The events of September 11, 2001, reinforced the need to enhance the security of the United States.  Since then Congress passed several laws to better prepare the nation that effect FDA.

In particular, on June 12, 2002 the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) was signed into law.  In 2004 section 564 of the Federal Food, Drug and Cosmetic Act (21 U.S.C 360bbb-3) was amended by the Project Bioshield Act of 2004 (Public law 108-276).

FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A (Protection of Food Supply) and Subtitle B (Protection of Drug Supply).

Public Health Emergencies are a concern of the US Department of Health and Human Services