1. New FDA Head Kyle Diamantas: A Corporate Lawyer’s Controversial Appointment
Kyle Diamantas, the newly appointed head of the FDA’s food division, has sparked controversy due to his background as a corporate lawyer. Previously a partner at Jones Day, Diamantas defended Abbott Laboratories against claims that their infant formula caused necrotizing enterocolitis (NEC) in premature babies. His transition from representing a major formula manufacturer to regulating the industry has raised eyebrows, with critics concerned about potential conflicts of interest. Despite these concerns, Diamantas is tasked with overseeing the safety of 80% of the U.S. food supply, including infant formula. His appointment, while controversial, highlights the revolving door between corporate law and government regulation.
2. Abbott Laboratories and the NEC Lawsuits: A Background
Abbott Laboratories faced numerous lawsuits alleging their infant formula caused NEC, a severe bowel condition. Notably, the case of Margo Gill resulted in a $495 million verdict against Abbott. Diamantas was involved in defending Abbott, though he did not address the jury. The case emphasized Abbott’s alleged failure to warn parents of NEC risks, with internal documents suggesting formula as a contributing factor. The verdict led Abbott’s CEO to warn of possible product withdrawals. This background underscores the challenges Diamantas may face in balancing industry interests with public health.
3. The Role of the FDA’s Food Division and Diamantas’s Responsibilities
The FDA’s food division, led by Diamantas, regulates a vast portion of the U.S. food supply. His responsibilities include implementing Health Secretary Robert F. Kennedy Jr.’s agenda, focusing on reducing food additives and addressing corruption. Critics, like Representative Rosa DeLauro, argue Diamantas’ appointment may prioritize corporate interests over public health. Despite these concerns, Diamantas is expected to uphold FDA’s mission, including handling high-profile crises such as the 2022 infant formula shortage. His role in shaping food safety policies will be crucial.
4. Ethical Concerns and Potential Conflicts of Interest
Diamantas’ transition from corporate law to FDA regulation raises ethical issues. He will recuse himself from Abbott and British American Tobacco cases, but transparency regarding his ethics agreement is lacking. While some defend his corporate experience as valuable insight, others fear it could sway decisions. The FDA’s defense of his appointment highlights his alignment with Kennedy’s vision, but ethical concerns persist.
5. The FDA’s Stance on Infant Formula Safety and NEC
The FDA recently issued a statement that there’s no conclusive evidence linking infant formula to NEC, aligning with Abbott’s defense. This stance may influence future lawsuits. The agency also emphasized human milk’s protective effects. While this aligns with Abbott’s position, the FDA continues to monitor formula safety, investigating manufacturing practices and foodborne illnesses. These efforts aim to prevent crises like the 2022 formula shortage.
6. Reactions to Diamantas’s Appointment and Future Implications
Reactions to Diamantas’ appointment are mixed. Activist Vani Hari sees his corporate experience as an asset, believing he can work effectively with companies. Others, like Representative DeLauro, remain skeptical. As Diamantas navigating this critical role, his decisions will impact public trust and corporate influence in regulation. The FDA’s credibility hangs in the balance, making his leadership a pivotal moment in food safety regulation.
