About FDA

Office of Criminal Investigations, Duties and Functions

The Office of Criminal Investigations (OCI) was established to provide the 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.

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. Such violations include:

  • Manufacture and sale of counterfeit or unapproved drugs
  • Illegal diversion of pharmaceuticals and other regulated products
  • Prescription Drug Marketing Act violations
  • Off-Label promotion of FDA approved drugs and medical devices
  • Health fraud -  schemes involving fraudulent treatments/cures/devices
  • New drug application fraud
  • Clinical investigator fraud
  • Product substitution crimes
  • Product tampering
  • Crimes affecting the safety/integrity of the nation’s blood supply
  • Crimes involving the adulteration and/or misbranding of food
  • Internet facilitated criminal violations involving FDA regulated products
  • Illegal importation of FDA regulated products
  • Crimes involving the manufacture, sale or distribution of unapproved FDA regulated 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, DC.

Page Last Updated: 08/13/2014
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