In 2026, the U.S. Food and Drug Administration (FDA) marks its 120th anniversary, commemorating more than a century of service as a cornerstone of public health protection in the United States. Since its establishment in 1906, the FDA has played a central role in safeguarding the quality, safety, and effectiveness of products that Americans rely on daily. Over time, the agency has evolved in scope and responsibility, responding to scientific progress, public health challenges, and societal needs while maintaining a consistent mission to protect and promote public health.
Origins and Historical Development
The FDA traces its origins to the passage of the Pure Food and Drugs Act of 1906, a landmark law enacted to address widespread concerns about adulterated and misbranded foods and medicines. This legislation laid the foundation for federal oversight of consumer products affecting health and safety.
Over subsequent decades, Congress expanded the FDA’s authority through additional statutes, reflecting lessons learned from public health crises and advances in science. These developments strengthened regulatory standards for food, drugs, medical devices, and other products, establishing a system designed to ensure that products entering the marketplace meet rigorous requirements for safety and quality.
Evolution into a Modern Regulatory Authority
From its early focus on food and drug integrity, the FDA has grown into a comprehensive regulatory agency overseeing a broad range of products, including human and veterinary drugs, biologics, medical devices, foods, cosmetics, and tobacco products. This expansion has been accompanied by the development of sophisticated scientific review processes and regulatory frameworks that integrate research, surveillance, and enforcement.
The FDA’s modern structure reflects its dual responsibility: protecting the public from unsafe or ineffective products while facilitating innovation by providing clear and science-based pathways for product development and approval.
Major Regulatory Achievements
Throughout its history, the FDA has been associated with significant milestones in public health protection. The agency established premarket review requirements for drugs, ensuring that new medicines demonstrate safety and effectiveness before approval. It later introduced structured pathways for biologics and medical devices, adapting regulatory approaches to the unique characteristics of these technologies.
The FDA has also played a critical role in strengthening food safety standards, implementing preventive controls, and responding to outbreaks of foodborne illness. These efforts have contributed to transforming the U.S. marketplace into a system widely regarded as a global benchmark for regulatory oversight.
Drug, Biologic, and Device Approvals
A central function of the FDA is the evaluation and authorization of medical products. Through rigorous scientific review, the agency assesses evidence from laboratory studies, clinical trials, and manufacturing data to determine whether products meet established standards.
Over the decades, this process has enabled the introduction of therapies that have significantly improved survival and quality of life across many diseases. The FDA has continually refined its review pathways to incorporate scientific advances, including mechanisms designed to address unmet medical needs while maintaining regulatory integrity.
How the FDA Transformed Public Health Over 120 Years
Building on its regulatory foundation, the FDA has fundamentally reshaped public health in the United States by transitioning the nation from a largely unregulated marketplace to a science-driven system centered on prevention, safety, and accountability. This transformation has influenced nearly every aspect of daily life and health outcomes.
From Reactive Oversight to Preventive Protection
In the early twentieth century, federal involvement in public health was limited, and regulatory action often followed widespread harm. Over time, the FDA shifted toward a preventive model by requiring evidence of safety and effectiveness before products reach consumers. This approach significantly reduced exposure to harmful foods, ineffective medicines, and unsafe medical products, establishing prevention as a defining principle of modern public health protection.
Strengthening Confidence in Medicines and Therapies
A major outcome of FDA regulation has been the establishment of public trust in medical products. Prior to federal oversight, medicines were frequently marketed without proof of benefit or standardized production. The FDA’s evolving approval frameworks introduced scientific evaluation, clinical evidence requirements, and post-market monitoring, providing assurance to patients and clinicians that approved therapies meet consistent standards and contribute meaningfully to improved health outcomes.
FDA Grants Orphan Drug Designation to Gotistobart in Squamous NSCLC
Advancing Food Safety and Nutrition
The FDA’s work in food regulation has had a sustained impact on population health. Through measures aimed at preventing contamination, improving labeling accuracy, and reducing foodborne illness, the agency has strengthened the safety of the food supply. Transparent nutrition and ingredient information have further enabled informed consumer choices, reinforcing the FDA’s role in both protection and public education.
Responding to Emerging Public Health Challenges
As science and technology advanced, the FDA adapted its regulatory oversight to address emerging areas such as biologics, complex medical devices, and novel manufacturing processes. The agency developed flexible regulatory pathways to respond to public health emergencies while preserving scientific rigor, reinforcing its role as a central authority during periods of rapid change.
Elevating Public Health Standards Globally
Over time, FDA regulatory standards for safety, quality, and effectiveness have gained international recognition. These standards have influenced global regulatory practices and served as reference points for health authorities worldwide, extending the FDA’s public health impact beyond U.S. borders.
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Long-Term Impact on Population Health
Collectively, the FDA’s actions over 120 years have contributed to measurable improvements in public health, including reduced exposure to unsafe products, broader access to effective therapies, and enhanced disease prevention. While many factors shape population health, the FDA’s evolution has been central to creating an environment in which science-based regulation supports longer life expectancy and improved quality of life.
Commitment to Science, Workforce, and Public Trust
Science has remained the foundation of FDA decision-making since its inception. The agency’s multidisciplinary workforce evaluates emerging technologies, monitors product performance, and responds to evolving risks. Transparency and evidence-based standards continue to underpin public confidence in the regulatory system.
Reflecting on its anniversary, the FDA shared the following message on LinkedIn
“This year – 2026 – marks FDA’s 120th anniversary serving as the backbone of public health protection and promotion in America.
Since 1906, the FDA has transformed an unreliable marketplace into a gold standard regulatory system Americans depend on every day for food, medicine, medical devices and more.
Today, Americans are safer, healthier, and living longer thanks to the vigilance and dedication of FDA staff and the work we do every day.”
Continuing Role in Public Health Protection
As the FDA enters its next century of service, its responsibilities continue to evolve alongside scientific progress and emerging public health challenges. While the tools and technologies under its oversight have changed significantly since 1906, the agency’s core mission remains unchanged: protecting public health through science-based regulation.
Written by Nare Hovhannisyan, MD