Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humansa

On September 11,2008, FDA learned that melamine may be contained in an infant formula manufactured by a firm in China. As of September 21, 2008, FDA learned that a total of 52,857 cases of nephrolithiasis (and, in some instances, renal failure) had been reported in China linked to consumption of this contaminated powdered formula. There have been approximately 13,000 hospitalizations, and at least 3 deaths have been confirmed to date. The vast majority of illnesses involved children under the age of 3 years (82% < 2 years; 17% 2-3 years; 0.8% > 3 years; and no cases involved adults). The results of an investigation conducted in China indicated that Chinese-produced powdered infant formula was linked to these illnesses; no cases were associated with liquid infant formula. An investigation of powdered formulas was conducted nationally by China's General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and revealed contamination of powdered formulas produced by 22 companies. Test results conducted in China on samples of the powdered infant formula showed that they contained a wide range of concentrations (0.1 ppm to greater than 2,500 ppm melamine). In addition, other countries have reported detection of melamine in other product categories, such as confections and beverages. We note that there are generally available analytical methods that can reliably detect a level of 1 ppm melamine in some food matrices.