logo
He Fought Claims of Harm From Infant Formula. Now He Regulates It.

He Fought Claims of Harm From Infant Formula. Now He Regulates It.

New York Times04-03-2025

The new head of the Food and Drug Administration division that regulates infant formula was in recent months a corporate lawyer defending a top formula maker from claims that its product gave rise to debilitating harm to premature babies.
Kyle A. Diamantas joined the F.D.A. last month to lead the food division, leaving the law firm Jones Day, which has served as a pipeline of talent to both Trump administrations.
As a partner in Jones Day's Miami office, Mr. Diamantas's recent work included defending Abbott Laboratories in lawsuits accusing the company of failing to adequately warn parents that its specialized formula for premature infants was associated with an elevated risk of a deadly bowel condition.
Abbott lost the case and was ordered to pay $495 million. Abbott is appealing the verdict. Mr. Diamantas's role in the Abbott cases has not been previously reported.
The leader of the F.D.A.'s food division has a wide-ranging role in ensuring the safety of about 80 percent of the food supply in the United States. In that job, Mr. Diamantas is also expected to take a lead role in enacting Health Secretary Robert F. Kennedy Jr.'s agenda, which calls for reducing additives in food and eliminating what Mr. Kennedy has described as corruption in public health agencies.
'We will shut the revolving door to re-establish public trust,' Mr. Kennedy told the Health and Human Services Department's staff during his first week in office.
The selection of Mr. Diamantas to run the food division struck Representative Rosa DeLauro, who has worked on infant formula issues, as a 'betrayal.' She has focused on infant formula since 2022, when a major formula shortage began after Abbott temporarily shut down its Michigan formula plant amid findings of unsanitary conditions.
'The F.D.A.'s job is to protect our babies, not the corporations that poisoned them,' Ms. DeLauro, a Connecticut Democrat, said in a statement emailed to The New York Times. 'Appointing an Abbott lawyer to oversee food safety, which includes infant formula, is letting the fox guard the henhouse.'
Mr. Diamantas did not respond to a request for comment. The F.D.A. said he will comply with his routine ethics agreement with the agency, which includes pledges to recuse himself from specific matters related to Abbott and also British American Tobacco, another prominent Jones Day client. Health and Human Services officials declined to make Mr. Diamantas's ethics agreement available to the Times.
'Mr. Diamantas shares Secretary Kennedy's vision of improving nutritional outcomes, ensuring the food supply is safe and healthy, and continuing to carry out the F.D.A.'s overall mission of protecting and promoting public health,' a spokesman for the department of Health and Human Services, Andrew Nixon, said.
The F.D.A. did not issue a formal announcement about Mr. Diamantas' role, but on Feb. 24, the agency put up a web page listing him as the acting deputy commissioner of human foods and calling him its 'top food executive.' He will also will represent the agency in dealings with foreign governments and the White House.
Before he joined Jones Day in 2021, Mr. Diamantas (who has also been shown hunting with Donald Trump Jr., the president's son, in a photo on social media) worked at another law firm. There, he defended a cannabis company called Hemp Bombs against claims about its CBD products, which are derived from the cannabis plant. He also defended Whole Foods Markets in a lawsuit claiming that it sold a CBD product that misled users to believe it would reduce pain.
The F.D.A. has taken the position that CBD is unsafe to add to the food supply and has gone after companies in situations it deemed high risk. The agency began an effort to determine how it would regulate CBD but in early 2023 concluded that Congress needed to step in.
The deadly bowel condition associated with infant formula for preterm infants has also been debated at the F.D.A. Hundreds of lawsuits are pending, many claiming that Abbott failed to warn parents of the outsized risk of infection that arises when very low-weight babies — around 3 ½ pounds or less — are fed formula instead of breast milk.
In three infant formula cases filed in a Missouri court, Mr. Diamantas was admitted to represent Abbott in March 2024, court records show. In two of the cases, his role was described in court records as representing two Abbott sales representatives.
He did not address the jury during the high-profile trial of Margo Gill v. Abbott, which ended with the jury levying $95 million in compensatory and $400 million in punitive damages against the company.
The case centered around whether Abbott had adequately warned Ms. Gill that very low-weight babies who are fed infant formula face an elevated risk of a bowel condition called necrotizing enterocolitis, or NEC, which can quickly lead to destruction of the intestines and death.
At six weeks old, Ms. Gill's daughter developed NEC about 24 hours after she was fed formula. She left the neonatal intensive care unit, or NICU, with extensive bowel and brain damage, according to court testimony viewed on Courtroom View Network. Ms. Gill testified during the trial that at 3, her daughter was unable to talk, walk or eat without a feeding tube.
Abbott did not argue that Ms. Gill had been warned, rather saying it was the doctor's role to counsel families. During the trial in July, a lawyer for Ms. Gill, Jake Plattenberger, showed jurors internal Abbott documents saying that infant formula 'is thought to be a contributing factor to the development of NEC.'
He also told the jury that about 90 percent of the preterm infants who got the condition had been fed formula. He showed a study of 1,800 preterm infants that concluded that formula feeding raises the risk of developing NEC by 180 percent.
James F. Hurst, the lead trial lawyer for Abbott, argued that formula does not cause the condition. The product is typically used in hospitals and is labeled 'for institutional use only' and 'use as directed by a doctor.' On a slide presented to the jury, Mr. Hurst wrote: 'Different Words On Abbott's Label (Or Anywhere Else) Wouldn't Have Changed Anything' for the infant.
He also argued that the cascade of injuries Ms. Gill's daughter sustained, including brain damage, were related to other factors, including her birth complications and very low oxygen level.
'These premature infant formulas and human milk fortifiers are part of the standard of care for premature infants and have been used safely for 45 years, nourishing generations of NICU babies,' Abbott said in a statement on Monday.
On July 26, jurors sided with Ms. Gill and awarded nearly half a billion to her family. Soon after, Abbott's chief executive, Robert B. Ford, publicly warned that the company might need to stop selling some formula for preterm infants.
Mr. Ford turned to the F.D.A. three days after the verdict, records show, and met with Dr. Robert Califf, the F.D.A. commissioner, and others in the food division.
Soon, officials with the F.D.A. and two other health agencies began to work quickly on a consensus statement about NEC. A person familiar with the process, who requested anonymity to discuss the dialogue, said formula companies had asked government officials to craft a consensus statement, but did not dictate what it said. Some working group members had relationships with Abbott, such as through accepting speaker fees, that were not specifically outlined in the final report, records show.
On Oct. 3, the health department released its conclusion: '1) There is no conclusive evidence that preterm infant formula causes NEC; and 2) there is strong evidence that human milk is protective against NEC.'
The statement echoes Abbott's position in court and is expected to help formula makers in upcoming cases. Since the Gill verdict, another similar case ended in a $60 million verdict in favor of a family and another case resulted in a victory for formula makers.
The F.D.A.'s food division handles myriad other matters in its role regulating the majority of the food supply. On infant formula, the division is trying to hold Abbott and other companies to a high standard after inspectors at Abbott's Michigan plant discovered a leaking roof, pooled water and evidence of a deadly bacteria. The plant was shut down for an overhaul, setting off a monthslong infant formula shortage in 2022 that left parents scrambling.
The food division also leads investigations into food-borne illnesses, working with states and other federal officials to use high-tech tools to connect sick patients to contamination at food plants or vegetable farms. The division has also been rolling out rules making it easier to trace food through the supply chain and helping farmers ensure irrigation water does not spread bacteria on crops.
Mr. Kennedy has outlined other priorities for the agency, including to scrutinize chemical additives in food. At least one influential supporter of Mr. Kennedy sees Mr. Diamantas's experience as an asset.
During the weekend of the inauguration, Vani Hari, a clean-food activist known online as the Food Babe, said she met and chatted with Mr. Diamantas at three different events. The first time, his wife leaned in and told Ms. Hari she had been a follower of her blog for years.
'He is all on board to change the way the regulatory system works,' Ms. Hari said. Rather than see his work with Abbott and other corporations as a potential conflict of interest, Ms. Hari said it gave him insight into how to work with them.
'It's just the way the world works. The companies will have to be involved in these discussions,' Ms. Hari said. 'He's very passionate about the Make America Healthy Again movement but he's also very levelheaded. He'll figure out a solution that is feasible to everyone to change our food system.'

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Trump's DOGE efficiency agency says it slashes $25B in federal spending as rehiring begins
Trump's DOGE efficiency agency says it slashes $25B in federal spending as rehiring begins

Fox News

time13 minutes ago

  • Fox News

Trump's DOGE efficiency agency says it slashes $25B in federal spending as rehiring begins

The Department of Government Efficiency (DOGE) announced on Wednesday it has decreased its annual non-defense federal obligations by an additional ~1.9% since last month. As of June 8th, annual non-defense federal obligations are down 22.4%, or ~$25B, as compared to 2024, DOGE announced on X. The cut marks an additional ~1.9% reduction from last month's figures, which were announced on May 8. "Cash outlays will follow as obligations come due," DOGE wrote in the post. "Our initiative to reduce wasteful spend, consistent with the DOGE Cost Efficiency Executive Order, continues to bear fruit." On May 14, DOGE announced the current year's non-defense federal obligations were down 20.5% as compared to 2024. The announcement came minutes before Fox News Digital was first to report the Department of Health and Human Services (HHS) is rehiring more than 450 previously fired employees belonging to multiple divisions within the agency's Centers for Disease Control and Prevention (CDC). The rehired CDC employees came from the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the National Center for Environmental Health; the Immediate Office of the Director, and the Global Health Center, according to an HHS official familiar with the matter. HHS Secretary Robert F. Kennedy Jr. told CBS News in April some personnel who were cut shouldn't have been. "We're reinstating them, and that was always the plan," Kennedy said. "Part of the—at DOGE, we talked about this from the beginning, is we're going to do 80% cuts, but 20% of those are going to have to be reinstated, because we'll make mistakes." In addition to the HHS rehires, the Internal Revenue Service, Food and Drug Administration, State Department, and Department of Housing and Urban Development started rehiring employees let go during DOGE cuts, the Washington Post reported. Another roadblock this week was a ruling from U.S. District Judge Denise Cote of the Southern District of New York, who ruled to restrict the agency's access to federal databases. The Trump administration previously said DOGE could not work effectively with the limitations, noting DOGE needed to access Social Security information to root out fraud.

Kennedy names 8 vaccine committee replacements, including COVID shot critic
Kennedy names 8 vaccine committee replacements, including COVID shot critic

Yahoo

time14 minutes ago

  • Yahoo

Kennedy names 8 vaccine committee replacements, including COVID shot critic

NEW YORK (AP) — U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday named eight new vaccine policy advisers to replace the panel that he abruptly dismissed earlier this week. They include a scientist who researched mRNA vaccine technology and transformed into a conservative darling for his criticisms of COVID-19 vaccines, and a leading critic of pandemic-era lockdowns. Kennedy's decision to 'retire' the previous 17-member panel was widely decried by doctors' groups and public health organizations, who feared the advisers would be replaced by a group aligned with Kennedy's desire to reassess — and possibly end — longstanding vaccination recommendations. The new appointees to the Advisory Committee on Immunization Practices include Dr. Robert Malone, the former mRNA researcher who emerged as a close adviser to Kennedy during the measles outbreak. Malone, who runs a wellness institute and a popular blog, rose to popularity during the COVID-19 pandemic as he relayed conspiracy theories around the outbreak and the vaccines that followed. He has appeared on podcasts and other conservative news outlets where he's promoted unproven and alternative treatments for measles and COVID-19. He has claimed that millions of Americans were hypnotized into taking the COVID-19 shots. He's even suggested that those vaccines cause a form of AIDS. He's downplayed deaths related to one of the largest measles outbreaks in the U.S. in years. Other appointees include Dr. Martin Kulldorff, a biostatistician and epidemiologist who was a co-author of the Great Barrington Declaration, an October 2020 letter maintaining that pandemic shutdowns were causing irreparable harm. Dr. Cody Meissner, a former ACIP member, also was named. Kennedy made the announcement in a social media post on Wednesday. The committee, created in 1964, makes recommendations to the director of the Centers for Disease Control and Prevention. CDC directors almost always approve those recommendations on how Food and Drug Administration-cleared vaccines should be used. The CDC's final recommendations are widely heeded by doctors and determine the scope of vaccination programs. ___ Associated Press reporter Amanda Seitz contributed to this report. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

MSNBC host tells Colbert that Trump has started to ‘f— around with the military'
MSNBC host tells Colbert that Trump has started to ‘f— around with the military'

New York Post

time14 minutes ago

  • New York Post

MSNBC host tells Colbert that Trump has started to ‘f— around with the military'

MSNBC host Nicolle Wallace said Tuesday that it felt different to have President Donald Trump 'f— around with the military' in his second term during an interview with late-night host Stephen Colbert. Wallace argued that there were no 'normal Republicans' in Trump's current administration and said 'what's different about Stephen Miller running the ICE raids, and running basically a siege of Los Angeles, is that there is no Mark Esper, Jim Mattis, and that's the big difference, and that is the danger.' Colbert then asked Wallace about the National Guard troops and the Marines that have been sent to Los Angeles to help quell the riots. 'We have seen Trump stretch his presidential powers over the last five months. Is this different?' 'It feels different, it feels different to, can we swear here?' she asked as Colbert said she could. 'To f— around with the military, it feels really different, and he wanted to the first time, but people like Mark Milley, people stopped him. It feels really different to use the military as pawns out loud and as a public tactic. That feels different to me.' A battalion of 700 U.S. Marines are mobilizing in Los Angeles to respond to anti-immigration enforcement riots, just days after Trump deployed the National Guard to the area as well. White House spokeswoman Abigail Jackson responded to criticism of Trump's actions on Tuesday, telling Fox News Digital that 'violent rioters in Los Angeles, enabled by Democrat Gov. Gavin Newsom, have attacked American law enforcement, set cars on fire, and fueled lawless chaos.' On The Late Show with Stephen Colbert, MSNBC host Nicolle Wallace said President Donald Trump 'f— around with the military' had a different feeling compared to what he has done throughout his time in office. Scott Kowalchyk/CBS 'President Trump rightfully stepped in to protect federal law enforcement officers. When Democrat leaders refuse to protect American citizens, President Trump will always step in,' she added. Colbert also asked Wallace about the state of the Democratic Party and asked the MSNBC host if they were 'in danger of an autocrat.' 'I don't know, and I think that, in politics, you are one leader away from a comeback, you're one moody character away from this unlikely hero. And so I think the Democratic Party hasn't rotted. I mean the Democratic Party has not corrupted itself, it hasn't turned on itself in the way that the Republican Party has. And I think the Democratic Party is one leader away from being something fresh and appealing to a majority of others again. I think the Republican Party is still heading down, down, down following Trump and his authoritarian ways,' she said. Wallace claims there are no 'normal Republicans' in Trump's current administration and that the difference is that with Stephen Miller running the ICE raids, it is basically running a siege in Los Angeles, California. AP Wallace previously made headlines earlier this year while covering Trump's address to Congress, during which the president made a 13-year-old cancer survivor, DJ Daniel, an honorary Secret Service agent. 'But I think this was a lesson in finding one thing that you let yourself feel,' Wallace said during her coverage of the address. 'And I let myself feel joy about DJ, and I hope he's alive for another, you know, 95 years, and I hope he lives the life he wants to live. He wants to be a cop. He knows what he wants to do, and maybe when you have childhood cancer, that crystallizes for you.' 'I hope he has a long life as a law enforcement officer,' she continued. 'But I hope he never has to defend the United States Capitol against Donald Trump's supporters, and if he does, I hope he isn't one of the six who loses his life to suicide, and I hope he isn't one who has to testify against the people who carried out acts of seditious conspiracy and then lived to see Donald Trump pardon those people.' The MSNBC host was criticized by Trump and the White House at the time.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store