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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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, Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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.”

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

This <a target="_blank" href="/health-industry/infant-formula-fortifier-high-stakes-corporate-battle-preemies-abbott-mead-johnson/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

Yet about 82% of the comments are identical to a letter that appeared on the website of a secretive advocacy group called , a data analysis by Ñî¹óåú´«Ã½Ò•îl Health News has found. 

The “” group does not reveal its funders or much else — other than to say it is “dedicated to protecting and strengthening Medicare Advantage” and is “powered by hundreds of thousands of local advocates nationwide.” 

“Our campaign provides information and offers tools for concerned Americans to use to reach decision makers,” spokesperson Darren Grubb said in an email. The group has spent more than $3.1 million on hundreds of Facebook ads since September 2024, according to , a database of the social media company’s online ads. 

There’s no doubt health insurers are unhappy with a from the Centers for Medicare & Medicaid Services, or CMS, to keep Medicare Advantage reimbursement rates essentially flat in 2027 — far less than they expected from the Trump administration. 

Medicare Advantage plans offer seniors a private alternative to original Medicare. The insurance plans enroll about members, more than half the people eligible for Medicare. 

CMS is set to announce a final rate decision by early next month. The agency solicited on the proposal from Jan. 26 through Feb. 25 to give interested parties and the public a chance to air their views. As of March 12, CMS said it had received 46,884 comments but had posted only 16,422 online. 

Medicare Advantage Majority, which says the rate proposal amounts to a “cut” in services and warns of dire consequences for seniors should it go through, accounted for at least 13,522 of the 16,422 published comments as of March 12. 

Critics warn that these sorts of campaigns may create a misleading impression of grassroots support, especially when it’s not clear who is financing them. 

“It puts a different spin on a massive groundswell of comments to know all are being driven by one specific organization,” said Michael Beckel, director of money in politics reform for Issue One, a group that seeks to limit the influence of money on government policy and legislation.

This <a target="_blank" href="/insurance/the-week-in-brief-medicare-advantage-payments-dark-money/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

Yet about 82% of the comments are identical to a letter that appeared on the website of a secretive advocacy group called Medicare Advantage Majority, a data analysis by Ñî¹óåú´«Ã½Ò•îl Health News has found.

The “” group does not reveal its funders or much else — other than to say it is “dedicated to protecting and strengthening Medicare Advantage” and is “powered by hundreds of thousands of local advocates nationwide.”

“Our campaign provides information and offers tools for concerned Americans to use to reach decision makers,” spokesperson Darren Grubb said in an email. The group has spent more than $3.1 million on hundreds of Facebook ads since September 2024, according to , a database of the social media company’s online ads.

There’s no doubt health insurers are unhappy with a from the Centers for Medicare & Medicaid Services, or CMS, to keep Medicare Advantage reimbursement rates essentially flat in 2027 — far less than they expected from the Trump administration.

Medicare Advantage plans differ from traditional Medicare because private insurance companies administer them. The insurance plans enroll about members, more than half the people eligible for Medicare. The plans offer things like vision and drug coverage, but Medicare Advantage insurers restrict the hospitals and doctors that patients can use and require prior approval for various procedures.

CMS is set to announce a final decision by early next month on the rate proposal. The agency solicited on the proposal from Jan. 26 through Feb. 25 to give interested parties and the public a chance to air their views.

Medicare Advantage Majority, which says the rate proposal amounts to a “cut” in services and warns of dire consequences for seniors should it go through, accounted for at least 13,522 of the 16,422 comments published as of March 12.

The proposed rate plan “puts my access to care at risk,” the group’s template letter to policymakers reads in part. “If the investment made by Washington in the Medicare Advantage program is nearly flat year-over-year, I could lose benefits I rely on every day, including affordable prescriptions, capped out of pocket costs, and access to trusted doctors and specialists.”

“Medicare Advantage is not optional for me. The cost protections alone have saved me thousands of dollars and made my health care manageable. Without this program, I would face higher costs, fewer providers, and fewer benefits at a time when I can least afford it,” the letter states.

Critics warn that these sorts of campaigns may create a misleading impression of grassroots support, especially when it’s not clear who is financing them.

“It puts a different spin on a massive groundswell of comments to know all are being driven by one specific organization,” said Michael Beckel, director of money in politics reform for Issue One, a group that seeks to limit the influence of money on government policy and legislation.

“There’s no way for the public to know what wealthy donors or special interests are funding dark money groups like this,” he said. “That means there’s no scrutiny of who’s really calling the shots.”

Some health care policy experts, who have long argued that the government overpays Medicare Advantage plans by tens of billions of dollars every year, believe industry groups or their surrogates routinely overstate possible negative impacts of rate decisions they don’t like.

“The plans always say that the sky is falling,” said Matthew Fiedler, a health care policy expert with the Brookings Institution. “The industry has a lot of money at stake here. They try to exert pressure on policymakers any way they can.”

At the same time, even critics concede that some of the millions of people enrolled in Medicare Advantage plans could face service cuts if insurance companies are not satisfied with government payments.

“It is legitimate for people to be worried,” said Julie Carter, counsel for federal policy at the Medicare Rights Center, a group that advocates for older adults and people with disabilities.

Her group argues that Medicare Advantage plans have never attained expected cost savings and instead have been overpaid for years at least partly due to “actions to maximize profits.” She said the health plans “are supposed to be saving money, not taking extra.”

People struggling to pay health care bills may have little use for the policy debate in Washington.

“If it wasn’t for being able to have this program, I really wouldn’t be able to afford any kind of medical services, to be honest,” said EsterAlicia Rose, 75, who works at the front desk of a hotel in Pagosa Springs, Colorado. She said she signed the Medicare Advantage Majority form letter to reach policymakers.

Kathy Lovely-Marshall, 66, a retired nurse who lives in Brookville, Ohio, did too. She said she receives “a lot of perks” from her plan, such as dental care, eyeglasses, and prescriptions.

“All those things are a big plus as far as I am concerned,” she said. “I’m very happy with the plan I have.”

But Corenia Branham, 90, a widow and cancer survivor who lives in Alum Creek, West Virginia, said she wants nothing to do with Medicare Advantage plans run by private health insurance companies. She said she didn’t turn in any of the four form letters under her name, which were posted online by CMS on Feb. 23 and signed, “Miss Corenia Branham Branham.” It’s not clear why her last name is signed twice.

Branham said she’s not on Medicare Advantage and doubts she could count on it for needed care.

“I wouldn’t recommend it to nobody,” she said. “I sure don’t want anything to do with it.”

Grubb, the Medicare Advantage Majority spokesperson, disputed that account. He said Branham responded to an ad on Facebook. On Feb. 6, she “completed the form with her information and chose to send her comment to CMS as well as to her representatives in Congress and the White House,” he said.

Other Medicare Advantage advocacy groups have stepped up ad campaigns as the rate decision looms.

The Better Medicare Alliance, whose “allies” include a range of health insurers, health care providers, and consumers, is urging seniors to “Tell Washington to Stand Up for Medicare Advantage.”

“We’ve mobilized beneficiaries to write letters and make phone calls, and we’ve run digital ads on streaming platforms,” spokesperson Susan Reilly said.

Reilly said that this year roughly 3 million seniors “were forced to find new coverage” because plans either shuttered operations or left some areas.

She also said Medicare Advantage plans have “scaled back” benefits such as offering transportation to medical appointments, nutrition support, and dental and vision coverage, while over the past two years beneficiaries have faced an average $900 increase in out-of-pocket maximums.

“We do view this as especially serious,” Reilly said. “This isn’t a single bad year; it’s the cumulative effect of years of underfunding and policy disruption from the previous administration that has left the program increasingly vulnerable.”

As of March 12, CMS said it had received 46,884 comments but had posted only 16,422 online.

CMS spokesperson Catherine Howden said the agency would make more comments public “as soon as practicable.”

“The agency focuses on reviewing the substance of timely submissions and does not speculate on volume, sentiment, or potential impact of comments while the comment period is open/under review,” she said in a statement.

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Scientists and public health advocates see deep disconnects between what the administration has said about health — notably, in “,” which President Donald Trump at the White House — and what it’s actually doing. 

For instance, the report says more research is needed on chronic diseases and the cumulative effects of chemicals in the environment. But the Trump administration’s mass cancellation of federal research grants has derailed studies on those subjects. 

The report denounces industry-funded research on chemicals and health as widespread and unreliable. But the administration is seeking to cut government funding that could serve as a counterweight. 

“There are many inconsistencies between rhetoric and action,” said Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, a philanthropy focused on health. 

The report, a cornerstone of President Donald Trump’s “Make America Healthy Again” agenda, was issued by a commission composed of Health and Human Services Secretary Robert F. Kennedy Jr. and other top administration officials. 

It quickly became famous for and that it was produced with help from artificial intelligence. White House press secretary Karoline Leavitt described the problems as “formatting issues,” and the administration revised the report. 

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article. 

For a glimpse of the bigger picture, consider the case of the poopy diapers. 

The MAHA Report says environmental chemicals may pose risks to children’s health — that the nation needs “to better understand the cumulative load of multiple exposures and how it may impact children’s health.” 

The Environmental Protection Agency was thinking along the same lines in 2020 when it ways of researching children’s exposure to chemicals from soil and dust. It said that, for young kids, ingesting particulates — by putting their hands on the ground or floor then in their mouths — could be a significant means of exposure to contaminants such as herbicides and pesticides. 

One grant went to a team of scientists at Johns Hopkins University and the University of California-San Francisco. Researchers gained permission to collect samples from people’s homes, including dust and diapers. 

But, beyond a small test run, they didn’t get to analyze the urine and stool samples because the grant was terminated this spring, said study leader Keeve Nachman, a professor of environmental health and engineering at Johns Hopkins. 

“The objectives of the award are no longer consistent with EPA funding priorities,” the agency said in a May 10 termination notice.

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Yet in its feverish purge of federal health programs, it has proposed eliminating the National Center for Chronic Disease Prevention and Health Promotion and its annual funding of $1.4 billion.

That’s one of many disconnects between what the administration says about health — notably, in “,” which President Donald Trump at the White House — and what it’s actually doing, scientists and public health advocates say.

Among other contradictions:

• The report says more research is needed on health-related topics such as chronic diseases and the cumulative effects of chemicals in the environment. But the Trump administration’s mass cancellation of federal research grants to scientists at universities, including Harvard, has derailed studies on those subjects.
• The report denounces industry-funded research on chemicals and health as widespread and unreliable. But the administration is seeking to cut government funding that could serve as a counterweight.
• The report calls for “fearless gold-standard science.” But the administration has sowed in the that it is out to stifle or skew its desired conclusions.

“There are many inconsistencies between rhetoric and action,” said Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, a philanthropy focused on health.

The report, a cornerstone of President Donald Trump’s “Make America Healthy Again” agenda, was issued by a commission that includes Secretary of Health and Human Services Robert F. Kennedy Jr. and other top administration officials.

News organizations found that it and that it was produced with help from artificial intelligence. White House press secretary Karoline Leavitt described the problems as “formatting issues,” and the administration revised the report.

Trump to assess causes of a “childhood chronic disease crisis.” His commission is now working on a plan of action.

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article.

Studies Derailed

The MAHA report says environmental chemicals may pose risks to children’s health. Citing the National Institutes of Health, it said there’s a “need for continued studies from the public and private sectors, especially the NIH, to better understand the cumulative load of multiple exposures and how it may impact children’s health.”

Meanwhile, the administration has cut funding for related studies.

For example, in 2020 the Environmental Protection Agency ways of researching children’s exposure to chemicals from soil and dust. It said that, for kids ages 6 months to 6 years, ingesting particulates — by putting their hands on the ground or floor then in their mouths — could be a significant means of exposure to contaminants such as herbicides, pesticides, and a group of chemicals known as PFAS.

One of the grants — for almost $1.4 million over several years — went to a team of scientists at Johns Hopkins University and the University of California-San Francisco. Researchers gained permission to collect samples from people’s homes, including dust and diapers.

But, beyond a small test run, they didn’t get to analyze the urine and stool samples because the grant was terminated this spring, said study leader Keeve Nachman, a professor of environmental health and engineering at Hopkins.

“The objectives of the award are no longer consistent with EPA funding priorities,” the agency said in a May 10 termination notice.

Another from 2020 addressed many of the issues the MAHA report highlighted: cumulative exposures to chemicals and developmental problems such as attention-deficit/hyperactivity disorder, obesity, anxiety, and depression. One of the resulting grants funded the at the University of North Carolina-Chapel Hill. That grant was ended weeks early in May, said the center’s director, Stephanie Engel, a UNC professor of epidemiology.

In a statement, EPA press secretary Brigit Hirsch said the agency “is continuing to invest in research and labs to advance the mission of protecting human health and the environment.” Due to an agency reorganization, “the way these grants are administered will be different going forward,” said Hirsch, who did not otherwise answer questions about specific grants.

In its battle with Harvard, the Trump administration has stopped paying for research the NIH had commissioned on topics such as how autism to paternal exposure to air pollution.

The loss of millions of dollars of NIH funding has also undermined data-gathering for long-term research on chronic diseases, Harvard researchers said. A series of projects with names like Nurses’ Health Study II and Nurses’ Health Study 3 have been tracking thousands of people for decades and aimed to keep tracking them as long as possible as well as enrolling new participants, even across generations.

The work has included periodically surveying participants — mainly nurses and other health professionals who enrolled to support science — and collecting biological samples such as blood, urine, stool, or toenail clippings.

Researchers studying health problems such as autism, ADHD, or cancer could tap the data and samples to trace potential contributing factors, said Francine Laden, an environmental epidemiologist at Harvard’s T.H. Chan School of Public Health. The information could retrospectively reveal exposures before people were born — when they were still in utero — and exposures their parents experienced before they were conceived.

Harvard expected that some of the grants wouldn’t be renewed, but the Trump administration brought ongoing funding to an abrupt end, said Walter Willett, a professor of epidemiology and nutrition at the Chan school.

As a result, researchers are scrambling to find money to keep following more than 200,000 people who enrolled in studies beginning in the 1980s — including children of participants who are now adults themselves — and to preserve about 2 million samples, Willett said.

“So now our ability to do exactly what the administration wants to do is jeopardized,” said Jorge Chavarro, a professor of nutrition and epidemiology at the Chan school. “And there’s not an equivalent resource. It’s not like you can magically recreate these resources without having to wait 20 or 30 years to be able to answer the questions” that the Trump administration “wants answered now.”

Over the past few months, the administration has fired or pushed out almost 5,000 NIH employees, blocked almost $3 billion in grant funding from being awarded, and terminated almost 2,500 grants totaling almost $5 billion, said Sen. Patty Murray (D-Wash.), vice chair of the Senate Appropriations Committee, at a on the NIH budget.

In addition, research institutions have been waiting months to receive money under grants they’ve already been awarded, Murray said.

In canceling hundreds of grants with race, gender, or sexuality dimensions, the administration engaged in blatant discrimination, a federal judge ruled on June 16.

Cutting Funding

After issuing the MAHA report, the administration published to cut funding for the NIH by $17.0 billion, or 38%, the Centers for Disease Control and Prevention by $550 million, or 12%, by $5 billion, or 54%.

“This budget reflects the President’s vision of making Americans the healthiest in the world while achieving his goal of transforming the bureaucracy,” the HHS “Budget in Brief” document says. Elements of Trump’s proposed budget for the 2026 fiscal year clash with priorities laid out in the MAHA report.

Kennedy has cited diabetes as part of a crisis in children’s health. The $1.4 billion unit the White House to eliminate at the CDC — the National Center for Chronic Disease Prevention and Health Promotion — has housed a program to track diabetes in children, adolescents, and young adults.

“To say that you want to focus on chronic diseases” and then “to, for all practical purposes, eliminate the entity at the Centers for Disease Control and Prevention which does chronic diseases,” said Georges Benjamin, executive director of the American Public Health Association, “obviously doesn’t make a lot of sense.”

In a May letter, Office of Management and Budget Director Russell Vought as “duplicative, DEI, or simply unnecessary,” using an abbreviation for diversity, equity, and inclusion programs.

Within the NIH, the White House has proposed cutting $320 million from the National Institute of Environmental Health Sciences, a reduction of 35%. That unit funds or conducts a wide array of research on issues such as chronic disease.

Trump’s budget proposes spending $500 million “to tackle priority activities to Make America Healthy Again,” including $260 million for his new Administration for a Healthy America to address the “chronic illness epidemic.”

Ceding Ground to Industry

The MAHA report argues that corporate influence has compromised government agencies and public health through “corporate capture.”

It alleges that most research on chronic childhood diseases is funded by the food, pharmaceutical, and chemical industries, as well as special interest organizations and professional associations. It says, for example, that a “significant portion of environmental toxicology and epidemiology studies are conducted by private corporations,” including pesticide manufacturers, and it cites “potential biases in industry-funded research.”

It’s “self-evident that cutbacks in federal funding leave the field open to the very corporate funding RFK has decried,” said Peter Lurie, president of the Center for Science in the Public Interest, a watchdog group focused on food and health.

Lurie shared the report’s concern about industry-funded research but said ceding ground to industry won’t help. “Industry will tend to fund those studies that look to them like they will yield results beneficial to industry,” he said.

In search of new funding sources, Harvard’s school of public health “is now ramping up targeted outreach to potential corporate partners, with careful review to ensure the science meets the highest standards of research integrity,” Andrea Baccarelli, dean of the school’s faculty, wrote in a to students, faculty, and others.

“It’s just simple math that if you devastate governmental funding by tens of billions of dollars, then the percentage of industry funding dollars will go up,” said Plough, who is also a clinical professor at the University of Washington School of Public Health.

“So therefore, what they claim to fear more,” he said, will “become even more influential.”

The MAHA report says “the U.S. government is committed to fostering radical transparency and gold-standard science.”

But many scientists and other scholars see the Trump administration waging a war on science that conflicts with its agenda.

In March, members of the National Academies of Sciences, Engineering, and Medicine of “destroying” scientific independence, “engaging in censorship,” and “pressuring researchers to alter or abandon their work on ideological grounds.”

In May, wrote that the administration was politicizing research — for example, by halting or censoring work on health disparities, health impacts of climate change, gender identity, and immunizations.

Recent comments by Kennedy pose another threat to transparency, researchers and health advocates say.

Kennedy said that he would probably create in-house government journals and stop NIH scientists from publishing their research in The Lancet, The New England Journal of Medicine, The Journal of the American Medical Association, and others.

Creating new government outlets for research would be a plus, said Dariush Mozaffarian, director of the Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University.

But confining government scientists to government journals, he said, “would be a disaster” and “would basically amount to censorship.”

“That’s just not a good idea for science,” Mozaffarian said.

We’d like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message Ñî¹óåú´«Ã½Ò•îl Health News on Signal at (415) 519-8778 or .

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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 Ñî¹óåú´«Ã½Ò•îl 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  and cellulose gum. Maltodextrin can be derived from substances such as cornstarch, rice starch, and wheat starch — but the FDA doesn’t consider it synonymous with the term “modified food starch.”

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

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

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

Gummed Up

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

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

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

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

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

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

A Growing Body of Research

Research on emulsifiers has been building in recent years.

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

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

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

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

Other findings diverge.

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

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

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

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

‘Keeping It Real’ (Or Not)

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

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

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

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

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

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

And the creamy filling doesn’t melt.

Instead, over 24 hours on a Ñî¹óåú´«Ã½Ò•îl Health News reporter’s kitchen counter, it bled a caramel-tinged fluid and shrank into a sticky white foam that could be cut with a knife.

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

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

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

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

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

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

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Instead, the agency will default to withholding 50% of old-age, survivors, and disability insurance benefits, the agency said in an “” to staff dated April 25.

The agency long made it a routine to halt benefits to recoup billions of dollars it sent recipients but later said they should not have received. A policy under the Joe Biden administration to provide relief to beneficiaries, who often live on the fringe of poverty, last year had capped the clawbacks at 10%.

The partial reversal is another twist in the Trump administration’s tumultuous approach to Social Security, which has included and the acting commissioner’s threat, which has , to essentially .

The emergency message involves the agency’s practice of paying beneficiaries money they were not supposed to receive — and then, often after years have passed and the amounts have ballooned to tens of thousands of dollars or more per person — demanding the money back, even if the overpayment was Social Security’s fault.

In many cases, recovering the money had entailed withholding 100% of monthly benefits.

Millions of beneficiaries, including people struggling to get by on monthly checks, have received overpayment notices, a 2023 investigation by Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group found. Clawbacks have left some homeless, the news organizations reported.

In the aftermath of that reporting, Martin O’Malley, tapped by President Joe Biden in 2023 to head the agency, sought to end what he described as “grave injustices” that left people “in dire financial straits.”

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In March 2024, O’Malley said the agency would stop “that clawback cruelty” of intercepting 100% of a beneficiary’s monthly check if they fail to respond to a demand for repayment. Instead, the agency would default to withholding 10% of the recipient’s monthly benefits, he said.

A year later, the Trump administration reversed that policy change, returning to 100% withholding for new overpayments. “It is our duty to revise the overpayment repayment policy back to full withholding, as it was during the Obama administration and first Trump administration, to properly safeguard taxpayer funds,” acting Commissioner Lee Dudek said in a .

Now, in a pattern that has played out on multiple fronts during the first 100 days of President Donald Trump’s second term, the administration is partly reversing the reversal.

This time, it issued no news release.

“I think that we had the policy right before,” O’Malley said in an interview April 28. “We looked at the various break points, and if you would depend entirely on your Social Security check, having half of it interrupted means what? That means you go without paying your heating bill for the month; that means you’d go without your medicine instead of buying medicine and food.”

“So it was a cruelhearted policy before,” he added. At 50%, “it’s half as cruel, but it’s still cruel.”

Withholding even 50% of monthly benefits will “cause hardship for many older and disabled people,” said Kathleen Romig, who worked at the Social Security Administration under O’Malley and is now director of Social Security and disability policy at the . “Going without half a Social Security check would make it harder for many people to afford basic needs like housing, food, and health care,” Romig said.

The SSA press office did not respond to questions for this article.

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The emergency message to SSA staff said the new policy applies to overpayment notices sent on or after April 25. In one place, the message said the new withholding rate will be “up to 50 percent.” If the recipient does not request a lower rate of withholding, reconsideration, or a waiver — and “if there is no fraud or similar fault” — the agency will begin cutting their benefit payment after about 90 days, it said.

That does not apply to withholding of benefits in the Supplemental Security Income program, which serves people who have disabilities and older adults who have little or no income or resources, as the . The agency said in March that withholding of SSI benefits would remain capped at 10%.

Kate Lang, director of federal income security at the advocacy group , welcomed the shift from 100% withholding but said she was disappointed the agency didn’t revert to 10%. Lang called the agency’s conduct “chaotic and confusing.”

“It creates more work for SSA — more people calling with questions, more errors being made that need to be corrected, more confusion and uncertainty about what is going on,” Lang said.

“It’s a nightmare,” O’Malley said, “for not only the staff to have all of the switcheroo on policy, but also for the beneficiaries.”

Do you have an experience with Social Security overpayments you’d like to share? to contact our reporting team.

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The agency had long made it a practice to reduce or halt benefit checks to recoup billions of dollars in payments it sent recipients but later said they never should have received.

Martin O’Malley, then the Social Security Administration commissioner, announced in March 2024 the agency would no longer cut off people’s monthly old-age, survivors, and disability checks to recoup money they had allegedly been overpaid — a pattern he called “.” Instead, it would default to withholding 10% of monthly benefits. The new policy allowed people who already live on little to pay their rent and keep food on the table.

Last Friday, the Trump administration reversed that policy.

Beginning March 27, to recover new overpayments, the Social Security Administration will automatically withhold 100% of recipients’ monthly benefits, .

The agency said it was acting in the interest of fiscal responsibility and that the reversal would save the government about $7 billion over a decade.

“It is our duty to revise the overpayment repayment policy back to full withholding, as it was during the Obama administration and first Trump administration, to properly safeguard taxpayer funds,” acting Commissioner Lee Dudek said in a news release.

Advocates for Social Security beneficiaries described the action as cruel and harmful.

“The results are predictable: more unnecessary suffering,” said Kathleen Romig, who worked at the Social Security Administration under O’Malley and is now director of Social Security and disability policy at the .

Kate Lang of the advocacy group said she was heartbroken.

“Those who are most vulnerable, with the fewest resources, are the ones who will feel the harsh impacts of this change,” she said. Many “are going to be unable to buy food or keep the roof over their head,” she said.

In 2023, after an investigation by Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group cast a spotlight on overpayments and clawbacks, lawmakers from both parties called on the Social Security Administration to change its approach.

The policy change a year ago was inspired in part by the plight of people such as Denise Woods, who was sleeping in her Chevy in Savannah, Georgia, in December 2023 while contending with lupus and congestive heart failure after the government cut off her disability benefits. The government was demanding she repay almost $58,000.

Many overpayments are the result of government error. It can take the government years to figure out it has been paying someone too much, and by then, the amount the government says it is owed can grow far beyond a beneficiary’s ability to repay. And it has often demanded that recipients repay the full amount within 30 days.

As of October, the SSA was withholding at least a portion of monthly benefit payments from hundreds of thousands of people, according to data the SSA provided last fall to Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group. The agency said it was withholding up to 10% from 669,903 people to recoup an overpayment. Asked whether those numbers covered all types of benefits administered by the SSA, the agency’s press office didn’t say.

“Under Trump’s leadership, Social Security has reinstated a cruel policy of clawing back Social Security overpayments with no regard for an American’s ability to pay or whether the overpayment was an error by the agency,” said Sen. Ron Wyden of Oregon, the top Democrat on the Senate Finance Committee.

The new plan to completely withhold monthly benefits from recipients who were allegedly overpaid does not extend to the Supplemental Security Income program, one of two Social Security programs for people with disabilities. SSI, , covers “people with disabilities and older adults who have little or no income or resources.”

The government’s estimate that cutting people off completely will save $7 billion over a decade implies it expects many more overpayments in the years ahead.

The SSA’s March 7 announcement was part of a broader dismantling of Biden-era policies under President Donald Trump. It was also part of a broader upheaval at the Social Security Administration, which announced in February that it would from about 57,000 to 50,000.

In an interview Monday, O’Malley predicted that the public will experience much longer wait times trying to get through to the agency by phone and longer waits for disability determinations.

Social Security runs on a very old computer system, he said, and driving people out of the agency who understand it “can only result in system collapse.”

“The risk of totally shutting down the agency is greatly increased by people mucking around that don’t know what they’re doing,” O’Malley said.

On the PBS NewsHour last week, he advised recipients to save money to prepare for an interruption of benefits.

Trump deputy Elon Musk has boasted of taking a and has called Social Security a . In a filed last week, a recently retired SSA official, Tiffany Flick, said she “witnessed a disregard for critical processes” as members of DOGE — the Department of Government Efficiency, which Trump established by executive order — demanded access to sensitive Social Security systems, including files that contain beneficiaries’ banking information.

New management at the SSA called its workforce “.” But, under the previous administration, the agency was telling a starkly different story.

A year ago, O’Malley that, as the number of people receiving benefits increased, “historic underfunding and understaffing” at the agency had created a “service delivery crisis.”

Late last year, the agency provided data to Ñî¹óåú´«Ã½Ò•îl Health News showing that in September its workforce was near a 50-year low. As of last month, applicants for disability benefits were waiting an average of more than seven months for a decision, according to the .

The staffing cuts will lead to more overpayments than ever and will make it harder for the people affected to clear up mistakes, said Jen Burdick, an attorney at Community Legal Services of Philadelphia.

As Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group revealed in 2023, about 2 million people a year were receiving notices from the SSA that they were overpaid and owed money back.

People can appeal overpayment notices, request a lower withholding rate, or ask the SSA to waive collection altogether, the agency said. The SSA does not pursue recoveries while an initial appeal or waiver request is pending, it said.

Shortly before O’Malley left the SSA in November, the agency implemented changes that made it easier for beneficiaries to get overpayments waived. The agency for determining the beneficiary was not at fault — for instance, if the agency continued to issue overpayments after the beneficiary reported a change in their financial circumstances that should have led to a reduction in benefits. Those policy changes remain intact.

Several Republicans who expressed concern about clawbacks in the aftermath of 2023 news coverage did not respond to inquiries for this article or declined to comment. One of them was Sen. Rick Scott (R-Fla.), who is now chair of the Senate’s Special Committee on Aging.

“Hardworking American taxpayers pay into Social Security all of their lives so that they can depend on it in the time they need it most,” Scott said in a 2023 . “The fact that the SSA’s actions are leaving some of them worse off, through no fault of their own, is absolutely unacceptable.”

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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 KFF 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 Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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.”

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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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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, Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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.”

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

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Yet about 82% of the comments are identical to a letter that appeared on the website of a secretive advocacy group called , a data analysis by Ñî¹óåú´«Ã½Ò•îl Health News has found. 

The “” group does not reveal its funders or much else — other than to say it is “dedicated to protecting and strengthening Medicare Advantage” and is “powered by hundreds of thousands of local advocates nationwide.” 

“Our campaign provides information and offers tools for concerned Americans to use to reach decision makers,” spokesperson Darren Grubb said in an email. The group has spent more than $3.1 million on hundreds of Facebook ads since September 2024, according to , a database of the social media company’s online ads. 

There’s no doubt health insurers are unhappy with a from the Centers for Medicare & Medicaid Services, or CMS, to keep Medicare Advantage reimbursement rates essentially flat in 2027 — far less than they expected from the Trump administration. 

Medicare Advantage plans offer seniors a private alternative to original Medicare. The insurance plans enroll about members, more than half the people eligible for Medicare. 

CMS is set to announce a final rate decision by early next month. The agency solicited on the proposal from Jan. 26 through Feb. 25 to give interested parties and the public a chance to air their views. As of March 12, CMS said it had received 46,884 comments but had posted only 16,422 online. 

Medicare Advantage Majority, which says the rate proposal amounts to a “cut” in services and warns of dire consequences for seniors should it go through, accounted for at least 13,522 of the 16,422 published comments as of March 12. 

Critics warn that these sorts of campaigns may create a misleading impression of grassroots support, especially when it’s not clear who is financing them. 

“It puts a different spin on a massive groundswell of comments to know all are being driven by one specific organization,” said Michael Beckel, director of money in politics reform for Issue One, a group that seeks to limit the influence of money on government policy and legislation.

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Yet about 82% of the comments are identical to a letter that appeared on the website of a secretive advocacy group called Medicare Advantage Majority, a data analysis by Ñî¹óåú´«Ã½Ò•îl Health News has found.

The “” group does not reveal its funders or much else — other than to say it is “dedicated to protecting and strengthening Medicare Advantage” and is “powered by hundreds of thousands of local advocates nationwide.”

“Our campaign provides information and offers tools for concerned Americans to use to reach decision makers,” spokesperson Darren Grubb said in an email. The group has spent more than $3.1 million on hundreds of Facebook ads since September 2024, according to , a database of the social media company’s online ads.

There’s no doubt health insurers are unhappy with a from the Centers for Medicare & Medicaid Services, or CMS, to keep Medicare Advantage reimbursement rates essentially flat in 2027 — far less than they expected from the Trump administration.

Medicare Advantage plans differ from traditional Medicare because private insurance companies administer them. The insurance plans enroll about members, more than half the people eligible for Medicare. The plans offer things like vision and drug coverage, but Medicare Advantage insurers restrict the hospitals and doctors that patients can use and require prior approval for various procedures.

CMS is set to announce a final decision by early next month on the rate proposal. The agency solicited on the proposal from Jan. 26 through Feb. 25 to give interested parties and the public a chance to air their views.

Medicare Advantage Majority, which says the rate proposal amounts to a “cut” in services and warns of dire consequences for seniors should it go through, accounted for at least 13,522 of the 16,422 comments published as of March 12.

The proposed rate plan “puts my access to care at risk,” the group’s template letter to policymakers reads in part. “If the investment made by Washington in the Medicare Advantage program is nearly flat year-over-year, I could lose benefits I rely on every day, including affordable prescriptions, capped out of pocket costs, and access to trusted doctors and specialists.”

“Medicare Advantage is not optional for me. The cost protections alone have saved me thousands of dollars and made my health care manageable. Without this program, I would face higher costs, fewer providers, and fewer benefits at a time when I can least afford it,” the letter states.

Critics warn that these sorts of campaigns may create a misleading impression of grassroots support, especially when it’s not clear who is financing them.

“It puts a different spin on a massive groundswell of comments to know all are being driven by one specific organization,” said Michael Beckel, director of money in politics reform for Issue One, a group that seeks to limit the influence of money on government policy and legislation.

“There’s no way for the public to know what wealthy donors or special interests are funding dark money groups like this,” he said. “That means there’s no scrutiny of who’s really calling the shots.”

Some health care policy experts, who have long argued that the government overpays Medicare Advantage plans by tens of billions of dollars every year, believe industry groups or their surrogates routinely overstate possible negative impacts of rate decisions they don’t like.

“The plans always say that the sky is falling,” said Matthew Fiedler, a health care policy expert with the Brookings Institution. “The industry has a lot of money at stake here. They try to exert pressure on policymakers any way they can.”

At the same time, even critics concede that some of the millions of people enrolled in Medicare Advantage plans could face service cuts if insurance companies are not satisfied with government payments.

“It is legitimate for people to be worried,” said Julie Carter, counsel for federal policy at the Medicare Rights Center, a group that advocates for older adults and people with disabilities.

Her group argues that Medicare Advantage plans have never attained expected cost savings and instead have been overpaid for years at least partly due to “actions to maximize profits.” She said the health plans “are supposed to be saving money, not taking extra.”

People struggling to pay health care bills may have little use for the policy debate in Washington.

“If it wasn’t for being able to have this program, I really wouldn’t be able to afford any kind of medical services, to be honest,” said EsterAlicia Rose, 75, who works at the front desk of a hotel in Pagosa Springs, Colorado. She said she signed the Medicare Advantage Majority form letter to reach policymakers.

Kathy Lovely-Marshall, 66, a retired nurse who lives in Brookville, Ohio, did too. She said she receives “a lot of perks” from her plan, such as dental care, eyeglasses, and prescriptions.

“All those things are a big plus as far as I am concerned,” she said. “I’m very happy with the plan I have.”

But Corenia Branham, 90, a widow and cancer survivor who lives in Alum Creek, West Virginia, said she wants nothing to do with Medicare Advantage plans run by private health insurance companies. She said she didn’t turn in any of the four form letters under her name, which were posted online by CMS on Feb. 23 and signed, “Miss Corenia Branham Branham.” It’s not clear why her last name is signed twice.

Branham said she’s not on Medicare Advantage and doubts she could count on it for needed care.

“I wouldn’t recommend it to nobody,” she said. “I sure don’t want anything to do with it.”

Grubb, the Medicare Advantage Majority spokesperson, disputed that account. He said Branham responded to an ad on Facebook. On Feb. 6, she “completed the form with her information and chose to send her comment to CMS as well as to her representatives in Congress and the White House,” he said.

Other Medicare Advantage advocacy groups have stepped up ad campaigns as the rate decision looms.

The Better Medicare Alliance, whose “allies” include a range of health insurers, health care providers, and consumers, is urging seniors to “Tell Washington to Stand Up for Medicare Advantage.”

“We’ve mobilized beneficiaries to write letters and make phone calls, and we’ve run digital ads on streaming platforms,” spokesperson Susan Reilly said.

Reilly said that this year roughly 3 million seniors “were forced to find new coverage” because plans either shuttered operations or left some areas.

She also said Medicare Advantage plans have “scaled back” benefits such as offering transportation to medical appointments, nutrition support, and dental and vision coverage, while over the past two years beneficiaries have faced an average $900 increase in out-of-pocket maximums.

“We do view this as especially serious,” Reilly said. “This isn’t a single bad year; it’s the cumulative effect of years of underfunding and policy disruption from the previous administration that has left the program increasingly vulnerable.”

As of March 12, CMS said it had received 46,884 comments but had posted only 16,422 online.

CMS spokesperson Catherine Howden said the agency would make more comments public “as soon as practicable.”

“The agency focuses on reviewing the substance of timely submissions and does not speculate on volume, sentiment, or potential impact of comments while the comment period is open/under review,” she said in a statement.

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Scientists and public health advocates see deep disconnects between what the administration has said about health — notably, in “,” which President Donald Trump at the White House — and what it’s actually doing. 

For instance, the report says more research is needed on chronic diseases and the cumulative effects of chemicals in the environment. But the Trump administration’s mass cancellation of federal research grants has derailed studies on those subjects. 

The report denounces industry-funded research on chemicals and health as widespread and unreliable. But the administration is seeking to cut government funding that could serve as a counterweight. 

“There are many inconsistencies between rhetoric and action,” said Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, a philanthropy focused on health. 

The report, a cornerstone of President Donald Trump’s “Make America Healthy Again” agenda, was issued by a commission composed of Health and Human Services Secretary Robert F. Kennedy Jr. and other top administration officials. 

It quickly became famous for and that it was produced with help from artificial intelligence. White House press secretary Karoline Leavitt described the problems as “formatting issues,” and the administration revised the report. 

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article. 

For a glimpse of the bigger picture, consider the case of the poopy diapers. 

The MAHA Report says environmental chemicals may pose risks to children’s health — that the nation needs “to better understand the cumulative load of multiple exposures and how it may impact children’s health.” 

The Environmental Protection Agency was thinking along the same lines in 2020 when it ways of researching children’s exposure to chemicals from soil and dust. It said that, for young kids, ingesting particulates — by putting their hands on the ground or floor then in their mouths — could be a significant means of exposure to contaminants such as herbicides and pesticides. 

One grant went to a team of scientists at Johns Hopkins University and the University of California-San Francisco. Researchers gained permission to collect samples from people’s homes, including dust and diapers. 

But, beyond a small test run, they didn’t get to analyze the urine and stool samples because the grant was terminated this spring, said study leader Keeve Nachman, a professor of environmental health and engineering at Johns Hopkins. 

“The objectives of the award are no longer consistent with EPA funding priorities,” the agency said in a May 10 termination notice.

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Yet in its feverish purge of federal health programs, it has proposed eliminating the National Center for Chronic Disease Prevention and Health Promotion and its annual funding of $1.4 billion.

That’s one of many disconnects between what the administration says about health — notably, in “,” which President Donald Trump at the White House — and what it’s actually doing, scientists and public health advocates say.

Among other contradictions:

• The report says more research is needed on health-related topics such as chronic diseases and the cumulative effects of chemicals in the environment. But the Trump administration’s mass cancellation of federal research grants to scientists at universities, including Harvard, has derailed studies on those subjects.
• The report denounces industry-funded research on chemicals and health as widespread and unreliable. But the administration is seeking to cut government funding that could serve as a counterweight.
• The report calls for “fearless gold-standard science.” But the administration has sowed in the that it is out to stifle or skew its desired conclusions.

“There are many inconsistencies between rhetoric and action,” said Alonzo Plough, chief science officer at the Robert Wood Johnson Foundation, a philanthropy focused on health.

The report, a cornerstone of President Donald Trump’s “Make America Healthy Again” agenda, was issued by a commission that includes Secretary of Health and Human Services Robert F. Kennedy Jr. and other top administration officials.

News organizations found that it and that it was produced with help from artificial intelligence. White House press secretary Karoline Leavitt described the problems as “formatting issues,” and the administration revised the report.

Trump to assess causes of a “childhood chronic disease crisis.” His commission is now working on a plan of action.

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article.

Studies Derailed

The MAHA report says environmental chemicals may pose risks to children’s health. Citing the National Institutes of Health, it said there’s a “need for continued studies from the public and private sectors, especially the NIH, to better understand the cumulative load of multiple exposures and how it may impact children’s health.”

Meanwhile, the administration has cut funding for related studies.

For example, in 2020 the Environmental Protection Agency ways of researching children’s exposure to chemicals from soil and dust. It said that, for kids ages 6 months to 6 years, ingesting particulates — by putting their hands on the ground or floor then in their mouths — could be a significant means of exposure to contaminants such as herbicides, pesticides, and a group of chemicals known as PFAS.

One of the grants — for almost $1.4 million over several years — went to a team of scientists at Johns Hopkins University and the University of California-San Francisco. Researchers gained permission to collect samples from people’s homes, including dust and diapers.

But, beyond a small test run, they didn’t get to analyze the urine and stool samples because the grant was terminated this spring, said study leader Keeve Nachman, a professor of environmental health and engineering at Hopkins.

“The objectives of the award are no longer consistent with EPA funding priorities,” the agency said in a May 10 termination notice.

Another from 2020 addressed many of the issues the MAHA report highlighted: cumulative exposures to chemicals and developmental problems such as attention-deficit/hyperactivity disorder, obesity, anxiety, and depression. One of the resulting grants funded the at the University of North Carolina-Chapel Hill. That grant was ended weeks early in May, said the center’s director, Stephanie Engel, a UNC professor of epidemiology.

In a statement, EPA press secretary Brigit Hirsch said the agency “is continuing to invest in research and labs to advance the mission of protecting human health and the environment.” Due to an agency reorganization, “the way these grants are administered will be different going forward,” said Hirsch, who did not otherwise answer questions about specific grants.

In its battle with Harvard, the Trump administration has stopped paying for research the NIH had commissioned on topics such as how autism to paternal exposure to air pollution.

The loss of millions of dollars of NIH funding has also undermined data-gathering for long-term research on chronic diseases, Harvard researchers said. A series of projects with names like Nurses’ Health Study II and Nurses’ Health Study 3 have been tracking thousands of people for decades and aimed to keep tracking them as long as possible as well as enrolling new participants, even across generations.

The work has included periodically surveying participants — mainly nurses and other health professionals who enrolled to support science — and collecting biological samples such as blood, urine, stool, or toenail clippings.

Researchers studying health problems such as autism, ADHD, or cancer could tap the data and samples to trace potential contributing factors, said Francine Laden, an environmental epidemiologist at Harvard’s T.H. Chan School of Public Health. The information could retrospectively reveal exposures before people were born — when they were still in utero — and exposures their parents experienced before they were conceived.

Harvard expected that some of the grants wouldn’t be renewed, but the Trump administration brought ongoing funding to an abrupt end, said Walter Willett, a professor of epidemiology and nutrition at the Chan school.

As a result, researchers are scrambling to find money to keep following more than 200,000 people who enrolled in studies beginning in the 1980s — including children of participants who are now adults themselves — and to preserve about 2 million samples, Willett said.

“So now our ability to do exactly what the administration wants to do is jeopardized,” said Jorge Chavarro, a professor of nutrition and epidemiology at the Chan school. “And there’s not an equivalent resource. It’s not like you can magically recreate these resources without having to wait 20 or 30 years to be able to answer the questions” that the Trump administration “wants answered now.”

Over the past few months, the administration has fired or pushed out almost 5,000 NIH employees, blocked almost $3 billion in grant funding from being awarded, and terminated almost 2,500 grants totaling almost $5 billion, said Sen. Patty Murray (D-Wash.), vice chair of the Senate Appropriations Committee, at a on the NIH budget.

In addition, research institutions have been waiting months to receive money under grants they’ve already been awarded, Murray said.

In canceling hundreds of grants with race, gender, or sexuality dimensions, the administration engaged in blatant discrimination, a federal judge ruled on June 16.

Cutting Funding

After issuing the MAHA report, the administration published to cut funding for the NIH by $17.0 billion, or 38%, the Centers for Disease Control and Prevention by $550 million, or 12%, by $5 billion, or 54%.

“This budget reflects the President’s vision of making Americans the healthiest in the world while achieving his goal of transforming the bureaucracy,” the HHS “Budget in Brief” document says. Elements of Trump’s proposed budget for the 2026 fiscal year clash with priorities laid out in the MAHA report.

Kennedy has cited diabetes as part of a crisis in children’s health. The $1.4 billion unit the White House to eliminate at the CDC — the National Center for Chronic Disease Prevention and Health Promotion — has housed a program to track diabetes in children, adolescents, and young adults.

“To say that you want to focus on chronic diseases” and then “to, for all practical purposes, eliminate the entity at the Centers for Disease Control and Prevention which does chronic diseases,” said Georges Benjamin, executive director of the American Public Health Association, “obviously doesn’t make a lot of sense.”

In a May letter, Office of Management and Budget Director Russell Vought as “duplicative, DEI, or simply unnecessary,” using an abbreviation for diversity, equity, and inclusion programs.

Within the NIH, the White House has proposed cutting $320 million from the National Institute of Environmental Health Sciences, a reduction of 35%. That unit funds or conducts a wide array of research on issues such as chronic disease.

Trump’s budget proposes spending $500 million “to tackle priority activities to Make America Healthy Again,” including $260 million for his new Administration for a Healthy America to address the “chronic illness epidemic.”

Ceding Ground to Industry

The MAHA report argues that corporate influence has compromised government agencies and public health through “corporate capture.”

It alleges that most research on chronic childhood diseases is funded by the food, pharmaceutical, and chemical industries, as well as special interest organizations and professional associations. It says, for example, that a “significant portion of environmental toxicology and epidemiology studies are conducted by private corporations,” including pesticide manufacturers, and it cites “potential biases in industry-funded research.”

It’s “self-evident that cutbacks in federal funding leave the field open to the very corporate funding RFK has decried,” said Peter Lurie, president of the Center for Science in the Public Interest, a watchdog group focused on food and health.

Lurie shared the report’s concern about industry-funded research but said ceding ground to industry won’t help. “Industry will tend to fund those studies that look to them like they will yield results beneficial to industry,” he said.

In search of new funding sources, Harvard’s school of public health “is now ramping up targeted outreach to potential corporate partners, with careful review to ensure the science meets the highest standards of research integrity,” Andrea Baccarelli, dean of the school’s faculty, wrote in a to students, faculty, and others.

“It’s just simple math that if you devastate governmental funding by tens of billions of dollars, then the percentage of industry funding dollars will go up,” said Plough, who is also a clinical professor at the University of Washington School of Public Health.

“So therefore, what they claim to fear more,” he said, will “become even more influential.”

The MAHA report says “the U.S. government is committed to fostering radical transparency and gold-standard science.”

But many scientists and other scholars see the Trump administration waging a war on science that conflicts with its agenda.

In March, members of the National Academies of Sciences, Engineering, and Medicine of “destroying” scientific independence, “engaging in censorship,” and “pressuring researchers to alter or abandon their work on ideological grounds.”

In May, wrote that the administration was politicizing research — for example, by halting or censoring work on health disparities, health impacts of climate change, gender identity, and immunizations.

Recent comments by Kennedy pose another threat to transparency, researchers and health advocates say.

Kennedy said that he would probably create in-house government journals and stop NIH scientists from publishing their research in The Lancet, The New England Journal of Medicine, The Journal of the American Medical Association, and others.

Creating new government outlets for research would be a plus, said Dariush Mozaffarian, director of the Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University.

But confining government scientists to government journals, he said, “would be a disaster” and “would basically amount to censorship.”

“That’s just not a good idea for science,” Mozaffarian said.

We’d like to speak with current and former personnel from the Department of Health and Human Services or its component agencies who believe the public should understand the impact of what’s happening within the federal health bureaucracy. Please message Ñî¹óåú´«Ã½Ò•îl Health News on Signal at (415) 519-8778 or .

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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 Ñî¹óåú´«Ã½Ò•îl 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  and cellulose gum. Maltodextrin can be derived from substances such as cornstarch, rice starch, and wheat starch — but the FDA doesn’t consider it synonymous with the term “modified food starch.”

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

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

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

Gummed Up

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

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

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

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

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

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

A Growing Body of Research

Research on emulsifiers has been building in recent years.

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

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

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

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

Other findings diverge.

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

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

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

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

‘Keeping It Real’ (Or Not)

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

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

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

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

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

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

And the creamy filling doesn’t melt.

Instead, over 24 hours on a Ñî¹óåú´«Ã½Ò•îl Health News reporter’s kitchen counter, it bled a caramel-tinged fluid and shrank into a sticky white foam that could be cut with a knife.

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

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

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

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

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

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

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Instead, the agency will default to withholding 50% of old-age, survivors, and disability insurance benefits, the agency said in an “” to staff dated April 25.

The agency long made it a routine to halt benefits to recoup billions of dollars it sent recipients but later said they should not have received. A policy under the Joe Biden administration to provide relief to beneficiaries, who often live on the fringe of poverty, last year had capped the clawbacks at 10%.

The partial reversal is another twist in the Trump administration’s tumultuous approach to Social Security, which has included and the acting commissioner’s threat, which has , to essentially .

The emergency message involves the agency’s practice of paying beneficiaries money they were not supposed to receive — and then, often after years have passed and the amounts have ballooned to tens of thousands of dollars or more per person — demanding the money back, even if the overpayment was Social Security’s fault.

In many cases, recovering the money had entailed withholding 100% of monthly benefits.

Millions of beneficiaries, including people struggling to get by on monthly checks, have received overpayment notices, a 2023 investigation by Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group found. Clawbacks have left some homeless, the news organizations reported.

In the aftermath of that reporting, Martin O’Malley, tapped by President Joe Biden in 2023 to head the agency, sought to end what he described as “grave injustices” that left people “in dire financial straits.”

()

In March 2024, O’Malley said the agency would stop “that clawback cruelty” of intercepting 100% of a beneficiary’s monthly check if they fail to respond to a demand for repayment. Instead, the agency would default to withholding 10% of the recipient’s monthly benefits, he said.

A year later, the Trump administration reversed that policy change, returning to 100% withholding for new overpayments. “It is our duty to revise the overpayment repayment policy back to full withholding, as it was during the Obama administration and first Trump administration, to properly safeguard taxpayer funds,” acting Commissioner Lee Dudek said in a .

Now, in a pattern that has played out on multiple fronts during the first 100 days of President Donald Trump’s second term, the administration is partly reversing the reversal.

This time, it issued no news release.

“I think that we had the policy right before,” O’Malley said in an interview April 28. “We looked at the various break points, and if you would depend entirely on your Social Security check, having half of it interrupted means what? That means you go without paying your heating bill for the month; that means you’d go without your medicine instead of buying medicine and food.”

“So it was a cruelhearted policy before,” he added. At 50%, “it’s half as cruel, but it’s still cruel.”

Withholding even 50% of monthly benefits will “cause hardship for many older and disabled people,” said Kathleen Romig, who worked at the Social Security Administration under O’Malley and is now director of Social Security and disability policy at the . “Going without half a Social Security check would make it harder for many people to afford basic needs like housing, food, and health care,” Romig said.

The SSA press office did not respond to questions for this article.

()

The emergency message to SSA staff said the new policy applies to overpayment notices sent on or after April 25. In one place, the message said the new withholding rate will be “up to 50 percent.” If the recipient does not request a lower rate of withholding, reconsideration, or a waiver — and “if there is no fraud or similar fault” — the agency will begin cutting their benefit payment after about 90 days, it said.

That does not apply to withholding of benefits in the Supplemental Security Income program, which serves people who have disabilities and older adults who have little or no income or resources, as the . The agency said in March that withholding of SSI benefits would remain capped at 10%.

Kate Lang, director of federal income security at the advocacy group , welcomed the shift from 100% withholding but said she was disappointed the agency didn’t revert to 10%. Lang called the agency’s conduct “chaotic and confusing.”

“It creates more work for SSA — more people calling with questions, more errors being made that need to be corrected, more confusion and uncertainty about what is going on,” Lang said.

“It’s a nightmare,” O’Malley said, “for not only the staff to have all of the switcheroo on policy, but also for the beneficiaries.”

Do you have an experience with Social Security overpayments you’d like to share? to contact our reporting team.

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The agency had long made it a practice to reduce or halt benefit checks to recoup billions of dollars in payments it sent recipients but later said they never should have received.

Martin O’Malley, then the Social Security Administration commissioner, announced in March 2024 the agency would no longer cut off people’s monthly old-age, survivors, and disability checks to recoup money they had allegedly been overpaid — a pattern he called “.” Instead, it would default to withholding 10% of monthly benefits. The new policy allowed people who already live on little to pay their rent and keep food on the table.

Last Friday, the Trump administration reversed that policy.

Beginning March 27, to recover new overpayments, the Social Security Administration will automatically withhold 100% of recipients’ monthly benefits, .

The agency said it was acting in the interest of fiscal responsibility and that the reversal would save the government about $7 billion over a decade.

“It is our duty to revise the overpayment repayment policy back to full withholding, as it was during the Obama administration and first Trump administration, to properly safeguard taxpayer funds,” acting Commissioner Lee Dudek said in a news release.

Advocates for Social Security beneficiaries described the action as cruel and harmful.

“The results are predictable: more unnecessary suffering,” said Kathleen Romig, who worked at the Social Security Administration under O’Malley and is now director of Social Security and disability policy at the .

Kate Lang of the advocacy group said she was heartbroken.

“Those who are most vulnerable, with the fewest resources, are the ones who will feel the harsh impacts of this change,” she said. Many “are going to be unable to buy food or keep the roof over their head,” she said.

In 2023, after an investigation by Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group cast a spotlight on overpayments and clawbacks, lawmakers from both parties called on the Social Security Administration to change its approach.

The policy change a year ago was inspired in part by the plight of people such as Denise Woods, who was sleeping in her Chevy in Savannah, Georgia, in December 2023 while contending with lupus and congestive heart failure after the government cut off her disability benefits. The government was demanding she repay almost $58,000.

Many overpayments are the result of government error. It can take the government years to figure out it has been paying someone too much, and by then, the amount the government says it is owed can grow far beyond a beneficiary’s ability to repay. And it has often demanded that recipients repay the full amount within 30 days.

As of October, the SSA was withholding at least a portion of monthly benefit payments from hundreds of thousands of people, according to data the SSA provided last fall to Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group. The agency said it was withholding up to 10% from 669,903 people to recoup an overpayment. Asked whether those numbers covered all types of benefits administered by the SSA, the agency’s press office didn’t say.

“Under Trump’s leadership, Social Security has reinstated a cruel policy of clawing back Social Security overpayments with no regard for an American’s ability to pay or whether the overpayment was an error by the agency,” said Sen. Ron Wyden of Oregon, the top Democrat on the Senate Finance Committee.

The new plan to completely withhold monthly benefits from recipients who were allegedly overpaid does not extend to the Supplemental Security Income program, one of two Social Security programs for people with disabilities. SSI, , covers “people with disabilities and older adults who have little or no income or resources.”

The government’s estimate that cutting people off completely will save $7 billion over a decade implies it expects many more overpayments in the years ahead.

The SSA’s March 7 announcement was part of a broader dismantling of Biden-era policies under President Donald Trump. It was also part of a broader upheaval at the Social Security Administration, which announced in February that it would from about 57,000 to 50,000.

In an interview Monday, O’Malley predicted that the public will experience much longer wait times trying to get through to the agency by phone and longer waits for disability determinations.

Social Security runs on a very old computer system, he said, and driving people out of the agency who understand it “can only result in system collapse.”

“The risk of totally shutting down the agency is greatly increased by people mucking around that don’t know what they’re doing,” O’Malley said.

On the PBS NewsHour last week, he advised recipients to save money to prepare for an interruption of benefits.

Trump deputy Elon Musk has boasted of taking a and has called Social Security a . In a filed last week, a recently retired SSA official, Tiffany Flick, said she “witnessed a disregard for critical processes” as members of DOGE — the Department of Government Efficiency, which Trump established by executive order — demanded access to sensitive Social Security systems, including files that contain beneficiaries’ banking information.

New management at the SSA called its workforce “.” But, under the previous administration, the agency was telling a starkly different story.

A year ago, O’Malley that, as the number of people receiving benefits increased, “historic underfunding and understaffing” at the agency had created a “service delivery crisis.”

Late last year, the agency provided data to Ñî¹óåú´«Ã½Ò•îl Health News showing that in September its workforce was near a 50-year low. As of last month, applicants for disability benefits were waiting an average of more than seven months for a decision, according to the .

The staffing cuts will lead to more overpayments than ever and will make it harder for the people affected to clear up mistakes, said Jen Burdick, an attorney at Community Legal Services of Philadelphia.

As Ñî¹óåú´«Ã½Ò•îl Health News and Cox Media Group revealed in 2023, about 2 million people a year were receiving notices from the SSA that they were overpaid and owed money back.

People can appeal overpayment notices, request a lower withholding rate, or ask the SSA to waive collection altogether, the agency said. The SSA does not pursue recoveries while an initial appeal or waiver request is pending, it said.

Shortly before O’Malley left the SSA in November, the agency implemented changes that made it easier for beneficiaries to get overpayments waived. The agency for determining the beneficiary was not at fault — for instance, if the agency continued to issue overpayments after the beneficiary reported a change in their financial circumstances that should have led to a reduction in benefits. Those policy changes remain intact.

Several Republicans who expressed concern about clawbacks in the aftermath of 2023 news coverage did not respond to inquiries for this article or declined to comment. One of them was Sen. Rick Scott (R-Fla.), who is now chair of the Senate’s Special Committee on Aging.

“Hardworking American taxpayers pay into Social Security all of their lives so that they can depend on it in the time they need it most,” Scott said in a 2023 . “The fact that the SSA’s actions are leaving some of them worse off, through no fault of their own, is absolutely unacceptable.”

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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 KFF 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 Ñî¹óåú´«Ã½Ò•îl 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.

Ñî¹óåú´«Ã½Ò•îl 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 Ñî¹óåú´«Ã½Ò•îl 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.”

This <a target="_blank" href="/public-health/food-ingredients-chemicals-additives-fda-oversight-lax-industry-honor-system/">article</a&gt; first appeared on <a target="_blank" href="">KFF Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">