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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 sound of gunshots quickly set off a panic at the Gilroy Garlic Festival in California late Sunday afternoon."It almost sounded like the amps were popping, like something had blew. but then it kept going," Emma Petersen said.Petersen was working one of the booths. She says her first instinct was to run with everyone else as fast as she could."I brought my eyes up and I just saw a cloud of people running at us," she said.The Garlic Festival has become Gilroy's most popular event. It's been around for 40 years, and the locals use it to raise money for charities, schools and nonprofit organizations. However, Sunday's attack has left the community in the "Garlic Capital of the World" feeling shattered."Here we have three families of people who have been murdered that are going to be devastated for eternity," Alex Larson said.Larson owns the Original Garlic Shoppe located in the heart of town. His community is in mourning but showing support to one another. "Currently all the high schools have grief counseling for the children even though they're not in school," he said."Gilroy is an amazing, tightly-knit community," Brian Bowe, the executive producer of the Garlic Festival said in a press conference Sunday night. "We are family. We have had the wonderful opportunity in this community to celebrate our family through our Garlic Festival, and for over four decades that festival has been our annual family reunion.""I feel that we'll be able to pull through from it, but it's still shocking in the moment," Petersen said. "There's gonna be a lot of hugging, a lot of kissing a lot of crying and that needs to happen first before everybody's gonna be able to get back online," Larson said. 1719

There's a new first responder on the lookout for anyone who may be experiencing mental health issues.“Most people probably see their pharmacists more than their primary care physicians or certified therapists, so pharmacists are in a really good position to be able to notice these early warning signs or risk factors,” said Chad Cadwell, a Walgreens pharmacist. Walgreens pharmacists just finished the first phase of mental health first aid training. The program was developed by the National Council for Behavioral Health.They're taught to look for risk factors and red flags in patients, everything from anxiety and depression to addiction.Pharmacists can connect those people with the right resources, support groups, or may just lend an empathetic ear.“Really listening to their needs, spending those extra couple of minutes, instead of trying to get the work out, but also spending that time talking and listening to your patients, right now with everything that is going on with the pandemic, everything is so busy,” said Cadwell. This training initiative was actually put into place pre-pandemic.Mental Health America has already seen significant increases in the number of daily screenings for depression and anxiety since the beginning of the year. 1270

The release of the James Bond film “No Time To Die” has been pushed back several months because of concerns about coronavirus and its impact on the global theatrical marketplace. MGM, Universal and producers Michael G. Wilson and Barbara Broccoli say Wednesday that the film would be pushed back from its April release to November 2020.“No Time To Die” will now hit theaters in the U.K. on Nov. 12 and worldwide on Nov. 25. Publicity plans for the film in China, Japan and South Korea had previously been canceled because of the outbreak. "No Time To Die" is the final film in the current series of Bond movies, which star Daniel Craig.The film will be released in the U.K. on November 12, 2020 with worldwide release dates to follow, including the US launch on November 25, 2020.— James Bond (@007) 812

There’s a unique museum in Estes Park, Colorado that's considered to be the key to thousands of memories. The Baldpate Inn is not only a museum but also serves as a bed and breakfast. The 102-year-old inn is ran by Lois Smith.“Only two families have owned the inn,” Smith says. “The two brothers who built it did 102 years ago. People recognize the creaky floors if they stayed at their grandmother’s house. The stairs are crooked. You don’t want to drop marbles anywhere, because everything is a little warped.”It’s a place full of stories. Even the name itself is a story. “It was named after a mystery novel,” Smith says. “The Seven Keys of Baldpate. The story is about seven people that go to the lodge, and they think they have the only key.”However, it’s the keys that are key to what gives this place its story. “Probably the most significant thing that people hear about is our really fun key collection,” Smith says. “Approximately 30,000 keys that have all been individually donated by people.”Smith says the keys have been given to the inn from all over the world. “We had a gentleman bring me a key that he had stolen when he was 7-years-old,” Smith says. “He brought it back to us 50 years later in a frame, and now, we have the original key to Room 7. That’s probably one of my favorite keys, but every key is special.” Smith says the museum started this tradition because of the novel written, and wants everyone to leave a memory. The inn is still accepting keys from anyone staying at the inn. 1523

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