Category: News This Week

New research by British American Tobacco (BAT) comparing the effects of cigarette smoke and electronic cigarette vapor has shown that, at equivalent or higher doses of nicotine, acute exposure to electronic cigarette vapor has very limited impact on gene expression when compared to the impact of cigarette smoke.

A BAT press note said that the human genome had tens of thousands of genes, and that the profile of genes that were switched on and off could be used to understand whether exposure to an aerosol had had a toxic effect.

‘Scientists at British American Tobacco used nicotine as a reference point and exposed MucilAir, a realistic in vitro 3D model of a human airway, to e-cigarette vapor and cigarette smoke to assess their comparative effect on gene expression,’ the press note said.

‘The MucilAir human respiratory tissue was exposed to smoke from a reference cigarette (3R4F) or vapor from an e-cigarette (Vype ePen) continuously for an hour. Two doses of vapor were tested, matching or doubling the amount of nicotine reaching the cells compared to smoke. Then, to measure the cell response, the scientists mapped the genes that were switched on and off at 24 hours and 48 hours after the one-hour exposure.

‘In the tissue exposed to smoke, the scientists found 873 and 205 genes were affected after 24 and 48 hours of recovery, respectively. However, significantly fewer genes – only 3 and 1, respectively – were affected after exposure to e-cigarette vapor.’

Further analysis was said to have revealed that the exposure to cigarette smoke had caused changes in the expression of genes involved in the development of lung cancer, inflammation and fibrosis, while the test electronic cigarette vapor had caused only minor changes in genes known to be involved in cell metabolism and oxidative stress mechanisms.

“Our results clearly show that cigarette smoke has an adverse effect on cells, triggering a robust gene expression response,’ said Dr. James Murphy, head of reduced risk substantiation at BAT. “However,” he said, “even at equivalent or higher dose of nicotine, acute exposure to the test e-cigarette vapor has very limited impact on gene expression compared to cigarette smoke exposure – it’s a striking difference.”

These results, which were published in Scientific Reports (DOI: 10.1038/s41598-017-00852-y), were said to add to an increasing weight of evidence that electronic cigarette vapor caused less damage to cells than did cigarette smoke.

‘Previous research conducted by British American Tobacco has shown that Vype ePen vapor contains around 95 percent less toxicants (Chem. Res. Toxicol, DOI: 10.1021/acs.chemrestox.6b00188) compared to cigarette smoke from a reference cigarette (in terms of the priority list of nine toxicants which the World Health Organization recommends to reduce),’ the press note said.

Switching from smoking to vaping greatly reduces the risk of dying in a fire, according to a Fire Magazine story citing London Fire Brigade figures.

While traditional tobacco cigarettes were the biggest cause of fatal fires, there had been no recorded deaths or injuries because of fires caused by electronic cigarettes.

During the past three years in London, UK, the Brigade had recorded 14 fires caused by electronic cigarettes compared to just over 3,500 smoking-related fires.

London Fire Brigade’s Assistant Commissioner, Dan Daly, said the best course of action was to quit smoking, but that switching to vaping also greatly cut the risk of fires.

The fire risks presented by electronic cigarettes usually arise from people using the wrong power source to charge them; so the Brigade has issued the following advice to avoid fires:

• Only use the battery and charger that is provided with the electronic cigarette, and buy these items from a reputable vendor;
• Keep electronic cigarettes away from heat sources, and keep them uncovered while charging;
• Never use a damaged electronic cigarette,  and never leave one on charge while unattended, including while asleep;
• Never use electronic cigarettes close to medical oxygen because of the danger of ignition;
• Damaged or old batteries should be replaced because they can lead to a fire caused by a short circuit, overheating or mechanical damage;
• Don’t leave batteries in a car, or in a pocket with loose change or keys; always use an approved case.

A US public health expert has described as absurd a suggestion that smoking cannot be said to be any more hazardous than is vaping.

Dr. Michael Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health, reported on his blog that an expert at Penn Medicine, the University of Pennsylvania’s health care system, was telling the public that smoking cigarettes, such as Marlboros, Camels, and Newports, might be no more hazardous to their health than was vaping a tobacco-free e-liquid.

“We know that cigarettes are unsafe after 40 years of exposure,” the expert was quoted as saying. “We don’t have 40 years of exposure to e-cigarettes to know what the danger is. We don’t know the safety profile, so we can’t say that e-cigarettes are safer than traditional cigarettes.”

Siegel said that if the expert was saying that it couldn’t be said that electronic cigarettes were safer than were traditional cigarettes, then the expert was saying was that it couldn’t be said that smoking was any more hazardous than vaping.

‘This is an absurd statement, completely in conflict with scientific evidence, and not even the tobacco companies would make such a claim,’ Siegel wrote…

‘In other words, the statement of this expert is essentially a huge advertisement for tobacco cigarettes, the most deadly consumer product on the market in terms of its toll on the lives and health of Americans.’

Siegel’s blog, The Rest of the Story, is at: http://tobaccoanalysis.blogspot.co.uk/2017/04/penn-medicine-expert-smoking-may-be-no.html

Tobacco smoking and the vaping of electronic devices have been banned in all public buildings and facilities in Manila, the Philippines, according to a story in The Manila Bulletin.

The ordinance is said also to prohibit the possession of any tobacco product or vaping device ‘whether the smoke [or vapor] is being actively inhaled or exhaled’.

And the smoking and vaping bans are not limited to inside city government buildings, but take in their compounds and any places within 100 meters of city government properties.

But the ordinance mandates the establishment of smoking areas outside each city government building provided it is not less than 10 meters away from where people pass or congregate and has visible ‘Smoking Area’ and ‘Minors Not Allowed’ signage, and graphic health warnings.

The new ordinance, which bans smoking in or at all public buildings, facilities, and establishments ‘owned, used, or controlled or administered by the city government of Manila’, was approved unanimously by the city council.

Ordinance No. 7812 or the ‘Smoke-Free Ordinance of the City Government of Manila’, authored by councilor Casimiro Sison, is said to have been intended to safeguard the health of the public and to set an example to the private sector in promoting a smoke-free environment.

But a previous ordinance (No. 7748) that has been in effect since 1991 already prohibits tobacco smoking in enclosed public places, such as bars, restaurants, theaters, malls, factories, vehicles, classrooms, school grounds, hospitals, clinics and markets.

Under the recently passed ordinance, violators will be liable to a fine of P2,000 and/or one day in prison for the first offense; P3,000 and/or two days in prison for the second offense; and P5,000 and/or three days in prison for the third offense.

Philip Morris International (PMI) submitted a Premarket Tobacco Product Application (PMTA) for its Electronically Heated Tobacco Product (EHTP) – such as its iQOS heat-not-burn device – to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the company’s stated goal of submitting its PMTA in the first quarter of 2017.

PMI’s PMTA seeks authorization to commercialize the EHTP in the United States. Should the FDA grant the requested marketing order, Altria Group would be responsible for commercializing and marketing the product in the United States under the terms of a licensing agreement with PMI, according to press note from PMI.

On December 5, 2016, PMI submitted a Modified Risk Tobacco Product (MRTP) application for its EHTP to the FDA. Administrative review of that application is ongoing. A PMTA marketing order is a prerequisite to commercializing a new tobacco product such as PMI’s EHTP. A decision on the PMTA would allow the marketing of PMI’s EHTP without modified risk claims independent of a decision on the MRTP.

The New Zealand has announced its plans to make nicotine-laced e-cigarettes legal, in a bid to regain lost ground on its noteworthy target to make New Zealand smokefree by 2025.

Associate Health Minister Nicky Wagner stated that the sale of nicotine infused vapor products and e-liquid will be made legal. The rules will likely come into force in late 2018, according to a story in the Manawatu Standard.

“Scientific evidence on the safety of e-cigarettes is still developing but there’s a general consensus that vaping is much less harmful than smoking,” said Wagner. “This is an opportunity to see if restricted access to e-cigarettes and e-liquid can help lower our smoking rates, reduce harm and save lives.”

Wagner said the government was taking a “cautious approach” by aligning vaping regulations with those for combustible cigarettes. “This ensures cigarette smokers have access to a lower-risk alternative while we continue to discourage people from smoking or vaping in the first place,” she said.

Just because you are filling tanks for customers doesn’t mean you must register as a manufacturer. Not long ago, retailers viewed vapor regulations to mean they could not perform services including filling tanks, changing coils, assembling a device or discussing how it works. Retailers felt they could not longer perform some of the simplest repairs. These activities, it was believed, was cause to classify shop owners as manufactures by the U.S. Food and Drug Administration’s (FDA) deeming rule for new tobacco products.

This is no longer true. In January, the FDA clarified the rule saying vape shop staff could explain how products work, as well as clean and perform maintenance on a purchased product. Retailers can also replace coils with new, identical coils, as well as assemble products for the customer (from the components packaged with the device).

The clarification also allows retailers to refill tanks, as long as no modifications are made outside of what is recommended by the manufacturer. Shop owners, however, are still banned from building coils and devices for customers, unless they register as a manufacturer.

The FDA requires vape shops that are tobacco product manufacturers be subject to the agency’s rules to provide ingredient listings, report HPHCs, and submit health documents. Vape shops that modify a product so that it is a new tobacco product are required to comply with the premarket authorization requirements. Finally, vape shops that are engaged in the manufacture, preparation, compounding, or processing of tobacco products (including e-liquids) are required to comply with establishment registration and product listing in accordance with the deeming rule.

The date for registration is quickly approaching.  Late last year, the FDA revised guidance concerning its “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” U.S. manufacturers of newly regulated tobacco products who first began manufacturing prior to Aug. 8, 2016, were given until June 30, 2017, to comply.

To read the new FDA compliance document released in January, click here.

Nicotine-containing e-liquid will remain illegal in Australia, despite appeals to support e-cigarettes for harm reduction, according to ECigIntelligence.

The Therapeutic Goods Administration (TGA) rejected a proposal submitted by the New Nicotine Alliance Australia (NNA), an e-cigarette lobbying group.

The TGA had previously declared nicotine a controlled substance and banned its use outside of nicotine replacement-therapy products and tobacco products.

Among other restrictions, the NNA had proposed a maximum nicotine concentration of 3.6 percent in e-liquid, a maximum container dosage of 900 mg and for all e-liquids to come in child-resistant bottles with warning labels.

However, the TGA said the current classifications for nicotine were appropriate as there was a risk of nicotine addiction, there was little evidence on the long-term effects of vaping, and views varied on the effectiveness of e-cigarettes in smoking cessation.

A new study predicts that, with electronic cigarettes available as alternatives to traditional tobacco cigarettes, by 2050, 32 percent of smokers in the UK who otherwise would have continued smoking would have completely switched to vaping, according to a British American Tobacco press note.

‘Our results show an overall beneficial effect of e-cigarettes on a population, reducing smoking prevalence and smoking-related deaths,’ said Dr. James Murphy, head of reduced risk substantiation at BAT.

The results, which are published today in Regulatory Toxicology and Pharmacology (doi: 10.1016/j.yrtph.2017.03.012), support the results of a study in 2016 by the Cochrane Review, which concluded that electronic cigarettes can help people stop smoking.

Scientists at BAT have developed a predictive model looking at a number of possible scenarios over a 50-year period between 2000 and 2050: There is a baseline scenario in which electronic cigarettes are not on the market and a counterfactual scenario, a predicted situation, based on the current trends in which both traditional tobacco cigarettes and electronic cigarettes are available to consumers.

“This modelling approach is an informative way of assessing population health effects when epidemiological data are not available,” says Murphy.

‘This model takes account of the way consumers use products and utilises the past to predict what might happen in the future,’ the press note said. ‘In 2000, smoking prevalence was 27 percent, and by 2010 it was 20.3 percent. This model predicts that when e-cigarettes are not available, this would fall to 12.4 percent of the overall population [by 2050]. This number falls to 9.7 percent (including dual users) when e-cigarettes are available. And the proportion of all deaths due to smoking-related diseases falls from 8.4 percent and 8.1 percent, respectively.’

The model is said to take into account all types of consumers, including current smokers, non-smokers, former smokers, electronic cigarette users, and dual users. ‘Behaviours, like starting, switching, becoming a dual user, and quitting are represented through a feedback system, as is the potential effect of smoking normalisation on starting and cessation rates,’ the note said. ‘Factors such as consumer age, gender, and aging are factored in, while time since quitting or relapsing is also considered.

‘Population benefits were seen even though the model is considered conservative: for instance, it ascribes no lowering of risk to consumers using both cigarettes and e-cigarettes, even though dual users are likely to smoke fewer tobacco cigarettes than they otherwise would; and it assumes that any potential health benefit from quitting cigarettes was lost on relapsing.

‘Future models may also study the use of additional products, such as tobacco-heating products and snus; characterise the UK population by ethnicity, social economic status, and education level; and factor in affordability, smoking bans, health campaigns/risk perception or packaging regulations, say the researchers.’

The U.S. Food and Drug Administration is delaying until March 19, 2018, its final rule for clarification of when products made or derived from tobacco are regulated as drugs, devices, or combination products under the Federal Food, Drug, and Cosmetic Act.

The agency wants to seek public feedback on issues raised by a petition from affected parties that asks for clarification on the amendments to the regulations regarding “intended uses.”

The delay will also provide additional time to the FDA to fully evaluate the comments.