Eye on FDA

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.

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets aside the Food & Drug Administration’s (FDA) final rule, Medical Devices; Laboratory Developed Tests (the LDT Rule).¹ The LDT Rule would have required laboratories offering LDTs to meet medical device requirements. The preamble to the LDT Rule provided a multi-stage phase out of FDA’s enforcement discretion policy, under which the first set of regulatory requirements would have been actively enforced beginning May 6. While many labs are breathing a sigh of relief after the publication of this order, questions remain as to how the agency will proceed and the broader implications for regulation of lab tests and in vitro diagnostics generally.

The Food and Drug Administration (FDA) has updated its website to provide new information on data integrity concerns relating to medical devices.

United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing the oversight of food ingredients to eliminate the ability of individuals and companies to self-affirm that their ingredients are Generally Recognized as Safe (GRAS). This would mark a massive shift in how new food ingredients are introduced to the market.