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The US Food and Drug Administration on Monday warned leading e-cigarette maker Juul Labs about illegally marketing its product as a safer alternative to cigarettes.The FDA ordered Juul to respond within 15 days with corrective actions and its plan to comply with federal law. It noted that failure to comply could result in fines, seizures or injunction."Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth," Acting FDA Commissioner Dr. Ned Sharpless said in a statement.The FDA sent a separate letter to Juul "expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL's outreach and marking practices, including those targeted at students, tribes, health insurers and employers."The agency requested documents related to marketing, including scientific evidence and data such as consumer perception studies "related to whether these statements and representations explicitly or implicitly convey that JUUL products pose less risk, are less harmful, present reduced exposure, are safer than other tobacco products or that the products are smoking cessation products.In November, the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since a year earlier. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States."We believe you have a continuing responsibility to take action to address the epidemic of youth use of your products, some of which appears to have been a direct result of your product design and marketing campaigns, whether or not some of these practices have been discontinued," the FDA's letter to Juul said.Juul has maintained that its products are intended to convert adult smokers to what it described in the past as a less-harmful alternative. In other communications, the company says it cannot make claims its products are safer, in line with FDA regulations."We are reviewing the letters and will fully cooperate," according to a Juul Labs spokesperson.Calls for action against JuulLast week, Rep. Raja Krishnamoorthi, chairman of the House Oversight Subcommittee on Economic and Consumer Policy, asked the FDA in a letter to take "appropriate enforcement action" against Juul. He said the agency should "protect the American public from the fraudulent and unapproved medical claims" made by the company.Krishnamoorthi's letter followed a two-day hearing in July, after which the committee concluded that "JUUL appears to be violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes."At the subcommittee hearing in July, several people testified that the company was directly marketing to children in high school, to the Cheyenne River Sioux Tribe and to smoking cessation groups.On Friday, the US Centers for Disease Control and Prevention announced that the agency is now aware of at least 450 possible cases of severe lung disease that could be caused by vaping across 33 states. There have been at least five deaths across five states -- one each in Illinois, Oregon, Minnesota, Indiana and California -- linked to the illnesses.After news of additional deaths spread on Friday, US Senate Democratic Whip Dick Durbin called on FDA's Sharpless to act on regulating e-cigarettes and flavors in the next 10 days. Durbin said he would call for Sharpless' resignation if he did not take action."As Acting Commissioner of the FDA, you alone have the power to stop this vaping epidemic, which has now reached the point where children and young adults are getting sick and dying," Durbin said in a statement. "If you continue to refuse to do your job -- which is to protect the public health -- then it is time to allow someone else to take the helm." 4254
The statistics around maternal mortality in the United States are startling. America has the highest maternal mortality rate out of any developed country in the world. Today, a woman in the U.S. is 50 percent more likely to die from giving birth to a child than her mother was, and if you are a woman of color you are 3 to 4 times more likely than that.At Rush University Hospital in Chicago, neonatal intensive care nurse and educator Christie Lawrence has dealt with maternal mortality both professionally and personally. “My cousin, Chante, she was a young healthy mother, 18 years old,” Lawrence says. “Actually, she had no risk factors that we knew of.” Ten years ago, Lawrence was at work when her cousin went into labor at another hospital. “I received a call to say, ‘Chante is in labor, we are going to have a baby today.’ Then, a couple of hours later, a turn of events,” she recalls. “Her mom is screaming, ‘I need you to get here quick! Something has gone terribly wrong.’” The healthy 18-year-old mom suddenly went into cardiac arrest while giving birth to her son, and she died. “It was very shocking, very shocking for my family to see that whole turn of events,” said Lawrence. “We were expecting everything to be normal.”Her cousin’s death was caused by medication that was administered to her the wrong way. When Chante went in labor, she was a first-time mom and had no access to transportation to the hospital, so an ambulance was called. The ambulance took her to a hospital that was different than the one she had been going to for care during her pregnancy. Lawrence believes that may have played into the quality of care her cousin received, and ultimately, the mistake that was made at the hospital. It all led to the death of Lawrence’s cousin, which she says was fully preventable. Unfortunately, Chante’s case isn’t unique. These kinds of mistakes are happening at an alarming rate across the country. According to a Center for Disease Control report published this year, 60 percent of all pregnancy-related deaths in this country are fully preventable. Hospitals and healthcare providers around the country are working to implement new procedures to reduce the maternal mortality rate. At Rush University, for example, it’s trying a new program that checks up on babies and new moms just three weeks after leaving the hospital. Typically, in the past, doctors recommended a three-week check-up that focused on the newborn. But with this new program called Rush Family Connect, a nurse will go to the parent’s home and give equal attention to mom. The hope is that any post-pregnancy complication can be caught early, since the top causes of maternal mortality are actually post-delivery complications. Additionally, this year, the Joint Commission has issued a new mandate and standard. By July 1, 2020, all hospitals must have life-saving medications immediately available and must plan rapid release of blood supplies for transfusions. Doctors and nurses at hospital maternity units must have training drills responding to a hemorrhage crisis, which is one of the top cases for fatal deliveries. While hospitals and healthcare providers work to reduce the dangers mothers are facing, Lawrence believes mother have some power over their outcomes. “Just being a great advocate for yourself is one of the biggest things that I would tell any new mom,” said Lawrence. “If you feel like something is not right, if you feel like something is wrong, make people listen to you. And if you feel like that person won’t listen to you, then you have to go up the chain of command in that system or you have to find someone who is willing to listen.”It’s advice Lawrence wishes she could go back in time and tell her cousin. 3754
The UAW-GM contract has been ratified and the strike has officially ended on day 40.United Autoworkers members have ratified a new four-year contract that covers employees at 55 UAW-represented sites across the U.S. Union and management inside the GM world headquarters in Detroit are watching the numbers and the union is reporting out two votes – production and skilled trades. "We delivered a contract that recognizes our employees for the important contributions they make to the overall success of the company, with a strong wage and benefit package and additional investment and job growth in our U.S. operations," said Mary Barra, GM Chairman and CEO. "GM is proud to provide good-paying jobs to tens of thousands of employees in America and to grow our substantial investment in the U.S. As one team, we can move forward and stay focused on our priorities of safety and building high-quality cars, trucks and crossovers for our customers."Big assembly plants in other states have been influencing the vote, with most leaning toward "yes."Workers at the Orion Assembly plant were among the last to have informational meetings and vote Thursday. 1164
Tucson will not become Arizona's first sanctuary city after voters rejected Prop 205 Tuesday night.The ballot measure was soundly rejected by 71.4 percent of voters in Tucson, according to unofficial election results released by the city, with all precincts reporting. Some remaining ballots will be counted in the coming days.The group Tucson Families Free and Together spearheaded the ballot initiative earlier this year, collecting thousands of signatures in the city. Despite several attempts to block the measure from appearing on Tuesday's ballot, their efforts were ultimately successful.The measure was widely opposed by local leaders including the Pima County Sheriff, Tucson Police officials and Tucson's largely Democratic city council and mayor.This article was written by Sam Radwany for KGUN. 818
The White House was briefly placed on lockdown Tuesday morning after an aircraft entered restricted airspace in the Washington area.The event caused senior national security officials across the agencies to convene to coordinate and monitor the situation, according to a US defense official, and aircraft have been deployed to monitor the situation, US Northern Command tweeted."Senior officials across the interagency are monitoring the situation on a national event conference call. NORAD aircraft are on site and responding," Lt. Col. Chris Mitchell, a Pentagon spokesman, told CNN.The White House lockdown has been lifted.Two US Capitol Police sources said the situation is being classified as an "aircon," which is an as yet unidentified incoming aircraft.The US Capitol Police have also given an all clear to the Capitol Hill complex, according to two US Capitol Police sources. 896