Category: Neil McKeganey

  • A Missed Opportunity

    A Missed Opportunity

    Photo: luciano

    E-cigarettes and older smokers

    Neil McKeganey, Gabe Barnard and Andrea Patton

    Amid the intense media focus and regulatory action directed toward youth vaping in the U.S., there is another population demographic whose e-cigarette use is worthy of attention—though in this case, more as a result of their relative lack of use of these devices. There are an estimated 17 million adults in the U.S. aged over 45 who are smoking every day or some days. With research showing that quitting smoking by age 50 is associated with a gain of around six years in life expectancy, the question of how best to boost smoking cessation efforts among older smokers is of increasing importance.

    Although e-cigarettes have become hugely popular as a means of quitting smoking, research undertaken by the Centre for Substance Use Research (CSUR) shows that the use of these devices by older smokers in the U.S. is only a fraction of what it is among younger smokers. According to the CSUR’s Tobacco Product Prevalence Study, while 11 percent of adult smokers aged 25 to 44 years report currently using e-cigarettes, that figure drops to 5.2 percent in the case of those aged over 45.

    The CSUR research also shows that the likelihood of older female smokers using e-cigarettes is even less than is the case for older male smokers. Even in the face of the overall low levels of e-cigarette use, it was evident that some brands were more successful than others in attracting older smokers, with Vuse, Smok and Voopoo reported as being used more widely than other brands.

    But why might there be a disparity in overall levels of current e-cigarette use between older and young smokers? We know from research that smoking quit attempts are influenced by the level of nicotine dependence and smoking duration. It may be that for these combined reasons, older smokers are less drawn to e-cigarettes as a route out of smoking.

    Equally, many older smokers might perceive e-cigarettes as devices that are more often associated with young adult lifestyles and for that reason alone may be seen as something that is not for them. Whatever the reasoning behind the lower levels of e-cigarette use among older smokers, there is much to be gained from identifying how that disparity might be tackled. To do this, it will be necessary to find out much more about why e-cigarettes appeal to some groups more than others and for e-cigarette manufacturers to explore ways of developing products that are specifically designed to appeal to the older smoker.

    There is a further reason why the vaping industry might be wise to give greater attention to the older smoker, which has to do with the importance of tackling youth vaping. If e-cigarette manufacturers succeed in developing a vaping product that appeals to the older smoker, there is a strong possibility that their success in this regard will result in a product that has low youth appeal.

    The likelihood of young people wanting to use a product that is associated with the older smoker is almost certainly less than the likelihood of an older smoker being drawn to a product they see as being associated with youth use. Vaping products developed specifically for the older smoker may have an increased chance of securing a marketing authorization from the U.S. Food and Drug Administration under its premarket tobacco product application process, securing access to a large market of potential new consumers. It’s worth remembering too that the market of smokers aged 45 and over within the U.S. may be in excess of 17 million, underlining the potential gain for the companies who succeed in winning that market.

  • A Risky Strategy

    A Risky Strategy

    Photo: kurgu128

    Banning e-liquid flavors may not achieve the outcomes that proponents have in mind.

    By Neil McKeganey, Gabriel Barnard and Christopher Russell

    In the world of drug development, very clever people spend a lot of time determining what chemicals need to be combined, in what quantities, over what duration and with what frequency, for a medication to have maximum therapeutic effect. By contrast, much less attention is directed at determining the color, shape, taste or aroma of the pill or capsule involved. If we think of e-cigarettes principally as drug delivery systems, with the drug in question being nicotine, we similarly may come to think that issues of taste and flavor are of secondary importance. In reality, flavors may exert a huge influence in shaping how, why, when and whether adults who smoke use e-cigarettes as an alternative to smoking.

    Faced with concerns around youth vaping, there have been increasingly strident calls to ban all e-liquid flavors other than those that tase and smell like tobacco or menthol. The belief here is that by restricting e-cigarette flavors in this way, fewer youth will vape while leaving adults who smoke able to access at least a couple of the flavors that have been available for use.

    The risks here are considerable. First, there is the possibility that, even in the face of a ban of e-liquids containing characterizing flavors, youth interest in and use of e-cigarettes remain unchanged. That possibility is by no means unlikely given that the U.S. National Youth Tobacco Survey has shown that flavors lag well behind “curiosity” and “family and friends use” in terms of youths’ reasons for vaping. Second, there is the risk that by reducing the range of available e-liquid flavors, fewer adults will use e-cigarettes as a route out of smoking.

    At the moment, e-cigarettes are very popular. They are typically cheaper than regular cigarettes, available in a huge range of flavors, can be discretely used in a wide range of settings, and they can help adults to quit smoking. As e-cigarettes sit increasingly in the crosshairs of regulatory control, we can see each of these benefits steadily being reduced as a result of initiatives to ban flavors, raise taxes, shrink the number of outlets selling e-cigarettes and increase restrictions on where people can vape. The upshot of those accumulated restrictions may be that youth vaping remains largely unchanged while fewer adults use e-cigarettes as a way out of smoking.

    In the past, when faced with an increase in rates of volatile solvent abuse (glue sniffing) among U.K. youth and ingestion of Tide Pod detergents by youth in the U.S., the call to ban these products was resisted in favor of restrictions that were placed on how these products could be displayed and sold in retail outlets. In the case of volatile solvent-based products, out went the open shelves of solvent-based glues and cleaning products and in came the locked glass cabinets and the requirement to ask sales staff directly to provide access to the desired product.

    Through restricting how these items could be displayed, we found a way to ensure a useful household product could continue to be sold while reducing youth access to harmful chemicals. The case for trying to do the same with e-cigarettes is even greater and more compelling. The price of failure here is not simply the loss of a range of helpful household products, for which there were available alternatives, but the loss of what may be the single most impactful innovation in promoting adult smoking cessation.

    The options are stark. In the face of proposals to ban characterizing flavors, it will become increasingly important for industry to support independent research showing what role flavors play in consumers’ decisions as to whether to vape, what to vape and, most importantly, whether to continue or cease smoking. Where flavor bans are initiated, it will be important to monitor what happens once the range of preferred flavors are no longer available; will adults who have already switched from smoking to vaping with the help of now-banned flavors revert back to smoking instead of using the narrowed range of available vape flavors to “stay switched?” Will fewer adults who smoke adopt and use e-cigarettes as a route out of smoking? In addition, industry would be wise to consider ways in which flavored e-cigarettes can be packaged and displayed that actually reduce youth interest in and access to these products.

    If we fail to find a way to balance the need for youth protection and the importance of adult consumer choice in promoting smoking cessation, there is a real risk that we will have undermined vaping as a popular, permanent road away from smoking. The cost of that failure will be measured not in the loss of a range of useful household products, as was the case with volatile solvents and Tide detergent pods, but in the loss of millions of lives of adults who smoke.

  • Show Them the Numbers

    Show Them the Numbers

    By Neil McKeganey and Andrea Patton

    To prevent nicotine pouches from being legislated out of the market, manufacturers must demonstrate the extent to which they are benefiting adult smokers, and quantify underage usage.

    By Neil McKeganey and Andrea Patton

    As tobacco companies seek to market lower harm alternatives to combustible cigarettes, there is one issue that is seriously undermining those efforts—youth use of their products. If you were in any doubt as to the scale of the threat that youth use of tobacco products represents for manufacturers, think Juul, Puff Bar, Elf Bar and disposable e-cigarettes in general. And now, critics of the tobacco industry have a new product in their sight. Fresh from their success in calling for the banning of disposable e-cigarettes, they are shifting attention to nicotine pouches with an increasingly familiar playbook of media alarm, political pronouncements and regulatory action.

    The widest-selling nicotine pouch product in the U.S. is Philip Morris International’s Zyn, which grew in sales from 126 million units in 2019 to 808 million units by March 2022 (Majmundar et al. 2022). Accounting for 58 percent of the U.S. nicotine pouch market, Zyn has become a key part of PMI’s next-generation nicotine product range. It is also a product that has not had to work hard to find its critics.

    Zyn is “a pouch packed with problems,” according to Senator Chuck Schumer. “These nicotine pouches seem to lock their sights on young kids—teenagers, and even lower—and then use the social media to hook them,” the senator said. Alongside Schumer’s dire warnings of a future in which young Americans are increasingly dependent on oral nicotine products, there has been a torrent of media articles casting Zyn as a major new threat to U.S. youth. In a New York Times article published at the start of the year, Emily Dreyfuss opened parents’ eyes to a world of “Zynfluencers”—social media personalities assiduously promoting oral nicotine products such as Zyn to their followers. Dreyfuss has called for age-gated advertising restrictions to limit young peoples’ exposure to “Zynfluencer” activities.

    In contrast to the often hysterical tone of the media reporting on underage use of nicotine pouches, the National Youth Tobacco Survey (NYTS) estimated that in 2023, 1.5 percent of U.S. middle school and high school students had used oral nicotine pouches in the past 30 days. Likewise, the 2023 Tobacco Product Prevalence Study (TPPS) undertaken by the Centre for Substance Use Research (CSUR) in Scotland estimated that 1.7 percent of 13-year-olds to 20-year-olds in the U.S. had used a nicotine pouch in the past 30 days.

    While the NYTS data relates to the category of oral nicotine pouch use, rather than Zyn in particular, the TPPS also quantifies the prevalence of underage use of Zyn and other tobacco products and devices, with 0.5 percent of 13-year-olds to 20-year-olds in the U.S. reporting past-30-day use of Zyn. Neither the NYTS nor the TPPS are detecting epidemic levels of oral nicotine pouch use among young people in the U.S. TPPS estimates show further that Zyn use is infrequent, with 70.8 percent of underage past-30-day pouch users reporting use on between one day and five days of the past 30 days.

    If most U.S. Zyn sales, and subsequent use, are among those aged over 21, the possibility exists that these products may be helping adult smokers to switch from combustible to noncombustible tobacco products. Despite this, the U.S. Truth Initiative has called for a nationwide ban of Zyn.  

    In the face of such calls, it will be inadequate for the industry to stress that these products are intended solely for adult smokers as an alternative to combustibles. The problem facing PMI and other oral nicotine product manufacturers is how to respond to claims of widespread use of their products by young people.

    There are two things that companies must do if they are to stand any chance of keeping their products on the market. The first is to show the extent to which these products are benefiting adults who smoke. The data required here involves showing the impact of an oral nicotine product such as Zyn on an adult smoker’s ability to completely switch away from smoking or to substantially reduce their use of combustible cigarettes over a six-month to 12-month period.

    Secondly, companies must quantify the extent to which their oral nicotine products are indeed being used by those below age 21. The CSUR’s Tobacco Product Prevalence Study is the only national probability-based study that collects data on a range of individual tobacco products among both adults and youth within the U.S. and provides timely estimates of use. As such, it can help manufacturers present important data to regulators on the actual extent of youth use of their products.

    Unless the industry assembles the evidence with which to respond to political and media commentators’ calls to ban oral nicotine products, these companies are going to face an increasingly difficult future. The calls to ban oral nicotine products, in the absence of data showing how widely specific products and devices are being used by youth, provides an indication of just how influential a coordinated campaign against a specific product or category of products can be. It is ironic that many of those calling for such bans, no doubt motivated by a commitment to public health, find themselves advocating for legislation that will narrow rather than expand the routes out of smoking.

  • The Risk of an Own Goal

    The Risk of an Own Goal

    Image: anekoho

    Making e-cigarettes available only on prescription may be a net negative for public health, writes Neil McKeganey.

    By Neil McKeganey

    In response to the rising level of vaping there have been discussions in the U.K. and elsewhere about making e-cigarettes available on prescription only. Within the U.K. Wes Streeting, shadow secretary for health and social care, recently announced that an in-coming Labour government would consider such a restriction as a way of reducing youth vaping.

    There is now clear evidence that e-cigarettes are both popular among smokers and that they can help smokers to quit. Alongside such positive evidence there is also the downside of rising numbers of young people using these devices irrespective of whether they are smoking.

    Whilst making e-cigarettes available on prescription may seem like an effective way of reducing youth use of these devices, the reality could prove very different. The fact that young people—including some below the legal age of purchase—are vaping underlines the reality that there are more routes to obtaining these devices than legal sale.

     It is entirely possible that even in a situation where e-cigarettes were available on prescription only that some young people would still source these devices through illicit routes. Whatever the impact on youth vaping, making e-cigarettes available only through prescription would reduce adult smokers access to these devices. In the event that such a policy were implemented, some adults would certainly go to their doctor seeking a prescription for these devices. Others, however, would be less inclined to go to their doctor. Some of those might source their e-cigarettes through illicit supply whilst others would simply continue to smoke.

    There is a further reason why making e-cigarettes available on prescription only may have a downside. Research has shown that using e-cigarettes can increase the likelihood of smoking cessation even when the individual had no prior intention of quitting. Analyzing data from the widely respected Population Assessment of Tobacco and Health study in the United States, Professor Karin Kasza and colleagues from the Roswell Park Comprehensive Cancer Center found that adult smokers who had no prior interest in quitting smoking still stopped smoking in impressive numbers following their use of an e-cigarette. Such “accidental quitting” has been found in other studies, with Professor Riccardo Polosa and colleagues in Catania, amongst others, showing that simply providing smokers with access to e-cigarettes helps many to quit even where they have expressed no prior interest in quitting.

    As is so often the case when it comes to regulating e-cigarettes, the question is one of how to balance the needs of young people, who ought not to be using these devices, with the needs of adult smokers who may benefit from their use. Whilst making e-cigarettes available on prescription only may reduce some young peoples’ use of these devices, regrettably it may have the same if not greater effect on adult smokers. 

    The public health goal of reducing smoking is too important to implement a policy that may be less effective than one might hope in reducing youth vaping whilst actually reducing adult smokers access to these devices. The challenge facing manufacturers, regulators and health educators is one of finding a way to reduce youth access to these devices whilst at the same time ensuring that any adult smoker wishing to use an e-cigarette can do so with the least possible difficulty. Requiring adult smokers to seek an appointment with their doctor before they can legally access an e-cigarette device is to place a huge barrier in the way of wider e-cigarette use by smokers and wider intended and accidental quitting on the part of those adult smokers. This is a restrictive regulation that needs to be given serious consideration before being implemented.

  • A Ban By Any Other Name

    A Ban By Any Other Name

    Photo: kurgu128

    The FDA’s reluctance to permit flavored e-cigarettes may be hindering adult smokers’ conversions to less harmful products.

    By Neil McKeganey and Andrea Patton

    If there is one phrase that must keep e-cigarette and e-liquid company executives awake at night, it must surely be “flavor ban.” In their public statements, U.S. Food and Drug Administration officials have always denied pursuing a ban on e-liquid flavors, encouraging e-cigarette manufactures instead to “show us the data” where e-cigarette flavors are compared to tobacco flavor in terms of their effectiveness in assisting adult smokers in quitting. 

    The reality of the premarket tobacco application process, however, tells a rather different story. Of the more than 6.7 million applications submitted—over 99 percent of which the FDA has adjudicated upon—not a single flavor other than tobacco has been awarded a marketing authorization. On the basis of those numbers, whether admitted or not, there is an e-cigarette flavor ban in the U.S. in all but name.

    But why have flavors drawn such restrictive regulatory action from the FDA? The answer, of course, lies in youth vaping. So great has been the concern at the increase in youth vaping that politicians, public health officials, the media, parents and others have found themselves asking the questions “why are so many kids vaping, and how can we stop it?” When Scott Gottlieb was the director of the FDA, he offered an answer to that question in railing against “kid-appealing flavors.” In the years following Gottlieb’s tenure, it seems the phrase “kid appealing” has been dropped in reference to characterizing flavors per se as the villain of the piece when it comes to youth vaping.

    But how can we be sure that it is indeed e-liquid flavors that are driving youth vaping? A surprising answer to that question can be found in the latest results from the 2022 National Youth Tobacco Survey. This survey draws upon data from over 28,000 middle school and high school pupils from across the U.S. and is one of the leading influences on government policy when it comes to e-cigarettes.

    When youth who had ever tried an e-cigarette were questioned about the reasons why they first used an e-cigarette, flavors were the ninth most frequently cited reason among middle school pupils and the seventh most frequently cited reason among high school pupils. In explaining their reasons for starting to vape, both middle school and high school pupils much more commonly mentioned curiosity about e-cigarettes, the fact that e-cigarettes were being used by friends or family members, or that they felt anxious, stressed or depressed.

    A very similar picture emerged in relation to the reasons youth participants in the survey offered for why they were currently using e-cigarettes. In this case, flavors were the ninth most frequently cited reason among middle school pupils and seventh among high school pupils. Again, much more influential in explaining their current e-cigarette use were the fact that these devices were seen to be a way of reducing stress, the fact that they were used by friends and the attraction of the nicotine buzz. Flavors may be part of the choices that youth make when they are using an e-cigarettes, but that does not mean that they are the key factor in the reason why youth start vaping or continue vaping.

    On the basis of those results, one would have to say that flavors may well have been miscast as the cause of youth vaping. There is, however, a further problem with restrictive regulatory action targeted on flavors apart from the fact that it may well not be flavors that are driving youth vaping—the fact that flavors might actually be an important part of adult smokers’ journeys away from combustibles. By reducing the range of tobacco flavors adult smokers can use in their e-cigarettes, regulators may be weakening the capacity of these devices to assist adult smokers in quitting. 

    With an e-cigarette flavor ban in all but name being applied in the U.S., it is important that e-cigarette companies, and others, monitor the extent to which the reduced range of available flavors may be resulting in fewer adult smokers using e-cigarettes and fewer smokers managing to quit smoking with these products. It is important to remember that the ratchet of restrictive regulatory prohibition can move both up and down depending upon the evidence. If evidence shows that flavors are not driving youth vaping and that those flavors are helping adult smokers to quit, then a case can be made for allowing flavors to reenter the world of adult vaping. In the meantime, attention needs to be focused on how manufacturers and others can work together to ensure that flavored e-cigarettes, while available for adult use, are inaccessible to youth.

     

  • Dropping Names

    Dropping Names

    Photo: oxygen_8

    After rooting out ENDS flavors, regulators may turn their attention to flavor names.

    By Neil McKeganey

    In the world of illegal drugs, there are few substances that have become popular as quickly as 3,4-Methylenedioxymethamphetamine. If you are wondering what that awkwardly named substance is, you will almost certainly recognize it by its street name, Ecstasy. In advance of its marketing, the drug developers thought about calling it Empathy but decided on Ecstasy instead—who, after all, could turn down the opportunity of experiencing “ecstasy”? And so it proved with a drug that sold in the millions in countries around the globe. That anecdote tells you something that every marketing person worth his or her salt knows all too well: Names matter. Indeed, when it comes to driving consumers to your product, names may matter more than the substance itself.

    In recent years, the vaping world has seen the heavy hand of regulatory intervention focused on limiting the range of flavors that can be legally sold. Senior health officials, sections of the media, lobbyists, parent groups and others have forcefully argued for banning “kid-appealing flavors.” Restrictions on flavors, though, have gone well beyond the flavors that are seen to be appealing to vulnerable groups.

    Out of some 1.6 million products for which premarket tobacco product marketing authorizations have been sought in the U.S., not a single flavor has been approved. Recent pronouncements from Brian King, head of the Food and Drug Administration’s Center for Tobacco Products, suggest that menthol is now in the regulatory agency’s crosshairs. In the face of such expanding regulatory action, it is by no means a stretch of the imagination to ponder a world in which only a single electronic nicotine-delivery system (ENDS) flavor—tobacco—remains, bringing vaping products that much closer to combustibles and in the process almost certainly weakening their capacity to offer a route out of smoking.

    In a mono-flavored ENDS world, flavor names may become the new fertile terrain—promising consumers a realm of limitless variations in taste that, like the world of expensive Hi-Fi, where differences in quality are barely discernible, nevertheless draw in consumers seeking particular sensorial and taste experience.

    With the removal of flavors from the market, next in line may be flavor names, with regulators galvanized by the belief that it is the names more than the flavors that are driving consumers to these products. In that event, it will become increasingly important for manufacturers to be able to present regulators with evidence that their specific-named tobacco-flavored products are not attracting young people and that those named flavors are assisting adults in quitting smoking.

    If anyone is inclined to think that this is an unlikely scenario, it is worth remembering that regulatory authorities within the U.S. already involve themselves in determining what words can and cannot be used when referring to tobacco products. Some states already ban the use of food terms when referring to tobacco products, and the Family Smoking Prevention and Tobacco Control Act bans words like mild, light and ultra-light when referring to tobacco products. In the face of such regulatory restrictions, companies replaced the names mild, light and ultra-light with terms such as gold, silver and blue. Research undertaken by Gregory Connolly and Hillel Alpert and published in Tobacco Control in 2014 showed that even in the face of such name-switching, smokers were still able to identify their preferred product.

    Within the world of ENDS, some e-liquid manufacturers have already chosen to move away from taste-based flavor names. Bidi Vapor, for example, uses product names such as Winter, Summer, Dawn and Marigold in describing its product range. Years before Bidi opted to anonymize the taste experience in its product names, e-liquid manufacturer Five Pawns opted to use words derived from chess, like Gambit and Grandmaster, to name its products. These are names that convey nothing about the taste or sensorial experience.

    In time, there may be a push from the anti-e-cigarette lobby to reduce the variety of tobacco flavor names even further, requiring manufacturers to differentiate their products by numbers alone. Seems unlikely? Probably not for those who remember Players No. 6, No. 10 and No. 555. Flavor names may be the next item on the regulatory hit list.

  • Logic Rejection Based on Fuzzy Math

    Logic Rejection Based on Fuzzy Math

    Photo: vchalup

    The FDA’s recent rejection of Logic products is based on questionable statistics, says the director of the Center for Substance Use Research.

    By Neil McKeganey

    Last week in Washington, D.C., at the FDLI Tobacco Conference, Brian King, director of U.S. Food and Drug Administration’s Center for Tobacco Products, explained that FDA would be using the recently released 2022 National Youth Tobacco Survey (NYTS) results to inform its judgment as to whether electronic nicotine-delivery system (ENDS) products being assessed under the premarket tobacco product application (PMTA) process would be deemed “appropriate for the protection of the public health.” For those unfamiliar with the National Youth Tobacco Survey, the just-published survey data showed that 9.4 percent of youth in the U.S. had used an e-cigarette in the last 30 days, that 84.9 percent of flavored e-cigarette-using youth had used a nontobacco flavor and that 26.6 percent of those had used menthol-flavored e-liquids.

    If anyone in the audience thought that there might be a disconnect between King’s words and FDA actions, they were proved wrong barely a week later when marketing denial orders (MDO) arrived at the doorstep of Logic Technology Development for its Logic Power Menthol E-Liquid Package and its Logic Pro Menthol E-Liquid Package, with the FDA press release accompanying those denial orders expressly referring to the NYTS findings. In the light of King’s warning, you might think that the company receiving those denial orders could hardly have expected anything else. On the face of it, the NYTS figures are very scary, seemingly justifying immediate action on the part of the FDA. But as with all percentages, you have to look a little closer at what is actually being reported before you push the red button of alarm.

    Within the CDC Mortality and Morbidity Weekly Report setting out the NYTS results, the prevalence of youth use of Logic products is shown to be 4.3 percent. However, that is not 4.3 percent of all U.S. youth but 4.3 percent of the 9.4 percent of youth who were currently vaping within the U.S. With that clarification, the numbers here begin to look very different to the headline announcements. Instead of alarming levels of Logic use among U.S. youth, the extent of that use reported by the CDC researchers is 4.3 percent of 9.4 percent, i.e., 0.4 percent. By their own calculations, the CDC authors estimate this to be 100,000 of all U.S. youth—hardly an epidemic of Logic use.

    But it gets worse than this because the 0.4 percent figure of youth Logic use actually refers to the Logic brand not the two denied products. Unfortunately, the NYTS does not collect information on the specific Logic devices that youth in the U.S. are using. However, research currently underway by the Centre for Substance Use Research in Scotland does have these data. The Scottish researchers have been studying ENDS use among representative samples of U.S. youth and adults in 2021 and 2022, collecting data on over 20 leading ENDS brands and over 200 specific ENDS devices.

    In this Scottish research, out of the 1,215 youth aged 13 to 17 surveyed in 2022, 0.2  percent had ever used a Logic Power and 0.5 percent had ever used a Logic Pro. When the Scottish researchers looked at youth e-cigarette use over the last 30 days, the levels of Logic use shrank even further with 0.1 percent of youth reporting having used the Logic Power in the last 30 days and the level of Logic Pro use so low that it was not even recorded.

    In dispatching the MDOs for these two products, the FDA seems to have set aside a commitment to review the data around individual devices and liquids and to formulate a response in terms of the brand of products being used and justify the denial orders issued by reference to the NYTS data.

    However, there is something even more troubling in the MDOs that have been dispatched this week. If the CDC researchers estimates of only 0.4 percent of U.S. youth having used a specific branded ENDS product is sufficient for the FDA to issue an MDO, one has to wonder at the relative value that is being placed here on the goal of helping adult smokers to quit and the goal of preventing youth vaping. 

    The good news in the NYTS research is that overall levels of e-cigarette use by youth in the U.S. is declining. The bad news is that it would appear from the Logic experience that for as long as the NYTS data reveal any level of youth ENDS use, no matter how small, the FDA may still regard that as sufficient to issue an MDO. The implicit suggestion here then is that the FDA are operating a zero-tolerance approach to youth ENDS use and are prepared to sacrifice the potential benefit of ENDS products for adult smokers on the altar of youth ENDS prevention. 

  • A Second Chance

    A Second Chance

    Photo: andranik123

    How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.

    By Neil McKeganey

    It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.

    Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.

    For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.

    With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.

    The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.

    By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.

    So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.

    To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.

    Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.

    To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.

  • Scientists denounce ‘McCarthyism’

    Scientists denounce ‘McCarthyism’

    Neil McKeganey
    Neil McKeganey
    Christopher Russel
    Christopher Russel

    Neil McKeganey and Christopher Russell of the Centre for Substance Use Research in Glasgow, Scotland, have cautioned against a “new McCarthyism” in the area of e-cigarette research.

    The scientists responded to a commentary in Addiction, in which Jim McCambridge of the University of York advocates a ban on industry-funded e-cigarette research and a creation of a register of financial and other disclosures that “does not rely exclusively upon self-disclosure,” with no statute of limitations.

    McKeganey and Russell said McCambridge is effectively calling for a list that is “based on suspicion, innuendo, some level of detective work, and unsubstantiated allegation.”

    McKeganey and Russell also said McCambridge’s proposal is a “new McCarthyism in which allegation stands in place of evidence and where the appearance upon such a blacklist could destroy a researcher’s career,” and risks undermining “the openness, and the free exchange of knowledge and understanding, that is at the very heart of the scientific enterprise.”