October, 2016:
Health Groups Sue FDA Over Cigarette Warning Labels
Eight public anti-tobacco groups are suing the government to require graphic and grotesque warning labels on packs of cigarettes.
http://www.nacsonline.com/Media/Daily/Pages/ND1006162.aspx
WASHINGTON – This week, eight public health groups filed a lawsuit against the U.S Food and Drug Administration to force the government to require graphic warning labels on packs of cigarettes.
The lawsuit was filed on Oct. 4 in the U.S. District Court of Massachusetts by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative and several individual pediatricians.
The groups maintain that the FDA is required by law to issue a final rule implementing Section 201(a) of the Family Smoking Prevention and Tobacco Control Act of 2009, which requires cigarette packages and advertisements to bear color graphic images and specified textual warnings.
On June 21, 2011, the FDA announced the nine graphic cigarette health warnings required to appear on every pack of cigarettes, carton and cigarette advertisement no later than September 2012. However, reports the Wall Street Journal, tobacco companies sued, and those labels were struck down in federal court on First Amendment grounds in 2013. The FDA has not taken up the issue of graphic warning labels since.
The Journal notes that the lawsuit filed this week is asking the court to set a deadline for the FDA to establish a new graphic warning rule, saying that the FDA “has been in violation [of the 2009 law] for more than four years.”’
Across the globe, the Campaign for Tobacco Free Kids estimates that more than 90 other countries have graphic warning labels, with Australia and Spain including photos on cigarette packs of gangrene feet and decaying teeth.
Tax will spur illicit sales: institute
WHITE-LABEL TOBACCO:Sales of illegal cigarettes are growing among the middle and upper classes due to stagnating income and anxiety over proposed tax hikes
http://www.taipeitimes.com/News/taiwan/archives/2016/10/06/2003656620
A proposed increase to a tobacco product tax has led to criticism that it would exacerbate an already growing trade in illegal cigarettes.
A joint policy meeting of executive and legislative branch officials on Monday resulted in the drafting of a proposal to raise the cigarette tax by NT$20 (US$0.64) per pack.
The new measure, which is to be finalized by the legislature, is forecast to increase tax revenue by NT$15.8 billion per year, the Executive Yuan said, adding that the government plans to use the money to fund a long-term care program for seniors and the physically challenged.
A pack of cigarettes is currently taxed NT$11.8, plus a NT$20 surcharge.
The Tobacco Institute of the Republic of China on Tuesday expressed concern that increasing the tax would stimulate the trade of illegal tobacco products, adding that the government’s plan ignores the issue and market practices.
It added that the proposed tax deviates from the institute’s advice to the government on a long-term tax plan, which it said should involve reasonable, slowly introduced and predictable tax increases, adding that this is the only way to prevent the spread of illegal tobacco sales, as well as a subsequent loss in tax revenue.
The institute cited research data from the past seven years that showed a high number of illegal tobacco sales that “cause an annual loss to the Treasury of more than NT$1 billion.”
So-called “white label” cigarettes make up the bulk of illegal sales, the institute said, adding that consumption of these cigarettes is on the rise among middle and upper-class consumers.
In particular, there is a steady increase in consumption of white-label cigarettes among consumers in remote parts of eastern Taiwan, as well as in Taipei, it said.
The institute said these consumers are turning to white-label cigarettes due to stagnating incomes, as well as anxiety over proposed tax increases on legal tobacco products.
“The psychological effect of anticipated tax increases is changing the consumer base for white-label cigarettes,” the institute said in a statement, adding that people in the NT$30,000 to NT$40,000 income bracket this year constituted 27 percent of illegal cigarette sales, up from 21 percent last year.
People with low monthly incomes of NT$10,000 or less continue to make up 30 percent of illegal cigarette sales, it said, adding that managers and other professionals made up only 7 percent of white-label consumers in 2013, but now account for 17 percent.
The institute said that while this number is still significantly lower than blue-collar workers’ 58 percent sales contribution, the rapid rise in illegal cigarette consumption among professionals is alarming.
Public health groups sue FDA on graphic cigarette warning labels
A group of anti-tobacco and public-health groups sued the Food and Drug Administration on Tuesday in an attempt to compel it to establish graphic warnings labels on cigarette packaging and marketing.
It’s been more than 3½ years since there’s been legal or regulatory movement on graphic warnings, particularly on what they will look like and when they will appear.
The 2009 federal Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and on 20 percent of cigarette advertising.
The FDA was given until June 22, 2011, to issue a final rule requiring such warnings.
The governments of more than 90 countries require similar graphic warning labels. Australia, which was among the first to introduce the labels and has some of the most graphic images, is perhaps the most noteworthy.
The FDA chose nine labels in June 2011, which were scheduled to debut in September 2012. The labels included smoke coming out of a tracheal hole, diseased lungs and gums, and a man who appears deathly ill.
A group of tobacco manufacturers that include R.J. Reynolds Tobacco Co. and Lorillard Inc. filed a lawsuit in September 2011 against the FDA regarding the labels.
Two parallel legal cases with differing judicial opinions have put the initiative on hold.
The anti-tobacco and public health groups argue that the federal Administrative Procedure Act, which governs federal agencies, gives federal courts the power to “compel agency action unlawfully withheld or unreasonably delayed.”
“The FDA is in violation of its nondiscretionary statutory duty,” according to the plaintiffs’ lawsuit.
The plaintiffs contend that one of the legal tracks gives the FDA clearance to implement its final rule on the warning labels. Some plaintiffs argue that the lack of warning labels “makes it more difficult” for them “to educate and counsel members of the public not to smoke.”
In August 2012, a panel of the U.S. Court of Appeals for the D.C. Circuit voted 2-1 that the proposed specific warning labels violated the First Amendment. That ruling did not address the law’s underlying requirement.
The FDA said in March 2013 that it declined to further appeal the D.C. Circuit ruling and would create new warning labels.
In March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that this provision did not violate the First Amendment. The U.S. Supreme Court declined in April 2013 to hear an appeal of the Sixth Circuit ruling.
“The FDA is undertaking research to support a new rulemaking consistent with (the Tobacco Control Act),” spokesman Michael Felberbaum said Wednesday.
While the industry and advocacy groups await the next FDA warning label proposals, several studies have been published that found mixed smoker reactions to the initial nine proposed labels.
In December 2010, an FDA study found putting graphicwarning labels on cigarette packs may stir emotions, but not lead to quitting.
UNC Chapel Hill researchers said in June that 40 percent of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34 percent with the text warning.
A February 2016 study published by University of Illinois researchers at the journal Communication Research suggests graphic images strike some people as manipulative, a reaction that could backfire on the attempt to steer individuals away from smoking.
Lawsuit plaintiffs
The lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative, and several individual pediatricians.
The Race to a Tobacco Endgame
http://tobaccocontrol.bmj.com/content/25/6/607.full
Ruth E Malone
Correspondence to
Professor Ruth E Malone, Department of Social and Behavioral Sciences, School of Nursing, University of California, San Francisco, CA 94118, USA; ruth.malone@ucsf.edu
Accepted 5 October 2016
During the past month alone, I have had an opportunity to participate in four different meetings—in Utah, Sweden, Canada and the USA—where ideas about how to achieve an ‘endgame’ for the tobacco epidemic were being discussed. Other previous meetings—in India, Finland and the UK—have been held over the last few years, and I know of several other such discussions. Even before the US Surgeon General’s 50th Anniversary report on the health consequences of smoking1 called explicitly for achieving a tobacco endgame and suggested a combination of policy strategies to do so, other countries such as Ireland, New Zealand, Finland and Scotland were having conversations that led them to set hard target dates by which they intend to reduce tobacco use and/or smoking prevalence to <5%.
Modelling studies suggest that current measures, even if they are greatly accelerated in countries that are tobacco control leaders, will not achieve these goals within the first half of this century.1 As the target dates move closer, will political leaders seize the opportunity to enact the bolder policy innovations that must be undertaken? Or, will they allow caution and inertia to shape another century of public health catastrophe?
The endgame requires consciously designing interventions to change permanently the structural, political and social dynamics that sustain the epidemic, in order to end it by a specific time.2 Thus, an endgame vision goes beyond ‘business as usual’ and calls for further policy innovations. No one knows how to do it yet, but the endgame conversation3–6 has become mainstream, and the first places that manage to achieve it will herald the beginning of the end of more than a century of industrially produced carnage. Which places will be first to cross the finish line?
Several factors will likely be decisive.
The first of these is whether the public health community can achieve some rough unity as to the goal and strategies to be employed. We do not have to agree on everything, and some places will do things differently than others, but within any locale, some consensus will be needed or we risk confusing the public and giving policymakers more excuses not to act. There is no doubt that the tobacco industry is eager to exploit and/or create such divisions,7 so compromises will be needed. The controversy over e-cigarettes, for example, has created multiple lines of division among public health proponents. This disunity does not serve well the advancement of new policy measures to end the epidemic.8 Yet, e-cigarettes and the burgeoning list of other non-combustible tobacco and nicotine products could represent potential leverage for accomplishing what once seemed unthinkable: phasing out combustible cigarettes, the single most deadly consumer product ever marketed. Yes, these other products may cause harm. Yes, there may be unintended and unanticipated negative consequences. But we do not require a single additional study to know with absolute certainty that the continued sale and use of cigarettes will reliably deliver more disease, death and suffering than any other product. And we do know that for at least some people who smoke, the use of these alternative tobacco and nicotine products is acceptable as a substitute or a transition to quitting. Let’s keep our eyes on the prize.
The second decisive factor is whether the ground has been sufficiently prepared in getting the public to believe in and support ending the tobacco epidemic. The incongruence of telling the public how bad cigarettes are, while simultaneously continuing to allow their widespread retail sale, contributes to confusion at best and cynicism at worst. In this regard, multiple studies from various countries suggest that the public—including smokers—may be further along the road to an endgame than we public health proponents have allowed ourselves to go. In Canada, for example, data from Wave 9 and preliminary analyses of Wave 10 of the ITC Survey, a nationally representative cohort study, show that more than half of smokers would support a complete ban on cigarettes within 10 years, if the government provided assistance to quit.9 These findings are consistent with several studies conducted in other countries, as well as internal data from tobacco company Philip Morris’s own public opinion surveys, which found that in the USA in 2004, 68% of those surveyed wished there was some way to get rid of cigarettes.10–12 However, such findings have never been used to develop effective campaign messaging to build a constituency for endgame measures.
A third element is whether policymakers in the location are courageous enough to tackle something new and politically risky, about which they will incur attacks from tobacco companies and their allies. Big Tobacco will raise every conceivable argument, arguing that protecting the public from these unreasonably dangerous and defective products infringes on rights, will create vast black markets, and will ruin economies. But governments have an obligation to act to protect public health, tobacco companies themselves have been implicated in black market trading, and to argue that we must keep killing people in order to sustain our economy seems to put the entire social enterprise in question. In addition, the places now closest to achieving a tobacco endgame are those where prevalence has dropped to historical lows, suggesting that the transition to new economic and business models is inevitable: policymakers should be anticipating and preparing for a different kind of economy.
Finally, achieving a tobacco endgame will reflect how well public health proponents work alongside and with the communities that are now most affected by the tobacco epidemic. ‘Nothing about us without us’ is an important principle as smoking and tobacco use become more concentrated among certain population groups, each of which has different resources, needs and priorities. The tobacco industry’s targeting and exploitation is one part of how these disparities in tobacco use came to be, but the whole story is much more complex, especially for indigenous peoples. Now Big Tobacco hides behind these groups, claiming, for example, that tax increases hurt the poor—despite evidence that such increases actually benefit poor people more (because they quit in greater numbers) than wealthier groups.13 But those alliances are beginning to fray. For example, activists in the US African-American community, concerned with the consequences of high menthol cigarette use, are providing aggressive leadership on efforts to pressure government to get menthol out of tobacco products.14 New Zealand Maori leaders’ report in 2010 led to establishment of that country’s Smokefree 2025 goal.15
While for many countries, combustible tobacco products are the biggest issue to be addressed, in others like India, dangerous oral tobacco products proliferate. Some countries already have robust regulatory infrastructures that are trusted by the public; others are only beginning to build the capacity that would allow more radical measures such as limiting sales outlets for cigarettes or setting a timetable for a phaseout. This is why ‘there is no single endgame’, as Arnott16 pointed out several years ago. But even tobacco companies are beginning to realise that the endgame is in sight.
I recently received in the mail a heavy envelope from overseas, containing a ‘Global Compact Report’ from Philip Morris International, along with a personalised letter encouraging me to review it and engage in dialogue. One line jumped out at the end of the first paragraph, which focused largely on spin about the company’s latest reinvention of itself as a responsible, transparent seller of death and disease: a reference to ‘acknowledging and addressing the social harms caused by our products, including the phase out of combustible cigarettes’. This oddly written sentence would be cause for genuine excitement if the report actually said anything specific about phasing out cigarettes, but it did not appear to do that. Nowhere could I find any plan or timetable for such a phaseout, despite the company’s touting of new ‘heat-not-burn’ products and reference to leading an effort to ‘replace’ cigarettes with them. Elsewhere, such products are also reassuringly reported as not ‘cannibalising’ existing cigarette brands in test markets,17 suggesting they are not really seen as substitutes for them any time in the near future. Meanwhile, the industry keeps marketing the same old deadly stuff all over the world. So, we simply cannot count on the tobacco companies to make the endgame happen.
They are getting ready for us to tell them they have to stop. But we have to make them do it. Let’s tell them when this epidemic has to end.
Which country will go first?
Footnotes
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.
References
↵ US Department of Health and Human Services. The health consequences of smoking: 50 years of progress: a report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.
↵ Malone RE, McDaniel PA, Smith EA. Tobacco control endgames: global initiatives and implications for the UK. Cancer Research UK, 2014. http://wwwcancerresearchukorg/sites/default/files/policy_july2014_fullendgame_reportpdf
↵ Malone RE. Imagining things otherwise: new endgame ideas for tobacco control. Tob Control 2010;19:349–50. doi:10.1136/tc.2010.039727 [FREE Full text]
↵ Smith EA. Questions for a tobacco-free future. Tob Control 2013;22(Supp1 1):i1–2. doi:10.1136/tobaccocontrol-2013-051066 [FREE Full text]
↵ Warner KE. An endgame for tobacco? Tob Control 2013;22(Supp1 1):i3–5. doi:10.1136/tobaccocontrol-2013-050989 [Abstract/FREE Full text]
↵ McDaniel PA, Smith EA, Malone RE. The tobacco endgame: a qualitative review and synthesis. Tob Control 2016;25:594–604. doi:10.1136/tobaccocontrol-2015-052356 [Abstract/FREE Full text]
↵ McDaniel PA, Smith EA, Malone RE. Philip Morris’s Project Sunrise: weakening tobacco control by working with it. Tob Control 2006;15:215–23. doi:10.1136/tc.2005.014977 [Abstract/FREE Full text]
↵ Gartner C, Malone RE. Duelling letters: which one would you sign? Tob Control 2014;25:369–70. Google Scholar
↵ Chung-Hall J, Craig L, Driezen P, et al. Canadian smokers’ support for tobacco endgame strategies: findings from the ITC Canada Survey. Ontario, Canada: ITC Project University of Waterloo, 2016. Google Scholar
↵ Edwards R, Wilson N, Peace J, et al. Support for a tobacco endgame and increased regulation of the tobacco industry among New Zealand smokers: results from a National Survey. Tob Control 2013;22:e86–93. doi:10.1136/tobaccocontrol-2011-050324 [Abstract/FREE Full text]
↵ Wang MP, Wang X, Lam TH, et al. The tobacco endgame in Hong Kong: public support for a total ban on tobacco sales. Tob Control 2015;24: 162–7. doi:10.1136/tobaccocontrol-2013-051092 [Abstract/FREE Full text]
↵ Altria [Parrish S]. Corporate affairs societal alignment/regulation update. 2004. https://wwwindustrydocumentslibraryucsfedu/tobacco/docs/znyv0024
↵ Furman J. Six lessons from the US experience with tobacco taxes. World Bank Conference paper: winning the tax wars: global solutions for developing countries. 2016. https://www.whitehouse.gov/sites/default/files/page/files/20160524_cea_tobacco_tax_speech.pdf
↵ Tavernise S. Black health experts renew fight against menthol cigarettes. New York Times. 13 September 2016. Google Scholar
↵ Maori Affairs Committee. Inquiry into the tobacco industry in Aotearoa and the consequences of tobacco use for Maori. 49th Parliament, New Zealand. 2010. https://www.parliament.nz/resource/en-NZ/49DBSCH_SCR4900_1/2fc4d36b0fbdfed73f3b4694e084a5935cf967bb
↵ Arnott D. There’s no single endgame. Tob Control 2013;22(Suppl 1):i38–i9. doi:10.1136/tobaccocontrol-2012-050823 [Abstract/FREE Full text]
↵ Caplinger D. Philip Morris International, Inc’s best move so far this year. The Motley Fool. 2016. http://wwwfoolcom/investing/2016/08/26/philip-morris-international-incs-best-move-in-2016aspx
Toxins Remain in Home Long After Smokers Quit
http://www.newsmax.com/Health/Health-News/toxins-tobacco-smoke-quit/2016/10/05/id/751753/
Toxins from tobacco smoke persists in smokers’ homes for at least six months after they quit and remain a threat to nonsmoking residents, according to researchers.
The team studied 65 smokers who were quit smoking and discovered that tiny particles from burning tobacco get into surfaces such as carpets, wallpaper, ceiling tiles upholstery, clothes, blankets and pillows and were still present long after a smoker quit, The New York Times reported.
There were large immediate declines in nicotine on surfaces and in dust, which then leveled off and remained the same, but still detectable, by the end of the study period, according to the study in the journal Tobacco Control.
And even six months after smokers quit, nonsmokers still in the same home still had detectable levels of a marker of tobacco exposure in their urine after six months, The Times reported.
Hungary regulates cigarette market further
http://bbj.hu/economy/hungary-regulates-cigarette-market-further_122940
Regulation of electronic cigarettes will further strengthen in Hungary as e-cigarettes and related products are expected to be treated the same as regular tobacco products in Hungary, under a bill Cabinet Chief János Lázár submitted to Parliament Tuesday, according to Hungarian news agency MTI.
If the bill is approved by Parliament, e-cigarettes could only be sold in licensed tobacco shops, the text of the bill says, according to MTI, which apparently means that only national tobacco shops will be eligible to sell such products.
The text of the bill says the regulatory changes aim to reduce smoking in Hungary, especially among the younger generation, while the country is required to comply with certain European Union directives.
The bill Lázár submitted would also abolish a progressive healthcare contribution tobacco companies must pay, after the European Commission expressed concerns in July related to the discriminatory nature of the contribution.
Hungary will soon introduce plain and uniform cigarette packaging and ban the distribution of flavored tobacco products. Under a decree published earlier this week, retailers of e-cigarettes will be required to pay additional fees.
Exposure to e-cigarette vapour induces negligible or no oxidative damage to lung epithelial cells
http://www.news-medical.net/news/20161005/Exposure-to-e-cigarette-vapour-induces-negligible-or-no-oxidative-damage-to-lung-epithelial-cells.aspx
E-cigarette vapour is much less harmful to lung cells than cigarette smoke. Lab tests show that, unlike tobacco smoke, which causes oxidative stress and cell death, e-cigarette vapour does not. Oxidative stress and cell death are driving factors in the development of many smoking-related diseases such as COPD and lung cancer.
Vapour from e-cigarettes has been found to contain significantly lower levels of the toxicants found in cigarette smoke (Chemical Research in Toxicology DOI: 10.1021/acs.chemrestox.6b00188), but suitable lab tests and clinical studies are necessary to understand whether this translates into reductions in biological responses and disease.
Researchers at British American Tobacco have developed a standardized way of measuring and comparing the potential of conventional cigarette smoke and e-cigarette vapour to cause oxidative stress in an in vitro model of lung epithelium.
To do this they bubbled matched amounts of smoke (from a reference cigarette) or vapour (from Vype ePen or Vype eStick) through cell-growth medium to produce a stock that could be diluted into various concentrations. They then exposed lung epithelial cells to the same concentrations of either smoke or vapour extract and, following exposure, used a panel of commercially available assays to measure and compare the stress responses of the cells.
Lung cells exposed to any of the concentrations of cigarette smoke showed signs of oxidative stress and, at higher doses, cytotoxicity. In stark contrast, vapour from e-cigarettes tested had no such effects, even at the highest concentration.
The research is published in a special edition on e-cigarettes of Toxicology Mechanisms and Methods DOI: 10.1080/15376516.2016.1222473.