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October 18th, 2016:

Tobacco giants return to court in battle against new plain-packaging rules

http://www.aol.co.uk/news/2016/10/18/tobacco-giants-return-to-court-in-battle-against-new-plainpackaging-rules/

Tobacco giants return to court today in their battle against the Government’s new plain-packaging rules.

They suffered what anti-smoking campaigners described as a ”crushing defeat” at the High Court in May.

The day before new regulations come into force, a judge in London declared that they were ”valid and lawful in all respects”.

Mr Justice Green rejected a judicial review action brought against Health Secretary Jeremy Hunt.

The judge declared: “There is no basis upon which I could or should strike down the regulations or prevent them coming into effect tomorrow.”

Philip Morris International, British American Tobacco, Imperial Tobacco and Japan Tobacco International had challenged the legality of the ”standardised packaging” regulations.

The judge heard submissions that the Standardised Packaging of Tobacco Products Regulations 2015 would destroy valuable property rights and render products indistinguishable from each other.

But he ruled: “The regulations were lawful when they were promulgated by Parliament and they are lawful now in the light of the most up-to-date evidence.”

His decision that the regulations were ”justified and proportionate in the public interest” came after Europe’s highest court rejected a series of legal challenges.

Action on Smoking and Health (Ash) chief executive Deborah Arnott, said at the time: “This landmark judgment is a crushing defeat for the tobacco industry and fully justifies the Government’s determination to go ahead with the introduction of standardised packaging.”

After the ruling, one of the companies, Philip Morris International (PMI) said it was ”disappointed”, but although there were ”strong grounds”, it would not be appealing.

Three Court of Appeal judges in London will now hear a challenge against the judge’s ruling, expected to last four days.

E-Cigarettes: Good Idea? Bad Idea?

To vape or not to vape subject of SPH Bicknell Lecture tomorrow

https://www.bu.edu/today/2016/2016-william-j-bicknell-lecture-e-cigarettes-good-idea-bad-idea/

To anyone who has followed the controversy around the perceived merits and health risks of e-cigarettes, the research and reactions can seem a jumble.

The handheld electronic devices, which vaporize a flavored liquid containing nicotine, have been touted as effective quit-smoking tools, safer than conventional cigarettes.

They’ve also been slammed as a gateway to tobacco cigarette use in young adults, with studies showing they contain detectable levels of toxic chemicals.

The School of Public Health will wade into the debate tomorrow, Wednesday, October 19, when two of the world’s leading experts on electronic cigarettes share the stage at the 2016 William J. Bicknell Lecture. Headlined E-cigarettes: Good Idea? Bad Idea? it is free and open to the public.

Linda Bauld, a University of Stirling professor of health policy and deputy director of the UK Centre for Tobacco and Alcohol Studies, says that while e-cigarettes are not risk-free, they are an important alternative to “a uniquely deadly product that kills one in two of its regular users.” She says there is no firm evidence that e-cigarettes are a gateway to conventional cigarette use among young adults.

Andrea Villanti, director for regulatory science and policy at the Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative, agrees that the devices are effective quit-smoking aids, but says there is a need for clear, accurate information about their potential harms. She says vaping devices are “a diverse product class and must not be treated as a single product.”

The discussion comes in the wake of the recent decision by the US Food and Drug Administration (FDA) to extend its tobacco oversight authority to e-cigarettes. The controversial FDA regulations require manufacturers to detail what is in their products and apply for marketing permission by 2018.

Moderating tomorrow’s Bicknell lecture is Ronald Bayer, a Columbia University Mailman School of Public Health professor of sociomedical sciences, whose research focuses on issues of social justice and ethics related to tobacco and other health concerns. Bayer says he views the e-cigarette hand-wringing as “not just a scientific controversy—it’s also political.” He plans to explore why public health groups in the UK “have seen in the evidence a justification for enthusiastically embracing e-cigarettes as a harm-reduction strategy for smokers, while in the United States there has been deep skepticism, if not hostility, in the tobacco control community.”

According to data from the Centers for Disease Control and Prevention (CDC), 12.6 percent of adults tried an e-cigarette in 2014. Only 3.2 percent of adults who had never smoked cigarettes tried them, but the CDC and some public health advocates have been alarmed by a dramatic rise in their use among teenagers. The CDC reports that in 2015, 16 percent of high school students said they had used electronic cigarettes in the past 30 days—an increase from 1.5 percent in 2011.

BU Today spoke to Bauld and Villanti about their views on the subject.

BU Today: Proponents of strict regulations say e-cigarettes are a gateway to regular cigarette use, especially for young adults. Is that just a worry or is it a fact?

Bauld: This may be a worry, but it is not an established fact. There is no firm evidence from anywhere—despite a couple of US studies and one Swiss study that followed up nonsmokers who used e-cigarettes and found some of them had tried tobacco—that this is occurring. There are high rates of experimentation with e-cigarettes among teenagers in the United States and some evidence of this in the UK and other jurisdictions. However, regular use is confined to teenagers and young adults who already smoke tobacco.

Villanti: A primary goal of tobacco control is to keep all youth from using tobacco or nicotine products, and it’s important to know how new tobacco or nicotine products impact use among young users. While we have long-term population surveillance data on cigarettes in youth, we only have a few data points on e-cigarettes, as they are a relatively new product.

Cross-sectional data have shown declines in past 30-day youth cigarette use at the same time that there has been a rise in past 30-day youth e-cigarette use. In fact, the most recent data show that youth cigarette use is at an all-time low, which is encouraging. The data also indicate that past 30-day youth e-cigarette use did not increase significantly from 2014 to 2015 and may be leveling off. The largest proportion of youth e-cigarette use is infrequent, which is more consistent with experimentation than regular use.

Focusing only on the gateway between e-cigarette and cigarette use detracts from understanding the full picture of youth tobacco and nicotine use and its impact on public health.

Do you think the FDA was right to regulate e-cigarettes as tobacco products? What’s your view on requiring premarket approvals for companies?

Bauld: E-cigarettes are not tobacco products, and in my view, a separate regulatory framework would have been more appropriate. However, I do appreciate the view of my FDA colleagues, which is that they wished to create a regulatory framework that includes all nicotine products. In the United States, it is disappointing to see that nicotine replacement therapy does not have a harm-reduction license to allow usage while cutting down on cigarette smoking or longer-term usage to avoid relapse to smoking. That needs to change.

I also appreciate the need for product standards of e-cigarettes and other vaping devices and am aware that the FDA regulations had this as one aim. However, the required premarket approval process and the rather arbitrary cutoff for products already on the market that won’t need approval will in my view create advantages for tobacco and tobacco companies over independent e-cigarette manufacturers. This is a potential unintended consequence of the FDA regulations and will perpetuate smoking.

Villanti: The short answer is yes. If prudently regulated, e-cigarettes hold promise as one means to move smokers to a less harmful product and reduce the devastating death and disease burden caused by combustible tobacco products such as cigarettes, cigars, or hookah.

Despite noncombustible tobacco and nicotine without tobacco being less toxic than combustible tobacco, e-cigarettes (and other new nicotine delivery devices) cannot fulfill any promise they may have of harm reduction if we do not know what is in them, who is manufacturing them, and how they are marketed and advertised. So, regulation is essential to ensure they are of good quality and as safe as possible and that the benefits are maximized while harms are minimized.

Shouldn’t we applaud e-cigarettes as a smoking-cessation device?

Bauld: The evidence on smoking cessation with e-cigarettes is positive overall, although the quality of evidence remains weak. The update of the Cochrane Review, published earlier this year, makes that clear. In the UK, we have a public health consensus statement endorsed by our main health charities, government agencies, and professional bodies. This makes clear that all the evidence suggests e-cigarettes are significantly less harmful than tobacco and smokers should not be discouraged from using them. In addition, smokers choosing to use e-cigarettes can receive free support (counseling and the offer of additional, licensed stop-smoking medications) through our National Health Service smoking cessation services. Smokers who access these services and also use an e-cigarette have very good cessation rates.

Villanti: The great opportunity of e-cigarettes is that they have been adopted by large numbers of smokers. Current research suggests that e-cigarettes can increase quit attempts, reduce symptoms of nicotine withdrawal, prevent relapse, and potentially serve as a pathway to cessation of cigarettes. Further high-quality, randomized controlled trials and rigorous observational studies are important to confirm findings from the research to date.

Given the wide variety of products and ingredients, it is hard to know which specific e-cigarette products are most effective as cessation devices. We also do not know the quality or safety specifications of those products, as we do with cessation medications and nicotine replacement therapies that have been FDA-approved. Smokers seeking a pathway to quitting deserve a device that is effective and meets quality and safety standards.

If the biggest concern is youth starting to vape, what can be done to keep e-cigarettes away from kids?

Bauld: In the European Union, the Tobacco Products Directive, which was introduced in May 2016, prohibits all broadcast advertising of e-cigarettes. In my own country, Scotland, further advertising restrictions (on billboards, free samples) will be introduced next year. Some limits on marketing are proportionate because of concerns about marketing to children, and age-of-sale laws are also in place in the UK. However, I believe some promotion is needed, particularly at the point of sale, to provide adult smokers with accurate information about these products and support switching. We can’t completely ignore the UK’s eight million adult smokers because of fears about youth uptake. An appropriate balance has to be struck.

Villanti: A first step in preventing youth from starting to use tobacco or nicotine products was the FDA’s decision to bring all products under its authority. This provided youth access restrictions across all products, including cigars, hookah, and e-cigarettes. Minimum age of e-cigarette purchase enacted at the federal level, and enforcement of these laws by state and local agencies, will reduce youth access.

Our experience in tobacco control has identified other interventions, like advertising restrictions. A novel intervention would be to extend the ban on flavored cigarettes to all tobacco products, especially the most harmful combustible products. Other possible interventions include adopting standards that reduce the toxicity and addictiveness of products to the lowest possible levels; additional limits on youth access, like raising the nationwide minimum age of sale for tobacco to 21; or taxing products in proportion to their harms.

The 2016 William J. Bicknell Lecture in Public Health is tomorrow, Wednesday, October 19, from 10 a.m. to noon at the School of Medicine Instructional Building Hiebert Lounge, 72 East Concord St. The event is free and open to the public. The lectureship is named in honor of the late William J. Bicknell, founder and chair emeritus of the SPH global health department (formerly the international health department). Live streaming will be available here.

Lisa Chedekel can be reached at chedekel@bu.edu.

VAPING MIGHT NOT BE A TOBACCO ALTERNATIVE

http://www.themonitordaily.com/vaping-not-tobacco-alternative/212620/

Although vaping is regarded as a safer alternative compared to tobacco, recent research suggests that e-cigarettes may be as dangerous as traditional cigarettes.

The primary reason is that both of them contain nicotine, the only difference consisting in the fact that these electronic devices vaporize the flavored nicotine liquid. This hotly debated topic will be discussed Wednesday on October 19 at the School of Public Health, where many experts will gather.

According to a Linda Bauld, the deputy director of the United Kingdom Centre for Tobacco and Alcohol Studies, e-cigarettes cannot be regarded as a safe alternative because they come with certain risks.

Therefore, they can only be seen as a possible short-term solution to ‘a uniquely deadly product that kills one in two of its regular users.’ She further adds that there is no current evidence that e-cigarettes can be a life-safer for young adults.

The director for regulatory science and policy at the Schroeder Institute for Tobacco Research and Policy Studies at Truth Initiative, Andrea Villanti, supports Bauld by saying that solid proof is needed in order to label these vaping devices as excellent quit-smoking tools.

Also, everyone knows that e-cigarettes are most likely harmful to a certain extent, but maybe not as harmful as tobacco. The United States Food and Drug Administration (FDA) has recently decided to focus not just on reducing tobacco use but also to prevent e-cigarettes from becoming widely popular across the country.

Needless to say that these new regulations are quite controversial because they require companies to specify exactly what their vaping devices contain by 2018 in order to receive marketing permission.

According to a professor of socio-medical sciences at the Columbia University Mailman School of Public Health, Ronald Bayer, e-cigarette use and tobacco are more than controversial topics as they are also quite political.

Based on the statistics from the Centers for Disease Control and Prevention (CDC), around 12.6 percent of American adults tried e-cigarettes in 2014, while 3.2 percent of them never smoked before.

CDC reports further reveal that last year, 16 percent of teenagers admitted they had used vaping devices in the past month before the study, showing a 1.5 increase compared to 2011. About 17,000 teenagers start smoking every year in California, and around 35 percent of them will most likely die because of nicotine and tobacco-related diseases