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The FDA wants to remind parents that infants under 1 year old can't have honey after four infants in Texas were hospitalized with botulism. Each of the infants had been given a pacifier containing honey, according to the Texas Department of State Health Services. Symptoms of infant botulism include difficulty breathing, constipation, poor feeding, general weakness, drooping eyelids and loss of head control. It can lead to death if left untreated. Botulism is a serious illness caused by a toxin that attacks the body’s nerves and can cause difficulty breathing, paralysis and even death. Honey may contain bacteria that produces the toxin in the intestine of babies that eat it.By the time children get to be 12 months old, they’ve developed enough other types of bacteria in their digestive tract to prevent the botulism bacteria from growing and producing the toxin. 910
The first full slate of preseason games kicked off Thursday night, bringing NFL players back into the field for more football and more protests.Several players took a knee, raised fists or did not take to the field while the National Anthem was played before a dozen preseason games began across the country.The Miami Herald reported that Dolphins wide receiver Kenny Stills, along with wide receiver Albert Wilson, knelt during the anthem before a home game against Tampa Bay.WTVJ Miami reported that Dolphins defensive end Robert Quinn raised his fist during the song. 578
The founder of Tower Records died Sunday while drinking whiskey and watching the Oscars, the Sacramento Bee reported.Russ Solomon ran the music store chain until it went bankrupt in 2006.At its height, Tower Records operated in 20 countries. The Tokyo branch was once the world’s largest music store.Solomon’s son believes his father died of a heart attack, according to the Sacramento Bee.Solomon was 92 years old.RELATED: Oscars get lowest ratings in show's historyThe Associated Press contributed to this report. 528
The Environmental Protection Agency blocked reporters from several news outlets from a national summit on Tuesday where Scott Pruitt, the agency's chief, was speaking.Journalists from CNN, the Associated Press and the trade publication E&E were barred by the EPA from entering the event, which was focused on harmful chemicals in water. A handful of other reporters from other news organizations, however, were allowed inside the event after having been previously invited by the agency.In a statement, Jahan Wilcox, an EPA spokesman, said the agency barred reporters from attending due to space limitations inside the venue. He said the EPA was able to accommodate only 10 reporters and that it provided a livestream "for those we could not accommodate.""This was simply an issue of the room reaching capacity, which reporters were aware of prior to the event," Wilcox said.A report published by The Hill, however, said a handful of seats in the press section remained vacant by the time Pruitt began speaking. A photo obtained by CNN also showed space for cameras.Additionally, the Associated Press said in a story that one of its reporters, denied entry, was grabbed by security guards and forcibly shoved out of the building after asking to speak to an EPA public affairs person. A CNN photographer saw the Associated Press journalist being shoved out of the building by a uniformed guard, and the Associated Press journalist recounted the incident to CNN immediately after it took place.When reached by phone and asked about the Associated Press report, Wilcox declined to comment to CNN beyond his original statement, which said he was "unaware of the individual situation that has been reported."CNN was also blocked from attending the summit. A CNN photographer was screened by security guards before the event and was waiting for an escort or further information. Wilcox arrived soon after and provided security with a list of news outlets and reporters, instructing them not to let anyone not on the list into the event. The CNN photographer then asked if he could enter the event and was told by security he couldn't.Separately, a CNN reporter and producer lined up with members of the public and presented their IDs and credentials, identifying themselves as reporters. The individual manning the door said he needed to ask the press office if they could be permitted to enter. A few minutes later, he returned and said the CNN journalists were not allowed in.In a statement, a CNN spokesperson said, "Today, CNN was turned away from covering the PFAS National Leadership Summit at the EPA after multiple attempts to attend. While several news organizations were permitted, the EPA selectively excluded CNN and other media outlets. We understand the importance of an open and free press and we hope the EPA does, too."Sally Buzbee, executive editor of The Associated Press, said in a separate statement, "The Environmental Protection Agency's selective barring of news organizations, including the AP, from covering today's meeting is alarming and a direct threat to the public's right to know about what is happening inside their government."Buzbee added, "It is particularly distressing that any journalist trying to cover an event in the public interest would be forcibly removed."The-CNN-Wire 3320
The Food and Drug Administration released updated safety standards Tuesday for makers of COVID-19 vaccines despite efforts by the White House to block them, clearing the way for requirements that are widely expected to prevent the introduction of a vaccine before Election Day.In the new guidelines posted on its website, the FDA said vaccine makers should follow trial participants for at least two months to rule out any major side effects before seeking emergency approval. That standard had been a sticking point between the FDA and White House officials, who said it could unreasonably delay the availability of COVID-19 vaccines.President Donald Trump has repeatedly insisted a vaccine could be authorized before Nov. 3, even though top government scientists working on the effort have said that timeline is very unlikely. On Monday Trump said vaccines are coming “momentarily,” in a video recorded after he returned to the White House.Former FDA officials have warned that public perception that a vaccine was being rushed out for political reasons could derail efforts to vaccinate millions of Americans.A senior administration official confirmed Monday that the White House had blocked FDA’s plans to formally publish the safety guidelines based on the two-month data requirement, arguing there was “no clinical or medical reason” for it.But on Tuesday, the FDA posted the guidance on its website, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”The requirements are aimed at companies seeking rapid approval through the FDA’s emergency authorization pathway. That accelerated process, reserved for health emergencies, allows medical products onto the market based on a lower bar than traditional FDA approval. But FDA has made clear only vaccines that are shown to be safe and effective will be authorized for coronavirus.Former FDA acting commissioner Dr. Stephen Ostroff said the requirements seem reasonable given the agency is in largely “uncharted territory” in terms of considering emergency use of a vaccine. The agency has only previously cleared one vaccine through the method — a decades-old shot that was authorized to prevent anthrax poisoning in 2005.“There really is no margin for error here,” Ostroff said. “Even when you’re talking about limited use of a vaccine there has to be some level of assurance that there isn’t a risk here that would far outweigh the benefit.”Dr. Peter Marks, the head of FDA’s vaccine division, said Tuesday that the two-month follow-up requirement was chosen to be “something reasonably aggressive, but not too conservative — right in the middle.” He spoke at a symposium organized by Johns Hopkins University.Initial doses of vaccines for emergency use would likely be reserved for medical workers and people with health conditions that make them particularly vulnerable to coronavirus. Full FDA approval for the general population will require significantly more data and is not expected until mid-2021.The White House attempt to block the guidance followed a string of instances in which the Trump administration has undercut its own medical experts working to combat the pandemic. FDA’s Hahn has been attempting to shore up public confidence in the vaccine review process for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective.Pfizer CEO Albert Bourla has stoked excitement by saying that he expects data on whether the company’s candidate works to be ready in late October. But a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.Vaccine development typically takes years, but the U.S. government has invested billions in efforts to accelerate the process and help multiple drugmakers prepare multiple candidates. All the doses will be purchased by the federal government for use vaccinating the U.S. population.Beyond exposing the rift between the White House and FDA, the delay in releasing the guidelines may have had limited practical effect.FDA scientists have been discussing the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.Former FDA Commissioner Scott Gottlieb said Tuesday that drugmakers depend on the FDA’s science-based endorsement to vouch for the safety and effectiveness of their products.“I can’t imagine a circumstance where a sponsor would challenge or seek to undermine the FDA’s role here,” Gottlieb said at the COVID-19 symposium. “This is precisely the moment when we need an objective, neutral arbiter.”Last week, Gottlieb and six other former FDA commissioners blasted the Trump administration for “undermining the credibility” of the agency in a op-ed calling for the release of the then-stalled vaccine guidelines.“Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests,” the officials wrote.___AP Medical Writer Lauran Neergaard contributed to this report.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 5644