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Dr. Scott Gottlieb, commissioner of the US Food and Drug Administration, announced Tuesday a "blitz" on retailers?for violations related to sales of Juul and other e-cigarettes to minors.Forty warning letters were sent to brick-and-mortar retailers as a first step toward stopping underage use of e-cigarettes, the FDA said. The government agency also said it sent Juul Labs, the maker of an e-cigarette popular among teens, a request to submit documents related to product marketing and research, including information about "youth initiation and use.""We don't yet fully understand why these products are so popular among youth," Gottlieb wrote in the public statement. "But it's imperative that we figure it out, and fast. These documents may help us get there."Juul spokeswoman Victoria Davis said the company "agrees with the FDA that illegal sales of our product to minors are unacceptable. We already have in place programs to prevent and, if necessary, identify and act upon these violations at retail and online marketplaces, and we will announce additional measures in the coming days."Electronic cigarettes (also called e-cigarettes or e-cigs), vapes, vaporizers and hookah pens are among the terms used to describe electronic nicotine delivery systems. These products use an "e-liquid" that may contain nicotine as well as flavorings and other ingredients. The liquid is heated into an aerosol that the user inhales. Some products resemble conventional cigarettes, but others look like pens or other ordinary items. Juul resembles an everyday flash drive, which may explain its popularity among teens.The FDA has conducted 908,280 inspections of tobacco retailers, issued 70,350 warning letters and initiated about 17,000 civil money penalty cases in its efforts to fight the sale of e-cigarettes and other tobacco products to minors, it said Tuesday. For the current "blitz," the agency said, it also contacted one online retailer, which removed listings for Juul products and then voluntarily implemented policies to prevent future listings.More than 2 million middle and high school students described themselves as current users of e-cigarettes in 2016 (the most recent year studied), according to a government report: about 11% of high school students and 4.3% of middle school students. Overall, e-cigarette use by high school students increased 900% from 2011 to 2015, according to a separate 2016 report from the US surgeon general.In a recent Johns Hopkins Bloomberg School of Public Health survey, 81% of minors who currently vape said their primary reason for doing so is "availability of appealing flavors.""Widespread reports of youth use of JUUL products are of great public health concern," Gottlieb said in the announcement. "Youth may not understand the nicotine or other characteristics of JUUL."On March 20, the FDA issued a warning that it would act to end the use of e-cigarettes among minors.Juul Labs' website tells the story of two founders, smokers and product designers who had become "increasingly dissatisfied with the health and social impacts of cigarettes" but could find no viable alternative and so created their own -- with "adult smokers in mind.""We are working with the FDA, lawmakers, parents and community leaders to combat underage use, and we will continue working with all interested parties to keep our product away from youth," Davis said on behalf of the company. 3473

E-cigarette maker Juul Labs says they are planning to make a significant "reduction in force" as it looks to the future.The company announced the move in a statement as it also looks to pull out of some international markets as they "have not provided the kind of return necessary given the cost to continue investing in the market."According to the Wall Street Journal, the company is reportedly looking to lay off about 1,200 employees, nearly half its workforce. Earlier this year, the company laid off 1,000 employees, Forbes reported.Last year, at least four lawsuits were filed against the company claiming its ads were targeting young people.They also stopped selling several flavored products in the United States last year.The company also replaced its CEO last year.The company said they are looking to rebuild trust with its key stakeholders and the public."To better serve our mission, we must prioritize how we use our resources to execute on our long-term, focused approach," the company said in a statement. "This will allow Juul Labs to continue to invest in science and evidence capabilities, access control technologies, and future products in core markets that make up a vast majority of our business. While those investments will not provide short-term revenue, they will help us earn trust and build a company for the long term to advance the potential for harm reduction for adult smokers and combat underage usage." 1446

EL CAJON (CNS) - A 49-year-old man was seriously injured after being struck by a vehicle in El Cajon Saturday.The pedestrian was hit crossing the road by a Toyota pickup in the 400 block of Jamacha Road around 6:25 p.m. Paramedics found him unconscious but breathing with serious head and leg wounds, authorities said.El Cajon police say the driver remained at the scene and isn't believed to have been under the influence of drugs or alcohol.Sgt. Steve Paz of the El Cajon Police Department said Jamacha would be closed between Lexington and Sunnyland avenues until around 11:30 p.m., and reminded pedestrians and motorists to always be aware."Only cross the street at designated, controlled intersections, and wear bright or light-colored clothing for visibility," he said, addressing people out and about at night on foot. "For those driving vehicles during hours of darkness, please pay extra attention to the roadway and be aware of pedestrians that may be crossing." 980

Dr. Anthony Fauci delivered more good news regarding a potential coronavirus vaccine, indicating some Americans could begin getting vaccinated by the end of this month.During an interview with CNN’s Wolf Blitzer, Fauci, the director of the National Institute of Allergy and Infectious Diseases National Institute of Allergy and Infectious Diseases, said it’s possible a vaccine could begin reaching some Americans by the end of the month, but was confident some would begin getting vaccinated by the end of the year.Fauci’s declaration came on the same day Pfizer said that its Phase 3 vaccine candidate was showing an effectiveness of over 90%. Fauci said the announcement was promising, but a few more questions need to be addressed before it is given approval. Fauci said that things like the vaccine’s durability and effect on the elderly are among concerns that still need to be tackled.“We may have doses that we’re able to give to people by the end of November, beginning of December,” Fauci told CNN’s Blitzer. “Now you have to go through the hoops of making sure all of the I’s are dotted and the T’s are crossed about the safety and regulatory aspects of it, but we would be giving vaccine, very likely, by the end of this year. That is good news.”Last month, the FDA put into place guidelines on approving a vaccine, which was more restrictive than what the White House had hoped for. 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.“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,” Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said.While it is possible some will begin getting vaccinated in the coming weeks or months, questions remain on how soon a majority of the country will have the opportunity to become vaccinated. The first Americans slated to become vaccinated will be health care workers and people with a high risk of coronavirus complications, such as the elderly and those living in assisted living facilities, according to an NPR report.Given that Pfizer’s vaccine candidate is showing a high level of effectiveness, Fauci called the development “extraordinary.”"We know there's light at the end of the tunnel, but that doesn't mean that we're going to give up the important public health measures that we continually still have to do every single day,” Fauci said.While there is urgency for both public health and economic reasons for a vaccine, some experts have expressed concern over the speed of a vaccine and whether the expedited timeline is long enough to demonstrate efficacy.Even though a vaccine could be ready by year’s end, trials will be expected to continue for over a year to monitor for possible side effects.According to the FDA, a typical Phase 3 trial would take one to three years.“NIH is committed to supporting several Phase 3 vaccine trials to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic,” said NIH Director Francis S. Collins, M.D., Ph.D. “We also know that preventing this disease could require multiple vaccines and we’re investing in those that we believe have the greatest potential for success.”Pfizer said based on current projections, it expects to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. 3823

Dropping soon… cookies inspired by Chromatica and @LadyGaga ?? ?? ?? pic.twitter.com/DaHbPxWRyf— OREO Cookie (@Oreo) December 2, 2020 141