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Firings at FDA Decimated Teams Reviewing AI and Food Safety

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Firings at FDA Decimated Teams Reviewing AI and Food Safety

In recent years, the Food and Drug Administration hired experts in surgical robots and pioneers in artificial intelligence. It scooped up food chemists, lab-safety monitors and diabetes specialists who helped make needle pricks and test strips relics of the past.

Trying to keep up with breakneck advances in medical technology and the demands of a public troubled by additives like food dyes, the agency enticed scores of midcareer specialists with remote roles and the chance to make a difference in their fields.

In one weekend of mass firings across the F.D.A., much of that effort was gone. Most baffling to many were the firings of hundreds whose jobs were not funded by taxpayers. Their positions were financed through congressionally approved agreements that routed fees from the drug, medical device and tobacco industries to the agency.

Known as user fees, the money provides adequate staffing for reviews of myriad products. While criticized by some, including the nation’s new health secretary, Robert F. Kennedy Jr., as a corrupting force on the agency, the industry funds are also widely viewed as indispensable: They now account for nearly half of the agency’s $7.2 billion budget.

Though the F.D.A. is believed to have lost about 700 of its 18,000 employees, some cuts hit small teams so deeply that staff members believe the safety of some medical devices could be compromised.

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Among the layoffs were scientists supported by the fees who monitor whether tests pick up ever-evolving pathogens, including those that cause bird flu and Covid. They hobbled teams that evaluate the safety of medical devices like surgical staplers, new systems for diabetes control and A.I. software programs that scan millions of M.R.I.s and other images to detect cancer beyond the human eye. The cuts also eliminated positions for employees who have played a role in assessing the brain-implant technology in Elon Musk’s Neuralink devices.

The layoffs affected so many key experts that a major medical device trade group has requested that the Trump administration reconsider the job cuts.

The dismissals also included lawyers who warned retailers about underage tobacco sales and scientists who studied the safety of e-cigarettes and new heat-not-burn devices. The tobacco division — which is fully funded by an excise tax on cigarettes — lost about 85 staff members.

Dr. Robert Califf, the F.D.A. commissioner under President Biden, said the personnel cutbacks seemed scattershot. Taking a not-so-subtle aim at Mr. Musk’s Department of Government Efficiency, which is reducing the federal work force, Dr. Califf said the layoffs were, in effect, “anti-efficiency.”

“These are not hires that are done arbitrarily,” he said. “They’re done to meet a need.”

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A lawsuit challenging the firings filed by unions, including one that represents some F.D.A. employees, failed to stop the layoffs in a ruling issued Thursday. Other cutbacks reduced the 2,000-member staff of the F.D.A.’s food division, which is supported by tax dollars.

Jim Jones, the former director of the division who resigned on Monday over the cuts, said that he had briefed the Trump transition team on his efforts to create a new office that would review a premier target of Mr. Kennedy and his agenda to Make America Healthy Again: food additives that are already on the market.

Nine people from that food-chemical-safety staff of 30 are gone, including specialized toxicologists and chemists, Mr. Jones said in an interview.

“They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment for free and you can’t ban chemicals by fiat.”

In interviews with 15 current and former agency staff members, they said those who were laid off had been probationary employees, a group that included agency veterans who took on new roles, were recently promoted or were hired in the last two years.

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Those who remained said that they had been scrambling to pick up pressing medical device reviews and move forward with studies to bulletproof methods for detecting deadly bacteria during inspections at food production sites.

Divisions that review novel medications, vaccines and gene therapies were largely spared. Officials with the F.D.A.’s parent agency, the Department of Health and Human Services, did not respond to requests for comment.

The F.D.A. employees fired last weekend were notified in uniformly worded emails that their skills were not needed and that their performance was “not adequate to justify further employment by the agency.” Yet many of them said that their performance reviews had said they exceeded expectations.

Tony Maiorana, 37, a chemist, worked on product approval and safety in the fast-changing field of diabetes devices. In the last decade, the field has moved from painful needle pricks and test strips to systems that measure glucose levels just below the skin and automatically infuse the needed insulin.

The work of reviewing new products is painstaking: Novel algorithms measure and dispense insulin; materials implanted in the body must evade rejection by the immune system; and millions of patients from toddlers to the elderly are at risk if devices malfunction.

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Still, about half of Dr. Maiorana’s product-review team was eliminated, he said.

“If you’re a patient and you complain, we are the ones that field your complaints,” he said. “We are the ones that monitor the death reports. We’re the ones that are telling companies: ‘Hey, there’s a big pattern of error happening here. People are dying or ending up in the hospital because of your device’ and ‘What has changed? What happened?’”

Dr. Maiorana said that he had expected his government job would be “chill,” but it turned out to be intense. His team had to assess whether studies of new devices that had never been used in humans were safe for adults and children. They also had to watch online marketplaces for diabetes technology that had not been approved by the agency.

“This is the reason the F.D.A. was founded — to protect the public,” Dr. Maiorana said.

Albert Yee, 59, an expert in biomechanics and robotics, was fired on Saturday. In his unit, four of 11 staff members, who review the safety of surgical robots, were let go.

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Robotic surgery is increasingly employed in operating rooms across the country, used in cardiothoracic, gynecological and bariatric surgeries. Dr. Yee had worked in the industry and in academia before joining the F.D.A.

He said his team was highly specialized, including an expert with a doctorate in medical robotics and a physician who had conducted robotic operations.

He said that robotic devices had become so complex that the team’s diverse expertise was critical to evaluate not just the safety of such tools but also concerns about cybersecurity.

“All of these devices now — if they’re attached to the hospital network, they become an avenue to get into the hospital network or get into the device itself,” Dr. Yee said.

He said the team also fielded a flood of applications for surgical apparatus developed abroad that were similar to those made by companies based in the United States. He said the applications required close attention to catch problems that could endanger patients.

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“The institutional knowledge we’re losing is just horrific,” he said. “I am concerned about public safety with this type of purge.”

Nathan Weidenhamer was a lead reviewer of cardiovascular devices and other high-risk implants.

He said he was shocked and disappointed to be laid off because he and other reviewers in the device division were partly funded by industry-generated fees.

“I naïvely thought we were important, critical public servants and I’d be spared,” he said.

The layoffs clearly did not skip over employee slots created and funded by the agreements negotiated with the industries, congressional lawmakers and F.D.A. officials. The industries provide billions of dollars in return for staff equipped to meet strict deadlines for decisions on product approvals — though not all go in companies’ favor. The money is also used to make the F.D.A. a competitive employer in specialized fields that require advanced degrees.

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Some of the deadlines are viewed by F.D.A. staff members as demanding, particularly the 30-day clock requiring them to authorize or add comments to studies of devices that are being implanted in humans for the first time. If the agency does not respond within that time-frame, the study is given a green light under the law.

The depth of cuts to medical device staff prompted AdvaMed, a trade association for the industry, to push back in a letter to a top Health and Human Services official.

The letter detailed about 180 medical device staff cuts, which included 25 experts in artificial intelligence, a 20 percent reduction in biostatisticians who evaluated studies of novel devices and the loss of molecular biologists with expertise in diagnostic tests that pinpoint a cancer subtype. The firings also applied to a top official who was recently recruited to oversee about 10,000 product applications and meeting requests per year.

The group said it appreciated the Trump administration’s efforts to improve efficiency. But “they may have missed the mark on how they rolled it out,” Scott Whitaker, the president of AdvaMed, said in an interview.

Medical device companies benefit when the F.D.A. is well staffed with people who have the expertise to guide the safe development of new technology, he added.

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“One that is slow and overregulates is not good,” he said. “One that is under-resourced and doesn’t regulate at all — that’s not good either.”

Alice Callahan contributed reporting.

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With a Friend in Trump, the Tobacco Industry Secures a Lucrative Win

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With a Friend in Trump, the Tobacco Industry Secures a Lucrative Win

Over lunch at his golf club in Jupiter, Fla., on the first Saturday of May, President Trump got an earful from a group of tobacco executives and lobbyists unhappy with the way the Food and Drug Administration was regulating their industry.

Eventually Mr. Trump had heard enough. He interrupted the conversation to call Dr. Marty Makary, the F.D.A. commissioner.

No answer.

Furious, the president then dialed Dr. Makary’s boss, Health Secretary Robert F. Kennedy Jr., and another top health official, Dr. Mehmet Oz, the head of the Centers for Medicare and Medicaid Services. He complained to them about the F.D.A.’s regulation of e-cigarettes, according to three people briefed on the meeting who were not authorized to discuss it.

The message was received. Less than one week later, the executives got what they wanted.

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On Friday, the F.D.A. issued new guidance that could pave the way for major tobacco companies to begin selling flavored vapes and to snare a chunk of the $6 billion e-cigarette market away from illegal Chinese competitors. The new policy bypassed the F.D.A.’s regular rule-making process.

In the intervening week, Dr. Makary continued to argue against approving flavored vapes as support from Mr. Kennedy and others collapsed around him. Health and Human Services Department staff began to draft the new plan, according to two people familiar with the events.

On Tuesday, Dr. Makary resigned, telling associates he could not in good conscience remain the head of an agency that backed such a policy.

Though there is no definitive evidence linking the new guidance to donations or lobbying, the episode represented a clear pivot in the federal government’s longtime approach to the tobacco industry.

Since the 1990s, when states extracted vast payments and other concessions from the major cigarette companies in a nationwide legal settlement, Big Tobacco has been in retreat. Cigarette sales have plummeted, and regulations have mounted as consumers and administrations from both parties embraced public health consensus about the dangers of smoking and nicotine addiction.

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Mr. Trump’s first administration initially continued the trend, proposing further restrictions on cigarettes and moving to outlaw flavored vapes over concerns that their rising popularity threatened the health of a generation of adolescents.

But since then, Mr. Trump has enthusiastically welcomed the financial support of the tobacco industry and has courted e-cigarette users as a political constituency.

The new vaping guidance highlights Mr. Trump’s willingness to use his executive authority to prioritize the causes of major corporate donors over public health concerns, taxpayer interests and the judgment of experts, sometimes including those in his own administration.

The president has developed a close relationship with tobacco companies including Altria and Reynolds American, which have donated millions of dollars to his political groups and projects, including his proposed White House ballroom. Their executives attended the lunch at the president’s golf club.

The Department of Health and Human Services, which oversees the F.D.A., referred requests for comment to the White House.

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Kush Desai, a White House spokesman, said in a statement that Mr. Trump has pushed to expand access to vapes to help Americans trying to quit smoking.

“The only guiding factor behind the Trump administration’s health policymaking is gold standard science,” Mr. Desai said.

Reynolds American and Altria did not respond to questions about their lobbying or the conversation at the lunch.

It was attended by Jeff Raborn, a top executive at Reynolds, and Phil Park and Todd Walker of Altria, according to the people familiar with the meeting. Also attending were Brian Ballard and Rich Haselwood, lobbyists for the firm Ballard Partners, which represents Reynolds and helped marshal a sophisticated and expensive influence campaign that culminated in the new vaping guidance. Mr. Ballard is a top fund-raiser for Mr. Trump. Mr. Haselwood had been an in-house lobbyist at Reynolds before joining Ballard Partners this year.

A spokesman for Ballard Partners declined to comment.

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While public health experts consider e-cigarettes a less harmful alternative to tobacco-burning cigarettes, the new guidance circumvents a scientific review process the F.D.A. had previously defended up to the Supreme Court. The disregarded procedures were meant to ensure approval of only those products shown in studies to help cigarette smokers transition to vapes without attracting a new generation of nicotine users.

The guidance also could allow higher nicotine levels in nicotine pouches. It includes a pledge to prioritize efforts to stop the import of illegal foreign vapes, an idea that has bipartisan support in Congress.

Taken together, the policy changes could help companies like Altria and Reynolds gain market share considered central to the survival of the industry.

The market for vapes and nicotine pouches, like Zyn, is about 30 million people in the United States, on par with the number of cigarette smokers. While the nicotine pouch market is rapidly growing, cigarettes still account for about $50.8 billion, or nearly 70 percent of the annual tobacco sales in the United States, according to a Goldman Sachs research report. Vape sales have lagged amid competition from illicit products.

In recent years, the F.D.A. has moved glacially to approve e-cigarettes, authorizing only those in tobacco or menthol flavors, including some sold by Reynolds and Altria. Unapproved Chinese vapes have poured into the United States, feeding a thriving illicit market with flavors like peach slush and watermelon ice. Last year, industry executives have said, illicit fruit-flavored vapes made up 60 percent of the e-cigarette market.

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When Mr. Trump mounted his bid to return to the White House, some in the tobacco industry went all in, hoping he would loosen regulations on vapes and abandon plans by the Biden administration to ban menthol cigarettes and crack down on other cigarette sales.

Mr. Trump in some ways makes for an unlikely savior for the tobacco industry. He has never smoked, but he pledged during his 2024 campaign to “save vaping again.”

Through a subsidiary, Reynolds, which is the biggest seller of menthol cigarettes, donated $10 million to a super PAC backing Mr. Trump’s campaign, according to campaign finance filings. There is no public record of the subsidiary donating to groups supporting Mr. Biden or the campaign of former Vice President Kamala Harris.

Mr. Ballard, whose firm has been paid more than $4.4 million by Reynolds since the beginning of 2017, arranged for Mr. Trump to have dinner during the campaign with Reynolds executives in New York, according to a person familiar with the interactions. The executives urged Mr. Trump to oppose the menthol cigarette ban and expressed concern about Chinese vapes.

Reynolds executives including Mr. Raborn and Mr. Haselwood were such a presence around the campaign that Mr. Trump took to calling them “my tobacco guys,” according to the person familiar with the interactions and a book coauthored by a New York Times reporter and published last year.

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When Mr. Trump won, the rest of the industry jockeyed to show support.

Altria donated $1 million to his inaugural committee; the Vapor Technology Association donated $1.25 million; and a subsidiary of Philip Morris donated $500,000.

On Mr. Trump’s second full day in office, his administration withdrew the proposed ban on menthol cigarettes, an initiative the Biden administration had already mostly abandoned. Mr. Trump’s team also set aside a Biden-era proposal to sharply restrict nicotine in cigarettes, an effort meant to speed the transition away from a product known to be deadly.

In applauding the withdrawal of the menthol ban, Billy Gifford, the chief executive of Altria, told investors on an April 2025 earnings call that “we’re hopeful that that activity and momentum continues.”

The courtship intensified.

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Reynolds pitched in another $3 million to a different Trump-backed super PAC, while Altria and Juul each donated $1 million.

And Reynolds and Altria each donated to the effort to raise private funds to build a new White House ballroom. Mr. Raborn of Reynolds and Mr. Walker of Altria were invited to a dinner at the White House in October for donors who gave $2.5 million or more, as was Mr. Ballard.

Tadeu Marroco, the chief executive of British American Tobacco, which owns Reynolds American, predicted to investors earlier this year that the Trump administration would clamp down on illegal vapes, saying “it’s very encouraging, the signs that the new administration is giving to address that.”

The companies’ lobbying strategy also has reached into the states, where they are pushing for so-called “registry laws” — of which there are now more than a dozen including in Florida, Virginia and Pennsylvania. Many of those laws restrict e-cigarette sales to only vapes on a list from the F.D.A.

The guidance released last week said it would create such a list.

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Sheryl Gay Stolberg contributed reporting.

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First clade I mpox case confirmed in Connecticut after patient traveled to Western Europe

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First clade I mpox case confirmed in Connecticut after patient traveled to Western Europe

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A case of clade I mpox — a more virulent version of the virus that causes monkeypox, according to the Centers of Disease Control and Prevention (CDC) — has been confirmed in the U.S., as global health officials also monitor newly reported hantavirus cases in Europe.

The Connecticut Department of Public Health (CDPH) said Wednesday that the state’s first identified case of clade I mpox was detected in a person who recently traveled to Western Europe, where officials continue to monitor infectious disease activity.

The World Health Organization (WHO) has also reported new hantavirus cases in Spain and France, drawing attention to the rare but potentially severe disease, which can cause serious respiratory complications in humans.

Hantavirus is typically spread through contact with infected rodents and can lead to severe respiratory illness, though cases remain rare, according to the WHO.

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While health officials said the mpox case “does not pose a risk to the general public,” they still encourage those who may be at risk to receive the JYNNEOS vaccine.

NEW MPOX STRAIN CONFIRMED IN US STATE FOR FIRST TIME

A pharmacist wearing a latex glove holds a photo of the mpox virus, which can spread through close, intimate contact with an infected person. (iStock)

Mpox symptoms can include fever, swollen lymph nodes and a characteristic rash, according to CDC.

“Mpox hasn’t gone away, and we want people to be protected, especially as many in our community prepare for travel, festivals, and gatherings this summer,” CDPH Commissioner Dr. Manisha Juthani said in the release.

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“The vaccine is safe, effective and widely available. Completing the two-dose series is the best way to protect yourself and your partners.”

HANTAVIRUS DEATHS ON CRUISE SHIP HIGHLIGHT DANGERS OF RODENT-BORNE DISEASE

Clade I mpox, a newer strain of the virus, first appeared in California in November 2024. (iStock)

Clade I and clade II mpox are genetically distinct forms of the virus with key differences in severity and geographic origin, according to the CDC and the WHO.

Clade I, historically identified in Central Africa, has been linked to more severe illness and higher mortality rates, with cases often involving more widespread rashes and complications.

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A traveler walks past a sign in a busy airport about mpox. (Yasuyoshi Chiba/AFP)

Clade II, which has circulated primarily in West Africa, is generally associated with milder disease and drove the global outbreak beginning in 2022, when most patients experienced less severe symptoms and lower hospitalization and death rates, according to the WHO.

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The CDC and WHO say distinguishing between the two clades helps guide risk assessments, particularly as international travel increases.

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The everyday places Americans could be exposed to hantavirus — without knowing it

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The everyday places Americans could be exposed to hantavirus — without knowing it

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Amid the current hantavirus outbreak that started on the MV Hondius cruise ship as it sailed across the Atlantic, health experts are now examining whether Americans may be encountering the virus in everyday places without realizing it.

The rare Andes strain, which was linked to the MV Hondius outbreak, is the only known hantavirus that has the capability to spread from person to person, usually through prolonged close contact with an infected person.

Most cases of hantavirus in the U.S. occur in the desert Southwest and on the West Coast, according to Dr. Linda Yancey, an infectious disease specialist at Memorial Hermann in the Houston area.

ANDES VIRUS LINKED TO CRUISE SHIP DEATHS RAISES CONCERN OVER HUMAN-TO-HUMAN SPREAD

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“In Texas, cases are mostly seen on the west side of the state,” she told Fox News Digital. “The strain of hantavirus native to east Texas and west Louisiana, the Bayou strain, is not as infectious in humans as the western strain, the Sin Nombre strain.”

Hantavirus is primarily spread through contact with infected rodents – primarily deer mice – and their urine, droppings or saliva. (iStock)

Hantavirus is mainly spread through contact with infected rodents – primarily deer mice – and their urine, droppings or saliva, according to the Centers for Disease Control and Prevention. 

People can become infected after breathing in contaminated particles that are stirred into the air or touching contaminated surfaces and then touching their nose or mouth. More rarely, rodent bites can spread the virus.

HANTAVIRUS OUTBREAK TIMELINE HIGHLIGHTS KEY MOMENTS IN DEADLY CRUISE CRISIS

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Exposure is most likely when cleaning enclosed or poorly ventilated areas where rodents may nest unnoticed for weeks or months, health officials say.

Risky locations can include garages, sheds, cabins, attics, barns and crawl spaces. Storage units, stables, kitchen cabinets and spaces behind appliances if rodents are present.

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Rodents can also nest in unused cars, RVs, campers and boats, which can be sources of exposure when reopened.

The National Park Service says that most human cases of hantavirus occur in the spring and are linked to buildings that become heavily infested with rodents over the winter.

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The risk of inhalation is also higher when opening buildings that have gone unused for longer periods of time, sweeping dusty floors, or moving and unpacking boxes. (iStock)

“Most people are exposed when cleaning out sheds and garages where rodents have been living,” Yancey confirmed. “You can be exposed by just the dust and droppings left behind by rodents – you don’t even need to even see the rodent to be exposed.”

The risk of inhalation is also higher when opening buildings that have gone unused for longer periods of time, sweeping dusty floors or moving and unpacking boxes, experts cautioned.

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Rodent exposure is not limited to buildings. Health officials say people can also encounter hantavirus risk while handling firewood, working in rodent-prone outdoor areas or disturbing rodent nests and burrows. 

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To prevent infection, if cleaning a structure that might have harbored rodents, Yancey recommends wearing a mask and using a diluted bleach solution to wet down any dust or loose debris.

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“This will help kill the exposed virus and reduce the amount of infectious dust,” Yancey said.

The CDC advises against vacuuming or sweeping rodent urine, droppings or nesting materials, as this can aerosolize the virus and increase the risk of inhalation.

A Spanish passenger boards a government plane after disembarking from the hantavirus-stricken cruise ship MV Hondius at the airport in Tenerife, Canary Islands, on May 10, 2026. (Arturo Rodriguez/AP Photo)

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Instead, health officials recommend wearing gloves, soaking rodent droppings with disinfectant, wiping them up with paper towels, properly disposing of waste and thoroughly cleaning surfaces, followed by careful handwashing.

Some signs of rodent activity can include droppings, shredded nesting materials, gnaw marks, strong musky odors and scratching sounds in the walls or ceilings, according to public health guidance.

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Dr. Marc Siegel, Fox News senior medical analyst, emphasized that hantavirus is not something that most Americans encounter in daily life, and is more prominent in certain parts of Europe and Asia.

“It is very rare in the U.S. and is seen out west, but rarely,” he told Fox News Digital. “We need to avoid overpersonalizing the risk of a very rare virus.”

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