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.

In March 1992, the formation of OCI began when FDA selected Terry Vermillion, a career federal law enforcement officer, to serve as the founding Director of this new law enforcement office. To accomplish this major undertaking, OCI selected experienced and trained managers, special agents, and technical and support staff from numerous federal law enforcement agencies and from within FDA. The management staff averaged over 22 years of federal law enforcement service and the special agents averaged 12 and 1/2 years of federal law enforcement experience. Today, OCI continues to hire experienced special agents from a variety of federal law enforcement agencies such as the U.S. Drug Enforcement Administration, Immigration and Customs Enforcement, the U.S. Secret Service, the U.S. Postal Inspection Service, the Federal Bureau of Investigations, and the Internal Revenue Service Criminal Investigations.

In January 1993, OCI opened its first three field offices in Kansas City, Miami, and San Diego. The special agents hired to staff these offices received OCI and FDA specific training tailored expressly toward FDA's many areas of responsibility using the facilities located at the Federal Law Enforcement Training Center (FLETC). While the agents were attending training at FLETC, OCI was required to become operational in response to reports that several consumers across the nation were claiming they had found syringes in Diet Pepsi products. OCI deployed agents from the FLETC training course to lead the investigation of this nationwide tampering scare. The United States Attorney's Offices recognized the serious ramifications of people making false tampering reports and provided their support for the OCI investigation. The resulting outcome of the investigation and the arrests of those making false tampering claims put a stop to the rash of tampering reports. In the end, over 60 individuals were successfully prosecuted for violation of the FATA.

In the summer of 1993, OCI opened three more offices in Chicago, New York and Metropolitan Washington, DC. Since opening six field offices in 1993, six resident offices and 26 domicile offices have been become operational throughout the United States and Puerto Rico.

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, prescription and over-the-counter drugs, biological products such as vaccines and blood, medical devices, cosmetics, radiation-emitting products, and more. Since 1993, OCI has investigated thousands of criminal schemes involving the distribution of potentially dangerous FDA-regulated products. These investigations have involved a wide variety of criminal conduct, including street level distribution of counterfeit, unapproved, and designer drugs, major organized illicit diversion of prescription drugs, fraudulent schemes involving ineffective AIDS, cancer, and Alzheimer cures, large scale product substitution conspiracies, application and clinical investigator fraud, and health frauds involving harmful FDA-regulated drugs and medical devices. As FDA’s criminal law enforcement arm, OCI protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.