The new head of the Food and Drug Administration Department regulating the infant formula has been a corporate lawyer in recent months defending a leading manufacturer of types of allegations that his product has caused debilitating damage to premature babies.
Kyle A. Diamantas joined the FDA last month to drive the food department, leaving the law firm Jones Day, which has served as a talent pipeline in both Trump’s administrations.
As a partner in the Miami Jone’s office, Mr Diamantas ‘recent work included Abbott Laboratories’ defense in a lawsuit accusing the company of failing to adequately warn parents that her specialized type of premature infants had been associated with an increased infant.
Abbott lost the case and was ordered to pay $ 495 million. Abbott is aimed at the verdict. Mr Diamantas’s role in this case and other cases Abbott has not been mentioned before.
The FDA Food Leader plays a wide role in securing the safety of about 80 % of the food supply in the United States. In this job, Mr Diamantas is also expected to take a leading role in the introduction of the agenda of Health Minister Robert F. Kennedy Jr., which requires the reduction of additives in food and the elimination of what Mr Kennedy described as corruption in public health services.
“We will close the rotating door to restore public confidence,” Mr Kennedy told the staff of the Department of Health and Human Services during his first week.
Mr Diamantas’s choice to run the Food Department hit the spokesman Rosa Delauro, who worked on infancy, as “betrayal”. It has been focused on the infant formula since 2022, when a significant lack of type began after the temporary area of ​​the Michigan formula plant amid findings of non -healthy conditions.
“FDA’s job is to protect our babies, not the companies that have been poisoned them,” said Ms Delauro, a Democrat of Connecticut, in a statement that sent an email to the New York Times. “The appointment of an Abbott lawyer for supervision of food safety, which includes infants, leaves Fox Guard the Henhouse.”
Mr Diamantas did not respond to a request for comments. The FDA said he will comply with his usual ethics agreement with the organization, which includes promises to overturn himself from specific issues related to Abbott and also British American Tobacco, another prominent Customer of Jones Day. Health and Human Services have refused to make Mr Diamantas’s ethics agreement to be available to the Times.
“Mr Diamantas shares the vision of Secretary Kennedy to improve nutritional results, ensuring that food supply is safe and healthy and continuing to perform the FDA’s overall mission to protect and promote public health,” said a spokesman for the Ministry of Health and Human Services.
The FDA did not issue an official announcement on the role of Mr Diamantas, but on February 24, the Agency set up a website that listed him as Deputy Commissioner for Human Foods and called him “his top executive food”. It will also represent the Agency in trading with foreign governments and the White House.
Before joining Jones in 2021, Mr Diamantas (who has also shown hunting with Donald Trump Jr., the president’s son, in a social media photo) worked for another law firm. There, he defended a cannabis company called hemp bombs against claims on CBD products, which come from the cannabis plant. He also defended Whole Foods markets in a trial claiming that he sold a CBD product that misleading users to believe that would reduce pain.
The FDA has taken the position that CBD is not safe to add to food supply and has passed after companies in situations that considered high risk. The organization began an attempt to determine how it would regulate the CBD, but in early 2023 it concluded that Congress had to enter.
The fatal state of the infants associated with infants for premature infants has also been discussed in the FDA hundreds of treatments pending, many claim that Abbott has failed to warn parents of excessive risk of infection resulting when babies are very low-weight.
In three cases for the formula filed in a Missouri court, Mr Diamantas was accepted to represent Abbott in March 2024, according to court records. In two of the cases, his role was described in the court records as representing two Abbott sales representatives.
He did not face the jury during Margo Gill’s high profile trial against Abbott, which ended with the jury imposing $ 95 million on compensation and $ 400 million on compensation against the company.
The case focused on whether Abbott had adequately warned Ms Gill that babies who are fed too low weight -powered weights face an increased risk of a condition of the bowel called necrotic enterocolitis or nec, which can quickly lead to destruction.
At the age of six weeks, Ms. Gill’s daughter developed a NEC about 24 hours after the formula. He left the Intensive Neonatal Intensive Care Unit or Nicu, with extensive bowel and brain damage, according to the court testimony examining the court’s projection network. Ms Gill testified during the trial that at 3, her daughter was unable to talk, walk or eat without a feeding pipe.
Abbott did not argue that Ms Gill had been warned, probably saying that it was the doctor’s role to advise families. During the trial in July, a lawyer for Mrs Gill, Jake Plattenberger, showed that Abbott’s internal Abbott documents saying that the infant formula “is considered to be a factor that contributes to the development of the NEC”.
He also told the jury that about 90 percent of premature infants who took the situation had been fueled with the formula. It showed a study of 1,800 premature infants who concluded that the type diet increases the risk of NEC development by 180 %.
James F. Hurst, a lawyer for Abbott, argued that the formula is not causing the situation. The product is typically used in hospitals and is characterized as “only for institutional use” and “use as a doctor’s instructions”. In a transparency presented to the jury, Mr Hurst wrote: “Words about Abbott’s label (or anywhere else) would not change anything” for the infant.
He also claimed that the waterfall of Ms Gill’s injuries, including brain injury, is associated with other factors, including birth complications and very low oxygen levels.
“These premature types of infant and human milk are part of the care for premature infants and have been safely used for 45 years, nutrient generations of baby Nicu,” Abbott said in a statement on Monday.
On July 26, the judges with Ms Gill are awarded almost half a billion to her family. Shortly afterwards, Abbott’s CEO Robert B. Ford publicly warned that the company may need to stop selling some formula for premature infants.
Mr Ford turned to the FDA three days after the verdict, the files show and meet with Dr. Robert Califf, the FDA Commissioner and others in the Food Department.
Soon, officials with the FDA and two other health services began working quickly in a Consensus Statement on NEC. A person familiar with the process, who asked for anonymity to discuss the dialogue, said formula companies had asked government officials to create a statement of consensus, but do not dictate what he said. Some work group members had relationships with Abbott, such as accepting fees, which were not specifically described in the final report, the files show.
On October 3, the Ministry of Health published its conclusion: “1) There is no decisive evidence that premature infant causes nec. And 2) there is strong evidence that human milk is protective from the NEC.”
The statement echoed Abbott’s position in court and is expected to help type manufacturers in upcoming cases. From Gill’s verdict, another similar case ended in a $ 60 million verdict in favor of one family and another case resulted in a victory for types manufacturers.
The FDA Food Department handles myriad other issues in its role by regulating the majority of food supply. In the infant formula, the division is trying to keep Abbott and other high -level companies after inspectors at the Abbott Michigan factory, discovered a roof leak, concentrated water and indications for a deadly bacteria. The factory closed for a review, starting with a monthly lack of infant formula in 2022 that let parents mix.
The Food Directorate also leads to research on food -transmitted diseases, working with states and other federal officials for the use of high -tech tools to connect patients with patients with contamination of foods or plant farms. Division has also released rules that facilitate food detection through the supply chain and helping farmers to ensure that irrigation water does not spread bacteria to crops.
Mr Kennedy described other priorities for the body, including controlling chemical additives in food. At least one major supporter of Mr Kennedy sees Mr Diamantas’ experience as an asset.
During the inauguration weekend, Vani Hari, a clean food activist known on the Internet as a Food Babe, said he met and talked to Mr Diamantas at three different events. For the first time, his wife leaned over and told Ms. Hari that she was a fan of her blog for years.
“Everyone is on board to change the way the regulatory system works,” Ms Hari said. Instead of seeing his job with Abbott and other companies as a possible conflict of interest, Ms Hari said she gave him a picture of how to work with them.
“It’s just the way people work. Companies should participate in these discussions,” Ms. Hari said. “He is very passionate about Make America Healthy again, but he is also very flat. He will understand a solution that is possible for everyone to change our food system.”
Julie Creswell They contributed reports.
