Eye on FDA

On July 25, the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA), unveiled the highly anticipated joint request for information on ultra-processed foods (UPFs). Specifically, the administration is seeking information and data to help develop a uniform definition for UPFs in the U.S. food supply.

Dr. George Tidmarsh has been selected to replace Dr. Jacqueline Corrigan-Curay as the director of the Center for Drug Evaluation and Research (CDER) at FDA as she prepares to retire from the agency. Dr. Tidmarsh is an adjunct professor of pediatrics and neonatology at Stanford University and is credited as having been involved in the development of several approved drugs. Until late May of this year, Dr. Tidmarsh was a member of the board of directors of Revelation Biosciences, a company engaged in developing an anti-inflammatory IV therapy. Among other roles and experiences he has had, he was a founding Co-Director of Stanford’s Master of Science in Translational Research and Applied Medicine (M-TRAM) program, and founded Horizon Pharma in 2005.

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon launch an advertising campaign encouraging Americans to use wearable health devices. The campaign is set to be “one of the biggest advertising campaigns in HHS history.”

Last week, the U.S. Food and Drug Administration (FDA) released two educational videos and a supplemental fact sheet to guide dietary supplement manufacturers and distributors through the New Dietary Ingredient Notification (NDIN) review process. Under Section 413 of the Federal Food, Drug, and Cosmetic Act, manufacturers and distributors must submit an NDIN to notify FDA before marketing a dietary supplement with a new dietary ingredient. These resources offer guidance on structuring submissions and outline what to expect during the agency’s review. Ultimately, they are intended to enhance the quality of NDIN submissions and minimize common pitfalls, with the goal of avoiding delays or unfavorable results in the agency’s review.

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory developed tests (LDTs), titled Medical Devices; Laboratory Developed Tests (the LDT Rule). The LDT Rule would have required laboratories to ensure that their offered LDTs met medical device requirements under a multistage phase out of Food and Drug Administration’s (FDA) enforcement discretion policy. While the government’s decision not to appeal this ruling may not have been a surprise, questions remain as to how FDA plans to clarify its policy towards lab test offerings going forward.

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as Secretary Kennedy and the Food and Drug Commissioner Dr. Makary have started to testify before Congress on the FY26 budget and the House and Senate Appropriations Committees are moving forward with their annual appropriations work. Further still, the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies is scheduled to markup their FY26 Ag-FDA Approps bill later this week.

In the last two weeks, the Department of Health and Human Services (HHS) has filled key artificial intelligence (AI) positions at HHS and the U.S. Food and Drug Administration (FDA). These appointments, as well as recent statements from HHS and FDA leadership, align with the Trump administration’s intention to use AI to improve regulatory efficiency at HHS and beyond.

This week, the U.S. Food and Drug Administration (FDA), in collaboration with the Department of Health and Human Services (HHS), announced a series of new measures to phase out all petroleum-based synthetic dyes in food by the end of 2026. This initiative is part of the broader “Make America Healthy Again” (MAHA) agenda aimed at bolstering food safety. Citing growing concerns about the potential role of petroleum-based food dyes in childhood diabetes, obesity, depression and attention-deficit/hyperactivity disorder (ADHD), the agency plans to establish a national standard and timeline for the food industry to transition to natural alternatives.

On April 10, 2025, the Food and Drug Administration (FDA) announced its plan to replace animal testing in the development of monoclonal antibody therapies and other drugs in one of the first announcements by the agency since Commissioner Makary was confirmed to lead it. In its announcement, FDA highlighted that this more modern approach is designed to improve drug safety and accelerate the evaluation process, while also reducing animal experimentation, lowering research and development costs, and lowering drug prices.