The Food Additives Amendment of 1958 is the foundation for the U.S. food additive regulatory program, which oversees most substances added to food. This article is a comprehensive review of the program, including original analysis of pre-and postmarket safety standards for various categories and subcategories of substances and their uses; assigning the more than 10000 substances currently allowed in human food to those categories; and analyzing the U.S. Food and Drug Administration's (FDA) review of more than 1900 petitions and notifications received from 1990 to 2010. Overall, federal agencies made approximately 40% of the 6000 safety decisions allowing substances in human food. These decisions allowed an estimated 66% of the substances currently believed to be used in food. Manufacturers and a trade association made the remaining decisions without FDA review by concluding that the substances were generally recognized as safe (GRAS). Robust premarket safety decisions are critical since FDA has limited resources to monitor potentially significant scientific developments and changing uses of a substance after it enters commerce and only has access to published data or data submitted to it. In the late 1990s, FDA moved from promulgating rules for its decisions for food contact and GRAS substances to reviewing manufacturer safety decisions and posting the results of the review on the agency's website. This shift appears to have encouraged manufacturers to submit their decisions to FDA for review but has limited public opportunity to provide input.

This paper addresses the role of governments, industry, academics, and non-governmental organizations in Food Fraud prevention. Before providing strategic concepts for governments and authorities, definitions of Food Fraud are reviewed and discussed. Next there is a review of Food Fraud activities by the Global Food Safety Initiative (GFSI), the Elliott Review in the United Kingdom, the European Commission resolution on Food Fraud, and the US Food Safety Modernization Act including the Preventative Controls Rule. Two key concepts for governments or a company are: (1) formally, and specifically, mention food fraud as a food issue and (2) create an enterprise-wide Food Fraud prevention plan. The research includes a case study of the implementation of the concepts by a state or provincial agency. This analysis provides a foundation to review the role of science and technology in detection, deterrence and then contributing to prevention.

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