Juul

2022 - 6 - 24

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Image courtesy of "Axios"

Juul decision triggers broader tobacco fight (Axios)

Juul decision triggers broader tobacco fight · These include numerous bottled vaping liquids sold to adults in different flavors and nicotine strengths, per the ...

Yes, but: It could be a drawn-out and costly fight. Driving the news: The Food and Drug Administration on Thursday announced it will order Juul to remove its e-cigarettes out of the U.S. market, taking away an e-cigarette option for millions of smokers. Why it matters: The move comes amid a push to cap nicotine in cigarettes and signals the Biden administration is escalating its attempt to limit tobacco use in the U.S., Axios' Arielle Dreher reports. The Food and Drug Administration on Thursday announced it will order top-seller Juul to take its e-cigarettes off the shelves in the U.S. market. - The burst in youth vaping led theFDA to banmost flavored cartridges products in a bid to cut off an alternative nicotine source. The FDA's decision to order Juul e-cigarette products off the U.S. market opens a new and grinding battle in the push to revamp the government’s rules for smoking and vaping.

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FDA Orders All JUUL Products Removed from the U.S. Market ... (HYPEBEAST)

FDA Orders All JUUL Products Removed from the U.S. Market (UPDATE): As they played a "disproportionate role in the rise in youth vaping."

This news comes after a two-year review by the FDA where all vaping products sold in the U.S. were reviewed to determine if they could be sold in the country. The FDA’s decision was backed by its findings which indicate that JUUL Labs’ products have “played a disproportionate role in the rise in youth vaping,” said FDA Commissioner Robert M. Califf. JUUL intends to fight the FDA’s decision as there’s also evidence that electronic nicotine delivery systems (ENDS) are a less hazardous substitute for adults who are addicted to cigarettes. Following Wednesday’s statement of a possible ban on the sale of JUUL vapes in the United States, The Food and Drug Administration has confirmed that it has issued a denial order for the sale of “all of their products currently marketed in the United States.”

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Image courtesy of "Entrepreneur"

How the Founders of PAVe Went to War With JUUL (Entrepreneur)

Along with their friend Dina Alessi, these New York City moms created PAVe in April 2018 as a grassroots response to the youth vaping epidemic that has impacted ...

We would be nowhere without the wisdom, generosity and partnership of our colleagues in tobacco control. Meanwhile, as PAVe, in Boublik's words, seeks to "move the goalpost" with regional and national webinars and parent virtual and in-person testimony at state and federal hearings, youth vaping continues to rage. The hearing–and Caleb and Phillip's testimony in particular-created a firestorm of negative international publicity that burned JUUL's tech-chic reputation and seriously damaged the unicorn's enormous bottom line. If it were not for our children, we would not have known what happened in school that day. The perfect moment to go public arrived in July 2019 when Congressman Raja Krishnamoorthi (D-Illinois), chair of the House Oversight Subcommittee on Economics and Consumer Policy led a two-day hearing about JUUL that included Berkman, Fuhrman and their sons along with other witnesses who shone an ugly light on JUUL's targeting of young people. Virtual and free so it would remain highly accessible to parents, the event drew over 2 thousand participants eager to hear fellow parents, educators, public- health advocates, and nationally-elected officials doing a deeper dive into all aspects of youth tobacco use. "We would have preferred to join a group like ours rather than start one", says Berkman, pointing out that she and her friends searched in vain for a Mothers-Against-Drunk-Driving-of-Vaping. "This crisis chose us, not the other way around. This despite a federal court order requiring FDA to finish reviewing these products by September 2021, a regulatory process already delayed for years. The moms began meeting with pediatricians, addiction psychiatrists and other experts in their own backyard and building out from there, creating important partnerships with and between institutions and researchers around the country, from Stanford Medical School to the Harvard School of Public Health. (The Campaign for Tobacco-Free Kids and the Truth Initiative, longtime leaders in tobacco control, became early supporters after the moms stumbled upon them during a Google search.) Heading to Washington, D.C. with their sons, they met with any elected officials who would listen and eventually with FDA leadership, sounding the alarm about youth vaping, but at the same time requesting that their JUUL- in-school story remain confidential. As Meredith Berkman and Dorian Fuhrman, two of the co-founders of Parents Against Vaping e-cigarettes (PAVe) like to put it, "Big Tobacco messed with the wrong moms." The women realized that they needed to take action — and that meant fighting for laws to protect kids from e-cigarettes. (In addition to seeking access to high schools, JUUL had even run a summer camp for younger kids.)

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Juul is ordered by the FDA to pull all of its vaping products from the ... (WVXU)

JUUL Labs is no longer allowed to sell or distribute its e-cigarette or vaping products in the U.S. The FDA said its review found Juul products potentially ...

The company plans to fight back. JUUL Labs is no longer allowed to sell or distribute its e-cigarette or vaping products in the U.S. The FDA said its review found Juul products potentially harmful. Juul is ordered by the FDA to pull all of its vaping products from the U.S. market

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Up in smoke: Why US has ordered leading vaping company Juul to ... (Firstpost)

The Food and Drug Administration banned all Juul products from the United States after recognising it 'played a disproportionate role in the rise of youth ...

It was a sign, she said, of the FDA's "staggering indifference to ordinary Americans and their right to switch" to vaping. The agency said that Juul’s application didn’t have enough evidence to show that marketing its products “would be appropriate for the protection of the public health.” The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavoured cartridges. Stopping these sales is an important step in ending the youth vaping epidemic,” it said on Twitter. Its appeal to young people, which has raised concerns of reversing long-term declines in the number of youths picking up smoking, is what first got the company into trouble with the FDA. In addition, those currently on the US market must be removed, or risk enforcement action.”

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Image courtesy of "Interesting Engineering"

Juul banned in US: FDA strikes a major blow to market leader of ... (Interesting Engineering)

FDA found data submitted by Juul was insufficient and conflicting and did not demonstrate public health protection.

This does not impact Juul products that users may already have for their individual consumption, the FDA said in the press release. According to CNBC, the FDA has received over 6.5 million PMTA from 500 companies in this space. Prior to this, Juul had already withdrawn fruit-flavored cartridges from the U.S. market since they were popular with teen users, CNBC reported. Makers of e-cigarettes argue that their devices prevent the harmful effect of smoking tobacco while helping those who are addicted to nicotine. The company can no longer sell or distribute its products in the U.S. An e-cigarette is aimed as an alternative for tobacco smokers, as it can deliver nicotine contained in liquid cartridges or pods by vaporizing it.

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Image courtesy of "Spectrum News"

New York health advocates cheer FDA's Juul move (Spectrum News)

The decision by the FDA comes after a years-long rise in vaping usage, especially among teenagers. In New York, tobacco usage has dropped significantly among ...

“Today’s decision is another step in protecting our nation’s youth from using e-cigarettes," said Parag Mehta, the president of the Medical Society of the State of New York. "It will play a significant role in preventing tobacco companies from using e-cigarette products to addict yet another generation of children to nicotine. In New York, tobacco usage has dropped significantly among kids under the age of 18 but has steadily increased when it comes to vaping. Assemblywoman Linda Rosenthal first introduced proposals meant to regulate the e-cigarette market in 2009.

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Media Bites 24 June: Juul, recession, Naked Wines (The Grocer)

US regulators have banned Juul Labs from selling its e-cigarette products in the country, while the papers also report of the looming threat of a recession ...

The odds of the UK economy falling into a recession shortened yesterday after data from companies, households and the government’s finances illustrated the impact that high inflation is having on businesses and consumers ( The Times £). But it argues, even with Juul’s problems, part-owner Altria’s stock still looks cheap. After a nearly two-year-long review of scientific and public health data submitted by the company, the US Food and Drug Administration said yesterday that the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health ( The Times £).

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Image courtesy of "The Pew Charitable Trusts"

Federal Regulators Ban Juul, Leapfrogging States' Efforts (The Pew Charitable Trusts)

The federal Food and Drug Administration on Thursday banned the popular Juul electronic cigarette, leapfrogging regulators from several states who ...

North Carolina was the first state to sue Juul. A year ago, North Carolina Attorney General Josh Stein, a Democrat, settled a lawsuit with the company that required Juul to pay $40 million and make changes in the way it handles marketing of its products in the state. The FDA said in a news release that it had issued marketing denial orders to Juul Labs Inc. for “all of their products currently marketed in the United States.”

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Juul asks court for temporary block on FDA's ban of its e-cigarettes (CNBC)

Juul asked a federal appeals court on Friday to block the Food and Drug Administration's ban on its e-cigarettes temporarily.

The request came less than a day after the health agency told the company that it had to pull its vaping products off the U.S. market, effective immediately. Juul claimed that the FDA subjected it to unfair treatment compared with other e-cigarette makers. Juul disagreed, saying in a statement that it provided sufficient research and evidence to address the issues raised by the agency.

FDA orders Juul to remove all its e-cigarettes from US market (The BMJ)

FDA commissioner Robert M Califf said, “Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine ...

Log in through your institution Log in using your username and password But it determined that the company’s premarket tobacco product applications …

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Juul is ordered by the FDA to pull all of its vaping products from the US market (KALW)

JUUL Labs is no longer allowed to sell or distribute its e-cigarette or vaping products in the U.S. The FDA said its review found Juul products potentially harmful. The company plans to fight back. Copyright 2022 NPR.

The company plans to fight back. JUUL Labs is no longer allowed to sell or distribute its e-cigarette or vaping products in the U.S. The FDA said its review found Juul products potentially harmful. Juul is ordered by the FDA to pull all of its vaping products from the U.S. market

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Image courtesy of "Bloomberg"

Juul Seeks Emergency Order Blocking FDA Ban From US Market (Bloomberg)

Juul Labs Inc. asked a federal court to grant an emergency order blocking a Food and Drug Administration decision to ban its e-cigarette products from the ...

Earlier this week, FDA officials refused to put the ban on hold themselves while Juul’s lawyers appealed it, according to court filings. Juul Labs Inc. asked a federal court to grant an emergency order blocking the Food and Drug Administration’s decision to ban its e-cigarette products from the U.S. market. The company asked the US Circuit Court of Appeals in Washington for a stay of the FDA order on Friday after filing an appeal the day before.

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Juul seeks to block FDA ban on its e-cigarettes in US (ABC News)

Juul has asked a federal court to block a government order to stop selling its electronic cigarettes.

The company said in its Friday court filing that it submitted a 125,000-page application to the FDA nearly two years ago. The next year, the FDA limited flavors in small vaping devices to just tobacco and menthol. While Juul remains a top seller, its share of the U.S. e-cigarette market has dipped to about half. To stay on the market, companies must show that their e-cigarettes benefit public health. Juul said that the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review. The FDA said Thursday that Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges.

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Image courtesy of "The Washington Post"

Understanding the Juul Ban and Concerns About Teen Vaping (The Washington Post)

The developers of the Juul e-cigarette say they created the device to help adult smokers quit. But their product achieved enormous success, becoming the ...

In 28 countries, the sale of all types of e-cigarettes is banned. Mitch Zeller, director of the FDA’s Center for Tobacco Products, has said that the burden is on companies applying for authorization to sell vaping products “to demonstrate that the benefit to adults is going to outweigh the harm to kids.” According to the FDA, Juul’s application lacked sufficient evidence to show that allowing its products to be sold in the US would be appropriate for the protection of public health. They include Brazil, India, Mexico, Qatar, Thailand and Uganda. In addition, Jamaica, Japan and Switzerland prohibit the sale of e-cigarettes that contain nicotine. Last year, the company struck a $40 million settlement with North Carolina over a suit claiming it aimed its products at the young. A report by the US National Academies of Sciences said there was substantial evidence that young vapers are more likely than nonvapers to try regular cigarettes. The company agreed to stop all marketing directed at young people as part of that deal. The FDA began regulating e-cigarettes as tobacco products in 2016, requiring companies to submit applications to continue selling existing or new products. (Michael R. Bloomberg, the majority owner of Bloomberg LP, the parent company of Bloomberg News, has funded efforts to ban flavored vaping products.) The developers of the Juul e-cigarette say they created the device to help adult smokers quit. More than 13% of middle- and high-school students said they vaped within the previous month, according to a national survey published in October. More than 80% of those students said they used flavored e-cigarettes. The Juul has a sleek design. The user inhales nicotine, an addictive alkaloid present in tobacco, and exhales aerosol.

FDA tells Juul to cease e-cig sales (Politico)

The Food and Drug Administration denied Juul's applications to sell its vape and menthol and tobacco-flavored pods.

“The FDA budget document has become unwieldy, running around 400 pages and providing a lot of information that is not directly relevant to the budget request itself.” The panel called on the agency to “radically revise” its document to follow the Department of Agriculture’s format. SENATE PANEL ADVANCES PBM BILL — On Wednesday. the Senate Commerce Committee approved a bill, S. 4293 (117), to forbid pharmacy benefit managers from setting “spread pricing” and arbitrarily clawing back payments made to pharmacies. Moderna plans to submit the data to regulators in hopes of supplying a bivalent booster beginning in August. But the CDC’s initial interval guidance dates back to February and has been discussed in the context of potentially shielding young people from the risk of myocarditis and pericarditis. Opioids: The committee signaled concern about a growing number of opioid overdose deaths among pregnant and postpartum people. However, another brand’s availability is unlikely to move the needle on vaccine uptake in those age groups. Up in puff: Juul is a massive player in the e-cigarette market. CDC Director Rochelle Walensky is expected to formalize the recommendation, which would make Moderna’s shot available for children of all ages. Senate Majority Whip Dick Durbin (D-Ill.) endorsed the FDA’s action, calling it a “historic step forward to protect the children across America from e-cigarette[s].” “We respectfully disagree with the FDA’s findings,” said Joe Murillo, the chief regulatory officer at Juul Labs, in a statement. FDA ORDERS ALL JUUL E-CIGS OFF THE MARKET — On Thursday, the Food and Drug Administration denied Juul’s applications to sell its vape and menthol and tobacco-flavored pods containing either 3 or 5 percent nicotine, Katherine reports. The FDA has no data showing that Juul’s products pose an immediate threat to users, but regulators felt those deficiencies prevented the products from being “appropriate for the protection of public health.

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Image courtesy of "Reuters"

Juul appeals to block FDA ban on its e-cigarettes (Reuters)

Juul Labs Inc on Friday asked a federal appeals court to temporarily block the Food and Drug Administration's order to take its e-cigarettes off the shelves ...

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