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Health

Juul Settles Multistate Youth Vaping Inquiry for $438.5 Million

Juul Labs, which is struggling to survive in the United States, on Tuesday tentatively agreed to pay $438.5 million to settle an investigation by nearly three dozen states into marketing and sales practices they allege they started the teenage e-cigarette crisis.

The company said it did not acknowledge any wrongdoing in the settlement but was trying to “resolve past issues” while awaiting a decision from the Food and Drug Administration on whether it can continue to sell its products. Juul has attempted to reposition itself as a seller of vaping products that could help adults quit smoking traditional cigarettes to restore its tarnished reputation and improve its diminished market value.

The preliminary agreement prohibits the company from marketing to youth, funding education in schools and misrepresenting the nicotine content of its products. But Juul had already halted several marketing practices and withdrawn many of its flavored pods, which appealed to teenagers, several years ago, under public pressure from lawmakers, parents, and health experts when the vaping crisis was at its height.

“We believe this will go a long way in stemming the influx of vaping among youth,” Connecticut Attorney General William Tong said at a news conference Tuesday. “We are under no illusions and cannot claim that it will discourage the youth from vaping. It remains an epidemic. It’s still a big problem. But we essentially took away a large chunk of the former leader.”

The cross-country investigation found the company was targeting young people by hiring young models, using social media to woo teenagers and giving out free samples, he said. And, he added, the research found that the company had a “weak” age verification system for its products and that 45 percent of its Twitter followers were between the ages of 13 and 17.

Virginia Attorney General Jason Miyares pointed out in a statement that the company’s previous strategy of selling flavors like mango and crème brûlée appealed to the youth, as did its device’s sleek design, which was easy to conceal. A condition of the settlement prohibited the company from depicting anyone under the age of 35 in its marketing images, Mr Miyares’ statement said.

Juul said Tuesday that the settlement agreement was “aligned with our current business practices, which we began implementing following our company-wide reset in the fall of 2019.”

“We remain focused on the future as we work to fulfill our mission to move adult smokers away from cigarettes – the leading cause of preventable deaths – while tackling underage smoking,” the company’s statement said.

The agreement does not resolve all of the Company’s litigation. While Juul previously reached settlements in lawsuits filed by attorneys general in North Carolina, Washington, Louisiana and Arizona, nine similar cases remain. Major lawsuits filed by New York and California, among others, remain pending. And about 3,600 lawsuits from individuals, school districts and local governments were consolidated in a lawsuit that is still moving through a California court.

Juul is still selling tobacco- and menthol-flavored capsules and vaping products while its application for permanent sale is under FDA review. The agency originally denied the company’s application in June, saying Juul failed to provide sufficient evidence that its products would benefit public health, citing “inadequate and conflicting” data from the company.

Juul received a temporary pardon in court. It has since argued that it has helped two million adult smokers quit traditional cigarettes and has taken issue with the agency’s conclusions on chemicals in its products. The FDA then relented its rejection and announced that it would conduct an additional review of “scientific issues” in the application.

States differ in how they use settlement funds, which must be paid over six to 10 years. A spokeswoman for the Connecticut Attorney General said her share (more than $16 million) would go towards vaping and nicotine cessation and addiction treatment. Texas estimated it would receive nearly $43 million, and Virginia put its share at $16.6 million.

Meredith Berkman, co-founder of Parents Against Vaping E-Cigarettes, said she was pleased to learn of the settlement. She became involved with the group after Juul sent a representative to her son’s ninth-grade high school to speak at a gathering in 2018. Her son passed on that the rep had called the product “perfectly safe,” a conversation Ms. Berkman told a congressional hearing in 2019.

Since then, she said, the group has heard from hundreds of families who claim their teens have become addicted to vaping Juul and other nicotine and marijuana devices. Some young people became seriously ill from vaping and others had to go to drug rehabilitation to get rid of nicotine addiction.

“It was Juul who showed up and opened this horrible Pandora’s box,” Ms. Berkman said. “No amount of money can undo the damage caused by Juul’s targeting and marketing to teenagers, whose use of the company’s stealth-by-design flavored products caused many children to experience severe nicotine addiction and physical harm.”

E-cigarette use among teens appears to have declined in recent years, although the coronavirus pandemic had brought new momentum to the leading monitor of teenage tobacco use, a survey conducted in schools by the Centers for Disease Control and Prevention. In March, that survey showed that nearly 8 percent, or about two million college students, said they had used e-cigarettes in the past 30 days.

While Juul was once the youth favorite, the survey showed that the candy and fruit flavored Puff Bar vapes were the most popular among youth, with Juul ranking fourth among college students. Data from IRI, a market research firm, suggests the brand was attracting more adult customers by closely competing for market leadership with another brand, Vuse Vapes, with about 30 percent of recent sales.

Altria, which bought a 35% stake in Juul for $12.8 billion in December 2018, said in a recent filing with investors that the company’s stake is now worth about $450 million — almost the same amount that Juul had just agreed to settle investigations from nearly three dozen states and Puerto Rico.

After Juul received a thorough scrutiny of its seal of approval among youngsters, it lost significant market share and value when it gave in to public pressure and stopped selling the flavors that appealed most to youngsters.

Although the vaping market still accounts for a small percentage of overall cigarette and other inhalation product sales, the FDA has repeatedly fallen short in its efforts to curb youth-friendly e-cigarettes, which continue to emerge in new candy colors and flavors. After the agency tried to crack down on existing brands, companies and the market turned to synthetic nicotine to evade regulation.

In March, Congress gave the FDA authority to take synthetic nicotine off the market. But the agency is methodical, reviewing about a million applications it received this spring from manufacturers of non-tobacco nicotine products. She has to exercise a degree of caution in order for her judgments to stand up in court.

The agency also continues to review and approve some marketing authorization applications that were submitted years ago for leading vapes, typically sold in gas stations and convenience stores. However, she recently said she does not expect to complete the review of the applications already submitted before next year.

Involved in the settlement: Alabama, Arkansas, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Maryland, Maine, Mississippi, Montana, Nevada, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin and Wyoming.

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Health

C.D.C. Advisers to Focus on Uncommon Coronary heart Issues in Vaccinated Youth

Advisors to the Centers for Disease Control and Prevention will meet on Wednesday to address reports of rare heart problems in young people immunized with Pfizer-BioNTech and Moderna’s coronavirus vaccines.

The reports pertain to conditions called myocarditis, inflammation of the heart muscle; and pericarditis, inflammation of the membrane surrounding the heart. Most of the cases were mild, with symptoms such as fatigue, chest pain, and irregular heartbeat that go away quickly. The agency is tracking nearly 800 reports, although not all of them have definitely been linked to the vaccines.

The CDC advisors meeting comes as the Biden administration publicly recognizes it expects to miss its goal of partially immunizing 70 percent of Americans by July 4th.

Experts have said that the benefits of vaccination far outweigh the risk of potential problems, but they are expected to revisit this debate, especially for adolescents and young adults.

More than half of heart problems were reported in Americans ages 12 to 24, while that age group accounted for only 9 percent of the millions of doses given. The numbers are higher than one would expect for this age.

As of May 31, 216 people had developed myocarditis or pericarditis after a dose of either vaccine and 573 after the second dose. While most of the cases were mild, 15 patients remained in hospitals at this point. The second dose of Pfizer BioNTech vaccine was associated with approximately twice as many cases as the second dose of Moderna’s vaccine.

“We look forward to more clarity about the potential risk of myocarditis after mRNA vaccines in order to increase vaccination confidence and rates,” said Dr. Yvonne Maldonado, Chair of the Committee on Infectious Diseases at the American Academy of Pediatrics.

Recommendations from CDC advisors after Wednesday’s meeting may also influence decisions about immunizing children under 12 if vaccines are available for that age group. Some experts have questioned whether the benefits to children outweigh the potential risks given the low likelihood of serious illness in young children.

The CDC strongly recommends Covid-19 vaccines for Americans 12 and older. The agency reported this month that Covid-19-related hospitalizations among teenagers in the United States were about three times higher than influenza-related hospitalizations for the past three flu seasons.

By June 10, according to the American Academy of Pediatrics, nearly 17,000 children in 24 states had been hospitalized for Covid-19 and 330 children had died.

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Health

U.S. sees rising Covid instances related to youth sports activities, CDC director says

Youth hockey has had more positive coronavirus cases across the country than most sports.

Adam Glanzman | The Washington Post | Getty Images

There are increasing reports of Covid-19 cases related to youth sports in the US, said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention on Friday.

The connection between youth sports and increased coronavirus cases is that the highly infectious B.1.1.7 variant identified for the first time in Great Britain has become the most common Covid strain in the USA

There are growing numbers of Covid cases related to variant B.1.1.7 in Michigan and Minnesota, Walensky said. “Both states have concerns about transmission in youth sports, both club and sport.” connected in schools. “

“What is happening in Michigan and Minnesota is similar to what we are seeing across the country: increasing reports of cases related to youth sports,” Walensky said at a White House press conference on Covid-19 Friday.

There were 291 outbreaks in Michigan between January and March that came from youth sports teams that involved at least 1,091 people, health officials said at a separate news conference on Friday. Governor Gretchen Whitmer urged schools and clubs to pause personal exercises and games for two weeks to control the outbreak. She also urged schools to stop personal learning during this time.

In Minnesota, the B.1.1.7 strain quickly spread throughout Carver County, with at least 68 cases of coronavirus linked to participants in school and club sports activities such as hockey, wrestling, basketball, alpine skiing, and other sports, the state reported Health Department March.

A Covid outbreak at a wrestling tournament in Florida in December resulted in at least 38 coronavirus cases, according to a CDC study.

Walensky emphasized that Covid-19 cases related to youth sports are not necessarily related to an increased risk of transmission in classrooms.

“As cases increase in the community, we expect the cases seen in schools to increase too. This is not necessarily indicative of school-based transmission,” Walensky said.

“We haven’t seen any evidence of significant transmission of Covid-19 within schools once schools have fully implemented the CDC’s harm control guidelines,” she said.

The CDC director also highlighted an increase in Covid-19 cases and emergency rooms in younger adults, most of whom have not yet been vaccinated.

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Entertainment

Rapper’s Arrest Awakens Rage in Spanish Youth Chafing in Pandemic

BARCELONA – It had all the hallmarks of a free speech showdown: Pablo Hasél, a controversial Spanish rapper, barricaded himself on a university campus to avoid a nine-month sentence for glorifying terrorism and denigrating the monarchy. While students surrounded him, the police dressed in riot gear; Mr. Hasél raised his fist defiantly when he was taken away.

But Oriol Pi, a 21-year-old in Barcelona, ​​saw a little more as he watched last week’s events on Twitter. He thought of the job he had as an event manager before the pandemic and how he was fired after the bans. He thought of the curfew and mask mandates, which he thought were unnecessary for young people. He thought of how his parents’ generation had never seen anything like it.

And he thought it was time for Spain’s youth to take to the streets.

“My mother thinks it’s about Pablo Hasél, but it’s not just that,” said Mr Pi, who joined the protests that broke out in Barcelona last week. “Everything just exploded. It’s a collection of so many things to understand. “

For nine nights, the streets of this coastal city, long quiet from pandemic curfews, erupted in sometimes violent demonstrations that have spread to Madrid and other Spanish hubs. What began as a protest against Mr Hasél’s prosecution has become a collective outcry from a generation that not only sees a lost future for itself, but also a gift that has been robbed, years and experiences it has even in a pandemic never get back is gone

Young people’s frustration with the pandemic is not just limited to Spain. Across Europe, university life has been severely restricted or turned upside down by the limitations of virtual teaching.

Social isolation is as endemic as contagion itself. Anxiety and depression have reached alarming rates in young people almost everywhere, according to mental health experts and studies. Police, and especially young demonstrators, have clashed in other parts of Europe as well, including last month in Amsterdam.

“It’s not the same now for a person who is 60 years old – or a 50 year old with life experience and everything that is fully organized – as it is for a person who is now 18 years old and feels like every hour is against to lose this pandemic It’s like losing your whole life, ”said Enric Juliana, opinion columnist at La Vanguardia, Barcelona’s leading newspaper.

Barcelona was once a city of beach music festivals and night bars, so there were few better places in Europe to be young. But the crisis that devastated tourism and the economy contracted 11 percent last year was a disaster for young adults in Spain.

It is an example of déjà vu for those who also lived through the 2008 financial crisis that took one of the highest tolls in Spain. Young people continued to have to return to their parents’ homes, with entry-level jobs being among the first to disappear.

But unlike previous economic downturns, the pandemic has worsened much further. It came at a time when the unemployment rate for people under the age of 25 in Spain was already high at 30 percent. Now 40 percent of Spanish youth are unemployed, the highest rate in Europe according to European Union statistics.

For someone like Mr Pi, the arrest of rapper Mr Hasél and his defiance against the machine has become a symbol of the frustration of young people in Spain.

“I loved that the man was walking with his fist in the air,” said Mr Pi, who said he had never heard of the rapper before Spain brought charges against him. “It’s about fighting for your freedom and he did it until the last minute.”

The case of Mr Hasél, whose real name is Pablo Rivadulla Duró, also sparked a debate about freedom of expression and Spain’s efforts to restrict it.

The authorities have charged Mr. Hasél under a law that provides prison sentences for certain types of fire statements. Known as both a provocateur and a rapper, Mr Hasél had accused the Spanish police of brutality, compared judges to Nazis and even celebrated ETA, a Basque separatist group that two years ago after decades of bloody terrorist campaigns that went around 850, collapsed people was dead.

In 2018, a Spanish court sentenced him to two years in prison, which was later reduced to nine months. The prosecution focused on his Twitter posts and a song he wrote about the former King Juan Carlos, whom Mr. Hasél referred to as a “mafioso”. (The former king abdicated in 2014 and completely decamped Spain for the United Arab Emirates last summer in a corruption scandal.)

“What he said in court is that they put him in jail for telling the truth because what he says about the king, apart from all the insults, is exactly what happened,” said Fèlix Colomer, a 27 year old documentary filmmaker who met Mr. Hasél while investigating a project about his trial.

Mr Colomer, who led protesters in Barcelona on certain nights, noted that others were being prosecuted in Spain for social media comments, which he believes is a worrying sign of Spanish democracy. A Spanish rapper named Valtònyc fled to Belgium in 2018 after being sentenced to prison for his lyrics found by a court glorified terrorism and insulted the monarchy – charges similar to those of Mr Hasél.

However, some believe that Mr Hasél has crossed a line in his texts. José Ignacio Torreblanca, professor of political science at the National Distance Learning University in Madrid, said while he was concerned about the application of the law, Mr Hasél was not the right figure to build a youth movement.

“He’s not a Joan Baez, he justifies and actively promotes violence. That is clear in his songs. He says things like, “I wish a bomb went off under your car,” said Mr Torreblanca, referring to a song by Mr Hasél that called for the killing of a Basque government official and another who said there was a mayor in Catalonia it deserves a bullet. “

Amid public pressure that was mounting even before the protests, the Justice Department said Monday it plans to amend the country’s criminal code to reduce penalties related to the types of language violations for which Mr Hasél has been convicted.

For Nahuel Pérez, a 23-year-old who works in Barcelona and cares for the mentally handicapped, freedom for Mr. Hasél is just the beginning of his worries.

Since arriving in Barcelona five years ago from his hometown on the holiday island of Ibiza, Mr Pérez said he has not found a job with a salary high enough to cover living costs. To save money on rent, he recently moved into an apartment with four other roommates. Because of the proximity, social distancing was impossible.

“The youth of this country are in a pretty deplorable state,” he said.

After Mr Hasél was arrested at the university, Mr Pi, who had seen the news on Twitter, saw people announcing protests on the Telegram messaging app. He told his mother that he wanted to go to the demonstrations, but she didn’t seem to understand exactly why.

“I’m not going to look for you at the police station,” she said to him, said Mr. Pi.

He thought about what it must have been like for his mother his age.

There was no pandemic. Spain was booming. She was a teacher and in her 20s married another professional, Mr. Pi’s father. The two found a house and started a family.

In contrast, Mr. Pi is an adult who still lives with his mother.

“Our parents got all the good fruit and here is what we have in front of us: There is no more fruit in the tree because they made the best of it,” said Mr. Pi Best of Spain – none of that is left for us. “

When he’s not attending the protests, Mr. Pi spends his days as an indoor monitor at a nearby school that runs a mix of online and socially distant face-to-face classes.

It’s not the career he wanted – not a career at all, he says – but it pays the bills and lets him speak to students to get their views on the situation in Spain.

He doesn’t crush words about what’s ahead of them.

“These are the people I will be ten years from now,” he said. “I think you’re hearing something that no one has told you before. I would have listened if someone had come up to me at 12 and said, ‘Listen, you’re going to have to fight for your future. ‘“

Roser Toll Pifarré reported from Barcelona and Raphael Minder from Madrid.