British American Tobacco (Malaysia) has said it will not introduce electronic cigarettes or other reduced-harm products in Malaysia until they are the subject of clear regulations, according to a story in The Edge Financial Daily.
“We are a bit concerned that if we do introduce these products, the regulatory framework would not be as sharp as they should be,” BAT Malaysia MD Erik Stoel told a media briefing after the group’s annual general meeting on April 19.
Guidelines were needed on the excise duties and marketing restrictions that would apply to such products.
“Fundamentally, we think that if we can sell potentially reduced-harm products to consumers in Malaysia then we should,” he said, adding that it was the “right” thing to do.
BAT had launched glo, a tobacco-heating device, in Japan in May last year, and had a “very good product portfolio” in Europe’s strong vaping market, Stoel said.
In 2015, several states in Malaysia banned the sale of e-cigarettes after the National Fatwa (religious edict) Council ruled that vaping was forbidden in Islam.
Introducing such reduced-harm products might be the lifeline needed by tobacco companies in Malaysia, which have seen their market size and subsequently their earnings, squeezed by the market for illegal cigarettes.
Category: Regulation
Reduced risk on hold
E-cig crackdown coming
The US Food and Drug Administration will step up its crackdown on electronic cigarette sales to teens, according to a story by Robert King for the Washington Examiner quoting the head of the agency.
Lawmakers on a House Appropriations subcommittee were said to have grilled FDA Commissioner Scott Gottlieb about ‘excessive’ use of e-cigarettes among young people.
The FDA has the authority ‘to go after’ e-cigarette makers and retailers if they violate a ban on sales to people under 18, but lawmakers questioned if the agency was doing enough.
“I am concerned that FDA’s silence on e-cigarettes could open the door to the next public health emergency,” said Rep. Nita Lowey, D-N.Y.
Gottlieb replied that the FDA would crack down on young people’s use of e-cigarettes in the coming weeks.
The agency has several avenues for targeting retailers that are selling to minors. Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.
Gottlieb said e-cigarettes could offer fewer health risks than traditional cigarettes, but the soaring use among minors was worrisome. A recent study had found that e-cigarette use grew by 900 percent among high school students from 2011 to 2015 [there was no mention of the level of use in 2011].
“We can’t just addict a whole generation of young people onto nicotine,” Gottlieb reportedly said.Listing ingredients
The US Food and Drug Administration has published its revised guidance on the Listing of Ingredients in Tobacco Products.
In a note issued through the FDA’s Center for Tobacco Products, the agency said the guidance was intended to assist manufacturers and importers making tobacco product ingredient submissions to the FDA, as required by the Tobacco Control Act.
The guidance announces that the FDA intends to enforce the ingredient listing submission requirements of section 904(a)(1) only with respect to finished tobacco products and their components or parts that are made or derived from tobacco, or containing ingredients that are burned, aerosolized or ingested during tobacco product use,’ the note said.
‘For example, ingredients of cigarette paper should be submitted to FDA as it is burned during the use of a cigarette and produces constituents that are inhaled by the smoker.’
The note added that, for example, the FDA did not intend to enforce the ingredient listing submission requirement in respect of coils, wicks and mouthpieces.
Information of what components and parts require an ingredient listing submission is at: https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm191982.htm?utm_source=Eloqua&utm_medium=email&utm_term=stratcomms&utm_content=guidance&utm_campaign=CTP%20News%3A%20Listing%20Guidance%20Update%20-%2041318.
The guidance is said to streamline the requirements for manufacturers by clarifying ways in which tobacco product manufacturers or importers can satisfy the ingredient listing requirements by providing one listing that corresponds to multiple products.
‘It explains the statutory requirement to submit a list of all ingredients in tobacco products, who submits ingredient information, what information is included in the submissions, how and when to submit the information, FDA’s compliance policies, and definitions,’ the note said.
The note issued a reminder to manufacturers and importers of ‘deemed tobacco products’ that were on the market as of August 8, 2016, that the deadline to submit ingredient listings is May 8, 2018. For small-scale manufacturers, the deadline was said to be November 8, 2018.Keeping track
Information on data storage and technical standards relating to the EU’s tobacco-products tracking and tracing system has been published in the Official Journal of the EU L 96, dated April 16.
The Journal includes:
1) The EU Commission’s Delegated Regulation (EU) 2018/573 of December 15 2017 on key elements of data storage contracts to be concluded as part of a traceability system for tobacco products;
2) The Commission’s Implementing Regulation (EU) 2018/574 of December 15 2017 on technical standards for the establishment and operation of a traceability system for tobacco products; and
3) The Commission’s Implementing Decision (EU) 2018/576 of December 15 2017 on technical standards for security features applied to tobacco products.
The Journal is at: http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2018:096:FULL&from=EN.Snus ban ‘valid’
The smokers’ lobby group Forest has criticized the opinion of a leading advisor to the European Court of Justice (ECJ) after he deemed the EU ban on the sale of snus to be “valid”.
According to the ECJ’s Advocate General, Saugmandsgaard Øe, the EU legislature “did not exceed the limits of its discretion in concluding that lifting the prohibition on the placing on the market of tobacco for oral use could result in an overall increase in the harmful effects of tobacco within the EU”.
Simon Clark, director of the smokers’ group Forest, said that maintaining an EU-wide ban on snus discriminated against adults who were looking for a safer means of consuming nicotine.
“Tobacco is legal and adults should have the right to purchase a range of products, some of which are less harmful than others,” he said.
“The evidence suggests that snus is not risk free but it’s significantly safer than combustible cigarettes.
“To deny consumers the choice of switching to an alternative, reduced-risk product defies logic or common sense.”
Snus is banned in all EU member states except Sweden, and, according to a report in The Local, snus producer Swedish Match failed in a 2004 attempt to challenge the rules restricting sales and exports of the product. It had since launched a challenge against UK laws preventing the sale of tobacco for oral use, which are in line with the EU’s 2014 Tobacco Products Directive, arguing that the EU legislature had failed since the earlier ruling to ‘take into account development in scientific knowledge’. The High Court of Justice for England and Wales subsequently asked the ECJ to judge whether the prohibition of the product was valid.
In a note posted on its website, Swedish Match said that though the Advocate General had found that the use of snus was less hazardous than smoking cigarettes, he did not recommend the ECJ to find the EU snus ban invalid.
‘In the opinion, the Advocate General gives the EU legislature a very broad discretion in areas which involve political, economic and social choices,’ the note said. ‘He states that in his opinion it is not the task of the Court to assess the scientific evidence submitted in the case but rather recommends that the Court leave such assessments to the EU legislature.’
“We are disappointed with the opinion and hope that the Court will come to a different conclusion in its final ruling,” Marie-Louise Heiman, general counsel at Swedish Match, was quoted as saying. “The reasoning behind the Advocate General’s opinion would severely limit the Court’s assessment of EU legislation. With this reasoning, almost any product could be banned in the EU without a meaningful judicial review.”
The final ruling is expected toward the end of the second quarter or in the third quarter of this year.US suffering flavor blur
The findings of two recently-published studies on the emergence of hookah use in the US indicate that public health officials might need to consider broadening their tobacco prevention efforts beyond traditional cigarettes, according to a story by David J. Hill of the University of Buffalo, US, published on medicalxpress.com.
“Taken together, the results from these two studies underscore the important role hookah has played in the tobacco product landscape,” Jessica Kulak, the lead author on both papers, was quoted as saying. Kulak, PhD, is a postdoctoral fellow in the Primary Care Research Institute of the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo.
Kulak published both papers as part of her dissertation through collaborations with colleagues at the Rutgers University School of Public Health and Roswell Park Comprehensive Cancer Center.
The first study, published in March in the American Journal of Health Behavior, examined patterns and trends of hookah use among public high school students in New Jersey.
The findings were said to have shown significant increases in hookah use across three indicators – those who had ever used hookah, those who were currently using hookah and those who smoked hookah frequently.
Overall, 23.6 percent of New Jersey high school students were found to have ever used hookah in 2014, significantly higher than the nearly 18 percent who reported ever using it in 2008, Kulak and her colleagues reported.
In 2014, past 30-day hookah use (11.8 percent) was said to be as high as e-cigarette use (12.1 percent) and higher than other-tobacco-product use. Among all high school students, frequent hookah use increased from 1.6 percent in 2008 to 2.9 percent six years later.
Kulak and her colleagues cited a variety of factors that might be contributing to the popularity of hookah among teens. For example, hookah tobacco was taxed at a lower rate than were cigarettes, and it was sold in a variety of flavors, many of which had been banned in cigarettes.
Many hookah users believed also that it was not as harmful as other tobacco products.
Kulak’s second dissertation-based paper, also published in March in Substance Use & Misuse, looked at hookah’s role in nicotine product initiation among college students.
For this study, Kulak surveyed 832 college students in Western and Central New York. Among study participants who reported having used a nicotine product at some point, 25 percent said hookah was the first product they had tried. Only combustible cigarettes (39.5 percent) were reported more frequently.
Among students who ever smoked cigarettes, most reported these as their introductory product. Nearly half of the students who had never smoked cigarettes reported that hookah was the first tobacco product they smoked.
This study suggested also that hookah users were less likely than were combustible-cigarette smokers to use multiple tobacco products – such as combustible cigarettes, cigars and chewing tobacco.
Based on the findings of the two studies, Kulak said public health agencies might need to consider revising the surveys and other data collection instruments they used to account more accurately for hookah use.
In addition, she said, there were opportunities for further regulation by the US Food and Drug Administration, especially banning flavors in hookah tobacco.
The full story is at: https://medicalxpress.com/news/2018-04-hookah-critical-role-tobacco-product.htmlBlack or white unattractive?
The government of Sri Lanka is planning to introduce a requirement that tobacco products are sold in standardized packaging, according to stories in The Daily News and The Times.
The Daily News reported that the Cabinet of Ministers had approved an amendment to the National Authority on Tobacco and Alcohol Act that would usher in packaging that, presumably with the exception of health warnings, would be in black and white.
The packs would bear only the name and quantity of the product, and information required by the government, such as health warnings.
Meanwhile, the Times story quoted Cabinet spokesman Dr, Rijitha Senaratne as saying that the standardized packaging would have to be in a single non-attractive color, such as white or black.In support of delay
Pushing the US Food and Drug Administration to regulate quickly on vaping products puts smokers at risk, according to a piece by Sally Satel for the American Enterprise Institute.
Satel, M.D., a practicing psychiatrist and lecturer at the Yale University School of Medicine, described teens and electronic cigarettes as comprising a combustible issue that’s been heating up the headlines lately.
She said it might (or might not) be a simple coincidence that the panicky coverage coincided with a recent lawsuit demanding that the FDA sped up regulation of vaping products. But, orchestrated or not, rushing the FDA to regulate put smokers at risk.
The lawsuit, filed at the end of March by a coalition of seven anti-tobacco groups, including the Campaign for Tobacco Free Kids, the American Academy of Pediatrics, and five individual pediatricians, took aim at a key decision the FDA made last July. The agency pushed back the pre-market application submission deadline for e-cigarettes from August 2018 to 2022.
The plaintiffs want the original deadline re-instated, claiming that the regulatory delay is illegal.
‘I believe that the delay is wise (and note that regulatory agencies routinely change compliance deadlines),’ Satel wrote. ‘The postponement gives the agency and Congress time to replace the burdensome and costly pre-market approval procedure, which would have crippled the vaping industry, with a more efficient regime.
Satel’s piece is at: http://www.aei.org/publication/why-the-panic-over-juul-and-teen-vaping-may-have-deadly-results/Seeking room for smokers
The Czech Constitutional Court is scheduled to rule next week on a draft amendment to the country’s public-places smoking ban that took effect in May last year, according to a CTK National News Wire story relayed by the TMA.
The amendment, proposed by MP Marek Benda of the Civic Democrats would allow hotels and other businesses to create separate smoking areas with their own ventilation systems.
The court chairman and judge rapporteur Pavel Rychetsky has examined the amendment and the court has published the terms of announcement of its decision on its official website.
Despite Prime Minister Andrej Babis rejecting the draft amendment, the Chamber of Deputies or the lower house of Parliament is expected to debate the proposal.
Radio Prague reported in February that eighty-six deputies from eight parties in the Czech Republic’s lower house had put their signatures to Benda’s proposal to loosen the ban on tobacco smoking in public places.
The report noted that as well as proposing the creation within these venues of separate smoking areas, the amendment proposed allowing the owners of bars with an area of 80 square meters or smaller to decide whether to allow smoking or not.
Meanwhile, towards the end of March, Reuters reported that Austria’s lower house of parliament had voted to scrap an impending ban on smoking in bars and restaurants.
The vote was a win for the coalition government and came despite opposition from health campaigners and opposition parties.
At present, large restaurants in Austria are required to provide separate smoking and non-smoking areas, but the rules are reportedly not rigidly implemented. Smaller restaurants need not have a separate area if the owner agrees to allow smoking on the premises.
Now that parliament has approved the bill, it has to be passed by the upper house and signed by the president. It is widely expected to pass in the upper house and to be signed into law.History in the making
A panel event in London, England, yesterday proved the adage that prediction is difficult – especially about the future.
The event, which was staged by the New Statesman magazine in association with Philip Morris International and chaired by Anna Hodgekiss, a freelance health/medical journalist and media consultant, set out to address the question: How long until smoking is history [in England]?
But given that all of the panellists – and possibly most of the 70 guests drawn from the ranks of parliament, the tobacco and cigarette industry, public health, public affairs, think tanks and professional services – seemed to support a harm-reduction rather than a quit-or-die policy, the debate turned largely on how smokers could be encouraged to switch to lower-risk products, such as vapor devices and oral tobacco products.
Nevertheless, Nick Fitzpatrick, an economist and consultant with Frontier Economics, which last year produced a report for PMI entitled: Working towards a smoke-free England, presented some of the findings from that report, one of which had it that the UK government would meet its smoke-free target of reducing the prevalence of smoking in England to five percent by 2040 given the continuation of current taxation policies and regulatory interventions. Fitzpatrick added that the target could be met by 2029 if a number of criteria were fulfilled, including increasing rapidly the number of smokers switching to smoke-free alternatives, such as e-cigarettes.
But these predictions were less important than the debate that they stirred – a debate that PMI has been encouraging since 2016 and one that, while based on an English experience, had universal echoes.
The panellists seemed to agree that there were too many unknowns to predict with any accuracy when smoking might end in England, But there was general agreement that vapor products had made a major step in the direction of encouraging smokers to quit and that they could make a further contribution given that they were the subject of sensible taxation policies that reflected their health impact, sensible, relevant regulation that was not simply moved over from tobacco regulation, and product improvement and innovation.
It would be necessary also to ensure that lower-risk messages were communicated to both smokers and the health care professionals who advised them, many of whom were still reluctant to talk with smokers about using vapor devices, even when those smokers had exhausted other methods of quitting.
The debate threw up the question of what it meant for smoking to be eliminated, and the idea that elimination would have been achieved once the smoking prevalence had been reduced to five percent was questioned. Panellist Mark Littlewood, the director of the Institute of Economic Affairs, pointed out that a five percent threshold, more widely applied, would mean that heroin was not used in the UK. Littlewood pointed out also that the rate of success in encouraging people to quit would be governed in part by a law of diminishing returns as the number of people still smoking was boiled down to a hard core of smokers.
One complicating factor in getting smokers to move to vapor devices was seen as the fact that smokers have different needs. Sarah Jakes, the chair of the New Nicotine Alliance and one of the panellists, told the event that she had switched to a vapor device even though it had not been her intention to do so. She was a smoker who decided to try e-cigarettes so that she could vape while in her car, but she had found that she liked the device to the point where she switched over completely. Littlewood, on the other hand, admitted that he had been unable to find a satisfactory substitute, and while he found heat-not-burn products better than e-cigarettes, he kept drifting back to traditional cigarettes. And another panellist, Dr. Roger Henderson, a general practitioner and smoking cessation expert, in a chilling intervention, told how some diabetics would choose smoking over their legs.
One interesting side issue had to do with the sympathy demonstrated for smokers who did not want to quit or could not quit. Although Henderson was passionate in his opposition to smoking and just as passionate in his support for harm reduction, he believes that in the end a smoker has to decide for herself what she does. If a smoker fully understood the risks she was taking and if she knew what cessation help was available to her but still decided to keep smoking, it was not for other people to tell her how to live her life.
