The upshot, : Babies fed rival Mead Johnson Nutrition’s acidified liquid human milk fortifier — a nutritional supplement used in neonatal intensive care units — 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 — whether they know it or not — 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 Â鶹ŮÓÅ Health News 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 — 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 — an investigator in the study — .

“We had another SAE” — serious adverse event — “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.

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 Â鶹ŮÓÅ Health News 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 ‘Hospital 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 — later used in the Whitfield trial — 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 Â鶹ŮÓÅ Health News, 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.

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 … and ‘taking 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 — 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.

“‘,” 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.

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” — health care providers, apparently — “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 Â鶹ŮÓÅ Health News.

“Thus, references in documents about wanting to ‘win’ or ‘own’ 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 — 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 — 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 — 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.

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 — illnesses or deaths potentially related to the products — 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.

‘At 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 ‘at 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 ‘infant formula seems responsible for developing NEC,’” Das wrote.

“Instead, we thought if we could state as ‘infant 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 Â鶹ŮÓÅ Health News sent by email.

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

‘In 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 ‘statistically 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 — a co-author of the paper and Mead Johnson’s director of medical affairs for North America when the study was completed — 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.

‘It 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.

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, Â鶹ŮÓÅ Health News 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.

Â鶹ŮÓÅ Health News 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 Â鶹ŮÓÅ Health News 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 Â鶹ŮÓÅ Health News 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 — in other words, the Mead Johnson fortifier — 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” — 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 — 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.”

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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.

Â鶹ŮÓÅ Health News senior correspondent Stephanie Armour explained on WAMU’s “Health Hub” on Aug. 6. how the Trump administration is reshaping America’s food safety system.

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An E. coli outbreak that occurred late last year — for which the investigation was concluded in February — signals how, with the FDA changes, more people could get sick with foodborne illnesses as companies and growers face less regulatory oversight and fewer consequences for selling tainted food products, according to interviews with consumer advocates, researchers, and former employees at the FDA and U.S. Department of Agriculture.Ìý

In addition, the administration withdrew a to of salmonella in raw poultry, a plan that could have saved more than $13 million annually by preventing roughly 3,000 illnesses. It is also disbanding a Department of Justice unit that pursues civil and criminal actions against companies that sell contaminated food and is reassigning its attorneys, according to a former FDA official, a publicly posted memo from the head of the department’s criminal division, and a white paper by the law firm Gibson Dunn.Ìý

“It’s all about destruction and not about efficiency,” said Siobhan DeLancey, who worked in the agency’s Office of Foods and Veterinary Medicine for more than 20 years before being laid off in April. “We’re going to see the effects for years. It will cost lives.”Ìý

Officials from the Department of Health and Human Services did not comment on the record for this article but have maintained that food safety is a priority.Ìý

Staffing cuts mean delays in publicizing deadly outbreaks, said Susan Mayne, an adjunct professor at the Yale School of Public Health who retired from the FDA in 2023. DeLancey said new requirements from the Trump administration for reviewing agency announcements became so arduous that it took weeks to get approval for alerts that should have been going out much sooner.Ìý

The November 2024 outbreak caused by E. coli bacteria in lettuce sickened nearly 90 people and killed one person. But after the investigation was completed under the Trump administration, the FDA redacted any information identifying the grower or processor. The FDA said in its that the grower wasn’t named because no product remained on the market.Ìý

The information is still important because it can prevent further cases, pressure growers to improve sanitation, and identify repeat offenders, said Bill Marler, a Seattle lawyer who specializes in food-safety litigation.Ìý

“The whole ‘Make America Healthy Again,’ the focus on taking food color dyes out of cereal?” said Chris George, of Avon, Indiana, whose son was hospitalized in the outbreak. “How about we take E. coli out of our lettuce, so it doesn’t kill our kids?”

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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 Ìýin 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.

‘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.’”

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?”

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Días más tarde, estaba en una cama de hospital, luchando por su vida. La Ìýdemanda presentada con fecha 17 de abril por sus padres contra un productor de lechugas ante un tribunal federal del Distrito Sur de Indiana asegura que el chico había comido una ensalada contaminada.

La bacteria E. coli, que devastó los riñones de Colton, era a la cepa que, en el otoño anterior, había matado a una persona y enfermado a otras 90, en 15 estados. Las agencias federales de salud investigaron los casos y los relacionaron con una granja que cultivaba lechuga romana.

Pero la mayoría de la gente nunca oyó hablar de ese brote de E coli al que un —fechado el 11 de febrero— relacionó con un único rancho y un único productor de lechuga como fuente de la contaminación.

En lo que muchos expertos calificaron como un cambio radical de las prácticas habituales, las autoridades nunca emitieron comunicados públicos luego de la investigación, ni tampoco identificaron al productor de la lechuga contaminada.

El gobierno de Trump ha impulsado recortes de recursos y redujo las regulaciones. Las consecuencias son desde no dar a conocer un brote importante hasta la reducción del personal especializado en alertas y normas de seguridad.

Defensores del consumidor, investigadores y ex funcionarios de la Administración de Drogas y Alimentos (FDA) y el Departamento de Agricultura de Estados Unidos (USDA) sostienen que esa política pone en riesgo un sistema fundamental que ayuda a proteger la seguridad alimentaria del país.

La investigación sobre las enfermedades comenzó hacia el final de la administración Biden, pero el trabajo sobre el brote relacionado con la lechuga no se completó hasta el 11 de febrero. En ese momento, la administración Trump tomó la decisión de no revelar los nombres ni del productor ni del procesador porque la FDA afirmó que no quedaba ningún producto en el mercado.

La administración también ha retirado una para reducir la presencia de Salmonela en las aves de corral crudas, según una alerta del USDA . La que esta medida ahorraría más de $13 millones al año al prevenir más de 3.000 casos de enfermedad.

Funcionarios del Departamento de Salud y Servicios Humanos (HHS) han afirmado que la seguridad alimentaria es una prioridad, y Marty Makary, comisionado de la FDA, declaró en una entrevista el 29 de abril con el boletín que los recientes recortes de personal no afectarían el funcionamiento de la agencia.

“La FDA tenía 9.500 empleados en 2007. El año pasado eran casi 19.000. ¿Ha aumentado el 100% de empleados los tiempos de aprobación, la innovación, la inteligencia artificial, la seguridad alimentaria o la moral de la agencia?”, se preguntó Makary. “No, no lo ha hecho. De hecho, ha aumentado la burocracia regulatoria”.

La FDA remitió las preguntas al HHS, que se negó a hacer comentarios o a poner a Makary a disposición para una entrevista.

En un comunicado, la agencia afirmó que “proteger la salud pública y garantizar la seguridad alimentaria siguen siendo prioridades fundamentales para el HHS. Los inspectores de la FDA no se han visto afectados [por los recortes de empleos] y esta labor fundamental continuará”.

Sin embargo, defensores de la salud pública advierten que, como resultado de las recientes medidas de la FDA, las empresas y los agricultores se enfrentarán a una menor supervisión reguladora, y vender productos alimenticios contaminados tendrá menos consecuencias.

Por ejemplo, la administración está disolviendo una unidad del Departamento de Justicia (DOJ) que lleva a cabo acciones civiles y penales contra las empresas que venden alimentos contaminados y está reasignando a sus abogados.

Algunas tareas serán asumidas por otras divisiones, según un memorándum publicado por el jefe de la división penal del departamento y un informe de la firma de abogados Gibson Dunn.

El DOJ no respondió a un correo electrónico en el que se le solicitaban comentarios.

“Necesitan que el Departamento de Justicia haga cumplir la ley”, afirmó Sarah Sorscher, directora de asuntos regulatorios del Center for Science in the Public Interest, una organización sin fines de lucro que defiende los derechos de los consumidores. “Para un ejecutivo que invierte en seguridad alimentaria, saber que podría ir a la cárcel si no lo hace es un motivador muy poderoso”.

Los reguladores federales también quieren que los estados realicen más inspecciones, según dos ex funcionarios de la FDA, que hablaron bajo condición de anonimato por temor a sufrir represalias. Pero algunos legisladores demócratas afirman que los estados no tienen los recursos necesarios para hacerse cargo de la mayoría de estas inspecciones.

“Delegar esa responsabilidad en las agencias estatales y locales es realmente preocupante”, afirmó la representante Shontel M. Brown (demócrata de Ohio). “No tienen los recursos necesarios y eso crea una situación potencialmente insegura que pone en riesgo a las familias de Ohio y de todo Estados Unidos”, agregó.

El alto costo de las enfermedades transmitidas por alimentos

Según datos federales, las enfermedades transmitidas por alimentos tienen un gran impacto económico en Estados Unidos y causan miles de muertes cada año. El USDA estima que las muertes, las enfermedades crónicas, el tratamiento médico y la pérdida de productividad derivadas de estas afecciones ascendieron a $75.000 millones en 2023.

Cada año, alrededor de 48 millones de personas en el país desarrollan enfermedades transmitidas por alimentos; 128.000 son hospitalizadas y 3.000 mueren, según los

En sus primeros meses, la administración ha suspendido un programa conocido como Food Emergency Response Network Proficiency Testing (Pruebas de Competencia de la Red de Respuesta a Emergencias Alimentarias), que garantiza que los laboratorios de análisis de alimentos identifiquen con precisión los patógenos que pueden enfermar o matar, explicó un ex funcionario de la FDA.

En marzo, la agencia anunció que retrasaría de enero de 2026 a julio de 2028 el cumplimiento de una norma de la época de Biden que tiene por objeto acelerar la identificación y retirada del mercado de los alimentos potencialmente contaminados.

Sin embargo, la FDA está apuntando contra la producción de alimentos en el extranjero, y en un aviso del 6 de mayo dijo que ampliaría las inspecciones fuera de Estados Unidos . “Este enfoque ampliado marca una nueva era en la aplicación de la ley por parte de la FDA: más fuerte, más inteligente y sin concesiones en defensa de la salud y la seguridad públicas de los estadounidenses”, decía el anuncio.

Algunos funcionarios de la FDA y del USDA afirmaron que ese objetivo no es realista, ya que los inspectores estadounidenses a menudo necesitan obtener visas que pueden alertar a las empresas de su llegada.

“Es muy, muy difícil realizar inspecciones sorpresa”, afirmó Brian Ronholm, director de política alimentaria de Consumer Reports y ex subsecretario adjunto de seguridad alimentaria del USDA. “El proceso de obtención del visado puede alertar a las autoridades locales”, explicó.

El HHS se negó a abordar las preocupaciones de Ronholm.

La FDA no ha cumplido los objetivos obligatorios de inspección de las instalaciones alimentarias desde el año fiscal 2018, y la agencia ha incumplido sistemáticamente sus objetivos anuales de inspecciones en el extranjero, según un informe de enero de la Oficina de Responsabilidad Gubernamental de Estados Unidos.

Las enfermedades transmitidas por alimentos pueden ser graves. En abril y mayo, la bacteria Salmonela presente en pepinos enfermó a decenas de personas, y dejó al menos nueve hospitalizadas, según la FDA.

En 2008-09, un brote de Salmonela en mantequilla de maní causó la muerte de nueve personas y dio lugar a cargos penales contra los ejecutivos de la empresa. Y en 2009, la E. coli presente en masa para galletas enfermó a más de 70 personas, entre ellas una madre de Nevada que murió por complicaciones derivadas de comer la masa cruda.

“La vida o la muerte de nuestro hijo”

La E. coli, que se encuentra comúnmente en las heces, puede ser especialmente peligrosa para niños como Colton, el niño de Avon, Indiana, que comió lechuga contaminada. La bacteria puede dañar los vasos sanguíneos y causar coágulos que destruyen los riñones, lo que provoca accidentes cerebrovasculares y coma.

Los consumidores que se enferman por la E. coli pueden contagiarla a otras personas y, en algunos casos, la bacteria acaba matando a víctimas que nunca consumieron los alimentos contaminados.

Cuando la madre de Colton lo llevó a la sala de emergencias aquel día de noviembre, la bacteria ya estaba liberando toxinas y dañando sus células sanguíneas y sus riñones, según el padre, Chris George.

Colton fue trasladado al Riley Hospital for Children de Indianapolis. Chris recuerda que los médicos les dijeron a él y a su esposa, Amber George, que su hijo tenía insuficiencia renal y que las siguientes 24 a 72 horas serían decisivas para su supervivencia.

“Dijeron que era una cuestión de vida o muerte para nuestro hijo, y yo pensé: “Esperen, si solo estaba jugando al baloncesto””, dijo Chris, quien es bombero. “Les dije: “Hagan lo que tengan que hacer para salvar a mi hijo””.

Normalmente, la FDA alerta al público e identifica a los productores y fabricantes de alimentos cuando se producen brotes como el que enfermó a Colton. La FDA dijo en su que no se reveló el nombre del productor porque no quedaba ningún producto en el mercado.

Pero Bill Marler, un abogado de Seattle especializado en litigios relacionados con la seguridad alimentaria y que representa a la familia George, dijo que la información sigue siendo importante porque puede prevenir más casos, presionar a los productores para que mejoren las condiciones sanitarias e identificar a los infractores reincidentes.

También ofrece a las víctimas una explicación de su enfermedad y les ayuda a determinar contra quién pueden emprender acciones legales, afirmó.

“Normalmente, veríamos la información en sus sitios web”, dijo Marler, agregando que las conclusiones de la investigación de la agencia sobre el brote fueron “todas censuradas” y que las obtuvo a través de una solicitud en virtud de la Ley de Libertad de Información.

La FDA, el USDA y los CDC desempeñan un papel fundamental en la supervisión de la seguridad alimentaria, incluidas las inspecciones y las investigaciones. La FDA y los CDC se han visto sacudidos por recortes de personal que forman parte de una reducción de 20.000 empleados en el HHS, su agencia matriz. El USDA también ha reducido su plantilla.

Los recortes de personal suponen retrasos en la divulgación de brotes mortales, según Susan Mayne, profesora adjunta de la Escuela de Salud Pública de Yale, quien se jubiló de la FDA en 2023.

“Se está informando a los consumidores con retraso sobre notificaciones importantes relacionadas con la seguridad alimentaria”, afirmó, en referencia a un brote reciente en pepinos. “Las personas pueden morir si hay patógenos como la listeria, que puede tener una tasa de mortalidad del 30%”.

Makary ha dicho que los recortes no afectarían a los inspectores o científicos de la agencia.

Sin embargo, la FDA despidió en abril a científicos que trabajaban en laboratorios de seguridad alimentaria en Chicago y San Francisco, donde realizaban análisis especializados para los inspectores de alimentos, según ex funcionarios de la FDA. Posteriormente, la FDA restableció algunos puestos.

“¿No se despidió a ningún científico? Eso es inexacto”, dijo Mayne.

Siobhan DeLancey, que trabajó en la Office of Foods and Veterinary Medicine de la agencia durante más de 20 años antes de ser también despedida en abril, dijo que los nuevos requisitos para revisar los anuncios de la agencia se volvieron tan arduos que se tardaba semanas en obtener la aprobación de alertas que deberían haberse emitido mucho antes.

Dijo que entre los empleados despedidos hay especialistas en comunicación y personal que trabaja en internet, que se dedican a la divulgación entre los consumidores con el fin de prevenir enfermedades. El USDA y la FDA han reincorporado a algunos trabajadores o han pedido a algunos que renunciaron que reconsideraran su decisión.

“Se trata de destruir, no de mejorar la eficiencia”, afirmó DeLancey. “Veremos los efectos durante años. Costará vidas”.

El HHS no respondió a un correo electrónico en el que se les pedía una respuesta a los comentarios de DeLancey.

Colton permaneció en diálisis en el hospital durante 13 días, inicialmente sin poder comer ni beber. Su madre mojaba una esponja para humedecerle los labios y la lengua.

Cumplió 10 años en el hospital. Chris George pegó carteles en las ventanas de la habitación de su hijo.

“No estoy contento con los CDC y la FDA”, dijo Chris George. “Las víctimas tienen derecho a saber quién les ha enfermado. Se trata de mi hijo. Él es mi vida”.

Colton pudo salir del hospital casi tres semanas después de comer por primera vez la lechuga contaminada, pero sigue teniendo pesadillas sobre la terrible experiencia, y está viendo a un terapeuta.

“¿Todo eso de “Make America Healthy Again” (Hagamos que Estados Unidos sea saludable de nuevo), el enfoque en eliminar los colorantes alimentarios de los cereales?”, dijo Chris George, quien se opone a la decisión de la administración Trump de censurar la información sobre el productor en el informe de febrero. “¿Qué tal si eliminamos la E. coli de nuestra lechuga, para que no mate a nuestros hijos?”.

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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 Â鶹ŮÓÅ Health News.

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.”

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 Ìýand 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.”

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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

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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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 — 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 Â鶹ŮÓÅ Health News, Jessie Hellmann of CQ Roll Call, Sarah Karlin-Smith of the Pink Sheet, and Rachel Roubein of The Washington Post.

Panelists

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: Â鶹ŮÓÅ Health News’ “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.

[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.]Ìý

Julie Rovner: Hello, and welcome back to “What the Health?” I’m Julie Rovner, chief Washington correspondent for Â鶹ŮÓÅ Health News, 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.Ìý

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

Rachel Roubein: Hi.Ìý

Rovner: Sarah Karlin-Smith of the Pink Sheet.Ìý

Sarah Karlin-Smith: Hi, everybody.Ìý

Rovner: And Jessie Hellmann of CQ Roll Call.Ìý

Jessie Hellmann: Hello.Ìý

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 Â鶹ŮÓÅ Health News 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.Ìý

So even without Senate-confirmed heads at — checks notes — 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?Ìý

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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?Ìý

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.Ìý

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.Ìý

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.Ìý

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 — 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.Ìý

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?Ìý

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.Ìý

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.Ìý

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 — this does not feel like a very efficient way to run the federal government.Ìý

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.Ìý

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.Ìý

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?.Ìý

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.Ìý

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.Ìý

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.Ìý

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?Ìý

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—Ìý

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

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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?Ìý

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.Ìý

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.Ìý

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?Ìý

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—Ìý

Rovner: I think most states have waiting lists.Ìý

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—Ìý

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.Ìý

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.Ìý

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?Ìý

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—Ìý

Rovner: Before the Marty Makary hearing.Ìý

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.Ìý

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

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.Ìý

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.Ìý

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.Ìý

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.Ìý

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?Ìý

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.Ìý

Rovner: Eating better and exercising.Ìý

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

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?Ìý

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.Ìý

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.Ìý

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.Ìý

Karlin-Smith: I took a look at a Â鶹ŮÓÅ 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.Ìý

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.Ìý

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 — and I mean sprawling — 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.Ìý

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?Ìý

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

Rovner: Jessie.Ìý

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

Rovner: Great. Rachel.Ìý

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

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

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This story can be republished for free (details).

, based on data from two prior studies, was led by a Virginia toxicologist who said then — and still believes today, decades after concerns first arose that the chemical could be carcinogenic — 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 Â鶹ŮÓÅ Health News after the FDA’s announcement. “I have no problem with my family — my kids and grandkids — 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.

“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, ‘Why 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 Â鶹ŮÓÅ Health News, 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.

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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The chemical ingredients with mystifying names. The references on product labels to unspecified natural or artificial flavors. The junk food that fits his budget but feels addictive and makes him feel unwell.

Shea, one of 1,310 people who responded to a poll the health policy research group Â鶹ŮÓÅ conducted on health care priorities, said he assumes the FDA is making sure the ingredients are safe.

In many cases, it is not.

The FDA’s restraints on food ingredients are limited and relatively feeble, especially compared with those in Europe, a Â鶹ŮÓÅ Health News examination found. There are at least 950 substances in our food that are not permitted in Europe, according to one expert’s estimate, and chemicals linked to health concerns show up in hundreds of products that line the shelves of American supermarkets.

Robert F. Kennedy Jr., the new head of the Department of Health and Human Services, has railed about the risks of food additives for years and has said he wants to end “.” At a March 6 confirmation hearing, Marty Makary, President Donald Trump’s nominee to head the FDA, expressed concern about foods “with a lot of molecules that do not appear in nature.”

“These are chemicals that the industry insists are safe, a subset of which are concerning,” he said.

But the Trump administration’s initial moves to reduce staff at the FDA led the director of its food safety unit, Jim Jones, to and raised fears among food safety specialists that the administration could weaken oversight.

To a great extent, the FDA leaves it to food companies to determine 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.

Though pharmaceutical companies are required to share research on humans with the FDA, the agency is largely blind to what food-makers know about their products.

“The food industry does massive amounts of research that we have no access to,” Robert Califf told a Senate committee in December on his way out as FDA commissioner.

As a result: The FDA’s oversight of food additives is much weaker than its oversight of prescription drugs.

“There is good reason to be concerned about the chemicals that are routinely included in much of our food,” Califf testified.

Food is a big business. American consumers spend almost $1.7 trillion annually on food and beverages, according to Circana, a research and advisory firm.

Yet American food companies keep secret much of what they put in their products.

Â鶹ŮÓÅ Health News asked nine of the largest food manufacturers — The Coca-Cola Co., Conagra Brands, General Mills, Kellanova (successor to Kellogg), The Kraft Heinz Co., MondelÄ“z International, Nestlé, PepsiCo, and Unilever — for the number of ingredients, if any, that go unnamed on their product labels and the names of those ingredients deemed safe without involvement by the FDA, and substances used in their products in the United States but not in Europe, and vice versa.

None provided answers to those questions.

“We focus on the quality of the ingredients that we use, and all comply with applicable regulatory requirements,” Nestlé spokesperson Dana Stambaugh said.

Chemicals such as titanium dioxide and potassium bromate, whose safety has been debated, are allowed in foods in the United States but not in Europe.

Corporations may turn a blind eye to potential dangers, a July 2024 FDA-funded report warned.

Potentially harmful ingredients “are not necessarily required to be named on a product label,” the Reagan-Udall Foundation for the FDA, an adjunct to the agency, , which was based largely on interviews with representatives of companies across the food supply chain.

“Companies may choose not to track the presence of these ingredients/compounds due to concern about future litigation,” the report said.

Some additives can remain hidden from the public behind such catchall terms as “spices” and “artificial flavors,” as the has reported, or shrouded by from disclosure requirements.

And some ingredients that should have been listed on product labels — potential allergens such as milk, wheat, eggs, and dyes — have at times gone undisclosed, according to a . Gaps in oversight have alarmed political leaders on both sides of the aisle, the U.S. , such as the CSPI, and .

Adding to the concern: the profusion of ultra-processed foods, which use a wide array of chemicals to add flavor and color, extend shelf life, reduce cost, control texture or consistency, and generally tempt people to eat more. Ultra-processed foods now make up 73% of the U.S. food supply, . Sen. Bernie Sanders of Vermont, the ranking member of the Senate Health, Education, Labor and Pensions Committee, has said there’s growing evidence they are “deliberately designed to be addictive,” contributing to an epidemic of obesity — a rare point of agreement between him and Kennedy.

At his confirmation hearing, Makary said some ingredients cause a chronic, low-grade inflammatory reaction in the gastrointestinal tract. “And what are we doing? We are drugging our nation’s children at scale,” he said.

The found that 58% of respondents want the Trump administration to prioritize setting stricter limits on chemicals in the U.S. food supply.

The Consumer Brands Association, which represents many of the largest food-makers, defends the regulatory system as “rigorous,” “evidence-based,” and “proven.” The system enables companies “to innovate to meet consumer demand,” Sarah Gallo, the association’s senior vice president of product policy, said in a statement to Â鶹ŮÓÅ Health News.

“Food manufacturers attest to the safety of an ingredient through the development of extensive scientific evidence and third-party expert review,” Gallo added.

More than a decade ago, estimated that there were about allowed in food in the United States — and that the FDA had not reviewed the safety of about 3,000 of them.

“The system is fundamentally broken,” said Thomas Neltner, one of the authors of the Pew study. “It’s so bad, nobody knows — not even FDA knows — what’s in our food.”

Banned Abroad

The FDA to be used to enhance the appearance of foods, among other purposes. According to an , it’s listed as an ingredient in more than 1,900 products, including many candies.

The European Union takes a more cautious approach. In 2021, an EU that titanium dioxide “can no longer be considered as safe when used as a food additive.” The panel said it couldn’t rule out the possibility that titanium dioxide could damage chromosomes.

The FDA to be used in baking, and, according to the EWG database, it’s listed as an ingredient in , including bread, buns, and bagels.

Potassium bromate has been banned from food in many countries, including those of the European Union, Canada, India, and Peru. In 2023, from food effective in 2027. The United Kingdom . The International Agency for Research on Cancer identified it as more than 25 years ago. A joint committee of the United Nations and the World Health Organization in 1992.

On , the FDA says it has worked with industry to minimize potassium bromate levels and is reviewing the chemical, among others.

The EWG says that it created the database and that the raw data on product labels is supplied by Label Insight — which is owned by NielsenIQ, a major provider of data to industry. The EWG has called for of foods.

Based on a review of FDA and European Commission databases, it appears that at least 950 more additives are used in foods in the United States than are allowed in the European Union, said Erik Millstone, an emeritus professor at the University of Sussex in England who has been studying food safety policy since the 1970s.

Direct comparisons are difficult because the two regulatory systems and the way they keep their records differ greatly.

A definitive count is elusive because the FDA doesn’t require industry to inform it of everything used in foods in the United States.

“That kind of casual neglect totally would be unacceptable in Europe,” Millstone said.

‘Several Decades Behind Europeans’

When the FDA formally approves substances for use in food, it can let decades pass without reassessing them — even when subsequent research raises doubts about their safety.

In January, when the FDA banned Red Dye No. 3 from foods, it . (The FDA said it had no evidence the dye puts people at risk; invoking one of the stricter consumer protections, it said prohibits the use of additives found to induce cancer in animals.)

In the European Union, substances used in foods must pass regulatory approval before being introduced. The EU has also required that its regulators reassess all additives that were on the market before Jan. 20, 2009, a process that is ongoing.

“In the FDA, although we have authorization to do post-market reviews, there’s no statutory mandate to do them,” Jones, the former deputy commissioner of the FDA’s Human Foods Program, told a Senate committee in December. “We are several decades behind Europeans and our Canadian counterparts because they have legal mandates to reevaluate chemicals that have been authorized at some point in the past.”

The FDA website lists that substances were not “generally recognized as safe.” Four involve chemical constituents of one mushroom and the mushroom itself. Others include an anabolic steroid, caffeinated alcoholic beverages, cannabidiol (CBD), Ginkgo biloba, melatonin, and partially hydrogenated oils.

Meanwhile, trichloroethylene, in December as “an extremely toxic chemical known to cause liver cancer, kidney cancer, and non-Hodgkin’s lymphoma,” is under FDA rules for in the production of foods.

FDA spokesperson Enrico Dinges said the agency will work with new leadership at HHS “to safeguard the food supply through pre-market and post-market safety evaluations of chemicals in the food supply.”

‘The Loophole Swallowed the Law’

The biggest gap in the FDA’s oversight of foods goes back generations.

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 — along with many chemicals.

Over time, “the loophole swallowed the law,” said a 2014 report by Neltner and Maricel Maffini for the .

Companies can unilaterally decide their ingredients are already recognized as safe and use them without asking the FDA for permission or even informing the agency.

A better translation of GRAS would be “,” the Natural Resources Defense Council report said.

A federal watchdog reached a similar conclusion. “GRAS substances can be marketed without FDA’s approval or even its knowledge,” the Government Accountability Office .

That spared the FDA from spending time reviewing countless substances.

For advice on whether ingredients are GRAS, companies may convene panels of specialists. The FDA has noted that panel members could be paid by the companies commissioning the review, but, in , it says “such compensation is not itself an unacceptable conflict.”

About 3,000 flavoring ingredients have been deemed GRAS by a panel of scientists working for an industry group, the Flavor and Extract Manufacturers Association of the United States, known as FEMA, said George Southworth, the organization’s executive director.

The scientists on the FEMA panel “adhere to stringent conflict-of-interest policies,” and their GRAS determinations are submitted to the FDA, which includes them in an online database, Southworth said.

Southworth described the panel as independent, and the says panel members have never been employees of companies in the food industry.

Asked how many times FEMA’s panel found that a flavoring didn’t meet the test, Southworth wouldn’t say. He indicated that some reviews are called off before a conclusion is reached.

“Publicly reporting these numbers without full context could lead to misinterpretations about the safety of substances,” he added.

Another Way

Food companies have another option: They can voluntarily notify the FDA that they believe their product is GRAS for its intended use and lay out their reasons — giving the FDA a heads up and essentially seeking its blessing.

If they take that route, they don’t have to wait for an answer from the FDA to begin marketing the product, the agency has said.

And they don’t risk much. If the FDA spots weaknesses in a company’s argument or reasons to worry about a chemical’s safety, it routinely calls off its review instead of declaring the substance unsafe.

FDA records posted on the agency’s website show that the FDA often coaches companies to ask the agency to . That, too, leaves the company free to sell the product, food watchdogs said.

For companies that voluntarily run their products past the FDA, victory is a letter saying the agency has no questions.

But if companies market products as “generally recognized as safe” without firm grounds, they run the risk that the FDA could one day take enforcement action, such as issuing a warning or stopping sales. That’s if the FDA notices.

Psyched Out

On March 8, 2022, a Canadian company, Psyched Wellness, saying it had a green light to market products in the United States.

An “independent review panel of scientific experts” concluded that an extract the company developed, AME-1, was “Generally Recognized As Safe,” paving the way for it to be sold in bulk and used as an ingredient, the company said.

The company described the panel’s judgment as a successful “certification” and “a key milestone.” The extract was derived from a hallucinogenic mushroom, Amanita muscaria, which the company said “has incredible healing and medicinal powers.” As the company later put it in a , it had obtained “self-Gras status.”

In June 2024, the that it would soon release Amanita muscaria watermelon gummies.

However, the FDA later took issue with the company and its product.

In a , an FDA toxicologist said Psyched Wellness’ claim of GRAS certification was false. The firm failed to show that its extract was generally recognized as safe, the FDA .

Speaking of the mushroom, its extracts, and its known “pharmacologically active constituents,” the FDA memo posted on the agency’s website said they have “potential for serious harm and adverse effects on the central nervous system.”

The FDA was focusing on the mushroom against the backdrop of a spate of medical problems linked to another company’s “Diamond Shruumz” brand chocolate bars, gummies, and infused cones. When it recalled those products in June 2024, that that a chemical found in Amanita mushrooms was a possible cause of symptoms, including seizures and loss of consciousness.

The FDA memo and said one death and 30 hospitalizations might have been related.

The memo did not connect Psyched Wellness to the outbreak or the Diamond Shruumz products.

The chief executive of Psyched Wellness, Jeffrey Stevens, did not respond to an interview request or written questions.

As recently as Feb. 1, Psyched Wellness said in a that it will “continue to market its products in the U.S. using the Self-GRAS designation.”

‘Probably Poisoning Us’

If food ingredients cause acute reactions — sending people to emergency rooms, for example — the potential dangers may be relatively easy to identify, and regulatory action might naturally follow. Some critics of the system say they worry more about health effects that could take years or decades to develop.

Then, when it’s too late, it could be hard to trace the harm to any particular ingredient.

All that leaves Joseph Shea of Myrtle Beach in a tough spot.

For a while, Shea tried shopping at a market that has a lot of organic offerings, he said in an interview. That proved too expensive.

Shea said the entire picture is “incredibly frustrating.”

“They’re probably poisoning us, and we don’t know,” he said. “We’ll figure it out 30 years down the road when we get sick.”

Â鶹ŮÓÅ Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at Â鶹ŮÓÅ—an independent source of health policy research, polling, and journalism. Learn more about .

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