Eye on FDA

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.

Yesterday, 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 inaugural health report titled, Make Our Children Healthy Again, delivering one of the first widely anticipated deliverables from the MAHA Commission Executive Order issued earlier this year and noted in our prior alert. The 72-page assessment examines the rising rates of childhood chronic disease in the country—including obesity, heart disease and diabetes—and explores potential contributing factors. Specifically, the report identifies and focuses on four potential drivers:

On November 19, 2024, FDA issued a request for information (RFI) on per-and polyfluoroalkyl substances (PFAS) in seafood. Specifically, the agency is seeking scientific data and information from the seafood industry and other stakeholders and experts (e.g., academia, state and other federal agencies), on PFAS concentrations in seafood, the surrounding environment and processing water. The agency is also looking for mitigation strategies for reducing exposure to PFAS in seafood.