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Introduction - Enforcement Story 2006


The year 2006 can be distinguished as a year of transformation, highlighted with centennial celebrations commemorating FDA’s remarkable history as a world leader in public health. Protecting and advancing public health is our legacy and it is our continuing commitment to all Americans in the 21st century. Being entrusted to enforce our public health laws and regulations is both a challenge and an honor for the men and women of FDA.

The Office of Regulatory Affairs (ORA) is undertaking our most significant transformation, an unprecedented effort to revitalize every aspect of our organization. This transformation is vital, as we honor our proud history and prepare for the challenges and opportunities that lie ahead. ORA will become a more dynamic, flexible, and responsive organization, prepared and positioned to accomplish our mission and realize our vision:

Mission: ORA protects consumers and enhances public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.

Vision: All food is safe; all medical products are safe and effective; and the public health is advanced and protected.

The domestic and import enforcement actions in 2006 cover all areas of product jurisdiction. Many of these actions were taken to protect public health in one or more of the following areas: preventing noncompliant products from entering the market, detecting noncompliance, and intercepting noncompliant products.

As you view the statistics and read the articles, I hope you will share my pride for all that was accomplished in 2006. Over and above the information presented herein, FDA’s investigative and compliance staffs, through skill, communication, persuasion and hard work also protected public health through less formal compliance approaches, leveraging industry’s cooperation and objective to comply voluntarily. Overall, our multi-dimensional compliance efforts have been remarkable and the public health protection and advancements that have been realized are now a matter of record. We now must look forward with courage and resolve to conquer tomorrow’s challenges.

It is my pleasure to present The Enforcement Story of 2006.



David K. Elder

Director, Office of Enforcement

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