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Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The FSMA also recognizes the increasing importance of imported food and enhances the ability of the FDA to safeguard the U.S. food supply from hazards originating abroad.

The act achieves its prevention objectives through requiring food production facilities to establish preventive control plans and by increasing inspection frequency—a shortcoming of the FDA in recent years. The act also enhances the FDA’s ability to respond to food safety problems when they occur. Through pilot projects on food tracing systems and an enhanced surveillance system, the FDA will be have better tools to determine the source of outbreaks. Additionally, the act gives the FDA new mandatory recall authority—a badly needed addition to its enforcement capabilities. In an increasingly globalized food environment, the FSMA gives the FDA new authority to regulate imported food. Among other provisions, the act allows FDA to inspect foreign facilities and to partner with foreign food regulatory agencies to help build capacity.

Through new tools and increased enforcement, the FSMA holds great promise for public health. The act, however, leaves several regulatory gaps, including keeping the food safety functions of the USDA and FDA separate. Additionally, the potential of the act to improve food safety may be thwarted by inadequate funding in the current budget environment.

The act includes numerous programs for building the capacity of domestic and foreign regulators and food producers. Such programs are essential to an improved food safety system, but require adequate funding from Congress to be fully implemented. In addition to national capacity building, FDA and Congress should fully engage partners in government and industry to improve global food safety at the international level.

Publication Citation

JAMA, June 14, 2011,