U.S. President Donald Trump is expected to nominate Dr. Scott Gottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration (FDA). If confirmed by the Senate, Gottlieb would be charged with implementing Trump’s plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.
A resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund, Gottlieb is a former FDA deputy commissioner who has frequently advocated a loosening of requirements needed for approval of new medical products.
Gottlieb’s could be a boom for manufacturers of electronic nicotine delivery systems such as e-cigarettes. The American Enterprise Institute has consistently argued that there is no evidence showing the risk of vaping is any where near as dangerous as smoking.
Daily users of vapor products 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 and vapor products 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.
A New Zealand doctor believes that shifting smokers onto electronic cigarettes represents a “win”, according to a story on TVNZ.
The doctor said that electronic cigarettes were going to be “absolutely fantastic”.
The report described electronic cigarettes as a product that was becoming increasingly popular among smokers.
But it claimed that new research had suggested that while vaping these products might be better than smoking traditional cigarettes, they came with their own set of problems.
But on TVNZ’s Breakfast program, Doctor John Cameron was upbeat.
“If we can get everyone who’s smoking tobacco related products and put them onto e-cigarettes, I think we have got a win,” he said.
It was known that the best thing to put in your lungs was fresh air, no question about it, he added.
And the worst thing you could put into your lungs was the smoke from burnt tobacco leaves.
Vaping sat somewhere in the middle.
There was nothing wrong with nicotine as a drug, it was the delivery system that mattered.
Talking about the down-sides of electronic cigarettes, Cameron said there was a risk people might turn to vaping who had never picked up a cigarette and smoked before.
“You are developing a behaviour which is inhaling a substance that may or may not do some damage to your lungs, it’s probably minuscule but are we going to say it is a good thing to do? So that is where the conundrum currently lies.”
With National No Smoking Day coinciding with Budget day in the UK, the Chancellor is being urged to recognize the role of vaping in ‘improving public health and saving billions of pounds for the NHS [National Health Service]’.
A press note from the UK Vaping Industry Association (UKVIA) said that it was known that in delivering his budget today, the Chancellor would be looking to impose a rise in tobacco excise.
But it was vital that he ignored calls from the EU to treat vaping products in the same way. Evidence from other European Countries demonstrated that imposing excise duties on vaping products put at risk a ‘potentially seismic public health opportunity that is already saving the NHS billions’.
‘The public have displayed a huge vote of confidence in vaping; figures show that over 2.8 million people have now embraced vaping, the press note said. ‘Public Health England is clear that vaping is at least 95 percent less harmful than smoking, and this view is now being endorsed by the wider UK public health community. It is self-evident that adopting a harm reduction approach, the promotion of safer alternatives to those who would otherwise smoke, can bring enormous public health benefits.
‘Smoking levels are being drastically reduced by the availability of hugely popular vaping alternatives. The NHS values each person who quits smoking as saving £74,000; even simple arithmetic shows that the smokers who have switched to vaping, and no longer smoke, already represent a saving of more than £96bn.
‘It would make no sense for the Chancellor to ignore these benefits and elect instead to follow the example of European Commission; the architects of the ill designed vaping regulations who to date have ignored the UK’s harm-reduction approach and are instead seemingly prioritizing excise measures on vaping products.’
Mark Pawsey MP, chairman of the All-Party Parliamentary Group on e-cigarettes, was quoted as saying that the group had taken evidence from many representatives of the public health and research community, as well as from vapers and the vaping industry itself.
“What is clear is that the key driver in the popularity of e-cigarettes is the desire from smokers to switch to a much less harmful alternative,” he said. “The UK is a leader in harm-reduction policy, and it is important that we continue to be. I am sure the Chancellor will be led by the evidence, and the evidence suggests that punitive taxation on vaping products discourages their uptake. Given the cost savings they potentially represent to the health service; punitive measures would surely be a backward step.”
Meanwhile, UKVIA’s Charles Hamshaw-Thomas, said that the almost half of Britain’s 2.8m vapers who no longer smoke already represented a saving of £96 billion.
“With there still being approximately nine million smokers in the UK just imagine the savings if we get more of them to switch,” he said.
“They say Mr Hammond [the Chancellor] has an eye for detail, so surely he can see how those numbers stack up, particularly while occupying the national platform he has on No Smoking Day.”
The CORESTA Secretariat has given details of the documents that it has published and the projects that it has launched since December. The following documents have been published and can be downloaded from the CORESTA website at www.coresta.org under the Documents section.
Report “3rd Round Robin Test for Air Permeability Calibration Standards 2014/2015” (2016-12-20)
Report “7th Proficiency Test (2014) for Physical Parameters of Cigarettes and Filters” (2017-02-08)
Report “8th Proficiency Test (2015) for Physical Parameters of Cigarettes and Filters” (2017-02-08)
Report “2016 Collaborative Study on Minor Alkaloids in Tobacco Products” (2017-02-16)
Report “2016 Collaborative Study on Nicotine in Tobacco Products” (2017-02-23)
Report “2016 Collaborative Study of CORESTA Monitor 8 (CM8)” (2017-02-27)
Report “2014 Collaborative Study Comparing CRM35 for the Determination of Total Alkaloids (as Nicotine) in Tobacco by Continuous Flow Analysis to a New Method with Safer Chemistry” (2017-03-01)
Report “2016 Collaborative Study of CORESTA Ignition Propensity Monitor Test Piece CM IP 2 for the Determination of Ignition Propensity” (2017-03-06)
Report “Joint Experiment Technical Study (JETS) Report 16/2 Maleic Hydrazide in Tobacco” (2017-03-06)
Report “2015 Collaborative Study for Determination of Glycerin, Propylene Glycol, Water and Nicotine in Collected Aerosol of E-Cigarettes” (2017-03-09)
Method “Determination of Glycerin, Propylene Glycol, Water, and Nicotine in the Aerosol of E-Cigarettes by Gas Chromatographic Analysis” (2017-03-09)
External publications
Report “An Inter-Laboratory Comparison for the Urinary Acrolein Biomarker 3-Hydroxypropyl-Mercapturic Acid (3-HPMA)” published in Beiträge zur Tabakforschung International/Contributions to Tobacco Research, Volume 27, Issue 5.
ISO19290:2016 Standard published, based on CORESTA Recommended Method (CRM) No. 75 (TSNA in Smoke)
Projects The following new projects were launched. A full list of active projects is available on the CORESTA website at www.coresta.org under the Study Groups/Active Projects section:
Project 129: STS SG – 2017 Benzo[a]Pyrene Collaborative Study
Project 130: AA SG – Joint Experiment Technical Study (JETS) on Maleic Hydrazide (2)
Project 131: AA SG – 13th CPA Analysis Proficiency Test – 2017
Project 132: ACAC – Guide on Responsible Use of CPAS in Tobacco Leaf Production
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.
The Maori public health organization Hapai Te Hauora believes subsidizing electronic cigarettes is a way to help many Maori break their addiction to tobacco, according to a story in the Waatea News.
Tobacco control advocacy service manager Zoe Hawke said she was seeing many Maori who were interested in vaping but couldn’t afford the high entry price.
She hopes a Ministry of Health review of electronic cigarettes and vaping will lead to the lifting of restrictions on nicotine-containing liquids, which at present must be bought from overseas via the internet because it can’t be sold in New Zealand.
But that will still leave consumers with a big up-front cost.
“We just need to support people to get the initial tools, to get the e-cigs, and then they will save money, especially when you look at the taxes on tobacco,” said Hawke.
Patches and gum were already subsidized, so it was no great leap to subsidize electronic cigarettes as part of cessation programs, she added.
Today, the Vapor Technology Association (VTA) announced vapor industry leaders representing small businesses and consumers across the country came together to support the “FDA Deeming Authority Clarification Act of 2017” (HR1136). This bipartisan legislation, introduced by Representatives Tom Cole and Sanford Bishop, would lift the industry-killing effect of the retroactive predicate date in FDA’s recent deeming regulations on electronic cigarettes, while instituting regulations that better fit the unique nature of vapor products.
In a letter of support to party leaders on both sides of the aisle, the VTA, Smoke Free Alternatives Trade Association, American Vaping Association and Consumer Advocates for Smoke-Free Alternatives Association praised Representatives Tom Cole and Sanford Bishop for their bipartisan effort to ensure this groundbreaking technology continues to be available as a healthier alternative for adult Americans.
Rep. Tom Cole
The VTA represents the manufacturers, wholesalers, small business owners and entrepreneurs who have developed innovative and quality vapor products, providing adult consumers with a better alternative to traditional combustible products. VTA and its members are leaders in the vapor community, promoting small businesses and job growth, responsible public policies and regulations, and strong industry standards.
The US Food and Drug Administration’s Center for Tobacco Products (CTP) is due to explain the processes it uses in the review of tobacco product applications. Vapor products are considered a tobacco product by the CTP.
In a press note, the FDA said it planned to hold a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) on April 6.
‘During this meeting, representatives from the FDA’s Center for Tobacco Products will present information to the Committee, which includes several new members, on the processes CTP uses in the review of tobacco product applications, including substantial equivalence (SE), modified risk tobacco product (MRTP) and premarket tobacco applications (PMTA),’ the note said. Vapor companies are expected to have to survive at least one of the regulatory pathways to keep products on the market.
‘Topics will include the statutory standards applicable to the different types of applications; the scientific basis for review decisions, with a focus on PMTA and MRTPA; and the role of the committee in the review process.
‘People interested in presenting data, information, or views, either in person or in writing, must send in their submissions by March 15 or March 23, respectively.’
Philip Morris International is unlikely to get permission to sell its iQOS heated tobacco device in Australia under current regulations, according to a story in the Sydney Morning Herald relayed by the TMA and quoting the assistant health minister, David Gillespie.
Gillespie said that the commercial supply of nicotine was effectively prohibited in Australia via state and territory poisons legislation, with some exceptions, such as for tobacco prepared and packed for smoking, and certain nicotine replacement therapies.
He was quoted as saying that these exemptions would be unlikely to apply to heat-not-burn products because ‘the nicotine in them would not be in the form of tobacco prepared and packed for smoking’.
The story said that the recent decision by Australia’s Therapeutic Goods Administration to retain nicotine on its poisons list, effectively banning eVapor products containing nicotine, also complicated PMI’s plans.
Despite the TGA having no direct role in making rules about heat-not burn products, Gillespie said that “further consideration of policy options to address heat-not-burn products may be considered in the context of a national response to e-cigarettes”.
Meanwhile, Tony Snyder, PMI’s vice president of communications, said that iQOS was for adult smokers “looking for product choices that offer the satisfying taste, ritual, and pleasure they get from cigarettes, but with far lower amounts of the harmful compounds found in smoke”.
