A $2.8-million grant to develop and evaluate a school-based, culturally-grounded e-cigarette prevention intervention for Hawaii’s rural youth has been awarded to University of Hawaii Cancer Center researcher, Scott Okamoto.
Funded by the National Institute on Drug Abuse, the project builds on Hoʻouna Pono, a drug prevention curriculum designed for rural Hawaiian adolescents, according to the university.
The e-cigarette intervention plan will update the existing Hoʻouna Pono curriculum and introduce new e-cigarette and vaping prevention content, including a social and print media campaign across middle/intermediate and multi-level public and public-charter schools on Hawaii Island.
More than 500 students are anticipated to enroll in the study over five years.
“To our knowledge, this is the first study to develop and test an e-cigarette prevention intervention tailored to rural Hawaiian youth,” Okamoto said. “Our proposed intervention will educate youth on the risks of e-cigarette use, while also reflecting the cultural and relational values of rural Hawaiian youth and communities.”
The European Commission this week decided to register a European Citizens’ Initiative (ECI) entitled “Call to achieve a tobacco-free environment and the first European tobacco-free generation by 2030.”
The organizers of the initiative call on the Commission to “propose legislation to save new generations from falling into tobacco addiction, to act against related environmental dangers and against smoking,” according to a release.
The group asks the Commission to propose legislation to end the sale of tobacco and nicotine products to citizens born in 2010 onwards.
The initiative also calls on specific measures to achieve vaping and tobacco-free and cigarette butt-free beaches and riverbanks, create a European network of tobacco and cigarette butt-free national parks, to extend outdoor non-vaping spaces, and to eliminate advertising.
As this European Citizens’ Initiative fulfils the formal conditions, the Commission considers that it is legally admissible. The Commission has not analyzed the substance of the proposal at this stage, the Commission states.
The organizers now have six months to open the signature collection. If a European Citizens’ Initiative receives 1 million statements of support within 1 year, from at least seven different Member States, the Commission will have to react.
The Commission could decide to take the request forward or not, and will be required to explain its reasoning.
Up to 60 percent of disposable vapor products sold in the U.K. are illicit, according to the U.K. Vaping Industry Association (UKVIA).
Speaking to the U.K. trade publication Convenience Store, UKVIA Director General John Dunne estimated that between 40 percent and 60 percent of disposable vapes currently on sale in the country were either noncompliant with domestic laws or counterfeit.
“Based on the amount of [illicit] products I see in the marketplace, the number of reports of illicit sales and what’s being reported to trading standards, I believe it’s that big and a huge concern,” he explained. “I probably receive between 200 [reports] and 400 reports of illegal sellers in the U.K. every month.”
Dunne warned that noncompliance among retailers could destroy a category with huge potential. “This is a market that has huge growth potential for retailers, if it’s allowed [to] grow in a responsible manner, but having a short-term view and ignoring compliance is going to have a detrimental effect. And potentially lead to things like the category being banned, flavor bans or plain packaging.”
He also called for more action on retailers found to be selling vaping products to those under the age of 18.
BAT is accelerating the pace of price hikes for its e-cigarette brands and traditional tobacco products even as inflation continues to clamp down on consumers’ discretionary spending.
Goldman Sachs analyst Bonnie Herzog released Monday a detailed analysis to investors of the R.J. Reynolds Vapor Co.’s top-selling U.S. e-cigarette Vuse.
Another round of price increases also is set for R.J. Reynolds Tobacco Co. products; list-price hikes went into effect Monday.
Herzog’s reports are based on “industry trade contacts” and are rarely wrong.
The list price is what wholesalers pay manufacturers for their traditional cigarette products. The increase typically is passed on to customers at retail, according to the Winston-Salem Journal.
“While there is some increased risk of potential downtrading and concerns that manufacturers have less pricing power today, we believe brands … with a very loyal customer base and strong/effective promotions should be able to keep those consumers within the franchise,” Herzog said.
Reynolds also is raising by 17 cents per pack the price of its heat-not-burn traditional cigarette Eclipse, which is sold in limited stock.
The market share between Vuse and Juul e-cigarettes continues to grow, according to the latest Nielsen analysis of convenience-store data.
The analysis, released Tuesday, covers the four-week period ending Aug. 13.
According to Barclays, Nielsen largely covers the big chains. For the smaller chains, the group extrapolates trends, which is why trend changes don’t appear immediately in Nielsen.
In recent months, the shadow of a potential banning of Juul Labs Inc.’s e-cigarettes from U.S. retail shelves has accelerated the market-share gains of R.J. Reynolds Vapor Co.’s Vuse brand.
Vuse’s market share rose from 37.4 percent in the previous report to 39 percent, compared with Juul declining from 30.7 percent to 29.4 percent.
Meanwhile, No. 3 NJoy dropped 3 percent to 2.9 percent, while Fontem Ventures’ blu eCigs slipped from 1.7 percent to 1.6 percent percent.
Juul’s four-week dollar sales in the latest report have dropped from a 50.2 percent increase in the Aug. 10, 2019, report to a 20.1 percent decline in the latest report, according to the Winston-Salem Journal.
By comparison, Reynolds’ Vuse was up 39.8 percent in the latest report, while NJoy was down 11.5 percent and blu eCigs down 29.9 percent.
Goldman Sachs analyst Bonnie Herzog wrote in her Tuesday note to investors that Juul’s market share decline occurred in part “following confusion around the FDA’s marketing denial order against Juul.”
Juul still maintains a 33.7 percent to 32.6 percent market-share lead over the previous 52 weeks.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.
Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.
Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.
As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.
According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.
A split 11th Circuit on Tuesday told the U.S. Food and Drug Administration it shouldn’t have denied six e-cigarette companies’ premarket tobacco product applications (PTMAs) to sell flavored vaping products without first taking a look at their marketing and sales plans designed to minimize youth exposure and access.
The U.S. Court of Appeals for the Eleventh Circuit granted petitions for review filed by Bidi Vapor, Diamond Vapor and four other companies challenging the FDA’s rejection of their e-cigarette applications in a 2-1 decision. According to Chief Judge William Pryor, the agency didn’t assess “the companies’ marketing and sales-access-restriction plans designed to minimize youth exposure and access.”
The court explicitly labeled the FDA’s decision-making as “arbitrary and capricious.” Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the court ruled that the FDA had not performed such consideration.
“These tobacco companies submitted survey information from their customers about smoking cessation, literature reviews, scientific studies about switching to e-cigarettes, smoking cessation, and the role of flavors, and details about its marketing and youth-access-prevention plans,” notes the court in its opinion. “For example, Diamond uses technology for its online sales that relies on public records to verify a purchaser’s age.”
Vapor industry advocates welcomed the decision. Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association said that while court ruling does not order the FDA to grant PMTAs—and that the agency is likely to deny the applications in the future—the companies involved could end up in the queue for review in 2025, which keeps them in business.
“Additionally, this leaves the door open for further litigation on these and other PMTAs,” Conley wrote on Twitter. “The FDA’s vague and undefined ‘appropriate for the protection of public health’ standard has long been open for attack. This is just the start.”
The 11th Circuit decision follows revelations that forced the FDA to admit to not considering all evidence when issuing marketing denial orders (MDOs) to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision-making must engage with all available evidence, not just evidence that leads to their preferred outcomes.
The court also recognized relevant distinctions between closed/cartridge systems and the e-liquids used in open systems. The court also found that the FDA’s refusal to review marketing plans was “error and not harmless” (disagreeing with Fifth and DC Circuits).
All petitioners’ appeals were granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote that anyone who knows all the relevant facts of this lawsuit probably already knows how this case will eventually end.
“The Majority faults the FDA for not considering the companies’ proposed restrictions on kids’ use. And to be sure, the FDA said that factor would be relevant,” stated Rosenbaum. “But even assuming that the FDA erred when it didn’t consider the Companies’ proposed marketing and access-restriction plans, the FDA’s framework for evaluating pre-market tobacco product applications leaves no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”
The U.S. Food and Drug Administration Today issued a final guidance on Guidance perception and intention studies.
This guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).
TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.
These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.
This final guidance addresses the following scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:
Developing study aims and hypotheses
Designing quantitative and qualitative studies
Selecting and adapting measures of study constructs
Determining study outcomes
Selecting and justifying study samples
Analyzing study results
This guidance document is intended to provide clarity to applicants regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited.
Milo Vapes Global (MVG) has announced its plan for its Fall 2022 product launch. The range of flavored nicotine vaping products will be released under two brands, Milo Vapour and Sahara Mist, which will be distributed exclusively in the Middle East market.
“Influenced by history and culture, we carefully selected and drafted new and innovative tobacco products that are tailored to the consumers’ tastes and cravings,” says Mike Khalil, president, and founder of MVG. “The company is committed to its mission of delivering solutions to the smoking epidemic by delivering new tobacco products that aim to better smokers’ quality of life.”
The e-cigarettes market is estimated to grow at a rate of 9.7 percent annually and is estimated to reach $485 million by 2025, up from $267.9 million in 2018. MVG aims to contribute to the growth of the e-cigarette market through innovations and brand recognition in conjunction with our harm reduction initiative, according to a press release.
“Governments could play an essential role in changing the population’s behavior toward smoking. The government must regulate and oversee the vape industry in each country, and the health departments should safeguard the vape industry and protect consumers in each country by ensuring the safety and integrity of e-cigarettes,” said Khalil. “Furthermore, healthcare providers should advise smoking patients to transition to less harmful alternatives such as e-cigarettes through healthcare strategies and disease prevention programs.”
I’ve been reading a book in which the author, in passing, casts doubt on the theory, invoked by some physicists trying to explain the complexities and contradictions thrown up by quantum physics, that there are an infinite number of universes in which an infinite number of possibilities are played out.
Although I don’t have a clue about quantum physics, I tend to agree with the author, but I am nevertheless holding the door open just in case the infinite universes theory can account for the following heading, appearing on spanishnewstoday.com: “Spanish in favor of banning smoking on bar terraces.” I am fond of odd headings, and the following one, apparently from rnz.co.nz, is interesting: “‘Young vapers consuming more nicotine than a pack-a-day cigarette habit,’ group says.”
Here, “a pack-a-day cigarette habit” is being compared with “young vapers” in respect of the nicotine they consume, but this cannot be right. A habit does not consume nicotine or anything else for that matter. “Habit” is an abstract noun. It is a construct of the imagination and cannot consume a material compound such as nicotine. A habit has no brain, no blood, no anima.
Even if you were able to add a battery to a habit, it wouldn’t keep banging on those meaningless cymbals, and going and going! What the heading wants to say is quite simple to state: Young vapers consume more nicotine than is consumed by pack-a-day cigarette smokers. The new heading has the advantage, too, of getting around the plural/singular problem of the original, where it seems that plural vapers are being compared with the smoking habit of a single person, leading to the observation: well, of course they would.
The confusion let loose by the heading is explained away in the first sentence of the story where the comparison is rightly made between some young vapers and some smokers. But the first sentence also throws up a further problem with the heading. The comparison is not with someone with a pack-a-day cigarette habit but with someone with a pack-and-a-half-a-day cigarette habit. Obviously, the headline writer didn’t want the longer reference, complete with five hyphens, so she or he merely changed the story.
There are times when numbers in headings have to be manipulated somewhat because they are unwieldy, but this is not the case here. It wouldn’t have taken much effort to figure how many cigarettes are in a pack, add half as many again and include the resulting number in the heading for an accurate tally. If there are 20 cigarettes in a pack in New Zealand, the heading could have read, “Some young vapers consume more nicotine than is consumed by 30-a-day cigarette smokers.”
Headings are there partly to draw the reader in, but they should bear a passing resemblance to the story and what it says.
But this, from brisbanetimes.com.au, is probably my most recent favorite heading: “Smoking laws set to get tougher in Queensland amid vaping concerns.” Here, it’s hard to get the connection. It’s like reading a heading that says, “Driving laws set to get tougher in Queensland amid flying concerns.” If you have concerns about flying, surely, the best approach is to address the laws around that mode of transport, not those regulating driving. And similarly, if you have concerns around vaping, you are best off addressing the laws around that habit, not those controlling the habit of smoking.
I’m fascinated, too, with the use of the passive voice giving rise to a lack of agency behind the possible new laws, which are “set to get tougher.” It seems that nobody is making them tougher; they are simply set to get tougher as the result of some natural law, or perhaps because in their universe, that’s the way things happen.
Credit: StockPhotoPro
But the worst aspect of the heading, in my view, is the reference to vaping because, outside of the heading, vaping is not mentioned in the nearly 500-word story. In fact, there are only three mentions of e-cigarettes, the first nearly two-thirds of the way through the piece. And astonishingly, whereas the heading references both smoking and vaping, the story starts off with “Drinking could be banned ….”
This is a story about an idea put out by Queensland Health (QH) for public discussion—an idea that seems to favor complexity over simplicity. The first sentence has it “Drinking could be banned in the dedicated outdoor smoking areas [DOSAs] of pubs, clubs and casinos in an attempt to compel more Queenslanders to quit cigarettes.” It seems to be an attempt by QH to promote drinking as being an OK habit but to cast people who smoke while drinking as being somehow beyond the pale.
The second sentence says DOSAs could be moved farther away from other patrons and young people banned from mingling with adult smokers. This is a strange concept given that it seems to suggest that DOSAs are patrons and given that the plan seems to be to move DOSAs away from actual patrons as if patrons were fixed objects. But the worst aspect of it is the idea that young people should not mingle with adult smokers.
My bet would be that the risk posed to young people of being close to smokers is very low compared with the risk of their being close to drinkers, especially drunks, and each drinker is a potential drunk. Not convinced? Well, let me ask a question. Given that you had no choice but to leave a young person in the care of somebody who you didn’t know well, would you sooner leave the young person in the care of somebody who had been smoking or in the care of somebody who had been drinking?
QH is fretting and obsessing about secondhand smoke. It says 946,000 Queenslanders, more than half of them nonsmokers, “spent time” in a DOSA during 2018. I suppose we are supposed to gasp in horror, and certainly there is one worrying aspect to this figure. Since 946,000 is about a fifth of the state’s population, and since one has to assume many more people went to drinking holes without going into a DOSA, you have to conclude that Queensland might have a drinking problem.
There is, however, one positive to come out of this. More than 473,000 nonsmoking drinkers in Queensland have the good sense to realize that they are not going to be permanently harmed by visiting a DOSA. Perhaps they have figured out that they are exposing themselves to far greater risk by sitting outside a drinking hole near a road. Around the world, more people die from the effects of outdoor air pollution than die from the effects of both primary and secondary tobacco smoke.
So why is QH attacking tobacco smoking but not pollution? I don’t know the answer, but it might have something to do with the fact that pollution is invisible to the naked eye, while smoke—along with vapor—is easy to spot. It is also the case, of course, that smoking—along with vaping—is a minority activity while polluting is a habit everybody seems to enjoy.
There is one hearteningly honest aspect to what QH is up to. The story states that QH’s aim is “to compel more Queenslanders to quit cigarettes.” QH, according to the story, is not beating about the bush as many anti-smoking organizations do by claiming to be attempting to “encourage” smokers to quit. It has a mission to compel. To compel smokers to quit, and, of course, to compel nonsmokers not to mix with smoker outcasts in the hallowed halls of the state’s drinking holes. What next, I wonder? Perhaps the aim will be to bludgeon smokers into quitting, perhaps even torturing them.
Credit: Anton Dios
But this magazine is about vaping, so let me move onto the last piece of the story, where e-cigarettes get a walk-on part. QH is apparently considering a licensing system for the “suppliers, wholesalers and retailers of smoking products, including e-cigarettes” that would allow those licences to be revoked for “serious breaches.”
Note the way that e-cigarettes are deemed, without even mentioning it, to be smoking products. This is what occurs, I suppose, in another of those multiple universes, also much loved by the U.S. Food and Drug Administration—a magical place where smoke is considered, scientifically, to be the same as vapor.
E-cigarettes are described by QH as being not a vehicle for shifting smokers away from their habit but as one of a number of “new challenges which threaten to erode success in reducing the negative effects of smoking.” “E-cigarettes have emerged to broaden the smoking product market and are promoted as less harmful, contained in attractive packaging and supplied in an array of interesting flavors,” QH is quoted as saying.
Here, to my way of thinking, QH loses the plot completely. E-cigarettes didn’t passively emerge; they were developed by responsible people who realized that existing efforts to help people stop smoking were failing and that this new vaping device could be more effective.
Everything about QHs statements on e-cigarettes seems designed to denigrate the product. The fact that they are offered in interesting flavors and contained in attractive packaging is made to seem negative. Note to QH If you want people to quit smoking, you need to make your offer interesting and attractive. Making smokers appear to be outcasts fails horribly because outcasts, by definition, are not bound by societal norms.
Then, we have the great finale. “While evidence on the safety and efficacy of these products continues to develop, there is now sufficient data that e-cigarettes are not without harms to health and that they pose a significant risk for creating a new generation of Queenslanders for whom smoking and regular nicotine use is normal,” QH is quoted as saying.
The “evidence” that is continuing to emerge on e-cigarettes—again, apparently without agency—is not stated in the story because, I assume, it is hugely in favor of the efficacy of e-cigarettes. What we get instead is a statement about how there is sufficient data that e-cigarettes are not without harms. Again, this is all over the place. What QH is saying is that the use of e-cigarettes is not risk-free. Well of course it isn’t. Nothing is risk-free. But what QH is trying to imply, without presenting any evidence, is that the use of e-cigarettes is riskier than anyone could possibly know.
QH might be right, however, in saying e-cigarettes could eventually regularize the use of nicotine, but then people do use recreational drugs, and vaping has to be a whole lot better for you than smoking cigarettes or drinking alcohol.
I’m sorry, but I cannot resist one last dig. The following sentence opened a recent neweurope.eu story: “The European Commission announced that the proposal for the revised tobacco excise directive will be made public at the beginning of 2022’s fourth quarter during a digital consultation session that was held on May 18, with the participation of commission officials and other interested parties such as retailers, associations, representatives of scientific and medical associations as well as representatives of the tobacco industry.”
What I like about this overlong sentence and the universe in which it works is that time is so fluid. Perhaps those quantum physicists would see it as existing or not in Schrodinger’s box. But to make it work on this planet of the known universe, you would have to rework it as something like, “The European Commission announced during a digital consultation session held on May 18 that the proposal for the revised tobacco excise directive would be made public at the beginning of 2022’s fourth quarter ….”
