Category: News This Week

The expertise of two regional research teams has earned a federal grant of nearly $20 million to create the first program in the United States dedicated to the study of flavored tobacco and vapor products. One of only nine projects to earn funding through the federal Tobacco Centers of Regulatory Science (TCORS) program, the WNY Center for Research on Flavored Tobacco Products (CROFT), will unite teams from Roswell Park Comprehensive Cancer Center and the University of Rochester Medical Center (URMC) in an effort to better document and understand one of the fastest-growing trends in tobacco use.

The five-year, $19.05 million competitive grant, awarded by the National Cancer Institute, will be shared by Roswell Park and URMC. Based at Roswell Park, the program will be led by Richard O’Connor and Maciej Goniewicz, PharmD, both internationally recognized experts on tobacco use and its health consequences.

The Roswell Park team will analyze various combustible and electronic tobacco products, their consequences for health and how users interact with these products. Collaborators from URMC, led by Irfan Rahman and Deborah Ossip, will contribute critical resources in biomarker screening, genetic analysis and toxicology assessment.

Internationally recognized tobacco experts Richard O’Connor and Maciej Goniewicz, PharmD, will lead a new WNY Center for Research on Flavored Tobacco Products based at Roswell Park.

“We’re really excited about initiating this work, because no one has ever looked at flavored tobacco in such a comprehensive and systematic way,” says O’Connor, a professor of oncology with Roswell Park’s health behavior and epidemiology and prevention programs and director of the Buffalo cancer center’s tobacco research laboratory.

“There are so many different flavorings, delivery systems and product options, and so much we don’t know about them.”

Current federal regulations prohibit the sale and manufacture of flavors other than menthol in combustible cigarettes but not in other tobacco products, including e-cigarettes. Data published last year from the PATH Study, the largest prospective U.S. study of tobacco use, indicated that use of flavored products was highest among youth and young-adult tobacco users, with 80 percent of tobacco users ages 12-17 and 73 percent of tobacco users ages 18-24 reporting that they’d used a flavored tobacco product in the previous 30 days.

“There are a number of flavoring chemicals that are regarded as safe for incorporation into food and drink, but we have such limited data about what happens when these products are inhaled,” adds Rahman, a professor of environmental medicine, dentistry, medicine (pulmonary) and public health sciences at URMC. “We’re going to study the impact on public health when these chemicals are added to e-cigarettes, vape pens, Juul and other pods, hookahs, waterpipes, cigars and cigarillos (little cigars) to be a resource for both policymakers and the general public.”

The TCORS program was initiated five years ago by the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) in order to generate evidence to inform the FDA’s regulatory activities.

The CROFT team will pursue projects in four main areas:

• assessing flavorant toxicity
• characterizing flavors and their impact on behavior
• determining respiratory health effects of flavors
• evaluating the effects of product marketing

The team will seek input from hundreds of tobacco and e-cigarette users as it pursues this work, implementing several surveys and clinical studies.

“We’re going to use a lot of different approaches to answer some very important questions: How does the concentration of flavorings affect use? Are there benefits to switching from one type of product to another? Does changing packaging or putting warnings on products change behavior? These are things people want and need to know,” notes Goniewicz, associate professor of oncology in the department of health behavior at Roswell Park.

“One of the most important aspects of this funding is that it will allow us to quickly mobilize to conduct seminars, workshops and other community outreach to inform the public of possible health hazards associated with emerging flavorings in tobacco products,” Ossip adds.

Other key collaborators include Maansi Bansal-Travers and Martin Mahoney from Roswell Park and Scott McIntosh, Scott Steele, Dongmei Li, Isaac Sundar and Luke Peppone of URMC.

The University of Michigan School of Public Health will house a new, multi-institutional center focusing on modeling and predicting the impact of tobacco regulation, funded with an $18 million federal grant from the National Institutes of Health and the Food and Drug Administration.

The Center for the Assessment of the Public Health Impact of Tobacco Regulations will be part of the NIH and FDA’s Tobacco Centers of Regulatory Science, the centerpiece of an ongoing partnership formed in 2013 to generate critical research that informs the regulation of tobacco products.

The center will provide evidence-based and expert-informed modeling projections of the behavioral and public health impacts of tobacco regulations to support the FDA in regulating the characteristics, marketing and sale of tobacco products, said Rafael Meza, associate professor of epidemiology at the U-M School of Public Health and co-principal investigator for the center.

“There is a particular need for modeling in the current environment, in which people are using many different forms of tobacco—cigarettes, cigars, chewing tobacco, etc.—and increased availability and use of alternative nicotine delivery products, such as e-cigarettes,” said Meza, who is also co-leader of the cancer epidemiology and prevention program at the U-M Rogel Cancer Center.

“We can create models that predict the impact of different regulations, from reducing the amount of nicotine in cigarettes to making cigarette packaging less appealing, based on the best available evidence.”

Collaborating institutions include the Georgetown Lombardi Comprehensive Cancer Center and the Yale University School of Public Health, in addition to researchers from across U-M, including the Rogel Cancer Center, Ford School of Public Policy, Institute for Social Research and Institute for Healthcare Policy and Innovation.

Under the Family Smoking Prevention and Tobacco Control Act, the FDA must demonstrate that any new tobacco-related regulation is appropriate for the protection of public health. The act requires the FDA to show the impact on the population as a whole, including tobacco users and nonusers, and take into account smoking initiation and cessation as well as toxicity of tobacco products.

“Modeling the impacts of potential regulations will help inform the FDA in evaluating alternative policies and setting agency priorities,” said David Levy, co-principal investigator of the center and professor of oncology at the Georgetown Lombardi Comprehensive Cancer Center. “Our goal is to provide the FDA with the most comprehensive and detailed external modeling capabilities to evaluate policies and to provide these capabilities on a rapid response basis.”

For example, Meza said, the center could create models to predict the health and behavioral impacts if the FDA were to regulate the amount of nicotine in cigarettes to bring it down to a non-addictive level.

“If someone is already addicted, are they going to switch to something else? Would this regulation incentivize a black market? Our center will look at the trade-offs and consequences of such regulations,” Meza said.

The center will tackle three major projects based on detailed analysis of historical tobacco-use patterns in the U.S., including:

• Evaluating the impact of tobacco regulations and policies on smoking and e-cigarette use and long-term health outcomes, including heart and lung disease and maternal and child health.
• Analyzing the possible consequences of regulating the amount of nicotine in smoked tobacco products.
• Modeling tobacco-related health disparities and investigating how potential policy options may impact those disparities.

The center will bring together panels of experts in tobacco policy and regulation to generate estimates for key policies and health effects that the projects will model. Hosted at Georgetown, the expert panels will also be available as a resource to the FDA.

Researchers at the center will analyze data from the Population Assessment of Tobacco and Health and Monitoring the Future surveys and other nationally representative surveys to provide estimates of initial levels of tobacco-use trends and will develop an infrastructure for model and results dissemination.

Meza said the center will also promote the development of a new generation of tobacco regulatory scientists by supporting students, postdoctoral researchers and junior faculty with an interest in tobacco regulation.

“This is the part I’m most excited about,” he said. “We will fund scholarships for students interested in tobacco regulation modeling and provide financial support for proposals from junior scientists related to and in support of the work the center is doing.

“It’s about ensuring that there is continued research and growth in this area into the future, educating the tobacco control community about the value and uses of modeling, and creating and supporting the new generation of tobacco modelers.”

In addition to Meza and Levy, the center’s lead investigators and steering committee members include Theodore Holford, the Susan Dwight Bliss professor of biostatistics and professor of statistics and data science at Yale; and several faculty members from the U-M School of Public Health, including David Mendez, associate professor of health management and policy; Nancy Fleisher, assistant professor of epidemiology; Ritesh Mistry, associate professor of health behavior and health education; and Kenneth Warner, the Avedis Donabedian Distinguished University Professor Emeritus of Public Health.

The Hong Kong-based consumer advocate factasia.org is urging the Government to allow the sale of regulated vaping products. It says that consumers have the right to choose what they buy and use, according to a story at harbourtimes.com.

Factasia backed its call on Tuesday with the results of a survey conducted by market researcher Ipsos. The survey showed that out of 1,000 smoking and non-smoking participants in Hong Kong, 65 percent said there should be tax and regulatory policies to help people switch from combustible cigarettes to alternative products, while ensuring those products were kept away from the young people.

Vaping devices seem to occupy a gray regulatory area in Hong Kong where the Government is considering its position in respect of these devices.

Heneage Mitchell, co-founder of Factasia, was quoted as saying that alternative products were less harmful than were combustible cigarettes.

“It should be a personal choice for people to use these products to improve their quality of life,” he said. “These products mimic smoking without causing the harmful effects.”

The survey found also that 60 percent of participants believed that if the consumption of a new product were scientifically proven to be potential less risky than smoking, adult smokers should have the right to access this information.

An Irish member of the EU Parliament has asked the Commission whether it will be taking account of the contents of a UK parliamentary report and a letter signed by four academics – both of which come out in favor of vaping – when the Commission produces its implementation report on the Tobacco Products Directive.

In a preamble to his questions, Luke Ming Flanagan thanked the Commission for its answer to his previous question on vaping and the Tobacco Products Directive (E-002293/2018).

Flanagan then asked, with reference to the Commission’s statement that it continuously monitored developments, whether it was aware of the recent all-party UK House of Commons Science and Technology Committee report that was published on August 17 and that came out strongly in favor of vaping.

He asked also; was the Commission aware of the submission to the World Health Organization of a letter signed by four top academics, again outlining, in great detail, the case in favor of vaping.

And he asked whether the Commission could confirm that it would now take those reports into consideration in the implementation report it was required to submit in 2021, in line with Article 28(1) of the directive.

The Commission is due to reply in writing.

The US Food and Drug Administration yesterday launched its The Real Cost Youth E-Cigarette Prevention Campaign, describing it as a ‘new, comprehensive effort aimed at educating kids about the dangers of e-cigarettes’.

The campaign is said to target nearly 10.7 million people aged 12-17 who have used electronic cigarettes or are open to trying them.

It features ‘hard-hitting’, public notices on digital and social media sites popular with teenagers, and includes posters with e-cigarette prevention messages posted in high schools across the nation.

During the past several years, e-cigarettes were the tobacco product [the FDA ‘deems’ e-cigarettes to be tobacco products] most commonly used by young people, the FDA said in a statement issued through its Center for Tobacco Products.

‘In fact, more than two million middle- and high-school students were current users of e-cigarettes in 2017, and the FDA now believes that youth use of e-cigarettes is reaching epidemic proportions,’ according to the statement.

‘With its tagline, “Know the Real Cost of Vaping,” the campaign aims to educate youth that using e-cigarettes, just like cigarettes, puts them at risk for addiction and other health consequences. The messages highlight that nicotine can rewire the brain to crave more nicotine, particularly because adolescent brains are still developing. Other messages highlight that e-cigarettes, among other things, can contain dangerous chemicals such as: acrolein, a chemical that can cause irreversible lung damage; formaldehyde, a cancer-causing chemical; and toxic metal particles, like [such as] chromium, lead and nickel, which can be inhaled into the lungs.

‘This new campaign is part of the FDA’s ongoing efforts to prevent disease and death caused by tobacco use and will complement the agency’s other youth tobacco prevention campaigns.’

More details, including the statement that e-cigarettes have become an ‘almost ubiquitous’ trend among young people, are here.

Fontem Ventures today filed comments on Health Canada’s proposed list of statements for use in the promotion of vaping products.

“As outlined in our filing, we think Health Canada has chosen the correct and responsible way to help smokers make the best, evidence-based decisions if they consider switching to vaping,” said Ross Parker, Fontem’s director of corporate affairs and communications.

Fontem is launching its myblu pod-based e-vapor device and myblu Intense flavors in retail outlets on a trial basis in Quebec, Canada, this month, ahead of a nation-wide launch in January.

In its filing, Fontem said that any promotional messages should reflect both the risks and the benefits of the category so that adult smokers can make informed choices.

‘Such information should not exaggerate risks to deter use, and Fontem believes Health Canada’s proposed statements strike a good balance,’ Fontem said in a note posted on its website.

‘If adopted, these statements would be the first authorised promotional statements to recognise and maximise the opportunities of vaping products in tobacco harm reduction.’

“More jurisdictions should follow Canada’s lead,” said Parker. “Informed consumers will make better choices, which could lead to better public health outcomes.”

Health Canada issued a request for comments on September 4, and said it was exploring options for future regulations that would permit the use of certain comparative statements in vaping product promotion, with the objective of preventing consumers from being misled about the health hazards of vaping products.

The selected permitted statements would be supported by science and expressed in clear terms to ensure that tobacco users were better informed about the relative health effects of using vaping products.

The statements proposed by Health Canada are:

* If you are a smoker, switching completely to vaping is a much less harmful option.

* While vaping products emit toxic substances, the amount is significantly lower than in tobacco smoke.

* By switching completely to vaping products, smokers are exposed to a small fraction of the 7,000 chemicals found in tobacco smoke.

* Switching completely from combustible tobacco cigarettes to e-cigarettes significantly reduces users’ exposure to numerous toxic and cancer-causing substances.

* Completely replacing your cigarette with a vaping product will significantly reduce your exposure to numerous toxic and cancer-causing substances.

* Switching completely from smoking to e-cigarettes will reduce harms to your health.

* Completely replacing your cigarette with an e-cigarette will reduce harms to your health.

Fontem’s response to Health Canada, including its suggested statements, can be found here.

‘FDA [the US Food and Drug Administration] seems to just be going around in circles,’ according to Lindsey Stroud, state government relations manager at The Heartland Institute.

Stroud was commenting on a recent FDA demand that five electronic-cigarette manufacturers address within 60 days what the agency describes as an “epidemic” of teenage vaping or face possible market restrictions on their products: blu, Juul, Logic, MarkTen, and Vuse.

‘Despite the alarmism, youth vaping dropped in 2016 and remained flat in 2017,’ said Stroud.

‘And youth cigarette smoking – it’s at an all-time low.

‘As tobacco companies have been doing for decades, electronic cigarette manufacturers are investing millions into anti-youth initiatives, and some states like Massachusetts have publicly refused to take their money.

‘Retailers in vape shops practice strict and responsible policies to ensure underage consumers are not purchasing vaping products.’

At the same time, Stroud said, the FDA had yet to approve a premarket tobacco product application. ‘Delaying such products limits companies’ ability to modify their current products to be even more child-resistant, including locks on these products,’ she said.

‘Although “protecting the children” is a laudable goal, this rhetoric is overused and threatens the millions of smokers who have quit smoking combustible cigarettes by using these products.’

The Imperial Brands subsidiary, Fontem Ventures, has said that it is ready to work with the FDA to further strengthen its ‘youth access prevention policies and procedures’.

The company was responding to a statement from the US Food and Drug Administration issued on Wednesday in which it gave electronic-cigarette manufacturers accounting for 97 percent of the US market 60 days to submit plans describing how they intend to address what the FDA sees as the widespread use of their products by young people.

Fontem Ventures said it strongly believed that e-vapor products such as blu and myblu were to be used only by adult smokers. ‘Minors should not use any tobacco or nicotine products, and we fully support and advocate for both legislation prohibiting sales of vaping products to minors and the ongoing FDA enforcement action against retailers selling e-vapor and other tobacco products to minors,’ the company said in a statement posted on its website on September 13.

‘We are evaluating today’s [Wednesday’s] request and statement from the FDA. On youth access, we have common aims. We welcome the opportunity to demonstrate, and work with the FDA to further strengthen, our youth access prevention policies and procedures. We will continue to work with regulators in the US and elsewhere to implement best practices in all our commercial activities.

‘Since 2009, blu has marketed e-vapor products to adult smokers in the US and around the world in a responsible manner. While youth smoking rates and use of combustible tobacco products have declined in the US, in line with trends in adult use, we fully understand and share current public concern about youth use of e-vapor products.’

Fontem Ventures said that marketing and advertising standards for blu ensured all communications were intended for, and presented to, adult audiences only. ‘We also take proactive measures to ensure responsible sales practices, both on our own online storefront and through third-party online and brick-and-mortar retail locations:

‘We conduct a thorough online age verification process via third party vendors Veratad and Experian, in addition to mandatory manual ID checks for anyone with a date of birth that shows them to be under 27.

‘We monitor all transactions for evidence of fraudulent activity, unauthorized wholesaling, or sales by proxy where products could potentially reach non-adult users.
‘We require a commitment from vape store partners to prohibit underage access.
‘We require retail partners’ compliance with all applicable local, state, and federal laws.
‘We conduct post-market surveillance to flag any concerning demographic trends.’

Fontem Ventures said it looked forward to working with FDA to address this critical issue.

India’s ban on vaping products comes with an upside for the country’s dominant cigarette manufacturer, ITC, according to a story by Kiran Kabtta Somvanshi for the Times of India quoting the ET Intelligence Group.

The story said that the blanket ban on the import, manufacture and sale of electronic cigarettes and other electronic nicotine delivery systems had nipped ITC’s plans of entering this sector in the bud.

But, the story added, the ban might be seen as saving the company from the threat of disruptive competition.

In India, the use of e-cigarettes was still in its infancy.

ITC had launched e-cigarettes in 2014 under the brand name Eon. But the company had not committed to making a major investment in the product, probably as it waited for clarity in respect of the introduction of regulations and the reaction of consumers.

Now, the Times said, the ban prevented the entry of products such as Philip Morris’ iQOS device into the Indian market, which had the second-largest number of smokers.

‘Little wonder then that ITC’s stock closed positive despite yet another regulatory measure being introduced to discourage smoking,’ the Times said.

‘It nevertheless remains to be seen how the country’s top tobacco company looks at innovating its conventional cigarettes business besides the strategy of premiumizing its portfolio,’ it said.

ITC was said to have entered the nicotine-replacement product market in 2013 with the launch of the chewing gum Kwiknic. But the company’s latest annual report had no mention of this product; so investors would want to know the company’s Plan B for innovation in its bread-and-butter business.

Prisoners who smoke are to be offered free vaping kits as Scotland’s jails prepare to go tobacco-free later this year, according to a story by Reevel Alderson for BBC Online.

The initiative, which will cost about £200,000, is part of a program to help inmates give up smoking.

Vaping kits will be issued from the start of November, before the ban comes into force at the end of the month.

For two months, the kits will be provided free of charge. They will then be sold at a discounted rate until April, after which prisoners will have to pay the normal price.

The Alderson story said it was believed that more than 70 percent of Scotland’s prison inmates smoked: a much higher rate than that within the general population. Among female inmates, the story said, the figure could be as high as 95 percent.

Smoking in enclosed public places was banned in Scotland in 2006, but the ban did not apply to prisons. Inmates have been permitted to smoke in their cells and some outside spaces.

But a year ago the Scottish Prison Service (SPS) announced plans to make prisons completely smoke-free.

The Scottish Conservative justice spokesman Liam Kerr said it was right to offer some transitional help for inmates, but that the cost should also be considered. “This is a cost to the public purse at the end of the day, but they have time limited it,” he was quoted as saying.

“I think that has to be the right thing to do. To say we will help you transition off smoking, but after that the public shouldn’t be shelling out to help you transition away.”