Most recent public concern and policy discussions about issues for food safety focus on surface (microbial) contamination, where substantial morbidity and mortality occurs in the United States (U.S.) each year. However, recent incidents of intentional adulteration of food with melamine have shown that harm arises not only from microbes, but from deliberately-added inappropriate substances as well. Within the U.S., the ability of regulatory bodies and food manufacturers to provide safe, high quality food to consumers is challenged by: 1) the increase in global trade, which places enormous competitive pressure on companies that, in turn, may put good quality and safe foods at risk; 2) supply chains that are longer, more complex, and international; and 3) fragmentation of the U.S. food regulatory framework, which is split among multiple agencies and levels with each frequently lacking sufficient resources. Further, if one looks at the value of all processed food sold globally—$3.2 trillion—the significance to global economies becomes obvious. This huge market is supported by a complex web of domestic and foreign food and food ingredient suppliers. Could the United States Pharmacopeial Convention (USP) help in some way? Does USP have an obligation to do what it can within its standards-setting role to protect U.S. citizens and people around the world from tainted foods and food ingredients?