FDA agrees to take down Ivermectin posts in legal settlement with doctors
The Food and Drug Administration has reportedly agreed to remove and stop reposting several social media messages suggesting that Ivermectin — a drug used by some doctors to treat COVID-19 — is intended for animals and not humans. The move settles a lawsuit by three doctors who accused the FDA of hurting their medical practices.
The lawsuit targeted both the FDA, the U.S. Department of Health and Human Services and both agencies’ secretaries. The case was initially dismissed in June of 2022, as a judge cited the FDA’s “sovereign immunity.”
However, the U.S. Court of Appeals for the Fifth Circuit overturned the ruling on Thursday, March 21. The court said that the FDA’s role is not to provide personalized medical advice.
Ivermectin is approved for both animal and human use, and it’s used to treat some parasitic infections. However, the FDA does not recommend the drug for COVID-19 treatment, saying that there is a danger in excessive doses.
Meanwhile, Ivermectin advocates celebrated the court’s decision, and independent presidential candidate Robert F. Kennedy Jr. claimed the FDA’s stance against Ivermectin amounted to bias against “low-cost therapies.”
The FDA declined to comment on Kennedy’s claims, but said again that clinical trial data does not support Ivermectin’s use to treat COVID-19.
The FDA told Newsweek that it decided to settle the lawsuit “rather than continuing to litigate over statements that are between two and nearly four years old.”
1 dead, 22 injured in Super Bowl parade shooting: The Morning Rundown, Feb. 15, 2024
One person is dead and more than 20 are wounded after shots are fired at a parade for the Super Bowl champions. And the lander looking to be the first U.S. spacecraft to touch down on the moon in five decades lifts off into space. These stories and more highlight The Morning Rundown for Thursday, Feb. 15, 2024.
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1 dead, 22 injured in shooting at Chiefs’ Super Bowl parade
At least one person was killed and 22 others were injured, including at least eight children, after shots were fired following following the Kansas City Chiefs’ Super Bowl victory parade on Wednesday, Feb. 14, sending fans running for cover outside Union Station. Video shows police holding down an apparent suspect.
Police confirmed three people have been detained but have not announced their identities or said if they will face charges. Authorities are looking into reports that bystanders tackled one of the three people being detained.
Kansas City Police Chief Stacey Graves told reporters she was angry over what had taken place.
“The people who came to this celebration should expect a safe environment,” Graves said. “We had over 800 law enforcement officers, Kansas City, and other agencies at the location to keep everyone safe. Because of bad actors, which were very few, this tragedy occurred.”
Hundreds of thousands of people gathered for the parade in downtown Kansas City to cheer on the Chiefs after their victory at Super Bowl LVIII. Police said all members of the Chiefs’ organization were safe. The NFL and several players issued statements following the shooting, including Chiefs quarterback Patrick Mahomes, who posted on X, “Praying for Kansas City.”
Warning of ‘serious national security threat’ prompts alerts on Russia
More details are coming to light after a cryptic message by Congressman Mike Turner, R-Ohio, who warned of a “serious national security threat.” Turner, the Republican Chair of the House Intelligence Committee, called on President Biden to declassify all information related to the threat but did not elaborate further.
Multiple news outlets, citing sources, said Turner was referring to Russia, specifically its attempts at developing a nuclear-capable weapon in space that could take down satellites. The sources added that it is not currently an active threat. Connecticut Congressman Jim Hines, D-Conn., the top Democrat on the House Intelligence Committee, told reporters that while the issue is serious, people should not panic.
Leaders in the Senate Intelligence Committee issued a statement saying they have the intelligence in question and have been tracking the issue. White House National Security Adviser Jake Sullivan said he had already scheduled a briefing for Thursday, Feb. 15, with congressional leaders and administration intelligence professionals to discuss the matter.
Houston-based Intuitive Machines hopes its lander, Odysseus, will be the first U.S. spacecraft to touch down on the moon in over five decades. NASA is paying the company $118 million to carry six items, including a camera to observe the dust upon landing and a radio receiver system to study charged particles on the moon’s surface.
Other items taken on the trip include insulation material from Columbia Sportswear and a sculpture from artist Jeff Koons. Odysseus is scheduled to land on the moon’s south pole on Feb. 22.
FDA approves first drug to treat severe frostbite
The U.S. Food and Drug Administration has approved the first drug to treat severe frostbite in adults and reduce the risk of finger or toe amputation. The drug, Aurlumyn, injects affected areas and treats frostbite by opening blood vessels and preventing clots. It is expected to be available in the spring of 2024.
Frostbite happens when the skin and tissue get damaged by cold temperatures and occurs in stages, with painkillers and antibiotics typically used to treat mild frostbite. Severe frostbite, which happens when the skin and underlying tissue freeze, stopping blood flow, sometimes requires amputations.
Lyft admits to typo in earnings report
One company just found out how important it is to check for typos. The rideshare company Lyft saw its stock soar over 60% following the release of its quarterly earnings report late Tuesday, Feb. 13. The report said Lyft was expecting one of its profit margins to expand by 500 basis points, meaning five percentage points. Still, in reality, it was only expected to expand by 50 basis points or 0.5%.
The company admitted to the error during a call with investors on Wednesday, Feb. 14. Its CEO told CNBC he hopes the missed extra zero doesn’t take away from Lyft delivering its best financial quarter in its history. And despite the error and correction, the company’s stock was still up on Wednesday, Feb. 14.
University of Pennsylvania to be first Ivy League offering AI program
The rise of artificial intelligence is bringing change to almost every aspect of our lives, which means companies are looking for engineers with AI skills. Now, students at one Ivy League university can earn a degree in AI, and it’s not a fake.
The University of Pennsylvania will become the first Ivy League school to offer an engineering degree in AI when the undergrad program starts in the fall of 2024. Penn said the program will allow students to unlock AI’s potential as they learn the ethics of AI, legal matters surrounding the technology, and other topics. Penn will be the first Ivy League to have an artificial intelligence program, but other U.S. colleges, including Carnegie Mellon and Purdue, also offer bachelor’s degrees in AI.
Dozens of Jeffrey Epstein court documents unsealed, naming high-profile figures: The Morning Rundown, Jan. 4, 2024
Dozens of court documents related to Jeffrey Epstein are unsealed to the public. And the Justice Department is suing Texas over its new immigration law. These stories and more highlight The Morning Rundown for Thursday, Jan. 4, 2024.
Previously sealed Jeffrey Epstein court documents released
Hundreds of pages of previously sealed court documents related to Jeffrey Epstein, the millionaire who was charged with sex trafficking, were released to the public for the first time Wednesday evening, Jan. 3.
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The 40 documents, of around 250 that are expected to be unsealed in days ahead, largely mentioned high-profile figures that have already been known, names of Epstein’s friends and victims who have spoken publicly. The documents are being unsealed as part of a lawsuit filed by alleged victim Virginia Giuffre against Epstein’s former girlfriend, Ghislaine Maxwell. Maxwell was convicted in 2021 for helping recruit underage victims for Epstein. She is serving a 20-year prison sentence.
The released documents include previously reported deposition transcripts by one of the girls hired by Maxwell, which mentioned former Presidents Bill Clinton and Donald Trump, neither of whom is accused of wrongdoing. A Clinton spokesperson responded to the release of the documents, referring to a 2019 statement that said the former president had flown on Epstein’s private plane but had no knowledge of his “terrible crimes.”
Trump did not immediately respond but had previously said he had not been in touch with Epstein for 15 years before his death. Epstein died by suicide in 2019 while awaiting trial. Other names in the document include Prince Andrew. Giuffre settled a lawsuit against him in 2022.
The judge, who decided what should be unsealed, said she ordered the release of the records because much of the information is already public. When all documents are unsealed, they are expected to include nearly 200 names, including accusers, well-known businesspeople, and politicians.
Imam dies after being shot outside New Jersey mosque
Police in New Jersey continue to search for the shooter who killed an Imam outside of a mosque while as they also look to determine a motive. The fatal shooting occurred around 6 a.m. Wednesday, Jan. 3, in Newark. Police said the Imam, Hassan Sharif, was shot multiple times. Sharif was taken to the hospital in critical condition but died hours later. Authorities said preliminary evidence indicated the shooting was not motivated by bias or was an act of domestic terrorism.
New Jersey Attorney General Matthew Platkin said the motive is still being investigated. Platkin said security at houses of worship in the state has been ramped up amid growing reports of threats and violence against Muslims and Jews in America since the start of the war between Israel and Hamas in October.
Justice Department sues Texas over immigration law
Last month, Texas Gov. Greg Abbott, R, signed a bill into law that allows local police to arrest migrants who cross the border illegally. Now, the Justice Department is taking Texas to court over it.
I like my chances.
Texas Gov. Gregg Abbott, R
The law has already been met with a lot of opposition; some critics said it could lead to racial profiling, and some sheriffs said it would overwhelm local jails and courts. The DOJ asked a federal court in Austin, Texas, to rule that the new law is unconstitutional as it violates the Supremacy Clause, which establishes that federal laws take precedence over state laws.
“Texas cannot run its own immigration system. Its efforts, through SB 4, intrude on the federal government’s exclusive authority to regulate the entry and removal of noncitizens, frustrate the United States’ immigration operations and proceedings, and interfere with U.S. foreign relations,” the lawsuit said.
Meanwhile, Abbott contends that the law is necessary as he called President Biden out for inaction as migrants continue to flood the southern border at record numbers. Abbot said that Texas has been left to fend for itself. In a post on “X” referring to the lawsuit, Abbot said, “I like my chances.”
Trump challenges Colorado’s decision to bar him from 2024 ballot
By considering the question of President Trump’s eligibility and barring him from the ballot, the Colorado Supreme Court arrogated Congress’ authority.
Trump’s legal team
Trump is now asking the U.S. Supreme Court to weigh in on Colorado’s Supreme Court ruling taking him off the ballot. Colorado’s landmark Dec. 19 ruling is the first time a presidential candidate has been disqualified under the 14th Amendment insurrection clause. Trump’s team contends that individual states do not have the authority to determine eligibility of presidential candidates, arguing that authority is reserved for the United States Congress.
“By considering the question of President Trump’s eligibility and barring him from the ballot, the Colorado Supreme Court arrogated Congress’ authority,” Trump’s team wrote.
The challenge to the U.S. Supreme Court follows a similar challenge to Colorado’s ruling by the state’s GOP. Colorado has paused the decision until the Supreme Court makes its ruling; the Colorado presidential primary is slated for March 5.
FDA investigating reports of Ozempic side effects of hair loss, suicidal thoughts
The Food and Drug Administration has announced that it is looking into three possible side effects that could be linked to a group of medications that have soared in popularity as weight loss aides. These drugs include:
Ozempic
Moujaro
Wegovy
The FDA said it is evaluating reports of side effects such as hair loss, aspiration, and suicidal thoughts in people taking these medications. These drugs have been approved to treat diabetes or weight loss. The FDA said while investigating these reported side effects, the agency has not concluded the drugs have these risks. Novo Nordisk, the company behind Ozempic and Wegovy, said it stands behind the safety of its medicines when they are used as indicated.
U-Haul report: Most Americans who moved in 2023 headed to Texas
Most Americans who decided to pick things up, rent a moving truck, and move to a different state in 2023 headed for Texas. That’s according to U-Haul, as the moving equipment company on Wednesday, Jan. 3, released its annual growth index report, which tracks the net gain of one-way equipment U-Haul trucks arriving in a state in a calendar year.
It was the third consecutive year Texas netted the largest number of movers. Florida ranked second, followed by North Carolina, South Carolina, and Tennessee. California saw the most one-way U-Haul trucks leaving the state. U-Haul said that while its growth index is based on more than 2.5 million moving transactions each year and indicates how well states attract new residents, it does not correlate directly to population or economic growth.
House Republicans propose $14.3 billion in aid to Israel, cut IRS funding: The Morning Rundown, Oct. 31, 2023
House Republicans unveil their plans to send aid to Israel with a bill cutting funding for the IRS. And have you purchased your Halloween candy yet? You might have some sticker shock when you do. These stories and more highlight The Morning Rundown for Tuesday, Oct. 31, 2023.
House GOP unveils $14.3 billion Israel aid bill; cuts IRS funding
Biden’s Inflation Reduction Act, which focused on climate change, health care costs and, taxes, allotted $80 billion in funding for the IRS, for the agency to hire thousands of agents, improve taxpayer services and target wealthy tax evaders.
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In an interview with Fox News on Monday, Oct. 30, Johnson defended the GOP’s bill, saying he knows it will be unpopular with Democrats in the Senate and plans to speak with Senate Majority Leader Chuck Schumer, D-N.Y.
“I understand their priority is to bulk up the IRS. But I think if you put this to the American people and they weigh the two needs, I think they’re going to say standing with Israel and protecting the innocent over there is in our national interest and is a more immediate need than IRS agents,” Johnson said.
Johnson has said he would want aid for Israel and Ukraine to be handled separately.
The House Rules Committee is expected to consider the Republican’s Israel funding bill on Wednesday, Nov. 1. If it passes the House, it would most likely be rejected by the Democratic-controlled Senate and White House.
In a statement, White House Press Secretary Karine Jean-Pierre called the bill a “non-starter.”
Netanyahu rejects calls for ceasefire; Israel frees hostage
Israel’s Prime Minister, Benjamin Netanyahu, said he is rejecting calls for a ceasefire in its ongoing war with Hamas. At a news conference in Tel Aviv on Monday, Oct. 30, Netanyahu said, “Israel will fight until this battle is won…The future of our civilization is at stake.”
Earlier in the day, the Israeli army said during a ground raid in Gaza, it had freed one of the more than 230 hostages taken by Hamas in the deadly terror attacks more than three weeks ago.
Officials said the Israeli soldier was found to be in good condition, and she was reunited with her family. Netanyahu said the soldier’s release a turning point in the war and called for the immediate release of all hostages.
Bankman-Fried is accused of defrauding FTX customers and investors of billions of dollars. In one instance, the prosecution brought up statements he made on social media, promising that customers’ assets would be safe.
Bankman-Fried responded multiple times throughout the questioning with a one-word answer of “yep” or “no.”
He has pleaded not guilty to all fraud and conspiracy charges. If convicted, Bankman-Fried could face decades in prison. The judge in the case has told jurors the trial might wrap up this week.
FDA warns certain over-the-counter eye drops may be contaminated
The Food and Drug Administration is warning consumers to stop using certain over-the-counter eye drops that could cause eye infections. The warning covers 27 eye drop products and includes some marketed under store brands like CVS Health, Rite Aid, Target’s Up and Up and Walmart’s Equate, in addition to drops from Rugby and Velocity Pharma brands.
The FDA advised manufacturers to recall the products on Oct. 25 after investigators found “unsanitary conditions” and harmful bacteria in the facility that manufactures the eye drops.
Cost of Halloween candy rises amid drought conditions
Tonight, Tuesday, Oct. 31, trick-or-treaters will be heading to house after house for some candy and chocolate, free of charge. But those same treats are costing shoppers much more at the grocery store this year.
According to the latest data from the Bureau of Labor Statistics, candy prices are up 7.5% compared to last year. Cocoa prices are trading at a 44-year-high, and global sugar prices are at 12-year highs.
Mexico saw its sugar production fall more than 15% this year due to drought.
Shoppers are expected to spend $3.6 billion on Halloween candy this year, up 16% from last year, per the National Retail Federation. Our business correspondent Simone del Rosario has more spooky stats in her latest Five For Friday.
How old is too old to go trick-or-treating?
If you live in Jacksonville, Illinois, it’s unlawful to trick or treat if you are 13 or older. The law is the same if you’re in Rayne, Louisiana. Until a few years ago, there was a law in Chesapeake, Virginia, from the 1970s threatening jail time for teens who went trick or treating.
The law was never enforced and eventually tossed in 2019, though an amendment did pass saying trick-or-treaters should be 14 years old or younger. Anyone older could be fined up to $250 — but no jail time.
According to a recent NBC News survey, 46% of parents believe children are never too old for trick or treating. The next highest number, 16% of adults, felt the trick or treating should stop around age 17 or 18.
FDA declines to approve first nasal spray alternative to EpiPen
On Tuesday, Sept. 19, the Food and Drug Administration decline to approve Neffy, a nasal spray equivalent of an EpiPen. The first needle-free option to treat severe allergic reactions made by ARS Pharmaceuticals was declined approval as the FDA requested more testing on repeat doses.
The decision by the FDA was surprising for the drug developer ARS. According to an ARS statement, in a May 2023 meeting, the FDA’s Pulmonary-Allergy Drugs Advisory Committee concluded the benefits of Neffy outweigh the risks.
“In that session, no member of the Committee raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose Neffy, which showed enhanced absorption during the time period when a clinical response would be expected,” the statement read.
The May 2023 conclusion came with a PADAC vote backing the use of the needle-injected epinephrine alternative in adults and children weighing at least 66 pounds.
The FDA wants a repeat-dose study on the nasal spray to compare results to an epinephrine injection before the drug can be approved. This is a requirement that ARS said had already been discussed.
“This request comes after the recommendation of the FDA Advisory Committee (PADAC) in May 2023 to approve Neffy without the need for additional studies to demonstrate its efficacy or safety,” the statement read.
ARS added a less expensive needle-free alternative is needed now more than ever as the cost of emergency allergy injectors increases. One study shows that two-thirds of patients pay $200 annually for emergency allergy injections.
ARS plans on resubmitting Neffy for FDA approval in 2024 and anticipates action in the second half of 2024.
FDA warns 3 baby formula makers over cleaning and sanitization
The FDA sent warning letters to three baby formula manufacturers regarding their cleaning and sanitizing practices. Each of the companies recalled products in the last year, and the FDA wants to ensure they’re taking steps to prevent it from happening again.
Each of those products were recalled in the last year due to possible contamination with Cronobacter sakazakii, a nasty germ that can lead to deadly infections. Although it’s rare, Cronobacter can cause sepsis and meningitis.
After inspecting the companies’ facilities, the FDA found “significant violations” of federal regulations regarding good manufacturing practice, quality control procedures and more. The companies have 15 days to respond with a list of corrective actions.
To be clear — this does not have anything to do with an ongoing recall, and the FDA explicitly stated it is not advising discarding or avoiding the purchase of any product.
“The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, said in a statement.
Prater was referring to the February 2022 recall of Abbott products Similac, Alimentum or EleCare powdered infant formulas made at the company’s facility in Sturgis, Michigan. That caused a nationwide shortage of formula which led the Biden administration to fly it in from overseas. The investigation and recall began after infants became ill, leading to four hospitalizations and two deaths that may have been linked to Cronobacter.
There are ways to ensure formula is safe at home. The FDA said the safest option for babies that are immuno-compromised or less than two months old is ready-to-feed liquid formula because it’s made sterile.
But if powdered formula is the only option, the FDA suggests heating the water to 158 degrees fahrenheit and mixing the powder in to protect against cronobacter. Let it cool to body temperature, or about 98 degrees, before feeding.
Some products, however, lose vitamins and nutrients if they are heated above 100 degrees, so check the manufacturer’s instructions.
Appeals court backs abortion pill limits, setting up SCOTUS case
Three judges on the 5th U.S. Circuit Court of Appeals in New Orleans backed some limits on the abortion pill Mifepristone. However, the ruling on Wednesday, Aug. 16 cannot take effect until the Supreme Court weighs in.
The appeals court ruling partially overturned a lower court ruling that revoked the Food and Drug Administration’s (FDA) approval of the abortion pill. However, Wednesday’s ruling left the following limits in tact:
A ban on receiving Mifepristone by mail
A reduction in when Mifepristone can be taken from up to 10 weeks of pregnancy to up to seven weeks
A requirement that Mifepristone be taken in the presence of a doctor
The legal challenge to Mifepristone followed changes the FDA made in 2016 and 2021 to ease conditions for administering the abortion pill.
“In loosening Mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” Judge Jennifer Walker Elrod wrote in the panel’s decision.
The Biden administration said it would appeal the decision with the Supreme Court, who has previously intervened to keep Mifepristone available during the legal battle. Abortion rights advocates said the ruling poses a major threat to abortion availability, as well as on the access of other medications.
“As I have continually said, this lawsuit is a threat to a woman’s freedom to make decisions about her own body and another step towards the ultimate goal of a nationwide abortion ban. It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA,” Vice President Kamala Harris said in a statement Wednesday. “Americans across the country should be able look in their medicine cabinets and know that FDA-approved medication prescribed by a doctor will remain available. This decision stands between doctors and their patients.”
Blinken speaks with Paul Whelan: The Rundown Aug. 17, 2023
Secretary of State Antony Blinken spoke with Paul Whelan, and Starbucks was ordered to pay millions of dollars as part of a wrongful termination suit. These stories and more highlight The Rundown for Thursday, Aug. 17, 2023.
Blinken speaks to Paul Whelan by phone
Secretary of State Blinken has spoken by phone with Paul Whelan, the American who is being held in a remote prison camp in Russia. The U.S. government has deemed Whelan is being wrongfully detained after he was sentenced to 16 years on espionage charges he and the U.S. said were fabricated.
Sources told multiple news outlets that Blinken told Whelan the U.S. is doing everything it can to bring him home as soon possible. This is the second time Blinken has spoken to Whelan since he was jailed in 2018.
In addition to speaking with the secretary of state, sources said Whelan was able to call his parents. Blinken said earlier in 2023 that the U.S. had made a “serious proposal” for Whelan’s release, but Moscow has not engaged in any serious negotiations.
The court wanted access to the pill to be limited after finding the Food and Drug Administration (FDA) overstepped its authority in three ways:
Allowing the drug to be taken late in pregnancy
Allowing the drug to be mailed directly to patients
Having medical professionals other than doctors prescribe the pill to women seeking abortions
While the ruling seeks to limit access to Mifepristone, availability will remain unchanged for now. The Justice Department says it will go back to the Supreme Court to appeal the latest ruling.
Fulton County DA recommends Trump trial begin day before Super Tuesday
Fulton County District Attorney Fani Willis has put forward the date she would like to see former President Donald Trump’s trial in Georgia to begin. She recommended it start on March 4, 2024.
The date happens to be the day before Super Tuesday, when voters in more than a dozen states cast their ballots for the Republican presidential nomination. Former President Trump’s team has not commented on the proposed date.
The proposed start date will have to be signed off by a judge. Trump’s other state trial in New York begins March 25, 2024.
According to a recent Associated Press poll, Americans are divided in their opinions about Trump’s most recent indictment. About half of Americans believe Trump should be prosecuted. The poll was split along party lines.
Items seized during police raid of newspaper returned
The search warrant was withdrawn after media across the country condemned the raid. The newspaper is sending the seized computers and reporters’ cell phones to a forensics lab to be examined in order to figure out what police did with the electronics.
The Marion County Record’s publisher has promised his paper will continue to operate despite the disruption. It published its first edition since the police raid with the front-page headline reading “Seized but not Silenced.”
“This is the way things go here too often and too often people are brought into silence and intimidated by reactions like this,” Marion County Record Publisher Eric Meyer said on Monday, Aug. 14.
Marion police have said the public doesn’t have all the facts to the story yet. According to police, the raid was related to an ongoing investigation into whether the paper illegally obtained and used personal information about a local business owner.
Starbucks ordered to pay $2.7 million more in wrongful termination suit
Starbucks has been ordered to pay an additional $2.7 million in wage loss damages as part of a wrongful termination suit. The latest ordered payment is in addition to the $25.6 million awarded to former regional director Shannon Phillips in June of 2023.
Phillips, who is white, sued her former employer saying that her race was a factor in Starbucks firing her after the controversial arrests of two black men at a Philadelphia location in 2018 sparked nationwide protests. The two men, who were waiting for a business meeting, were arrested after an employee called 911 saying they were trespassing due to them not ordering anything while inside the store.
Phillips, who worked for Starbucks for 13 years, said she was not at the store when the incident occurred. She was fired the following day.
Starbucks said there was no evidence of intentional discrimination. The two men arrested at the store reached a private settlement with Starbucks and the city.
Chick-fil-A unveils twist to Original Chicken Sandwich
After experimenting for more than a year, Chick-fil-A has created what it calls the first ever twist to its beloved Original Chicken Sandwich. It is called the Honey Pepper Pimento Chicken Sandwich.
The sandwich will feature a chicken filet topped with pimento cheese, pickled jalapenos and honey. The Honey Pepper Pimento Chicken Sandwich will be available at Chick-fil-A restaurants nationwide beginning Monday, Aug. 28.
Trader Joe’s announces recalls over rocks, insects found in food
Well-known grocery chain Trader Joe’s issued a few unusual recalls during the week of July 23. The primary concerns of the recalls were bugs and rocks found in various food items.
“We will never leave to chance the safety of the products we offer,” Trader Joe’s said in an emailed statement to Straight Arrow News. “In each of these cases – there was an issue in the manufacturing processes in the facilities. We pulled the product from our shelves as soon as we were made aware of the issue.”
The recalls from Trader Joe’s follow what was a significant increase in the number of food items recalled last year.
According to a report released back in March, the total number of units recalled in 2022 by the Food and Drug Administration (FDA) increased 700% compared to 2021. This, despite the total number of recalls issued only rising 2.2% from year to year.
The average FDA food recall affected about 125,000 in 2021. That number shot up to more than 985,000 units in 2022.
The report cites two major food recall-related crises in 2022. A major recall of peanut butter products impacted 21 different food items, with over 12 million units recalled. Then there was the infant formula recall, which affected nearly 15 million units and led to a nationwide shortage.
“A recall of infant formula that [was connected to] two deaths was the biggest story of the year in terms of food recalls,” the report reads. “While it was not the largest recall by volume, it had lasting repercussions on the supply of formula for months and led to calls for reform in the industry and within the FDA itself.”
Read full statement from Trader Joe’s:
“We have a close relationship with our vendors. We will never leave to chance the safety of the products we offer. In this case, there was an issue in the manufacturing processes. We voluntarily pulled the product from our shelves as soon as we were made aware of the issue. Once we understood the issue we notified our customers.
FDA gives approval to RSV prevention drug ahead of cold season
The Food and Drug Administration (FDA) announced it has approved the Respiratory Syncytial Virus (RSV) prevention drug Beyfortus. The injection was given the go-ahead for infants and children up to 2 years old who face increased risk of severe RSV.
“RSV can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” John Farley, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement on Monday, July 17. “Today’s approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system.”
Beyfortus is made by AstraZeneca. The drug is a laboratory-made version of an antibody that helps the immune system fight off RSV.
FDA officials approved Beyfortus based on three studies showing the drug reduced the risk of RSV infection between 70% and 75% among infants and young children. With the FDA’s approval, babies will be able to receive a single injection to protect against their first season of RSV, which typically lasts about five months. Children up to the age of 2 will be able to get another dose to protect them during their second season of facing the virus.
Advisers to the Centers for Disease Control and Prevention (CDC) will meet in August to recommend exactly who should get the drug.
The FDA’s approval of the RSV prevention drug comes just over a month before the annual cold season gets underway. While RSV is a cold-like nuisance for most healthy people, it can be life-threatening in the very young and the elderly.
“While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection, develop lower respiratory tract disease such as pneumonia and bronchiolitis (swelling of the small airway passages in the lungs), that often leads to an emergency department or physician office visit,” the FDA said. “Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease. Approximately 1% to 3% of children under 12 months of age in the United States are hospitalized each year due to RSV, according to the American Academy of Pediatrics.”