China Estimates 300,000 Infants Sickened by Melamine-Tainted Formula
China has reportedly estimated that nearly 300,000 infants were sickened and six died after ingesting melamine-tainted formula linked to kidney stones and renal failure. The government has increased the number of illnesses six-fold from its first calculations and doubled the death toll as the Health Ministry investigated fatalities purportedly involving infant formula. “The new figures are more realistic and objective than previous figures,” said one Beijing lawyer who represents several families seeking compensation and is considering the
creation of a public fund for victims. “I assume the government is worried about the situation of the dairies and is afraid the companies may fall if they have to pay compensation amid the current financial crisis. The government may be worrying about the interests of the companies first.” See Associated Press, December 2, 2008.
In a related development, the U.S. Food and Drug Administration (FDA) recently updated its safety assessment for melamine and cyanuric acid to include infant formula. The agency had previously concluded that “levels of melamine and its analogues below 2.5 [parts per million] in foods other than infant formula do not raise public health concerns,” but declined to set a safety threshold for infant formula because regulators lacked adequate information. At the time, FDA noted, this decision “was based on several factors specific to infant formula contaminated with more than one melamine analogue, such as the product represents the totality of caloric exposure for most infants, exposure is chronic over months, and the persons ingesting the products are infants and toddlers whose renal systems may not be fully developed.” Many infant formula manufacturers, however, interpreted this announcement to mean that FDA would not allow any detectable level of melamine in their products.
Once it discovered “extremely low levels” of melamine and cyanuric acid in U.S.-manufactured infant formula, FDA revised its interim assessment to set a safety level that takes into account “a worst case exposure scenario in which all of an infant’s total daily dietary intake (typically 0.15 kg powdered infant formula) is contaminated with melamine.” Based on this assumption, the agency has determined that “levels of melamine or one of its analogues alone below 1.0 ppm in infant formula do not raise public health concerns.” See Associated
Press, November 26, 2008.
