Category: News This Week

Scott Gottlieb has resigned as commissioner of the U.S. Food and Drug Administration (FDA), reports The Washington Post. He will leave his position in about a month. Gottlieb has been commuting weekly to Washington from his home in Connecticut and reportedly wants to spend more time with his family.

During his tenure, Gottlieb won praise and criticism for his stance on tobacco and vapor products.

In July 2017, a few months after becoming commissioner, he unveiled a comprehensive tobacco blueprint calling for reduced nicotine levels in cigarettes. But he also delayed for several years a tough new regulation for e-cigarettes.

After new government data suggested a sharp increase of vaping by minors, Gottlieb changed course, calling teen vaping “an epidemic” and threatening vapor companies that he would pull their products off the market if they didn’t curb use by minors.

In November, he proposed limiting sales of most flavored e-cigarettes—except mint and menthol—to age-restricted stores and sharply tightening online purchases. He said he also wanted to ban menthol cigarettes and flavored cigars, as well as reduce nicotine levels.

Well Fargo Securities said that while Gottlieb’s resignation would likely be broadly viewed as positive for the tobacco industry, it also introduces uncertainty.

“We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives,” wrote Bonnie Herzog, managing director of equity research beverage, household & personal care, tobacco & C-stores.

“We also believe his resignation could have implications—positive, we hope—for the FDA’s approvals of the premarket and modified risk applications for iQOS—long overdue, in our view.”

Regular vaping among young people remains low in Britain and has plateaued among adults, according to a press note posted on the gov.uk website citing an independent report led by researchers at King’s College London and commissioned by Public Health England (PHE).

The report is said to be the first in a new set of three, commissioned by PHE under the Government’s Tobacco Control Plan for England. ‘It looks specifically at the use of e-cigarettes rather than health impacts, which will be the subject of a future report,’ the note said.

‘The findings show that while experimentation with e-cigarettes among young people has increased in recent years, regular use remains low. Only 1.7 percent of under-18s use e-cigarettes weekly or more, and the vast majority of those also smoke. Among young people who have never smoked, only 0.2 percent use e-cigarettes regularly.’

The note went on to say that regular e-cigarette use among adults had plateaued over recent years, and remained largely confined to smokers and ex-smokers, with ‘quitting smoking’ the main motivation for adult vapers.

Professor John Newton, Health Improvement Director at Public Health England, was quoted as saying that, in contrast to recent media reports in the US, Britain was not seeing a surge in e-cigarette use among young people.

“While more young people are experimenting with e-cigarettes, the crucial point is that regular use remains low and is very low indeed among those who have never smoked,” he said.

“We will keep a close watch on young people’s vaping and smoking habits to ensure we stay on track to achieve our ambition of a smoke-free generation.”

The note said that, despite e-cigarettes now being the most popular quit aid, just over a third of smokers had never tried one. And only four percent of quit attempts through Stop Smoking Services in England were made using e-cigarettes, despite this being an effective approach.

The report recommended that Stop Smoking Services should do more to encourage smokers that want to quit with the help of an e-cigarette.

The Chinese city of Shenzhen is to strengthen its regulations on tobacco smoking in public places, according to a story in The China Daily citing a Nanfang Daily report.

The change in direction has been made necessary because the city authorities have reportedly run into problems in implementing their original regulations.

The problems apparently arose in the form of difficulties with law enforcement and evidence collection, complex punishment procedures and excessive fines.

Since the implementation of tobacco smoking regulations in Shenzhen on March 1, 2014, the authorities have raked in 3.745 million yuan in fines, comprising 3.325 million yuan in fines on smokers and 420,000 yuan in fines on venues.

Deputies of the Shenzhen People’s Congress on January 18 proposed that Shenzhen should revise its policy on tobacco smoking in public places to make the regulations more practical.

The revised draft of the Regulation on Smoking Control expands the definition of smoking to include the use of electronic cigarettes and other lit tobacco products.

It expands the scope of smoke-free areas, which now include outdoor queuing areas for public transport, such as buses, coaches, taxis, subways, ships and civil aircraft. Smoking is prohibited also within five meters of subway entrances and exits.

And it stipulates that no tobacco products are to be sold within 100 meters of kindergartens, primary and secondary schools, and children’s activity centers.

A ban on the sale of electronic cigarettes and heat-not-burn (HNB) devices is due to be lifted in the UAE by mid-April, according to a story in The Khaleej Times.

The lifting of the ban had been expected following an announcement on February 16 that the Emirates Authority for Standardization and Metrology (ESMA) had approved new standards for electronic cigarettes and HNB devices.

And the intention to lift the ban was confirmed the next day by Abdullah Al Maeeni, director general of the ESMA. “We issued the regulation to legalize it, and it will be enforced by mid of April 2019, as the Authority is working hard through the development of technical standards and regulations,” he said.

UAE residents readily smoke electronic cigarettes in public though their sale has been illegal.

The new standards set by ESMA will reportedly regulate a range of matters, including nicotine components, technical specifications, packaging, and labeling.

They will apply to e-cigarettes and HNB devices, and to their associated products such as e-liquids and tobacco sticks.

The story said that the new ESMA standards were in line with the Government’s efforts to curb smoking and put a stop to the illegal sale of electronic cigarettes.

A US health expert says that despite widespread claims that vaping is a gateway to smoking initiation among young people, the most definitive study to date of this issue has failed to provide any evidence to support that contention.

Providing ‘The Rest of the Story’ on his tobacco analysis blog, Dr. Michael Siegel, Professor in the Department of Community Health Sciences, Boston University of Public Health, said: ‘If anything, it provides evidence suggesting that vaping acts as a kind of diversion that can keep some youth away from cigarette smoking’.

Siegel was commenting on a landmark study, published on January 25 in the Journal of the National Cancer Institute. This was the largest, longitudinal study of youth smoking initiation – the PATH (Population Assessment of Tobacco and Health) study – and included two waves of observations on nearly 12,000 young people in the US.

The main reported finding of the study was that ever use of e-cigarettes at baseline was a risk factor for ever use of cigarettes at follow-up, said Siegel. This was consistent with the findings of several other studies.

‘Buried deep within the article is the rather startling, but most critically relevant finding of the entire study: The investigators were unable to report a single youth out of the 12,000 in the sample who was a cigarette naive, regular vaper at baseline who progressed to become a smoker at follow-up,’ he said. ‘Why? Because the number of these youth was so small that it was impossible to accurately quantify this number.’

Siegel said that it was necessary to await the results from future waves of the PATH study to have a clearer idea of the trajectory of youth vaping and smoking.

Electronic cigarettes will not be offered as an aid to help UAE smokers quit their habit until the full health impact of these devices is determined, according to a story in thenational.ae.

This week the Government’s product regulator said that vaping products could be sold legally from mid-April, overturning the current ban.

New regulations are being introduced to ensure product standards are maintained and to help the authorities stamp out the black market in these devices.

But government doctors said the country would not go as far as some nations in promoting the devices to smokers who wanted to quit but who had failed to do so using other methods.

Dr. Mohammad El Disouky, who is in charge of Dubai Health Authority’s smoking cessation clinic, said more long-term research was needed.

“Consumers will now have full details of the chemicals contained in the products and information on how to use them,” he said.

“From a public health perspective, this is a good move as people who are using these products will know they have been legally distributed under supervision from the authorities.

“That will guarantee their content and will restrict what materials some companies are using.

“But legalising and regulating e-cigarettes does not mean they can be offered as a quitting aid for tobacco smokers.”

A cardiologist and tobacco-harm-reduction researcher has said that widely-reported studies claiming to show that electronic-cigarette use is associated with an increased risk of heart disease are misleading, according to a story by Diane Caruana at vapingpost.com.

“They do not prove an increased risk and of course they do not prove that no such risk exists,” Dr. Konstantinos Farsalinos (pictured) was quoted as saying. “They simply cannot address the question of whether e-cigarettes increase the risk for heart disease or not.”

Caruana’s story said that a recently-published study and conference abstract released earlier this month had concluded that daily e-cigarette use, adjusted for smoking conventional cigarettes as well as other risk factors, was associated with an increased risk of myocardial infarction.

Media coverage of the conference abstract had stated that E-cigarettes linked to higher risk of stroke, heart attack, diseased arteries.

But Farsalinos responded to these claims by saying that both conclusions were wrong and constituted epidemiological malpractice and misinformation.

Farsalinos said the claims were based on cross-sectional studies, which provided information about whether participants had heart disease and if they used e-cigarettes, but no information about whether the participants initiated e-cigarette use before or after the development of the disease, or for how long. So the participants could have started vaping following a heart disease diagnosis in order to quit smoking and improve their health.

Farsalinos said he was confident that both the authors of the published study and the American Heart Association, which released the press statement for the conference abstract, must be aware that statements about “increased risk” were wrong.

The US Food and Drug Administration on Friday issued a draft guidance to help ‘lay out a framework for new potential clinically relevant outcomes for smoking cessation products, such as reducing the chance of a smoker going back to using cigarettes long term’.

‘This draft guidance takes into consideration the input received at the public hearing in January 2018 and is intended to serve as a focus for continued discussions among the FDA, pharmaceutical sponsors, the cessation research community, and the public,’ the FDA Commissioner Scott Gottlieb, M.D., said in a statement posted on the agency’s website.

‘The aim of the guidance is to describe new endpoints that are meaningful to helping currently addicted adult smokers, and that can promote innovation in NRT by outlining a broader set of criteria that can serve as the basis for new approvals.’

The draft guidance, Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products, follows the issue of the FDA’s first guidance in August 2018: Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.

The Gottlieb statement ends with: ‘As we look toward the future and the possibility of a world where combustible cigarettes could no longer create or sustain addiction, these guidances are part of comprehensive steps to pave the way for new, safe and effective products that can help currently addicted smokers quit the deadliest form of nicotine delivery.’

If there is one thing of which the tobacco industry is painfully aware, it is that once public trust is lost, it is extremely difficult, if not impossible, to gain it back.

And yet, even with the example of the tobacco industry being up there in lights, it’s not unusual to see other industries and businesses handling the truth of their activities carelessly.

But one area of human endeavor must surely be immune to such shenanigans: public health.

Or is it? Writing on his blog, a US public health expert yesterday said that he was pained to have to report that the Pennsylvania Department of Health was urging parents to lie to their children about electronic cigarettes in order to dissuade them from vaping. ‘In addition, the Pennsylvania Department of Health is lying to the public about the dangers of e-cigarettes and tobacco cigarettes as well,’ said Dr. Michael Siegel (pictured), who is a Professor in the Department of Community Health Sciences, Boston University School of Public Health.

‘The Pennsylvania Department of Health put out a tweet that read: “E-cigarettes, e-cigs, e-hookahs, mods, vape pens or vapes — whatever you call them, they are NOT safer than other tobacco products”.’

Siegel points out that telling the truth is a critical component of the public health code of ethics. ‘It is important not only because it is unethical to lie, but also because we greatly risk losing credibility and the public’s trust if we are found to be lying,’ he said.

He then goes on to say that it is not true that e-cigarettes are as dangerous as tobacco cigarettes, or that vaping is as dangerous as smoking.

And he ends his piece with some simple truths: ‘The rest of the story is that lying to kids isn’t justified even if it did prevent them from vaping. But it is doing just the opposite, as kids see through the lies and in some ways, it makes vaping more attractive.’

Altria Group Inc. shares gained 3.3 percent to $49.40 by the close of trading on Jan. 31, despite pedestrian fourth-quarter results after the company said that e-cigarette maker Juul topped $1 billion in sales in 2018, a five-fold jump from $200 million the prior year, according to a story on msn.com.

Altria purchased a 35 percent stake in Juul in December for $12.8 billion.

“Altria enters 2019 with an evolved business platform that includes our strong core tobacco businesses and new strategic investments with tremendous potential for growth,” said Howard Willard, Altria’s chairman and CEO.