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 headline sponsor of the UK Vaping Industry Association’s (UKVIA) Vaping Industry Forum and the Vaping Celebration and Awards dinner after the conference has been announced as VPZ, a UK-based independent vape retailer and manufacturer.
The UKVIA organizes both events. VPZ, one of the founding members the UKVIA, is the UK’s largest vaping specialist with over 150 stores throughout the country.
Last year VPZ introduced a national vape clinic service and is now taking this on the road throughout the UK to help more people start their stop smoking journey.
Other sponsors currently include FEELM, the flagship tech brand belonging to SMOORE and the world’s leading closed vape system solution provider; Geek Bar, the leading disposable vape manufacturer in the UK and 1account, an age and identity verification service provider used by some 40 percent of the UK’s online vape retailers, according to a press release.
Official event and media partners of the event include World Vape Show and ECigIntelligence, Vapouround, Vapour magazine, Planet of the Vapes, Vape Business and Vapor Voice.
The UKVIA forum, which is being held at the QEII Centre in Westminster on Friday, Sept. 9th, will cover many of the current dominant issues in the vaping industry, including the regulatory landscape, compliance and enforcement, youth access prevention and the sustainability of the vaping industry.
The findings of the industry’s first ever economic impact report, commissioned by the UKVIA, will also be unveiled at the forum by Owen Good, head of economic advisory at the Centre for Economics and Business Research.
John Dunne
“We are expecting a record turnout as the forum comes at a key time for the industry, in between a government-commissioned independent review by Javed Khan, which highlighted that vaping has a pivotal role to play in making smoking obsolete; and the delivery of a new Tobacco Control Plan which is an opportunity for the government to positively review the vaping regulatory landscape post-Brexit,” said John Dunne, director general for the UKVIA.
The event will also feature an exhibition alongside the conference and an evening dinner where a number of industry recognition awards will be handed out to individuals and organizations that have done the most to promote and progress the vaping sector.
Headline sponsor for the awards dinner is VPZ and the entertainment sponsor is Alternative Nicotine Delivery Solutions (ANDS).
Regulating the vaping industry in South Africa is complicated by deception and distraction.
By Asanda Gcoyi
The advent of electronic nicotine-delivery systems (ENDS) and electronic non-nicotine delivery systems (ENNDS) has taken the world of public health policy by surprise, it would seem. Nowhere is this more apparent than in developing and under-developed countries.
Where previously countries with little public health policymaking capacities could rely on the World Health Organization for guidance on tobacco regulation, the deep uncertainties plaguing the WHO on the best way to regulate ENNDS have left many countries unsure how to regulate important innovation in nicotine delivery.
In South Africa, this challenge has proven particularly acute. As a former leader in tobacco control, the country has struggled to institute an ENNDS regulatory framework. In May 2022, it was four years since the government first published the draft Control of Tobacco Products and Electronic Delivery Systems Bill for public comment. The bill updates the country’s longstanding Tobacco Products Control Act, first adopted in 1993.
It does this by introducing more restrictions on tobacco sales and consumption. In a stroke of policy confusion, the bill extends the restrictions imposed on combustible cigarettes to ENNDS. To date, the draft bill has not been approved by the Cabinet for tabling in Parliament, precisely because it is based on misinformation and hubris.
In general, proposals to restrict smoking and make it difficult for nonsmokers to be initiated into the habit are to be welcomed. However, it is entirely misguided to have the prevention of initiation as its sole objective of public health policy in a country with a staggering 8 million smokers out of a population of 60 million.
South Africa does not have the resources to support smokers quitting. Other than a barely functional quit line, the country does not have any smoking cessation programs sponsored by the public health system. Nicotine-replacement therapy is not freely available. There are no counselling facilities.
Asanda Gcoyi
While the South African government cannot generally be regarded as lacking in policy-making capacity, especially in the area of tobacco control, it can be concluded that shifting narratives about ENNDS have left the government in a difficult position. WHO prevarication on the topic has not helped matters.
Where government could previously rely on the WHO to issue unequivocal policy guidance, the growing impasse between the WHO and members of the public health community in support of ENNDS as a harm reduced alternative to smoking has put government at a loss on how to proceed on ENNDS regulation. Growing scientific evidence challenging the natural inclination of the WHO to castigate behaviors it does not agree with is proving especially challenging.
While the ENNDS industry in South Africa shares government’s concern about a new generation of nicotine consumers, it remains a concern that government proposals to regulate ENNDS do not correlate with the intended outcome of reducing smoking.
As has been demonstrated in places such as the U.K., ENNDS are an efficient tool for moving smokers to potentially less harmful alternatives, with some even deciding to quit. It is a major public health policy opportunity, especially for developing countries such as South Africa, to reduce their costs of public health resulting from noncommunicable diseases associated with smoking.
In the four years that the government has attempted to come up with a regulatory framework for ENNDS, the Vapour Products Association of South Africa (VPASA) has been at the forefront of calling on government to consult beyond its fellow travelers in the anti-tobacco advocacy lobby. Sadly, this has not happened.
Instead, the government has continued to rely on outdated, heavily biased studies to back up its untenable policy positions, including the rightly maligned and withdrawn study by Stanton Glantz, a researcher with the University of California, San Francisco School of Medicine, titled “Electronic Cigarette Use and Myocardial Infarction Among Adults in the U.S. Population Assessment of Tobacco Health,” published by the Journal of the American Heart Association in 2019.
Currently, the government looks set to introduce a tax on vaping products. This is partly justified on the basis of this and other problematic studies, some conducted as long ago as 2014. This happens against the backdrop of new scientific studies demonstrating the likely benefits of adopting ENNDS as part of a broader tobacco control strategy.
Regrettably, South Africa is not alone in embracing such misdirected policies on ENNDS. Whereas there are easy wins on tobacco control, it seems governments across the developing world have resolved to limit the very innovation that promises the most success in weaning smokers off their deadly habit. From Botswana to Kenya to Mauritius, governments in Africa and other parts of the world are resorting to draconian measures to control ENNDS rather than looking closely at the science and embedding this in their regulatory approaches.
Overall, smokers, especially poor ones, are likely to be the biggest losers in the overzealous regulation of the vaping industry. This is a direct result of governments that fail to take into account their duty to listen not only to the views they like but also those they may not necessarily appreciate.
The truth is that even the most rabid anti-ENNDS campaigner accepts that there are major differences between smoking and vaping. As such, it makes sense that governments should differentiate between the two behaviors when putting in place regulatory measures. Such differentiation should favor ENNDS over combustible products. This is not happening in the developing world. Certainly, it is not happening in South Africa. Quite the opposite is being pursued.
Given tobacco’s dominant and entrenched position as the preferred nicotine-delivery system for most nicotine addicts, stringent restrictions against ENNDS disincentivize smokers from switching. Sustained disinformation and outright lies about ENNDS make this worse. Governments complain about the costs of smoking to the public purse yet seek to protect the biggest drivers of such costs by protecting the tobacco industry from the only real alternative to emerge against smoking.
The VPASA will remain committed to the fight against senseless regulation in South Africa. To not do so would be to fail the millions of South African smokers who are desperate for alternatives to tobacco.
Asanda Gcoyi is the CEO of the Vapour Products Association of South Africa.
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 ….”
The city council for Foster City, California has tabled an ordinance prohibiting sales of flavored e-cigarettes and other tobacco products over potential litigation concerns and a desire to see what actions the state takes in November.
The council voted 2-2 on the proposed ordinance ban. Councilmember Sam Hindi recused himself because his business sells tobacco products, according to The Daily Journal.
Councilmember Patrick Sullivan wanted to table the item over litigation concerns because some tobacco retailers have sued cities like Palo Alto for ordinances. However, Forest City staff said no litigation has successfully overturned the ordinances.
“I’m not comfortable with moving forward,” Sullivan said.
San Mateo County and cities like Half Moon Bay, South San Francisco, Burlingame, San Carlos, San Mateo and Redwood City have prohibited selling flavored tobacco, with several others considering bans.
The state has also weighed in with Senate Bill 793, signed into law in 2020, which calls for tobacco retailers not to sell flavored tobacco products.
However, implementation has been halted due to a referendum calling for its repeal, stalling a decision.
Recently, U.S. Food and Drug Administration Commissioner Robert Califf announced an external evaluation of both the Human Foods Program and the Center for Tobacco Products (CTP). The FDA press release observed that “… even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. To that end, the review will push toward ‘organizational excellence.’”
Califf is right—the CTP clearly requires assistance. The purpose of this article is to review how the CTP arrived in this untenable situation and to suggest areas of focus for the review of the CTP processes.
How Did We Get Here?
There is little doubt that the CTP is in an unenviable position. No matter which way the agency turns, it is impossible to please everyone. The anti-tobacco/vaping groups will never be satisfied until all tobacco products are gone—so realistic harm reduction propositions from the center will always be met with opposition. And when the CTP tries to develop policies with a focus on efficiency, many in the industry claim that they are “prohibitionist” and that they have no regard for harm reduction and/or the human and economic consequences of their decision-making.
Recently, several court opinions and CTP actions have significantly contributed to the challenging environment for the CTP:
West Virginia v. EPA. While not directly related to the CTP, the West Virginia v. EPA Supreme Court decision has reopened the question as to whether discretion of regulatory agencies may become more limited in the future. The court seems poised to chip away at longstanding doctrines (or apply them more forcefully) to limit agency power and place policymaking back with the legislature.
Cigar Association of American v. FDA. More recently, in the Cigar Association of America v. FDA case, Judge Amit Mehta of the U.S. District Court for the District of Columbia examined whether the FDA’s decision not to exempt premium cigars from the Deeming Rule was arbitrary and capricious. The court ultimately found that the FDA ignored evidence in the rulemaking record—and ruled against the agency.
Juul v. FDA. Days later, the CTP found toxicological issues with Juul’s popular vapor products and issued marketing denial orders (MDOs) for those products. Not surprisingly, Juul immediately requested and received an emergency stay of the MDOs from the D.C. Circuit. Without missing a beat, the CTP promptly “… administratively stayed the marketing denial order. The agency [determined] that there are scientific issues unique to the Juul application that warrant additional review.” Several commentators questioned the CTP’s rationale for its decision to re-review Juul’s applications, and some have gone so far as to suggest that this quick reversal indicates a less than appropriate review of Juul’s data or worse—a lack of confidence in the CTP’s decision-making. Either way, the entire chain of events draws into question the CTP’s review process.
Finally, the CTP is still under pressure to complete decisions on premarket tobacco product applications (PMTAs) for those companies addressed in the Maryland court decision which, according to the CTP, will not be completed until next summer. Further compounding the CTP’s problems, the center continues “processing” approximately 1,000,000 synthetic nicotine PMTAs past the congressional deadline for marketing decisions on July 13, 2022. How the center will respond to this pressure is anyone’s guess. So far, it seems like the CTP continues to move at its own pace, following the Maryland court’s order to the best of its abilities.
These external and internal factors point to one conclusion that cannot be ignored—the CTP appears to be struggling and needs something to change. With the above in mind, the following are a few areas ripe for external (and internal) review at the CTP.
Credit: Fizkes
Operational Changes
Operationally, the CTP seems to have the resources (personnel and budget) to successfully regulate tobacco products. That said, certain policy choices and administrative actions (both self-inflicted and externally inflicted) appear to hamper the center’s ability to effectively manage the space. Importantly, effective regulation is hamstrung by the complexity of the U.S. tobacco regulatory scheme, a lack of clear standards for product testing and approval and a too opaque product application process.
The most challenging operational issues come from the existing regulatory scheme, which is too complex for tobacco products. The Tobacco Control Act dictates the parameters/guardrails, but the CTP has latitude in how the process is implemented. The comprehensive PMTA guidance and robust final rule demand a scientific depth that goes too far. The question is: Is all of the delineated scientific data really necessary to determine that a product is appropriate for the protection of public health (APPH)?
If comparing to combustible cigarettes, it would seem that most electronic nicotine-delivery product APPH determinations could be made based on chemistry alone. Piling on bench toxicology, human factors, pharmacokinetic and behavioral studies, it’s no wonder the review process takes so long.
Standards are not clear. Without clear standards, the CTP and industry both are left constantly employing guesswork and conjecture to facilitate decision-making. While understandably there is no simple formula for APPH, clear expectations would be beneficial and efficient. By way of example, which device characteristics really need testing? What is the depth of stability testing necessary? What constitutes a sufficient PK [pharmacokinetic] study? While the initial meeting with the Office of Science is often useful to help answer questions like these, better defining product-specific standards and setting minimums would go a long way to streamlining the approval process.
Transparency is lacking. While one can review the Technical Project Lead Reviews and some of the review standards memos that the CTP places on its website, few PMTA applicants have any idea what’s going on with their applications at any given time. Other than the initial pre-PMTA meeting and the sole deficiency letter, there is little that applicants know about the status (both administratively and substantively) of their applications. While more transparency about the status of applications would be welcome, more back and forth on issues in applications would benefit everyone—particularly the CTP. In the case of Juul, reports indicate that Juul provided thousands of pages of data related to the toxicological issue that the CTP raised in the MDOs. If the now outdated additional information requests were utilized by the CTP, Juul would have pointed out this data, and at least one issue could have been resolved well short of a trip to the courthouse.
Credit: Oleg
Policy Changes
It goes without saying that U.S. government policy can be fickle to say the least. Setting and maintaining long-term policy is difficult—especially in light of changing administrations every few years. Despite this, overriding policy tenants as they relate to harm reduction can, and should, form the cornerstone of tobacco regulatory policy. If harm reduction is the priority, then regulators need to prioritize pathways for reduced-harm products to enter the market, incentivize innovation and focus on providing offramps to combustible cigarette smokers seeking to quit smoking.
Harm reduction policy. During the tenure of former Commissioner Gottlieb at the FDA, many in the industry thought harm reduction would prevail and that all would recognize vapor products’ place at the opposite end of the continuum of risk from combustible cigarettes. Unfortunately, the significant uptick in youth experimentation with a few types of vapor products prodded the CTP into a tough position. Public health groups, dissatisfied with the CTP’s pace, forced the center into a corner via litigation.
Assuming the goal of the Tobacco Control Act remains to reduce smoking-related morbidity and mortality, harm reduction strategies are central to achieving that goal. Importantly, harm reduction strategies should be palatable to all stakeholders. While the CTP has several initiatives moving forward, is there a plan for initiatives dedicated to moving smokers to safer alternatives? Efforts to move smokers to less risky alternatives do nothing when those less risky alternatives cannot succeed via the PMTA pathway. Current tobacco policy is remarkably dissimilar from the variety of strategies employed for other unsafe behaviors where harm reduction is embraced as the primary alternative. In areas such as drug use and sexually transmitted diseases, our society generally accepts reduced-harm efforts, but for tobacco, collectively we are still searching for that sweet spot.
Given all the challenges that the CTP faces, working on harm reduction policies hand-in-glove with nongovernmental groups and industry probably does not seem like the best use of time. When the center was first formed, frequent scientific meetings were held on various issues (such as harmful and potentially harmful constituents). These have fallen off in recent years, likely in part due to Covid and also due to the onerous demands on the center. Prioritizing genuine and open conversations between the CTP, industry and tobacco control groups is critical to developing strong harm reduction policies. Holding scientific meetings (either through the CTP or the Tobacco Products Scientific Advisory Committee) on harm reduction plans and policies would add transparency and bring all ideas to the table.
The FDA should not let the perfect be the enemy of the good when considering reduced-harm products. At present, PMTA reviews appear to be searching for the perfect. Reviews seem to focus on the smallest details that might pose a risk while ignoring a more generalized comparison to combustible products with 70 known carcinogens (and a track record of 480,000 deaths per year). APPH does not mean no risk—it means less risk than the deadliest consumer product ever invented, the combustible cigarette. Reconsidering how APPH is adjudged would be an excellent first step in combatting morbidity and mortality attributable to smoking.
Investing in harm reduction must be incentivized. If one wants to develop a new product, the timeline is a hard stop. A year of product development, up to three years of PMTA testing (including two years of stability and time to plan, conduct and write up the studies) plus one year to three years of the CTP review before the possibility of a marketing order sounds like a pretty poor investment. The PMTA process must change to bring less risky products more rapidly to market.
Society must not forget about smokers. Youth tobacco issues are important, but the 1,300 smokers dying each day are important too. A balanced harm reduction policy—controlling youth access and exposure while moving combustible cigarette smokers to quitting tobacco altogether or moving to a less risky product is necessary.
Moving Forward
Hopefully the external review will be a fruitful exercise—one that provides robust alternatives for the CTP to consider. The review, if rightly focused, will address foundational issues that will, in the end, lead tobacco regulation to a reasonable, reduced-harm world where smokers are given hope for a future.
Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
Rich Hill is the compliance director and associate general counsel of E-Alternative Solutions.
The UK’s largest vaping retailer VPZ has announced its intent to open 10 additional stores by the end of the year.
It comes as the business called for the UK Government to introduce tighter controls and licensing for selling vaping products.
The business will increase its portfolio to 160 locations across England and Scotland, including stores in London and Glasgow, according to a press release.
VPZ made the announcement as it takes its mobile vape clinic on the road throughout the country.
It comes as Government ministers continue to promote vaping, with Public Health England claiming e-cigarettes carry a “fraction of the risk of smoking”.
However, last month research indicated a steep rise in underage vaping over the last five years, according to Action on Smoking and Health.
Doug Mutter, director of VPZ, said that VPZ is spearheading the fight against the nation’s No. 1 killer – smoking.
“Our plans to open 10 new stores and the launch of our mobile vape clinic responds 100 percent to our ambition to engage with more smokers throughout the country and help them take the first steps on their quit journey.”
Mutter added that the e-cigarette sector could be improved, calling for greater scrutiny of those selling products,
“At the moment we have a challenge in the industry where imported, many unregulated, disposable vaping products are readily available from local convenience stores, supermarkets and several other general retailers with no age verification control or regulation in many of these,” said Mutter.
“We are urging the UK Government to act now and follow best practice from countries like New Zealand, where flavoured products can only be sold from specialist licensed vaping stores, where a challenge 25 policy is in place and consultation is aimed towards adult smokers and vapers.
“VPZ is also in favor of substantial fines for those who breach the rules.”
