The Food and Drug Administration (FDA) capped 2025 with a year-end report on Thursday, highlighting reforms, enforcement gains, and expanded collaboration aimed at improving access to safe health products while strengthening public trust in regulation.
The agency said its reform agenda focused on fixing systems that shape daily interactions with regulators, emphasizing clarity, responsiveness, and fairness without compromising science-based standards.
“Public health is a shared responsibility, and protecting it takes more than one agency working alone. Through inter-agency cordination, stakeholder dialogues, and platforms such as Coffee Meetings and Public Dialogues, the FDA opened more spaces for collaboration, listening, and shared action,” it said.
One major milestone was the opening of the Food and Drug Action Center, which consolidated frontline services and provided a more accessible venue for guidance, inquiries, and regulatory assistance.
To ease the burden on stakeholders while systems were being strengthened, the FDA temporarily suspended selected fees and rolled out targeted support for micro, small, and medium enterprises, as well as local manufacturers.
The agency also pushed forward with digital transformation, upgrading payment and processing platforms to improve transparency, accountability, and efficiency in regulatory transactions.
These reforms were supported by sustained information campaigns, media engagements, and stakeholder briefings.
“Through these engagements, the FDA brought regulatory and advisory services directly to communities, providing on-site consultations and information campaigns on product safety and regulatory compliance,” the statement read.
Alongside reform, the FDA intensified inspection and enforcement activities to prevent unsafe and unregistered products from reaching consumers in physical markets and online platforms.
Through the Field Regulatory Operations Office, regional field offices, and enforcement units, the agency carried out coordinated nationwide inspections and post-market surveillance in partnership with local governments, law enforcement, and other stakeholders.
The FDA reported conducting more than 22,000 post-market surveillance activities and inspecting 17,348 licensed and unlicensed establishments throughout the year.
Weekly nationwide operations enforced advisories against unregistered, counterfeit, and unsafe products, supported by on-site actions such as inventory checks, sealing, segregation, and product verification.
To address risks in e-commerce, the agency strengthened oversight of online marketplaces, documenting 1,174 cases that led to 876 confirmed takedowns and a reported compliance rate of 74 percent following intervention.
Beyond enforcement, the FDA expanded community outreach by supporting the Lab for All initiative and other on-ground activities that brought regulatory and advisory services directly to communities.
“By meeting people where they are, the FDA improved access to regulatory guidance for consumers and small businesses,” the agency concluded.
