The new director of the Food and Drug Administration, which regulates prescriptions for toddlers, has been a corporate lawyer in recent months defending top formula manufacturers over allegations that the product has produced debilitating harm to premature babies.
Kyle A. Diamantas joined the FDA last month, leading the food division and left law firm Jones Day.
As a partner at Jonesday's Miami office, Diamantas' recent study included the Abbott Institute's defense in a lawsuit accusing the professional formula of preterm births of failing to properly warn parents that it was linked to an increased risk of fatal intestinal conditions.
Abbott lost his lawsuit and was ordered to pay $495 million. Abbott is suing the verdict. Diamantas' role in that case and other Abbott cases have not been previously reported.
The FDA's food sector leaders play a broad role in ensuring the safety of approximately 80% of the US food supply. In that job, Diamantas is also expected to play a leading role in enacting Robert F. Kennedy Jr.'s Agenda Secretary of Health.
“We will close the rotating doors to reestablish public trust,” Kennedy told Department of Health and Human Services staff in his first week of office.
Diamantas' choice to run the food sector hit Rosa Delauro, who has been working on the issue of prescribing infants as “betrayal.” She has focused on prescribing for toddlers since 2022, when major formula shortages began after Abbott temporarily closures of Michigan's formula plant amidst the discovery of unsanitary conditions.
“The FDA's job is not to protect our babies, but to protect our babies,” Delauro, a Connecticut Democrat, said in a statement sent to the New York Times in an email. “Appointing Abbott's attorney to oversee food safety, including prescriptions for toddlers, is to protect the chickens to Fox security guards.”
Diamantas did not respond to a request for comment. The FDA said he would comply with routine ethical agreements with the agency. This includes pledging to reject yourself from certain issues related to Abbott and another prominent Jonesday client, British-American tobacco. Officials from the Department of Health and Human Services refused to make Diamantas' ethics agreement available to the Times.
“Mr. Andrew Nixon shares Secretary Kennedy's vision to continue the FDA's overall mission to improve nutritional supply outcomes, ensure food supply is safe and healthy, and to protect and promote the FDA's public health.
The FDA did not make a formal announcement about Diamantas' role, but on February 24, the agency posted a web page calling him a “top food executive” that listed him as a vice-committee on human food. He also represents the institution in transactions between foreign governments and the White House.
Before he joined Jones Day in 2021, Diamantas (who was also shown hunting with the president's son Donald Trump Jr. in social media photos) worked for another law firm. So he defended a cannabis company called cannabis bombs against claims about CBD products derived from the cannabis plant. He also defended Whole Foods Markets in a lawsuit alleging that they sold CBD products that users misunderstood to believe they would reduce pain.
The FDA has taken the position that CBD is not safe to add to food supplies, and is chasing businesses in situations where it is deemed high risk. The agency has begun efforts to decide how to regulate CBD, but concluded in early 2023 that Congress should intervene.
Fatal intestinal conditions associated with preterm infant formulas have been debated in hundreds of lawsuits in the FDA. Many argue that Abbott did not warn his parents of the great risk of infection that arises when a very low-weight baby (less than about 3.5 pounds) is given in place of breast milk.
Diamantas was granted representation of Abbott in March 2024 in three infantry ceremonies filed in Missouri Court, court records show. In two cases, his role was described in court records as representing two Abbott salespeople.
He is Margo Gillv. He didn't talk to the ju judge at Abbott's high-profile trial. This ended with the ju apprentice imposing $95 million in compensation and $400 million in punitive damages.
The case centers on whether Abbott properly warned that very low-weight babies fed infant formula were facing an increased risk of intestinal conditions called necrotizing enteritis, or an increased risk of NEC.
At six weeks of age, Gil's daughter developed NEC about 24 hours after being given formula. According to court testimony seen on the Court View Network, she left the Neonatal Intensive Care Unit (NICU) after extensive gut and brain damage. Gil testified at 3am during the trial that her daughter was unable to talk, walk or eat without a feeding tube.
Abbott did not claim that Mr. Gill had been warned. At a July trial, Gill's lawyer, Jake Platternberger, presented an Abbott document inside the ju-degree judge that the infant formula is “are considered a factor that contributes to the development of the NEC.”
He also told the ju umpire that about 90% of preterm babies who achieved this condition were given formula. He presented a study of 1,800 preterm babies and concluded that formulated milk intake increases the risk of developing 180% of NEC.
James F. Hurst, Abbott's chief trial lawyer, argued that the formula did not cause any conditions. This product is usually used in hospitals and is labelled “institutional use only” and “used as per doctor's instructions.” In a slide presented to the ju judge, Mr. Hearst wrote:
He also argued that the cascade of injuries sustained by Gill's daughter, including brain damage, was associated with other factors, such as her birth complications and very low oxygen levels.
“These immature infant formulas and breast milk forts are part of standard care for premature babies, which have been in safe use for 45 years and are nourishing generations of NICU babies,” Abbott said in a statement Monday.
On July 26th, the ju judge took on Gill's side and awarded nearly 5 billion to his family. Soon after, Abbott's chief executive, Robert B. Ford, publicly warned that it may be necessary to halt sales of some formulas for preterm babies.
Ford turned to the FDA three days after the verdict, set records and met with FDA committee member Dr. Robert Caliph and others.
Soon, officials from the FDA and two other health agencies began to work quickly on the consensus statement on the NEC. Those familiar with the process said those who requested anonymity to discuss the dialogue had asked the formula company to prepare a consensus statement but did not direct what it said. Some working group members had relationships with Abbott, including accepting speaker fees, not specifically outlined in the final report, the record shows.
On October 3, the Health Department released its conclusions. “1) There is no conclusive evidence that preterm babies cause NEC. 2) There is strong evidence that breast milk is protected against NEC.”
The statement reflects Abbott's position in court and is expected to support formula makers in the future. Since Gill's verdict, another similar lawsuit ended with a $60 million verdict in favour of the family, with another case bringing the Formula Maker victory.
The FDA's food sector handles countless other issues in its role in regulating most of its food supply. In infant formula, the department is trying to keep Abbott and other companies at high standards after inspectors at Abbott's Michigan plant discovering evidence of roof leaks, water leaks and deadly bacteria. The plant was closed due to an overhaul, causing a few months of infant formula deficiency in 2022 when parents scrambled.
The food department is also leading the investigation into foodborne diseases and working with state and other federal officials to use high-tech tools to link sick patients to contamination on edible plants and vegetable farms. The department is also rolling out rules that make it easier for farmers to follow food through the supply chain and to prevent irrigation water from spreading bacteria on crops.
Kennedy outlined the agency's other priorities, including scrutinizing chemical additives in food. At least one influential supporter of Kennedy considers Diamantas' experience an asset.
During the inauguration weekend, Vani Hari, a clean dining activist known online as The Food Baby, said he met and chatted with Diamantas at three different events. For the first time, his wife leaned down and told Hari that she had been a follower of her blog for years.
“He's all involved to change how the regulatory system works,” Hari said. Rather than viewing work with Abbott and other companies as a potential conflict of interest, Hari said it gave them insight into how they can work with them.
“It's the way the world works. Companies will have to be involved in these discussions,” Hari said. “He's very passionate about exercising again for American health, but he's also very flat. He'll understand a viable solution for everyone who can change our food system.”
Julie Creswell reported.
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