The Office of Criminal Investigations (OCI) was established to provide the US Food and Drug Administration (FDA) with a specific Office to conduct and coordinate Criminal investigations. OCI special agents employ customary federal law enforcement methods and techniques in the investigation of suspected criminal violations of the Federal Food, Drug, and Cosmetic Act, the Federal Anti-Tampering Act, and other related federal statutes. OCI investigations concentrate on significant violations of these laws, with a priority on conduct that may present a danger to the public health. OCI is a relatively small agency, employing approximately 180 Special Agents.
The FDA regulates approximately 25 cents of every dollar spent annually by American consumers. FDA is responsible for regulating products to ensure the safety of foods, drugs, biological products, medical devices, cosmetics, radiation-emitting devices, and more. As the law enforcement arm of FDA, the Office of Criminal Investigations conducts and coordinates criminal investigations regarding possible violations of the laws which regulate these products.
Pursuant to its investigative mission, OCI maintains liaison and cooperative investigative efforts with various federal, state, local, and international law enforcement agencies. OCI is designated by the Commissioner as the Agency’s point of contact with the U.S. intelligence community as it relates to the Agency's counter-terrorism mission. OCI has representation at the Interpol U.S. National Central Bureau in Washington, D.C.
In 1991, in the wake of the generic drug scandal, the Commissioner of Food and Drugs announced the establishment of an Office of Criminal Investigations (OCI) within the Food and Drug Administration (FDA). This newly created law enforcement office, which was created with the support and urging of FDA's Congressional Oversight Committee, would conduct and coordinate criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), the Federal Anti-Tampering Act (FATA), other related acts, and applicable violations of Title 18 of the United States Code.