The US Food and Drug Administration is planning to hold a ‘public hearing’ on December 5 because it believes that a rising number of young people are becoming addicted to vaping.
A note issued through the FDA’s Center for Tobacco Products said that, on November 2, the FDA commissioner, Scott Gottlieb, M.D., had issued a statement on the agency’s ‘concern with rising numbers of youth becoming addicted to e-cigarettes and the current lack of adequate research or approved treatments to help kids quit using e-cigarettes or other tobacco products’.
‘To help address these issues, the agency will hold a public hearing at the FDA White Oak Campus on December 5 to hear public perspectives on the available scientific evidence related to drug therapies for e-cigarette cessation as it relates to youth users and how the FDA may support further research in this area’.
‘Individuals interested in presenting at the hearing must register by November 23, 2018. Those interested in attending the hearing in person or watching the free, live webcast must register by December 3, 2018.
‘Regardless of attendance at the public hearing, interested parties may also submit a public comment to docket FDA-2018-N-3952 starting Monday, November 5, 2018, through January 2, 2019.
‘Further information, including instructions for presenters, is included in the Federal Register notice.’
Category: Science
FDA to hold e-cig meeting
Attempt to calm moral panic
A group of academics and tobacco control and public health experts is trying to convince the US Food and Drug Administration to slow down and consider the risks of hasty regulation, according to a piece by Jim McDonald at Vaping360.
The National Tobacco Reform Initiative (NTRI) is said to have sent a letter to Dr. Scott Gottlieb, calling on the FDA commissioner to hold a summit of stakeholders to discuss the FDA’s policy on vapor products and vaping.
In introducing his piece, McDonald said the FDA seemed dead set on restricting the vapor industry very soon. The agency had given JUUL Labs and the four major tobacco companies that also sell vapor products 60 days to submit plans to eliminate sales to teenagers. That 60-day deadline expired soon after next week’s elections.
Meanwhile, McDonald said that NTRI co-ordinator Allan Erickson had written to Gottlieb saying that to address the situation fully would require the involvement and support of not only the FDA, but other stakeholders as well. Erickson, a former American Cancer Society vice president, believes that e-cigarettes can play a part in tobacco control efforts to reduce smoking.
‘We therefore wish to recommend that the FDA/CTP [the FDA’s Center for Tobacco Products] sponsor a national dialogue related to youth use of tobacco and nicotine products as well as the need to provide the 30 million adult smokers in this country with lower risk alternative tobacco and nicotine products, to be held sometime in early 2019,’ he said in his letter.
The NTRI leadership includes David Abrams and Ray Niaura of New York University (both formerly with the Truth Initiative), former American Heart Association vice president Scott Ballin, and former American Cancer Society president John Seffrin. The organization’s advisory group includes Clive Bates and Iowa Attorney General Tom Miller. Miller was one of the state attorneys general who sued the tobacco companies, leading to the 1998 Master Settlement Agreement. He was the chair of the Truth Initiative board last year.
McDonald’s piece says, however, that the NTRI letter may be too late to affect Gottlieb’s thinking.
‘He’s shown no signs of cooling his reckless “epidemic” rhetoric,’ McDonald said. ‘There’s nothing the FDA commissioner needs more now than wisdom from clear-headed and open-minded veterans of the tobacco wars. But he appears less and less likely to listen.’GFN registration opens
Registration has opened for the Global Forum on Nicotine (GFN) 2019, with a special offer on delegate fees.
The sixth GFN is scheduled to be held at the Marriott Hotel, Warsaw, Poland, on June 13-15.
The organizers say that those who register by the end of this year will pay the same fee as they paid for attending this year’s event.
The GFN 2018 attracted about 450 people from more than 60 countries and was reckoned by the organizers to have been the most successful GFN to date.
Pre-event publicity for the 2018 event described it as including a conference comprising plenary sessions, parallel sessions and panel debates; a film festival; and the second International Symposium on Nicotine Technology (ISoNTech).
Further information is available from: joanna@kachange.eu.Drug link to lung cancer
Millions of ‘Americans’ take angiotensin-converting enzyme (ACE) inhibitors to lower their blood pressure, but a new study suggests these drugs might increase their odds of developing lung cancer, according to a story by Steven Reinberg for HealthDay citing a new study.
But lead researcher Laurent Azoulay, an associate professor of epidemiology and oncology at McGill University, Montreal, Quebec, Canada, cautioned that the research was based on an observational study that could not prove that these drugs caused lung cancer.
Among people taking the drugs for more than five years, the increased risk might be as high as 14 percent, which could represent a large number of patients, the study authors noted.
“The silver lining of our findings is that while we found an association, the risk at the individual patient level is likely low, even after 10 years of use,” Azoulay was quoted as saying.
“For this reason, this should not deter patients from taking these drugs, should their physician deem the treatment appropriate.”New IQOS versions
Philip Morris International said yesterday that it had launched the next generation of its heated-tobacco product, IQOS.
‘The new IQOS 3 and IQOS 3 MULTI integrate extensive consumer insights and feedback to improve design and user experience while maintaining signature taste, sensory attributes and ritual — all underpinned by strong scientific substantiation,’ PMI said in a note posted on its website.
‘The new versions aim to further encourage a growing number of smokers to switch, to the benefit of their health, public health and, ultimately, society.
‘The new iterations were launched today in Tokyo, Japan – the country considered the birthplace of IQOS.’
“Our dream was to create a better alternative for smokers, and IQOS has made this dream a reality; it’s a revolution for the 1.1 billion people who smoke,” André Calantzopoulos, PMI’s CEO, was quoted as saying. “IQOS 3 and IQOS 3 MULTI deliver significant improvement and innovation and mark another step toward convincing all men and women who would otherwise continue to smoke to switch to smoke-free alternatives. IQOS consumers know that this product changes many things in their lives – we thank them, and we thank Japan for leading this positive change.”
PMI said that robust science underpinned every development at PMI. ‘Its scientific assessment program is based on longstanding practices of the pharmaceutical industry and is in line with US Food and Drug Administration (FDA) guidance,’ the note said.
‘IQOS produces an aerosol that contains on average 90 percent lower levels of harmful chemicals than cigarette smoke. The totality of PMI’s preclinical and clinical evidence indicates that switching completely to IQOS presents less risk of harm than continued smoking.
‘Evidence also shows that IQOS does not negatively affect indoor air quality. On average, 70 to 80 percent of IQOS users have quit cigarettes, which makes IQOS the most compelling smoke-free alternative today.’
PMI said it had filed a Modified Risk Tobacco Product Application (MRTPA) for IQOS with the FDA, which was still under review.A THR 'backwater'
Vaping groups in the Philippines are calling for the adoption there of the UK’s approach to tackling tobacco use, according to a story at businessmirror.com.ph.
The groups referred to a recent UK House of Commons Science and Technology Committee report, E-cigarettes, that said these products were estimated to be 95 percent less harmful than conventional cigarettes.
The report recommended in part that: ‘Regulations should be relaxed relating to e-cigarettes’ licensing, prescribing and advertising of their health benefits’. ‘Their level of taxation and use in public places must be reconsidered,’ the report said.
“E-cigarettes are helping many people in the UK quit smoking,” said Peter Paul Dator, president of The Vapers Philippines. “The government should seriously consider the UK tobacco control model in order to reduce the harms caused by conventional cigarettes to Filipino smokers.”
Meanwhile, Philippine E-Cigarette Industry Association president Joey Dulay said that the Philippines would remain a backwater in tobacco harm mitigation if the Department of Health continued its ill-informed and myopic position on e-cigarettes.
“It’s high time that the Department of Health take its cue from the UK and other countries that have acknowledged the growing body of scientific evidence supporting e-cigarettes and tobacco harm reduction,” he said during a forum held in Quezon City last week.PATH-study data available
The US National Institutes of Health (NIH) and the Food and Drug Administration (FDA) said yesterday that new data files from the Population Assessment of Tobacco and Health (PATH) Study had been released.
In a note issued through its Center for Tobacco Products, the FDA said the PATH Study was a household-based, nationally-representative, longitudinal cohort study of youth (12-17 years old) and adults in the US. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.
The latest release includes:
* New Wave 3 Questionnaire Public-Use Files (PUF).
‘Data in the third wave were collected from October 2015 to October 2016,’ the FDA said. ‘Public-use questionnaire data files (PUFs) from the third wave of the PATH Study may be downloaded from the National Addiction & HIV Data Archive Program (NAHDAP) of the Inter-university Consortium for Political and Social Research (ICPSR).’
* Updates to Wave 1 Biomarker Restricted-Use Files (BRUF).
‘Data and documentation for five Wave 1 Biomarkers of Potential Harm assay panels were added to the PATH Study Biomarker Restricted-Use Files (BRUF),’ the note said. ‘Data in the first wave were collected from September 2013 to December 2014. The updated files were added to the existing biomarkers of tobacco exposure data in the BRUF, which include measurements of arsenic, creatinine, metals, polycyclic aromatic hydrocarbons, tobacco-specific nitrosamines, nicotine metabolites, and volatile organic compounds in urine and measurements of cotinine and hydroxycotinine in serum. Qualified researchers may apply for access to the PATH BRUF.’
The FDA said it encouraged researchers interested in the PATH Study to join the PATH Study Data User Forum. ‘The forum enables researchers using PATH Study data to submit and answer questions,’ it said. ‘Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users are also posted to the forum.’
There is more information here.Setting standards
UL, a global safety science company, said yesterday that Joyetech, a global manufacturer of electronic cigarettes and vaporizers, had become the first organization to certify to UL 8139, a safety standard that evaluates the electrical and battery systems of ‘vaping devices and electronic cigarettes’. The certification was issued to Joyetech’s vapor pen, eGO AIO.
In a press note issued through PR Newswire, UL said it had recently published ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices, which had been recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products. The development of UL 8139 addressed also specific fire safety concerns raised by North American fire officials.
“UL strives to help manufacturers bring safer products to market and empower consumer trust,” said Ghislain Devouge, vice president and general manager for UL’s Consumer Technology division. “UL 8139 is a collaborative effort with government agencies and industry stakeholders to further enhance consumer safety.”
The testing requirements for UL 8139 evaluate the safety of the electrical, heating, battery and charging systems, but the standard does not address devices that have removable battery cells, e-cigarette consumables or the long-term or physiological effects of the consumables.
Joshua Church, chief compliance officer for the Joyetech Group, said Joyetech strived to be a leader in the ENDS [electronic nicotine-delivery system] industry and was constantly looking for ways to ensure the safety of its high-end technology. “For us, this UL 8139 certification is a validation of our commitment to using scientific and expert methods to test our products,” he said. “For our customers, it illustrates our dedication to providing greater peace of mind.”
Meanwhile, Maggie Gowen, executive director of the Global Vaping Standards Association, a non-profit trade group, said the Association had been working toward the introduction of safety standards such as UL 8139 that helped manufacturers bring the best products to the consumer. “Our membership base is dedicated to pursuing higher quality standards, especially those that cover hardware and battery design, she said”Swedish Match tries again
The US Food and Drug Administration said yesterday it had posted an amendment to the modified risk tobacco product applications (MRTPAs) for General Snus products submitted by Swedish Match North America.
The FDA said that, on December 14, 2016, it had denied the company’s request ‘to remove a currently required warning statement that products can cause gum disease and tooth loss’.
‘With respect to the company’s other requests to remove or revise two additional currently required warnings, FDA deferred final action and issued a response that offered the company an option to amend its applications,’ it said in a note issued through the Center for Tobacco Products.
‘FDA will post any future amendments to the application on the Center for Tobacco Products’ website on a rolling basis as the materials are redacted.’
More information is available here.E-cigarettes most promising
A man who helped invent stop-smoking products such as nicotine patches and the prescription drug Chantix says that electronic cigarettes are one of the most promising developments in the field of smoking cessation, according to a story by Rishi Dasgupta published at dukechronicle.com.
Dr. Jed Rose, who is director of the Duke Center for Smoking Cessation, Durham, North Carolina, US, and a professor of psychiatry and behavioral science, said that currently more than 500,000 people in the US died every year of smoking related disease, a number that continued to rise. Cigarette smoking imposed a completely unacceptable burden of death and disease, he added.
Rose, who has studied nicotine since 1979, said smokers didn’t just crave nicotine; they also craved the physical action of smoking a cigarette.
“We’ve done studies where we’ve intravenously administered smokers with the same dose of nicotine they would get from a cigarette and found that this doesn’t satisfy their craving,” Rose said. “On the other hand, if they smoke a denicotinized cigarette, their craving is relieved quite a bit.”
Unlike other cigarette alternatives such as nicotine gum and patches, e-cigarettes replace the physical behavior of smoking and deliver nicotine in a way familiar to smokers.
Rose said the Duke Center for Smoking Cessation was doing a Juul trial and that there was “good reason to believe” it could help people quit smoking. And while the Food and Drug Administration claimed that e-cigarettes were introducing minors to nicotine, it was worth the risk.
“The ‘epidemic’ of youth addiction is greatly exaggerated,” Rose said. “This isn’t good, but it has to be weighed against the 500,000 preventable deaths that can be lessened using e-cigarettes.”
Rose said later that while e-cigarettes were less harmful than traditional ones, they still posed risks, including not just the obvious risk of addiction, but also the unknown effects of nicotine on adolescent brains and the trace amounts of cancer-linked compounds.
Nevertheless, Rose maintained that e-cigarettes were a much safer alternative to paper-and-tobacco cigarettes.
“Ultimately, if you’re going to do something, do the thing that’s less harmful,” Rose was quoted as saying. “We do that with things like safe sex and clean-needle exchanges for heroin users, so it should also apply to cigarette smoking—which kills more than all those other things put together.”
Rose was skeptical about e-cigarettes being gateways to tobacco. “If anything, restricting e-cigarettes may incentivize youth to try combustible cigarettes instead,” Rose said.
