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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration
day. FDA is now a federal agency under the jurisdiction of DHHS and has a staff of over 12,000 and a budget of over $3.3 billion (FDA 2010b). FDA has regulatory oversight of over $2 trillion in consumer products (FDA 2010c) and regulates over 375,000 establishments worldwide (FDA 2007; see Figure 1-1). The five centers described below provide regulatory oversight of foods, drugs, biologics, veterinary products, and medical devices. The information provided is not meant to be a comprehensive review of FDA and all its various activities but simply to highlight the breadth of the agency’s responsibilities.
Center for Food Safety and Applied Nutrition (CFSAN). CFSAN has the responsibility for safeguarding the nation’s food supply except meat, poultry, and some egg products, which are regulated by the U.S. Department of Agriculture. CFSAN also has regulatory responsibility over dietary supplements and cosmetics and for ensuring that such products are properly labeled. Premarket approvals are not required for foods, dietary supplements, or cosmetics, but premarket notifications or approvals are required for food additives and color additives. To ensure product quality, selected manufacturing or processing facilities are inspected in conjunction with FDA’s Office of Regulatory Affairs (ORA) to ensure that they are in compliance with good manufacturing practice (GMP). Other activities include monitoring the food supply for contaminants, such as melamine, dioxins, and pesticides; developing new methods to speed detection of contaminated or adulterated food; and maintaining and monitoring a database for adverse-event reporting.
FIGURE 1-1 Worldwide distribution of establishments regulated by the U.S. Food and Drug Administration. Source: FDA 2007, p. 12.