A Netherlands-based anti-tobacco coalition comprising ex-smokers and medical associations is threatening to bring legal action to ban cigarettes that exceed ‘European norms for nicotine, tar and carbon monoxide,’ according to a story in DutchNews.nl relayed by the TMA.
Tests performed on 100 brands of cigarettes, the results of which were published by the Dutch public health institute RIVM in June, were said to have found that ‘the amount of tar can be up to 26 times the official norm’, while ‘nicotine and carbon monoxide levels were also high’.
The tests were carried out with the ventilation holes in the cigarette filters covered, whereas the official government test leaves these holes uncovered, which allows more environmental air – and therefore less smoke – to enter the testing machine.
Both the RIVM and the health and safety watchdog NVWA had previously pulled out of a commission which designed the European measuring method because 10 of the 12 members worked in the tobacco industry.
Philip Morris and British American Tobacco said their cigarettes complied with European norms and national Dutch legislation regarding tobacco.
“[T]he European test was never meant to measure “actual exposure” of smokers to tar, nicotine and carbon monoxide,’ said Peter van den Driest, spokesperson for Philip Morris. ‘It was meant to enable to compare brands of cigarettes that are smoked in an identical way.’
The coalition said that if the safety watchdog NVWA failed to enforce the tobacco legislation, it would go to court.
This issue has been the subject of at least one question posed to the European Commission. Last month, in answer to one such question, the Commission said that it was aware of the limitations of currently available methods for the measurement of cigarette deliveries of tar, nicotine and carbon monoxide.
It said that this issue was carefully considered during the revision of the Tobacco Products Directive (TPD) and that it was concluded there was insufficient evidence that would support the revision of the existing provisions.
The Commission said the results presented recently by the RIVM were in line with the measurements conducted by Hammond et al. in 2006, which indicated that ‘none of the smoking regimens currently in use adequately “represent” human smoking behaviour and none are significantly associated with measures of nicotine uptake among human participants’.
‘As the Commission pointed out in its replies to written questions E-003557/2017 and E-001317/2018, Article 4(3) of TPD empowers the Commission to adopt delegated acts to adapt the measurement methods, based on scientific and technical developments or internationally agreed standards,’ the Commission said. ‘The Commission will report on the application of the TPD by 2021.’
Category: Science
A holey argument
Time for urgent action
The US’ National Tobacco Reform Initiative (NTRI) is calling on the Food and Drug Administration actively and expeditiously to pursue the course of action the agency announced in July 2017 ‘with respect to its proposed tobacco and nicotine regulatory framework that would focus on nicotine and support innovations to promote tobacco harm reduction based on the continuum of risk for nicotine-containing products’.
On July 28, 2017, the NTRI said, the FDA commissioner, Scott Gottlieb, and the director of the agency’s Center for Tobacco Products, Mitch Zeller, announced new policy directions on tobacco and nicotine that called for a ‘comprehensive regulatory plan’ that would accelerate efforts in winning the war against cigarette smoking.
In a letter to the commissioner on the one-year anniversary of his announcement, the public health leaders who are part of NTRI said that while they had seen progress during the past 50 plus years in respect of declining smoking prevalence, an estimated 32 million US adults still smoked cigarettes. ‘Cigarette smoking remains this nation’s leading cause of preventable disease and death, responsible for about 480,000 deaths each year and costing this country approximately $300 billion in health care costs and lost productivity,’ the NTRI said in a press note. ‘With so many lives on the line each year, there must be an urgency to take bold, visionary actions immediately to reduce the disease burden that smoking addiction inflicts on the health of Americans.
‘While the NTRI fully supports the FDA’s announced visionary initiatives, we are concerned that the FDA is/will become mired in overly bureaucratic processes that will delay taking necessary and obvious steps to protect the public’s health. While some attention is being focused on the priority to consider reducing nicotine levels in cigarettes, the other equally important priority to establish a more workable and flexible regulatory framework to regulate all tobacco and nicotine products based on their risks and relative risks (continuum of risk) is nowhere to be seen.’
“[I]f prudent product standards and reasonable guidelines for making truthful modified risk claims are not available before introducing a product standard for reducing nicotine’s addictiveness in combustible cigarettes, the opportunity to accelerate a mass-migration away from smoked tobacco products, relegating cigarettes to the ashtray of history, will be lost,” veteran tobacco and nicotine researcher and NTRI member, David B. Abrams, PhD, was quoted as saying. Abrams is a professor at the Department of Social and Behavioral Sciences, NYU College of Global Health, New York University.Smoking compared
Smoking marijuana once a week can cause coughing, wheezing and the production of phlegm, all signs of chronic bronchitis, according to a story by Dennis Thompson in HealthDay citing new evidence review reports.
For the evidence review, researchers led by Dr. Mehrnaz Ghasemiesfe, of the San Francisco VA Medical Center, analyzed data from 22 studies of the effects of pot smoking on lung health.
Pot smoking reportedly doubles a person’s risk of developing a regular hacking cough.
It also triples the risk of coughing up phlegm and suffering from wheezy constricted breathing, researchers found.
“We know that smoke from tobacco and other entities – including burning wood in your fireplace – causes chronic bronchitis, so it’s not at all surprising they found chronic bronchitis in prior marijuana research,” said Dr. Norman Edelman, senior scientific adviser to the American Lung Association.
Edelman said he’s concerned that heavy marijuana use could lead to bigger health problems for those who develop chronic bronchitis.
Meanwhile, Paul Armentano, deputy director of NORML, a group supporting reform of marijuana laws, was quoted as saying that, unlike the inhalation of tobacco smoke, cannabis smoke exposure – even long-term – was not associated with the kinds of serious respiratory effects that were often identified with long-term tobacco use, such as COPD, emphysema or lung cancer.Supporting research
Imperial Brands Ventures, a subsidiary of Imperial Brands, said on Thursday that it had taken an equity stake in Oxford Cannabinoid Technologies (OCT).
‘OCT is a biopharmaceutical company focused on researching, developing, and licensing cannabinoid-based compounds and therapies,’ Imperial Brands said in a note on its website.
‘Its activities are licensed for operation by the UK Home Office.’
Matthew Phillips, Imperial Brands’ chief development officer, was quoted as saying that Imperial was pleased to be partnering with OCT.
“Cannabinoid products have significant potential and our investment enables Imperial to support OCT’s important research while building a deeper understanding of the medical cannabis market.”Clearing the smoke
Philip Morris International says it has taken another step towards a smoke-free future by entering a strategic collaboration with Parallax, a Canadian-based start-up.
‘The agreement focuses on advancing the development and commercialization of an effective nicotine-delivery system that leverages the most advanced technologies in pulmonary medicine,’ PMI said in a note posted on its website.
‘The co-founders of Parallax, Drs. Noe Zamel and Arthur Slutsky, are Canadian leaders in pulmonary research and medicine, with global reputations and more than 750 peer-reviewed publications between them. For years, they have been firm believers in tobacco harm reduction: the policy of providing safer alternatives to people who smoke as a complement to measures meant to encourage quitting and discourage people from starting to smoke.
‘Since its founding, Parallax has assembled a world-class team of experts in formulation, device design, pharmaceutical quality manufacturing, product research and consumer insights.’
Prof. Manuel Peitsch, PMI’s chief scientific officer, said that science and technology would be essential to a future where all men and women who smoked switched to better alternatives. “Our collaboration with Parallax, founded by world-renowned experts in pulmonary research and technology, is another step forward and will give us access to innovative technologies and expertise.”
Meanwhile, Zamel and Slutsky were quoted as saying: “As physicians and co-founders of Parallax, we believe that to save lives requires technology, innovation, and a paradigm shift in the mainstreaming of the concept of harm reduction”.
And Steven Ellis, Parallax’s CEO, was quoted as saying: “Our team couldn’t be more excited about this next step in our journey – working with the global leader in smoke-free innovation and collaborating with its scientific team in fulfilling our joint mission of replacing what we all know is the most harmful delivery system for nicotine – the cigarette – with innovative alternatives that clearly move smokers to a better place in the harm reduction continuum”.Smoke-free simulcasting
Philip Morris International yesterday issued a call to action for the creative, media and communications communities to embrace its ongoing commitment to creating a smoke-free world.
‘As part of this initiative, PMI will offer smoke-free alternatives wherever we can, including heated tobacco products and e-cigarettes, to current smokers in the industry who would otherwise continue to smoke,’ the company said in a press note.
The initiative was announced during a keynote speech at the PMI Science Lounge at The Cannes Festival of Creativity, where senior vice president of communications Marian Salzman said: “We are asking the creative community to join us in raising awareness of the potential of science, technology and innovation for those who smoke and the people around them”.
PMI described the move as being part of its vision ‘to lead the charge towards greater innovation and technology in the tobacco industry, all of which is backed by science’.
Agencies interested in joining the movement can contact Marian Salzman at marian.salzman@pmi.com.
“People who smoke deserve information about better alternatives,” said COO Jacek Olczak (pictured). “The media industry can play an important role in making this happen, including by championing this initiative.
“Quitting tobacco and nicotine remains the best option for smokers, but for those who don’t, science-based non-combustible alternatives are a better choice than continuing to use cigarettes.”
Olczak said PMI wanted a world where all people who would otherwise continue to smoke instead switched to less harmful alternatives. “We started with a bold statement in Cannes: we are looking to create a world where all these smokers switch to better alternatives,” he said. “Now it’s time to make sure people know we are serious. And now, we are following up with concrete actions.”
The press note said that the Emakina Group, an independent group of communication agencies in Europe, had been the first agency network to declare its commitment to a smoke-free future by pledging support to the initiative across its 13 offices. “A smoke-free future for the whole company? Challenge accepted,” said Brice Le Blévennec, CEO, Emakina Group. “And you know what? Let’s start now!”
PMI says it is developing and assessing a range of smoke-free alternatives to cigarettes including heated tobacco products, e-cigarettes, and other innovative technologies. ‘The company is conducting extensive research to examine the risk reduction potential of the products compared to continued smoking,’ it said. ‘All evidence to date indicates that PMI’s smoke-free alternatives are a better choice for smokers than cigarettes.’MRTP applications meeting
The US Food and Drug Administration has issued a Federal Register notice announcing a meeting of its Tobacco Products Scientific Advisory Committee (TPSAC) to discuss scientific issues related to the modified risk tobacco product (MRTP) applications submitted by R.J. Reynolds Tobacco Company for six Camel Snus smokeless tobacco products, which are currently under scientific review by the FDA.
The meeting is scheduled for September 13-14 at the FDA’s White Oak campus.
The role of the TPSAC is to review and evaluate scientific issues, including safety, dependence, and health issues, relating to tobacco products and provide advice, information, and recommendations to the FDA.
By law, the FDA must refer MRTP applications to the TPSAC, and the TPSAC must report its recommendations on the applications. In providing their recommendations, TPSAC members may not necessarily read the entirety of the applications.
The FDA reviews and makes the determination as to whether to authorize an MRTP, and is not required to follow TPSAC recommendations, including votes. However, the FDA takes into consideration TPSAC members’ insights, along with public comments and other information made available to the agency, before making a determination on any MRTP application.
Before the meeting, TPSAC members receive materials prepared by the FDA and the company that provide context to inform TPSAC members’ discussions, including those materials that relate to specific issues and questions from FDA staff that arose during the agency’s scientific review of the MRTP applications.
The FDA posts all materials provided to the TPSAC (redacted in accordance with applicable laws) on the agency’s website two days before the relevant meeting; so the agency intends to post the materials for the September TPSAC meeting on the FDA website on September 11.
During the upcoming meeting, representatives from R.J. Reynolds Tobacco Company and the FDA’s Center for Tobacco Products’ Office of Science will present information about the company’s MRTP applications currently under FDA scientific review. TPSAC members may then discuss available scientific evidence related to issues and questions posed by FDA about the applications. During this discussion, TPSAC voting members may vote on specific issues and questions, or on other topics arising during the committee’s discussion.
TPSAC meetings include also time for in-person public comments; and instructions on how to submit public comments to the TPSAC are to be found on the Federal Register notice.
Requests to present an oral comment at the September meeting must be received by August 16, while written comments related to the meeting must be received by August 29.
These deadlines apply only to the TPSAC meeting and do not apply to the public docket for R.J. Reynolds Tobacco Company MRTP applications. There is currently no deadline for public comments on these applications.What's not to like?
Vaping helps people stop smoking – and can even encourage them to quit when they aren’t looking to do so, according to new research from the UK’s University of East Anglia (UAE).
In a piece on the eurekalert.org website, the University said its study had shown that smokers who switched to vaping might be better able [than those using other quit methods] to stay smoke-free in the long term.
It had shown, too, that even people who weren’t looking to stop smoking had eventually quit because they found vaping more enjoyable than smoking.
“E-cigarettes are at least 95 percent less harmful than tobacco smoking, and they are now the most popular aid to quitting smoking in the UK,” said lead researcher Dr. Caitlin Notley of the UEA’s Norwich Medical School.
“However, the idea of using e-cigarettes to stop smoking, and particularly long-term use, remains controversial.”
The research team carried out in-depth interviews with 40 vapers and, in doing so, found that vaping might support long-term smoking abstinence.
“Not only does it substitute many of the physical, psychological, social and cultural elements of cigarette smoking, but it is pleasurable in its own right, as well as convenient and cheaper than smoking,” said Notley. “Our study group also felt better in themselves – they noticed better respiratory function, taste and smell.
“But the really interesting thing we found was that vaping may also encourage people who don’t even want to stop smoking, to eventually quit.”
While most of the sample group reported long histories of tobacco smoking and multiple previous quit attempts, a minority (17 percent) said they enjoyed smoking and had never seriously attempted to quit.
“These were our accidental quitters,” said Dr Notley. “They hadn’t intended to quit smoking and had tried vaping on a whim, or because they had been offered it by friends. They went on to like it, and only then saw it as a potential substitute for smoking.”
“Many people talked about how they saw vaping …as a no pressure approach to quitting,” she said.Application will be ‘robust’
The 22nd Century Group says it has initiated three short-term studies ‘investigating the behavioral and biochemical responses’ to its proprietary ‘Very Low Nicotine Content’ tobacco.
The company said in a press note that its scientists would submit to the US Food and Drug Administration the data collected from these studies as part of its ‘revised and enhanced Modified Risk Tobacco Product (MRTP) application for “BRAND A” Very Low Nicotine Content cigarettes’.
In announcing in April/May last year that the FDA had granted it authorization to conduct a clinical trial on its Brand B low tar-to-nicotine ratio cigarettes, the company said it intended to submit an MRTP application to the FDA for Brand B.
‘Slated for submission this year, 22nd Century’s MRTP application will request a marketing order from the US Food and Drug Administration (FDA) to allow 22nd Century to disclose to consumers that the VLN™ tobacco of “BRAND A” cigarettes contains at least 95 percent less nicotine than the tobacco in conventional cigarettes,’ the company said in its most recent press note.
’22nd Century is the only company in the world that has grown commercial crops of proprietary VLN™ tobacco with nicotine levels of just 0.4 mg per gram of tobacco – a level that has been recognized by many public health officials as only “minimally or non-addictive”. Independent clinical trials using 22nd Century’s proprietary SPECTRUM® research cigarettes have shown that Very Low Nicotine Content cigarettes “reduce cravings, reduce consumption of cigarettes, and increase quit attempts”.
‘As announced by the FDA in July 2017, the FDA is seeking to dramatically reduce the nicotine levels in all cigarettes for precisely the same reasons 22nd Century is developing “BRAND A” as a Modified Risk Tobacco Product. Accordingly, 22nd Century may be the first company in the world to win FDA approval to market a combustible cigarette as a “Modified Risk Tobacco Product”.
‘22nd Century’s clinical studies are designed to confirm and substantiate further data previously collected by independent researchers. 22nd Century’s short-term studies will expand the demographic reach of the independent trials, thus demonstrating the suitability of the Company’s Very Low Nicotine tobacco for a wide range of smokers.
‘Summaries for two of the studies, “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes” and “Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes,” are already posted at www.clinicaltrials.gov.
‘The third study, “A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption Behavior and Biomarkers of Exposure during a 6-Week Switch to Very Low Nicotine Cigarettes”, will be added soon.
‘While the FDA is engaged in the rule-making process to limit nicotine in all cigarettes to minimally or non-addictive levels, 22nd Century’s MRTP application for “BRAND A” Very Low Nicotine Content cigarettes pursues a complementary and potentially faster pathway for regulatory approval.’
“22nd Century’s team of scientists, regulatory experts, and specialist consultants are meticulously assembling our revised MRTP application for “BRAND A” Very Low Nicotine Content cigarettes,” president and CEO Henry Sicignano, III was quoted as saying.
“Later this year, we will submit a robust MRTP application that answers many of the questions the FDA is asking with regard to the agency’s planned national nicotine reduction mandate. The public deserves – and desperately needs – a minimally or non-addictive cigarette … sooner, rather than later.”HNBs offer positive change
Philip Morris International said yesterday that a clinical study had proved that switching to its heat-not-burn (HNB) device could reduce the health risks posed by smoking combustible cigarettes, according to a story in The Korea Herald.
PMI’s study results come two weeks after the South Korean health authorities released the result of their study, which found that HNB devices to be equally harmful as combustible cigarettes, if not more harmful.
According to PMI, its latest clinical test was conducted on 984 smokers of combustible cigarettes over the age of 30 in the US.
As part of the test, it asked 488 people to switch to IQOS for six months.
The clinical risk assessment related to diseases associated with heart, lung and organ systems changed positively in the case of those who switched to IQOS, compared to those who continued smoking conventional cigarettes.
“The latest research was conducted to demonstrate clinical, biological and functional health changes in smokers switching to the HNB product,” said Manuel Peitsch, chief scientific officer at PMI. “The result has proven that the HNB product can reduce the risk of smoking-related diseases.”
