Eye on FDA

The White House’s Make America Healthy Again (MAHA) Commission, led by the Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., released its highly anticipated strategy outlining a multi-agency approach focused on addressing childhood chronic disease. The strategy builds on the Commission’s inaugural health assessment, a report which examined the rising rates of childhood chronic diseases in the country and identified four primary drivers: poor diet due to consumption of ultra-processed foods (UPFs), exposure to environmental chemicals; increased technological use; and overmedicalization. To combat these challenges, the strategy released on September 9, 2025, outlines a four-prong approach which provides further insight into the areas the administration sees as key areas of MAHA going forward: advancing research, realigning incentives, increasing public awareness and fostering private sector collaborations.

On September 3, 2025, the Food and Drug Administration (FDA) announced Rare Disease Evidence Principles (RDEP) with processes aimed at providing greater predictability and facilitating the development and review of drugs intended to treat rare diseases with very small patient populations and significant unmet medical needs driven by a known genetic defect. In conjunction with the agency’s announcement of the new processes jointly proposed by the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), the agency also unveiled additional information regarding eligibility and the potential for post-marketing requirements for those sponsors who participate in it.

Food dye reform has been an area of focus for the Trump administration as part of its Make America Healthy Again (MAHA) initiative, giving momentum to an effort the Food and Drug Administration (FDA) had already started by banning Red No. 3 for use in food and ingested drugs. FDA has continued to prioritize this work by taking actions to phase out the use of synthetic dyes and move to natural dyes since calling for these changes earlier this year, as discussed in our previous blog on the related announcement by the administration.

Last week, former Food and Drug Administration (FDA) Commissioner David Kessler submitted a citizen petition urging FDA to revoke the generally recognized as safe (GRAS) status of refined carbohydrates used in industrial food processing. The petition follows FDA’s and the United States Department of Agriculture’s (USDA) joint request for information (RFI) to establish a formal definition for ultra-processed foods (UPFs) and offers FDA a legal pathway to change the regulatory status of these ingredients.

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review of fluoropolymers in medical devices showed no conclusive evidence of health issues, FDA concluded that fluoropolymers are “very unlikely to cause toxicity” because of molecular size and further that they are essential for medical devices to function. As a result, “FDA’s evaluation is that currently there is no reason to restrict their continued use in devices.” This announcement will be a source of relief to the device and diagnostics industries.

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.