the components of his proposal need to work together as ‘a package deal – ‘it is really all or nothing,’ as he put it,” Myers said in a statement.
“At the same time, it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products.
“This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight. There is no reason to allow these products to stay on the market while developing and implementing the comprehensive strategy Dr. Gottlieb outlined today [Friday].”
July 31, 2017
Smoking ban opposed
Legislation aimed at banning public-places tobacco-smoking in Japan is in limbo because of disagreement between the health ministry and the ruling Liberal Democratic Party, according to a story by Yumiko Doi and Miyuki Wakabayashi Kyodo for the Japan Times.
After an attempt to submit the bill to the Diet failed earlier this year, the Health, Labor and Welfare Ministry is reportedly hoping to submit such a bill to an extra session of the Diet that is expected to convene this fall.
The Times piece said that though Japan was to host the 2020 Olympics and though it lagged many of its peers in taking steps to eradicate passive smoking, the prospects for a legislative compromise were dim.
“We were unable to hold sufficient science-based discussions,” health minister Yasuhisa Shiozaki was quoted as saying after the Diet session ended earlier this year.
Shiozaki, who belongs to the LDP but is a key proponent of curbing second-hand smoking, read out a three-page statement explaining how Japan fell short in this area and what measures were needed.
The health ministry in October 2016 proposed imposing an indoor smoking ban on restaurants that would have allowed them to set up smoking sections, but many of the LDP’s politicians protested against the idea.
Tobacco farmers are traditionally major LDP supporters, and the party has a 280-strong group that lobbies heavily for smoking rights.
At a meeting of the LDP’s health policy board in February, one member said, “I have been smoking for more than 50 years but I’m healthy”, while another said, “Car exhaust is more harmful”.
The ministry made a concession and submitted a new proposal in March that suggested exempting small bars with up to 30 m² of floor space from the proposed indoor smoking ban.
The LDP countered that the exemption should be expanded to restaurants and bars of up to 150 m²on condition that they put up signs saying smoking was allowed, or if they set up separate smoking areas. But this would have effectively left most of the nation’s restaurants exempt.
The Japan Society for Tobacco Control and its supporters have begun a petition to urge Prime Minister Shinzo Abe to retain Shiozaki as health minister when he reshuffles his Cabinet as expected in early August.
Without Shiozaki in the Cabinet, “the party will take the initiative and water down the measures” to counter second-hand smoking, an LDP lawmaker said.
July 31, 2017
Ready for display ban
Days before a rule banning the display of tobacco products comes into force in Singapore, most – but not all – stores selling cigarettes told Channel NewsAsia they had done what was necessary to ensure they meet regulations.
As part of the new requirements, tobacco products must be out of the public’s view at all times, except during restocking or during a transaction.
Operators of a large proportion of supermarkets and convenience stores said most, if not all, of their outlets had been installed with opaque cabinets to store cigarettes when the regulation came into force on August 1.
But Channel NewsAsia reported also that when it visited provision shops ‘in the heartlands’ on July 25, some were taking a more casual approach, with no designated cabinets in sight.
Dairy Farm, which operates supermarkets such as Giant, Jasons and Cold Storage, and convenience stores, said all its stores had installed grey or white opaque cabinets ahead of the deadline. The cabinets were fitted with auto-close mechanisms.
It said cigarettes were sold at all 7-Eleven stores, and most Cold Storage and Giant outlets.
In addition to installing the cabinets, Dairy Farm said staff had been trained to ensure they were aware of the new rules. “Training and briefing sessions on the new rulings and internal standard operating procedures have been conducted for all staff across all banners to ensure they understand the new rules and to help them to manage customer queries,” a spokesperson told Channel NewsAsia.
July 31, 2017
Beijing sales down
The number of cigarettes sold in Beijing during 2016 fell by eight percent year-on-year, according to a story by Wang Xiaodong for the China Daily citing a report on the health of the city’s population released by the Beijing municipal government on Wednesday.
This was said to have been the biggest decline in recent years.
The incidence of smoking among people aged 15 or older last year stood at 22.3 percent, a drop of 4.7 percentage points from that of 2014.
The number of smokers had decreased by about 200,000, the report said.
The number of cigarettes sold in Beijing last year reached 93.8 billion, the report added, citing the Beijing Bureau of Statistics.
In introducing a public-places tobacco-smoking-ban in June 2015, Beijing was said by Wang Xinmei, a member of the Shanghai Municipal Committee of the Chinese People’s Political Consultative Conference, Shanghai’s political advisory body, to have done a good job.
Wang, who was comparing the performances of Chinese cities in introducing bans, pointed out that on all flights and trains bound for Beijing there had been repeated broadcasts informing people about the smoking ban.
That was a powerful message from which Shanghai could learn, said Wang.
July 28, 2017