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June 30th, 2016:

The FDA’s Deeming Rule On Vapor Products Must Be Challenged

http://www.forbes.com/sites/realspin/2016/06/30/the-fdas-deeming-rule-on-vapor-products-must-be-challenged/#58f5a11f3e0e

Legal challenges to the U.S. Food and Drug Administration’s (FDA) final deeming rule on vapor products are mounting, with lawsuits focusing on various aspects of the regulations, including claims ranging from violations of the Regulatory Flexibility Act and Administrative Procedure Act, to infringement of freedom of speech under the First Amendment and encroachment of the Fifth Amendment’s due process clause.

It is likely that more lawsuits will follow. In fact, the Smoke-Free Alternatives Trade Association (SFATA) supports the Right to Be Smoke-Free Coalition (RSF) who have filed a suit of their own challenging the FDA’s industry-crushing rule.

One of our fundamental objections to the deeming rule is that the FDA lacks the authority to regulate vapor products in the absence of therapeutic claims. Many legal experts agree that the Tobacco Control Act was never intended to apply to vapor products.

FDA is trying to extend its jurisdiction over e-cigarettes

The courts have been vigilant in policing the FDA’s over assertion of jurisdiction. The Supreme Court rejected the agency’s attempt to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “devices” in FDA v. Brown & Williamson Tobacco Corporation. Likewise, in Sottera Inc. v. FDA, the U.S. Court of Appeals for the D.C. Circuit rejected the FDA’s attempt to regulate e-cigs as unregulated medical devices, holding that unless a vapor product is marketed for therapeutic purposes, the agency may not regulate them as drugs, devices or combination products.

At the time the D.C. Circuit issued its ruling in Sottera, the FDA had not yet deemed e-cigs to be subject to its authority. Thus, the question presented in Sottera was not whether e-cigs are tobacco products, but whether they were, as FDA then asserted, “drugs” or “devices.” The D.C. Circuit rejected the FDA’s position, noting that the agency had frequently expressed the view that “cigarettes are beyond the scope of the Food, Drug and Cosmetic Act (FDCA) absent health claims establishing a therapeutic intent on behalf of the manufacturer or vendor.”

The FDA’s final regulations purport to address the jurisdictional lines established by Sottera by deeming vapor products as tobacco products subject to the FDCA. However, vapor products do not meet the definition of a “tobacco product.” As defined in Section 201 of the FDCA, as amended by the Tobacco Control Act, a “tobacco product” is “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

More people turning to vaping as tobacco price rises

http://www.nzherald.co.nz/northern-advocate/news/article.cfm?c_id=1503450&objectid=11666207

A Northland retailer selling e-cigarettes is “astounded” by the growth in sales since tobacco prices increased 10 per cent on January 1.

People puffing on the electronic devices, or “vaping” as the practice was known, were becoming a common sight around Northland with the retailer – who spoke anonymously – describing the cigarette substitutes as “the best thing I’ve ever sold”.

E-cigarettes – or electronic cigarettes – are devices that allow users to mimic the ritual of smoking a cigarette. Many glow at the end when activated, as real cigarettes do. Instead of inhaling smoke from burning tobacco, users inhale vapour containing nicotine.

“I’m astounded at how many people are buying them, and at how many people are giving up smoking using them. It’s a quiet little revolution,” said the retailer, who lost both his parents to smoking-related illnesses.

“I gave up cold turkey 10 years ago and it was hell – for about a year. The hardest thing to give up about smoking is the puff and the kick. These [customers] say it’s easy, and they’ve been trying for years and years.”

Holly Bognar said she had smoked for most of her life from about age 13 – apart from when she was pregnant.

“I’d always gone back to it,” the 38-year-old said.

“I was heavily smoking until four months ago and now I don’t at all, not even when I drink alcohol, I’ve transitioned to e-cigarettes.”

Ms Bognar said, when she first switched to her e-cigarette, she puffed on it a lot, a pattern the retailer said a lot of his customers reported.

“Now I’ve sort of weaned myself down, which just gradually happened,” she said.

“It’s also the amount you can save. It was about $65 initially, and a thing of oil (for the e-ciggie) is about $10, which lasts a couple of weeks. That’s compared to probably a 30g in five days, which is $55 and heaps to take out of your benefit.”

The use of e-cigarettes was not governed by the Smokefree Act, meaning that, legally, users could vape where they liked.

“I’m studying at the moment, and, out of reflex, I put it to my mouth in class and my tutor wasn’t too impressed,” Ms Bognar said.

I’m astounded at how many people are buying them, and at how many people are giving up smoking using them. It’s a quiet little revolution.

“But apparently it’s OK in the pubs. I’ve had a few puffs in the shops, but more just to see if I got a reaction.”

From a health professional’s perspective, the jury was still out. Northland DHB general manager child, youth, maternal, public and oral health services Jeanette Wedding said research suggested e-cigarettes were about 90 per cent safer than smoking tobacco.

However, they had not been clinically trialled as a quitting method. She agreed, anecdotally, there was a rise in people using the devices to stop smoking.

“We’ve heard mixed results when discussing stopping smoking with patients. Some have successfully stopped smoking using e-cigarettes, while others had tried them with no success.”

She said while the most important thing was for tobacco smokers to quit, e-cigarettes could present new problems.

These could include “re-normalising” smoking which looked similar to the act of vaping, a lack of regulation of what went into the liquid vapour, and liquids coming in flavours that appeal to the young, like chocolate and strawberry.

British American Tobacco vows to investigate child workers in Bangladeshi farms

http://www.dailymail.co.uk/wires/reuters/article-3667748/British-American-Tobacco-vows-investigate-child-workers-Bangladeshi-farms.html

NEW DELHI, June 30 (Thomson Reuters Foundation) – British American Tobacco (BAT), the world’s second biggest cigarette company, vowed on Thursday to investigate some of its supply farms in Bangladesh after a Swedish campaign group uncovered the use of child workers to grow and process tobacco.

Swedwatch, which surveyed three tobacco farming districts in Bangladesh, said it found child labour was “widespread” in farms supplying BAT and its local subsidiary British American Tobacco Bangladesh, jeopardising their health and education.

“Girls and boys of all ages are responsible for irrigating and leveling the field. Some of them carry loads as well and bring seedlings from the bed to the field,” said the study, which was conducted between July 2015 and May 2016.

“After harvesting, they break the leaves, cut the stems, and help to monitor the kiln temperature while curing.”

Swedwatch said children were not only pulled out of school to work for up to 16 hours a day during the harvest season but were also engaged in tasks that exposed them to green tobacco plants, dust from tobacco and smoke from kiln drying.

Group Head of Corporate Affairs at British American Tobacco Simon Cleverly told the Thomson Reuters Foundation that the company had investigated the report’s findings, including allegations of unfair contracts to farmers, but found no evidence of any human rights violations.

He said BAT’s investigations were consistent with the findings of several independent studies commissioned by BAT to look into tobacco growing and rural livelihoods in Bangladesh that found the company has a positive socio-economic impact.

But Cleverly said BAT, the maker of Lucky Strike and Dunhill cigarettes, has asked Swedwatch for details of the farm locations where children were said to be working so the company can investigate further and act if necessary.

“We believe this report presents a misleading and inaccurate view of our tobacco leaf farming supply chain in Bangladesh, a country where we have a long-standing history of working with farmers and the government for mutual benefit,” said Cleverly.

“I FEEL WEAK”

According to the International Labour Organization (ILO), over five million children aged between 5 and 17 years are engaged in some kind of employment in Bangladesh.
For although Bangladesh laws set a minimum working age of 14, poverty causes many families to send children to work.

But UNICEF estimates 93 percent of child labourers work in the informal sector, saying this makes enforcement of labour laws virtually impossible.

Almost half of working children are believed employed in the farm sector, which is considered the most dangerous in terms of work-related fatalities and occupational diseases due to sharp tools, dangerous machinery, and use of agro chemicals.

The Swedwatch report said children working in Bangladesh’s tobacco farms in Bandarban, Chakoria and Lalmonirhat districts were no exception and faced nicotine absorption through the skin as well as pesticide exposure due to no protective equipment.

“I cannot sleep or eat regularly and that leads to other health problems. I feel weak,” said one boy, 16, in the report.

“When I work in front of the kiln, my eyes burn, I feel pain in my chest and I cough a lot,” he added, describing the process of curing tobacco leaves which involves heating them in a kiln.

The study, based on interviews with over 150 people including farmers, government officials, community leaders and activists, also found tobacco work had an adverse impact on schooling and future prospects as children were pulled out of class to work.

“The report urges BAT and other tobacco companies to remove the ‘smokescreens’ over their supply chains by publishing impact assessments and third party audits, and to take immediate action to protect people and the environment,” Swedwatch said.

(Reporting by Nita Bhalla, Editing by Belinda Goldsmith; Please credit the Thomson Reuters Foundation, the charitable arm of Thomson Reuters, that covers humanitarian news, women’s rights, trafficking, corruption and climate change. Visit news.trust.org)

Plain packaging bill passes second reading

https://nz.news.yahoo.com/top-stories/a/31957689/plain-packaging-bill-passes-second-reading/#page1

The bill that will force cigarettes to be sold in plain packets is back in parliament and on track to become law.

It passed its second reading on Thursday after being on hold since 2014.

The government last month confirmed it was going to put it through, and unveiled the proposed new brown-green packaging which is similar to that used in Australia.

Prime Minister John Key said at the time plain packages could be on the shelves early next year.

The government first mooted plain packaging back in 2012, the year Australia introduced it, and the bill passed its first reading in February 2014.

It went to a select committee, which supported it, but the government didn’t want to take it any further at that time because it was worried about the possibility of costly legal challenges from big multi-national tobacco companies.

The Australian government was being sued at the time, but in December last year legal action by Philip Morris failed.

Australia is still waiting for the outcome of a challenge to its plain packaging laws that is being dealt with by the World Trade Organisation.

Despite that, the government decided to put the bill through its remaining stages.

It passed its second reading 108-13, with NZ First and ACT opposing it.

NZ First’s position is that the government should ban tobacco rather than meddle with the sale of a legal product, and it doesn’t believe plain packaging will work.

ACT leader David Seymour said the impact of plain packaging in Australia had been minimal.

“Every company wants to have its own brand so it can compete with other companies, that’s perfectly understandable,” he said.

The bill still has to pass its committee and third reading stages to become law.

It’s estimated that between 4500 and 5000 New Zealanders die from smoking-related illnesses each year.

About 15 per cent of adult New Zealanders smoke. The figure for Maori is 35 per cent and for Pacific people it’s 22 per cent

16 outrageous tobacco ads that would be illegal today

http://uk.businessinsider.com/vintage-tobacco-adverts-that-would-be-illegal-today-2016-6

Everyone knows by now that smoking isn’t good for your health. The cigarette was even called “the deadliest artefact in the history of human civilisation” by Stanford University researchers.

But thanks in part to ingenious marketing campaigns throughout the 1900s, 10 million cigarettes were being sold every minute around the world by the year 2000, according to the World Health Organization.

This year marks the 10th anniversary of the Stanford School of Medicine’s “Research into the Impact of Tobacco Advertising.”

Over the years, the project has published more than 16,000 vintage tobacco ads.

Most of them would be completely illegal in many countries today — including Britain, where all tobacco advertising is outlawed.

Until direct links were found between smoking and poor health in the 1960s, cigarettes were marketed as a remedy for a number of ailments, including sore throats and asthma. Even dentists recommended them.

Until direct links were found between smoking and poor health in the 1960s, cigarettes were marketed as a remedy for a number of ailments, including sore throats and asthma. Even dentists recommended them.

The tobacco industry put people's faith in science to the test. They claimed that their products caused no adverse side-effects​, with the apparent backing of "medical specialists."

The tobacco industry put people’s faith in science to the test. They claimed that their products caused no adverse side-effects​, with the apparent backing of “medical specialists.”

this-advert-claimed-to-prevent-throat-irritation-and-coughing

This advert claimed to prevent “throat irritation and coughing.”

It was considered uncouth for a woman to smoke at the turn of the 20th century, but as the Prohibition era came to an end, tobacco companies aggressively targeted the untapped female market.

It was considered uncouth for a woman to smoke at the turn of the 20th century, but as the Prohibition era came to an end, tobacco companies aggressively targeted the untapped female market.

Some of them were outrageously sexist.

Some of them were outrageously sexist.

This one claimed passive smoking was a way of getting women to follow you.

This one claimed passive smoking was a way of getting women to follow you.

However, like any business should know, they had to move with the times, and just decades later, they were latching onto the feminist movement as well.

However, like any business should know, they had to move with the times, and just decades later, they were latching onto the feminist movement as well.

As World War II came to an end, the tobacco industry ventured into new markets to keep profits up during a time of austerity — the African American market became one of the most important demographics.

As World War II came to an end, the tobacco industry ventured into new markets to keep profits up during a time of austerity — the African American market became one of the most important demographics.

Children were also regularly used in advertising. Stanford researchers suggest that this was an effective way of reinforcing the idea that smoking is part of regular family life.

Children were also regularly used in advertising. Stanford researchers suggest that this was an effective way of reinforcing the idea that smoking is part of regular family life.

This ad campaign showed small children admiring their parents' choice of cigarettes. The use of children was part of the industry's master plan​ to rope in more female consumers.

This ad campaign showed small children admiring their parents’ choice of cigarettes. The use of children was part of the industry’s master plan​ to rope in more female consumers.

No child was too young for the tobacco marketers.

No child was too young for the tobacco marketers.

Celebrity endorsements have always been a winning tactic. If Lucille Ball smokes, it must be cool.

Celebrity endorsements have always been a winning tactic. If Lucille Ball smokes, it must be cool.

From as early as the 1930s, smoking was advertised as a dieting technique, encouraging people to "reach for a Lucky" instead of a sweet.

From as early as the 1930s, smoking was advertised as a dieting technique, encouraging people to “reach for a Lucky” instead of a sweet.

Advertisers really bucked the weight-loss trend in the 1970s. This was perhaps one of the few medical claims that had an element of truth to it.

Advertisers really bucked the weight-loss trend in the 1970s. This was perhaps one of the few medical claims that had an element of truth to it.

Impressionable teens were a popular target market. According to the Stanford research, these ads presented smokers as "young, attractive, vibrant, athletic, happy, and full of vitality. Without claiming health benefits outright, Lucky Strike portrayed its brand as healthy and enticing through these campaigns."

Impressionable teens were a popular target market. According to the Stanford research, these ads presented smokers as “young, attractive, vibrant, athletic, happy, and full of vitality. Without claiming health benefits outright, Lucky Strike portrayed its brand as healthy and enticing through these campaigns.”

Sometimes cigarettes were simply marketed as a quick pick-me-up.

Sometimes cigarettes were simply marketed as a quick pick-me-up.

A breath of fresh air for diners: Smoking ban begins in all outdoor dining areas in South Australia

  • Smoking in all alfresco dining venues is now banned in South Australia
  • Cancer Council SA wants to protect the public from second hand smoke
  • If caught smoking – diners receive a $200 fine, businesses are fined $1,250

Smoking will be banned from all alfresco dining venues in South Australia, starting from Friday.

The new rules apply to pubs, clubs, café, restaurants and fast food outlets after years of campaigning to try and protect the public from second hand smoke.

Cancer Council SA’s chief executive Lincoln Size says he is pleased workers and diners can now be protected.

‘We believe that South Australians of all ages should be able to enjoy alfresco dining areas without putting their health at risk from second hand smoke,’ Mr Size said.

‘Tobacco smoke contains thousands of chemical compounds – at least 250 of these found in secondhand smoke are known to be toxic or carcinogenic.

The law now requires a two metre wall be installed to divide the two areas of smoking and nonsmoking if venues hope to continue allowing diners to smoke.

Those caught smoking in outside areas will be given a $200 fine while businesses will be fined $1,250.

Cigarettes, cigars, pipes, shisha, hookah and water pipes all fall under the no-smoking ban.

Mr Size said 21 people in South Australia are killed as a result of smoking every week and the ban will help ‘de-normalise the behaviour.’

Smoking will only be allowed in beer gardens where ‘pre-packaged food of a kind generally intended to be consumed between meals,’ is served.

Sheila Duffy: Continuing to make smoking a thing of the past

MSPs can help to change lives across the country says Sheila Duffy

The fifth session of the Scottish Parliament has begun. Once they have settled in to their new offices, found out who’s got which job and recruited their office staff, the new MSPs will have to consider what issues to focus on over the next five years.

I would guess that Scotland’s health, and health inequality, will be at the top of many lists. If someone were able to offer these MSPs a popular, cost-effective means of greatly improving health, saving the NHS money, supporting businesses and putting significant funds into the pockets of our poorest communities, you imagine they would jump at the chance.

I’m hoping that they do, because I have exactly such a proposal for them.

Robust action on tobacco from successive Scottish administrations has helped sustain a steady decline in the smoking rate. Yet the latest Scottish Household Survey still indicates an adult smoking rate of 20 per cent in 2014. That translates into nearly 900,000 people in Scotland who have significantly increased risks of cancer, heart disease, dementia, stroke and diabetes.

Smoking remains far and away our largest preventable cause of ill health and death, so that around 300,000 people in Scotland will currently be living with serious illness due to tobacco use. They each spend an average of £125 a month on tobacco and smoking costs push an extra 32,000 Scottish households over the poverty line, while deepening the poverty experienced by many others.

Crucially, surveys year after year show that most people in Scotland who smoke say that they want to stop. The harm caused by tobacco arises from engrained habit and addiction rather than from lifestyle choice.

The Scottish Government has set a target of a “tobacco-free generation” by 2034. This is defined as a 5 per cent smoking rate by 2034 – which ASH Scotland articulates as achieving a situation where cigarettes are out of sight, out of mind and out of fashion and the only people who smoke are the small number of informed adults who
actively choose to do so.

The national tobacco strategy sets an intermediate target of a 12 per cent smoking rate by 2021, the lifetime of this Parliament. If this goal can be achieved then, over time and compared with the latest survey figures 350,000 people in Scotland will benefit from the single, largest gain which anyone who smokes can achieve for their health

Reduced smoking-related admissions would lead to annual savings of between £100 million and £170m from NHS budgets, to be spent on other priorities. Scotland’s economy will benefit, with employers hit by 1 million fewer sick days each year

The poorest fifth of communities will gain an extra £100m of disposable income every year

All of these gains would result from meeting an existing Scottish Government commitment. To ensure that these gains are successfully delivered we need robust political action, of the sort which has helped achieved the reduced smoking rates to date.

In this session of the Parliament we need to see clear recognition that tobacco use is part of the problems faced by people with mental health issues, and a commitment that stop smoking support should be offered as part of the care provided. We need robust, well-resourced action from police, trading standards and others to keep tobacco out of the hands of our children and illicit tobacco out of our communities. We need to ensure financial support services, from money advice to food banks, understand that smoking is not a lifestyle choice but a further burden on the already disadvantaged and that stop smoking support is one element of the road to financial stability.

Recently Scotland celebrated ten years of smoke-free enclosed public spaces, a move that seemed risky at the time yet which has been uniquely successful and smoothly implemented and remains one of the Scottish Parliament’s most popular actions. As of last month all tobacco manufactured for use in the UK must come in plain, standardised packaging. Soon packets without brand imagery will present consumers with a more honest presentation of the product.

There is a long way to go on Scotland’s journey towards being tobacco-free in 2034. But the evidence is clear that a tobacco-free generation will not just be healthier, but wealthier and fairer too. Our successes to date, achieved against huge opposition from vested commercial interests, should inspire us that we can get there.

• Sheila Duffy, chief executive, ASH Scotland

E-cigarettes ‘ARE a gateway to smoking for young people – AND their use is linked to a greater risk of alcohol abuse’

  • College students who use e-cigarettes are more likely to smoke cigarettes
  • New study links devices to greater risk of alcohol use, experts say
  • Also found male college students are more likely to use the devices

The debate is complex, and provokes strong opinions on both sides of the scientific fence.

In one camp are those people who view e-cigarettes as a tool in the quest to quit smoking, a means by which smokers can cut down and eventually kick their habit.

Yet, a growing body of evidence is questioning that rationale.

For, studies have shown the devices act as a gateway, encouraging previous non-smokers to take up the habit.

A new piece of research appears to consolidate that theory, adding that e-cigarettes may also tempt young people into drinking alcohol and trying psychoactive substances.

The findings focus on college students, and link e-cigarette use with high rates of alcohol consumption.

Furthermore, researchers at Texas Tech University also warn the devices indicate a general propensity to use psychoactive drugs.

They note the rise of e-cigarette use ‘may be a positive consequence’ of traditional smokers who use the devices to try and quit smoking or to avoid the toxicity of cigarettes.

But, among young people, they warn of an emerging trend.

‘The current findings suggest that e-cigarettes may represent another “tool in the tool chest” among college students with a proclivity to use, and misuse, psychoactive substances.’

Researchers set out to examine e-cigarette use and the relation of such use with gender, race/ethnicity, traditional tobacco use, and heavy drinking.

They analyzed a sample of 599 college students enrolled in General Psychology at a state university, who each completed a self-report questionnaire.

The findings revealed 29 per cent of students reported prior use of e-cigarettes, with 14 per cent reporting use in the past 30 days.

Researchers noted male college students were more likely to use the devices, but noted there was no difference when the results were broken down by race or ethnicity.

Dual use – simultaneous use of both e-cigarettes and traditional cigarettes – was linked to heavier smoking.

And, using nicotine was linked to pronounced rates of heavy drinking.

Of greatest concern, the researchers said, was the association found between e-cigarette use and heavy drinking.

They said: ‘Although smoke-free legislation has led to several public health benefits, the increasing popularity and presence of e-cigarettes may allow college students to circumvent these bans and more readily co-use alcohol and nicotine.

‘Several lines of evidence suggest that nicotine use enhances the reinforcing effects of alcohol use, especially among men.

‘It increases the duration of a drinking episode, and leads to higher levels of cravings for both alcohol and cigarettes when co-used with alcohol.

‘Further, alcohol and tobacoo use disorders are prospectively linked in college students.’

The results showed that e-cigarette use among college students is exponentially on the rise, and its co-use with alcohol may contribute to negative outcomes in this population.

The findings are published in the Journal of American College Health, published by Taylor & Francis.