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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.

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

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.

Toxins Remain in Home Long After Smokers Quit

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

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

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.

Azerbaijan subsidizes tobacco manufacturers

President of Azerbaijan Ilham Aliyev has issued an order on providing state support to development of tobacco-growing.

APA reports that AZN 0.05 will be paid in subsidy to the tobacco manufacturers for each 1 kg of dry tobacco and 10 kg of wet tobacco sold to the processing enterprises.

The subsidy also concern dry and wet tobacco sold to the processing enterprises in 2016.

The Cabinet of Ministers is to approve the rules on paying subsidies to the manufacturers by agreeing with the Azerbaijani President within two months, and the Ministry of Finance is to provide the funding.

Transparency, Yes. Interference, No.

Vera Luiza da Costa e Silva Head of the Secretariat of the WHO FCTC

There was a time when public health discussions on tobacco were an extraordinarily open process. Government officials met a wide range of people and listened to their concerns and ideas as they formulated policy.

Among the “contributors” were representatives of the tobacco industry, which offered assurances about its earnest intentions. The tobacco industry had access to policy-makers and infiltrated public health forums and because everyone involved was open the industry gained access to internal government documents listing a wide range of ways of regulating the industry.

All that changed when courts, particularly in North America, began considering cases from tobacco victims. Judges ordered – as is normal in such matters – that the tobacco industry discloses internal documents to plaintiffs. It became clear that the industry lied when denying the harms caused by their products, disputing scientific findings, and luring millions, including the world’s youth, into addiction, in a drive to build its business.

The publication of this mountain of paperwork (the documents are now numbered in the millions) from the late 20th and early 21st centuries was a watershed moment, providing incontrovertible evidence that the tobacco industry could not be trusted. There was no sign of the earnest partner the industry claimed to be.

Documents show how the industry worked behind the scenes successfully lobbying policy makers to discontinue or water down tobacco control measures. The documents mapped efforts to delay and confound policy initiatives and to create vast new markets in the developing world. They also show how the tobacco industry created or co-opted front groups to defend their interests and used tobacco farmers to prevent governments pushing on with public health policies.

As British American Tobacco’s (BAT) chairman noted in an internal memo in 1990: “We should not be depressed simply because the total free world market appears to be declining… There are areas of strong growth, particularly in Asia and Africa… it is an exciting prospect.”

The revelations kept on coming, including the disclosure that industry research was suppressed or secretly moved to other countries to put material beyond the reach of the courts. Other documents showed how the industry conspired in attempts to raise the proportion of women smokers to the levels of men.

The tobacco industry documents had a significant effect – firstly on the court cases to which they related, but just as importantly in creating a resolution among policy-makers. If the tobacco industry was now a global industry seeking to expand to new markets, the response must be equally global.

The UN Tobacco Control treaty itself, the WHO Framework Convention on Tobacco Control (WHO FCTC), was a response to the transnational nature of the business and the need for a global response to curb the epidemic. It entered into force in 2005 becoming the first global health treaty, an attempt to strongly regulate the trade in this noxious product.

The Convention brought together various government sectors with public health experts, researchers and others in the certainty that unified action was required to counteract the industry’s behaviour. This, we fervently hoped would save millions of lives.

We have been successful in doing so, even as we recognise that the tobacco industry is expanding its markets, placing many more people at risk of premature death.

The tobacco industry is targeting Parties’ delegations attending the world’s largest intergovernmental meeting solely dedicated to tobacco control. At the last Conference of the Parties in 2014, letters were sent representing tobacco industry interests petitioning finance officials on taxation.

We cannot sit at the negotiating table with the people who caused this global disaster because one thing is crystal clear – this industry lies. Publicly it speaks in a mild voice, while behind the scenes it executes policies in absolute opposition to its public statements, ultimately killing one in every two regular users of its products.

So when we meet in Delhi in November for the WHO FCTC’s seventh session of the Conference of the Parties (COP), we will be making documents available, we will be briefing journalists and we will publicize our decisions.

We will also guard against tobacco industry interference, this most untrustworthy of businesses. It would be a dereliction of our duty to do otherwise.

That means some sessions will be held in public and some behind closed doors, normal in international meetings and as provided by the rules of the FCTC Conference of the Parties. We will be as open as possible, but we are not naive. We have learned a critical lesson – this industry can never be trusted and will try to disrupt and confound the tobacco control process.

COP7 will, I believe, send an unequivocal message to the tobacco peddlers. The world understands who you are and what you do, and is determined to stamp out the global plague which you do so much to spread.

Follow Vera Luiza da Costa e Silva on Twitter:

The Real Reason Why E-Cigarettes Can’t Help More American Smokers

Dr. Amy Fairchild Professor of Sociomedical Sciences, Columbia University’s Mailman School of Public Health

Co-Authored by Amy L. Fairchild, Ronald Bayer, and Sharon H. Green

Over the past few years, the chances are high that you have seen fewer smokers and more vapers—that is, people using e-cigarettes. These devices have become ever more popular, but they also have ignited a bitter battle. Remarkably, this dispute has not pitted public health professionals against Big Tobacco flacks, as in decades past. Rather, the fight is playing out among scientists committed to drastically reducing if not eliminating the prevalence of smoking. Traditional cigarettes kill 480,000 Americans each year and will take one billion lives worldwide this century. Scientists around the world are actively debating: What can be done to stop them?

Given the anti-e-cigarette messaging of some influential anti-tobacco groups, many may be surprised to learn that it is increasingly difficult to make a scientific case against e-cigarettes. Last month, a second Cochrane Review—the gold standard when it comes to assessing the state of the evidence on hot topics from salt to fat to smoking—concluded that e-cigarettes may help smokers quit without serious health consequences. The review concluded that of all 24 studies included, not a single one reported serious health risks to vapers from up to two years of e-cigarette use. Like the first review in 2014, this update is guarded, but it also gives an approving nod to 15 currently ongoing randomized trials that are underway.

As the evidence moves in favor of e-cigarettes, this latest report is sure to add fuel to a raging firestorm. This debate highlights two key tensions. First, what do we do in the absence of scientific certainty about all possible harms? This question was at the heart of a furious exchange of letters between scientists over the course of 2014. This feud over e-cigarettes can’t be understood absent the values that animate it.

Framing the position of those who favor e-cigarettes is Michael Russell, a pioneer of smoking cessation methods who famously wrote, “People smoke for nicotine but they die from the tar.” By extension, many scientists argue that e-cigarettes can satisfy nicotine addictions without causing harmful exposures to tar and combustion. They believe e-cigarettes could drastically reduce if not eliminate cigarettes.

This “harm reduction” perspective acknowledges that many smokers cannot or will not quit. Even if e-cigarettes carry some risks, those risks are far less serious than those of smoking. Thus, weighing the risks of e-cigarettes requires a comparison to the well-documented harms of smoking.

On the other side of the debate are those who preach precaution. Until the uncertainty about e-cigarettes is resolved, these devices have no place in a public health anti-tobacco arsenal. And there is uncertainty regarding the harms smokeless products may pose, particularly in the face of unknowns about how the FDA’s new regulatory regime may impact quality control. But even if e-cigarettes may be a better option for any individual smoker who wants to quit but cannot, how might they change the pattern of disease in the long run? The fundamental question, in other words, isn’t how e-cigarettes might help or harm individuals, but whether they will change population-level smoking patterns.

This tension between harm reduction and precaution, then, highlights a second vital question: Whose risk matters?

In 2015, Public Health England, the United Kingdom’s equivalent to the CDC, roiled the waters when it endorsed e-cigarettes for harm reduction. Remarkably, while they drew fire from the Lancet and the British Medical Journal, they received the backing of ASH, a major anti-tobacco NGO with an unimpeachable record of opposition to cigarettes. In 2016, they were also joined by the Royal College of Physicians, which advocated for a harm reduction approach that included not only e-cigarettes but also other forms of smokeless tobacco.

The positions of British organizations that embraced e-cigarettes reflected a long history of support for harm reduction. Also, the UK organizations have focused on populations in immediate, certain danger: smokers themselves.

In the US, in sharp contrast, federal agencies have remained staunchly opposed, not only because of precaution, but also because of a focus on a different population: vulnerable youth and non-smokers. Former FDA commissioner David Kessler and Campaign for Tobacco-Free Kids president Matthew Myers wrote in an op-ed in the New York Times, “we cannot afford to waste more time while the tobacco industry addicts another generation of kids.” For advocates of precaution, protecting populations that haven’t yet been seduced by tobacco has remained paramount. For the non-smoker, an e-cigarette does nothing but increase risk.

Data alone cannot tell us what to do. Interpreting the emerging evidence on e-cigarettes relies on values and priorities: harm reduction or precaution, immediate peril or potential risks. While there can be no question that the public health community must look for emerging scientific data regarding risks and benefits, we must acknowledge the values that animate the controversy. Only then will we be able to reduce the enormous health burden of tobacco.

Are E-Cig Injuries Exploding Upward?

These images show injuries to the thigh and hand that resulted from burns from flames after the lithium-ion battery of an e-cigarette exploded.  Credit: The New England Journal of Medicine © 2016

These images show injuries to the thigh and hand that resulted from burns from flames after the lithium-ion battery of an e-cigarette exploded.
Credit: The New England Journal of Medicine © 2016

Injuries from exploding e-cigarettes appear to be on the rise, according to a new analysis from a Seattle hospital.

Over a nine-month period from October 2015 to June 2016, health care workers at the University of Washington Medical Center treated 15 patients for injuries from exploding e-cigarettes.

For comparison, from 2009 to 2014, there were a total of 25 reports of injuries in the U.S. from these devices, the authors wrote in a letter published today (Oct. 5) in the New England Journal of Medicine. [E-Cigarettes: What Vaping Does to Your Body]

“We suspect that with the growing use of [e-cigarettes], many hospitals around the country will see an increase in injuries related to e-cigarette explosions,” the authors, led by Dr. Elisha Brownson, a surgeon specializing in burn care, wrote in the letter.

Of the 15 Seattle patients, 12 experienced burns from flames, according to the report. These injuries require extensive wound care and a procedure called skin grafting — in which a piece of the patient’s healthy skin from another part of the body is transplanted to the burned area — the authors wrote.

Chemical burns were also a common type of injury from an exploding e-cigarette: among the Seattle patients, five experienced such burns, which also require wound care.

These burns are caused by the alkaline chemicals found in the device’s battery, according to the report.

Four of the patients experienced “blast injuries,” the authors wrote. These injuries caused tooth loss and “extensive” soft-tissue loss in the patients, and some patients needed surgery to remove damaged tissue and close up their wounds, according to the report.

Some of the patients with blast injuries also had “traumatic tattooing,” which occurs when foreign particles get embedded below the surface of a person’s skin, creating a tattooed appearance.

The authors noted that more than half of the injuries were to the thigh or groin, one-third of the injuries were to the hands and one-fifth of the injuries were to the face.

Patients injured by e-cigarettes often require medical treatments from a number of different specialists, including emergency medicine providers, plastic surgeons, burn care providers, vocational counselors and psychologists, according to the report.

In all of the cases that the authors described, the device’s lithium-ion battery caused the explosion.

The authors noted that the Food and Drug Administration recently announced that it would begin to regulate all tobacco products, including e-cigarettes, but that it’s unclear if the agency would also regulate the batteries.

Originally published on Live Science.

Plain packaging on cigarettes and tobacco due in May 2017

Health warnings with graphic images of health consequences to dominate packaging

Plain packaging on cigarette and tobacco products will come into effect in Ireland in May next year, Minister for Health Simon Harris has confirmed in the Dáil.

The Government has been adamant it will introduce plain packaging despite threats from the tobacco industry of legal action and the loss of 87 jobs in Mullingar following the decision to close the Imperial Tobacco manufacturing plant.

Health warnings with graphic images of the consequences of smoking will feature predominantly on packaging.

Mr Harris was speaking as he introduced the Health (Miscellaneous Provisions) Bill – an amalgam of measures to amend four pieces of legislation relating to different aspects of health.

The Bill amends six sections of the Public Health (Standardised Packaging of Tobacco) Act 2015 relating to the regulation of the appearance of tobacco packaging.

Reducing appeal

Mr Harris said the regulation of the appearance of tobacco packaging is aimed at improving public health by reducing the appeal of tobacco products to consumers, and increasing the effectiveness of health warnings on the retail packaging of tobacco products.

It will also reduce the ability of the packaging of tobacco products to mislead consumers about the harmful effects of smoking, the Minister said.

The Bill will allow the Minister prescribe “the colour of the outer and inner surfaces of tobacco packaging, the form and manner of barcodes and the manner in which a name may be printed on tobacco products”.

The legislation also amends the Irish Medicines Board Act 1995 to allow fees to be paid to board members of the Health Products Regulatory Authority, former the Irish Medicines Board, which licenses medication in the State.

Board members will be paid €7,695 a year, resulting in an overall additional cost to the authority of about €61,560.

The Minister said some members might choose to waive their fee and he pointed out that the “One Person One salary” principle would apply to members of the board who are also in receipt of a salary from the public service.

‘Onerous responsibility’

Mr Harris said he was introducing the changes because “there is an onerous responsibility and significant time commitment placed on members of the authority and we wish to attract the highest calibre of people to apply to be members of such boards”.

A separate amendment to the Nursing Homes Support Scheme Act 2009 will mean that anyone applying for the nursing home Fair Deal scheme will not have to include for means testing certain ex-gratia payments received arising from Government decisions.

The legislation deals with four Government schemes including three linked to the Lourdes Hospital – the hospital’s Redress Board which involved 119 women; the hospital’s payment scheme which compensated women excluded from the Redress Board on age grounds, affecting 47 women; the Surgical Symphysiotomy Payment Scheme which made awards to some 400 women and payments made by the government or the German Contergan Foundation to 32 Irish survivors of thalidomide.