Tag Archives: ecigarettes

E-cigarettes cause MORE lung inflammation than normal cigarettes

Vape users suffer more inflammation of the lungs than people who smoke regular cigarettes, a study suggests.

University of Pennsylvania researchers said the electronic devices cause ‘unique’ damage to the lungs not yet fully understood.

The study is the latest evidence to highlight how vaping is not the risk-free cessation method it was initially touted as.

Other researchers have found e-cigarettes cause heart and lung damage on par with traditional cigarettes.

Researchers found that vapers suffered more inflammation in their lungs than people who smoke regular cigarettes (file photo)

The radiotracer used by researchers was able to highlight areas of inflammation in the lungs within 45 seconds (red)

The researchers gave 15 people a tracing chemical that sticks to inflammation on the lungs and makes it visible on CT scans.

Participants were either vape users, traditional smokers or people who had never used either device. 

Results showed significantly more inflammation in the lungs of vapers than smokers or non-smokers.

But interestingly, tobacco smokers did not suffer more inflammation than those that used neither device. 

‘We find evidence that [e-cigarette] use causes a unique inflammatory response in the lungs,’ researchers wrote in the study. 

More than 2.5million US minors use e-cigarettes, according to a Centers for Disease Control and Prevention study published last year.

Experts have described the youth’s use as a crisis, and some warn America will face a surge in lung-related health issues in the future.

‘Commercial tobacco product use continues to threaten the health of our nation’s youth,’  Dr Deirdre Lawrence Kittner, the director of the CDC’s Office on Smoking and Health, said in November.

For the Penn study, researchers gathered five non-smokers, five people who smoke typical combustible cigarettes and five vapers.

They were matched by age and gender to one another to control for inflammation tied to outside factors.

Each was injected with a radiotracer called, 207 MBq F-18 NOS. These traces are often used to find radioactive irregularities as they can be spotted on CT scans.

In cancer treatment, for example, a doctor may inject a tracer that binds to tumor tissue and scan a person to find signs they could soon develop the disease.

Within 42 seconds of the injection, the tracer had fully covered a person’s lungs and could spot signs of inflammation.

Researchers, who published their findings last week in the Journal of Nuclear Medicine, found no difference in lung inflammation between non-smokers and cigarette users. 

They did find a significant increase in lung inflammation in the group of vapers when compared to the others, though.

Lung inflammation is not always permanent or serious. It is well-known that some suffer lung inflammation after suffering a viral illness such as the common cold.

In some cases, though, the inflammation can lead to tissue scarring – which could later lead to cancer.

This type of damage is also linked to the development of chronic obstructive pulmonary disease (COPD).

The true impact e-cigarettes have on the lungs is still being researched by health officials, but early data shows the devices could have devastating long-term. 

One chemical included in many flavored vape products, diacetyl, has been linked to the devastating condition popcorn lung.

Medically known as bronchiolitis obliterans, it occurs when the chemical forms scar tissue in the lungs and blocks the flow of air.

Other studies have linked long-term vaping to obstruction of the lung’s airways, which are linked to conditions such as asthma and COPD.

Another recent study found the devices can cause DNA damage comparable to that of cigarettes – opening users up to developing cancer in the future. 

The devices are still believed to be less harmful than cigarettes, though, with the combustible versions linked to many types of cancer and lung conditions. 

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US bans Juul but young vapers are already switching to newer products | E-cigarettes

This week, the US effectively banned Juul after the Food and Drug Administration ordered the e-cigarette maker to remove its popular products from the marketplace.

Experts have hailed the move as significant. But they are also concerned that such efforts are failing to keep up with a fast-moving vaping industry – one where young people leap quickly from one product to another.

The FDA ban caps years of controversy for Juul, whose discreet vapes have been accused of helping hook an entire new generation on nicotine. In 2020 the FDA ordered mint- and juice-flavored e-cigarette pods off the shelves, hitting many of Juul’s products. This week’s escalation came because regulators said Juul failed to provide sufficient evidence to assess their toxicity and hazards of their tobacco and menthol-flavored e-cigarettes, leaving the FDA unable to “assess the potential toxicological risks of using the Juul products”.

Juul, meanwhile, has argued its vapes help regular smokers quit cigarettes, and has said it will fight back. On Friday, an appeals court temporarily put the ban on hold while Juul appeals.

The ban is still momentous, says Lauren Czaplicki, a researcher at Johns Hopkins Bloomberg School of Public Health, because it’s one of the first marketing denials for a brand with substantial market share in the US and for a menthol-flavored product. She points out that other brands like Vuse, Logic and NJOY have received market authorization for various tobacco flavored e-cigarette products and systems, but Juul was denied.

Research shows that bans of flavored cigarettes do make a difference – a 2020 study by George Mason University analyzed a 2009 FDA flavored cigarette ban, and found it reduced smoking by underage youth by 43% and young adults by 27%.

“It is likely that the FDA’s marketing denial will have an impact,” says Czaplicki. “Juul is still a popular product among young people who do use e-cigarettes, and Juul has a certain level of brand recognition and cultural cachet among youth that may be susceptible to nicotine use.”

But while Juul still commands a dominant share of the US market, its popularity among young people has waned over the last few years, says Dr Devika Rao, a pediatric pulmonologist at UT Southwestern. A recent federal survey found Juul was only the fourth most popular product among middle and high school students: the disposable e-cigarette Puff Bar came in first, with Vuse and Smok the second and third most popular.

“We know from data that Juul is not the most commonly used,” says Rao. “Adolescents today are favoring disposable vapes, devices you can purchase online or in a store.” They cost as little as $10 each for a single-use device and do not fall under the 2020 flavor ban, even though they use the same technology as Juul.

Adolescents often switch from product to product, creating a Whac-a-Mole prevention strategy, says Monica M Zorilla, a researcher at Stanford. When the FDA prioritized enforcement against flavored e-cigarette devices like Juul in 2020, it exempted disposable e-cigarettes and menthol-flavored e-cigarette products, says Zorilla. A Stanford study found that adolescents then moved to those e-cigarettes that were exempt. “Youth went from pod-based [like Juul] to disposables like Puff Bar,” Zorilla says. “As a youth said to me, ‘anything with fruit’ is popular among their peers. This was in part due to the enforcement and in part because the disposables continued to have many flavors.”

Rao points out that social media marketing is clever – and insidious – enough so teens will switch vaping products before adults are even aware of them. She points out that the newest trend is so-called wellness vapes which are not even marketed as e-cigarettes. “You can vape things like melatonin or vitamins to feel better and fall asleep faster,” she says. These are really vaping devices disguised, and companies are not required to state the concentration or what is in these products. “Newer products present a whole new level of risk.”

Flum Float disposable vape flavored vaping e-cigarette products are displayed in a convenience store in El Segundo, California Photograph: Patrick T Fallon/AFP/Getty Images

More action is needed, says Czaplicki. She says the FDA should immediately issue an order to remove all vape products that are being sold without market authorization, from retail shelves and online. This would include Puff Bar. “Reducing the number and type of flavored, e-cigarette devices for sale in the US is likely to have a substantial impact on reducing youth vaping,” she says. “At the same time, it is unlikely to reduce the usefulness of tobacco flavored e-cigarettes from helping adult smokers completely quit smoking.”

Vaping is exposing a new generation to nicotine addiction, says Rao – and researchers are still figuring out how to treat nicotine addiction in kids rather than adults.

These products are often perceived as less harmful than smoking, but they still come with risk because adolescents are wired to become addicted to substances. Rao, who cares for patients at Children’s medical center in Dallas, explains that Juul had figured out how to make the nicotine more potent to give a more potent hit to the brain – allowing for a greater sense of pleasure from using the vape.

“It may take just a few hits of a vape before they are addicted, and it affects things like school performance, athletic performance, and can lead to severe consequences like lung injury,” says Rao. Studies also show that vaping leads to an increase in heart rate and blood pressure.

She says that the rates of vaping declined for two years during the pandemic, but doctors are now concerned that re-establishing of social networks and easing restrictions mean that those rates could again rise.

“When I talk to my patients, they are either vaping or all their friends are vaping and they may be feeling pressure to start using these products,” says Rao. “Parents and educators need to have these conversations about the harm they can have.”

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Juul can keep selling e-cigarettes, after an appeals court paused the FDA’s ban

Juul can continue selling its e-cigarettes despite the Food and Drug Administration ordering a ban Thursday, according to the US Court of Appeals for the District of Columbia (via TechCrunch). In its order, the court says it’s issuing the temporary stay to give Juul time to file an emergency motion, which it can then consider along with a response from the FDA.

The FDA says the reason for the ban is that there’s “insufficient evidence to assess the potential toxicological risks of using the Juul products.” Juul had petitioned for clearance to sell its tobacco and menthol-flavored vape products, but the FDA turned down the application. The regulator notes that it’s only illegal to sell the Juul device and Juul pods, not to own or use them.

According to the court’s order, uploaded by Axios, Juul has until noon on the 27th to file its emergency motion. As the FDA’s website notes, the court says it’s not permitting Juul to sell its vaping products based on the merits of the company’s request — that decision will come later.

In its petition for the stay, which you can read in full below, Juul said that it faced “significant irreparable harm” if it wasn’t allowed to sell its products while it prepared its full motion for a stay. “FDA cannot credibly argue that there is a critical and urgent public interest in removing JLI’s products from the market right now, rather than after this Court reviews FDA’s action,” the company wrote (emphasis Juul’s).

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FDA’s ban on Juul e-cigarettes delayed by appeals court

The U.S. Court of Appeals for the District of Columbia temporarily delayed the FDA’s ban on Juul devices on Friday after the e-cigarette giant called the agency’s order “extraordinary and unlawful” in a court filing, the Wall Street Journal reports. 

The FDA said Thursday that it has not “received clinical information to suggest an immediate hazard associated with the use of” Juul devices, but that there is “insufficient evidence to assess the potential toxicological risks” of using the products.

Packages of Juul e-cigarettes are displayed for sale in the Brazil Outlet shop on June 22, 2022 in Los Angeles, California.  (Photo by Mario Tama/Getty Images / Getty Images)

Juul hit back on Friday, arguing that it will “suffer significant irreparable harm.”

FDA BANS JUUL E-CIGARETTE PRODUCTS

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health,’” Juul said. 

A shopkeeper demonstrates smoking a Juul brand vaping pen to customers. (REUTERS/Ajeng Dinar Ulfiana/File Photo / Reuters Photos)

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The Wall Street Journal reported that Juul is considering a bankruptcy filing and other options if it is unable to avoid the FDA’s ban. 

Juul did not immediately respond to a request for comment on Friday. 

Reuters contributed to this report. 

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U.S. bans sales of Juul e-cigarettes, company to seek stay on enforcement

June 23 (Reuters) – Sales of Juul e-cigarettes were blocked by the U.S. Food and Drug Administration on Thursday, in a major blow to the once high-flying firm whose products have been tied to a surge in teenage vaping.

The agency said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health, following a nearly two-year-long review of data provided by the company.

Some of the findings raised concerns due to insufficient and conflicting data, including whether potentially harmful chemicals could leach out of the Juul pods, the FDA said.

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“We respectfully disagree with the FDA’s findings … intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” said Joe Murillo, chief regulatory officer at Juul.

The company said it had appropriately characterized the toxicological profile of its products and that the data met the statutory standard of being “appropriate for the protection of the public health”.

Juul and other e-cigarette brands, including British American Tobacco’s (BATS.L) Vuse and Imperial Brands’ (IMB.L) Blu, had to meet a September 2020 deadline to file applications to the FDA showing the products provided a net benefit to public health.

The heath regulator had to judge whether each product was effective in getting smokers to quit and, if so, whether the benefits to smokers outweighed the potential health damage to new e-cigarette users, including teenagers, who never smoked.

BAT’s Vuse Solo was the first e-cigarette to get the agency’s clearance in October. read more

“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize … many have played a disproportionate role in the rise in youth vaping,” FDA Commissioner Robert Califf said in a statement.

Teenage use of e-cigarettes surged with the rise in popularity of Juul in 2017 and 2018. Its use among high school students grew to 27.5% in 2019 from 11.7% in 2017, but fell to 11.3% in 2021, a federal survey showed.

Juul did not provide evidence to show the products were up to its standards and that raised “significant questions”, the FDA said, but added it has so far not received clinical information to suggest an immediate hazard tied to the device or pods.

“Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders,” Michele Mital, acting director of the FDA’s Center for Tobacco Products, said.

Shares of tobacco giant Altria Group Inc (MO.N), which partly owns Juul, have lost about 7%, or nearly $6 billion in market value, since Wednesday when the Wall Street Journal first reported the FDA was preparing to order Juul’s e-cigarettes off the market.

‘HAWKISH FDA’

Juul had sought approval for its vaping device and tobacco and menthol flavored pods that had nicotine content of 5% and 3%.

E-cigarette makers have been selling products in the United States for years without being officially authorized by the FDA, as regulators repeatedly delayed deadlines for the companies to comply with federal guidelines.

Thursday’s decision was cheered by public health groups, who had long warned that e-cigarettes were getting a new generation of teenagers hooked on nicotine after major strides in reducing youth cigarette use.

In 2020, the FDA banned all flavors except tobacco and menthol for cartridge-based e-cigarettes such as Juul. The company pulled all other flavors including mint and mango in late 2019.

The Biden administration has been looking at other ways to help people quit smoking in an effort to cut down on preventable cancer deaths. It said this week it plans to propose a rule establishing a maximum nicotine level in cigarettes and other finished tobacco products to make them less addictive. read more

The surprise decision was an indication of a more hawkish FDA, some analysts said, as it was expected that some Juul products would be approved, following the agency’s clearance of several other e-cigarette products.

BAT overtook Juul as the leader of the U.S. vaping market in April, according to data Nielsen provided to brokerage J.P. Morgan. Juul led the market in 2021, with a 38% share of the $11 billion retail sales market.

“The only opportunity for Juul to create value may be in international markets, but we expect other regulators to take a similar stance to the FDA in limiting the marketing of e-cigarettes to minors,” Morningstar analyst Philip Gorham said.

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Reporting by Chris Kirkham and Aishwarya Venugopal; Additional reporting by Praveen Paramasivam, Ananya Mariam Rajesh and Uday Sampath in Bengaluru; Editing by Bill Berkrot, Sriraj Kalluvila and Shounak Dasgupta

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Juul e-cigarettes to be ordered off U.S. shelves – WSJ

A woman holds a Juul e-cigarette while walking in New York, U.S., September 27, 2018. REUTERS/Brendan McDermid

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June 22 (Reuters) – The U.S. Food and Drug Administration is preparing to order Juul Labs Inc to take its e-cigarettes off the market in the United States, the Wall Street Journal reported on Wednesday, citing people familiar with the matter.

Shares in tobacco giant Altria Group (MO.N), which owns a 35% stake in the vaping products maker, fell 8.5% following the report. The decision could come as early as Wednesday, the report said.

Juul has faced heightened scrutiny from regulators, lawmakers and state attorneys general over the appeal of its nicotine products to teenagers. Under pressure, the company in late 2019 had halted U.S. sales of several flavors.

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The FDA declined to comment on the report, while Altria and Juul did not respond to requests for comment from Reuters.

“This clearly comes as a surprise to the market … we would expect that Juul would appeal the decision, and remain on the market through that process, which would likely take a year or more,” Cowen analyst Vivien Azer said.

The looming verdict comes nearly two years after Juul had applied for approval to keep selling e-cigarettes in the country.

The FDA’s review of the applications was based on whether the e-cigarettes are effective in getting smokers to quit and, if so, whether the benefits to smokers outweigh the health damage to new users, including teenagers.

In October, the FDA had allowed Juul rival British American Tobacco Plc (BATS.L) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, the first-ever vapor product to get clearance from the health regulator. read more

The estimated fair value of Altria’s investment in Juul was $1.6 billion as of March end, a fraction of the $12.8 billion it paid in 2018, as a crackdown on vaping has upended the once fast-growing industry.

“The investment in Juul was always a mistake, the company paying top dollar for a business which was already clearly (on) the wrong side of the regulators,” said Rae Maile, analyst at Panmure Gordon.

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Reporting by Praveen Paramasivam and Deborah Sophia in Bengaluru; Editing by Devika Syamnath and Sriraj Kalluvila

Our Standards: The Thomson Reuters Trust Principles.

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Men who use e-cigarettes twice as likely to suffer erectile dysfunction, study finds

Men who vape or use e-cigarettes are more than twice as likely to suffer from erectile dysfunction, a new study has suggested.

American researchers surveyed nearly 14,000 men over the age of 20 and found those who used the devices had a 2.4 times higher chance of impotence than non-smokers.

While the study did not prove the link, the experts believe a high level of nicotine in vaping liquid reduces blood flow to the penis by hampering the ability of blood vessels to dilate.

And even fluids without nicotine contain chemicals that may reduce the amount of testosterone circulating in the body, researchers say.  

The team, from New York’s Grossman School of Medicine and Johns Hopkins University, said men should be warned about the potential impact vaping could have on their love life — as England gets ready to become the first country in the world to prescribe e-cigarettes to help smokers quit.

About one in five men in the UK and US are believed to suffer from impotence and with it becoming more common as men age, with over half of cases in the over 50s. 

Men who use e-cigarettes or vapes could be twice as likely to have problems getting or maintaining an erection according to a new study (stock image)

Traditional smoking has been long established as cause of erectile dysfunction due to the chemicals contained in tobacco products, such as nicotine, damaging the blood vessels connected to the penis. 

While vaping is generally considered healthier than traditional smoking  scientists have recently been exploring a possible relation between the sexual health problems and e-cigarette products.

WHAT IS IMPOTENCE?

Erectile dysfunction, also known as impotence, is when a man is unable to get or maintain an erection.

It is more common in the over-40s but affects men of all ages.

Failure to stay erect is usually due to tiredness, stress, anxiety or alcohol, and is not a cause for concern.

However, it can be a sign of an underlying medical condition such as high blood pressure or cholesterol, side effects of medication, or hormonal issues.

Lifestyle factors than can affect the condition include obesity, smoking, cycling too much, drinking too much, and stress. 

Source: NHS Choices 

Lead author of the latest study, Dr Omar El Shahawyl, said the findings indicated that, vapers were more likely to suffer erection problems than non-vapers, even considering previous smoking history.  

‘Our analyses accounted for the cigarette smoking history of participants, including those who were never cigarette smokers to begin with, so it is possible that daily e-cigarette vaping may be associated with higher odds of erectile dysfunction regardless of one’s smoking history,’ he said.

With vaping on the rise as a healthier alternative to smoking, Dr Shahawyl said more research was needed to explore any potential consequences on men’s sexual health.

‘We need to fully investigate the relationship between vaping products and erectile dysfunction, and potential implications for men’s sexual health,’ he said.

‘Our findings underscore the need to conduct further studies to contextualize the e-cigarette use pattern that is relatively safer than smoking.’

The research was based on the a survey, with the 13,711 original participants later narrowed down to 11,207 with no prior cardiovascular disease diagnosis. 

In both groups men who used e-cigarette products were twice as likely to experience erectile dysfunction, 2.2 times more likely in the larger sample size and rising to 2.4 times as likely in the sample without cardiovascular disease. 

Almost half of all participants were former cigarette smokers, 21 per cent were current cigarette smokers, and 14 percent used vapes and e-cigarettes.  

In total, 10 per cent of all men in the sample reported experiencing erectile dysfunction.

One limitation of the study was that it based on self-reporting meaning that the results may be influenced by men lying on the questionnaire. 

The authors also did not state whether the risk erectile dysfunction for people who use vapes and e-cigarettes was higher or lower than that of traditional smoking. 

The researchers, who published their findings in the American Journal of Preventive Medicine said they next plan to examine if different types of electronic nicotine delivery devices have differing affects on erectile dysfunction and if it can be reversed by stopping.  

Vaping damages DNA and raises risk of cancer study claims — but it’s not as bad as traditional smoking 

Vaping damages people’s DNA in the same way as smoking normal cigarettes — but to a lesser degree — a study warned today.

These biological changes can cause diseases such as cancer, according to the University of Southern California study.

Vaping has been viewed as a safer alternative to smoking, with the UK mulling plans to prescribe e-cigarettes to cigarette users to help them quit.

 There have been several studies that suggests e-cigarettes are harmful, but many questioned whether smoking was still to blame since most vapers also smoke traditional cigarettes or have a prior history of smoking.

But a team of researchers at the University of Southern California found that these biological changes happen even in vapers who’ve never touched a cigarette.

However, the changes are much more extensive in people who smoke tobacco products, the scientists said.

Laws restricting what manufacturers are allowed to put in vapes are stricter in the UK than the US, so the American study may not entirely reflect effects of E-cigarettes available on the British market.

The study looked at 82 healthy adults split them into three categories — current vapers, people who only smoke cigarettes and a control group who had never smoked or vaped.

They then analysed the genes of all paricipants and looked for changes in gene regulation in the blood cells of each participant.

When the normal regulation of genes is disrupted it can interfere to gene function, leading to disease.

 

Reacting to the study consultant uro-andrologist Giulio Garaffa of private health clinic International Andrology in London said the study’s findings made sense. 

‘The idea of e-cigarette use negatively impacting men’s ability to get erections does have a foundation,’ he said.

However Dr Garaffa said any damage caused by e-cigarettes and vapes, is both likely to be reversible and less than that caused traditional smoking due to the absence of substances like tar and carbon monoxide. 

‘Nicotine has an immediate, short term vasoconstrictor effect, and therefore it may reduce the blood flow to the penis and may impact negatively the ability of getting an erection,’ he said. 

‘With time the vasoconstrictor effect of nicotine disappears with no long term damage to erections.

‘Instead, the chemicals inhaled by tobacco smokers, will also cause long term damage to the vessels of the cardiocirculatory system thus causing long term worsening of the erections on top of the short term effects of nicotine.’

But he added it was the duty of all clinicians to inform patients of the risk of erectile dysfunction in vaping products.

Dr Garaffa also urged all patients to contact a health professional if they are suffering from erectile dysfunction as it can be a warning sign of a cardiovascular disease.

Last month it was announced England is set to become the first country in the world to prescribe e-cigarettes to help smokers quit.

Despite a torrent of evidence on the health risks of vaping, the medical regulator is to ‘pave the way’ for it to be offered on the NHS.

Manufacturers will be able to submit e-cigarettes to the Medicines and Healthcare products Regulatory Agency to undergo the same ‘approvals process’ as other medicines.

This means they could then be licensed as a medical product and prescribed by doctors on a case-by-case basis to people who want to quit traditional cigarettes.

Currently, the NHS advises that vaping can help smokers – though it is not available on prescription.

E-cig devices typically cost around £20 to £30, plus more for replacement cartridges.

The controversial move comes despite the World Health Organization saying last year that the devices are ‘undoubtedly harmful’.

Some 3million Britons use vapes at present, more than triple the 700,000 nearly a decade ago. 

What is an e-cigarette and how is it different to smoking tobacco?

An electronic cigarette (e-cigarette) is a device that allows users to inhale nicotine by heating a vapour from a solution that contain nicotine, propylene and flavourings.

As there is no burning involved, there is no smoke like a traditional cigarette.

But while they have been branded as carrying a lower risk than cigarettes, an increasing swell of studies is showing health dangers.

E-cigarettes do not produce tar or carbon monoxide, but the vapor does contain some harmful chemicals.

Nicotine is the highly addictive chemical which makes it difficult for smokers to quit.  

Nearly three million people in Britain use e-cigarettes, and more than nine million Americans.

TYPES:

1. Standard e-cigarette

Battery-powered device containing nicotine e-liquid.

It vaporizes flavored nicotine liquid.

2. Juul

Very similar to normal e-cigarettes but with sleeker design and, in the US, a higher concentration of nicotine. In the UK and EU limited to 20 mg/ml. 

Thanks to its ‘nicotine salts’, manufacturers claim one pod delivers the amount of nicotine as a pack of cigarettes.

It is composed of an e-cigarette (battery and temperature control), and a pod of e-liquid which is inserted at the end.

The liquid contains nicotine, chemicals and flavorings.

Like other vaping devices, it vaporizes the e-liquid.

3. IQOS by Philip Morris

Pen-shaped, charged like an iPod.

Vaporizes tobacco.

It is known as a ‘heat not burn’ smokeless device, heating tobacco but not burning it (at 350C compared to 600C as normal cigarettes do).

The company claims this method lowers users’ exposure to carcinogen from burning tobacco.

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F.D.A. Authorizes E-Cigarettes to Stay on U.S. Market for the First Time

The Food and Drug Administration for the first time on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades.

In greenlighting a device and tobacco-flavored cartridges marketed by R.J. Reynolds under the brand name Vuse, the agency signaled that it believed that the help that certain vaping devices offer smokers to quit traditional cigarettes is more significant than the risks of ensnaring a new generation.

“The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the F.D.A. said in a statement announcing the decision.

The statement concluded, “The F.D.A. determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”

The watershed decision could pave the way for authorization of some other electronic cigarettes, including from the once-dominant maker Juul, to stay on the market. For more than a year, the manufacturers of e-cigarettes have been in a holding pattern — their products on the market but awaiting official authorization — as the F.D.A. has investigated whether they were a benefit or a danger to public health.

Over the past few months, as part of that review, the agency ordered thousands of vaping products off the market, including a brand that has surpassed Juul as a favorite among teenagers for their fruity and candy flavors, Puff Bars. On Tuesday, the agency also ordered 10 other Vuse flavored products off the market but declined to say which products it rejected.

Condemnation of the decision was swift.

“This throws young people under the bus,” said Erika Sward, national assistant vice president for advocacy at the American Lung Association. She said the concern was both with the broader logic endorsing these products but also with the Vuse, which in the government’s most recent survey on youth tobacco use was found to be one of the most popular vaping brands with young people.

Vuse’s owner, R.J. Reynolds, is one of the world’s largest cigarette companies. Juul is owned by another, Altria. Ms. Sward said that an industry that lied about hooking generations on a deadly product that killed millions was now positioned to control the next iteration of the nicotine market.

“The industry has been waiting for their next big thing and they found it with e-cigarettes,” she said.

Kaelan Hollon, a spokeswoman for Reynolds American, R.J.R.’s parent company, said the decision “represents an important moment for Reynolds” and that it showed that the authorized products “are appropriate for the protection of the public health.”

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US FDA OKs Vuse e-cigarettes, its first vape authorization

“While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved.’ All tobacco products are harmful and addictive and those who do not use tobacco products should not start,” the FDA said in a statement.

The FDA said it had denied the company permission to sell 10 flavored products but did not say what they were. The three authorized products are all tobacco flavored, and the FDA said they were less likely to appeal to children and teens, and more likely to be used by smokers to reduce their risk of harm.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, who heads FDA’s Center for Tobacco Products, said in a statement.

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption — by reducing their exposure to harmful chemicals,” Zeller added.

“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization.”

The FDA’s action restricts digital, radio and television advertising for the products, the FDA said.

“These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes,” the FDA said.

“The FDA is aware that the 2021 National Youth Tobacco Survey found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products,” it added.

“The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.”

E-cigarette products have been allowed to remain on the market for years, even though none have been given the official green light by the FDA. Manufacturers were given until September 9 of last year to submit applications for the agency’s authorization to remain on the market.

The FDA said in September it needed more time to decide on the applications.

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