Traces of Melamine Found in U.S. Infant Formulas

The Food and Drug Administration (FDA) acts as our airport security for food products and pharmaceuticals being manufactured and distributed in the United States. When China’s outbreak of melamine—a chemical used in plastics that is common in packaging as well as sanitization—found in infant formula and the cause of up to 3 recorded infant deaths (and 5 others under investigation) and leaving 50,000 children ill since September 2008, tensions have run high within the FDA. To keep track of all recalled items that may contain the harmful chemical, the FDA has been working hard to test and retest companies within the United States that produce infant formula to make sure melamine and its related content has not been found in order to ensure the safety of American families.

The last press release from the FDA about the melamine scare was updated on November 13,  which the FDA states that they were unable to detect any level of melamine or any chemical related to melamine (such as cyanuric acid) that, “does not raise public health concerns.” The FDA blames this lack of knowledge on gaps in scientific evidence to support the toxicity level in infants because the variables are not consistent. The unknown variables are the consequences of infant formula as the only nutrition source for the children, the possibility of multiple melamine compounds being absorbed into the body simultaneously, and the unknown effects of contaminated infant formula ingested by premature babies whose kidneys are not yet fully developed and therefore could be at a greater risk for failure through exposure to any level of melamine amounts.

The FDA sums up its report by saying, “There is too much uncertainty to set a level in infant formula and rule out any health concern.  However, it is important to understand this does not mean that any exposure to any detectable level of melamine and melamine –related compounds in formula will result in harm to infants.”

Since September, the FDA has been conducting tests of 77 popular infant formulas and in results only recently acquired by The Associated Press three manufacturers have been put under the microscope with positive results. Either melamine or cyanuric acid—a chemical related to melamine—have been found in miniscule amounts in one or more products by three major manufacturers, Abbott Laboratories, Nestle, and Mead Johnson, who make up 90 percent of the domestic production of infant formulas.

Director of the Center for Food Safety and Applied Nutrition at the FDA, Dr. Stephen Sundlof, contends that there is no immediate concern and in the best interest of the babies, parents should continue to use the intended formula that works best for their child and they should not be changing their diet because of extremely low traces of a potentially dangerous chemical.

Since there have been no reports of illness due to infant formla or melamine content, which causes binding qualities when mixed with urine and can cause kidney or bladder stones or in extreme cases result in kidney failure, the cause for concern is staying low within the FDA.

In an interview with the Associated Press this week, Sundlof says the positive results are very low and should not result in panic, "[the amounts] so far are in trace range, and from a public health or infant health perspective, we consider those to be perfectly fine." Sundlof fends off questions of unsafe infant formula by redirecting the FDA's original November 13th stance that no level of melamine was able to be determined as safe, and assures that the FDA never implied U.S. made formula could be entirely free of melamine and that he wasn't sure if the FDA's statements had been misinterpreted.

Of the three companies in question, the products that tested positive for melamine or cyanuric acid were: Mead Johnson's Infant Formula Powder Enfamil LIPIL with Iron, Nestle's Good Start Supreme Infant Formula with Iron, and for very sick babies Nestle’s Peptamen Junior medical food and Nestle’s Nutren Junior-Fiber, but there is no recall just yet. Although 18 samples of popular brand Similac returned no results for the FDA, spokesman Colin McBean said their individual company tests did turn up with the chemical. The manufacturers agree that the amounts are very small and should not be compared to the amount found throughout China’s formula, noting that the results in the United States are 10,000 times smaller and comparable to finding one drop in a 64-gallon container.

The major distinction between these reports in United States and China is one of intention. China’s melamine contamination was intentionally done to trick the amount of protein the formula actually contained whereas the United States traces were only found in the manufacturing process because melamine is found in formulas used to clean equipment as well as inside some packaging, for instance inside can liners, and we now know that it can leak out into the products. Without knowing the long term effects of melamine and cyanuric acid on the body, more tests will need to be conducted as to whether or not melamine should be allowed to continue to be part of the manufacturing process and the FDA should be setting stricter rules on regulating future contamination scares.