Abstract

http://ssrn.com/abstract=1865442
 
 

References (7)



 


 



Food and Drug Administration Regulation of Food Safety


Katie F. Stewart


Georgetown University Law Center - O’Neill Institute for National and Global Health Law

Lawrence O. Gostin


Georgetown University - Law Center - O'Neill Institute for National and Global Health Law


Journal of the American Medical Association (JAMA), June 14, 2011
Georgetown Public Law Research Paper No. 11-88
Georgetown Law and Economics Research Paper No. 11-10

Abstract:     
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.

Number of Pages in PDF File: 3

Keywords: Food Safety, FDA, Food Safety Modernization Act, Food-Borne Illness

JEL Classification: I18, K32, K23, Q18

Accepted Paper Series


Download This Paper

Date posted: June 19, 2011  

Suggested Citation

Stewart, Katie F. and Gostin, Lawrence O., Food and Drug Administration Regulation of Food Safety. Journal of the American Medical Association (JAMA), June 14, 2011; Georgetown Public Law Research Paper No. 11-88; Georgetown Law and Economics Research Paper No. 11-10. Available at SSRN: http://ssrn.com/abstract=1865442

Contact Information

Katie F. Stewart
Georgetown University Law Center - O’Neill Institute for National and Global Health Law ( email )
600 New Jersey Avenue, NW
Washington, DC 20001
United States
Lawrence O. Gostin (Contact Author)
Georgetown University - Law Center - O'Neill Institute for National and Global Health Law ( email )
600 New Jersey Avenue, NW
Washington, DC 20001
United States
202-662-9038 (Phone)
202-662-9055 (Fax)
Feedback to SSRN


Paper statistics
Abstract Views: 1,090
Downloads: 131
Download Rank: 126,901
References:  7

© 2014 Social Science Electronic Publishing, Inc. All Rights Reserved.  FAQ   Terms of Use   Privacy Policy   Copyright   Contact Us
This page was processed by apollo3 in 0.360 seconds