The purpose of this project was to evaluate the performance of the program against its primary objective of determining compliance of imported foods with the requirements of the Federal Food, Drug, and Cosmetic Act and the food and color additive regulations. The performance of this compliance program was evaluated based on data collected by the Food and Drug Administration (FDA) field offices in FY 2004 from analyzing samples of imported food products for food and color additive violations. The study found continued high violation rates in 2004 for undeclared sulfites (45 percent), cyclamates (45 percent), and coumarin (36 percent). The violation rates for all targeted food and color additives were 44 percent and 58 percent, respectively. The report makes a number of recommendations: (1) Target cyclamates in all foods, not just mixed fruit products; (2) Target 3-MCPD (a carcinogenic impurity) in Asian-style sauces and acid-hydrolyzed protein; (3) Target unsafe herbal and other dietary supplement- type ingredients in conventional foods; (4) Spend more resources on medium and high risk violations (e.g., unapproved color additives such as Sudan I) and less on low risk problems (e.g., undeclared color additives that are approved for food use); (5) Use moderate surveillance program with focus on problems identified by foreign food-control authorities (e.g., the illegal color additive Sudan I); (6) Delete undeclared benzoates, sorbates, and nitrates/nitrites as violations that should be targeted; (7) Keep abreast of software for finding food and color additive violation trends; (8) Determine whether betel nuts are still being offered for import; (9) Implement an equivalent of the EC’s Rapid Alert System.
PIC ID: 8247; Agency Sponsor: FDA-CFSAN, Center for Food Safety and Applied Nutrition; Federal Contact: Zajac, Andrew, 301-436-1267; Performer: FDA, Center for Food Safety and Applied Nutrition, Washington, DC