{"id":10323,"date":"2025-03-04T10:31:30","date_gmt":"2025-03-04T10:31:30","guid":{"rendered":"https:\/\/site.itshrt.com\/worldnews\/he-fought-claims-of-harm-from-infant-formula-now-he-regulates-it\/"},"modified":"2025-03-04T10:31:30","modified_gmt":"2025-03-04T10:31:30","slug":"he-fought-claims-of-harm-from-infant-formula-now-he-regulates-it","status":"publish","type":"post","link":"https:\/\/site.itshrt.com\/worldnews\/he-fought-claims-of-harm-from-infant-formula-now-he-regulates-it\/","title":{"rendered":"He Fought Claims of Harm From Infant Formula. Now He Regulates It."},"content":{"rendered":"<p> <script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<\/p>\n<div data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Kyle A. Diamantas <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/about-fda\/fda-organization\/kyle-diamantas\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">joined the F.D.A.<\/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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">As a partner in Jones Day\u2019s Miami office, Mr. Diamantas\u2019s 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Abbott lost the case and was ordered to pay $495 million. Abbott is appealing the verdict. Mr. Diamantas\u2019s role in the Abbott cases has not been previously reported.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The leader of the F.D.A.\u2019s 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.\u2019s agenda, which calls for reducing additives in food and eliminating what Mr. Kennedy has described as corruption in public health agencies.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cWe will shut the revolving door to re-establish public trust,\u201d Mr. Kennedy told the Health and Human Services Department\u2019s staff during his first week in office.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The selection of Mr. Diamantas to run the food division struck Representative Rosa DeLauro, who has worked on infant formula issues, as a \u201cbetrayal.\u201d She <a class=\"css-yywogo\" href=\"https:\/\/delauro.house.gov\/media-center\/press-releases\/delauro-calls-fda-prioritize-reducing-risk-infant-formula-vulnerable\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">has focused<\/a> 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThe F.D.A.\u2019s job is to protect our babies, not the corporations that poisoned them,\u201d Ms. DeLauro, a Connecticut Democrat, said in a statement emailed to The New York Times. \u201cAppointing an Abbott lawyer to oversee food safety, which includes infant formula, is letting the fox guard the henhouse.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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\u2019s ethics agreement available to the Times.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">\u201cMr. Diamantas shares Secretary Kennedy\u2019s vision of improving nutritional outcomes, ensuring the food supply is safe and healthy, and continuing to carry out the F.D.A.\u2019s overall mission of protecting and promoting public health,\u201d a spokesman for the department of Health and Human Services, Andrew Nixon, said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The F.D.A. did not issue a formal announcement about Mr. Diamantas\u2019 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 \u201ctop food executive.\u201d<span class=\"css-8l6xbc evw5hdy0\">  <\/span>He will also will represent the agency in dealings with foreign governments and the White House. <\/p>\n<p class=\"css-at9mc1 evys1bk0\">Before he joined Jones Day in 2021, Mr. Diamantas (who has also been shown hunting with Donald Trump Jr., the president\u2019s son, in a <a class=\"css-yywogo\" href=\"https:\/\/x.com\/osceolaoutdoors\/status\/1374805948037013504\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">photo on social media<\/a>) 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The F.D.A. has taken the position that CBD <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/consumers\/consumer-updates\/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">is unsafe to add<\/a> 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 <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">concluded that Congress<\/a> needed to step in.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 \u2014 around 3 \u00bd pounds or less \u2014 are fed formula instead of breast milk.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-3\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-4\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">At six weeks old, Ms. Gill\u2019s 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.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-5\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">Abbott did not argue that Ms. Gill had been warned, rather saying it was the doctor\u2019s 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 \u201cis thought to be a contributing factor to the development of NEC.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He also told the jury that about 90 percent of the preterm infants who got the condition had been fed formula. He <a class=\"css-yywogo\" href=\"https:\/\/www.cochranelibrary.com\/cdsr\/doi\/10.1002\/14651858.CD002971.pub5\/full#CD002971-abs-0005\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">showed a study of 1,800 preterm infants<\/a> that concluded that formula feeding raises the risk of developing NEC by 180 percent.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 \u201cfor institutional use only\u201d and \u201cuse as directed by a doctor.\u201d On a slide presented to the jury, Mr. Hurst wrote: \u201cDifferent Words On Abbott\u2019s Label (Or Anywhere Else) Wouldn\u2019t Have Changed Anything\u201d for the infant.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">He also argued that the cascade of injuries Ms. Gill\u2019s daughter sustained, including brain damage, were related to other factors, including her birth complications and very low oxygen level.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cThese 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,\u201d Abbott said in a statement on Monday.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-6\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">On July 26, jurors sided with Ms. Gill and awarded nearly half a billion to her family. Soon after, Abbott\u2019s chief executive, Robert B. Ford, <a class=\"css-yywogo\" href=\"https:\/\/www.bnnbloomberg.ca\/business\/company-news\/2024\/07\/18\/abbott-weighs-halting-specialized-baby-formula-tied-to-lawsuits\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">publicly warned<\/a> that the company might need to stop selling some formula for preterm infants.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Mr. Ford turned to the F.D.A. three days after the verdict, <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/news-events\/public-calendar-meetings-fda-officials\/public-calendar-july-28-august-3-2024\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">records show<\/a>, and met with Dr. Robert Califf, the F.D.A. commissioner, and others in the food division.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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 <a class=\"css-yywogo\" href=\"https:\/\/public3.pagefreezer.com\/content\/HHS.gov\/02-01-2025T05:49\/https:\/\/www.nichd.nih.gov\/sites\/default\/files\/inline-files\/2024.09.16_NEC_WG_report_FINAL.pdf\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">in the final report<\/a>, records show.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">On Oct. 3, the health department <a class=\"css-yywogo\" href=\"https:\/\/public3.pagefreezer.com\/browse\/HHS.gov\/02-01-2025T05:49\/https:\/\/www.hhs.gov\/about\/news\/2024\/10\/03\/fda-cdc-nih-consensus-statement-recent-advisory-council-report-premature-infants-necrotizing-enterocolitis.html\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">released its conclusion<\/a>: \u201c1) There is no conclusive evidence that preterm infant formula causes NEC; and 2) there is strong evidence that human milk is protective against NEC.\u201d<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The statement echoes Abbott\u2019s position in court and is expected to help formula makers in upcoming cases. Since the Gill verdict, another similar case ended in a <a class=\"css-yywogo\" href=\"https:\/\/www.insurancejournal.com\/news\/national\/2024\/03\/18\/765365.htm\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">$60 million verdict<\/a> in favor of a family and another case resulted in a victory for formula makers.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div data-testid=\"companionColumn-7\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The F.D.A.\u2019s food division handles myriad other matters in its role regulating the majority of the food supply. On infant formula, the division is <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/food\/hfp-constituent-updates\/fda-announces-release-long-term-national-strategy-increase-resiliency-us-infant-formula-market\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">trying to hold<\/a> Abbott and other companies to a high standard after inspectors at Abbott\u2019s Michigan plant discovered a <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2022\/05\/25\/health\/fda-baby-formula-shortage.html\" title=\"\">leaking roof, pooled water<\/a> and evidence of a deadly bacteria. The plant was shut down for an overhaul, setting off a monthslong <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2022\/05\/13\/briefing\/baby-formula-shortage-us-economy.html\" title=\"\">infant formula shortage<\/a> in 2022 that left parents scrambling.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">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\u2019s experience as an asset.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">During the weekend of the inauguration, Vani Hari, a clean-food activist known online as the <a class=\"css-yywogo\" href=\"https:\/\/foodbabe.com\/\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Food Babe<\/a>, 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cHe is all on board to change the way the regulatory system works,\u201d 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.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">\u201cIt\u2019s just the way the world works. The companies will have to be involved in these discussions,\u201d Ms. Hari said. \u201cHe\u2019s very passionate about the Make America Healthy Again movement but he\u2019s also very levelheaded. He\u2019ll figure out a solution that is feasible to everyone to change our food system.\u201d<\/p>\n<p class=\"css-798hid etfikam0\">Julie Creswell<!-- --> contributed reporting.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<p><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-6606220950177433\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- ItShrt World News -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-6606220950177433\"\r\n     data-ad-slot=\"1882483372\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<br \/>\n<br \/><a href=\"https:\/\/www.nytimes.com\/2025\/03\/04\/health\/fda-infant-formula-kyle-diamantas.html\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The new head of the Food and Drug Administration division that regulates infant formula was in recent months a corporate<\/p>\n","protected":false},"author":1,"featured_media":10324,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[3539,202,1185,502,960,232,3536,3540,3541,3538,3537,219,193,111],"class_list":["post-10323","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-science","tag-abbott-laboratories","tag-appointments-and-executive-changes","tag-babies-and-infants","tag-conflicts-of-interest","tag-food","tag-food-and-drug-administration","tag-infant-formulas","tag-jones-day","tag-kyle-diamantas","tag-necrotizing-enterocolitis","tag-premature-babies","tag-regulation-and-deregulation-of-industry","tag-suits-and-litigation-civil","tag-united-states-politics-and-government"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>He Fought Claims of Harm From Infant Formula. 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