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.
Category: Technology
MRTP applications meeting
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.”No trace of reality
The ‘major tobacco companies’ are acting as corporate chameleons, spending millions on make-overs, trying to convince the world they have changed when they have not, according to a story by AB Gilmore and A Rowell of the University of Bath.
The story, published as a Tobacco Control blog, said that, shattering the ‘expensive illusion’ of change was the latest evidence, published this week in Tobacco Control, that had uncovered one of their greatest scams.
Not only were tobacco companies still involved in tobacco smuggling, but they were positioning themselves to control the very system governments around the world had designed to stop them from doing so.
Their elaborate and underhand effort, implemented over years, involved front groups, third parties, fake news and payments to the international regulatory authorities meant to hold them to account.
Towards the end of their piece, Gilmore and Rowell said that many intergovernmental organisations and national tax and customs authorities around the world appeared to have swallowed, without question, the tobacco industry’s misleading version of events.
‘It is vital that they wake up and realise what is at stake: if the tobacco industry’s tricks work, they will be left in charge of the very system meant to keep them in check, the system meant to stop them from smuggling their own products, the system meant to safeguard government revenues,’ they said.
‘Yet identifying which are the industry’s latest front groups, spokespeople, linked companies or coalitions is increasingly difficult given the lengths industry will go in order to disguise these interests.
‘If there is a simple message it is this: no government should implement a track and trace system linked in any shape or form to the tobacco manufacturers. In short, no-one can trust the tobacco industry chameleons.’BAT investing in glo
British American Tobacco said yesterday that it would invest €800 million during the next five years in its factory in Ploiești, Romania.
‘The investment, which will generate 200 new jobs in Romania, will support the expansion of BAT’s innovative tobacco heating product – glo – in countries across Europe during the second half of 2018,’ the company said in a press note posted on its website.
‘A completely new manufacturing hall will be built dedicated to producing the specially designed tobacco sticks – called Neostiks – which work with the glo tobacco heating device. In total, an additional 7,000 square metres of production space will be created and, once completed, the Romanian production plant will be the sole supplier of glo Neostiks across Europe, as BAT continues its ambition to transform the tobacco industry with a range of potentially reduced-risk alternatives for smokers.’
The investment will enhance also the cigarette-making capabilities within the factory.
“We have a long-held ambition to offer smokers a range of potentially reduced-risk products – like tobacco heating devices, e-cigarettes and oral tobacco,” Tadeu Marroco, regional director – Europe and North Africa, was quoted as saying. “This ambition has seen us launch vaping products and tobacco heating devices in 16 countries in the last five years and we’ve bold plans to increase our geographical footprint in the second half of 2018. The significant investment in our factory in Romania is testament to our commitment to offer smokers a wider range of tobacco and nicotine products – with a particular focus on potentially reduced-risk alternatives to smoking – in an increasing amount of countries.”
The factory will supply Neostiks also for the Romanian market following the launch of glo there in December. In the six months since its launch, first in Bucharest and then in 17 other major cities around Romania, almost 25,000 consumers are said to have bought glo and tens of millions of Neostiks have been sold.
In 2017 BAT said, its revenues outside of the US from e-cigarettes and tobacco heating products quadrupled to £397 million. On a full year basis including Reynolds American’s contribution, this would have been more than £500 million.
And the company aims to generate more than £1 billion revenue from NGPs by the end of 2018 and to more than £5 billion by 2022.'Clarification' sought
A statement made last week by the Korean Food and Drug Administration (KFDA) could mislead millions of people into thinking that the use of heated tobacco products is as harmful as smoking cigarettes, according to Philip Morris International.
‘There is compelling scientific evidence, including KFDA’s own findings, that heated tobacco products generate an aerosol that is completely different from cigarette smoke, and that they are a better choice than cigarettes, a PMI press note said.
‘And yet, with their June 7 statement, the agency could be risking the health of millions of Koreans who use tobacco products. These are the very people they are charged with protecting.
‘Those who are still smoking may be discouraged from switching, and those who have switched may turn back to cigarette smoking.’
PMI said that everybody agreed that smoking was harmful. Now, it said, there was a much better alternative, made possible by technology and science, for the millions of Koreans who would put themselves at the greatest risk of serious health consequences if they continued to smoke cigarettes.
‘Rather than focusing on the significant reductions in harmful chemicals compared to cigarette smoke that the agency’s own science shows, KFDA points to “tar” measurements to judge the relative risk of tobacco products,’ the note said.
‘However, the World Health Organization (WHO) – an objective and respected group with the public good as its goal – has been crystal clear on this matter: “Tar need not be measured, as it is not a sound basis for regulation, and the levels can be misleading”. Exactly. The concept of “Tar” applies to cigarette smoke, which is not the same as the aerosol from heated tobacco products – a fact that has been confirmed by numerous studies.
‘Scientific evidence shows that switching to heated tobacco products, while not risk-free, is a much better choice than continuing to smoke. ‘Koreans who use tobacco products, and those around them, deserve truthful information based on 21st-century science – not political agendas. Measuring “tar” is yesterday’s approach misapplied to today’s innovative products.
‘For the benefit of the people of Korea, we believe KFDA should consider issuing a clarification.’High nicotine levels needed
Vapers using low- rather than high-nicotine e-liquids in electronic cigarettes may be using their devices more intensely, potentially increasing the risk of exposure to toxins in the vapor, according to a medicalxpress.com story citing new research funded by Cancer Research UK and published in Addiction on June 7.
Researchers, based at London South Bank University, studied 20 e-cigarette users and found that people using low-nicotine e-liquid in their devices puffed more deeply and more often than did those using high-nicotine liquid. Those using low-nicotine liquids also increased the power of their vaping devices when possible.
Despite this ‘compensatory’ behaviour, the low nicotine vapers were unable to get as much nicotine as could the high-nicotine group. But in their quest to do so their puffing behavior may have increased their exposure to toxins such as formaldehyde, a chemical formed when the e-cigarette liquid is heated.
While there can be toxic chemicals present in vapor, they are far fewer and generally at lower concentrations than in tobacco smoke. Evidence so far still shows that the use of both high- and low-nicotine e-cigarettes is far less harmful than is smoking.
“Some vapers might believe that starting out on a low nicotine strength is a good thing, but they should be aware that reducing their nicotine concentration is likely to result in the use of more e-liquid,” said Dr. Lynne Dawkins, lead author of the study.
“This obviously comes with a financial cost but also possibly with a health cost. The results of our study suggest that smokers who want to switch to vaping may be better to start with higher, rather than lower, nicotine levels to reduce compensatory behaviour and the amount of e-liquid used.”PMI issues research update
Philip Morris International yesterday published its latest Scientific Update for Smoke-Free Products, a regular publication on its research efforts to develop and assess a range of smoke-free alternatives to cigarettes.
‘We are focusing this issue on the growing body of independent research on our electrically heated tobacco product (EHTP, marketed as IQOS), the most advanced smoke-free alternative in our portfolio,’ according to a press note posted on the company’s website.
‘The covered research comprises independent, peer-reviewed publications on smoke-free products that focus on EHTP, and also includes four recent government reports from the UK, the US, Germany, and the Netherlands.’
Other sections are said to include an update on the assessment of each product in PMI’s smoke-free portfolio, recent R&D milestones and a compendium of the company’s peer-reviewed publications on its smoke-free products this year.
“We are happy to see growing interest in studying our smoke-free products and that the general trend among independent results is in line with our own research,” said Prof. Manuel Peitsch, PMI’s chief scientific officer.
“Independent research on our electronically heated tobacco product, ETHP, demonstrates significant improvements relative to cigarettes, and is crucial to our efforts to change the lives of millions of smokers around the world.”
PMI said its extensive research and assessment program was inspired by the well-recognized practices of the pharmaceutical industry and in line with the draft guidance of the US Food and Drug Administration for Modified Risk Tobacco Product (MRTP) Applications.World No Smoking Days
Philip Morris International is marking World No Tobacco Day, May 31, with a call to recognize it as ‘World No Smoking Day’.
PMI said in a note posted on its website that it was publishing informational advertisements highlighting that people who smoke deserve the opportunity to learn about smoke-free alternatives to cigarettes.
‘It is clear that despite the well-known health risks associated with smoking, many people continue to smoke,’ it said. ‘The World Health Organization (WHO) predicts that there will be more than one billion people who smoke in 2025, about the same number as today.
‘Their best choice would be to quit – but many don’t. It makes sense that these men and women should have access to and information about less-harmful alternatives to cigarettes.
‘Why would anyone deny them this opportunity?’
PMI said it was calling for an additional, bold approach to public health.
“For people who will otherwise continue to smoke, WHO is in the perfect position to drive switching from cigarettes to sensible alternatives,” said André Calantzopoulos, PMI’s CEO.
“A policy that informs people about those alternatives – in essence, a World No Smoking Day – would reduce smoking prevalence to a far greater extent and at a much faster rate than the existing suite of tobacco-control measures alone.
“People who smoke deserve a sensible plan that takes full account of better alternatives to cigarettes.
“For our part, we’re determined to deliver a smoke-free future through innovations that stand up to scientific scrutiny and that meet consumer needs.”
PMI said it had already committed $4.5 billion in supporting a team of 400 world-class scientists, engineers and technicians who had spent years creating and testing a range of smoke-free products that offered a much better choice for the millions of smokers who didn’t quit.
It said that more than five million smokers worldwide had already completely abandoned cigarette smoking and switched to IQOS, PMI’s heated tobacco product, with 10,000 smokers switching every day. And PMI added that it was not the only company pursuing innovation as important to the world’s one billion smokers worldwide – the tobacco industry generally is beginning to move in this direction, to the benefit of men and women who smoke.
“Our short-term ambition is that one out of three of our consumers, 40 million men and women who smoke, will have switched to better alternatives by 2025,” said Calantzopoulos. “Ultimately, we want to be in a position to stop selling cigarettes entirely. However, we need the support of governments and the public health community to make this happen in as short a time as possible. I believe that instead of just designating one day as World No Tobacco Day, we should promote every day as World No Smoking Day.”
PMI said it was proposing that governments and authorities investigate thoroughly how scientifically substantiated smoke-free products could be used as a complementary public health strategy alongside smoking prevention and cessation. With appropriate government control and oversight, these products could have a meaningful and positive impact on public health, it added.
More information about PMI’s views on World No Tobacco Day is at: http://www.pmi.com/world-no-smoking-day-2018.Heated tobacco warning
A scientist and health advocate says it is important that the European Parliament is presented with the available evidence that heated tobacco products ‘remain both harmful and highly addictive’.
Writing an opinion piece in The Parliament Magazine, Professor Charlotta Pisinger said that no product that damaged the lungs and human health should be promoted to young people across the EU, especially in the ways these new products were presented.
‘As Chair of the European Respiratory Society (ERS) Standing Committee on Tobacco Control, I will present my research findings to the European Parliament in Strasbourg on the 30th May, alongside MEP Gilles Pargneaux and the European Network for Smoking and Tobacco Prevention (ENSP), on the occasion of World No Tobacco Day,’ she said.
‘Independent research suggests that there is a substantially higher health risk than claimed by the tobacco industry.
‘I have discovered that tobacco companies have not informed the public that some harmful substances – such as particulate matter, tar, acetaldehyde (a carcinogen), acrylamide (a potential carcinogen) and an acrolein metabolite (toxic and irritant) – were found in high concentrations in their studies.
‘Some studies also found much higher concentrations of formaldehyde (a potential carcinogen) in heated tobacco products than in conventional cigarettes.’
New Heated Tobacco Products: No Smoke, No fire? hosted by MEP Gilles Pargneaux is due to be held from 13:30 to 15:30 on May 30 at the European Parliament in Strasbourg, room Louise Weiss N3.5. Registration is at: https://forms.ersnet.org/new-heated-tobacco-products.ITM an industry powerhouse
The ITMGroup said today that it had taken an important step toward being self-sufficient in electrical power.
‘With the official activation of Elestor’s hydrogen bromide flow battery [HBr], ITMGroup has taken its first steps to expand its smart grid in Kampen [the Netherlands] with a sustainable and cost-effective electricity storage technology,’ the company said in a press note. ‘It enables the machine builder to take an important step in fully self-generating the electricity the company needs.’
‘The installation at ITMGroup is intended to demonstrate on a limited scale, that the HBr flow battery, developed inhouse by Elestor, is cost-effective for companies. The technology can thus contribute to reducing CO2 emissions and achieving climate targets.’
The installation at ITMGroup is the first commercial installation that Elestor has made.
ITMGroup said that, from 2019 onwards, its storage capacity would be expanded, something that would allow it to become self-sufficient in energy needs, even when its own smart grid did not generate sufficient electricity.
‘An HBr flow battery makes energy storage more economical and environmentally friendly, compared to existing technologies such as lithium-ion batteries,’ the note said. ‘The economic yield of, for example, solar panels and windmills, is much higher due to the storage capacity. This makes it more attractive for more companies to invest in sustainable energy generation and storage.’
Because ITMGroup has a smart grid with, among other things, 1,700 solar panels, two heat pumps and a wood chip boiler, it offered Elestor the perfect environment for applying its innovative energy storage technology.
“Worldwide we are faced with an enormous task when it comes to the energy transition,” said ITMGroup board member Hester Kuypers. “By only installing more solar panels and windmills, we will not make the switch to sustainable energy. Making electricity storage affordable is therefore a necessity and Elestor’s technology brings it within reach. We think, it is important that we, as an international company, can demonstrate that it works!”
Meanwhile, Elestor director Guido Dalessi said his company was very pleased with the co-operation that ITMGroup had provided. “Everyone is willing to buy the fiftieth installation of a proven technique; but the first sales are often much more difficult,” he said. “ITMGroup fulfils a pioneering role in scaling up our technology. In addition, ITMGroup has plenty of technical experts who want to share their knowledge with us. They think along with us to further optimize this innovative way of storing electricity.”
ITMGroup said that, as a family business, it strived to minimize its ecological footprint. In addition to investing in sustainable energy, it supplied electric bikes and cars for the daily transport of its employees, and it was keeping bees on the company premises, it added.
“As a global player, we want all our sites to operate as energy-neutral as possible, in 10 different countries and we are happy to support our approximately 1,200 employees in realizing sustainable solutions,” said Kuypers. “In this way we not only leave a beautiful company to future generations, but hopefully also a world as beautiful as possible.”
