Category: Harm Reduction

  • The cost of success

    The cost of success

    JUUL Labs has said that it will take additional decisive action to build on its existing ‘youth prevention and education programs.
    The Commissioner of the US Food and Drug Administration, Dr. Scott Gottlieb, said on April 24 that the agency was introducing several enforcement actions as part of a new Youth Tobacco Prevention Plan to stop young people from using and gaining access to JUUL and other electronic cigarettes.
    In a note issued through PRNewswire on April 25, JUUL said it would support state and federal initiatives to raise the minimum age for buying tobacco products to 21+.
    Such support would be funded by an investment of $30 million during the next three years that would be dedicated to ‘independent research, youth and parent education, and community engagement efforts’.
    ‘JUUL Labs has seen significant success in its efforts to enable adult smokers to transition from cigarettes and also recognizes that young people have become aware of and gained access to its products,’ the company said.
    ‘The company is committed to combatting underage use of its products and engaging with the US Food and Drug Administration (FDA), members of Congress, local and state officials and members of the public health community on this important issue.
    ‘JUUL Labs will work with Tom Miller, the Iowa Attorney General, and a group of public officials and tobacco control individuals he will assemble to continue strengthening existing initiatives and new efforts to keep JUUL out of the hands of young people.
    ‘In addition, Attorney General Miller and the same group will work with JUUL Labs to develop a transparent and effective framework for independent research focused on the scientific and societal implications of vapor products.’
    “Our company’s mission is to eliminate cigarettes and help the more than one billion smokers worldwide switch to a better alternative,” said JUUL Labs CEO Kevin Burns.
    “We are already seeing success in our efforts to enable adult smokers to transition away from cigarettes and believe our products have the potential over the long-term to contribute meaningfully to public health in the US and around the world.
    “At the same time, we are committed to deterring young people, as well as adults who do not currently smoke, from using our products. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try JUUL.”
    The company said its support for state and federal efforts to raise the minimum age of purchase for JUUL and other vapor products to 21+ followed its announcement in August 2017 that it had raised the minimum age of purchase on its own e-commerce site to 21+, even though the legal age of purchase in many states remained at 18.
    As part of its note, JUUL said that additional programs to be launched or expanded in 2018 included:

    • Investing in research and development to evaluate potential technologies to help prevent youth from gaining access to, and/or using JUUL;
    • Building on the company’s efforts to enforce appropriate age verification at retail through its ‘secret shopper’ program;
    • Calling on social media platforms to remove content showing, and/or encouraging, youth use of JUUL;
    • Calling on online marketplaces to remove content that violates JUUL resale agreements by offering JUUL products for sale without age verification;
    • Providing educational material at retail locations where JUUL products are sold and on the JUUL website to help increase parents’ awareness of JUUL and provide information on the negative impacts of nicotine on youth.
  • FDA’s aptitude questioned

    FDA’s aptitude questioned

    An opinion piece published in The Hill poses and answers the question: How much does the US Food and Drug Administration do to promote public health?
    Lindsey Stroud, a state government relations manager at The Heartland Institute, a non-profit group aimed at promoting limited government, describes how, in recent years, the FDA has become increasingly more involved in ‘protecting the public health by ensuring the safety, efficacy, and security’ of numerous products, including prescription medications, tobacco, and food and cosmetic products.
    ‘In many cases, the agency has proven itself to be exceptionally biased against harm reduction devices and services, while at other times, FDA has failed to protect the public from potentially dangerous substances,’ Stroud writes.
    ‘Such is the case with OxyContin, one of the most important contributors to America’s current opioid epidemic.
    ‘In countless instances, FDA has been too stringent and inflexible. In others, it has seemingly been ignorant of the dangers of particular drugs, leading many (this writer included) to wonder: Does FDA have any clue what it’s doing?’
    Later in her piece, Stroud says that it is important to note that, while the FDA has shown it is willing to allow powerful prescription painkillers to become one of the few relief methods available for chronic pain, it has at the same time applied a narrow standard to other products that could save lives.
    ‘For instance, FDA has yet to allow many e-cigarette, heat-not-burn, and snus products to be marketed as less harmful alternatives to combustible cigarettes – even though ample evidence shows they are,’ she writes.
    Stroud’s piece is at: http://thehill.com/opinion/healthcare/384407-how-much-does-the-fda-really-do-to-promote-public-health.

  • BAT embracing change

    BAT embracing change

    British American Tobacco’s chairman, Richard Burrows, was due today to tell the company’s Annual General Meeting that the industry was entering a dynamic period of change.
    The AGM was due to start at 11.30 in London.
    “An unprecedented confluence of technology, consumer demand, societal change and public health awareness has created a unique opportunity; the opportunity to make a substantial leap forward in our long-held ambition to provide consumers with less risky tobacco and nicotine choices,” he was quoted as saying in a note posted on the company’s website ahead of the meeting.
    “The Group’s wide range of potentially less harmful products which provide the enjoyment of smoking without burning tobacco, means that your company is ideally positioned to further shape the future of the business during a period of profound change which can deliver benefits for: consumers, who will have a range of potentially safer choices; society, which could benefit from real progress in tobacco harm reduction; and shareholders, who will own a sustainable and profitable business.
    “Our portfolio of potentially reduced-risk products includes next generation products, comprising vapor and tobacco heating products, as well as oral tobacco and nicotine products such as snus and moist snuff. These smokeless products offer genuine choices to consumers searching for alternatives to traditional cigarettes and form the centre piece of our strategy to transform tobacco – with the consumer at its core.
    “Our commitment to this transformation is not new, but the progress we have made to date gives us confidence to set clear ambitions for the future. By the end of 2018 our objective is to more than double our revenue from next generation products to substantially more than £1 billion.
    “Our tobacco heating product, glo, is already demonstrating this opportunity in Japan and has now grown to a 4.3 percent share of the total market, despite capacity constraints limiting the supply of heating devices. We remain confident that these constraints will be removed during Q2.
    “Notwithstanding the good progress we are making with our potentially reduced-risk products, combustible products will remain at the core of our business for many years to come – delivering growth today and providing the funds required for investing in the future. I am therefore pleased that 2017 saw the Group deliver another good underlying performance illustrating its ongoing strength – delivering against our financial commitments while investing for the changing environment. The Group’s market share, revenue and profit all grew in 2017 and total Group cigarette and tobacco heating product volume grew 3.2 percent to 686 billion while the industry was estimated to have declined by around 3.5 percent.
    “The Group’s approach of placing the consumer at the centre of its strategy, along with a multicategory portfolio of products designed to address their varying preferences, ensures that our business is in an even stronger position to deliver long-term, sustainable growth. We are the only company growing share in all key product categories – in vapor, tobacco heating, oral tobacco and combustible cigarettes.”
    Turning to 2018, Burrows was quoted as saying that foreign currency exchange rates were a headwind for the business this year. “If rates were to stay at current levels, the Group would face a translational foreign exchange headwind of seven percent on organic operating profit and eight percent on earnings per share,” he was expected to tell the AGM. “As previously announced, mainly due to volume shipment phasing and pricing in certain markets, including the GCC and Russia, profit growth is expected to be skewed to the second half.
    “Given the success of the next generation product portfolio, the Group has decided to further increase investment plans behind next generation products during 2018, with a significant number of roll-outs and launches planned towards the end of Q3. And although trading conditions remain challenging, the Group remains on track for another good year of earnings growth, excluding the impact of currency translation…”

  • London vaping conference

    London vaping conference

    Members of parliament chaired three panel discussions as about 160 participants took part in a conference in London yesterday staged by the UK Vaping Industry Association.
    Mark Pawsey, the MEP for Rugby and chair for the All Party Parliamentary Group for E-cigarettes, chaired a regulatory-landscape session that was enlivened and overshadowed by Brexit unknowns.
    The theme of the conference was, Going for Growth, but considerable time was spent on discussing why e-cigarette growth had faltered and what was needed to get it going again.
    Many of the challenges the sector faced were familiar. One such challenge was overcoming the misunderstandings among smokers about the potential health benefits of switching to vaping: misunderstandings in part caused by the over-enthusiastic reporting of the results of poor-quality research into e-cigarettes and vaping.
    Other challenges seemed less familiar but no less daunting. Wide product choice, normally seen as being essential in the quest to encourage smokers to switch to vaping, was seen by some as causing confusion and therefore as being a deterrent to switching. This problem seemed to be about the proliferation of versions of a single product, such as is comprised by e-cigarettes, rather than the introduction of different categories of products, such as e-cigarettes, snus and heat-not-burn (HNB) devices.
    Gareth Johnson, the MP for Dartford [London] and parliamentary private secretary to the secretary for state for Exiting the European Union, chaired a session on the role of the tobacco and pharmaceutical industries in the future of vaping. This session was almost entirely about the tobacco industry’s role because the pharmaceutical representative who had been scheduled to take part did not. And much of the session involved the tobacco-industry representatives (British American Tobacco, Imperial Brands, Japan Tobacco International and Philip Morris International) trying to explain how they could convince smokers and public health bodies to trust their research given the distrust built up in previous years.
    The conference was noteworthy, among other things, for the level of tension in respect of heat-not-burn (HNB) products. Some participants representing e-cigarettes seemed to take the view that HNB products and e-cigarettes should not be too closely aligned. One person questioned whether HNB products were piggybacking on the reduced-harm credentials of e-cigarettes.
    The Rt Hon Norman Lamb (pictured), the MP for North Norfolk, chaired a session on bolstering public health evidence. Lamb is a former minister of state for Care and Support at the Department of Health and the chair of the Science and Technology Select Committee. He is leading an inquiry into e-cigarettes that is looking into their effectiveness as a smoking cessation tool and their impact on the health of the nation.
    One of the panellists made the point that what was not needed was more research. What was needed was responsible research and the dissemination of the results of that research.
    And at this point, as the one-day conference wound down, it was back to where it started: the challenge of addressing misinformation.
    A report on the conference is due to be included in a future issue of Vapor Voice magazine.

  • Reduced risk on hold

    Reduced risk on hold

    British American Tobacco (Malaysia) has said it will not introduce electronic cigarettes or other reduced-harm products in Malaysia until they are the subject of clear regulations, according to a story in The Edge Financial Daily.
    “We are a bit concerned that if we do introduce these products, the regulatory framework would not be as sharp as they should be,” BAT Malaysia MD Erik Stoel told a media briefing after the group’s annual general meeting on April 19.
    Guidelines were needed on the excise duties and marketing restrictions that would apply to such products.
    “Fundamentally, we think that if we can sell potentially reduced-harm products to consumers in Malaysia then we should,” he said, adding that it was the “right” thing to do.
    BAT had launched glo, a tobacco-heating device, in Japan in May last year, and had a “very good product portfolio” in Europe’s strong vaping market, Stoel said.
    In 2015, several states in Malaysia banned the sale of e-cigarettes after the National Fatwa (religious edict) Council ruled that vaping was forbidden in Islam.
    Introducing such reduced-harm products might be the lifeline needed by tobacco companies in Malaysia, which have seen their market size and subsequently their earnings, squeezed by the market for illegal cigarettes.

  • E-cig crackdown coming

    E-cig crackdown coming

    The US Food and Drug Administration will step up its crackdown on electronic cigarette sales to teens, according to a story by Robert King for the Washington Examiner quoting the head of the agency.
    Lawmakers on a House Appropriations subcommittee were said to have grilled FDA Commissioner Scott Gottlieb about ‘excessive’ use of e-cigarettes among young people.
    The FDA has the authority ‘to go after’ e-cigarette makers and retailers if they violate a ban on sales to people under 18, but lawmakers questioned if the agency was doing enough.
    “I am concerned that FDA’s silence on e-cigarettes could open the door to the next public health emergency,” said Rep. Nita Lowey, D-N.Y.
    Gottlieb replied that the FDA would crack down on young people’s use of e-cigarettes in the coming weeks.
    The agency has several avenues for targeting retailers that are selling to minors. Those include a warning letter, massive fines, or banning the retailer from selling any tobacco or e-cigarettes.
    Gottlieb said e-cigarettes could offer fewer health risks than traditional cigarettes, but the soaring use among minors was worrisome. A recent study had found that e-cigarette use grew by 900 percent among high school students from 2011 to 2015 [there was no mention of the level of use in 2011].
    “We can’t just addict a whole generation of young people onto nicotine,” Gottlieb reportedly said.

  • Elevating passive smoking

    Elevating passive smoking

    The Ikoma city government in the Nara Prefecture of Japan is forcing smokers to undergo a ‘decontamination’ period before they can enter elevators, a health rule praised by some but described as draconian by others, according to a story in The Asahi Shimbun.
    Workers and visitors to the city government’s offices must wait for 45 minutes after they smoke if they want to use elevators on the grounds that ‘exhaled air from smokers could cause passive smoking’, and because the impact of such passive smoking ‘is especially serious in closed spaces’.
    The elevator policy started this month.
    Violators face no specific penalties, but the city government is asking even visitors to abide by the rule.
    Hiroshi Yamato, a health development professor at the University of Occupational and Environmental Health, Japan, believes the move will protect the health of non-smoking elevator riders. It was his research that led to Ikoma’s elevator policy.
    One reason for the elevator policy is that the Ikoma city government is getting tough with smokers generally.
    Starting in June, the city will impose an administrative fine of 20,000 yen ($187) on those who smoke on public roads around Kintetsu Ikoma Station.
    ‘City officials must actively engage in countermeasures against the issue of second-hand smoke because the burden is put on the citizens,’ according to the Ikoma government.
    A law introduced in 2003 stipulates that proper countermeasures should be taken to prevent second-hand smoke negatively impacting health. The legislation was the first of its kind in Japan.
    The story said it was estimated that 15,000 people died each year in Japan of heart attacks, lung cancer and brain and other diseases caused by passive smoking.

  • Snus ban ‘valid’

    Snus ban ‘valid’

    The smokers’ lobby group Forest has criticized the opinion of a leading advisor to the European Court of Justice (ECJ) after he deemed the EU ban on the sale of snus to be “valid”.
    According to the ECJ’s Advocate General, Saugmandsgaard Øe, the EU legislature “did not exceed the limits of its discretion in concluding that lifting the prohibition on the placing on the market of tobacco for oral use could result in an overall increase in the harmful effects of tobacco within the EU”.
    Simon Clark, director of the smokers’ group Forest, said that maintaining an EU-wide ban on snus discriminated against adults who were looking for a safer means of consuming nicotine.
    “Tobacco is legal and adults should have the right to purchase a range of products, some of which are less harmful than others,” he said.
    “The evidence suggests that snus is not risk free but it’s significantly safer than combustible cigarettes.
    “To deny consumers the choice of switching to an alternative, reduced-risk product defies logic or common sense.”
    Snus is banned in all EU member states except Sweden, and, according to a report in The Local, snus producer Swedish Match failed in a 2004 attempt to challenge the rules restricting sales and exports of the product. It had since launched a challenge against UK laws preventing the sale of tobacco for oral use, which are in line with the EU’s 2014 Tobacco Products Directive, arguing that the EU legislature had failed since the earlier ruling to ‘take into account development in scientific knowledge’. The High Court of Justice for England and Wales subsequently asked the ECJ to judge whether the prohibition of the product was valid.
    In a note posted on its website, Swedish Match said that though the Advocate General had found that the use of snus was less hazardous than smoking cigarettes, he did not recommend the ECJ to find the EU snus ban invalid.
    ‘In the opinion, the Advocate General gives the EU legislature a very broad discretion in areas which involve political, economic and social choices,’ the note said. ‘He states that in his opinion it is not the task of the Court to assess the scientific evidence submitted in the case but rather recommends that the Court leave such assessments to the EU legislature.’
    “We are disappointed with the opinion and hope that the Court will come to a different conclusion in its final ruling,” Marie-Louise Heiman, general counsel at Swedish Match, was quoted as saying. “The reasoning behind the Advocate General’s opinion would severely limit the Court’s assessment of EU legislation. With this reasoning, almost any product could be banned in the EU without a meaningful judicial review.”
    The final ruling is expected toward the end of the second quarter or in the third quarter of this year.

  • In support of delay

    Pushing the US Food and Drug Administration to regulate quickly on vaping products puts smokers at risk, according to a piece by Sally Satel for the American Enterprise Institute.
    Satel, M.D., a practicing psychiatrist and lecturer at the Yale University School of Medicine, described teens and electronic cigarettes as comprising a combustible issue that’s been heating up the headlines lately.
    She said it might (or might not) be a simple coincidence that the panicky coverage coincided with a recent lawsuit demanding that the FDA sped up regulation of vaping products. But, orchestrated or not, rushing the FDA to regulate put smokers at risk.
    The lawsuit, filed at the end of March by a coalition of seven anti-tobacco groups, including the Campaign for Tobacco Free Kids, the American Academy of Pediatrics, and five individual pediatricians, took aim at a key decision the FDA made last July. The agency pushed back the pre-market application submission deadline for e-cigarettes from August 2018 to 2022.
    The plaintiffs want the original deadline re-instated, claiming that the regulatory delay is illegal.
    ‘I believe that the delay is wise (and note that regulatory agencies routinely change compliance deadlines),’ Satel wrote. ‘The postponement gives the agency and Congress time to replace the burdensome and costly pre-market approval procedure, which would have crippled the vaping industry, with a more efficient regime.
    Satel’s piece is at: http://www.aei.org/publication/why-the-panic-over-juul-and-teen-vaping-may-have-deadly-results/

  • History in the making

    History in the making

    A panel event in London, England, yesterday proved the adage that prediction is difficult – especially about the future.
    The event, which was staged by the New Statesman magazine in association with Philip Morris International and chaired by Anna Hodgekiss, a freelance health/medical journalist and media consultant, set out to address the question: How long until smoking is history [in England]?
    But given that all of the panellists – and possibly most of the 70 guests drawn from the ranks of parliament, the tobacco and cigarette industry, public health, public affairs, think tanks and professional services – seemed to support a harm-reduction rather than a quit-or-die policy, the debate turned largely on how smokers could be encouraged to switch to lower-risk products, such as vapor devices and oral tobacco products.
    Nevertheless, Nick Fitzpatrick, an economist and consultant with Frontier Economics, which last year produced a report for PMI entitled: Working towards a smoke-free England, presented some of the findings from that report, one of which had it that the UK government would meet its smoke-free target of reducing the prevalence of smoking in England to five percent by 2040 given the continuation of current taxation policies and regulatory interventions. Fitzpatrick added that the target could be met by 2029 if a number of criteria were fulfilled, including increasing rapidly the number of smokers switching to smoke-free alternatives, such as e-cigarettes.
    But these predictions were less important than the debate that they stirred – a debate that PMI has been encouraging since 2016 and one that, while based on an English experience, had universal echoes.
    The panellists seemed to agree that there were too many unknowns to predict with any accuracy when smoking might end in England, But there was general agreement that vapor products had made a major step in the direction of encouraging smokers to quit and that they could make a further contribution given that they were the subject of sensible taxation policies that reflected their health impact, sensible, relevant regulation that was not simply moved over from tobacco regulation, and product improvement and innovation.
    It would be necessary also to ensure that lower-risk messages were communicated to both smokers and the health care professionals who advised them, many of whom were still reluctant to talk with smokers about using vapor devices, even when those smokers had exhausted other methods of quitting.
    The debate threw up the question of what it meant for smoking to be eliminated, and the idea that elimination would have been achieved once the smoking prevalence had been reduced to five percent was questioned. Panellist Mark Littlewood, the director of the Institute of Economic Affairs, pointed out that a five percent threshold, more widely applied, would mean that heroin was not used in the UK. Littlewood pointed out also that the rate of success in encouraging people to quit would be governed in part by a law of diminishing returns as the number of people still smoking was boiled down to a hard core of smokers.
    One complicating factor in getting smokers to move to vapor devices was seen as the fact that smokers have different needs. Sarah Jakes, the chair of the New Nicotine Alliance and one of the panellists, told the event that she had switched to a vapor device even though it had not been her intention to do so. She was a smoker who decided to try e-cigarettes so that she could vape while in her car, but she had found that she liked the device to the point where she switched over completely. Littlewood, on the other hand, admitted that he had been unable to find a satisfactory substitute, and while he found heat-not-burn products better than e-cigarettes, he kept drifting back to traditional cigarettes. And another panellist, Dr. Roger Henderson, a general practitioner and smoking cessation expert, in a chilling intervention, told how some diabetics would choose smoking over their legs.
    One interesting side issue had to do with the sympathy demonstrated for smokers who did not want to quit or could not quit. Although Henderson was passionate in his opposition to smoking and just as passionate in his support for harm reduction, he believes that in the end a smoker has to decide for herself what she does. If a smoker fully understood the risks she was taking and if she knew what cessation help was available to her but still decided to keep smoking, it was not for other people to tell her how to live her life.