The new head of the Food and Drug Administration division that regulates the formula for babies was a company lawyer in recent months who defended a top formula maker against claiming that her product gave rise to debilitating damage to premature babies.
Kyle A. Diamantas came to the FDA last month to lead the food division, which serves the Jones Day law firm, which served as a pipeline of talent for both Trump administrations.
As a partner in Miami's office of Jones Day, the recent work of Mr Diamantas included defending Abbott Laboratoria in a lawsuit that accused the company of not sufficient warning that the specialized formula for premature babies was associated with an increased risk of a deadly intestinal condition.
Abbott lost the case and was instructed to pay $ 495 million. Abbott appeals to the verdict. The role of Mr Diamantas in that case and other Abbott cases has not been reported before.
The leader of the FDA's food department plays a broad role in guaranteeing the safety of around 80 percent of food supply in the United States. In that task, Mr Diamantas is also expected to play a leading role in carrying out health secretary Robert F. Kennedy Jr., who calls on to reduce food additives and to eliminate what Mr Kennedy has described as corruption in public health institutions.
“We will close the rotating door to restore the public,” Mr. Kennedy told the staff of the Health and Human Services Department during his first week.
The selection of Mr Diamantas to run the Food Division, represented representative Rosa Delauro, who worked on problems with the infants, as a 'betrayal'. She has focused on the formula of the baby since 2022, when a large shortage of formulas started after Abbott had temporarily closed his Michigan formule factory in the midst of findings of unsanitary conditions.
“It is the task of the FDA to protect our babies, not the companies they have poisoned,” said Mrs. Delauro, a Democrat from Connecticut, emailed in a statement to the New York Times. “The naming of an Abbott lawyer to supervise food safety, including the formula for children, is to let the fox guard the chicken coop.”
Mr Diamantas did not respond to a request for comment. The FDA said that he will meet his routine ethical agreement with the agency, including promises to recover from specific matters related to Abbott and also British -American tobacco, another prominent customer of Jones Day. Health and human service officials refused to make the ethical agreement of Mr Diamantas available for time.
'Mr. Diamantas shares the vision of the Kennedy secretary to improve the nutritional results, ensuring that food supply is safe and healthy, and continues to carry out the general mission of the FDA to protect and promote public health, ”said a spokesperson for the Ministry of Health and Human Services, Andrew Nixon.
The FDA did not make a formal announcement about the role of Mr Diamantas, but on 24 February the agency posted a web page with a list of him as the acting deputy commissioner of Human Foods and called him his 'top food manager'. He will also represent the agency in dealing with foreign governments and the White House.
Before he came to Jones Day in 2021, Mr Diamantas (who was also shown hunting with Donald Trump Jr., the son of the president, worked in a photo on social media at another law firm. There he defended a cannabis company named Hemp Bombs against claims about his CBD products, which are derived from the cannabis factory. He also defended Whole Foods markets in a lawsuit that claimed that it sold a CBD product that misled users to believe it would reduce pain.
The FDA has taken the position that CBD is unsafe to add to the food supply and has been entered into behind companies in situations that considered it a high risk. The agency started an attempt to determine how the CBD would regulate, but at the beginning of 2023 concluded that the congress had to intervene.
The deadly intestinal disease associated with baby formula for premature babies is also debated at the FDA Hundreds of lawsuits are in treatment, many claim that Abbott has not warned the parents about the high risk of infection when very lowweight babies-on-bond or less nourished.
In three cases in the formula of children submitted to a court in Missouri, Mr Diamantas was admitted to represent Abbott in March 2024, according to judicial data. In two of the cases his role was described in the court reports as representatives of two Abbott sales representatives.
He did not address the jury during the controversial process of Margo Gill v. Abbott, which ended with the jury that $ 95 million in compensating and $ 400 million in punitive compensation against the company.
The case concentrated on the question of whether Abbott Mrs Gill had sufficiently warned that babies with a very low weight are fed with babies, run an increased risk of intestinal disease that is called necrotizing enterocolitis or NEC, which can quickly lead to destruction of the intestine and death.
In six weeks old, Mrs. Gill's daughter developed about 24 hours after she received the formula. She left the neonatal Intensive Care, or Nicu, with extensive intestinal and brain damage, according to the testimonies of the court viewed on the network of the courtroom. Mrs Gill testified during the process that her daughter could not talk, walk or eat at 3 o'clock without a food tube.
Abbott did not claim that Mrs. Gill had been warned, and said earlier that it was the role of the doctor to advise families. During the July trial, a lawyer showed Mrs. Gill, Jake Plattenberger, internal Abbott documents that say that the Baby Formula is considered a contributing factor to the development of NEC. “
He also told the jury that about 90 percent of the premature babies who received the condition had received the formula. He showed a study of 1,800 premature babies who concluded that formula feeding increases the risk of the development of NEC by 180 percent.
James F. Hurst, the main problems for Abbott, argued that the formula did not cause the condition. The product is usually used in hospitals and is labeled “only for institutional use” and “use as prescribed by a doctor.” On a slide before the jury, Mr Hurst wrote: “Different words on the Abbott (or somewhere else) label would have changed” for the child.
He also argued that the cascade of injuries suffered Mrs. Gill's daughter, including brain damage, related to other factors, including her birth combatations and a very low oxygen level.
“These premature baby formulas and fortifiers of breast milk are part of the care standard for premature babies and have been used safely for 45 years, nourish generations of Nicu -Babies,” Abbott said in a statement on Monday.
On July 26, jury members chose Mrs. Gill's side and her family admitted almost half a billion. Shortly thereafter, the director of Abbott, Robert B. Ford, publicly warned that the company may have to stop selling a formula for premature babies.
Mr. Ford turned three days after the FDA verdict, according to records, and met Dr. Robert Califf, the FDA Commissioner and others in the Food Division.
Soon officials with the FDA and two other health authorities quickly started working on a consensus statement about NEC. A person who was familiar with the process, who for anonymity to discuss the dialogue, said that formula companies had asked government officials to make a consensus statement, but did not dictate what it said. Some members of the working group had relationships with Abbott, such as by accepting speaker costs, which were not specifically described in the final report, according to records.
The health department released its conclusion on 3 October: “1) There is no convincing evidence that premature baby formula causes NEC; And 2) There is strong evidence that breast milk is protective against NEC. “
The statement reflects Abbott's position in court and is expected to help formula makers in coming cases.
A few months before Gill's verdict, a similar case against Mead Johnson, who makes Enfamil formula, ended in a $ 60 million judgment in favor of a family. In November a case against both formula makers resulted in a victory for the companies.
The FDA's Food Division deals with countless other things in its role that the majority of food supply regulates. On infant nutrition, the Abbott and other companies division tries to keep a high standard after inspectors in Abbott's Michigan factory discovered a leaking roof, combined water and evidence of a deadly bacteria. The factory was closed for an overhaul, so that in 2022 a shortage of infants was rejected in 2022, causing parents to clamber.
The Food Division also leads research into diseases transferred by food, together with states and other federal officials to use high -tech tools to connect sick patients with contamination in food plants or greengroceries. The division has also rolled out rules, making it easier to trace food through the supply chain and help farmers to ensure that irrigation water does not spread bacteria on crops.
Mr. Kennedy has outlined other priorities for the agency, including investigating chemical additives in food. At least one influential supporter of Mr. Kennedy sees Mr Diamantas' experience as a plus.
During the weekend of inauguration, Vani Hari, a clean-food activist who is known online as the food babe, said she met and talked to Mr. Diamantas at three different events. The first time his wife bent in and told Mrs. Hari that she had been a follower of her blog for years.
“He is completely on board to change the way the regulatory system works,” said Mrs. Hari. Instead of seeing his work with Abbott and other companies as a potential conflict of interest, Mrs. 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, “said Mrs. Hari. “He is very passionate about the Make America Remory Remement, but he is also very Levelheaded. He will come up with a solution that is possible for everyone to change our food system. “
Julie Creswell contributed reporting.
