Restricting access to non-tobacco vaping flavors might discourage smokers from switching to e-vapor products, according to a EurekAlert story citing the results of a study involving more than 20,000 adult US vapers
The story said that peer-reviewed research published on Monday in the Harm Reduction Journal showed that flavors played a critical role in attracting smokers into and retaining them in the vaping category, directly contributing to tobacco harm reduction.
“The results show that non-tobacco flavors, especially fruit based flavors, are being increasingly preferred to tobacco flavours by adult vapers who have completely switched from combustible cigarettes to vapor products,” said Dr Christopher Russell (pictured), deputy director of the Centre for Substance Use Research (CSUR), who led the research.
The survey, one of the largest of its kind to focus on flavors, was conducted by the CSUR and funded by Fontem Ventures, a subsidiary of Imperial Tobacco.
Of the 20,836 adult, frequent users of e-vapor products who took part in the survey, nearly 16,000 were said to have completely switched from smoking to vaping, while 5,000 were dual users who were smoking and using e-vapor products.
“The data suggest that US vapers’ journeys towards quitting smoking are increasingly likely to start with, progress to, or be sustained by frequent use of vaping devices containing non-tobacco flavors”, said Russell.
Meanwhile, Dr. Grant O’Connell, corporate affairs manager at Fontem Ventures, said the declining popularity of tobacco flavors among adult vapers strongly suggested that flavor bans, such as the one recently passed in San Francisco, could see vapers return to cigarette smoking and discourage other adult smokers from switching.
The full peer-reviewed article can be downloaded for free at the Harm Reduction Journal.
Tag: United States
Flavors key to switching
Spam flavor
In a battle to destroy vaping, ‘bad actors’ have spammed more than 255,000 fake anti-vaping comments into the system overseeing the public consultation process for the US Food and Drug Administration’s proposed rulemaking on the Regulation of Flavors in Tobacco Products, according to a story by Brent Stafford for regulatorwatch.com.
The regulations in question could include restrictions on the use of flavors in e-liquids, or an outright flavor ban.
FDA sources were said to have told RegWatch that the spammed entry of more than a quarter of a million fake comments was “extraordinary” and “unprecedented”.
It was said that the assault nearly brought down federal servers and so bogged-down the internal network that it became next-to-impossible to process any submissions.
RegWatch described what happened as a massive assault on the credibility of the public consultation process.
Meanwhile, according to a Vaping 360 story relayed by the TMA, the 255,000 comments originated from four IP addresses.
The agency was said to have been able to stem the flow of comments but had not approved or published a single comment from the pending queue of hundreds of thousands of comments.
The spammed comments were unsigned and followed one of four templates, including three that used language copied from an April Campaign for Tobacco-Free Kids letter to FDA Commissioner Scott Gottlieb, and another from a form letter to California mayors created by the California Department of Public Health.
The comments were said to ‘critique the use of flavors and packaging to increase addictiveness and appeal’.
As of July 9, there were more than 517,000 submissions waiting to be reviewed and each comment on the FDA regulatory docket must be read and approved by FDA staff before inclusion.
Vaping organizations have been encouraging comment submissions from vapers but are concerned that confusion and uncertainty over the corrupted comment docket will discourage many vapers from telling their stories.Late-adolescence crisis
By living more dangerously and settling down later than people of previous generations, Millennials could be creating a new generation of addicted smokers and e-cigarette users, according to the results of research by The University of Texas Health Science Center at Houston (UTHealth), published on Newswise.
Statistics highlighted in an article in the Journal of Adolescent Health had shown greater numbers of new smokers and e-cigarette users among young adults than among adolescents, marking a reversal of previous social norms, the Newswise story said.
“Historically, it used to be that nearly everything started by age 18,” Cheryl Perry, PhD, senior author and professor and regional dean at the UTHealth School of Public Health in Austin, was quoted as saying. “That’s no longer the case, as young adults are experimenting with things once more common during high school years. Young adults are starting to act like adolescents.”
The new statistics indicate that people are much more likely to start smoking as young adults rather than as adolescents. Using the National Survey on Drug Use and Health, analysis of cross-sectional data from 2006-2013 is said to show that the rate of onset of cigarette smoking among young adults (6.3 percent) was more than three times higher than onset among adolescents (1.9 percent) during this time.
“If adolescence now extends to age 30, this makes the battle against tobacco much bigger and more complicated,” Perry was quoted as saying toward the end of the story.
“Just when we thought we were nearing the end game, we might have been outsmarted.
“It’s a challenge, which will demand new ways of trying to communicate with and influence young adults who may be much harder to reach than adolescents.”Smoking compared
Smoking marijuana once a week can cause coughing, wheezing and the production of phlegm, all signs of chronic bronchitis, according to a story by Dennis Thompson in HealthDay citing new evidence review reports.
For the evidence review, researchers led by Dr. Mehrnaz Ghasemiesfe, of the San Francisco VA Medical Center, analyzed data from 22 studies of the effects of pot smoking on lung health.
Pot smoking reportedly doubles a person’s risk of developing a regular hacking cough.
It also triples the risk of coughing up phlegm and suffering from wheezy constricted breathing, researchers found.
“We know that smoke from tobacco and other entities – including burning wood in your fireplace – causes chronic bronchitis, so it’s not at all surprising they found chronic bronchitis in prior marijuana research,” said Dr. Norman Edelman, senior scientific adviser to the American Lung Association.
Edelman said he’s concerned that heavy marijuana use could lead to bigger health problems for those who develop chronic bronchitis.
Meanwhile, Paul Armentano, deputy director of NORML, a group supporting reform of marijuana laws, was quoted as saying that, unlike the inhalation of tobacco smoke, cannabis smoke exposure – even long-term – was not associated with the kinds of serious respiratory effects that were often identified with long-term tobacco use, such as COPD, emphysema or lung cancer.Vapers; here’s your chance
People in the US who have quit smoking by using vapor products are being offered the opportunity to submit sworn statements about their quitting to help forestall bans or restrictions on flavored e-liquids – and, thereby, allow current and future smokers the chance of taking the same route to quitting.
In a blog last week, Brad Rodu, who is a professor of Medicine at the University of Louisville and who holds an endowed chair in tobacco harm reduction research, noted that a year and a half ago, he had blogged about government agencies ignoring federal survey data showing that 2.5 million former smokers were current vapers.
Rodu said that when the Food and Drug Administration’s tobacco-center director Mitch Zeller dismissed this evidence as mere “anecdotal reports”, he – Rodu – had argued that such data constituted legitimate population-level evidence.
Rodu went on to say that, in aiming to build a fresh dataset on smokers’ success in using vapor as a quitting aid, the Vapor Technology Association and Consumer Advocates for Smoke-Free Alternatives had recently launched a national campaign called I Am Not An Anecdote.
‘The groups are asking vapers to submit to the FDA detailed, sworn statements to “encourage Congress and federal regulators to reject any proposal that would ban OR limit flavored e-liquid products”, said Rodu. ‘The groups note that FDA Commissioner Scott Gottlieb has said that your “personal stories are important to me”. But, he also refers to your stories of quitting cigarettes with vapor products as “anecdotes”.’
Rodu admitted that, in scientific terminology, individual cases were anecdotal, but said that their cumulative value was considerable.
‘FDA should give weight to published studies, even when they do not conform to visions of a tobacco-free society,’ he said. ‘The agency should also recognize the scientific value of mass declarations of smoking cessation accomplished through vaping substitution.’MRTP applications meeting
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.LL Flex Restructures
LL Flex a supplier of paper, film and metals-based laminates for packaging and industrial applications, has said it is to realign its executive management team and focus its assets in core markets.
This is said to follow Centre Lane Partners’ (CLP) sale of the Oracle Packaging business in Winston-Salem.
Headquartered in Louisville, Kentucky, LL Flex will remain a part of the CLP portfolio of companies. Industry veteran Victor Dixon has been appointed CEO.
The company said it planned to allocate resources to support continued growth, expansion into new lines of business and development of innovative laminated materials solutions for the wire and cable, tobacco, building and construction, and specialty markets.
‘For tobacco companies, LL Flex is North America’s largest supplier of cigarette inner bundling material, as well as custom-printed laminations for cigar, pipe and smokeless tobacco,’ the company said in a press note.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.”Smoking in rapid decline
The incidence of smoking in the US dropped to 13.9 percent last year, from 15.2 percent the year before, according to preliminary figures from the Centers for Disease Control and Prevention.
An Associated Press story quoted K. Michael Cummings of the tobacco research program at the Medical University of South Carolina as saying that there hadn’t been much change during the previous two years, but that it was clear there had been a general decline and that the new figures showed the decline was continuing.
“Everything is pointed in the right direction,” including falling cigarette sales and other indicators, Cummings said.
In the early 1960s, 42 percent of US adults smoked. At the turn of the millennium, the smoking incidence was about 23 percent.
The story quoted ‘experts’ as saying that anti-smoking campaigns, cigarette taxes and smoking bans were combining to bring down adult smoking rates.
The launch of electronic cigarettes and their growing popularity was said to have ‘likely played a role’ in the decline.
Meanwhile, teenagers too are shunning cigarettes, with figures out last week showing that smoking among high-school students down to nine percent. About 13 percent of high-school students use electronic cigarettes, while the figure for adult use of these devices in 2016 was three percent.No, no; it's easy to quit
Major tobacco manufacturers in the US have from yesterday been compelled to include on their websites so-called corrective statements.
Altria, Philip Morris USA, R.J. Reynolds Tobacco and Lorillard have been ordered by a federal court to make the statements.
The statements cover the health effects of smoking; the addictiveness of smoking and nicotine; low-tar and light cigarettes; the design of cigarettes; and the health effects of second-hand smoke.
According to a CNBC story relayed by the TMA, the statements were ordered on May 1 as part of a 2006 federal court decision that found the major cigarette manufacturers had defrauded the public about the health risks of their products.
CNBC said that the statements must be included also with cigarette packs as ‘onserts’ by November 21, running for 12 weeks over two years.
