The Office of Criminal Investigations (OCI) is the division of the FDA that conducts investigations of any suspected criminal violation of the Food, Drug, and Cosmetic Act (FDCA) and other related acts, including violations of the Federal Anti-Tampering Act (FATA) and Title 18 of the United States Code. The OCI collects evidence to prosecute violators of FDA regulations through federal or state court.
When enforcing FDA regulations, the Agency has several options. The FDA utilizes several forms of criminal sanctions when it finds a manufacturer, distributor, or importer in violation of the FDCA. Because the FDCA is a strict-liability statute, a firm in violation of the FDCA can face criminal punishment even if the firm did not intend to do engage in any criminal activity. The FDA, through the United States Department of Justice (DOJ), prosecutes violators of the FDCA and criminal sanctions can be imposed in the form of incarceration, forced relinquishment of any profits or gains that arose from criminal activity, and criminal penalties in the form of monetary fines.
The Fuerst Ittleman team works with clients to implement measures, including policies and procedures, to avoid violations of the FDCA and involvement in criminal activity. Additionally, our attorneys are there to handle FDA charges against our clients. We are experienced dealing with FDA personnel and various departments. Fuerst Ittleman’s white collar crime team, led by partners Mitchell Fuerst, Esq. and Andrew Ittleman, Esq., has the resources and skills necessary to work for our clients to ensure their rights are protected.
For more information, please contact Fuerst Ittleman at contact@fuerstlaw.com.
