By MARTHA MENDOZA and JUSTIN PRITCHARD
FDA finds traces of melamine in US infant formula
Traces of the industrial chemical melamine have been detected in samples of top-selling U.S. infant formula,
The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said
“The levels that we are detecting are extremely low,” said Dr. Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition. “They should not be changing the diet. If they’ve been feeding a particular product, they should continue to feed that product. That’s in the best interest of the baby.”
Melamine is the chemical found in Chinese infant formula in far larger concentrations that has been blamed for killing at least three babies and making at least 50,000 others ill.
Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show that the FDA has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.
Separately, a third major formula maker told AP that in-house tests had detected trace levels of melamine in its infant formula.
The three firms Abbott Laboratories, Nestle and Mead Johnson manufacture more than 90 percent of all infant formula produced in the United States.
melamine, which can bind with other chemicals in urine, potentially causing damaging stones in the kidney or bladder and, in extreme cases, kidney failure.
Melamine is used in some U.S. plastic food packaging and can rub off onto what we eat; it’s also contained in a cleaning solution used on some food processing equipment and can leach into the products being prepared.
FDA scientists said then that they couldn’t set an acceptable level of melamine exposure in infant formula because science hadn’t had enough time to understand the chemical’s effects on infants’ underdeveloped kidneys. Plus, there is the complicating factor that infant formula often constitutes a newborn’s entire diet.
The agency added, however, that its position did not mean that any exposure to a detectable level of melamine and melamine-related compounds in infant formula would result in harm to infants.
It was not until the AP inquired about tests on domestic formula that the FDA articulated that while it couldn’t set a safe exposure for infants, it would accept some melamine in formula raising the question of whether the decision to accept very low concentrations was made only after traces were detected.
On Sunday, Sundlof said the agency had never said, nor implied, that domestic infant formula was going to be entirely free of melamine.
In China, melamine was intentionally dumped into watered-down milk to trick food quality tests into showing higher protein levels than actually existed. Byproducts of the milk ended up in infant formula, coffee creamers, even biscuits.
And while the FDA said tests of 18 samples of formula made by Abbott Laboratories, including its Similac brand, did not detect melamine, spokesman Colin McBean said some company tests did find the chemical. He did not identify the specific product or the number of positive tests.
The FDA tests also detected melamine in two samples of nutritional supplements for very sick children who have trouble digesting regular food. Nestle’s Peptamen Junior medical food showed 0.201 and 0.206 parts per million of melamine while Nestle’s Nutren Junior-Fiber showed 0.16 and 0.184 parts per million.
The agency said that while there are no established exposure levels for infant formula, pediatric medical food often used in feeding tubes for very sick, young children can have 2.5 parts per million of melamine
The FDA shared its results with Nestle a few weeks ago, Huber said. He said he wasn’t sure whether Nestle had tested other of its products beyond what it did related to the FDA.
Rep. Rosa DeLauro, D-Conn., who heads a panel that oversees the FDA budget, said the agency was taking a “marketplace first, science last” approach.
“It’s just a tiny amount, it’s very unlikely to cause stones,” said Stanford University Medical School pediatrics professor Dr. Paul Grimm.
Dr. Jerome Paulson, an associate professor of pediatrics at Children’s National Medical Center in Washington, D.C., said he didn’t think the FDA’s decision was unreasonable. He added, however, that the agency should research the impacts of long-term, low-dose exposure, “and not just assume it’s safe, and then 15 years from now find out that it’s not.”