Tag: FDA

Record-setting cyclospora outbreak is over, U.S. health officials declare

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Rotting cabbage surrounded by eggshells and soil in a compost bin

The cyclospora food poisoning outbreak linked to recalled iceberg lettuce is over, U.S. health officials said Friday. The Centers for Disease Control and Prevention said there is no longer a risk of people getting sick with cyclosporiasis from this outbreak and is confident that all related iceberg lettuce is off the market. The U.S. Food and Drug Administration said that while the outbreak is over, it will continue its investigation of cyclospora infections linked to the iceberg lettuce sourced from central Mexico and recalled by Taylor Farms de Mexico.

“FDA will continue to work with federal, state, and international partners to complete its investigation and will provide updates as they become available,” the agency said on Friday. Nearly 13,000 reported cyclospora cases were tied to the outbreak spanning 21 states, federal officials say. They represent the bulk of an unprecedented surge in the parasitic diarrheal illness this year. More than 570 people have been hospitalized and two died, according to the FDA and CDC, as of Friday. Even with the outbreak deemed over, several questions remain, including about its origin. The parasite is spread through human feces, and it still isn’t clear how sewage could have contaminated enough food to sicken so many people.

“This contamination can happen if produce is grown in soil or comes into contact with water that has been contaminated,” said Ellen Shumaker, director of outreach for a North Carolina State University food safety program, Safe Plates. Since May 1, the government has received reports of nearly 20,000 lab-confirmed cases, or more than 16 times the number reported during the same period last year. More than 6,100 suspected cases also have been reported. The worst previous year in the U.S. for infections was 2019, when about 4,700 illnesses were reported nationally. This year’s surge in cases was dominated by an outbreak in 21 states linked to iceberg lettuce.

But there are thousands of other cases that have not been linked to that outbreak. Michigan was the hardest-hit state, with the most reported cases and the two U.S. deaths tied to the outbreak. Cyclospora is a microscopic, spherical parasite that commonly causes watery diarrhea “with frequent and sometimes explosive bowel movements,” according to the CDC. Outbreaks tend to occur most often in the late spring and summer. The illness, called cyclosporiasis, is less common than foodborne illnesses caused by other germs, including salmonella and E. coli. Many cases are never linked to a specific food or other source. In this outbreak, investigators initially zeroed in on lettuce served at Taco Bell.

Federal officials subsequently focused on Taylor Farms as the source of the lettuce, and the company recalled iceberg lettuce grown in central Mexico. The Taylor Farms recall involved thousands of packaged salad products combining iceberg lettuce with other vegetables. The products were shipped to major U.S. restaurant chains, including Yum Brands, which owns Taco Bell, Pizza Hut and KFC. The FDA has ended its on-site inspections and sample collection at iceberg lettuce growers and the processing facility in Mexico, the agency said Friday.

Samples from the on-site inspections are pending analysis, the FDA said. The outbreak cast a spotlight on a worsening problem: U.S. regulators are conducting fewer international inspections to catch contaminated produce before it lands on American plates.

Source: Record-setting cyclospora outbreak is over, U.S. health officials declare – CBS News

Show me Your ways, O LORD; Teach me Your paths.
Psalm 25:4

Hunted for Following Jesus

In some communities, Muslims who leave Islam to follow Christ face rejection, threats, violence, and even death because of their faith. For Muslim-background believers, choosing to follow Jesus can place…

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Another Alzheimer’s blood test gets OK from FDA

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FDA sign with official government building

The US Food and Drug Administration has cleared Roche and partner Eli Lilly’s blood test to help ​identify signs of Alzheimer’s disease in people age ‌55 and older with cognitive decline. The test, Elecsys pTau217, is a biomarker blood test that can help doctors identify patients who are ​likely or unlikely to have Alzheimer’s-related brain changes, ​Roche said Monday. The FDA clearance follows European ⁠approval for the test in May. The test can be ​run on more than 4,500 Roche laboratory analyzers already installed ​across the United States, which the company said could help broaden access. Labcorp and Quest Diagnostics have said they plan to offer ​the test through their laboratory networks, potentially expanding availability. Roche did not disclose the test’s price.

The FDA clearance ​comes as ⁠drugmakers and diagnostic companies race to develop simpler tests for Alzheimer’s disease to meet growing ​demand for earlier diagnosis and treatment. Fujirebio’s Lumipulse became ​the ⁠first blood test cleared by the FDA to aid in the assessment of Alzheimer’s disease in 2025. Roche and Lilly’s Elecsys pTau181 test, which measures a different protein than the newly cleared test, also received the FDA’s green light last year. Last week, the agency cleared C2N Diagnostics’ Precivity AD2 test. Traditionally, diagnosing Alzheimer’s required expensive and invasive procedures like PET scans or spinal taps. However, blood tests that measure levels of the biomarker phosphorylated tau 217, or p-tau217, “strongly predict” the buildup of sticky beta-amyloid plaques in the brain, Rachel Buckley, an associate professor of neurology at Harvard Medical School, told CNN earlier this year.

The amyloid plaques, which trigger inflammation and damage communication between neurons, can collect in the brain decades before memory loss or cognitive decline — even when people are in their 30s and 40s. As beta-amyloid levels rise in the brain, tangles of proteins called tau begin gathering inside brain cells, causing neurons to collapse and die. In some diseases such as frontal lobe dementia, which damages executive function instead of memory, tangles can accumulate without the presence of amyloid. Not everyone with high levels of amyloid will progress to dementia, just as having tau in the brain does not dictate cognitive impairment later in life, Buckley said. “We do not recommend blood tests in individuals without symptoms; until there is a disease modifying therapy available for asymptomatic individuals, a physician would not currently change their clinical guidance based on pTau217 levels alone in this population,” Buckley said in an email this week. Elecsys pTau217 is not ⁠intended ​to be used as a standalone ​diagnostic test, and results should be interpreted alongside other clinical information, Roche ​said. “Single ‘Alzheimer’s blood tests’ can be fraught with challenges, and this new test is no different,” Alzheimer’s prevention researcher Dr. Richard Isaacson, director of research at the Institute for Neurodegenerative Diseases in Florida, told CNN in an email Monday.

“Just like when a doctor orders a cholesterol test, do they ever order only 1 test? No – they order a panel of tests and that is the strategy that I advocate for to minimize confusion and improve clinical diagnostic and risk prediction accuracy.” Isaacson noted that the new test “has a sufficient negative predictive value (likelihood that it rules out a diagnosis of Alzheimer’s disease correctly)” but says the “positive predictive value is not great.” “False positive tests are a problem in clinical practice so we need to be careful (especially with a new test like this that has both positive, negative AND indeterminate classifications),” he wrote. Trouble with the way samples are handled or the presence of other medical conditions such as kidney problems or viral illnesses can also lead to confusion with interpreting the results. Instead of using p-tau217 and amyloid blood tests for diagnosis, Isaacson runs them to look for clues on how people are responding to treatment and lifestyle changes. Personalized lifestyle interventions such as an improved diet, exercise, sleep and socialization — combined with the management of insulin, cholesterol and other risk factors as needed — have reduced amyloid and tau levels in patients dedicated to improving their health.

“Research is now showing up to 45% of dementia cases can be prevented with lifestyle interventions such as exercise, diet, social engagement, cognitive training, and management, vascular and metabolic risk factors,” Laura Nisenbaum, interim chief science officer at the Alzheimer’s Drug Discovery Foundation, which funds Alzheimer’s research, told CNN earlier this year.

Source: Another Alzheimer’s blood test gets OK from FDA | CNN

For what profit is it to a man if he gains the whole world, and loses his own soul? Or what will a man give in exchange for his soul?
Matthew 16:26

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New chip-based sensor could let consumers test food for contaminants at home

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Food safety concerns are becoming too-frequent headlines. Right now, it’s a cyclosporiasis outbreak possibly linked to tainted lettuce. But the nation has also dealt with E. coli, Salmonella, and Listeria – a long list of threats. Consumers already know to thoroughly wash fresh fruits and vegetables. But is it enough? And how would you know? Many have wondered what’s next. Researchers at the University of Texas at Dallas are exploring a quick, cost-effective way to test for food contaminants at home using technology most people already carry in their pockets: computer chips.

“We have re-engineered those devices to be able to have what is called a ‘single capture measurement,'” said Shalini Prasad, PhD, department head of bioengineering and a Cecil H. and Ida Green Professor in Systems Biology Science in the Erik Jonsson School of Engineering and Computer Science at UTD. “Say, it’s a lettuce sample, or it’s a strawberry,” Prasad said. “And you take it, mush it with your hand, and drop it on the sensor. CBS News Texas “The sensor is engineered so that it can measure any of these 16 things. So, a panel of antibiotics, a panel of pesticides, a panel of bacteria, a panel of parasites, and a panel of fungi. It can do all of this.” The device, called READ – Rapid Electro Analytical Device – can detect contaminants in food and water in just a couple of minutes.

Prasad said the research grew out of her curiosity as a mother trying to better protect her two sons. “As a mom, you’re a problem solver, right? And you don’t know what’s coming at you at any given point of the day. But what is important is how do I make people’s lives easier, better, healthier, and more accessible,” she said. The technology is nimble, allowing researchers to tweak and respond to outbreaks as they happen. “That is the idea,” Prasad said, “because we don’t know what’s the next epidemic, and we cannot wait to have it all built.” The research team is preparing for pilot testing, with hopes of having the technology in consumer kitchens within the next year or so.

“What worries us most is that which we cannot see,” Prasad said. “It is the invisible that I am making visible through this technology. That is the hope. And that is the dream.”

Source: New chip-based sensor could let consumers test food for contaminants at home – CBS Texas

As newborn babes, desire the pure milk of the word, that you may grow thereby.
1 Peter 2:2

Powerful earthquake shakes Panama

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Plague in Russia?

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Taylor Farms lettuce sample that tested positive for cyclospora was a false positive, FDA says

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Scientist with blue gloves handling lettuce leaf samples with tweezers in a laboratory

A sample of lettuce from Taylor Farms that had tested positive for cyclospora was a false positive, the Food and Drug Administration said Sunday. “Due to the complexity in detection of Cyclospora, FDA laboratory experts re-reviewed the sample results and have concluded that the finding does not represent true amplification and should be considered a false positive,” the FDA said. In the statement announcing the false positive, the FDA said that as of Sunday it had not found any “confirmed positive sample results for product testing for Cyclospora.”   Taylor Farms on Friday said it was “voluntarily removing” iceberg lettuce sourced from central Mexico after the lettuce had been linked to one of the largest outbreaks of cyclosporiasis in the U.S. in recent years.   

“While the FDA traceback is indicating a specific independent farm, which represents less than 1% of the U.S.’s iceberg lettuce supply, as the potential source of the outbreak, we have removed all iceberg lettuce from the region indefinitely,” the company said Friday in a statement. Taylor Farms said Sunday in a statement after the false positive was announced that, “Our thoughts remain with everyone who has fallen ill in this outbreak. We are committed to working with public health authorities as the ongoing outbreak investigation continues.” On Thursday, the U.S. Centers for Disease Control and Prevention identified lettuce supplied to select Taco Bell restaurants as a source of the multistate outbreak, more than a month after cases first began to appear. The iceberg lettuce was distributed to Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia, according to the CDC. Taco Bell said on Friday it had “completed removal of affected Taylor Farms lettuce from our restaurants.”

Walmart also announced over the weekend it had removed four Marketside bagged iceberg lettuce salad products from its stores in more than two dozen states, but added there was “no indication that products sold in our stores are affected by the current Cyclospora investigations.” The outbreak, first reported in May, has spread to 34 states and sickened more than 1,600 people, according to the CDC. However, the CDC’s tally lags behind state health departments, which have reported much larger numbers of cases. For instance, the Michigan Department of Health and Human Services reported more than 5,000 confirmed cases as of Friday. No deaths have been reported.  Cyclosporiasis is a food- and waterborne illness caused by the cyclospora parasite, which causes long-lasting, watery and sometimes explosive diarrhea, according to public health experts.  Outbreaks typically occur in late spring and summer and have historically been linked to bagged salads, cilantro, basil, raspberries, snow peas and green onions.

Source: Taylor Farms lettuce sample that tested positive for cyclospora was a false positive, FDA says – CBS Boston

Riches do not profit in the day of wrath, But righteousness delivers from death.
Proverbs 11:4

2 Timothy 3:12 

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John 15:18–20

“If the world hates you, know that it has hated me before it hated you. If you were of the world, the world would love you as its…

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Galatians 1:6-10

“When truth becomes negotiable, faith becomes vulnerable so know the Gospel, stand on God’s Word, and seek His approval above the world’s applause.” “I am astonished that…

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FDA identifies Taco Bell lettuce as source of diarrhea…

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Three inspectors in safety vests and masks examining romaine lettuce and recording data

Federal health investigators officially linked the multistate cyclosporiasis outbreak to shredded iceberg lettuce served at Taco Bell, the Food and Drug Administration reported on Thursday. Lab results as of Monday confirmed over 1,600 cyclosporiasis cases reported since the beginning of May across 34 states, according to the Centers for Disease Control and Prevention. The illness hospitalized dozens of patients but has not proved fatal.

Officials on Monday also reported over 5,100 suspected cyclosporiasis cases across the nation which have not been formally diagnosed. Cyclosporiasis occurs when individuals consume food or water infected with the microscopic Cyclospora parasite, which will infect the small intestine and cause watery diarrhea, bloating, nausea, and other gastrointestinal symptoms. Symptoms appear up to two weeks after a patient’s initial exposure to the parasite, according to the CDC. Health investigators specifically analyzed a group of 190 patients from across five states and found that over 90% reported eating lettuce at Taco Bell, according to the FDA. Despite over 30 states reporting cases, officials only warned against eating Taco Bell in Indiana, Kentucky, Michigan, Ohio, and West Virginia.

Michigan reported the most cases of any state, local health officials reporting more than 5,000 cases as of Friday. New York marked the second-highest case count, with nearly 400 cases reported as of Monday, according to state officials. Where is the lettuce coming from? The FDA tracers identified a specific lettuce supplier from Mexico that supplied shredded iceberg to the same Taco Bell locations where people got sick. Federal officials planned to work with the Mexican supplier to determine how much potentially contaminated lettuce remained on the market. It remains unclear whether the same lettuce also caused illnesses outside of the five confirmed states.

Previous U.S. cyclosporiasis outbreaks stemmed from contaminated produce, including raspberries, basil, broccoli, sugar snap peas, and leafy greens, according to the CDC. Several Democratic lawmakers blamed the outbreak on the Trump administration’s budget cuts. Beginning on July 1, 2025, the Foodborne Diseases Active Surveillance Network, or FoodNet, a Trump administration collaboration between several federal and state health agencies, made testing for cyclospora optional. Health and Human Services Secretary Robert F. Kennedy Jr. was responsible for that change, Sen. Chris Coons, D-Del., wrote Wednesday. Trump officials removed cyclosporiasis from the CDC’s tracked pathogens when it reduced foodborne illness tracking requirements last year, Rep. Betty McCollum, D-Minn., wrote earlier this week.

Source: FDA identifies Taco Bell lettuce as source of diarrhea… | WORLD

The grace of the Lord Jesus be with God’s people. Amen.
Revelation 22:21

Isaiah 45:2

“I will go before you and level the exalted places, I will break in pieces the doors of bronze and cut through the bars of iron, This verse reminds us that God can…

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Proverbs 21:23

Whoever keeps his mouth and his tongue keeps himself out of trouble. This verse emphasizes that people who carefully watch what they say will protect themselves from serious trouble. “Guarding your mouth and…

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Ice cream sold in 17 states recalled for potential metal fragments

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News broadcast announcing recall of Straus Family Creamery ice cream for potential metal contamination

Straus Family Creamery is voluntarily recalling a variety of organic ice cream flavors and sizes sold in 17 states because of concerns there may be metal fragments in the frozen treats, the Food and Drug Administration said Friday.  No injuries have been reported because of the issue, the FDA said.  The recall affects some products sold in Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Maryland, New Jersey, Oregon, Pennsylvania, South Carolina, Texas, Washington and Wisconsin. The affected items were on shelves beginning on May 4, the FDA said.  Pints of Straus Family Creamery’s dutch chocolate ice cream. Michael Macor/The San Francisco Chronicle via Getty Images The affected products can be determined by their best-by dates, the FDA said. Best-by dates are printed on the bottom of the container.

The recalled products include:  Vanilla bean pints with best-by dates of Dec. 23 and 28, 2026, with the manufacturing code 7-84830-10030-6.  Strawberry pints with a Dec. 25, 2026, best-by date and the manufacturing code 7-84830-10095-5.  Strawberry quarts with a Dec. 24, 2026, best-by date and the manufacturing code 7-84830-10097-9.  Cookie dough pints with a Dec. 26, 2026, best-by date and the manufacturing code 7-84830-10104-4.  Dutch chocolate quarts with a Dec. 27, 2026, best-by date and the manufacturing code 7-84830-10012-2.  Mint chip quarts with a Dec. 30, 2026, best-by date and the manufacturing code 7-84830-10050-4.

Straus Family Creamery is working with retailers to remove the affected products from shelves, the FDA said. Anyone who has purchased an affected container should dispose of the product.  Straus said it would not offer refunds, but would issue vouchers to interested customers so they can buy another carton. Voucher information is available on the company’s website. 

Source: Ice cream sold in 17 states recalled for potential metal fragments – CBS News

A good man deals graciously and lends; He will guide his affairs with discretion.
Psalm 112:5

Psalm 5:8

Lead me, O Lord, in your righteousness because of my enemies; make your way straight before me. In the verse David is praying in the morning while people who…

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Good & Gather snack, other nut mixes recalled due to salmonella risk

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Recall notice for Good & Gather assorted snack mixes due to undeclared semolina allergen

An Illinois food manufacturer is recalling several snack products due to concerns that they may be contaminated with salmonella, according to a recall notice with the Food and Drug Administration. The recall affects nut mixes and a corn mix manufactured by John B. Sanfilippo and Son and sold under the brand names Southern Style Nuts, Fisher, Squirrel Brand and Good & Gather.  The Good & Gather product, a Mexican street corn-inspired trail mix, was sold at Target, while the others were sold at various retail stores, online and by QVC, according to the FDA notice.

Source: Good & Gather snack, other nut mixes recalled due to salmonella risk – CBS Sacramento

Good and upright is the LORD; Therefore He teaches sinners in the way. The humble He guides in justice, And the humble He teaches His way.
Psalm 25:8-9

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RECALL: Infant formula batches from a2 Milk Company recalled over possible cereulide toxin, FDA says

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Recall notice for certain Similac, Alimentum, and Elecare baby formulas on an empty store shelf

The a2 Milk Company has voluntarily recalled three specific batches of infant formula after detecting a possible toxin, according to the U.S. Food and Drug Administration. The baby formula in question was sold via Amazon and at Meijer, the FDA said, in addition to the company’s website. The reason for the recall is “presence of cereulide toxin produced by some strains of the bacterium Bacillus cereus.” 

Source: Infant formula batches from a2 Milk Company recalled over possible cereulide toxin, FDA says – CBS Detroit

Let not him who eats despise him who does not eat, and let not him who does not eat judge him who eats; for God has received him.
Romans 14:3

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Oysters, clams sent to multiple states could be contaminated with norovirus, FDA warns

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photo of a person s hand holding a platter of oysters

The U.S. Food and Drug Administration has issued an advisory for certain raw oysters and Manila clams, warning they could potentially be contaminated with norovirus. The March 9 FDA advisory states that restaurants and retailers “should not serve or sell and should dispose of” the affected shellfish, and consumers should “not eat” them, as they may be contaminated with the virus.

Source: Oysters, clams sent to multiple states could be contaminated with norovirus, FDA warns – ABC News

He who believes and is baptized will be saved; but he who does not believe will be condemned.
Mark 16:16

Kansas will see an increase in monarch butterflies this fall

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Invasive spotted lanternfly threatens trees, plants in Massachusetts

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Ford recalls nearly 149,000 Mustang vehicles over potential power issue

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Woman, young girl fall off chairlift ride at the Jersey Shore

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