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The Food and Drug Administration's (FDA) primary mission is to protect public health by assuring the safety, efficacy, and security of human and veterinary drugs, the food supply, medical devices, and other products. IP enforcement is not part of FDA’s mission or its enforcement priorities; however, FDA carries out IP-related enforcement actions in fulfilling its mission to protect public health and safety, such as investigating criminals that traffic in counterfeit pharmaceuticals. FDA investigates illegal activity pertaining to food, drugs, medical devices, and other products because of the impact on public health.[1]

FDA’s Office of Regulatory Affairs, in collaboration with other agency components, carries out the agency’s enforcement activities. This office houses, among other entities, FDA’s Office of Criminal Investigations and the Division of Import Operations. The Office of Criminal Investigations, with six field offices and presence in 25 U.S. cities, has the primary responsibility for all criminal investigations conducted by the FDA.

The Division of Import Operations provides guidance on the agency’s import policy to FDA field staff, including at numerous ports around the country. FDA field staff that discover suspected counterfeit imports of products that are regulated by FDA would refer these to the Office of Criminal Investigations for further action. In addition, Office of Regulatory Affairs laboratories play a role by analyzing samples of suspected counterfeit products.


  1. The Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.) provides legal authority for FDA to conduct counterfeit product investigations and enforcement actions. In addition, FDA brings charges under the statute that prohibits trafficking in counterfeit goods (18 U.S.C. §2320).