Philip Morris International said on Friday that it had submitted a Premarket Tobacco Product Application (PMTA) for its iQOS Electronically Heated Tobacco Product (EHTP) to the US Food and Drug Administration’s (FDA) Center for Tobacco Products.
A PMTA marketing order is a prerequisite to commercializing on the US market a new tobacco product such as PMI’s EHTP. A favorable decision on the PMTA would allow the marketing of the EHTP, without modified risk claims, independent of a decision on the Modified Risk Tobacco Product (MRTP) application that PMI submitted to the FDA on December 5
In a note posted on its website, PMI said the filing of the PMTA application was consistent with its stated goal of submitting it during the first quarter of 2017.
‘PMI’s PMTA seeks authorization to commercialize the EHTP in the United States,’ the note said. ‘Should FDA grant the requested marketing order, Altria Group Inc. would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI.’
Meanwhile, in a note posted on its website, Altria confirmed that, should the PMTA be granted, it would commercialize the product in the US.
With Philip Morris International having made in the US a Premarket Tobacco Product Application for its iQOS heated-tobacco product, US tobacco retailers are being told to look to Japan to gauge how the market might develop, according to a story by Melissa Kress for Convenience Store News.
David Bishop, managing partner of sales and marketing firm Balvor LLC, reportedly has pointed to Japan as an area retailers should be watching.
For one thing, Japan Tobacco International and Philip Morris International are both opening standalone stores in Japan through which they are introducing their new heat-not-burn products.
Additionally, according to Bishop, research in Japan indicates that iQOS is creating a drag, or headwind, for traditional mass-made cigarettes.
“As that product enters the United States – as people expect it to in 2018 – what will happen if and when they open up a similar type of store in the US?,” Bishop said.
“Convenience retailers could be faced with some very stiff headwinds if similar trends develop in the US as in Japan.”
Kress writes that there are many reasons why PMI, JTI and other tobacco companies would pursue standalone outlets. One of the lessons learned from electronic cigarettes is that convenience stores aren’t necessarily the best place to introduce new innovation that requires educating the consumer.
“Speed of service is paramount; the c-store staff isn’t necessarily trained to be as knowledgeable as a vape shop or tobacconist,” Bishop said. “So, anything new that requires any degree of explanation or education is better handled in other classes of trade.”
A link is now available to a report that was described here on February 28 under the heading, End game within reach.
The report, Ending cigarette use by adults in a generation is possible, was the work of a team of tobacco control and health experts whose goal was to assess the views of 120 US tobacco control experts about what they saw as some of the key areas and priorities for significantly reducing or eliminating cigarette use.
According to the executive summary, the researchers consulted 120 key tobacco control leaders across the US. ‘They represent a broad swath of tobacco control experience and expertise, ranging from researchers and academics, to advocates, state and urban tobacco control staff, government officials, and local front-line workers,’ the summary said. ‘Their input is integrated into a proposed strategy to achieve the goal of reducing cigarette smoking in adults to less than 10 percent in all communities nationwide by 2024.
‘This is not a consensus report. We considered all inputs, and focus here on what represents the needed balance between what has worked to reduce smoking in the US, and additional steps that are now needed. These steps draw upon advances in technology and deeper insights into what drives behavior change.’
A US public health expert has said that the Surgeon General is continuing to lie about tobacco in electronic cigarettes.
Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, was referring to an article published earlier this month in JAMA Pediatrics.
In it, the Surgeon General had claimed that electronic cigarettes were “now the most commonly used form of tobacco among youth in the United States, surpassing cigarettes, chewing tobacco, cigars, and hookah”.
Writing on his Rest of the Story blog, Siegel said the article referred to electronic cigarettes as a form of tobacco and to vaping as a “form of tobacco use”.
‘There’s just one problem with the Surgeon General’s claim that vaping is a form of tobacco use: it’s not true,’ he said.
Siegel went on to say that even if the Surgeon General wrongly believed that consuming any product that contained nicotine was a form of tobacco use, then he was still lying to the public.
‘Under that definition, e-cigarettes are not the most commonly used form of tobacco among youth,’ Siegel pointed out. ‘Potatoes are.’
Registration for a US workshop examining safety concerns surrounding electronic-cigarette batteries is due to end on March 17.
In a press note, the Food and Drug Administration said that its Center for Tobacco Products was due to host a science-based public workshop to gather information and stimulate discussion on batteries used in electronic nicotine delivery systems (ENDS), including electronic cigarettes.
‘In particular, CTP seeks to gather information about battery safety concerns (e.g., overheating, fire, explosion, other modes of failure), risk mitigation, and design parameters related to ENDS,’ the note said.
‘Additionally, information related to the communication from tobacco product manufacturers or importers to distributors, wholesalers, retailers, consumers, and the general public on battery-related safety concerns with the use of ENDS products will also be collected.’
The workshop is due to be held on April 19-20.
Registration by electronic or written request should be made no later than March 17.
Four US vapor-industry organizations have written to the speaker of the House of Representatives, Paul Ryan, and the House minority leader, Nancy Pelosi, urging them to support a bill that would take the sting out of the Food and Drug Administration’s deeming regulations in respect of electronic cigarettes.
The letter writers believe that the FDA Deeming Authority Clarification Act of 2017, which was introduced by Representatives Tom Cole and Sanford Bishop, would lift the ‘industry-ending’ effect of the retroactive predicate date in the FDA’s regulations.
At the same time, it would institute regulations that better fitted the unique nature of vapor products. Without it, only major tobacco companies would have a chance to survive beyond 2018.
Ensuring this ground-breaking technology continued to be available as a healthier alternative for adult US smokers was key in the mission ultimately to eliminate cigarette smoking and smoking-related disease.
The writers said the FDA’s plan to regulate vapor products out of existence was misguided.
‘There is a large and rapidly growing body of scientific evidence that supports the premise that vapor products are the most important tobacco harm reduction opportunity of the last decade,’ they wrote. ‘The most recent study, published in the Annals of Internal Medicine, conducted and authored by researchers from the US Centers for Disease Control and Prevention (CDC), University College London and King’s College, Roswell Park Cancer Institute, found that consuming e-cigarettes exposes vapers to dramatically lower levels of toxins than smoking conventional cigarettes. Moreover, the difference between smokers’ and vapers’ exposure is actually similar to the difference between smokers and non-smokers, as found by the same CDC scientist in a 2012 study. Additionally, the Royal College of Physicians released a comprehensive scientific review that concluded that vapor products are at least 95 percent less harmful than combusted cigarettes. In the UK, Public Health England published a report recommending these products as a harm-reducing alternative for smokers.’
The writers said the proposed bill would allow an entire vapor products industry to remain afloat, saving tens of thousands of US jobs while providing unprecedented regulation of vapor products appropriate for this innovative technology.
‘Unlike the FDA’s regulations issued in 2016, the Cole-Bishop bill addresses the issues of product safety and enhances youth protections,’ the letter said. ‘Additionally, the legislation provides the strictest industry standards while also preserving access to vapor products for the millions of adult Americans who now use them every day instead of smoking.
‘Specifically, the FDA Deeming Authority Clarification Act of 2017 would:
Amend the current law’s highly-problematic retroactive predicate date from February 15, 2007 to the effective date of the final deeming regulations, allowing products that meet all regulatory requirements to remain on the market and keeping thousands of small businesses, and their tens of thousands of employees, afloat.
Protect consumers by preserving access to the diverse vapor marketplace, as opposed to the current law and FDA’s deeming regulations that threaten to force millions of adult consumers back to smoking or into the black market.
Set higher standards for product safety by requiring the FDA to implement rulemaking on product standards for batteries used in the devices within 12 months.
Protect teens by severely restricting marketing and youth access to vapor products.’
The writers said that if the FDA’s deeming regulations were allowed to stand, small- and mid-sized vapor retailers and manufacturers across the US would close their doors, leaving consumers – who were battling every day to quit smoking – without access to these life-changing and possibly lifesaving alternatives to combustible cigarettes.
‘Although it does not purport to solve every issue with the FDA’s deeming regulations, the FDA Deeming Authority Clarification Act of 2017 is a significant first step toward correcting the FDA’s misguided approach to regulation of the vapor industry,’ they wrote.
The writers are, in alphabetical order, Tony Abboud, executive director of Vapor Technology Association; Alex Clark, executive director Consumer Advocates for Smoke-Free Alternatives Association; Gregory Conley, president American Vaping Association; and Pamela Gorman, executive director Smoke Free Alternatives Trade Association.
Daily users of electronic cigarettes view them as almost as satisfying or even more satisfying than traditional cigarettes, according to a story by Henry L. Davis for buffalonews.com citing the results of a small study carried out by the University at Buffalo, New York, US.
Daily users also view the use of electronic cigarettes as being less harmful than the consumption of traditional cigarettes.
The study of 105 US Army Reserve and National Guard soldiers and their partners found that the study participants who vaped daily reported electronic cigarettes as being ‘at least as satisfying’ as cigarettes. Fifty-eight percent of them said that vaping was ‘much more’ satisfying.
Researchers reported also that the perceived level of danger posed by the use of electronic cigarettes decreased as frequency of use increased.
The research, which was funded by the National Institute of Drug Abuse, appears online in the journal Preventive Medicine Reports.
“The results argue that satisfaction, perceived harm or danger and product type seem to all work together to promote use or avoidance,” Lynn Kozlowski, lead author and a professor of community health and health behavior, said in a statement.
“The mistaken belief that e-cigarettes are more harmful than cigarettes can influence some smokers to not use e-cigs. If the type of product they use is less satisfying, this also can influence likelihood of use,” Kozlowski said.
The authors of a new booklet are urging US lawmakers and regulators to rethink traditional strategies for combating tobacco smoking and its negative health outcomes.
In a press note issued yesterday, The Heartland Institute said that for decades, lawmakers and regulators had used taxes, bans, and strong regulations in an attempt to reduce the negative health effects of smoking. And recently, some had sought to extend those policies to electronic cigarettes.
‘A new booklet published by The Heartland Institute titled Vaping, E-Cigarettes, and Public Policy Toward Alternatives to Smoking urges policymakers to re-think that tax-and-regulate strategy,’ it said.
‘Health professionals have long known that the smoke created by combustible cigarettes, rather than the nicotine, is what makes smoking harmful. Smokeless tobacco and e-cigarettes provide a much safer and healthier alternative delivery system for nicotine.
‘Tobacco harm reduction is a proven strategy for helping smokers reduce their tobacco use or quit altogether.
‘Dr. Brad Rodu, lead author of Vaping, E-Cigarettes, and Public Policy Toward Alternatives to Smoking, has been at the forefront of tobacco harm reduction research and policy development for more than 20 years. He is a professor of medicine at the University of Louisville, where he is a member of the James Graham Brown Cancer Center and holds an endowed chair in tobacco harm reduction research.
‘Dr. Rodu and his co-authors – Matthew Glans and Lindsey Stroud of The Heartland Institute – encourage policymakers to be mindful of the extensive research that supports tobacco harm reduction and understand that “bans, excessive regulations, or high taxes on e-cigarettes could encourage smokers to stay with more-harmful traditional cigarettes”.’
The booklet discusses issues including:
■ Indoor and outdoor bans on vaping.
■ Prohibiting e-cigarette purchases by minors.
■ Regulating flavors.
■ Myths and facts about e-cigarettes.
■ The idea there is an epidemic of children being poisoned by e-cigarettes.
In the US, New Jersey has moved one step closer to banning the sale and distribution of most flavored electronic smoking products, according to a story by Brent Johnson for NJ Advance Media.
The state Assembly’s health committee voted 7-2, with two abstentions, on Monday to approve the bill, which would ban the sale of vaping devices and products in flavors other than clove, menthol and tobacco. Currently there are hundreds of flavors available, such as honey, chocolate and cherry.
New Jersey already bans the sale or distribution of flavored cigarettes, except those with clove, menthol or tobacco flavors.
If passed by both houses of the state legislature and then signed by the governor, the new bill would extend that law to ban electronic smoking devices, cartridges, and liquid refills with flavors other than the three allowed.
Sponsors of the bill say its goal is to prevent vaping products from being targeted at young people, and possibly luring them into smoking tobacco products.
But opponents of the proposed ban say electronic cigarettes are less risky than are tobacco cigarettes, and can help people quit smoking. Plus, they say, banning the products would cause many vape shops to close.
Kevin Roberts, a former spokesman for Governor Chris Christie who now represents Logic Technology, the nation’s third-largest supplier of electronic cigarettes, said Monday that the bill went against “public health goals and would undoubtedly push countless individuals back toward conventional cigarettes and their known harms”.
A new report says that this is a critical moment in determining how the U.S. federal government is going to deal with alternative products to smoking.
‘The federal government can either allow people to make free choices that might help save their lives or be co-opted by misguided public health extremists who aim to eradicate tobacco and even nicotine altogether, regardless of the potential damage to millions of Americans who want to stop smoking,’ the report warns.
A summary of the report says that Congress and the Trump Administration can both help smokers move away from smoking and lower regulatory burdens by embracing tobacco harm reduction as a preferred strategy. ‘This requires no government interventionist policies,’ it says. ‘Instead, the federal government simply needs to step aside and allow the market to make it possible for smokers to have access to innovative products that can help them stop smoking.’
Three key takeaways from the report are given as:
* As a result of private innovation in the marketplace, important alternatives to smoking can reduce the risks associated with the delivery of nicotine.
* When it comes to the alternatives to smoking, the federal government is blocking products and much-needed innovation that could help save the lives of Americans.
* Congress and the Trump Administration should move the government away from blocking access to products that may help individuals reduce their cigarette smoking.
The report’s recommendations include:
* Congress should reform the Tobacco Control Act of 2009.
* Federal agencies should correct misleading information and provide proper information to the public.
* Congress and the Administration should make tobacco harm reduction the policy norm throughout the federal government.
Daren Bakst is research fellow in agricultural policy in the Center for Free Markets and Regulatory Reform, of the Institute for Economic Freedom, at The Heritage Foundation.
Jeff Stier (pictured) is a senior fellow at the National Center for Public Policy Research in Washington, DC, and heads its Risk Analysis Division. The full report is here.
link is now available to a report that was described here on February 28 under the heading, End game within reach.
lawmakers and regulators to rethink traditional strategies for combating tobacco smoking and its negative health outcomes.
