Category: News This Week

The American Medical Association (AMA) has announced a new policy that will further strengthen its support of the regulatory oversight of e-cigarettes. The update is an extension of the organization’s existing policy, which calls for all e-cigarettes to be subject to U.S. Food and Drug Administration regulations that apply to cigarettes and smokeless tobacco products.

The AMA’s new policy calls for laws and regulations that would set the minimum legal age to buy e-cigarettes and e-liquids at 21; mandate child-resistant containers for e-liquids; and enforce laws against the sale of tobacco products to minors. The existing policy also seeks a ban on claims that e-cigarettes are effective tools for smoking cessation.

“Improving the health of the nation is AMA’s top priority, and we will continue to advocate for policies that help reduce the burden of preventable diseases like cardiovascular disease and type 2 diabetes, both of which can be linked to smoking,” said AMA president Robert M. Wah.

Vape Organics, an e-liquid manufacturer based in Riverside, California, USA, announced on June 2 that it had received U.S. Department of Agriculture certification for its organic nicotine designed for e-cigarettes. According to the company, the product is “both USP grade and uniquely free of any petroleum-derived solvent.”

Vape Organics director of operations Sheerlie Ryngler said that “as consumers are starting to care more about what’s in their e-liquids, we at Vape Organics have risen to the challenge and are doing our part to propel the vape industry forward with certified organic products and long-term vision.” Ryngler also added that consumers appreciate the company’s products, which “harmoniously honor the connection between personal well-being and the well-being of the environment which sustains us.”

According to Vape Organics, the company’s USDA-certified organic nicotine allows consumers to “vape with confidence and peace of mind, knowing that they are using a nicotine delivery option that not only mitigates the harm from tobacco combustion, but also from pesticides.”

North Korea has banned foreign cigarettes, reportedly as part of efforts to reduce the country’s high smoking rate, according to a story in The Korea Times (Seoul).

“We have also prohibited people from using electronic cigarettes and smokeless cigarettes,” Choi Hyun-sook, a high-ranking official at the health ministry, was quoted as telling the Korean Central News Agency on Saturday.

“To create a social environment where non-smoking is encouraged, the North has enforced strict smoking bans in public areas such as educational institutions or health facilities, and launched hygiene promotion campaigns.”

The official said the anti-smoking movement had helped reduce the smoking rate among men from 50.3 percent in 2009 to 43.9 percent in 2014. There were said to be no women smokers.

“The number of young smokers has sharply decreased due to the toughened education in schools and society,” he said.

What is being described as the first practical guide to ensure the safe use of flavors in electronic cigarettes has been published by Nicoventures, a nicotine company established by British American Tobacco (Regulatory Toxicology and Pharmacology DOI: 10.1016/j.yrtph.2015.05.018).

A BAT press note said today that while electronic cigarettes and other vapor products delivered nicotine without smoke toxicants, some in the public health community had expressed concerns over the potential health impacts of flavors used in electronic cigarettes. Consequently, the British Standards Institute (BSI) was developing product standards for electronic cigarettes that would provide guidance on manufacturing, testing and safety requirements.

These guidelines laid out the “what” (including the toxicological risk assessment of flavors), said Dr. Sandra Costigan, the principal toxicologist at Nicoventures, while the new guide provided the “how”.

The flavors typically used in electronic cigarettes are food grade, which means that they have been generally ingested rather than inhaled. “This means that the data available is oral and there are large data gaps,” said Costigan, who is a member of the BSI steering committee on electronic cigarettes. “Safe to eat is not the same as safe to inhale. “The data gaps need to be filled.

“In the meantime, what are the kinds of data sources, approaches and scientific rationale that will allow us to determine if we can use a flavor and at what level? This guide explains how to do that.”

The first step apparently is to ensure that any flavors are food grade and to screen out any potential carcinogens or respiratory allergens. “At this stage, in the absence of inhalation data we make quite a lot of use of what are called TTCs or Toxicological Thresholds of Concern,” said Costigan. “TTCs are used by agencies like the WHO and FDA and they basically help define how much of something can be used in the absence of other toxicity data. We use TTCs to determine how much of any particular flavor ingredient can be used.

“The next step is to assess the compounds produced as a result of heating these flavor molecules, as it is the ‘vapor’ – i.e. the aerosol produced on heating the e-liquid – that consumers are exposed to, not the e-liquid itself.  Here we are dealing with new compounds and potential thermal breakdown products, rather than ingredients, and so our approach to acceptable levels will be different.

“None of the draft standards and regulations tell us how to do such a risk assessment, and the scientific literature thus far has focused on problems, such as lack of inhalation data, rather than solutions. Ours is the first sensible and practical guide to help actually conduct such a risk assessment on the flavors, based on sound toxicological principles,” said Costigan.

Essentra Scientific Services (ESS) has increased the capacity of its laboratory at Jarrow, UK, with the addition of a new facility dedicated to testing electronic cigarettes.

‘The new laboratory complements Essentra’s full-service e-cigarette offering, and ensures it can continue to respond to the industry’s growing demand for reliable and high quality testing and analysis,’ Essentra said in a press note.

Commenting on the opening of the new facility, the director of scientific development, Mike Taylor, said the investment in the new laboratory reflected Essentra’s commitment to help customers stay at the forefront of industry trends and meet the latest regulatory and product quality requirements.

“Essentra Scientific Services has over five years’ experience in the field of e-cigarette testing and, as demand for these services grows, separating our facilities in order to create a new, purpose-built laboratory specifically for smokeless nicotine devices was the logical next step.”

ESS’ laboratory in Jarrow is said to operate a range of industry leading research and testing equipment, including a gas chromatography machine with a triple detector system. ‘Used exclusively for e-cigarette testing, the machine enables measurement of multiple analytes from a single vaping test,’ the press note said. ‘A thermal conductivity detector measures the sample for water, while a second detector analyses it for propylene glycol and glycerol, and also measures the nicotine level. The third detector uses mass sensitive detection to analyse the sample for diethylene glycol and ethylene glycol, which are compounds that can be present in e-cigarette vapour, but should not be.

‘The scope of Essentra’s UKAS accreditation has recently been extended to include e-liquids, and the new laboratory also offers analysis using a wide variety of puff volumes, frequencies durations profiles as well as catering for flavoured e-cigarettes. Testing for a comprehensive range of compounds can also be carried out, or bespoke methods developed on request.

In addition to its improved e-cigarette testing service, ESS, which is part of Essentra plc’s Filter Products business, has more than 50 years’ experience in the analysis of traditional tobacco products.

Indonesia seems to be having second thoughts on imposing an outright ban on electronic cigarettes – but then again, perhaps not.

A story in The Jakarta Post at the beginning of last week had the Trade Minister Rachmat Gobel saying that sales of electronic cigarettes would be banned in line with concerns voiced by the Health Ministry.

Then, at the end of last week, the Health Ministry secretary-general Untung Suseno Sutarjo was quoted by another Post story as saying that the consumption of electronic cigarettes could help to reduce tobacco consumption though it would not eradicate it.

But he then went on to say that while electronic cigarettes would help to reduced consumption, the ministry had found that “that the impact on health is the same”.

Meanwhile, the health ministry’s head of health promotion, Lily S. Sulistyowati, said the implementation of the regulation would be discussed with the trade ministry. “We will discuss the regulation, Lily said. “The health ministry understands the impact of e-cigarettes, but the product is still permitted to be sold at the moment.”

Cultex Laboratories—a leader in the research and development of cell-based exposure systems and cultivation technologies based in Hannover, Germany—has examined the cytotoxic effects of the vapor emitted by e-cigarettes. Using specially designed exposure models that made it possible to keep cells at an atmosphere that mimicked the real characteristics of a human lung, researchers conducting the in-vitro study exposed healthy human bronchial epithelial cells to e-cigarette vapor.

The study compared e-cigarette vapor containing 0.0 percent and 2.4 percent nicotine with the smoke emitted by combustible cigarettes, and results indicated that the toxicological effects of e-cigarette vapor were 4.5 to 8 times lower than those of tobacco smoke. No differences regarding the cytotoxicology were found between nicotine-free vapor versus the vapor that contained nicotine. Cultex Laboratories will continue its e-cigarette research and plans to analyze the possible long-term effects of e-cigarette use.

Read the full study here.

The number of vapers in Britain has risen by 500,000 recently, according to a Press Association story citing figures from Action on Smoking and Health (ASH).

ASH was quoted as saying that there were now 2.6 million vapers in Britain, up from 2.1 million in 2014, with nearly all of this increase attributable to a rise in the number of ex-smokers using electronic cigarettes.

The campaign group said the figures showed the ‘value’ of electronic cigarettes in helping smokers give up tobacco.

But it warned of a ‘worrying’ increase in people falsely believing that electronic cigarettes were as harmful as or even more dangerous than traditional tobacco cigarettes.

Twenty two percent of people were said to believe that electronic cigarettes were as harmful as or even more dangerous than traditional tobacco cigarettes, up from 15 percent last year.

ASH said analysis by researchers at King’s College London had shown that electronic cigarette use had increased among ex-smokers from 4.5 percent in 2014 to 6.7 percent in 2015, but remained the same among current smokers at 17.6 percent.

Vaping remains rare amongst people who have never smoked, with just 0.2 percent of users falling into this category during the past three years.

A new study has challenged a previous suggestion that some electronic cigarettes could deliver levels of formaldehyde greater than those of traditional tobacco cigarettes.

In January, a report published as a research letter in the New England Journal of Medicine (NEJM) found that a 3rd generation electronic cigarette (one with variable power settings) operated at its maximum power setting and with a long puff duration generated levels of formaldehyde that, if inhaled in this way throughout the day, would several times exceed formaldehyde levels that smokers ingest from traditional tobacco cigarettes, according to a press note from the journal Addiction.

This apparent new electronic-cigarette health hazard was reported worldwide.

But a new study published online today in the scientific journal Addiction took a closer look at the NEJM findings in the context of real-world conditions and came to a different conclusion. ‘It concluded that 3rd generation e-cigarettes can indeed produce high levels of aldehydes – but only under extreme conditions which human smokers can be expected to avoid because of the immediate unpleasant sensory effects,’ the press note said.

‘The Addiction study, led by cardiologist Dr. Konstantinos Farsalinos, found that it was possible to get e-cigarettes to produce high levels of aldehydes, but only in what is known colloquially as “dry puff” conditions.  As Farsalinos explains: “Our results verify previous observations that it is possible for e-cigarettes to generate high levels of aldehydes; however, this is observed only under dry puff conditions, which deliver a strong unpleasant taste that vapers detect and avoid, by reducing power levels and puff duration or by increasing inter-puff interval. Minimal amounts of aldehydes are released in normal vaping conditions, even if high power levels are used. In those normal-use conditions, aldehyde emissions are far lower than in tobacco cigarette smoke.”’

Professor Peter Hajek, director of the Tobacco Dependence Research Unit at Barts and The London School of Medicine and Dentistry, UK, was quoted as saying that the findings of the Addiction study emphasized the importance of making clear the conditions in which tests were undertaken and avoiding sweeping assertions that could mislead the public.

“Vapers are not exposed to dangerous levels of aldehydes,” he said.

“My reading of the evidence is that e-cigarettes are at least 95 percent safer than smoking. Smokers should be encouraged to switch to vaping.”

The Indonesian government plans to ban the sale of electronic cigarettes amid ‘growing concerns over the product’s negative impact on people’s health’, according to a story in The Jakarta Post.

The Post reported that one in five Indonesians currently smoked and that ‘a high number’ of those smokers were using electronic cigarettes to help them quit the habit, ‘said to cause various serious illnesses, including cancer, chronic respiratory problems and cardiovascular diseases’.

Nevertheless, the Trade Minister Rachmat Gobel said on Monday that sales of electronic cigarettes would be banned in line with concerns recently voiced by the Health Ministry.

“It has been deemed that e-cigarettes pose health risks and that’s why we need to impose a ban,” he said.

There are no domestic electronic cigarette producers; so consumers are said to rely on imports from China.