Food Safety Archives - 吃瓜不打烊 /tag/food-safety/ 吃瓜不打烊 produces in-depth journalism on health issues and is a core operating program of KFF. Fri, 28 Aug 2026 22:13:27 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.8 /wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=32 Food Safety Archives - 吃瓜不打烊 /tag/food-safety/ 32 32 161476233 With Midterms Looming, Journalists Consider Measles, Food Recalls, and Obamacare /on-air/on-air-august-29-2026-measles-vaccination-food-recalls-midterm-elections/ Sat, 29 Aug 2026 09:00:00 +0000 /?p=2281043&preview=true&preview_id=2281043

Céline Gounder, 吃瓜不打烊’ editor-at-large for public health, discussed fatal measles cases on CBS News 24/7’s Mornings on Aug. 26. Gounder fact-checked Centers for Medicare & Medicaid Services Administrator Mehmet Oz’s comments about vaccines and drug prices on CBS News 24/7’s The Daily Report on Aug. 24. She also discussed food recalls this summer on CBS News 24/7’s The Takeout With Major Garrett on Aug. 24.

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吃瓜不打烊 chief Washington correspondent Julie Rovner discussed kindergarten vaccination rates on WNYC’s The Brian Lehrer Show on Aug. 25.

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吃瓜不打烊 contributor Mark Kreidler discussed the use of artificial intelligence for Medicaid reenrollment on KVPR’s Central Valley Daily on Aug. 24.


吃瓜不打烊 senior correspondent Julie Appleby discussed the state of the Affordable Care Act on Vox’s Today, Explained podcast on Aug. 24.

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吃瓜不打烊 Georgia correspondent Briah Lumpkins discussed the importance of healthcare policy in upcoming elections on WUGA’s The Georgia Health Report on Aug. 21.

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吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Nurses Chase Cyclospora, Aided by Interviews, Fast-Food Receipts 鈥 And the Messy Details /public-health/cyclospora-cyclosporiasis-outbreak-diarrhea-contact-tracing-michigan/ Tue, 04 Aug 2026 09:00:00 +0000 /?p=2268222

More than 900 people in Washtenaw County, Michigan, have been sickened with cyclosporiasis since mid-June. Linda Kim, a public health nurse, has called more than 100 of them. Almost everyone has said the same thing: It’s excruciating, and one of the worst illnesses they’ve experienced.

But on a Wednesday in July, she called one man who said he wouldn’t mind having it again, actually.

“You’re enjoying the weight loss?” Kim said, laughing as she took notes in a small conference room at the Washtenaw County Health Department building, just outside Ann Arbor. “Well, I’m glad to hear that. At least you got something good out of it!”

Normally, Kim’s supposed to be working downstairs in the clinic, where families wait in gray plastic chairs in the lobby for free or low-cost immunizations. But she hasn’t been there in months.

In March, Kim was transferred to a different department to help deal with a measles outbreak that sickened seven people in the county, five of them children. It was an all-hands-on-deck situation; everyone worked overtime. The state issued an advisory urging families in Washtenaw and surrounding counties to get babies 6 months or older vaccinated ahead of schedule, if possible.

The contact-tracing calls for measles could be contentious, Kim said. People were suspicious, asking her how she knew they had tested positive, or why they should give her any information.

“People were like, 鈥極h, you’re just trying to restrict my life,’ or 鈥榊ou’re just trying to get information out of me and get me in trouble,’” she said. “It’s like, no, we’re actually not doing that at all.”

As she tried to explain to them, tracing the spread of the virus and publicizing possible exposure sites was an effort to “keep it contained, so it doesn’t become something huge.”

A white sign on a sidewalk says "Stop. If measles testing, return to car. Call 7345446700"
Before reports of cyclosporiasis cases started pouring in this summer, Washtenaw County Health Department staff in Michigan were working to contain a measles outbreak with contact tracing and testing. The county’s outbreak ended in May. (Kate Wells/吃瓜不打烊)

The county’s measles outbreak ended in late May. Then in June, reports of cyclosporiasis cases started pouring in 鈥 so far in Michigan, including two deaths. Both people who died had “significant underlying health conditions that may have been impacted by cyclosporiasis and dehydration,” the state health department said on its website Aug. 3. Health officials aren’t providing more details, department spokesperson Lynn Sutfin said in an email, but are stressing that cyclosporiasis generally isn’t life-threatening and that deaths from it are uncommon in the U.S.

Kim said the cyclosporiasis surveillance has been very different from her experience with the measles outbreak. Now, people seem eager to divulge even the most graphic details, such as “pooping their beds, and, like, putting down towels and it’s not enough.”

Since she’s a nurse, such confessions don’t faze her, she said. Still, staffers have hundreds of these calls to make, so they try to keep each conversation under an hour.

But foodborne illness investigations are complex. Especially for this parasite, cyclospora. Symptoms can take as long as two weeks to appear after people have eaten contaminated food. And no one remembers what they ate two weeks ago, public health staffers said.

The interview process can be extremely detailed. Kim and her colleagues ask people to pull up their restaurant receipts, scroll through purchases on their grocery store apps, even try to recall details such as the exact brand of bagged salad mix they bought, or the type of taco they got at Taco Bell.

“Is that the crunchy one or the soft one?” Kim asked on a recent call, typing on a laptop decorated with cat and vaccine-themed stickers.

Kim has been working with the health department for two years, a period defined by federal funding cuts.

Laina Stebbins, a spokesperson for the Michigan Department of Health and Human Services, said the Trump administration’s sweeping cuts to public health grants eliminated a contract between the state health department and 44 of the state’s 45 local departments that funded 123 full-time employees.

Those cuts also affected the state’s disease surveillance labs, “reducing funding for equipment maintenance contracts, data modernization, and the ability to innovate laboratory processes during emerging disease response,” Stebbins said.

Some of that funding was restored after Michigan against the Trump administration. But Washtenaw’s health department still had to scale back some disease surveillance and outbreak response work. Currently, employees who leave or retire aren’t replaced, except for those on the nursing team, which is hiring but still understaffed.

The county’s , which aims to reduce health disparities, including in mental health, was shuttered suddenly in early 2025. Nearly a year later, it resumed its work, with funding at least through this September.

An image of a building where the sign on its wall reads, "State of Michigan Department of Health & Human Services."
Staff at the Washtenaw County Health Department in Ypsilanti, Michigan, have been working to trace the sources of the recent cyclospora outbreaks by conducting detailed, often lengthy interviews with hundreds of people. (Kate Wells/吃瓜不打烊)

An employee from the Centers for Disease Control and Prevention had been stationed at the department. During the funding chaos, the worker was fired, then rehired, then furloughed.

The federal response to cyclosporiasis has felt frustratingly slow, according to Christina Zilke, a nursing supervisor at the Washtenaw health department.

“It took them forever to say that this was lettuce, and fast-food restaurants were taking it off the shelves before the CDC ever said what it was,” she said.

During a July 14 press call, the deputy director of the CDC’s Division of Foodborne, Waterborne, and Environmental Diseases, Gwen Biggerstaff, said it’s not unusual for it to take a specific source for cyclosporiasis 鈥 if it’s identified at all. That’s partly due to the lag time between exposure and the appearance of symptoms, and the complexity of tracing this particular parasite.

Meanwhile, Zilke’s been stocking the coffee station and bringing in pizza, trying to keep up staff morale. It’s not a reward, she said. “It’s more like: 鈥楬ere’s some food for survival. Here’s a break so you don’t quit.’”

Kim, for her part, remains enthusiastic about the job but said it’s been a surreal introduction to a public health career 鈥 first measles, now cyclospora.

“If nationally they don’t know what’s going on, how are we locally expected to know what’s going on?” she said. “And also just frustrating to be, like, 鈥榃ow, I don’t think even our government knows how important public health is.’”

But there’s no time to dwell. She has to move on to the next call, as soon as she can wrap up this one. She gives each person her work number, so people can call or text with any follow-up questions.

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Cyclospora Boosts Fears That Worse Foodborne Outbreaks Are Ahead /public-health/cyclospora-outbreak-foodborne-monitoring-cdc-fda-trump-cuts-michigan/ Tue, 28 Jul 2026 09:00:00 +0000 /?p=2265133 The next foodborne illness outbreak could be much worse.

That’s the concern of food safety leaders across the U.S. who are raising alarms over federal cuts they say have made it harder to detect and stop the spread of foodborne illnesses, such as the recent outbreaks of cyclospora, which has in dozens of states. And they’re especially worried the next pathogen will be much more deadly.

Food safety in the U.S. is monitored by a piecemeal system of state and federal agencies. That network is in charge of detecting, investigating, and stopping outbreaks of foodborne illnesses. Key to the system is the Centers for Disease Control and Prevention’s FoodNet program, created after four children died from E. coli in hamburgers in the early 1990s. States participating in the program, officially called the Foodborne Diseases Active Surveillance Network, contact labs to get case data that can signal when a problem is emerging.

But in President Donald Trump’s second term, his administration has slashed billions of dollars in public health funding and fired thousands of workers at federal health agencies. It has also curtailed FoodNet, stopping the program’s mandatory tracking of cyclospora and five other pathogens that together kill hundreds of people in the U.S. each year.

“You’re basically allowing for outbreaks to continue without being figured out. Invariably more people will get sick,” said Bill Marler, a Seattle-area food safety lawyer and advocate who has filed lawsuits against Taco Bell on behalf of people who allege they were sickened by cyclospora after eating there.

Under the changes to the FoodNet surveillance system, the 10 participating states 鈥 meant to represent a cross section of the broader population 鈥 no longer have to report cases of listeria, for example. That bacteria of people who are diagnosed with it.

Complications from listeria infections can include convulsions, miscarriage, and sepsis that damages organs. It’s much more rare than the type of E. coli bacteria still required to be tracked by FoodNet, but of people infected with listeria wind up hospitalized. Listeria infections result in an estimated according to numbers from the CDC and the Food and Drug Administration.

“It’s very hard to identify listeria outbreaks,” said Neal Fortin, the director of the Institute of Food Laws and Regulations at Michigan State University. Seeing it cut from FoodNet’s mandatory surveillance “really does disturb me,” he said.

Thirty-three people died and a pregnant woman had a miscarriage in 2011 after with listeria. The FDA identified the cause in .

States participating in FoodNet also no longer have to report illnesses caused by campylobacter, a bacteria often contracted from raw and undercooked poultry that afflicts an estimated 1.5 million people each year. The bacteria sickened about 60 people in Idaho this year in an outbreak linked to raw milk 鈥 a product Health and Human Services Secretary Robert F. Kennedy Jr. has championed, even though pasteurization kills harmful bacteria.

HHS denies that the changes to FoodNet or Trump administration staffing cuts have elevated the risk that future outbreaks will be harder to identify and stop.

“FDA investigators were not affected by staffing changes or force reductions, and the FY 2027 President’s Budget proposes a $33 million increase for food safety activities,” HHS spokesperson Emily Hilliard said in an email. And the CDC never stopped monitoring illnesses caused by cyclospora, she said.

The CDC has other, passive surveillance systems, but they rely on states to report problems.

“There’s no requirement of how long it takes them to do that,” said Barbara Kowalcyk, the director of the Institute for Food Safety and Nutrition Security at George Washington University.

And the FDA meets only a fraction of the number of inspections mandated by Congress. The FDA for domestic and foreign inspections since 2018, according to a report early last year by the Government Accountability Office.

Food safety by the FDA plummeted from 10,641 facilities in 2011 to about 4,500 a decade later. The agency had for domestic and foreign inspections in 2024, according to a GAO report.

That was before the Trump administration in a push to reduce federal spending.

Now, food safety leaders say the situation could get worse, because the Trump administration wants to push more routine food inspections to the states and further reduce the number of federal staffers that handle investigations and inspections.

State health departments are already overburdened from federal funding cuts and staffing shortages, forcing some to reduce or halt prevention programs so they can focus on more emergent concerns.

The cuts are being felt in Michigan, which has reported more than 7,000 cases of cyclosporiasis, the most of any state. The cyclospora parasite can cause frequent diarrhea that can last for days or even weeks, as well as abdominal pain, nausea, and fatigue.

The health department in Washtenaw County, Michigan, already pulled some staff off other work, such as immunizations and sexual health, to handle a recent measles outbreak that sickened seven people, including five kids. Now those same nurses are spending hours on the phone with hundreds of people with cyclosporiasis, trying to trace the source of their illness through weeks-old takeout receipts, bank statements, and recollections.

“We are starting to see the consequences of an underfunded public health system in 2026,” said Natasha Bagdasarian, Michigan’s chief medical executive. “Currently it’s cyclospora. Eventually, we are going to lose the ability to detect something else.”

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Inside the High-Stakes Corporate Fight Over Feeding Preterm Babies /health-industry/infant-formula-fortifier-high-stakes-corporate-battle-preemies-abbott-mead-johnson/ Mon, 30 Mar 2026 09:00:00 +0000 /?p=2165280&post_type=article&preview_id=2165280 In 2013, a scientist at Abbott Laboratories saw study results with potentially big implications for the company’s profits and the lives of some of the world’s most fragile people: preterm infants.

The upshot, : Babies fed rival Mead Johnson Nutrition’s acidified liquid human milk fortifier 鈥 a nutritional supplement used in neonatal intensive care units 鈥 developed certain complications at higher rates than those given an Abbott fortifier, a researcher at the University of Nebraska had found.

At least one of those complications .

The Abbott scientist, Bridget Barrett-Reis, described the results in the email to colleagues, using two exclamation points. Then she proposed that Abbott test the Mead Johnson fortifier, acidified for sterilization, against another Abbott product.

The clinical trial among preterm infants that Abbott subsequently sponsored, , is a case study of corporate warfare in the high-stakes business of infant nutrition, wherein preemies have been coveted like commodities; their anxious, vulnerable parents have been 鈥 whether they know it or not 鈥 targets of calculated commercial pursuit; and scientific research has been used as a marketing tool.

In hospitals around the country, dozens of babies born an average of 11 weeks early were fed Mead Johnson’s fortifier. Dozens of others were fed an Abbott fortifier that wasn’t acidified.

The clinical trial became a boon for Abbott, which to wrest market share from Mead Johnson. But for some of the babies enrolled, it didn’t turn out so well, a 吃瓜不打烊 investigation found.

Far more infants given Mead Johnson’s product developed a buildup of acid in the blood called metabolic acidosis than those fed Abbott’s product 鈥 19 versus four, according to results published in the journal .

Two outside doctors monitoring infants in the study became so alarmed that they refused to enroll any more babies, according to an April 2016 email one of them sent to Abbott.

In a related email to Abbott, neonatologist Robert White of Memorial Hospital in South Bend, Indiana, and Pediatrix Medical Group 鈥 an investigator in the study 鈥 .

“We had another SAE” 鈥 serious adverse event 鈥 “today in which a child developed profound metabolic acidosis while on the study fortifier,” White wrote. The severity was “unlike what we would see in most children with these issues.”

A manager at Abbott replied that the company was “taking your concerns very seriously.”

The study continued for almost a year.

In a Jan. 19, 2024, deposition, Abbott scientist Bridget Barrett-Reis testified about her reasons for undertaking the AL16 clinical trial. 吃瓜不打烊 obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

At least some of the consent forms used to inform parents about risks did not mention metabolic acidosis or the often-fatal necrotizing enterocolitis, another condition identified in the 2013 email that led to the study.

In a November response to questions for this article, Abbott spokesperson Scott Stoffel said the clinical trial “was safe and ethical” and that the fortifiers it compared were “on the market and widely used.”

The study was “led by 20 non-Abbott investigators,” Stoffel said.

According to a federal website, chaired the study.

Stoffel added that the study was approved “by 14 independent safety review boards at hospitals” and “published in a leading peer-reviewed scientific journal.”

“It is reckless and not credible to suggest that these doctors and institutions conducted and then published the results of an unsafe or unethical study,” Stoffel said.

A spokesperson for Mead Johnson, Jennifer O’Neill, did not comment on Abbott’s clinical trial but said in a November statement to 吃瓜不打烊 that existing studies “cannot responsibly support” any connection between the acidified fortifier and conditions such as necrotizing enterocolitis or metabolic acidosis.

Mead Johnson executive Cindy Hasseberg argued in a deposition that Abbott waged a “smear campaign” against the acidified fortifier that was “very hard to come back from.”

In 2024, Mead Johnson discontinued the product.

Winning the 鈥楬ospital War’

Behind their warm-and-fuzzy marketing, industry giants Abbott, maker of Similac products, and Mead Johnson, maker of the Enfamil line, have turned neonatal intensive care units into arenas of brutal competition.

This article quotes from and is based largely on records from three lawsuits against formula manufacturers that went to trial in 2024 and are now on appeal. The cases are , , and The records include emails, internal presentations, and other company documents used as exhibits in litigation, as well as court transcripts and witness testimony from depositions.

The records provide an inside view of the business of infant formula and fortifier, a nutritional supplement added to a mother’s milk. For example, a Mead Johnson slide deck for a 2020 national sales meeting 鈥 later used in the Whitfield trial 鈥 outlined a plan for “Branding NICU Babies.”

Urging employees to win more sales from neonatal intensive care units, the document said: “’”

In internal documents and other material from litigation reviewed by 吃瓜不打烊, formula makers described hospitals as gateways to the much larger retail market because parents are likely to stick with the brand their babies started on. Products used in the NICU help win hospital contracts, and hospital contracts help establish brand loyalty, according to court records.

Urging employees to win hospital contracts, a Mead Johnson slide for a 2020 national sales meeting said: “It is time to open up a can of 鈥榃hoop Ass.’” The slide was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.
A Mead Johnson slide for a 2020 national sales meeting outlined a plan for “Branding NICU Babies.” The slide featured a product for babies born prematurely transitioning to home. The slide deck was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.

Manufacturers vie for contracts that can be “exclusive” or nearly so, according to records from the litigation, including company documents and testimony by people who have worked in management for the companies.

An undated Abbott presentation used in the Gill case, apparently referring to inroads with hospitals in its rivalry with Mead Johnson, boasted of “MJ Strongholds Broken!”

It saluted two employees who “Own 27K Babies Exclusively,” and said another “Stole 600 formula feeders from MJ.”

Still others were praised for “Playing in Mom’s mailbox” or “kicking 鈥 and 鈥榯aking names.’”

In July 2024, Abbott CEO Robert Ford said in a conference call for investors that formula and fortifier for preterm infants generated total annual revenue of about $9 million 鈥 a small portion of Abbott’s total sales of $42 billion in 2024 and its $2.2 billion of sales in the United States from pediatric nutritional products.

Industry documents cited in litigation provide a different perspective.

“鈥,” stated an Abbott training presentation from about a decade ago used in the Gill and Whitfield trials.

That described a baby’s first formula feeding in the hospital, the document said. Over 74% of the time, an infant fed formula in the hospital stays on that brand at home, the document said.

Abbott’s goal was that the first-bottle-fed strategy , the document showed. A staff training slide displayed during the Whitfield trial showed how that momentum could pay off in bonuses for Abbott sales representatives, leading to a “Happy Rep.”

Mead Johnson has espoused a similar strategy.

A slide from an Abbott training presentation showed how the company’s “First Bottle Fed” strategy could lead to retail sales, bonuses, and happy sales reps. The presentation was used in the Whitfield v. St. Louis Children’s Hospital lawsuit.

The company rolled out a with cash rewards for flipping hospitals from Abbott, according to a 2019 document marked for internal use by Mead Johnson and its parent company, England-based Reckitt Benckiser Group, and admitted into evidence in the Watson case.

“ is critical to contract gains and acquisition,” stated a company plan for 2022 that was cited in the Whitfield case.

One Abbott document shown in the Whitfield trial said more than half of first feedings happen at night, adding, “.”

A “Mead Johnson University” training document described a scenario in which a sales rep overhears patient information in a NICU and encouraged the rep to promote the company’s products. The document, titled “,” was admitted as evidence in the Watson case.

“[Y]ou are walking back into your most important NICU,” it said. “You overhear the HCP’s” 鈥 health care providers, apparently 鈥 “stating all of the notes,” it said. “There may be some information that may help you to position your products as a resource for this patient and to handle any objections that the HCP may present you with.”

To win parents’ business, companies have supplied formula to hospitals free or at a loss, court records show. That has resulted in such curiosities as a Mead Johnson “purchasing agreement” cited in the Watson case, listing the price for product after product as “no charge.”

In a 2017 strategy document prepared for Mead Johnson, a consulting firm laid out a plan “to win hospital war.”

Why focus on hospitals? “,” it explained.

The document was displayed in the Whitfield case.

In the market for preterm nutrition, Abbott and Mead Johnson compete with each other, not against the use of human milk, the companies told 吃瓜不打烊.

“Thus, references in documents about wanting to 鈥榳in’ or 鈥榦wn’ the NICU refer to out-performing Mead Johnson by offering the highest-quality products,” Abbott’s Stoffel said in February.

Asked specific questions about business strategies and internal documents, Mead Johnson’s O’Neill said the company was “concerned that you are presenting a misleading and incomplete picture.”

Mead Johnson’s products “are safe, effective, and recommended by neonatologists when clinically appropriate,” O’Neill added.

On the Defensive

In courthouses around the country, Abbott and Mead Johnson are on the defensive 鈥 and have been for years.

In hundreds of lawsuits, parents of sickened or deceased preterm infants have alleged that formula designed for preemies has caused necrotizing enterocolitis, or NEC, a devastating condition in which immature intestinal tissue can become infected and die, spreading infection through the body.

Lawsuits also accuse the manufacturers of failing to warn parents of the risk.

One of the cases on which this article is based, , resulted in a against Mead Johnson. , Gill v. Abbott Laboratories, et al., resulted in a against Abbott. , Whitfield v. St. Louis Children’s Hospital, et al., resulted in a , but the judge found errors and misconduct on the part of defense counsel, faulted his own performance, and .

The cases have involved children like Robynn Davis, who was born at 26 weeks, lost 75% to 80% of her intestine to NEC, suffered brain damage 鈥 and, at almost 3 years old, couldn’t walk, couldn’t really talk, and was eating through a tube, as Jacob Plattenberger, an attorney representing her, in 2024.

An attorney for Abbott, James Hurst, that Robynn suffered a catastrophic brain injury at birth, 10 days before she received any Abbott formula, and that her NEC resulted not from formula but from many health problems.

In at least three cases, a federal judge has in favor of Abbott 鈥 ruling for the company before the lawsuits even reached trial.

The formula makers have repeatedly denied fault.

Addressing stock analysts in 2024, as “without merit or scientific support” the theory that preterm infant formula or milk fortifier caused NEC.

In a issued in 2024, the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health said there was “no conclusive evidence that preterm infant formula causes NEC.”

Mead Johnson’s O’Neill said the scientific consensus is that there is no established causal link between the use of specialized preterm hospital nutrition products and NEC.

Neonatologists use the products routinely, O’Neill said.

O’Neill cited a statement by the saying the causes of NEC “are multifaceted and not completely understood.”

In a legal brief filed with an Illinois appeals court in the Watson case, the company said “the NEC-related risks” of a formula for preterm infants “are the subject of medical debate,” adding that trial evidence “demonstrated, at a minimum, uncertainty as to the magnitude of the risk, as well as the causal role of various feeding options in the development of NEC.”

Manufacturers say formula is needed when mother’s milk or human donor milk isn’t an option. Fortifier, a product tailored to preemies, is meant to augment mother’s milk when babies are born prematurely and a mother’s milk alone doesn’t deliver enough nutrition. The Mead Johnson fortifier used in the head-to-head clinical trial sponsored by Abbott was acidified to prevent bacterial contamination.

A woman holds a small newborn baby to her chest. The baby holds the woman's pinky finger.
(Moment/Getty Images)

In March 2025, Health and Human Services Secretary Robert F. Kennedy Jr. announced that his department, which encompasses the FDA, was undertaking a review of infant formula, dubbed “Operation Stork Speed.” It includes and increasing testing for heavy metals and other contaminants, HHS said.

However, is limited. The agency doesn’t approve the products or their labeling. Whether to report adverse events 鈥 illnesses or deaths potentially related to the products 鈥 to the FDA is largely at manufacturers’ discretion.

The business of infant formula further spotlights a central contradiction in the Trump administration’s health policies. When it comes to food and medical products, the administration has criticized industry-funded research as unworthy of trust. Yet under Kennedy, it has disrupted, defunded, or sought to cut government-funded research, which could leave industry-funded research with a larger and more influential role.

It “is entirely appropriate for the Department to scrutinize research design, conflicts of interest, and funding sources, particularly when research is used to inform public policy,” HHS spokesperson Andrew Nixon said.

鈥楢t the Table’

Company emails cited in litigation shed light on the industry’s approach to research.

In a 2015 email, when Mead Johnson was considering supplying some of its formula to a researcher for a study, a company neonatologist expressed concern that the results could be spun to make the preemie product look unsafe.

“However, we are more likely to have control over final language if we provide the small support and are 鈥榓t the table’ with him,” Mead Johnson’s Timothy Cooper added in the email, which was cited in the Watson trial.

In 2017, Abbott with researchers at Johns Hopkins University about a study on how the composition of infant formula might affect NEC in mice. The email thread became an exhibit in the Whitfield case.

Abbott was both funding and collaborating on the work, shows.

Forwarding a draft of the resulting paper to Abbott, David Hackam, chief of pediatric surgery at the Johns Hopkins University School of Medicine, said in one of the emails, “We hope you like it.” He also requested help from Abbott in filling in information.

“The manuscript looks great!” Abbott’s Tapas Das , after a back-and-forth.

But Abbott had some changes, the email thread shows.

“We (VM & DT) made some edits in the text especially to soften a bit with the statement 鈥榠nfant formula seems responsible for developing NEC,’” Das wrote.

“Instead, we thought if we could state as 鈥榠nfant formula is linked to severity of NEC’. So we made changes throughout the text emphasizing on severity of NEC by infant formula rather than development of NEC by infant formula,” Das wrote.

Das wrote that “other factors are involved for NEC development as described in the text.”

Hackam did not respond to questions 吃瓜不打烊 sent by email.

Efforts to reach Das and Cooper 鈥 including by phoning numbers and sending letters to addresses that appeared to be associated with them 鈥 were unsuccessful.

When Mead Johnson provided support to scientific researchers, the company would want to make sure they reported the results “in an honest way,” Cooper said in a deposition played in the Watson trial.

The Abbott co-authors “proposed routine edits to the article for scientific accuracy and for the consideration of the other authors, some of the most well-respected NEC researchers in the world,” Abbott’s Stoffel said.

“Abbott regularly collaborates with and publishes studies with leading NEC scientists for the benefit of both premature infants and the entire scientific community,” Stoffel said.

“The research studies Mead Johnson supports are conducted independently and appropriately, with full transparency,” said O’Neill, the Mead Johnson spokesperson.

鈥業n the Wrong Direction’

Transparency can be subjective.

More than a decade ago, Mead Johnson sponsored a clinical trial testing what was then a new acidified liquid fortifier against a powdered fortifier already on the market.

In the study, which enrolled 150 babies, 5% of infants fed the acidified liquid developed NEC compared with 1% of infants fed the powder, according to deposition testimony and a record of the clinical trial used in the Watson case.

That information was not included in a 2012 that reported the study results.

The article, in the journal Pediatrics, whose authors included two Mead Johnson employees, concluded it was safe to use the new liquid fortifier instead of the powdered one. The article also said that, comparing babies fed the liquid with those fed the powder, the study observed no difference in the incidence of NEC.

The unpublished finding of 5% to 1% represented so few babies that it was not statistically significant.

Nonetheless, retired neonatologist Victor Herson, who ran a NICU in Connecticut and has studied fortifiers, said in an interview he would have wanted to see those numbers.

“The trend was in the wrong direction,” Herson said, “and would have, I think, alerted the typical neonatologist that, well, maybe not to rush in and adopt” the new fortifier.

It’s common for study publications to include tables showing complications even if they aren’t statistically significant so that readers can draw their own conclusions, Herson said.

Neonatologist Fernando Moya, a co-author of the Pediatrics article, had a different perspective.

“You may not be very familiar with medical literature but when there are no 鈥榮tatistically significant’ differences, we do not comment on whether something was increased or decreased,” Moya said by email. He referred questions to Mead Johnson.

Mead Johnson’s O’Neill gave several reasons why “the data you cite was not included in the publication.” She said the study was designed to examine infant nutrition and growth, NEC was a “secondary outcome,” the NEC numbers weren’t statistically significant, and the size of the study, “while appropriate, was not powered to draw any conclusions with respect to any potential differences in NEC.”

In a deposition used in the Watson trial, Carol Lynn Berseth 鈥 a co-author of the paper and Mead Johnson’s director of medical affairs for North America when the study was completed 鈥 testified that the article was peer-reviewed and that no reviewer asked for additional data.

“Had they asked for it, we would have shown it,” Berseth testified.

Berseth did not respond to a phone message or to an email or letter sent to addresses apparently associated with her.

鈥業t Should Not Be in a NICU’

The Abbott scientist who flagged research on Mead Johnson’s acidified fortifier in 2013, Bridget Barrett-Reis, was later of AL16, the follow-up clinical trial Abbott sponsored, and of .

In a deposition, she was asked why she conducted the study.

“I conducted that study because I thought [the acidified fortifier] could be dangerous,” she said, “and I thought it would be a good idea to find out if it really was because nobody was doing anything about it.”

Elaborating on the thinking behind the study, she testified: “It should not be in a NICU in the United States. That product should not be anywhere for preterm infants.”

In her 2013 email recommending that Abbott conduct a study, Barrett-Reis cited findings by “an independent investigator,” Ann Anderson-Berry, that showed, compared with preterm infants fed an Abbott powder, those on Mead Johnson’s acidified liquid “had slower growth, higher incidence of metabolic acidosis and NEC!!”

Asked about the exclamation points, Barrett-Reis testified in a January 2024 deposition used in the Gill case that she wasn’t excited about the findings. “I am known to put exclamation points instead of question marks and everything anywhere, so I have no idea at the time what those meant,” she testified.

In a Jan. 19, 2024, deposition, Abbott scientist Bridget Barrett-Reis testified about her use of exclamation points in a 2013 email. 吃瓜不打烊 obtained deposition video clips from the Missouri Court of Appeals Eastern District. The video was filed with the court in an appeal of the Gill v. Abbott lawsuit.

The research that caught her eye in 2013 reviewed patient records from the Nebraska Medical Center. The institution had switched to the acidified fortifier with high hopes but stopped using it after four months because it was concerned about patient outcomes, Anderson-Berry and Nebraska co-authors .

In an interview, Anderson-Berry said she set out to analyze why, during those four months, babies’ growth “fell apart in our hands.”

Abbott was “very pleased” with Anderson-Berry’s findings and paid her to go around the country discussing them, she said.

Metabolic acidosis can be fatal, Anderson-Berry said. But typically it can be managed, she said, adding that she didn’t know of deaths from metabolic acidosis caused by the acidified fortifier.

Research has found that metabolic acidosis “is associated with poor developmental and neurologic outcomes in very low birth weight infants,” according to . In addition, it is “a risk factor for neonatal necrotizing enterocolitis,” the paper said.

Barrett-Reis did not respond to inquiries for this article, including a message sent via LinkedIn and a letter sent to an address that appeared to be associated with her.

In court, Abbott representative Robyn Spilker testified that metabolic acidosis and that nobody should knowingly put kids at risk for getting NEC in an effort to make money.

Before infants were enrolled in the AL16 study, their parents or guardians had to sign consent forms disclosing, among other things, the risks that clinical trial subjects would face.

International ethical principles for medical research on humans, known as the , say each participant must be adequately informed of the “potential risks.”

Questioning Abbott’s Spilker in litigation, plaintiff’s attorney Timothy Cronin said, “Ma’am, despite the hypothesis going in, are you aware Abbott on the informed consent form given to parents that signed their kids up for that study?” Spilker, who identified herself in court as a senior brand manager, said she didn’t know what was on the consent forms.

Through a request under a Kentucky open-records law, 吃瓜不打烊 obtained an informed consent form for the AL16 study used at a public institution, the University of Louisville. The form mentioned risks such as diarrhea, constipation, gas, and fussiness. It did not mention metabolic acidosis or NEC.

吃瓜不打烊 also reviewed an informed consent form for the AL16 study used at Memorial Hospital of South Bend. It was largely identical to the one used in Louisville and did not mention metabolic acidosis or NEC.

Cronin, the plaintiff’s attorney, said in an interview that Abbott showed disregard for the health and safety of premature babies participating in the AL16 clinical trial.

“I think it’s unethical to do a study if you know you are subjecting participants in the study to an increased risk of a potentially deadly disease and you don’t at least tell them that,” Cronin said.

Anderson-Berry told 吃瓜不打烊 that Abbott was “ethically well positioned” to conduct the AL16 clinical trial because her paper was not definitive.

Yet she said she was unwilling to enroll any of her patients in the Abbott clinical trial because she didn’t want to take the chance that they would be given the acidified liquid.

White, the neonatologist who stopped enrolling patients in the study, defended the decision to conduct it. In an interview, he said it was appropriate to conduct a large, properly controlled clinical trial to see whether concerns raised in earlier research were borne out. The two babies whose serious adverse events he reported to Abbott ended up doing fine, he said.

But White, who went on to be listed as a co-author of the study, told 吃瓜不打烊 that parents should have been informed that the risks included metabolic acidosis and NEC.

“In retrospect, obviously, that is something that we, I think, should have informed parents of,” he said.

Abbott did not directly answer questions about the consent forms.

The results of AL16 were in 2018. The conclusion: Infants fed the acidified product 鈥 in other words, the Mead Johnson fortifier 鈥 had higher rates of metabolic acidosis and poorer feeding tolerance. Plus, poorer “initial weight gain.”

The title of the article trumpeted “Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier” 鈥 in other words, the Abbott product.

Eight of the 78 infants receiving the Mead Johnson fortifier were treated for metabolic acidosis, compared with none of the 82 receiving the Abbott product, the article said. Four infants on Mead Johnson’s product experienced serious adverse events, compared with one on the Abbott product, the article reported.

One infant receiving the Mead Johnson product died 鈥 from sepsis, the article said. One had a case of NEC, and infants on Mead Johnson’s fortifier “had significantly more vomiting,” the article said.

However, in a pair of letters to the editor published in the Journal of Pediatrics, the article as hyped. Writers said the article emphasized findings that were .

In its business battle with Mead Johnson, Abbott deployed the study. It produced an annotated copy for its sales force, which was shown in the Whitfield trial.

Abbott’s use of AL16 as a marketing tool worked.

In 2019, when Barrett-Reis applied for a promotion at Abbott, she wrote that the results of the study had been “leveraged to secure whole hospital contracts which have increased hospital share to > 70%.”

Her letter was displayed in a deposition video filed in the Gill litigation.

Internally, Mead Johnson conceded it had been beaten in the fight over fortifiers. In the slide deck for a 2020 national sales meeting, the company said, “Abbott won the narrative.”

Share your story with us: Do you have experience with infant formula or any insights about it that you’d like to share? We’d like to hear from you. Click here to contact our reporting team.

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Listen: Regulatory Rollbacks and Federal Layoffs Threaten America鈥檚 Food Supply /news/wamu-health-hub-regulatory-rollbacks-food-safety-fda-usda-salmonella-rules/ Mon, 11 Aug 2025 09:00:00 +0000

LISTEN: The Trump administration cut stricter rules for what’s considered a on the chicken you buy at the grocery store. Stephanie Armour tells WAMU’s “Health Hub” how regulatory rollbacks and job cuts could weaken our food safety system.

If there were an outbreak of E. coli or another foodborne pathogen, would you want to know about it? Some scientists at the Food and Drug Administration worry that looser regulations and layoffs could make it harder for people to get that news and protect themselves.

吃瓜不打烊 senior correspondent Stephanie Armour explained on WAMU’s “Health Hub” on Aug. 6. how the Trump administration is reshaping America’s food safety system.

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Silence on E. Coli Outbreak Highlights How Trump Team鈥檚 Changes Undermine Food Safety /public-health/food-safety-foodborne-illness-trump-health-agency-cuts-e-coli-outbreak-silence/ Wed, 28 May 2025 09:00:00 +0000 /?post_type=article&p=2032939 Colton George felt sick. The 9-year-old Indiana boy told his parents his stomach hurt. He kept running to the bathroom and felt too ill to finish a basketball game.

Days later, he lay in a hospital bed, fighting for his life. He had eaten tainted salad, according to a lawsuit against the lettuce grower filed by his parents on April 17 in federal court for the Southern District of Indiana.

The E. coli bacteria that ravaged Colton’s kidneys was to the strain that killed one person and sickened nearly 90 people in 15 states last fall. Federal health agencies investigated the cases and linked them to a farm that grew romaine lettuce.

But most people have never heard about this outbreak, which a Feb. 11 linked to a single lettuce processor and ranch as the source of the contamination. In what many experts said was a break with common practice, officials never issued public communications after the investigation or identified the grower who produced the lettuce.

From failing to publicize a major outbreak to scaling back safety alert specialists and rules, the Trump administration’s anti-regulatory and cost-cutting push risks unraveling a critical system that helps ensure the safety of the U.S. food supply, according to consumer advocates, researchers and former employees at the FDA and U.S. Department of Agriculture.

The investigation into the illnesses began near the end of the Biden administration but work on the lettuce outbreak wasn’t completed until Feb. 11. At that time, the decision was made by the Trump administration not to release the names of the grower and processor because the FDA said no product remained on the market.

The administration also has withdrawn to reduce the presence of salmonella in raw poultry, according to an . It was projected to save more than $13 million annually by preventing more than 3,000 illnesses, according to .

Officials from the Department of Health and Human Services have said that food safety is a priority, and FDA Commissioner Marty Makary said in an April 29 interview with the newsletter that the recent job cuts would not affect agency operations.

“The FDA had 9,500 employees in 2007. Last year it was nearly 19,000. Has the 100% increase in employees increased approval times, innovation, AI, food safety, or agency morale?” Makary asked. “No, it hasn’t. In fact, it’s increased regulatory creep.”

The FDA referred questions to HHS, which declined to comment or make Makary available for an interview. In a statement, the agency said “protecting public health and insuring food safety remain top priorities for HHS. FDA inspectors were not impacted [by job cuts] and this critical work will continue.”

Public health advocates warn companies and growers will face less regulatory oversight and fewer consequences for selling tainted food products as a result of recent FDA actions.

The administration is disbanding a Justice Department unit that pursues civil and criminal actions against companies that sell contaminated food and is reassigning its attorneys. Some work will be assumed by other divisions, according to a publicly posted memo from the head of the department’s criminal division and a white paper by the law firm Gibson Dunn.

The Justice Department did not respond to an email requesting comment.

“They need the DOJ to enforce the law,” said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, a nonprofit consumer advocacy group. “For an executive investing in food safety, the knowledge they could go to jail if they don’t is a really strong motivator.”

Federal regulators also want states to conduct more inspections, according to two former FDA officials, who spoke on the condition of anonymity out of fear of retaliation. But some Democratic lawmakers say states lack the resources to take over most food safety inspections.

“Handing that duty to state and local agencies is really troubling,” said Rep. Shontel M. Brown (D-Ohio). “They don’t have the resources, and it creates a potentially unsafe situation that puts families in Ohio and America at risk.”

The High Cost of Foodborne Illnesses

Foodborne illnesses exact a major economic toll in the United States, according to federal data, and cost thousands of lives each year. The U.S. Department of Agriculture estimates the deaths, chronic illness, medical treatment, and lost productivity from food-related illnesses amounted to $75 billion in 2023.

Each year, about 48 million people in the U.S. get sick with foodborne illnesses, 128,000 are hospitalized, and 3,000 die, according to the .

In its first few months, the administration has suspended a program known as the Food Emergency Response Network Proficiency Testing that ensures food-testing labs accurately identify pathogens that can sicken or kill, according to a former FDA official.

In March, the agency said it would delay from January 2026 to July 2028 compliance with a Biden-era rule that aims to speed up the identification and removal of potentially contaminated food from the market.

However, the FDA is taking aim at foreign food manufacturing, saying in a May 6 notice that it would expand overseas. “This expanded approach marks a new era in FDA enforcement — stronger, smarter, and unapologetically in support of the public health and safety of Americans,” the notice said.

Some former FDA and USDA officials said that goal isn’t realistic, because U.S. inspectors often need to obtain travel visas that can wind up alerting companies to their arrival.

“It’s really, really difficult to do surprise inspections,” said Brian Ronholm, director of food policy for Consumer Reports and a former USDA deputy undersecretary for food safety. “The visa process can alert the local authority.”

HHS declined to address Ronholm’s concerns.

The FDA hasn’t met the mandated targets for inspecting food facilities in the U.S. since fiscal year 2018, and the agency has consistently fallen short of meeting its annual targets for foreign inspections, according to a by the U.S. Government Accountability Office.

Foodborne illness can turn serious. Salmonella bacteria in cucumbers  in April and May and left at least nine people hospitalized, according to the FDA. A 2008-09 salmonella outbreak involving peanut butter , resulting in criminal charges against company executives. Andsickened more than 70 people in 2009, including a Nevada mother who died of complications from eating the raw dough.

A scanning electron microscope image of E. coli bacteria. (Callista Images/Getty Images)

‘Life or Death for Our Son’

E. coli, commonly found in feces, can be especially dangerous to children like Colton, the boy from Avon, Indiana, who ate contaminated lettuce. The bacteria can damage blood vessels and cause clots that destroy the kidneys, leading to strokes and comas. Consumers sickened by E. coli can pass it along to others, and, in some cases, the bacteria end up killing victims who never consumed the contaminated food.

By the time Colton’s mother brought him to the emergency room that November day, the bacteria were releasing toxins and damaging his blood cells and kidneys, according to his father, Chris George.

Colton was sent to Riley Hospital for Children in Indianapolis. Chris said doctors told him and his wife, Amber George, that their son was in kidney failure and the next 24 to 72 hours would determine whether he would survive, the father recalled.

“They said it was life or death for our son, and I was like, wait, he was just playing basketball,” said Chris, a firefighter. “I told them, ‘You do what you need to do to save my son.’”

A boy in a baseball uniform and holding a bat and glove, sits atop a large green metal box with his legs dangling and smiles at the camera. A baseball field and covered seating area are behind him.
Colton George was among those who got sick with E. coli and landed in the hospital after ingesting tainted lettuce. (Amber George)

Usually, the FDA alerts the public and identifies growers and food manufacturers when there are outbreaks like the one that sickened Colton. The FDA said in its February internal summary that the grower wasn’t named because no product remained on the market.

But Bill Marler, a Seattle lawyer who specializes in food-safety litigation and represents the George family, said the information is still important because it can prevent more cases, pressure growers to improve sanitation, and identify repeat offenders.

It also gives victims an explanation for their illnesses and helps them determine whom they might take legal action against, he said.

“Normally we would see the information on their websites,” Marler said, adding that the agency’s investigatory findings on the outbreak were “all redacted” and he obtained them through a Freedom of Information Act request.

The FDA, USDA, and CDC play central roles in overseeing food safety, including inspections and investigations. The FDA and CDC have been rocked by job cuts that are part of a reduction of 20,000 staff at HHS, their parent agency. The Agriculture Department has also shrunk its workforce.

Staffing cuts mean delays in publicizing deadly outbreaks, said Susan Mayne, an adjunct professor at Yale School of Public Health who retired from the FDA in 2023.

“Consumers are being notified with delays about important food safety notifications,” she said, referring to a recent outbreak in cucumbers. “People can die if there are pathogens like listeria, which can have a 30% fatality rate.”

Makary has said the at the agency.

But the FDA laid off scientists in April who worked at food safety labs in Chicago and San Francisco, where they performed specialized analysis for food inspectors, former FDA officials said. The FDA later restored some positions.

“No scientists were fired? That was incorrect,” Mayne said.

Siobhan DeLancey, who worked in the agency’s Office of Foods and Veterinary Medicine for more than 20 years before she also was laid off in April, said new requirements for reviewing agency announcements became so arduous that it took weeks to get approval for alerts that should have been going out much sooner.

She said some employees who were laid off include communications specialists and web staff who do consumer outreach aimed at preventing illness. The USDA and FDA have been or are asking some who accepted deferred resignations to take back their decisions.

“It’s all about destruction and not about efficiency,” DeLancey said. “We’re going to see the effects for years. It will cost lives.”

HHS did not respond to an email seeking a response to DeLancey’s comments.

For 13 days, Colton stayed on dialysis at the hospital, initially unable to eat or drink. His mother wet a sponge to moisten his lips and tongue.

He turned 10 in the hospital. Chris George bought paint markers to make signs on the windows of his son’s room.

“I am not happy with the CDC and FDA,” Chris George said. “Victims have a right to know who made them sick. This is my kid. He’s my life.”

Colton was able to leave the hospital almost three weeks after first eating the contaminated lettuce but still has nightmares about the ordeal and is seeing a therapist.

“The whole ‘Make America Healthy Again,’ the focus on taking food color dyes out of cereal?” said Chris George, who objects to the Trump administration’s decision to redact information about the grower in the February report. “How about we take E. coli out of our lettuce, so it doesn’t kill our kids?”

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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This News Might Ruin Your Appetite 鈥 And Summer /health-industry/emulsifiers-foods-chemical-risks-fda-regulation-ice-cream-gut-microbiome-polysorbate-80/ Tue, 20 May 2025 09:00:00 +0000 /?post_type=article&p=2034832 It’s a marvel of food technology: ice cream that resists melting.

In a video explaining the science behind it, a seller of shows scoops of ice cream holding their shape under . The super ingredient? Polysorbate 80.

Polysorbate 80 is an emulsifier, a chemical used to control the consistency of thousands of supermarket products. Other widely used emulsifiers or stabilizers include carboxymethyl cellulose, carrageenan, and maltodextrin.

Recently, such ingredients have been showing up in scientific studies for another reason: Researchers say they may cause a variety of health problems.

Studies have found that emulsifiers can of bacteria , known as the microbiome or microbiota; of the gastrointestinal tract; and , potentially contributing to .

Emulsifiers and stabilizers are among the most common ingredients in ultraprocessed foods, a prime target of the “Make America Healthy Again” campaign by Health and Human Services Secretary Robert F. Kennedy Jr.

They are on the department’s radar: Their potentially harmful effects were flagged in a document HHS recently produced to support Kennedy’s drive to eliminate petroleum-based food dyes.

But they illustrate the complexity of the war on food additives.

They show how, when it comes to food science, regulators are chronically playing catch-up. In the meantime, for many ingredients, regulators and consumers alike are left in a gray zone between suspicion and proof of harm in humans.

Emulsifiers’ assault on the microbiome could help explain inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis, metabolic disorders, and even cancer, the studies suggest.

“There is a lot of data showing that those compounds are really detrimental for the microbiota and that we should stop using them,” said Benoit Chassaing, a research director at the French National Institute of Health and Medical Research and a co-author of several related studies.

Yet much larger and more ambitious clinical trials in humans are needed, Chassaing added.

For Lewis Rands, who has suffered from gastrointestinal illness, the research fits his own experience as a consumer. Changing his diet to avoid emulsifiers has made a shocking difference, easing symptoms that were debilitating, Rands said.

“Clinically, many patients have reported an improvement in symptoms with such changes,” said Ashwin Ananthakrishnan, a gastroenterologist and researcher at Massachusetts General Hospital.

The scientific findings come with caveats. For instance, much of the research has been done in mice, or by mimicking the human gut in a tube. There are many unknowns. Not all emulsifiers have bad effects, or the same effects, and some people are thought to be much more vulnerable than others. Even some researchers who have co-authored papers say that the substances have not been proven harmful to humans and that it’s too soon to say regulators should ban them.

Still, the research poses a challenge for the FDA.

When emulsifiers began spreading through the food supply, the agency wasn’t focusing on the gut microbiome, a relatively recent scientific frontier, researchers said.

Martin Makary, appointed by President Donald Trump to head the FDA, mentioned the microbiome in March. Though he didn’t cite emulsifiers specifically or identify chemicals by name, he said substances that affect the microbiome deserve the FDA’s attention.

“There’s a body of research now that suggests concern with some of these ingredients,” he said. “We have to look at those ingredients, and you have my commitment to do so if confirmed as FDA commissioner.”

“These chemicals are creating an inflammatory response in the gastrointestinal tract, and with an altered microbiome lining that GI tract, kids feel sick,” he added.

The FDA and the Department of Health and Human Services did not respond to questions about Makary’s testimony.

However, when journalist asked HHS for the science behind its recent announcement that it is phasing out petroleum-based food dyes, the agency provided a compilation of information on potentially harmful compounds commonly found in ultraprocessed foods. The document, which appeared to be a draft, included a section on emulsifiers, such as xanthan gum and carrageenan. It noted that the section needed more work.

HHS subsequently provided the document to 吃瓜不打烊.

As far back as 2020, an international organization for the that, for people with those conditions, it “may be prudent to limit intake” of maltodextrin, carrageenan, carboxymethyl cellulose, and polysorbate 80.

Emulsifiers are developed from a variety of sources, including plants and bacteria.

Some ingredients that might affect the microbiome show up in foods because they were deemed “generally recognized as safe,” or GRAS.

“New information may at any time require reconsideration of the GRAS status of a food ingredient,” the says.

‘More of a Difference Than Any Drug’

Rands, a genetic scientist, took matters into his own hands to battle severe inflammatory bowel disease. The illness caused bloating, stomach pain, cramps, frequent bowel movements, and bleeding, he said. It left him in a constant state of anxiety and stress, he added, wondering where the nearest bathroom was and whether he’d reach it in time.

Even taking a walk around the block with his wife and baby near their home in Australia was problematic.

Then, on the advice of a dietitian, Rands began avoiding foods with emulsifiers: chemicals such as carboxymethyl cellulose, carrageenan, guar gum, xanthan gum, and maltodextrin — plus other additives.

For instance, instead of eating Ben & Jerry’s ice cream, he switched to Häagen-Dazs ice cream that is free of the substances at issue.

The relief was dramatic.

“It’s a huge difference,” Rands said. “To me, it’s made more of a difference than any drug.”

A photo of a man outside with a baby in a stroller.
Lewis Rands, whose gastrointestinal illness had been debilitating, says changing his diet to avoid emulsifiers has improved his life dramatically. Now, for instance, he can take long walks with his family. (Roisin Rands)

He has been able to scale back or stop taking several drugs, which is an added relief — not least because some can have harmful side effects, and, he said, one was taking its toll.

Rands said he used a scientific approach, isolating variables in his diet and logging the results. Avoiding artificial sweeteners helps, he said, but most of the benefit relates to avoiding the emulsifiers.

Ben & Jerry’s did not respond to a request for comment.

‘Science That Hasn’t Been Done Yet’

The Consumer Brands Association, which represents makers of processed foods, stands behind use of the chemicals.

“Food safety and protecting the integrity of the food supply is priority number one for the makers of America’s food and beverage products,” Sarah Gallo, the group’s senior vice president of product policy, said in a statement.

“Emulsifiers and thickening agents play an important role in improving food texture and consistency, and have been studied by the FDA through a rigorous scientific and risk-based process,” Gallo said.

Asked for specifics on how the FDA had analyzed potential effects on the microbiome, the group did not respond.

Chassaing said the chemicals were “never considered for the potential effect on the microbiota.”

Robert Califf, who led the FDA under Presidents Barack Obama and Joe Biden, said in an interview that scientists are just beginning to understand the microbiome. He compared it to where the field of genomics was 20 years ago, only much more complicated — “multiplied by a thousand dimensions.”

He said the substances “fell within the standards” when they were greenlighted. “But hopefully most people agree that the standards need to be upgraded,” he added.

“This is different than traditional food safety thinking about, ‘Does it cause an immediate problem?’” Califf said. “We’re talking about long-term health outcomes here.”

And has the FDA evaluated those?

“How could it? There was no way to do it,” Califf said. The answers will vary depending on the emulsifier, and “proving whether it’s bad or good is going to require rigorous science that hasn’t been done yet.”

More recent scientific capabilities expand the possibilities, he said.

‘A Lot of Confusion in the Field’

For a consumer, trying to steer clear of emulsifiers can be difficult. Without realizing it, people can consume a variety of emulsifiers from a variety of foods — and the same chemicals from multiple sources.

Polysorbate 80 was listed as an ingredient on the labels of as of May 12, according to an online database posted by the Environmental Working Group using information from NielsenIQ. Carrageenan was listed on ; maltodextrin, ; and xanthan gum, .

Some emulsifiers have multiple names, making them harder to recognize. Some names can apply to more than one emulsifier. And some chemical names that appear on product labels don’t appear in the FDA’s “” inventory.

Carboxymethyl cellulose — not to be confused with methyl cellulose — is also known as carboxymethylcellulose  and cellulose gum. Maltodextrin can be derived from substances such as cornstarch, rice starch, and wheat starch — but the FDA doesn’t consider it synonymous with the term “modified food starch.”

The naming practices can frustrate efforts to track the chemicals in food, to measure how much of the stuff people are taking in, and even to figure out precisely which chemicals a scientific study evaluated, researchers said.

“There’s a lot of confusion in the field,” said Christine McDonald, a researcher at the Cleveland Clinic who has . She called for more consistent naming of additives in the United States.

The very term “emulsifier” is problematic. By strict definition, emulsifiers create an emulsion — a stable blend of liquids that would not otherwise mix, such as oil and water. However, the term is used broadly, encompassing chemicals that thicken, stabilize, or alter texture.

Gummed Up

Emulsifiers can be found in foods marketed as natural or healthy as well as ones that look artificial. Some products contain multiple emulsifiers.

Products sold at Whole Foods, for instance, list a variety of emulsifiers on their labels. 365 brand Organic Vegan Ranch Dressing & Dip contained organic tapioca maltodextrin and xanthan gum. Pacific Seafood Starfish brand Cornmeal Crusted Fishsticks — marked as wild-caught and MSC-certified (sustainably sourced) — contain guar gum. Flour tortillas by 365 included monoglycerides of fatty acids and “stabilizer (guar gum, xanthan gum, carrageenan).”

At a Safeway supermarket, Healthy Choice Grilled Chicken Pesto With Vegetables listed modified potato starch, modified corn starch, carrageenan, xanthan gum, and guar gum.

The label on Newman’s Own Caesar salad dressing said the product contained no artificial preservatives or flavors, no colors from an artificial source, and was gluten-free. The ingredient label listed, “as a thickener,” xanthan gum.

In response to questions for this article, Whole Foods Market more than 300 ingredients commonly found in food. “Our experts evaluate ingredients for acceptability in all food products we sell based on the best available scientific research,” the company said in a statement provided by spokesperson Rachel Malish.

Safeway’s parent company, Albertsons Companies, did not respond to inquiries. Nor did Pacific Seafood, Newman’s Own, or Conagra Brands, which makes Healthy Choice.

A Growing Body of Research

Research on emulsifiers has been building in recent years.

For example, a study published in January by the concluded that a diet low in emulsifiers is an effective treatment for mild or moderate Crohn’s disease. The eight-week clinical trial, which tracked 154 patients in the United Kingdom, focused on carrageenan, carboxymethyl cellulose, and polysorbate 80.

A study published in February 2024 in the journal found that higher intakes of carrageenan and mono- and diglycerides of fatty acids were associated with higher risks of cancer. The study observed 92,000 French adults for an average of 6.7 years.

A study published in September 2023 in , formerly known as the British Medical Journal, found that intake of several types of emulsifiers was associated with the risk of cardiovascular disease. The study observed more than 95,000 French adults for a median of 7.4 years.

A series of earlier studies found that emulsifiers “can promote chronic intestinal inflammation in mice”; that two in particular, carboxymethyl cellulose and polysorbate 80, “profoundly impact intestinal microbiota in a manner that promotes gut inflammation and associated disease states”; and that, based on a laboratory study of human samples, “numerous, but not all, commonly used emulsifiers can directly alter gut microbiota in a manner expected to promote intestinal inflammation,” as recounted in a in the journal Microbiome.

Other findings diverge.

A study from Australia, published in February in , followed 24 Crohn’s patients over four weeks and concluded that, in the context of a healthy diet, the emulsifier content had “no influence over disease activity.”

Authors declared , including payments from PepsiCo, drug companies, and Mindset Health Pty, which promotes hypnosis-based therapy.

One of the authors, gastroenterology professor Peter Gibson of Monash University in Australia, said the conflicts of interest “have nothing whatsoever to do with the study.”

“It is important not to overinterpret results of studies,” he said, adding that his team’s report “does not mean that emulsifiers are good for you or that there are no health benefits in avoiding emulsifiers.”

‘Keeping It Real’ (Or Not)

Häagen-Dazs touts the absence of such chemicals as a virtue.

“Keeping it real, the way it should be,” it said in an for its vanilla ice cream. “No emulsifiers. No stabilizers.”

However, at the company that makes Häagen-Dazs in the United States, , there are limits to that approach.

Under other brand names — such as Edy’s, Dreyer’s, and — it markets products that contain emulsifiers or stabilizers. The company did not respond to questions. In addition, a spokesperson for Nestlé, which markets Drumstick and Häagen-Dazs brands internationally, did not respond.

Drumstick Vanilla Caramel Sundae Cones have no artificial flavors or colors, the package says — but they feature an array of other ingredients, including soy lecithin, guar gum, monogylcerides, and carob bean gum.

The cones, the , offer “one incredibly creamy experience.”

And the creamy filling doesn’t melt.

Instead, over 24 hours on a 吃瓜不打烊 reporter’s kitchen counter, it bled a caramel-tinged fluid and shrank into a sticky white foam that could be cut with a knife.

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Watch: How the FDA Opens the Door to Risky Chemicals in America’s Food Supply /courts/fda-risky-chemicals-food-supply-gras-regulation-explainer-video/ Wed, 07 May 2025 09:00:00 +0000 /?post_type=article&p=2029309

Lining the shelves of American supermarkets are food products with chemicals linked to health concerns. To a great extent, the FDA allows food companies to determine for themselves whether their ingredients and additives are safe.

Companies don’t have to tell the FDA about those decisions, and they don’t have to list all ingredients on their product labels. Instead, companies can use broad terms such as “artificial flavors.”

In 1958, Congress mandated that before additives could be used in foods manufacturers had to prove they were safe and get FDA approval. However, Congress carved out an exception for substances “generally recognized as safe,” which came to be known simply as GRAS.

As conceived, GRAS promised regulatory relief for standard ingredients like salt, sugar, vinegar, and baking powder. Over time, “the loophole swallowed the law,” said a 2014 Natural Resources Defense Council report.

Health and Human Services Secretary Robert F. Kennedy Jr. wants to close or tighten the GRAS loophole. He has railed about the risks of food additives for years and has said he wants to end “the mass poisoning of American children.”

Whether changes come from the FDA or the food companies, it’s clear Americans are becoming more concerned about what they’re buying.

Credits

David Hilzenrath Reporter
Hannah Norman Video producer & animator
Oona Zenda Art director & illustrator
吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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2029309
Federal Health Work in Flux /podcast/what-the-health-389-federal-health-work-courts-march-20-2025/ Thu, 20 Mar 2025 19:10:00 +0000 The Host
Julie Rovner photo
Julie Rovner 吃瓜不打烊 Read Julie's stories. Julie Rovner is chief Washington correspondent and host of 吃瓜不打烊’ weekly health policy news podcast, "What the Health?" A noted expert on health policy issues, Julie is the author of the critically praised reference book "Health Care Politics and Policy A to Z," now in its third edition.

Two months into the new administration, federal workers and contractors remain off-balance as the Trump administration ramps up its efforts to cancel jobs and programs 鈥 even as federal judges declare many of those efforts illegal and/or unconstitutional.

As it eliminates programs deemed duplicative or unnecessary, however, President Donald Trump’s Department of Government Efficiency is also cutting programs and workers aligned with Health and Human Services Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” agenda.

This week’s panelists are Julie Rovner of 吃瓜不打烊, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Rachel Roubein of The Washington Post.

Panelists

Jessie Hellmann photo
Jessie Hellmann CQ Roll Call
Sarah Karlin-Smith photo
Sarah Karlin-Smith Pink Sheet
Rachel Roubein photo
Rachel Roubein The Washington Post

Among the takeaways from this week’s episode:

  • Kennedy’s comments this week about allowing bird flu to spread unchecked through farms provided another example of the new secretary of health and human services making claims that lack scientific support and could instead undermine public health.
  • The Trump administration is experiencing more pushback from the federal courts over its efforts to reduce and dismantle federal agencies, and federal workers who have been rehired under court orders report returning to uncertainty and instability within government agencies.
  • The second Trump administration is signaling it plans to dismantle HIV prevention programs in the United States, including efforts that the first Trump administration started. A Texas midwife is accused of performing illegal abortions. And a Trump appointee resigns after being targeted by a Republican senator.

Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:

Julie Rovner: The Washington Post’s “,” by Michael Lewis.

Rachel Roubein: The Washington Post’s “” by Carolyn Y. Johnson.

Sarah Karlin-Smith: 吃瓜不打烊’ “Scientists Say NIH Officials Told Them To Scrub mRNA References on Grants,” by Arthur Allen.

Jessie Hellmann: Stat’s “,” by Elaine Chen.

Also mentioned in this week’s podcast:

  • The Wall Street Journal’s “,” by Liz Essley White, Dominique Mosbergen, and Jonathan D. Rockoff.
  • The Washington Post’s “,” by Amanda Morris.
click to open the transcript Transcript: Federal Health Work in Flux

[Editor’s note: This transcript was generated using both transcription software and a human’s light touch. It has been edited for style and clarity.] 

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for 吃瓜不打烊, and I’m joined by some of the best and smartest health reporters in Washington. We’re taping this week on Thursday, March 20, at 10 a.m. As always, news happens fast and things might have changed by the time you hear this. So, here we go. 

Today we are joined via videoconference by Rachel Roubein of The Washington Post. 

Rachel Roubein: Hi. 

Rovner: Sarah Karlin-Smith of the Pink Sheet. 

Sarah Karlin-Smith: Hi, everybody. 

Rovner: And Jessie Hellmann of CQ Roll Call. 

Jessie Hellmann: Hello. 

Rovner: No interview today, but, as usual, way more news than we can get to, so let us jump right in. In case you missed it, there’s a bonus podcast episode in your feed. After last week’s Senate Finance Committee confirmation hearing for Dr. Mehmet Oz to head the Centers for Medicare & Medicaid Services, my 吃瓜不打烊 colleagues Stephanie Armour and Rachana Pradhan and I summarized the hearing and caught up on all the HHS [Department of Health and Human Services] nomination actions. It will be the episode in your feed right before this one. 

So even without Senate-confirmed heads at 鈥 checks notes 鈥 all of the major agencies at HHS, the department does continue to make news. First, Robert F. Kennedy Jr., the new HHS secretary, speaks. Last week it was measles. This week it was bird flu, which he says should be allowed to spread unchecked in chicken flocks to see which birds are resistant or immune. This feels kind of like what some people recommended during covid. Sarah, is there any science to suggest this might be a good idea? 

Karlin-Smith: No, it seems like the science actually suggests the opposite, because doctors and veterinary specialists are saying basically every time you let the infection continue to infect birds, you’re giving the virus more and more chances to mutate, which can lead to more problems down the road. The other thing is they were talking about the way we raise animals, and for food these days, there isn’t going to be a lot of genetic variation for the chickens, so it’s not like you’re going to be able to find a huge subset of them that are going to survive bird flu. 

And then the other thing I thought is really interesting is just it doesn’t seem economically to make the most sense either as well, both for the individual farmers but then for U.S. industry as a whole, because it seems like other countries will be particularly unhappy with us and even maybe put prohibitions on trading with us or those products due to the spread of bird flu. 

Rovner: Yeah, it was eyebrow-raising, let us say. Well, HHS this week also announced its first big policy effort, called Operation Stork Speed. It will press infant formula makers for more complete lists of ingredients, increase testing for heavy metals in formula, make it easier to import formula from other countries, and order more research into the health outcomes of feeding infant formula. This feels like maybe one of those things that’s not totally controversial, except for the part that the FDA [Food and Drug Administration] workers who have been monitoring the infant formula shortage were part of the big DOGE [Department of Government Efficiency] layoffs. 

Roubein: I talked to some experts about this idea, and, like you said, they thought it kind of sounded good, but they basically needed more details. Like, what does it mean? Who’s going to review these ingredients? To your point, some people did say that the agency would need to staff up, and there was a neonatologist who is heading up infant formula that was hired after the 2022 shortage who was part of the probationary worker terminations. However, when the FDA rescinded the terminations of some workers, so, that doctor has been hired back. So I think that’s worth noting. 

Rovner: Yes. This is also, I guess, where we get to note that Calley Means, one of RFK Jr.’s, I guess, brain trusts in the MAHA movement, has been hired as, I guess, in an Elon Musk-like position in the White House as an adviser. But this is certainly an area where he would expect to weigh in. 

Hellmann: Yeah, I saw he’s really excited about this on Twitter, or X. There’s just been concerns in the MAHA movement, “Make America Healthy Again,” about the ingredients that are in baby formula. And the only thing is I saw that he also retweeted somebody who said that “breast is best,” and I’m just hoping that we’re not going back down that road again, because I feel like public health did a lot of work in pushing the message that formula and breast milk is good for the child, and so that’s just another angle that I’ve been thinking about on this. 

Rovner: Yes, I think this is one of those things that everybody agrees we should look at and has the potential to get really controversial at some point. While we are on the subject of the federal workforce and layoffs, federal judges and DOGE continue to play cat-and-mouse, with lots of real people’s lives and careers at stake. Various judges have ordered the reinstatement, as you mentioned, Rachel, of probationary and other workers. Although in many cases workers have been reinstated to an administrative leave status, meaning they get put back on the payroll and they get their benefits back, but they still can’t do their jobs. At least one judge has said that does not satisfy his order, and this is all changing so fast it’s basically impossible to keep up. But is it fair to say that it’s not a very stable time to be a federal worker? 

Karlin-Smith: That’s probably the nicest possible way to put it. When you talk to federal workers, everybody seems stressed and just unsure of their status. And if they do have a job, it’s often from their perspective tougher to do their job lately, and then they’re just not sure how stable it is. And many people are considering what options they have outside the federal government at this point. 

Rovner: So for those lucky federal workers who do still have jobs, the Trump administration has also ordered everyone back to offices, even if those offices aren’t equipped to accommodate them. FDA headquarters here in Maryland’s kind of been the poster child for this this week. 

Karlin-Smith: Yeah, FDA is an interesting one because well before covid normalized working from home and transitioned a lot of people to working from home, FDA’s headquarters couldn’t accommodate a lot of the new growth in the agency over the years, like the tobacco part of the FDA. So it was typical that people at least worked part of their workweek at home, and FDA really found once covid gave them additional work-from-home flexibilities, they were able to recruit staff they really, really needed with specialized degrees and training who don’t live near here, and it actually turned out to be quite a benefit from them. 

And now they’re saying everybody needs to be in an office five days a week, and you have people basically cramped into conference rooms. There’s not enough parking. People are trying to review technical scientific data, and you kind of can’t hear yourself think. Or you’re a lawyer 鈥 I heard of a situation where people are basically being told, Well, if you need to do a private phone call because of the confidentiality around what you’re doing, go take the call in your car. So I think in addition to all of the concerns people have around the stability of their jobs, there’s now this element of, on a personal level, I think for many of them it’s just made their lives more challenging. And then they just feel like they’re not actually able to do, have the same level of efficiency at their work as they normally would. 

Rovner: And for those who don’t know, the FDA campus is on a former military installation in the Maryland suburbs. It’s not really near any public transportation. So you pretty much have to drive to get there. And I think that the parking lots are not that big, because, as you pointed out, Sarah, the workforce is now bigger than the headquarters was created to accommodate it. And we’re seeing this across the government. This week it happened to be FDA. You have to ask the question: Is this really just an effort to make the government not work, to make federal workers, if they can’t fire them, to make them quit? 

Hellmann: I definitely think that’s part of the underlying goal. If you see some of the stuff that Elon Musk says about the federal workforce, it’s very dismissive. He doesn’t seem to have a lot of respect for the civil servants. And they’ve been running into a lot of pushback from federal judges over many lawsuits targeting these terminations. And so I think just making conditions as frustrating as possible for some of these workers until they quit is definitely part of the strategy. 

Roubein: And I think this is overlaid with the additional buyout offers, the additional early retirement offers. There’s also the reduction-in-force plans that federal workers have been unnerved about, bracing for future layoffs. So it’s very clear that they want to shrink the size of the federal workforce. 

Rovner: Yeah, we’ve seen a lot of these people, I’ve seen interviews with them, who are being reinstated, but they’re still worried that now they’re going to be RIF-ed. They’re back on the payroll, they’re off the payroll. I mean there’s nothing 鈥 this does not feel like a very efficient way to run the federal government. 

Karlin-Smith: Right. I think that’s what a lot of people are talking about is, again, going back to offices, for many of these people, is not leading to productivity. I talked to one person who said: I’m just leaving my laptop at the office now. I’m not going to take it home and do the extra hours of work that they might’ve normally gotten from me. And that includes losing time to commute. FDA is paying for parking-garage spaces in downtown Silver Spring [Maryland] near the Metro so that they can then shuttle people to the FDA headquarters. I’ve taken buses from that Metro to FDA headquarters. In traffic, that’s a 30-minute drive. They’re spending money on things that, again, I think are not going to in the long run create any government efficiency. 

And in fact, I’ve been talking to people who are worried it’s going to do the opposite, that drug review, device review, medical product review times and things like that are going to slow. We talked about food safety. I think The New York Times had a really good story this week about concerns about losing the people. We need to make sure that baby formula is actually safe. So there’s a lot of contradictions in the messaging of what they’re trying to accomplish and how the actions actually are playing out. 

Rovner: Well, and finally, I’m going to lay one more layer on this. There’s the question of whether you can even put the toothpaste back in the tube if you wanted to. After weeks of back-and-forth, the federal judge ruled on Tuesday that the dissolution of USAID [the U.S. Agency for International Development] was illegal and probably unconstitutional, and ordered email and computer access restored for the remaining workers while blocking further cuts. But with nearly everybody fired, called back from overseas, and contracts canceled, USAID couldn’t possibly come close to doing what it did before DOGE basically took it apart, right?. 

Karlin-Smith: You hear stories of if someone already takes a new job, they’re lucky enough to find a new job, why are they going to come back? Again, even if you’re brought back, my expectation is a lot of people who have been brought back are probably looking for new jobs regardless because you don’t have that stability. And I think the USAID thing is interesting, too, because again, you have people that were working in all corners of the world and you have partnerships with other countries and contractors that have to be able to trust you moving forward. And the question is, do those countries and those organizations want to continue working with the U.S. if they can’t have that sort of trust? And as people said, the U.S. government was known as, they could pay contractors less because they always paid you. And when you take that away, that creates a lot of problems for negotiating deals to work with them moving forward. 

Rovner: And I think that’s true for federal workers, too. There’s always been the idea that you probably could earn more in the private sector than you can working for the federal government, but it’s always been a pretty stable job. And I think right now it’s anything but, so comes the question of: Are we deterring people from wanting to work for the federal government? Eventually one would assume there’s still going to be a federal government to work for, and there may not be anybody who wants to do it. 

Roubein: Yeah, you saw various hiring authorities given to try and recruit scientists and other researchers who make a lot, lot more in the public health sector, and some of those were a part of the probationary workforce because they had been hired recently under those authorities. 

Rovner: Yeah, and now this is all sort of coming apart. Well, meanwhile, the cuts are continuing even faster than federal judges can rule against them. Last week, the administration said it would reduce the number of HHS regional offices from 10 to four. Considering these are where the department’s major fraud-fighting efforts take place, that doesn’t seem a very effective way of going after fraud and abuse in programs like Medicare and Medicaid. Those regional offices are also where lots of beneficiary protections come from, like inspections of nursing homes and Head Start facilities. How does this serve RFK Jr.’s Make America Healthy Again agenda? 

Karlin-Smith: I think it’s not clear that it does, right? You’re talking about, again, the Department of Government Efficiency has focused on efficiency, cost savings, and Medicare and Medicaid does a pretty good job of fighting fraud and making HHS OIG [Office of Inspector General], all those organizations, they collect a lot of money back. So when you lose people鈥 

Rovner: And of course the inspector general has also been laid off in all of this. 

Karlin-Smith: Right. It’s not clear to me, I think one of the things with that whole reorganization of their chief counsel is people are suggesting, again, this is sort of a power move of HHS wanting to get a little bit more control of the legal operations at the lower agencies, whether it’s NIH [the National Institutes of Health] or FDA and so forth. But, right, it’s reducing head count without really thinking about what people’s roles actually were and what you lose when you let them go. 

Rovner: Well, the Trump administration is also continuing to cut grants and contracts that seem like they’d be the kind of things that directly relate to Make America Healthy Again. Jessie, you’ve chosen one of those as your extra credit this week. Tell us about it. 

Hellmann: Yeah. So my story is from Stat [“”], and it’s about a nationwide study that tracks patients with prediabetes and diabetes. And it was housed at Columbia University, which as we know has been the subject of some criticism from the Trump administration. They had lost about $400 million in grants because the administration didn’t like Columbia’s response to some of the protests that were on campus last year. But that has an effect on some research that really doesn’t have much to do with that, including a study that looked at diabetes over a really long period of time. 

So it was able to over decades result in 200 publications about prediabetes and diabetes, and led to some of the knowledge that we have now about the interventions for that. And the latest stage was going to focus on dementia and cognitive impairment, since some of the people that they’ve been following for years are now in their older ages. And now they have to put a stop to that. They don’t even have funding to analyze blood samples that they’ve done and the brain scans that they’ve collected. So it’s just another example of how what’s being done at the administration level is contradicting some of the goals that they say that they have. 

Rovner: Yeah, and it’s important to remember that Columbia’s funding is being cut not because they deemed this particular project to be not helpful but because they are, as you said, angry at Columbia for not cracking down more on pro-Palestinian protesters after Oct. 7. 

Well, meanwhile, people are bracing for still more cuts. the administration plans to cut domestic AIDS-HIV programming on top of the cuts to the international PEPFAR [President’s Emergency Plan for AIDS Relief] program that was hammered as part of the USAID cancellation. Is fighting AIDS and HIV just way too George W. Bush for this administration? 

Hellmann: It’s interesting because President [Donald] Trump unveiled the Ending the HIV Epidemic initiative in his first term, and the goal was to end the epidemic in the United States. And so if they were talking about reducing some of that funding, or I know there were reports that maybe they would move the funding from CDC [the Centers for Disease Control and Prevention] to HRSA [the Health Resources and Services Administration], it’s very unclear at this point. Then it raises questions about whether it would undermine that effort. And there’s already actions that the Trump administration has done to undermine the initiative, like the attacks on trans people. They’ve canceled grants to researchers studying HIV. They have done a whole host of things. They canceled funding to HIV services organizations because they have “trans” in their programming or on their websites. So it’s already caused a lot of anxiety in this community. And yeah, it’s just a total turnaround from the first administration. 

Rovner: I know the Whitman-Walker clinic here in Washington, which has long been one of the premier AIDS-HIV clinics, had just huge layoffs. This is already happening, and as you point out, this was something that President Trump in his first term vowed to end AIDS-HIV in the U.S. So this is not one would think how one would go about that. 

Well, it’s not just the administration that’s working to constrict rights and services. A group of 17 states, led by Texas, of course, are suing to have Biden-era regulations concerning discrimination against trans people struck down, except as part of that suit, the states are asking that the entirety of be declared unconstitutional. Now, you may never have heard of Section 504, but it is a very big deal. It was the forerunner of the Americans With Disabilities Act, and it prevents discrimination on the basis of disability in all federally funded activities. It is literally a lifeline for millions of disabled people that enables them to live in the community rather than in institutions. Are we looking at an actual attempt to roll back basically all civil rights as part of this war on “woke” and DEI [diversity, equity, and inclusion] and trans people? 

Hellmann: The story is interesting, because it seems like some of the attorneys general are saying, That’s not our intent. But if you look at the court filings, it definitely seems like it is. And yeah, like you said, this is something that would just have a tremendous impact. And Medicaid coverage of home- and community-based services is one of those things that states are constantly struggling to pay for. You’re just continuing to see more and more people need these services. Some states have waiting lists, so鈥 

Rovner: I think most states have waiting lists. 

Hellmann: Yeah. It’s something, you have to really question what the intent is here. Even if people are saying, This isn’t our intent, it’s pretty black-and-white on paper in the court records, so鈥 

Rovner: Yeah, just to be clear, this was a Biden administration regulation, updating the rules for Section 504, that included reference to trans people. But in the process of trying to get that struck down, the court filings do, as you say, call for the entirety of Section 504 to be declared unconstitutional. This is obviously one of those court cases that’s still before the district court, so it’s a long way to go. But the entire disability community, certainly it has their attention. 

Well, we haven’t had any big abortion news the past couple of weeks, but that is changing. In Texas, a midwife and her associate have become the first people arrested under the state’s 2022 abortion ban. The details of the case are still pretty fuzzy, but if convicted, the midwife who reportedly worked as an OB-GYN doctor in her native Peru and served a mostly Spanish-speaking clientele, could be sentenced to up to 20 years in prison. So, obviously, be watching that one. Meanwhile, here in Washington, Hilary Perkins, a career lawyer chosen by FDA commissioner nominee Marty Makary to serve as the agency’s general counsel, resigned less than two days into her new position after complaints from Missouri Sen. Josh Hawley that she defended the Biden administration’s position on the abortion pill mifepristone. 

Now, Hilary Perkins is no liberal trying to hide out in the bureaucracy. She’s a self-described pro-life Christian conservative hired in the first Trump administration, but she was apparently forced out for the high crime of doing her job as a career lawyer. Is this administration really going to try to evict anyone who ever supported a Biden position? Will that leave anybody left? 

Roubein: I think what’s notable is Sen. Josh Hawley here, who expressed concerns and I had heard expressed concerns to the White House, and the post on X from the FDA came an hour before the hearing. There were concerns that he was not going to make it out of committee and鈥 

Rovner: Before the Marty Makary hearing. 

Roubein: Yes, sorry, before the vote in the HELP [Health, Education, Labor and Pensions] Committee on Marty Makary. And Hawley said because of that, he would vote to support him. What was interesting is two Democrats actually ended up supporting him, so he could have passed without Hawley’s vote. But I think in general it poses a test for Marty Makary when he’s an FDA commissioner, and how and whether he’s going to get his people in and how he’ll respond to different pressure points in Congress and with HHS and with the White House. 

Rovner: And of course, Hawley’s not a disinterested bystander here, right? 

Karlin-Smith: So his wife was one of the key attorneys in the recent big Supreme Court case that was pushed down to the lower courts for a lack of standing, but she was trying to essentially get tighter controls on the abortion pill mifepristone. But it seems like almost maybe Hawley jumped too soon before doing all of his research or fully understanding the role of people at Justice. Because even before this whole controversy erupted, I had talked to people the day before about this and asked them, “Should we read into this, her being involved in this?” And everybody I talked to, including, I think, a lot of people that have different views than Perkins does on the case, that they were saying she was in a role as a career attorney. You do what your boss, what the administration, wants. 

If you really, really had a big moral problem with that, you can quit your job. But it’s perfectly normal for an attorney in that kind of position to defend a client’s interest and then have another client and maybe have to defend them wrongly. So it seems like if they had just maybe even picked up the phone and had a conversation with her, the whole crisis could have been averted. And she was on CNN yesterday trying to plead her case and, again, emphasize her positions because perhaps she’s worried about her future career prospects, I guess, over this debacle. 

Rovner: Yeah, now she’s going to be blackballed by both sides for having done her job, basically. Anyway, all right, well, one big Biden initiative that looks like it will continue is the Medicare Drug Price Negotiation program. And we think we know this because CMS announced last week that the makers of all of the 15 drugs selected for the second round of negotiations have agreed to, well, negotiate. Sarah, this is news, right? Because we were wondering whether this was really going to go forward. 

Karlin-Smith: Yeah, they’ve made some other signals since taking over that they were going to keep going with this, including last week at his confirmation hearing, Dr. Oz, for CMS, also indicated he seemed like he would uphold that law and they were looking for ways to lower drug costs. So I think what people are going to be watching for is whether they yield around the edges in terms of tweaks the industry wants to the law, or is there something about the prices they actually negotiate that signal they’re not really trying to get them as low as they can go? But this seems to be one populist issue for Trump that he wants to keep leaning into and keep the same consistency, I think, from his first administration, where he always took a pretty hard line on the drug industry and drug pricing. 

Rovner: And I know Ozempic is on that list of 15 drugs, but the administration hasn’t said yet. I assume that’s Ozempic for its original purpose in treating diabetes. This administration hasn’t said yet whether they’ll continue the Biden declaration that these drugs could be available for people for weight loss, right? 

Karlin-Smith: Correct. And I think that’s going to be more complicated because that’s so costly. So negotiating the price of drugs saves money. So yes, basically because Ozempic and Wegovy are the same drug, that price should be available regardless of the indication. But I’m more skeptical that they continue that policy, because of the cost and also just because, again, HHS Secretary Robert F. Kennedy seems to be particularly skeptical of the drugs, or at least using that as a first line of defense, widespread use, reliance on that. He tends to, in general, I think, support other ways of medical, I guess, treatment or health treatments before turning to pharmaceuticals. 

Rovner: Eating better and exercising. 

Karlin-Smith: Correct, right. So I think that’s going to be a hard sell for them because it’s just so costly. 

Rovner: We will see. All right, that is as much news as we have time for this week. Now, it is time for our extra-credit segment, that’s where we each recognize the story we read this week we think you should read, too. Don’t worry if you miss it. We will put the links in our show notes on your phone or other mobile device. Jessie, you’ve done yours already this week. Rachel, why don’t you go next? 

Roubein: My extra credit, the headline is “” In The Washington Post by my colleague Carolyn Y. Johnson. And I thought the story was particularly interesting because it really dove into the personal level. You hear about all these cuts from a high level, but you don’t always really know what it means and how it came about. So the backstory is the National Institutes of Health terminated dozens of research grants that focused on why some people are hesitant to accept vaccines. 

And Carolyn profiled one researcher, Nisha Acharya, but there was a twist, and the twist was she doesn’t actually study how to combat vaccine hesitancy or ways to increase vaccine uptake. Instead, she studies how well the shingles vaccine works to prevent the infection, with a focus on whether the shot also prevents the virus from affecting people’s eyes. But in the summary of her project, she had used the word “hesitancy” once and used the word “uptake” once. And so this highlights the sweeping approach to halting some of these vaccine hesitancy research grants. 

Rovner: Yeah that was like the DOD [Department of Defense] getting rid of the picture of the Enola Gay, the plane that dropped the atomic bomb, because it had the word “Gay” in it. This is the downside, I guess, of using AI for these sorts of things. Sarah. 

Karlin-Smith: I took a look at a KFF story by Arthur Allen, “Scientists Say NIH Officials Told Them to Scrub mRNA References on Grants,” and it’s about NIH officials urging people to remove any reference to mRNA vaccine technology from their grants. And the story indicates it’s not yet clear if that is going to translate to defunding of such research, but the implications are quite vast. I think most people probably remember the mRNA vaccine technology is really what helped many of us survive the covid pandemic and is credited with saving millions of lives, but the technology promise seems vast even beyond infectious diseases, and there’s a lot of hope for it in cancer. 

And so this has a lot of people worried. It’s not particularly surprising, I guess, because again, the anti-vaccine movement, which Kennedy has been a leader of, has been particularly skeptical of the mRNA technology. But it is problematic, I think, for research. And we spent a lot of time on this call talking about the decimation of the federal workforce that may happen here, and I think this story and some of the other things we talked about today also show how we may just decimate our entire scientific research infrastructure and workforce in the U.S. outside of just the federal government, because so much of it is funded by NIH, and the decisions they’re making are going to make it impossible for a lot of scientists to do their job. 

Rovner: Yeah, we’re also seeing scientists going to other countries, but that’s for another time. Well, my extra credit this week, probably along the same lines, also from The Washington Post. It’s part of a series called “” This particular piece [“”] is by bestselling author Michael Lewis, and it’s a sprawling 鈥 and I mean sprawling 鈥 story of how a mid-level FDA employee who wanted to help find new treatments for rare diseases ended up not only figuring out a cure for a child who was dying of a rare brain amoeba but managed to obtain the drug for the family in time to save her. It’s a really good piece, and it’s a really excellent series that tells the stories of mostly faceless bureaucrats who actually are working to try to make the country a better place. 

OK, that’s this week’s show. As always, if you enjoy the podcast, you can subscribe wherever you get your podcasts. We’d appreciate it if you left us a review. That helps other people find us, too. Thanks as always to our producer, Francis Ying, and our editor, Emmarie Huetteman. As always, you can email us your comments or questions. We’re at whatthehealth@kff.org, or you can still find me at X, , and at Bluesky, . Where are you guys these days? Sarah? 

Karlin-Smith: A little bit everywhere. , , 鈥 @SarahKarlin or @sarahkarlin-smith. 

Rovner: Jessie. 

Hellmann: I’m @jessiehellmann and , and I’m also on more these days. 

Rovner: Great. Rachel. 

Roubein: at Bluesky, on X, and also on . 

Rovner: We will be back in your feed next week. Until then, be healthy. 

Credits

Francis Ying Audio producer
Emmarie Huetteman Editor

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吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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Scientist Whose Work Led FDA To Ban Food Dye Says Agency Overstated Risk /health-industry/food-additive-chemical-red-dye-number-3-fda-ban-january-delaney-clause/ Mon, 17 Mar 2025 09:00:00 +0000 /?post_type=article&p=1997614 When the , before President Joe Biden’s term ended, that it would ban a dye called red dye No. 3 in food and ingested drugs, the federal agency cited just one 1987 study on rats to support its action.

, based on data from two prior studies, was led by a Virginia toxicologist who said then 鈥 and still believes today, decades after concerns first arose that the chemical could be carcinogenic 鈥 that his research found the petroleum-derived food coloring doesn’t cause cancer in humans.

“If I thought there was a problem, I would have stated it in the paper,” , 94, a professor emeritus of pharmacology and toxicology at Virginia Commonwealth University, told 吃瓜不打烊 after the FDA’s announcement. “I have no problem with my family 鈥 my kids and grandkids 鈥 consuming Red 3. I stand by the conclusions in my paper that this is not a problem for humans.”

Soon after Borzelleca’s paper was published in a scientific journal, Food and Chemical Toxicology, the FDA examined the data his team had collected and reached its own conclusion: that the dye caused cancer in male lab rats. In 1990, the FDA cited the study in banning Red 3 in cosmetics.

In 1992, the FDA said it wanted to revoke approval of Red 3 in food and drugs. But the agency didn’t act at the time, citing a lack of resources.

More than 30 years later, after a renewed push by consumer advocates, the Biden administration announced the ban in its last days in power. The move came just weeks before the Senate confirmed Robert F. Kennedy Jr., President Donald Trump’s nominee to head the Department of Health and Human Services, which oversees the FDA.

Kennedy has been a vocal critic of food additives, including Red 3. On March 10 he met with top food industry executives and told them if they don’t eliminate artificial food dyes from their products, the federal government will force them to do so, .

Consumer advocacy groups cheered the Red 3 ban, even as the FDA said there is no evidence that the dye is dangerous to people. “Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans,” , FDA deputy commissioner for human foods, said in a statement.

Jones resigned from FDA in February, that he said hobbled his office.

The FDA did not respond to a request for comment, but Marty Makary, Trump’s nominee to lead the agency, said at his Senate confirmation hearing on March 6 that he is concerned about whether food additives such as Red 3 harm children.

“It did not make sense that red dye No. 3 was banned in cosmetics but allowed in the food supply,” Makary told Sen. Tommy Tuberville, who questioned why the FDA ban doesn’t take effect until 2027.

A photo of Marty Makary speaking into a microphone in a Senate hearing room.
Marty Makary, President Donald Trump’s pick to lead the FDA, at his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on March 6. (Eric Harkleroad/吃瓜不打烊)

“We want to kill people for two more years?” the Alabama Republican said. “I would hope that you would, if you’re confirmed, you’d go in and look at it very quickly and say, 鈥榃hy do we want to put our people in harm’s way?’”

The International Association of Color Manufacturers says Red 3 is safe in the tiny levels typically consumed by humans. The dye was approved for use in foods in the U.S. in 1907, and today it’s an ingredient in thousands of products including cereals, candy, beverages, and cake toppings.

, principal scientist for food additives and supplements at the Center for Science in the Public Interest, which petitioned the FDA for a ban, said that a federal regulation known as the Delaney Clause prohibits any ingredient that causes cancer in animals from being included in foods. (The publisher of 吃瓜不打烊, David Rousseau, is on the CSPI board.)

“At the end of the day, this is an unnecessary additive,” he said. “It’s a marketing tool for the industry to make foods look more appealing so consumers will buy them. But federal law is clear: No amount of cancer risk is acceptable in foods.”

Galligan said he was not surprised Borzelleca’s opinion on Red 3 had not changed or that the food dye industry has played down the risk.

In October 2023, California became the first state to ban Red 3 in food starting in 2027, superseding the FDA’s earlier rule allowing small amounts in foods as a color additive. The state legislature acted after a concluded the dye could cause hyperactivity in children.

The European Union and Australia are among the locations that already ban the chemical in most foods. The EU also requires food makers to include a warning that certain other food dyes may “have an adverse effect on activity and attention in children.”

The IACM points to research by scientific committees operated by the World Health Organization, including a that affirmed the safety of Red 3 in food.

Some food manufacturers have already reformulated products to remove Red 3. In its place they use beet juice; carmine, a dye made from insects; or pigments from foods such as purple sweet potato, radish, and red cabbage.

It isn’t clear how the FDA determined that Red 3 can cause cancer in male rats. Borzelleca’s paper said some rats that were fed Red 3 developed polyps in their thyroid gland but doesn’t mention cancer.

Borzelleca, whose study was funded by the IACM, then known as the Certified Color Manufacturers Association, said he was stunned the FDA banned the dye and used his research to back the move.

“I am surprised all this time has gone by and it’s been safe for human use, and now it’s being pulled from the market due to concerns not supported by the data,” Borzelleca said. “Our study did not find this was a carcinogen.”

His study was a response to the FDA’s requirement in the 1980s for additional long-term feeding studies in rats and mice as a condition for the continued provisional approval of several color additives, including Red 3.

Over decades, Borzelleca published dozens of research papers on the toxicology of food additives, pesticides, and water contaminants. He also served on advisory boards for the tobacco industry and represented cigarette maker R.J. Reynolds in negotiations with the Department of Health and Human Services about cigarette additives, according to a 1984 corporate memo. Borzelleca is a former president of the Society of Toxicology and consulted for the National Academy of Sciences and the World Health Organization.

The commonwealth of Virginia gave him a lifetime achievement award in 2001 for his work helping assess dangers in foods, drugs, and pesticides.

吃瓜不打烊 is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF鈥攁n independent source of health policy research, polling, and journalism. Learn more about .

This article first appeared on 吃瓜不打烊 and is republished here under a .

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