health

FDA bans the sale of Juul e-cigarettes in the US 


Juul e-cigarettes are to be pulled from shelves across the United States from today as a health official accused them of a ‘disproportionate’ role in the rise of youth vaping.

The Food and Drug Administration said Thursday it was banning the sale of their products after the company failed to provide ‘sufficient evidence’ they were safe.

A spokeswoman said the restriction would apply from today, although it is likely many shops will have a ‘grace period’ before needing to remove the products.

There is no rule in place against owning or using Juul devices.

Juul vowed to appeal the move, saying it ‘respectfully disagrees’ with the FDA’s decision based on data submitted ‘over two years ago’.

E-cigarette support groups also blasted the ban on America’s most popular vape product as one of the ‘greatest episodes of regulatory malpractice in history’.

The move is part of the FDA’s crackdown on vaping products, which many fear could also be a gateway for many to start smoking. The products have been blamed for a surge in smoking among youngsters which hit one-in-four in 2019.

The Biden administration is also cracking down on smokers, voicing plans to limit the amount of nicotine in cigarettes in the hopes of making them less addictive.

Popular e-cigarette brand Juul has its products pulled from shelves after the FDA denied its application to get around a ban of flavored nicotine

Popular e-cigarette brand Juul has its products pulled from shelves after the FDA denied its application to get around a ban of flavored nicotine

The FDA said today’s ban applied to the sale and distribution of any Juul device.

It includes JUULpods (Virginia Tobacco five percent), JUULpods (Virginia Tobacco three percent), JUULpods (Menthol five percent), JUULpods (Menthol three percent).

But Juul’s website is currently still allowing Americans to purchase e-cigarettes and refills on their devices.

The FDA has threatened enforcement action on any businesses that continues to sell e-cigarettes from Juul, but has failed to detail what this would entail. 

Sean Hannity promises to ‘vape live on air’ if Biden bans Juul e-cigarettes 

On the Wednesday night edition of his Fox News show, Sean Hannity vowed to defy the law and proudly vape his e-cig live on air in a segment discussing a possible FDA ban on Juul products.

Less than 24 hours after the broadcast, the FDA confirmed a ban on Juul products.

Reporter Trace Gallagher told Hannity during the segment: ‘Juul has been trying to get on the right side of regulators by limiting its marketing and banning mango, mint, other sweet flavors. The company even suggested a vaping device that can only be unlocked if you’re 21.’

He noted that while Juul has the right to appeal a ban, those appeals can take a long time and are expensive.

That’s when Hannity chimed in to say: ‘They ban it, and I’ll do it live on TV and they can come and arrest me. How about that?’

The ban forbids the sale of Juul products but does not ban personal use of the product.

Michele Mital, the agency’s acting director for tobacco products, said today that Juul had failed to demonstrate its products met safety standards.

‘As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their product meets these standards,’ she said.

‘However, the company did not provide that evidence and instead left us with significant questions.

‘Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.’

FDA commissioner Robert Califf accused Juul of playing a ‘significant part’ in the rise of vaping among youngsters.

Responding to the ruling, the chief regulatory officer for Juul Joe Murillo said the company ‘respectfully disagrees with the FDA’s findings and decision, and continues to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency’.

He added: ‘We 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.

‘We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.’ 

After the FDA ordered a review of all vaping products in 2020, Juul had been seeking approval for its devices.

Today’s ruling is just the latest nail in the coffin for the company.

A mint and fruit flavor ban has been in place for the industry since 2020.

Juul is the most popular e-cigarette brand in America, believed to be behind about 42 percent of all devices sold.

But it has been accused of sparking a surge in vaping among younger adults, and providing a gateway for people to start smoking.

Federal data shows one-in-four children vaped in 2019 — more than double the 11.7 percent two years beforehand.

This has now come back down to 11.3 percent, however, amid heightened regulations and concerns over the habit.

The American Vapor Manufacturing Association — which represents the industry — blasted today’s ban on selling Juul products.

Devices like JUULs have largely been blamed for recent upticks in teen tobacco usage due to their fruity flavors and an easy way to carry and use them without detection (file photo)

Devices like JUULs have largely been blamed for recent upticks in teen tobacco usage due to their fruity flavors and an easy way to carry and use them without detection (file photo)

Its president Amanda Wheeler said: ‘Measured in lives lost and potential destroyed, the FDA’s staggering indifference to ordinary Americans and their right to switch to the vastly safer alternative of vaping will surely rank as one of the greatest episodes of regulatory malpractice in American history.’

Several public health groups have, however, welcomed the move.

Erika Sward, the vice-president of advocacy for the American Lung Association, said: ‘The FDA’s decision to remove all Juul products from the marketplace is both most welcomed and long overdue.

‘Juul’s campaign to target and hook kids on tobacco has gone on for far too long.’

The FDA’s ban comes just a day after the Biden administration called on tobacco companies to drastically cut the amount of nicotine in cigarettes.

Each one currently contains around 7.5 to 13.4 milligrams of the substance which makes them addictive, estimates suggest.

But the administration hopes to see this cut to ‘minimal’ levels in order to make smoking less addictive and easier to quit.

They say it could also help stop people from starting to smoke in the first place.

FDA commissioner Califf said in a statement that nicotine is ‘powerfully addictive’, adding that ‘lowering levels… would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit’.

The agency estimates reducing these levels could stop about 33 million people from becoming regular smokers and allow about five million more to quit every year.

It comes after the FDA also proposed a ban on menthol cigarettes in the United States, which account for about a third of all those being sold.

They said the move could help reduce disease and death from smoking by making people less likely to pick up the habit.

The FDA is also seeking to ban dozens of sweet and fruity flavors from small cigars, which are becoming more popular among young people.

The Centers for Disease Control and Prevention (CDC) also published a study in March finding that more than 2.5 million U.S. students had used a tobacco product of some sort in 2021.

Officials reported that 80 percent of tobacco use was attributable to disposable e-cigarettes and cartridge products – like a Juul.

In the study, around 2.06 million high schoolers — 13 percent of the study population, and four percent of middle schoolers — 470,000 participants – reported ‘current’ tobacco use.

For comparison, in 2020 the CDC reported that eight percent of high schoolers and three percent of middle schoolers were current tobacco users.

The CDC reports that more than 2.5 million students in the U.S. were 'current' users of tobacco products in 2021. This includes 13% of high schoolers and 4% of middle schoolers

The CDC reports that more than 2.5 million students in the U.S. were ‘current’ users of tobacco products in 2021. This includes 13% of high schoolers and 4% of middle schoolers

Disposable e-cigarettes and refillable cartridges account for over 80% of teen tobacco product usage in America

Disposable e-cigarettes and refillable cartridges account for over 80% of teen tobacco product usage in America

Students were also asked if they had ever used tobacco products in their life, with 34 percent of high schoolers and 11 percent of middle schoolers reporting at least one use.

E-cigarette devices were most to blame for the increase in nicotine and tobacco use over the past year, according to the CDC study.

Of the students who did report being current smokers, 54 percent use a disposable e-cigarette and 29 percent reported using some sort of refillable device – similar to a Juul.

Between them, the devices which allow teens to easily and conspicuously use nicotine account for over 80 percent of overall student tobacco use.

Nicotine does not carry many of the same negative effects and cancer risks that tobacco, but does increase the risk of high blood pressure, artery shrinking and increased heart rate.

E-cigarettes’ use among school-aged children can be attributed to their flavors, and the devices resemblance to a USB stick, allowing kids to easily carry them at school without getting caught.

Some states and cities have banned the sale of flavored nicotine products, though there have been mixed results as to whether they successfully prevented teens from picking up the habit.

Opponents to these bans say that they will push teens to using more harmful tobacco products like cigarettes, instead of nicotine, which carries less risk.

‘By bashing safer nicotine products such as vaping we are going to inadvertently encourage high schoolers to smoke instead, which will be an awful outcome,’ Mark Oates, director of consumer advocacy group We Vape, told DailyMail.com in March.



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