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The FDA continued on Monday to warn the public about using methanol-based hand sanitizers that the agency calls “dangerous.”The FDA has published a “Do Not Use” list of products. As of Monday afternoon, 87 products are on the do not use list. Adding to the confusion for consumers, many of the products do not have methanol on the label.Methanol can be toxic when absorbed through the skin as well as life-threatening when ingested, the FDA said. Retailers are being encouraged to recall these products.Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death, the FDA warns."Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA's list of dangerous hand sanitizer products," said FDA Commissioner Stephen M. Hahn, M.D. "We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers."The FDA’s warnings come following a hand sanitizer shortage in the consumer and commercial markets. Amid the shortage companies that do not ordinarily produce hand sanitizers began bottling products before obtaining FDA approval. 1771
The Food and Drug Administration resisted pressure from the Trump administration on Tuesday by releasing a set of guidelines that could push an emergency use authorization of a coronavirus vaccine past Election Day.The FDA’s new guidance notes that an Oct. 22 meeting of its Vaccines and Related Biological Products Advisory Committee will not be to discuss specific vaccine candidates. The FDA noted that a vaccine candidate must be at least 50% effective. Vaccine candidates should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s risk-benefit."Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said. The FDA's new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision.“In addition to outlining our expectations for vaccine sponsors, we also hope the agency's guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved."Trump previously said he would consider overruling the FDA on its vaccine guidelines in hopes of speeding up the process. There is both health and economic pressure for a vaccine to be developed as the coronavirus continues to claim an average of 800 US lives a day, according to Johns Hopkins University data. The number of deaths per day related to the coronavirus is expected to increase as the weather gets colder, according to the University of Washington’s Institute for Health Metrics and Evaluation.On Tuesday, House Speaker Nancy Pelosi blasted the Trump administration for involving itself in the vaccine approval process.“Trust in the vaccine is key to the acceptance of the American people, which is essential to crushing the virus.“The White House’s decision to reject FDA medical experts’ minimum safety and efficacy standards for emergency use authorization of a vaccine is an extremely dangerous act. We are all praying for a safe and effective vaccine as soon as possible, but the damage of the Trump Administration rushing a vaccine before it is known to be safe and effective could be catastrophic."Dr. Anthony Fauci told CNN's Chris Cuomo on Monday that he expects a vaccine candidate to be given an emergency use authorization by the end of 2020. "By the time we get to November, December, maybe earlier, I don't think it's going to be earlier, but it's still possible," Fauci said. "It will be early, but I think comfortably around November or December we'll know whether or not the vaccine is safe and effective. I actually am cautiously optimistic from what I've seen about preliminary data in phase one, that there's a very good chance we'll have a safe and effective vaccine." 3256
The fury of the lava from the Kilauea volcano swallowed a car whole.A time lapse video from Brandon Clement shows a Ford Mustang being consumed on the Big Island.The video from the lava and ash flow across the road, eventually overtaking the car on the side of the road. 278
The death toll in a series of wildfires in California, Oregon and Washington rose to 36 as officials warn that an already-historic fire season is "far from over."As of Tuesday morning, wildfires have killed 25 people in California, 10 people in Oregon and one person in Washington dating back to mid-August.Fifteen people alone have died in California's North Complex Fire, which is currently burning in the Sierra Nevada mountains north of Sacramento. According to Cal Fire, the fire which has been burning for nearly a month, is currently 39% contained.In Oregon, the Beachie Creek fire and the Alameda Fire have each killed four people in recent days. The Beachie Creek fire, currently burning in the northern part of the state since Aug. 16, is 15% contained. The Alameda Fire is 100% contained, according to the Oregon wildfire dashboard.Though 2020 has already marked a record-setting year for wildfires in the western U.S., officials are bracing for more damage in the coming weeks. Wildfire season typically lasts through the end of October on the West Coast."We've had major destruction and, even sadly, two dozen fatalities already and we still have several months to go in our fire season here. Unfortunately, this record-setting year is far from over," Cal Fire spokesperson Daniel Berlant told Fox News on Monday night.The wildfires garnered the focus of both President Donald Trump and his political rival, Democratic presidential nominee Joe Biden on Monday. After receiving a briefing from officials in California, Trump placed the blame for the fires on "forest management," and seemed to downplay the effect of climate change during a conversation with California Gov. Gavin Newsome. In a speech from Delaware, Biden promised to address climate change should be elected president, and slammed Trump for ignoring the facts on the changing climate. 1872
The Environmental Protection Agency has handed documents to Congress that show new travel expenses from agency administrator Scott Pruitt, totaling some ,000 in hotel stays and air travel, The Washington Post reported Tuesday.The documents, which were requested by House Oversight Committee Chairman Trey Gowdy and obtained by the Post, reportedly show that Pruitt traveled on government business dozens of time on first-class and domestic flights from August 2017 through February 2018.The reported expenses include a four-day, ,631 trip to Morocco in December, a series of first-class flights following Hurriciane Harvey totaling ,330, and a two-day domestic trip for media interviews and a visit to Florida that amounted to ,767. Pruitt's travel expenses listed in the records reportedly do not include the costs of his security team or aides who travel with him.The EPA justified the travel spending as necessary to ensure Pruitt's security."EPA's Protective Service Detail identified specific ongoing threats associated with Administrator Pruitt's travel and shifted his class based on certain security protocols that require him to be near the front of the plane," said Jahan Wilcox, a spokesperson for the agency.Previously, CNN reported that from June through August 2017, the EPA justified several expensive charter flights for Pruitt -- including a ,000 bill for a business trip around his home state.In late August, the EPA inspector general announced it would investigate Pruitt's travel practices. Since beginning the probe, the IG has twice expanded its scope, which now encompasses all of Pruitt's 2017 taxpayer-funded travel.According to an earlier Post analysis of other EPA records, Pruitt's travel choices distinguish him from his predecessors in that he brings a larger group of aides with him on trips, he usually flies first or business class on international and domestic trips, and he often flies Delta Airlines even though the government has contracts with certain airlines on specific routes.In response to the travel probes, earlier this month Pruitt said he'll be seeking alternative accommodations -- including potentially flying in coach class -- on his "very next flight."Other Trump administration Cabinet secretaries have attracted scrutiny of their travel spending, including Interior Secretary Ryan Zinke, Veterans Affairs Secretary David Shulkin, Treasury Secretary Steve Mnuchin and former Health and Human Services Secretary Tom Price, who resigned after using private planes for multiple government business trips.Pruitt has also been under scrutiny for the costs the agency has accrued changing EPA headquarters, including a ,000 secure phone booth for Pruitt's calls.Other Cabinet members' spending for office renovations has been criticized recently. Zinke's office doors were to be replaced to the the tune of nearly 9,000. The department later said it would obtain the doors at a reduced price. And last month, Housing and Urban Development Secretary Ben Carson withdrew his request for a ,000 dining room set for his office. He told Congress this week that the redecorating decision was left to his wife. 3185