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‘E-cigarettes lead to tobacco cessation, not initiation’

| March 6, 2015

Two new United States surveys have found that 15-21 million U.S. adults used e-cigarettes regularly in 2013-2014; 3.2-4.3 million e-cigarette users no longer smoked cigarettes on a regular basis; and approximately 90 percent of regular e-cigarette users were/are regular cigarette smokers. The studies—which were presented in Philadelphia, Pennsylvania, USA, from Feb. 25-28 at the annual meeting of the Society for Research on Nicotine and Tobacco—lead their authors to note that regular cigarette smokers were more likely to switch to regular use of less-harmful e-cigarettes than regular e-cigarette users were to transition to combustible cigarette use.

The first study analyzed 30,136 people from the National Tobacco Behavior Monitor survey. Results indicated that 8.7 percent of U.S. adults reported regular use of e-cigarettes, of which nearly 90 percent reported regular use of combustible cigarettes. More than 97 percent of those surveyed in the first study reported regular e-cigarette use after regular cigarette smoking; 23.7 percent indicated that they no longer use combustible cigarettes on a regular basis; and only 1.3 percent of those who use e-cigarettes regularly reported transitioning to current regular use of combustible cigarettes.

The second study—which analyzed data from the Total Tobacco Migration Tracker—involved 11,173 people and indicated that 6.1 percent of U.S. adults identified themselves as current, regular e-cigarette users, with more than 91 percent of those e-cigarette users reporting regular use of combustible cigarettes. More than 97 percent reported regular use of e-cigarettes after regular use of combustible cigarettes; 24.5 percent of those who regularly used e-cigarettes no longer reported regular smoking of traditional cigarettes; and only 1.7 percent of current, regular e-cigarette users reported switching to regular use of combustible cigarettes.

The results of this study lead its authors to determine that smokers of traditional cigarettes were 13.5 times more likely to transition to current, regular use of e-cigarettes than current, regular users of e-cigarettes were to transition to regular use of combustible cigarettes.

The studies were funded by RAI Services Co. and conducted by a team led by the company’s senior director of regulatory oversight, Geoffrey Curtin.

Califf appointed deputy commissioner of FDA

| March 6, 2015

Robert Califf, a cardiologist and researcher at Duke University in Durham, North Carolina, USA, was appointed as the U.S. Food and Drug Administration’s (FDA) deputy commissioner for medical products and tobacco on March 2. Califf—who was previously overseeing the FDA’s drug, medical device and tobacco policy—is a recognized global leader in cardiology, clinical research and medical economics, according to the FDA. He was appointed by FDA Commissioner Margaret A. Hamburg, who will leave the organization at the end of March, leading to speculation that Califf may be nominated to lead the FDA following her departure.

In his new role as deputy commissioner, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Tobacco Products, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health. His duties will include providing policy direction and advice on the FDA’s medical product and tobacco priorities, and he will manage clinical, scientific and regulatory initiatives in areas ranging from pediatric science and personalized medicine to orphan drugs and the advisory committee system.

Califf previously served as vice chancellor of clinical and transnational research at Duke University, professor of medicine at Duke University Medical Center’s Division of Cardiology, director of the Duke Transnational Medicine Institute and founding director of the Duke Clinical Research Institute, the world’s largest academic research organization. The Institute for Scientific Information has recognized Califf as one of the top 10 most-cited medical authors due to his more than 1,200 peer-reviewed publications.

Cigarette smoke releases more toxins than e-cigs, study says

| March 6, 2015

A study examining the vapor released from Blu Ecigs’ and Skycig’s e-cigarettes in comparison to the smoke emitted by Philip Morris USA’s Marlboro Gold and Imperial Tobacco’s Lambert & Butler cigarettes found that levels of harmful and potentially harmful constituents (HPHCs) in cigarette smoke were 1,500 times higher than the levels found in e-cigarette vapor.

The study—titled “Comparison of select analytes in aerosol from e-cigarettes with smoke from conventional cigarettes and with ambient air”—was published in the December 2014 issue of Regulatory Toxicology and Pharmacology. According to proponents of vapor product use, the study lends credence to the belief that, although the long-term effects of inhaling the propylene glycol and glycerin found in e-cigarette vapor are not yet known, such products provide a safer alternative to smoking combustible cigarettes.

According to the study, the e-cigarettes tested contained and delivered mostly glycerin and/or propylene glycol and water, and emitted an aerosol nicotine content that was 85 percent lower than the cigarette smoke nicotine content levels. The study also found the levels of HPHCs to be consistent with the air blanks—at <2 μg/puff—and no significant contribution of tested HPHC classes was found for the e-cigarettes tested. The e-cigarettes and combustible cigarettes in the study were tested on a smoking machine to compare the amount of nicotine delivery and the relative yields of chemical constituents.

Judge: U.K. smoking ban applies in prison too

| March 6, 2015

A high court judge has ruled that the U.K public-places smoking ban must be enforced in state prisons despite the possibility of unrest this could provoke in jails throughout England and Wales. According to Justice Singh, the justice secretary misunderstood an exemption made in 2006 to health legislation that banned smoking in workplaces and enclosed public spaces. Although the government had argued that state prisons were exempt from smoke-free legislation because of their status as Crown premises, Justice Singh ruled that prison communal areas are subject to the laws, therefore the smoking ban must be extended to such locations.

The exemption in the 2006 Health Act indicated that smoking is allowed in enclosed public places where a person resides permanently or temporarily, which includes prisons, hotels and long-term care facilities. However, the exemption also states that these places should provide designated smoking rooms to avoid subjecting other residents and staff members to secondhand smoke. According to The Guardian, more than 80 percent of prisoners smoke, and the justice ministry fought for the exemption when the health legislation went through parliament—partly in response to warnings by prison governors and unions who said banning smoking in prisons could trigger turmoil among prisoners who use tobacco as currency as well as a legal stimulant.

To continue providing prisoners with access to nicotine—but also to protect nonsmoking prisoners and staff members from the dangers of secondhand smoke—three U.K. prisons now offer e-cigarettes, which are generally believed to be less harmful than their combustible counterparts. Prisoners are currently permitted to smoke combustible cigarettes in their prison cells—as long as the smoker is over the age of 18 and the door is closed—as well as in outside exercise yards, but they cannot use these products in communal spaces.

Justice Singh has postponed the implementation of the ban and granted the justice secretary time to appeal against the ruling.

FDA changes TPSAC membership to address conflicts of interest

| March 6, 2015

Four members have resigned from the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC), and three new ones have joined. The FDA made the changes to comply with a court ruling that requires the agency to address certain members’ alleged conflicts of interests.

On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia ordered the FDA to reconstitute the TPSAC. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law.

TPSAC members Claudia Barone, Joanna Cohen and Suchitra Krishnan-Sarin, along with Chairman Jonathan Samet, have resigned or their terms on TPSAC have been terminated.

The new members are Pebbles Fagan, Gary A. Giovino and Thomas E. Novotny. The FDA is working to fill the remaining vacancy. All future TPSAC meetings will continue as planned.

In a statement, Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that, while the FDA disagrees with the court’s decision, the agency has no option but to comply.

“This is a loss for the FDA and for public health,” he wrote. “Under other circumstances, there would be strong reasons for the agency to consider a waiver or authorization that would allow these individuals to continue their valuable service. However, in light of Judge Leon’s ruling, we do not believe we are able to exercise our discretion to consider this option at this time.”

The 2014 ruling is the same one that bars the FDA from using TPSAC’s 2011 Menthol Report.


Plain packs said to work like a ‘vaccine’ on young

| March 6, 2015

A New Zealand public health expert says that evidence from Australia shows that standardized tobacco packaging has worked almost like a vaccine against tobacco use in children and young people.

According to a story by Martin Johnston for the New Zealand Herald, Robert Beaglehole, a University of Auckland emeritus professor, is one of a number of individuals and organizations lobbying the government to bring its standardized tobacco packaging bill back to parliament for a final vote.

The health select committee last year supported the bill but the government delayed bringing it back pending the outcome of the challenges being made against Australian standardized packaging legislation.

But those lobbying the government say that the decline in smoking seen in Australia since its standardized tobacco packaging law came into force in December 2012 means New Zealand can dally no longer.

‘Australian survey data shows the prevalence of daily smoking in those aged 14 or older declined from 15.1 percent in 2010, before the new law came into effect, to 12.8 percent in 2013,’ Johnston wrote.

The 2011 and 2012 figures were not given.

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