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The FDA is offering formal guidance on the amount of inorganic arsenic allowed in infant rice cereal.Exposure to inorganic arsenic has been associated with neurodevelopmental effects, according to the Food and Drug Administration, including lung and bladder cancer risk. Arsenic occurs naturally in the soil, and rice has been shown to absorb a small amount during the growing process.The new guidance identifies a level of at or below 100 micrograms per kilogram and is based on draft guidance from 2016. The guidance is recommended, but not legally enforceable.“It is important to note that the agency’s data show that most products on the market are already below this level and that parents and caregivers should know that a well-balanced diet also includes a variety of grains like oats and barley,” said a statement from Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition.According to the FDA, results from testing in 2018 showed 76 percent of samples were at or below the 100 ppb level, compared to 47 percent of samples tested in 2014 and 36 percent of samples tested between 2011-2013.The FDA attributes the drop in inorganic arsenic presence to changes manufacturers are making in sourcing rice and testing their ingredients. 1279
The Environmental Protection Agency announced on Monday that some Lysol products could kill COVID-19 on surfaces in just two minutes.In a press release, the agency said that Lysol Disinfectant Spray and Lysol Disinfectant Max Cover Mist could effectively kill the coronavirus.“EPA is committed to identifying new tools and providing accurate and up-to-date information to help the American public protect themselves and their families from the novel coronavirus,” said EPA Administrator Andrew Wheeler in the release. “EPA's review of products tested against this virus marks an important milestone in President Trump’s all of the government approach to fighting the spread of COVID-19."The agency said the Lysol products were the first products that had been reviewed by its laboratory testing data and approved label claims. 834

The Federal Aviation Administration has issued a safety alert about flying with dry ice onboard, in anticipation of the huge nationwide distribution project anticipated to start in the next few days once the Pfizer COVID-19 vaccine is approved for use.The Pfizer and Moderna vaccines both need to be kept at extremely cold temperatures, requiring the use of dry ice during transit.Dry ice is frozen carbon dioxide that is pressed into blocks or pellets. It doesn’t melt into a liquid, it moves directly from a solid to a gas and that process can happen quickly at high altitudes.That can cause problems onboard a plane, such as causing the plane to weigh less at times during the flight and change its center of gravity.“CO2 sensors installed or carried in the aircraft or worn by the pilots and other crewmembers will assist the operator and crew in recognizing hazardous concentrations of CO2 and implementing effective risk controls,” the FAA’s safety alert recommends.In addition, they encourage maximum ventilation onboard while on the ground and in the air, asking crewmembers to check air conditioning units and auxiliary power units before flight.Exposure to elevated levels of CO2 can cause drowsiness or dizziness, and higher levels can impact breathing eventually leading to hypoxia and death.The FAA also recommends that “pilot training on specific conditions and procedures can improve pilot decision-making in the event of a CO2 detector alert or other system abnormalities.”Friday morning, Health and Human Services Director Alex Azar said Americans could begin getting the COVID-19 vaccine next week once the FDA and CDC give it emergency use approval. 1676
The brother of the accused Parkland shooter has been involuntarily committed to a mental facility, sources tell Scripps station WPTV in West Palm Beach, Florida.Nikolas Cruz’s brother was involuntarily committed to a mental institution, under Florida's Baker Act.The Palm Beach County Sheriff’s Office detained Cruz Friday afternoon, according to sources. The Broward Sheriff’s Office placed the Baker Act on Cruz. Under Florida's Baker Act, an adult can be held for an involuntary exam for up to 72 hours under the law. Anyone 17 or younger can be help for up to 12 hours.This is a developing story. More information will be posted once available. 692
The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has endorsed Pfizer’s coronavirus vaccine, in a major step toward an epic vaccination campaign that could finally conquer the outbreak. The group, in a 17-4 vote with one abstention, concluded that the shot appears safe and effective against the coronavirus in people 16 and older.The Food and Drug Administration is expected to follow the recommendation issued Thursday by its expert advisers. A final FDA decision is expected within days. The vaccine had already been authorization by officials in Canada and the UK.An emergency use authorization allows practitioners to administer a vaccine despite it not gaining full FDA approval. The EUA means that the vaccine is allowed to be used in non-clinical settings, which would allow Americans not in a trial or hospital setting to get the vaccine.Millions of shots would then ship to begin vaccinating health care workers and nursing home residents, but the Centers for Disease Control and Prevention will need to formally recommend the vaccine before health care officials can begin distributing the shots.Once it is authorized, it is expected that several million doses of the vaccine will immediately begin being distributed throughout the US to high-risk individuals. The first group of those expected to be inoculated includes health care workers and those who live or work in assisted living facilities.“The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA has been preparing for the review of EUAs for COVID-19 vaccines for several months and stands ready to do so as soon as a EUA request is submitted. While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible.”Pfizer says that the vaccine is showing a 95% efficacy against coronavirus infection. It is one of two vaccines that could be approved by the FDA in the next few weeks. Moderna also has a vaccine candidate that is showing the efficacy of 95%.“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”One concern over the Pfizer vaccine is possible side effects on those prone to allergic reactions. The UK’s National Health Service is advising those prone to allergic reactions to not take the Pfizer vaccine as it investigates two health care workers having apparent reactions after receiving the vaccine.Once given authorization, officials will be forced to confront two challenges: Public confidence in the vaccine and distribution. Both the Moderna and Pfizer vaccines are required to be refrigerated until use, complicating distribution methods.Also, polls are showing that a significant number of Americans are hesitant to take the vaccine. Public health experts say getting the vast majority of Americans immunized is important in order to reach herd immunity against the virus and to allow for normalcy to return to the US.In addition to a number of public health experts saying they’ll get the vaccine as a way to instill trust, former Presidents Bill Clinton, George W. Bush, and Barack Obama said they would publicly take the vaccine in order to instill faith in the shot.Widespread access to the general public is not expected until the spring. 4342
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