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The US Food and Drug Administration pressed forward with its investigation of e-cigarette companies Friday, sending letters to 21 companies in an effort to uncover whether they are marketing products illegally and outside the agency's compliance policy.This latest phase of the investigation addresses more than 40 e-cigarette products and is part of the agency's ongoing efforts to combat e-cigarette use among youth. It also comes less than two weeks after the agency conducted a surprise inspection of e-cigarette maker Juul's corporate headquarters in San Francisco, seizing thousand of documents, many of which relate to its sales and marketing practices."Companies are on notice," FDA Commissioner Dr. Scott Gottlieb said in a statement Friday. "The FDA will not allow the proliferation of e-cigarettes or other tobacco products potentially being marketed illegally and outside of the agency's compliance policy, and we will take swift action when companies are skirting the law."In September, Gottlieb called the increasing teen use of e-cigarettes "an epidemic," adding that teen nicotine use is dangerous to young people's health and brains.Federal law prohibits the sale of e-cigarettes to people under the age of 18, but more than 2 million middle and high school students were current users of e-cigarettes in 2017, according to the FDA. The US Centers for Disease Control and Prevention says it's the most common nicotine product used by middle and high schoolers.Also last month, the FDA requested that five major e-cigarette manufacturers, including Juul, explain how they plan to combat the use of their products by minors. The agency said it was looking into steps to eliminate the sale of flavored products and unveiled a public education campaignabout e-cigarettes.The FDA said it's considering civil and criminal avenues to enforce these regulations, including fines, seizures and injunctions, according to Friday's announcement.CNN reached out to some of the companies that received letters for comment but did not immediately receive a response."We're going to address issues related to the access kids have to e-cigarettes, as well as the youth appeal of these products," Gottlieb said Friday. "We know flavors are one of the principal drivers of the youth appeal of e-cigarettes and we're looking carefully at this."No reasonable person wants to see these products reaching epidemic use among kids," he said. 2500
The XFL will return in 2022, according to Dwayne “The Rock” Johnson, who now owns the league.Officials with the league had to shut down their inaugural 2020 season because of the coronavirus pandemic earlier this year and filed for bankruptcy in April. Johnson and his investor group bought the league in August for million, reportedly.“As owners, we’re proud to champion our XFL players, coaches, cities and fans into an electrifying 2022 season!” Johnson wrote on Twitter Thursday morning. “A league of culture, passion & purpose.” 549
The US Food and Drug Administration approved two cancer treatments, Vitrakvi and Xospata, this week after expedited reviews.Vitrakvi, approved Monday, is "a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker)."The FDA said in a statement that it is the second approved cancer treatment that is based on a tumor biomarker instead of the place in the body where the tumor originated.Vitrakvi will be used for the treatment of solid tumors that have an NTRK (neurotrophic receptor tyrosine kinase) gene fusion that do not have a known resistance mutation, that are not metastatic or where surgical removal is likely to lead to severe morbidity, and that have no alternative treatments or have progressed after treatments.NTRK genes are rare but occur in many types of cancer, the FDA said, such as mammary analogue secretory carcinoma and infantile fibrosarcoma.Xospata tablets, approved Wednesday, are for the "treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation," according to the FDA.Alongside the tablets, the agency also approved a diagnostic to detect the mutation."Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in the statement.AML is a rapidly progressing cancer that affects the numbers of normal blood cells and calls for continuous transfusions, the FDA said.Both treatments were granted Priority Review designation.Priority Review, established in 1992, means the FDA aims to review the drug or treatment within six months, opposed to 10 months for a standard review."A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications," the FDA says.Both treatments also received?orphan drug?designation, a status granted to drugs for rare diseases or conditions. 2261
The Trump administration supports reopening schools this fall, in addition to sending 125 million reusable masks to school districts they released new guidance this week for districts to reopen safely.The Schools Should Reopen Safely policy is based on three assumed facts by the administration: that prolonged school closures cause harm, children are at low risk for serious illness from Covid-19, and that educating children is a top national priority.President Trump attended a discussion Wednesday about getting children back to school where the policy was discussed with administration leaders, medical experts and educators. Some of the speakers referenced how the coronavirus pandemic has provided an experiment for virtual learning.“But the virtual learning is not like being in a classroom, and we’ve learned that, I think, very strongly — in almost all cases. People thought for a long time that would be the answer but it’s — that’s not the answer. The answer is an old-fashioned one,” President Trump said.The recommendations encourage the use of masks and social distancing, as well as educating students, teachers and staff about Covid-19 symptoms. They follow guidance released earlier this year from the Centers for Disease Control and Prevention.The document lists eight recommendations for schools:Ensure all students, teachers, and staff understand the symptoms of COVID-19 and its risk factors.Require all students, teachers, and staff to self-assess their health every morning before coming to school; if they are symptomatic they should consult their physician.Encourage frequent handwashing or hand sanitizing during the school day, beginning upon entrance to the school, by ensuring that handwashing facilities are widely available throughout the school.Minimize large indoor group gatherings; hold large gatherings outdoors whenever possible.Maintain high standards of hygiene and ventilation within all classrooms, including keeping windows and doors open and running fans and AC units whenever possible.Require students, teachers, and staff to socially distance around high-risk individuals.Encourage the use of masks when social distancing is not possible.Liberally post instructions regarding hygiene and social distancing around the school.There are also recommendations for high-risk teachers and students, including giving these individuals options to stay home.“Provide high-risk students, or students who have high-risk family members, the choice to stay home and engage in distance learning,” the guidance states.The policy is a set of recommendations and not mandatory for schools to reopen. States and districts are able to make their own decisions. 2694
The Supreme Court has ruled that LGBTQ employees are protected under federal employment discrimination laws in a landmark decision.The court ruled 6-3 in favor of granting protection from discrimination to LGBT workers, with conservatives Chief Justice John Roberts and Justice Neil Gorsuch siding with the majority.According to the ruling, Title VII of the Civil Rights Act of 1964 that prohibits discriminating against workers on the basis of sex also applies to gay, lesbian, transgender people.“An employer who fires an individual for being homosexual or transgender fires that person for traits or actions it would not have questioned in members of a different sex,” Justice Neil Gorsuch wrote in the opinion. “Sex plays a necessary and undisguisable role in the decision, exactly what Title VII forbids.”Justice Samuel Alito wrote the dissenting argument.The case Bostock vs. Clayton County, Georgia entered around a Georgia man, Gerald Bostock, who claimed he was fired for "unbecoming" conduct from his job with Clayton, County, Georgia, after he began participating in a gay softball league.The decision also ruled in favor of Aimee Stephens in the case R.G. & G.R. Harris Funeral Homes Inc. v. Equal Employment Opportunity Commission. Stephens, a trans woman, was fired from her job at a Michigan funeral home when she expressed her desire to live full time as a woman. 1391