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

New York Times

04-03-2025

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.'