Category: News This Week

The Food and Drug Administrations’s (FDA) acting commissioner, Ned Sharpless, announced on Tuesday that he’ll keep pressure on teen vaping. Sharpless assured staff during his first official remarks that he plans to “maintain FDA’s current course of action in every area and proceed full-speed ahead.”

“We’ll maintain our focus on ending the use of combustible cigarettes among adults, and on preventing kids from ever starting,” Sharpless said.

Sharpless, former director of the National Cancer Institute, took over after Scott Gottlieb stepped down. He assured staff that the FDA would not ease any pressure on e-cigarette makers under Sharpless’ new leadership.

“Let me dispel any misconceptions that the change in leadership reflects some desire of the president or the secretary for the FDA to go in a different direction from the Gottlieb era,” Sharpless said.

Representatives from Juul have met with officials in Lexington County, South Carolina, USA to discuss the possibility of establishing a production plant, reports The State. 

State Senator Katrina Shealy said the possibility of a South Carolina plant is still “up in the air and negotiations are ongoing,” but bringing more jobs to Lexington County would be a big bonus. A Juul spokesperson said the company did not have plans to announce as Juul does not disclose which contractors it works with or where production plants are located.

However, according to The State, recent job postings have shown that Juul Labs is seeking to fill two key positions: A site manufacturing engineer in Columbia, South Carolina, and a senior supplier quality engineer is needed to work as a “quality representative at our Columbia site…”

The Food and Drug Administration (FDA) has authorized sale of the iQOS heated tobacco system in the U.S. market. FDA authorization follows review of the Premarket Tobacco Product Applications (PMTA) submitted by Philip Morris International Inc. (PMI). Philip Morris USA (PM USA), under an exclusive licensing agreement with PMI, will commercialize IQOS in the U.S. with three HeatStick variants.

“With FDA authorization, PM USA will introduce IQOS in the U.S. for adult smokers in Atlanta, Georgia, to learn as much as possible, as quickly as possible, and intends to make the most of the company’s first-mover advantage in heated tobacco,” said Howard Willard, chairman and chief executive officer of Altria. “IQOS has had terrific success internationally. We’re very excited to bring this platform to adult smokers in the U.S.”

There are approximately 40 million adult smokers in the U.S. and IQOS offers an innovative alternative to cigarettes. More than 7 million people around the world have fully switched to IQOS, according to PMI.

PM USA will test a range of marketing, sales and consumer engagement approaches to raise adult smokers’ awareness of IQOS, facilitate guided trial of the product and provide post-purchase support – all while taking steps to minimize reach to unintended audiences, consistent with the FDA order and marketing requirements.

To support the introduction of IQOS, PM USA plans to have a number of retail touchpoints in Atlanta, including an IQOS store at Lenox Square, numerous mobile retail units and HeatStick distribution in approximately 500 retail trade partner stores including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway and select additional retail partners.

“PM USA will act on market insights and expects to scale IQOS quickly and efficiently,” said Willard.

PM USA is adding IQOS to the Altria companies’ portfolio of products for adult smokers looking for an alternative to cigarettes. PM USA’s goal is to convert U.S. adult smokers interested in non-combustible alternatives to IQOS.

To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

The FDA is still reviewing PMI’s Modified Risk Tobacco Product (MRTP) application for IQOS, which the company submitted in December 2016. MRTP approval would allow the marketing of the product with modified risk claims.

Bonnie Herzog of Wells Fargo securities described the PMTA approval as a big ‘win’ for PMI and PM USA, as it represents the first premarket approval of an vapor/heat-not-burn product product by the FDA and “effectively sets the standard for all future premarket applications/approvals.”

“We believe PMTA approval confers an immense competitive advantage to iQOS,” she wrote.

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A study by a Swiss lab, commissioned by the Blue Cross of Bern, Solothurn and Fribourg, found dangerous toxins called isocyanates escaping from the filters of IQOS e-cigarettes produced by Philip Morris International.

“If isocyanates are inhaled during the use of IQOS, it is very problematic,” says Rainer Kaelin, a pulmonologist and former vice-president of the Swiss Lung League.

Philip Morris acknowledges the problem, but a spokesman for the tobacco company assured the newspaper that the toxin is not inhaled when using an IQOS cigarette.

The study did not check whether the substance is inhaled by the smoker.

The Philippines’s Department of Health (DOH) is stubbornly refusing to consider the growing body of evidence supporting electronic cigarettes as comprising a less harmful alternative to combustible cigarettes and an effective smoking cessation aid, according to an opinion piece by Mary Ann LL. Reyes published in The Philippine Star.

Health Undersecretary Eric Domingo was said recently to have reiterated the DOH’s warning that the use of e-cigarettes was not a good alternative to cigarette smoking and that, because e-cigarettes contained nicotine, the DOH was concerned that vapers would become addicted to nicotine and then become cigarette smokers.

Reyes said that Domingo’s statement was hardly surprising. The DOH followed the World Health Organization position that the only way to reduce smoking was for smokers to quit or die, and that anything less than an abstinence-only approach was unacceptable. Like the WHO, the DOH was highly skeptical of the potential for new technologies, such as e-cigarettes, to reduce smoking-related harms.

What was worrying, Reyes wrote, was the DOH’s stubborn refusal to consider the growing body of evidence supporting e-cigarettes as a less harmful alternative to conventional cigarettes and an effective smoking cessation aid.

February 27 had seen the publication by Public Health England of its latest evidence update summary on vaping.

One of the updated evidence review’s key findings immediately stood out because it ran completely counter to Domingo’s statement. E-cigarettes were not a gateway to smoking.

The evidence showed that e-cigarette use in the UK remained largely confined to those who already smoked or ex-smokers who had now quit using an e-cigarette, while quitting smoking remained the key motivation among adult vapers. The fear that the number of young people using e-cigarettes regularly would increase sharply was not happening in the UK. While experimentation was increasing, vaping among young people remained low at 1.7 percent and was mainly confined to those who already smoked.

A study by BMC Public Health has concluded that health professionals should provide balanced information about the possible short- and long-term positive and negative health effects of electronic cigarette use.

The study, Perceived health effects of vaping among Hungarian adult e-cigarette-only and dual users: a cross-sectional internet survey, was said to have been aimed at exploring self-reported adverse events (AEs) and perceived health changes due to e-cigarette use among Hungarian adult e-cigarette-only users (former smokers who switched completely to e-cigarette use) and dual users (smokers who used e-cigarettes and combustible tobacco cigarettes concomitantly).

It was described as a cross-sectional, web-based survey of 1042 adult Hungarian e-cigarette users conducted in 2015, in which participants reported AEs and changes in physiological functions since they switched from smoking to e-cigarette use or while dually using e-cigarettes and combustible cigarettes. Confirmatory factor analysis with covariates was applied to explain perceived health changes due to e-cigarette-only use and dual use.

The results showed that dual users were significantly more likely to report AEs of vaping than were e-cigarette-only users. ‘Experiencing health improvements were significantly more likely among e-cigarette-only users than for dual users for all surveyed physiological functions, the study found.

‘E-cigarette-only users reported larger effects of vaping on sensory, physical functioning, and mental health factors compared to dual users.

‘Self-reported changes in sensory and physical functioning were significantly higher among individuals using e-cigarettes more than a year and people who were past heavy smokers (smoked ≥20 cigarettes per day).

‘Gender was related to sensory improvement only; males reported greater improvement than females.’

The researchers concluded that the majority of e-cigarette-only users reported more perceived beneficial changes in physiological functions and fewer AEs than did dual users.

‘Perceived short-term benefits of e-cigarette use may reinforce users despite the uncertainty of long-term health consequences,’ they concluded.

‘Health professionals should provide balanced information regarding the possible short- and long-term positive and negative health effects of e-cigarette use during consultations with patients.’

The Seychelles is to legalize the use of electronic cigarettes with a new regulation that will place ‘alternative nicotine products’ (ANDs) under the country’s tobacco control law, following the approval of Cabinet Ministers, according to a Seychelles News Agency story.

Bharathi Viswanathan, program manager within the Prevention and Control of Cardiovascular Diseases unit at the Seychelles Hospital, was said to have told the news agency that currently all ANDs were banned in the Seychelles.

But the agency reported that, under the new regulation, ANDS would be classified as tobacco products so that nearly all provisions in the Seychelles tobacco control law would extend to their manufacture, distribution, sale and use.

ANDs were not on the market when the Seychelles’ first Tobacco Control Act was drafted in 2009, said Viswanathan; so amending the law would ensure that a ‘framework’ existed for consumers and sellers. Under the new regulation, sellers would need a license.

Viswanathan said that the only difference in treatment of traditional tobacco products and ANDs would be in respect of labeling. The warning labels would not be the same as those on cigarette packaging, but the details were still being worked out.

Presumably, ANDs warning labels will reflect the comparative risks because Viswanathan said that ANDs comprised a good option to help smokers who wanted to quit smoking.

“It is a good way to help smokers quit the habit and it is also less detrimental to health as it contains less nicotine and other harmful substances found in real cigarettes,” she said.

Twenty-one percent of Swiss boys and thirteen percent of girls aged 11-15 have tried electronic cigarettes at least once, according to a story at swissinfo.ch reporting on a survey of addiction among schoolchildren.

The findings were said to have alarmed the group Addiction Switzerland, which carried out the study of 11,000 children between the ages of 11 and 15.

“Vaping should not become normal consumer behavior among young people,” said Grégoire Vittoz, director of Addiction Switzerland, in a statement.

Swiss law is currently being adapted in relation to vapor products, but Addiction Switzerland has called also for such products to be priced beyond the means of schoolchildren, and for advertising restrictions.

The organization said that nicotine was addictive and could damage brain development in young people.

Overall, marginally fewer 11-15-year-olds said they had tried addictive substances than was the case during the previous survey in 2014.

In 2018, 10 percent of boys and eight percent of girls said they had smoked conventional cigarettes at least once a week, while in 2014 the respective figures were 12 percent and nine percent.

About 11 percent of boys and four percent of girls said that they had drunk alcohol at least once a week (10 percent and six percent in 2014).

The survey found also that 27 percent of boys and 17 percent of girls had used illegal cannabis at least once in their lives (30 percent and 19 percent in 2014). The figures for trying CBD (cannabidiol) products were nine percent and five percent for boys and girls.

The 2018 survey was part of an international Health Behavior in School-aged Children external link (HBSC) study carried out under the auspices of the World Health Organization external link, and was financed in Switzerland by the Federal Office of Public Health external link and cantons. It was the ninth time the HSBC study has been conducted in Switzerland.

A study from Cardiff University has found that the rapid spread of e-cigarette use among teenagers, aged 13 to 15 years, has not normalized smoking among the same age group.

Published in the BMJ journal Thorax, the study found that e-cigarettes are not a gateway drug for tobacco, as it was once thought. Only 27 percent of teens in 2015 said it was “OK to try a cigarette”, compared with 70 percent 15 years earlier.

The National Institute on Drug Abuse reported last November that 10 percent of teens aged 13-to-14 admitted to vaping within the last month, but less than four percent had lit up a cigarette.

However, vaping in the United States has jumped by more than 75 percent in 2018 compared with the year before.

Vaping groups in the Philippines have urged the Department of Health (DOH) to educate smokers about alternative products, such as electronic cigarettes, to help them quit smoking, according to a story in The Philippine Daily Inquirer.

The appeal was made by The Vapers Philippines (TVP) and the Philippine E-cigarette Industry Association after Public Health England published new evidence on vaping.

“We call on the DOH and local health care professionals to look at the latest evidence on vaping from England, a country which is experiencing tremendous success in reducing adult smoking rates,” Peter Paul Dator, the president of TVP, was quoted as saying.

Dator lauded public health officials in the country for doing a good job in raising public awareness about the health risks associated with smoking.

“Unfortunately, their efforts stop there,” he said. “The public should also be educated about alternative products that can help smokers quit.”