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FDA food inspector vacancies near 20% after Trump hiring freeze

Nearly 1 in 5 positions across the Food and Drug Administration’s human food inspection divisions are now vacant, multiple agency officials tell CBS News, in the wake of departures encouraged by the Trump administration’s cost-cutting efforts and a government-wide hiring freeze that had stalled efforts to replenish their ranks.

While the FDA has long struggled with hiring and retaining qualified investigators to inspect food producers and distributors, multiple federal health officials — who spoke on the condition of anonymity and were not authorized to speak to the press — say that the staffing gap has worsened due to early retirements and resignations.

“The FDA remains fully capable of fulfilling its public health mission to protect the safety of the American people. Under Commissioner Makary’s leadership, the agency continues to meet its inspection obligations, ensuring that all facilities are reviewed within mandated timeframes,” Emily Hilliard, a spokesperson for the Department of Health and Human Services, told CBS News.

FDA Commissioner Dr. Marty Makary has claimed in interviews that no inspectors were laid off at the agency as a result of the sweeping restructuring ordered by Health and Human Services Secretary Robert F. Kennedy Jr. that began in April, but has not acknowledged the retirements and resignations.

And despite Makary’s statements, multiple FDA officials said they are worried about worsening attrition in the agency’s ranks of investigators. 

“They’re not going to admit our mission is at risk and we’re missing timeframes, even though I’ve heard that’s happening,” a current FDA official told CBS News in a message. 

A separate current FDA official and one former official said that close to 20% of investigational positions are vacant across the agency’s human foods inspectorate. 

“Since 2017, our ability to fulfill its public health mission is increasingly constrained by reduced inspectional capacity. We continue to face significant obstacles in recruiting and retaining qualified investigators, particularly in the foods program, where nearly 90 investigative positions remain vacant,” the agency said last month in response to a draft of a report by the HHS inspector general. 

The inspector general had concluded that the FDA would need to increase inspections by more than 3,000 each year, in order to meet its goals. Under requirements laid out by Congress, the FDA is required to inspect food facilities at specific intervals, benchmarks that government watchdogs have long faulted the agency for falling short of.

“For FDA to meet the inspection timeframes moving forward, it would need to inspect approximately 7,000 high-risk facilities each year. However, FDA inspected only about 58 percent of that amount,” the inspector general’s June 2025 report said.

Around 40% of investigator positions are vacant for the group of investigators tasked with inspecting “critical foods” like infant formula plants, a current official said.

“Critical foods has had difficulty with staffing because every inspection is high profile and the team is traveling more often than not. It isn’t sustainable for everyone,” a former FDA official said.

The job of an FDA investigator has gotten harder in recent months, as the Trump administration imposed additional hurdles to make small purchases necessary for their work, ranging from buying everyday supplies to shipping samples, officials said.

“The reality is that the extra steps in budget approval processes have caused inspections to be delayed, and investigators have had to take on administrative tasks that eat into their time being productive. Everything was taking longer,” the former FDA official said.

Many administrative staff and laboratory scientists supporting the FDA’s food inspectors were also eliminated through layoffs, resulting in backlogs of testing and reimbursements. Some have since been reinstated by the agency.

One current and one former FDA official said the agency also had many investigators that were in the process of being hired months ago, before attempts to fill the slots were blocked by an order signed by President Trump that now extends through July 15. 

Multiple officials said Friday morning they were hopeful that the Trump administration might grant an exemption to the hiring freeze after weeks of lobbying by officials within the agency.

On Friday afternoon, after HHS responded to a CBS News request for comment about this story, the FDA published its first new hiring announcement for food investigators in months, among a handful of new job postings.

“This position is being filled under a stream-lined hiring authority,” the job posting reads.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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FDA to

Health and Human Services Secretary Robert F. Kennedy Jr. has asked Food and Drug Administration Commissioner Marty Makary “to review the latest data on mifepristone,” raising questions about the drug commonly referred to as the abortion pill. 

A spokesperson for the FDA confirmed the plans in a statement to CBS News Tuesday, but did not respond to questions about when the review is scheduled to start and what exactly it will be reviewing about the medication.

According to a letter published on social media Monday by Republican Sen. Josh Hawley of Missouri, Makary’s review aims to closely monitor the drug’s safety. But experts say concerns about its safety are misguided, fueled in part by a report from the Ethics and Public Policy Center, an advocacy group that promotes religious traditions and is funded by multiple right-wing organizations.

Mifepristone, which is taken with a second drug, misoprostol, to end an early pregnancy, was first approved by the FDA in 2000 after “a thorough and comprehensive review” determined it was safe and effective, the agency says. Periodic reviews since its approval have not found new safety concerns, according to the FDA.

In the Ethics and Public Policy Center report, which was not published in a peer-reviewed scientific journal, the authors, who don’t have medical training, claim the pill harms women, causing 1 in 10 patients to experience what they call a “serious adverse event,” including hemorrhage, ER visits, ectopic pregnancy and an undefined category of “abortion-specific complications.”

Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, said some of the instances described as “adverse events” are questionable. 

“When you have a medication abortion, you bleed. That is normal. That is not an adverse event unless the bleeding is so significant that a woman needs a transfusion,” she explained. “It is to be expected that not all medication abortions will successfully eliminate the pregnancy. A surgical abortion after incomplete/failed medication abortion should not be considered an adverse event. … An ectopic pregnancy is not caused by mifepristone and should not be considered a serious adverse event.”

Gounder added that the report lacks transparency and doesn’t disclose the data source, meaning no one can reproduce and verify the findings, something Kennedy himself said he’s a proponent of, noting in his confirmation hearings that he wants to replicate studies.

It also lacks a comparison group, Gounder said, which is important for examining how experiences compare to pregnant women who did not take the drug. 

CBS News has reached out to the makers of the generic and brand name of mifepristone for comment. 

While it’s unclear whether the latest review of the drug will impact access, this isn’t the first time it has come under fire. 

In 2024, the Supreme Court rejected a challenge targeting the availability of the widely used pill, preserving access to the drug in its first major abortion-related ruling since the reversal of Roe v. Wade. If the challengers had prevailed, the ruling would have restricted access to mifepristone nationwide, even in states where abortion is legal.

The justices unanimously ruled that the anti-abortion rights doctors and medical associations who brought the lawsuit against the FDA did not have the legal right to do so. They did not address whether the FDA acted lawfully when it took a series of steps in 2016 and 2021 that relaxed the rules for mifepristone’s use.

Makary had previously said that he had “no plans to take action on mifepristone,” which has been a target of abortion opponents and conservatives who have called on the FDA to reconsider its approval.

Since it was approved, mifepristone has been taken by more than 5 million patients, according to the FDA. Medication abortions made up more than half of all abortions in the United States health care system in 2023, a study from the Guttmacher Institute, an abortion rights research group, found. 

In 28 states, there are policies restricting access to mifepristone in some way, according to the Guttmacher Institute, four of which prohibit the mailing of abortion pills to patients.

Melissa Quinn and

Alexander Tin

contributed to this report.

Sara Moniuszko

Sara Moniuszko is a health and lifestyle reporter at CBSNews.com. Previously, she wrote for USA Today, where she was selected to help launch the newspaper’s wellness vertical. She now covers breaking and trending news for CBS News’ HealthWatch.

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U.S. reports cases of new COVID variant NB.1.8.1 behind surge in China

The Centers for Disease Control and Prevention‘s airport screening program has detected multiple cases of the new COVID-19 variant NB.1.8.1, which has been linked to a large surge of the virus in China. 

Cases linked to the NB.1.8.1 variant have been reported in arriving international travelers at airports in California, Washington state, Virginia and the New York City area, according to records uploaded by the CDC’s airport testing partner Ginkgo Bioworks.

Details about the sequencing results, which were published in recent weeks on the GISAID, or Global Initiative on Sharing All Influenza Data, virus database, show the cases stem from travelers from a number of countries, including Japan, South Korea, France, Thailand, the Netherlands, Spain, Vietnam, China and Taiwan. The travelers were tested from April 22 through May 12, the records show.

A spokesperson for the CDC did not immediately respond to CBS News’ request for comment.

Cases of NB.1.8.1 have also now been reported by health authorities in other states, including Ohio, Rhode Island and Hawaii, separate from the airport cases. In California and Washington state, the earliest cases date back to late March and early April.

Experts have been closely watching the variant, which is now dominant in China and is on the rise in parts of Asia. Hong Kong authorities say that rates of COVID-19 in the city have climbed to the worst levels they have seen in at least a year, after a “significant increase” in reported emergency room visits and hospitalizations driven by COVID-19. 

While authorities in Hong Kong say there is no evidence that the variant, a descendant of the XDV lineage of the virus, is more severe, they have begun urging residents to mask when in public transportation or crowded places as cases have climbed.

Health authorities in Taiwan have also reported a rise in emergency room visits, severe cases and deaths. Local health authorities say they are stockpiling vaccines and antiviral treatments in response to the epidemic wave.

Preliminary data from researchers in China suggest the NB.1.8.1 variant is not better at evading the immune system compared to other strains on the rise, but it does have a greater ability to bind to human cells, suggesting it could be more transmissible.

“A more predictable pattern”

The strain came up multiple times during a Thursday meeting of the Food and Drug Administration‘s outside vaccine advisers, as they wrestled with whether and how to recommend updating COVID-19 vaccines for the coming fall and winter seasons.

Vaccines from last season targeted a descendant of the JN.1 variant called KP.2. Early data presented to the committee by Pfizer and Moderna suggested switching to a different JN.1 descendant that has been dominant in recent months, called LP.8.1, could boost protection against NB.1.8.1, too. 

“The LP.8.1 vaccine has the highest titers against LP.8.1, which is dominant in the U.S. and many other regions and cross-neutralizes other currently circulating variants, including NB.1.8.1, a dominant JN.1 subvariant in many Asian countries,” Darin Edwards, lead of Moderna’s COVID-19 program, told the panel.

The committee unanimously backed recommending that the coming season’s vaccines should target some kind of JN.1 variant, but was split on the details. Some favored allowing vaccine makers to stick with last season’s vaccines, while others called for the update to target the LP.8.1 descendant of JN.1 that Pfizer and Moderna have prototyped.

“Although one can’t predict evolution, and you don’t know how this is going to keep diversifying, the overwhelming odds are that what does come and predominate in the next few months, the next six months, next year will come from something that’s circulating now. It won’t come from something that doesn’t exist any longer,” Jerry Weir, director of the FDA’s division of viral products, said.

For now, CDC and FDA officials told the panel that only one strain — a variant called XFC — has been significantly growing in the U.S. But they cautioned that the evolution of the virus has been unpredictable, even as the country has settled into a relatively predictable pattern of two surges a year: once in the summer and once over the winter.

This past season only saw an evolutionary “drift” in the virus, as opposed to the kind of sweeping replacements driven by highly mutated strains in some earlier years. While COVID-19 trends climbed over the winter, they remained far below previous peaks.

“Throughout this winter, we didn’t see that strain replacement that we have in the past couple of years. But I’m not saying that the virus will not shift again in the immediate future,” the CDC’s Natalie Thornburg told the panel. Thornburg is the acting chief of the laboratory branch in the CDC’s division for coronaviruses and other respiratory viruses.

Rates of COVID-19 have now fallen back to low levels nationwide, measured through emergency room visits and wastewater testing.

“I do think after five years now, we are seeing very distinct patterns that [are] falling into a more predictable pattern,” Thornburg said, citing a “seasonality analysis” that the agency has been working on about the virus. 

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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FDA expands COVID vaccine warning about heart side effect risk for young males

The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data.

Orders to expand the warnings were posted Wednesday by the FDA, in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine.

Both vaccines previously carried warnings about how the risk of the heart side effects — which doctors call myocarditis (an inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) — looked to be higher in young men, generally within the first week after vaccination. While the earlier labels specified ages 18 to 24 years old for Moderna’s vaccine and 12 to 17 years old for Pfizer’s, the new warning will apply to males ages 16 to 25 for both vaccines.

“Following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines, the highest estimated incidence of myocarditis and/or pericarditis was in males 16 through 25 years of age,” the FDA says in the new blanket warning it will require for both vaccines.

The rate of myocarditis and pericarditis was around 8 cases per million doses for children and adults under 65 years old after use of that season’s vaccines, the FDA says.

The new warnings ordered by the FDA add that the “highest estimated incidence was in males 16 through 25 years of age,” with a rate of 38 cases per million.

The Centers for Disease Control and Prevention has previously described rates of myocarditis and pericarditis as rare after COVID-19 vaccination. 

CDC officials told the agency’s vaccine advisers last month that acute myocarditis “tends to resolve quickly” after vaccination, and no increased risk had been seen in data from recent seasons in people 12 to 39 years old.

It is unclear whether Pfizer or Moderna disputed the order. They had “within 30 calendar days of the date of this letter” to try to rebut the demand. Spokespeople for Moderna and Pfizer did not immediately respond to a request for comment.

“Americans deserve radical transparency around the safety and efficacy of COVID vaccines and the FDA is delivering on their promise to do just that. Spikevax and Comirnaty should take steps to ensure that individuals are aware of COVID vaccine-related adverse events resulting in myocarditis and pericarditis,” Andrew Nixon, a spokesperson for the Department of Health and Human Services, told CBS News in an email. Nixon did not explain why the letters were posted more than a month after they were written.

They appeared on the FDA’s website hours ahead of a hearing organized by the Republican-led Senate Homeland Security and Governmental Affairs Committee on “how health officials downplayed and hid myocarditis and other adverse events associated with the COVID-19 vaccines.”

Aaron Siri, an attorney who worked closely with Health and Human Services Secretary Robert F. Kennedy Jr. in the past to call on the FDA to pull COVID-19 and other vaccines and vet nominees during the transition, is among the witnesses.

The FDA says the warnings were spurred by new data from the agency’s safety surveillance system and results published in October from scientists following up with people who developed COVID-19 vaccine-associated myocarditis.

Talks about this kind of safety labeling change began before the ouster of the FDA’s previous top vaccines official, Dr. Peter Marks, multiple people familiar with the situation said, but had not yet been finalized as officials wrestled with how to accurately present the findings. Marks left the FDA on April 5.

Scientists in that study followed up with people who had faced chest pain and elevated amounts of troponin in their blood, a protein that usually signals some kind of heart damage. They were predominantly young adolescent males.

“While their clinical course was nearly always mild with a low prevalence and extent of cardiac dysfunction, myocardial injury was common,” the scientists wrote in the study, which was co-authored by FDA officials.

Similar to what the study described, the FDA’s new warning also says that the heart MRI findings showed “improvement over time in most people.”

“It is not known if these heart MRI findings might predict long-term heart effects of myocarditis. Studies are underway to find out if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine,” the FDA said.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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Who can get updated COVID vaccines this fall? FDA will OK for high-risk groups, calls for new clinical trials

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use. The decision means many Americans without underlying conditions may not have access to updated shots.

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” the agency said in an article published by The New England Journal of Medicine, authored by FDA Commissioner Dr. Martin Makary and his new top vaccines official, Dr. Vinay Prasad.

Vaccine manufacturers will need to conduct “randomized, placebo-controlled trials” before the FDA will approve future applications to give shots to “all healthy persons” between the ages of 6 months and 64 years old, they wrote. 

Otherwise, companies will only be able to get their routine COVID-19 vaccine updates approved for seniors as well as people with an underlying medical condition that increases the risk of severe disease, like pregnancy or diabetes.

“The range of diseases in the CDC definition of high risk of severe disease is vast, including obesity and even mental health conditions such as depression. Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,” they wrote.

Makary and Prasad criticized the U.S. for adopting “a one-size-fits-all regulatory framework” to grant broad authorization for past COVID-19 vaccine boosters in the past, and cited poor uptake of past annual COVID-19 booster shots. 

They also pointed to other developed countries that have already limited annual COVID-19 vaccine boosters to only older adults and those with underlying conditions that increase their risk of severe disease.

“The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view,” they wrote. 

The new “regulatory framework for COVID-19 vaccination” laid out by the FDA’s new leadership under Health and Human Services Secretary Robert F. Kennedy Jr. comes ahead of a key meeting of the agency’s outside vaccine advisers this Thursday, to decide on how to update the strain used in next season’s shots. 

In recent years, the FDA has greenlighted those updates in a process similar to the annual flu shots, based largely on laboratory data showing the vaccines can trigger antibody levels similar to previously approved shots. 

That is a lower bar than requiring brand new randomized trials of the vaccines tested against a placebo to show it prevents symptomatic disease — a process which is usually only required for new shots when there is no currently approved immunization available. 

But Makary and Prasad said COVID-19 shots should be held to a different standard, citing differences in how the virus mutates and the immunity offered by vaccines and previous infection. 

“Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based,” they wrote.

It is unclear whether and when vaccine makers would be able to conduct these kinds of trials, if they wanted to try again for a broader approval from the FDA. Makary and Prasad floated the possibility of trials as soon as the coming months.

“Covid-19 has summer transmission that can facilitate the conduct of randomized studies that continue to apply in future time periods,” they wrote. 

Spokespeople for vaccine manufacturers Pfizer and Moderna did not immediately respond to a request for comment. A Novavax spokesperson declined to comment.

Novavax earned a narrow FDA approval over the weekend for its COVID-19 vaccine, which was limited to seniors as well as adults and adolescents with at least one underlying condition.

While U.S. health care providers are usually allowed to administer vaccines with FDA approval “off-label” outside the limits laid out by the agency, a narrower approval can affect access and limit insurance coverage for the vaccinations. 

It comes as the Centers for Disease Control and Prevention has also been weighing narrowed recommendations for the shots.

The CDC’s recommendations directly impact which vaccinations health insurers are required to cover under the law. 

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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FDA to revisit approval of

The Food and Drug Administration is planning to revisit its approval of the food additive ADA, the agency’s top foods official announced Thursday, after longstanding questions over the safety of the so-called “yoga mat” chemical that can be a bread ingredient in the U.S. but is banned in Europe. 

Also called azodicarbonamide, the FDA previously approved ADA’s use to whiten cereal flour and improve baking bread dough. 

Advocacy groups have criticized the use of this chemical in food for years, over concerns about its potential health risks. The “yoga mat” nickname comes from ADA’s other uses in the manufacturing of plastics and rubbers. 

In Europe, it is illegal to add the ingredient to bread, given the possibility it could result in a possible carcinogen called semicarbazide when it breaks down into other chemicals during bread making. 

After international health authorities in recent years also raised concerns over its use in food, guidance from 1965 that had previously allowed for its use was withdrawn by a committee convened by the United Nations over worries that there was not enough data to support its safety.

The FDA previously said that it thought azodicarbonamide remained safe to add to food, after studying how much semicarbazide Americans might be eating. The agency said studies in some mice found that semicarbazide could cause tumors, but only at levels that “far exceed” the estimated amounts people are eating through bread and other foods.

Other ingredients that the agency is planning to add to its list of food additives that it’s prioritizing for a renewed safety review include BHT and BHA, two preservatives that are authorized for some food uses in Europe but have also faced concerns over the risk they could cause cancer.

News of the ingredients being prioritized for review was announced by Kyle Diamantas, the current acting deputy commissioner in charge of the FDA’s Human Foods Program, alongside a new plan he said would further step up scrutiny of previously approved food chemicals.

“That plan will include the creation and rolling out of a modernized, evidence-based prioritization scheme for reviewing chemicals presently in the food supply, and that will be made available for public comment later this month,” Diamantas said.

The Food Fix newsletter previously reported that the plan would soon be released.

Diamantas also said that details of the agency’s systematic process to review the safety of chemicals in the food supply will soon be finalized, after the Biden administration first proposed laying out a more formal approach last year. 

“As many of you know, there were meetings last year and we ultimately had over 70,000 comments on our post-market review process framework,” Diamantas said at a session of the Food Safety Summit conference Thursday. 

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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Do COVID-19 tests still work after they expire? Here’s how to tell.

With COVID-19 cases on the rise again in the U.S., Americans are reviving a familiar precautionary measure: Screening for the virus using rapid at-home tests.

Many people still have kits the government formerly provided to all households for free, especially as some schools and businesses again require tests. Yet different COVID-19 tests bear expiration dates on their packaging that have long since passed, raising questions about whether they’re still effective. 

Once in short supply, test kits are now easier to come by, but they can be costly in stores, roughly $25 for a pack of two tests. It’s also possible for both insured and uninsured people to get free testing.

If you still have any older tests stored away, the good news is that some COVID-19 test kits that are past their expiration dates may still be effective. Here’s how to find out if your  COVID-19 test is safe to use. 

Why did the FDA extend expiration dates?

The Food and Drug Administration maintains a list of authorized over-the-counter  COVID-19 diagnostic tests that indicate if the expiration date printed on their packaging is valid or if it has been extended. 

The FDA has extended the expiration dates of several different test brands, lengthening their shelf lives to up to two years. The extensions come in response to manufacturers testing their kits for accuracy beyond their printed expiration dates and sharing the results with the FDA. 

See the FDA’s full list of test-kit expiration date extensions here. 

Which test brands can you use after they’ve “expired”?

Abbott’s widely used BinaxNow COVID-19 test kits now have a shelf life of up to 22 months, depending on when the tests were manufactured. In January of 2023, the pharmaceutical firm told customers that kits they’d previously purchased “may now have a longer than labeled product expiry date.” To see if a BinaxNOW COVID-19 Antigen Self Test kit in your possession has a new expiration date, you can search for its lot number in the attached list here.

“All BinaxNOW COVID-19 Antigen Self Test kits currently have a twenty-two-month expiry date,” the company said. Abbott added that expiration dates could be extended again in the future, pending new data on their viability.

The Flowflex COVID-19 Antigen Home Test from Acon Laboratories can also be used well past its printed expiration date, according to the FDA, which granted the extension in March. The tests are good for an additional year past their expiration dates. For example, tests with printed “October 2022” expiration dates should be considered appropriate for usage until October 2023. 

What happens if a COVID-19 test is truly expired?

Users of other tests, like Ellume’s COVID-19 Home Test, should refer to the expiration date printed on the tests’ packaging. If a test truly has expired, the results it delivers cannot be trusted, according to the FDA.

“COVID-19 tests and the parts they are made of may degrade, or break down, over time. Because of this, expired test kits could give inaccurate or invalid test results,” the FDA said in a statement on its website. 

Megan Cerullo

Megan Cerullo is a New York-based reporter for CBS MoneyWatch covering small business, workplace, health care, consumer spending and personal finance topics. She regularly appears on CBS News 24/7 to discuss her reporting.

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FDA head falsely claims no scientists laid off, as agency shutters food safety labs

The head of the Food and Drug Administration has repeatedly claimed in recent interviews that no scientists have been laid off at his agency, but one of the scientists in a food safety lab shuttered by the FDA’s cuts says he is either “blatantly lying” or “out of touch.”

“There were no layoffs to scientists or food inspectors,” FDA Commissioner Dr. Marty Makary told CNN on Wednesday. Makary previously said in an April 17 interview with Megyn Kelly that there “were not cuts to scientists, or reviewers, or inspectors. Absolutely none.”

“That just made me so mad, that he said no scientists were cut,” said one laid-off FDA scientist, a chemist who had worked for the agency for years.

Nearly all of the scientists at food safety laboratories run by the FDA in the San Francisco and Chicago areas received layoff notices this month, four laid-off chemists and microbiologists said. The scientists, who were not authorized to speak publicly, spoke on the condition of anonymity. 

The San Francisco lab, opened during the first Trump administration, had been ramping up testing of infant formula. Its closure has now reduced the agency’s baby formula testing capacity by a quarter, at a time when Health and Human Services Secretary Robert F. Kennedy Jr. has called for stepped up testing, laid-off scientists said.

“Do you know and you’re blatantly lying? Or do you not know, and you’re just that out of touch,” the chemist said of Makary’s comments.

An FDA spokesperson said that the labs were planned to be decommissioned by the agency before the reorganization by the White House’s Department of Government Efficiency and Kennedy that resulted in the layoffs. The spokesperson declined to comment on the discrepancy between Makary’s remarks and the layoffs.

Most of the staff at those labs have not been back in the building since April 1, when they packed up their belongings. 

Like other laid-off employees at the FDA, the scientists received a “reduction in force” notice that they were being put on leave and would be let go from the FDA on June 2. The letters said that their “duties have been identified as either unnecessary or virtually identical to duties being performed elsewhere in the agency.”

For now, a handful of employees say they have been asked back to work for a few more weeks, but only to start the process of shuttering their former labs, disposing of samples and supplies.

They were previously responsible for everything from researching the safety of new techniques of food processing to investigating food products for contamination with toxic metals. 

Scientists in the San Francisco lab had been the only ones able to test for bird flu contamination in pet food in the agency’s network, multiple FDA officials said. The lab’s scientists were the only ones with the expertise and specialized “biocontainment infrastructure” to do the testing, a memo shared with CBS News circulated among agency officials said.

Scientists in that lab had also been responsible for major food safety investigations in recent years, given its proximity to major agricultural producers in the region. More than half of the fresh produce in the U.S. is grown in Northern and Central California. 

Outbreak investigators would often rush samples back to the lab for testing, multiple laid-off scientists recounted, sometimes requiring staff in the lab to work through the weekends and holidays. 

“Every day they were getting samples, five or six samples a day. During the onion outbreak, oh my goodness, there were onions everywhere. The whole lab smelled like onions,” one laid-off scientist in the San Francisco lab recalled of their work during the 2024 investigation of contaminated onions used in McDonald’s Quarter Pounders. 

The FDA had also recently poured tens of millions of dollars into moving and updating the San Francisco lab to a new location, scientists and officials said. It had a ribbon-cutting near the end of the first Trump administration. 

FDA officials at the time touted the lab as critical for a range of food safety testing efforts. It had a lab set up to be free of any metal, needed for advanced investigations into products that could be contaminated with toxic heavy metals like lead and cadmium.

The agency had also purchased new technology for the lab to test food for unapproved color dyes that had been added to products, which could pose a safety risk.

“FDA scientists will be able to process samples of food and other products and to detect dangerous components, like heavy metals, with extraordinary sensitivity: in the parts-per-trillion range,” Dr. Amy Abernethy, one of the agency’s top officials during the end of the first Trump administration, said in 2019 at the lab’s reopening.

Scientists there had been preparing to ramp up testing of baby formula as part of “Operation Stork Speed,” ordered by Kennedy earlier this year to increase checks for heavy metal contaminants. They were also working on launching the capacity to analyze the nutrients in baby formula, which only one other lab in the FDA’s network is equipped to do. 

“We have a lot of brand new equipment that’s sitting on the bench waiting to be used. We have to do massive verification, validation before we can start analysis. So we were in the middle of that. Now, all of those brand new equipment will go to waste,” one laid-off scientist said.

Multiple FDA scientists said they estimated it would likely take millions of dollars and months of work to formally shut down the lab, let alone to transfer their workload to the FDA’s remaining scientists. 

“The other labs, they are overwhelmed with some samples because we’re not doing the testing anymore,” one laid-off scientist said.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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FDA to undo some layoffs, after cuts to inspections and drug safety

Food and Drug Administration officials have told some scientists and inspections staff that their layoffs will be reversed, after the job cuts led to disruptions in drug and food safety work.

The move marks a significant reversal of a portion of Health and Human Services Secretary Robert F. Kennedy Jr.‘s layoffs. Kennedy initially planned to cut 3,500 employees from the FDA.

In team-wide meetings that started last week, multiple FDA employees said they were informed by their supervisors that they should expect to have their layoffs reversed. 

Among the laid-off staff told they would be brought back are scientists for drug safety labs in Puerto Rico and Detroit as well as food safety labs in Chicago and San Francisco. A handful of support staff for the FDA’s inspectors are also being brought back.

Multiple FDA scientists said they were eager to go back to work, though they had yet to receive official paperwork for reversing the layoffs.

The New York Times first reported that the FDA’s food safety labs were being reinstated.

A spokesperson for the Department of Health and Human Services blamed errors in the layoffs on inaccurate data from the department’s “siloed HR divisions.”

“This is exactly why HHS is reorganizing its administrative functions to streamline operations and fix the broken systems left to us by the Biden Administration. Streamlining this into one operation will allow for enhanced data integrity and coordination,” the spokesperson said.

Kennedy has previously said some layoffs would be walked back, like to the Centers for Disease Control and Prevention’s lead poisoning teams. But that reversal never ended up happening, leaving the agency’s lead poisoning work largely abandoned.

Some CDC laboratories also remain closed, including the agency’s now-shuttered labs for investigating outbreaks of hepatitis and sexually transmitted diseases or for worker safety, like oversight of N95 masks.

FDA inspections falling behind

Around two dozen of the support staff for the FDA’s inspectors have been told their layoffs would be reversed, out of nearly 200 who were cut. The employees being restored are focused on booking travel for foreign inspections.

Cuts to the FDA’s Office of Inspections and Investigations have taken a steep toll on the agency’s inspections, especially for overseas manufacturers of drugs and food products. 

A pilot program started under the Biden administration to expand unannounced foreign inspections stalled due to the cuts, multiple officials said. In a recent week, one FDA official said less than 60% of the agency’s planned foreign inspections had been completed. 

Sidelined inspectors of foreign firms have been asked to find ways to “pivot to” local inspections they can do within the U.S. instead, according to internal emails shared with CBS News. More than $700,000 of expenses incurred by inspectors have also yet to be paid, an official said, due to the layoffs to support staff.

Hopes by FDA leaders to increase inspections have also run up against an ongoing federal hiring freeze, officials said, especially as the ranks of supervisors for inspectors have been depleted by early retirements and resignations.

FDA Commissioner Dr. Marty Makary had initially greenlighted a plan to use contractors to fill the gap, before the department moved to reverse some of the layoffs. 

FDA drug safety work stalls

Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency’s drug safety work. Virtually all the scientists in the FDA’s San Juan and Detroit labs were cut, leaving only labs in New York and Irvine, California. 

The FDA labs in Detroit and San Juan had also been responsible for checking the shelf life of medical treatments stockpiled by the federal government for the military and pandemics, under a program administered by the Department of Defense. 

The layoffs also cut chemists based out of the labs who worked as foreign inspectors for the FDA, often assigned to travel with badge-carrying investigators to help with more complex or urgent frontline inspections of drugmakers.

Some of the agency’s work to detect and investigate fraudulent medical products had also effectively stalled, they said, amid complications around transferring the custody of the samples and a backlog of work that predated the April 1 layoffs. 

The FDA’s labs had already been struggling with new hurdles to purchasing that had slowed their work, as staff waited for weeks in some cases for supply orders, officials said.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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FDA chief says they’re looking at whether to approve COVID shots for next winter

The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.

“We’re taking a look. I can’t comment on any particular application. As you know, we have a bunch of applications for those booster shots,” FDA Commissioner Dr. Marty Makary told CBS News chief Washington correspondent Major Garrett.

Makary said many health care workers did not get the last round of COVID-19 vaccine booster shots, calling it “a bit of a public trust problem.”

“I think there’s a void of data. And I think rather than allow that void to be filled with opinions, I’d like to see some good data,” Makary said.

His answer marks a change from during the Biden administration, when FDA officials backed plans to routinely update the COVID-19 vaccines each year.

Last year, the FDA issued guidance on what strain should be targeted by the shots for the following winter. Updates to Moderna and Pfizer’s COVID shots for the new strain were approved in August.

The Centers for Disease Control and Prevention is also now weighing whether to significantly narrow its recommendations for COVID-19 vaccines.

Makary’s remarks echo his justification for delaying Novavax’s COVID-19 vaccine, which was expected to get full approval on April 1. Novavax said Monday that the FDA had asked the company to commit to another clinical trial of the shot.

“Today, there is broad population immunity, and the big question is does it provide a benefit? Without a study on the new formulation and product, we can’t give an honest evidence-based answer to that question,” Makary told the newsletter “Inside Medicine” this week.

Multiple companies are now also being asked “to do clinical studies, a basic clinical study, so we can educate the population and have information to work with,” Makary told CBS News.

“It’s my general feeling, not with this particular product, which I can’t discuss in depth, but with drugs in general, that we need to know if they work today in order to be able to recommend them,” he said. 

He also praised his special assistant, Dr. Tracy Beth Høeg, when asked what role she played in the agency’s evaluation of Novavax’s application. 

“Dr. Høeg is an amazing M.D.-Ph.D. who has joined my staff as a special assistant to the commissioner. And she is involved in reviewing data sets at the agency. And I’m really excited to have her in the process,” Makary said.

Trade industry publication The Pink Sheet previously reported that Høeg had been asked to step in on Novavax’s application. Høeg was also added to the CDC’s Advisory Committee on Immunizations, in a slot previously filled by a career vaccines official from the FDA.

Former FDA officials have criticized the agency’s new political leadership for their intervention in vaccine approvals, a process which is usually entrusted to career scientific officials.

In a commentary published this week, former officials Phil Krause and Luciana Borio called on the FDA to “stick to its normal processes.”

“Shifting standards and late-stage demands for new data — based on faulty scientific assumptions — erode trust, delay access to important tools, and discourage developers from advancing vaccine innovation,” they wrote.

Alexander Tin

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers federal public health agencies.

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