FDA: Some Amounts of Melamine Are Safe
In a surprising turnaround, the U.S. Food and Drug Administration (FDA) reversed its statement in October that said any amount of exposure to melamine, no matter how small, is not safe for infants.
On Friday, Nov. 28, the FDA announced that trace amounts of melamine (or its by-products) found in infant formula produced by the three biggest American manufacturers were safe. It then proceeded to set an “acceptable” level of melamine in infant formula: 1 part per million.
The new threshold is identical to the standards announced in October by health authorities in Canada and China. This standard accepts a melamine content that is much greater than the levels detected in the US-made formulas.
According to the FDA, there is a difference between food having trace amounts of melamine and food having amounts of cyanuric acid, a chemical by-product of melamine. If separately present in food, neither chemical will cause harm. But if the two chemicals are together, this leads to formation of crystals that cause kidney damage. The FDA standard requires that the two chemicals should not be present together.
The first reports of melamine contamination in U.S.-made infant formula first came out Tuesday, Nov. 25, involving only one American manufacturer. A little later, the FDA corrected this announcement and said melamine or its by-product had been detected in formula from all three major brands — Similac (from Abbot Labs); Enfamil (Mead Johnson Nutritionals); and Good Start (Nestle) — which together account for 90 percent of all infant formula sales in the country.
As a result of the melamine-contaminated milk scandal in China, which left 4 Chinese infants killed and more than 50,000 infants sickened, the American infant formula producers had assured the FDA that their ingredients did not include imports from China. But the FDA secretly tested their products, coming up with melamine in one product and cyanuric acid in another. The readings indicated an average of 140 parts per billion of melamine and 247 parts per billion of cyanuric acid — well below the FDA’s new threshold of 1 part per million (or 1,000 parts per billion).
In October, the FDA said it did not have enough information “to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns." But on Friday, the agency said it already had test results on 74 of 87 samples (85 percent) tested starting September.
The FDA further said the low levels of contamination appear to indicate there was no direct contamination on the infant formula ingredients; rather, it may have resulted from the manufacturing process or the can liners used in product packaging.
Safety Tip:
* Refrain from abruptly switching infant formulas. The FDA advises that it is to the baby’s best interest to continue feeding the same formula. Consult your pediatrician before you make any changes.
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