OT:FDA says melamine in top US infant formula safe

[Guest guest]

AP did an FOIA to find test results- the FDA had no plans to tell

anyone about the traces of melamine they found. The culprits-- Abbot

Labs (Similac), Nestle (Good Start Supreme) and Mead

(Enfamil)-- supply most commercial formula to the US.

http://tinyurl.com/6qa6bw

FDA finds traces of melamine in US infant formula

By MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers

Martha Mendoza And Pritchard,

Reuters – A child suffering from kidney stones receives medical

treatment at a hospital in Hefei, Anhui province … Traces of the

industrial chemical melamine have been detected in samples of top-

selling U.S. infant formula, but federal regulators insist the

products are safe. 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 it would be a " dangerous

overreaction " for parents to stop feeding infant formula to babies

who depend on it.

" The levels that we are detecting are extremely low, " said Dr.

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 —

manufacture more than 90 percent of all infant formula produced in

the United States.

The FDA and other experts said the melamine contamination in U.S.-

made formula had occurred during the manufacturing process, rather

than intentionally.

The U.S. government quietly began testing domestically produced

infant formula in September, soon after problems with melamine-spiked

formula surfaced in China.

Sundlof said there have been no reports of human illness in the

United States from 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.

Sundlof told the AP the positive test results " so far are in the

trace range, and from a public health or infant health perspective,

we consider those to be perfectly fine. "

That's different from the impression of zero tolerance the agency

left on Oct. 3, when it stated: " FDA is currently unable to establish

any level of melamine and melamine-related compounds in infant

formula that does not raise public health concerns. "

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.

Still, the announcement was widely interpreted by manufacturers, the

news media and Congress to mean that infant formula that tested

positive at any level could not be sold in the United States.

The Grocery Manufacturers Association, for example, told its

members: " FDA could not identify a safe level for melamine and

related compounds in infant formula; thus it can be concluded they

will not accept any detectable melamine in infant formula. "

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. He

said he didn't know if the agency's statements on infant formula had

been misinterpreted.

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.

The concentrations of melamine there were extraordinarily high, as

much as 2,500 parts per million. The concentrations detected in the

FDA samples were 10,000 times smaller — the equivalent of a drop in a

64-gallon trash bin.

There would be no economic advantage to spiking U.S.-made formula at

the extremely low levels found in the FDA testing. It neither raises

the protein count nor saves valuable protein, said University of

California, chemist Filigenzi, a melamine detection

expert.

According to FDA data for tests of 77 infant formula samples, a trace

concentration of melamine was detected in one product — Mead

's Infant Formula Powder, Enfamil LIPIL with Iron. An FDA

spreadsheet shows two tests were conducted on the Enfamil, with

readings of 0.137 and 0.14 parts per million.

Three tests of Nestle's Good Start Supreme Infant Formula with Iron

detected an average of 0.247 parts per million of cyanuric acid, a

melamine byproduct.

The FDA said last month that the toxicity of cyanuric acid is under

study, but that meanwhile it is " prudent " to assume that its potency

is equal to that of melamine.

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.

McBean did say the detections were at levels far below the health

limits set by all countries in the world, including Taiwan, where the

limit is 0.05 parts per million.

" We're talking about trace amounts right here, and you know there's a

lot of scientific bodies out there that say low levels of melamine

are always present in certain types of foods, " said McBean.

Mead spokeswoman Gail Wood said her company's in-house tests

had not detected any melamine, and that the company had not been

informed of the FDA test results, even during a confidential agency

conference call Monday with infant formula makers about melamine

contamination.

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, just like food products other than infant formula.

The head of manufacturing for Nestle Nutrition in North America,

Walter Huber, said in an interview that the company took samples

alongside FDA officials who visited a manufacturing plant, and that

those samples showed similar results to what FDA found for the two

pediatric medical foods. Huber added that Nestle didn't fund cyanuric

acid in any of the samples.

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. DeLauro, D-Conn., who heads a panel that oversees the FDA

budget, said the agency was taking a " marketplace first, science

last " approach.

" The FDA should be insisting on a zero-tolerance policy for melamine

in domestic infant formula until it is able to determine conclusively

based on sound independent science that the trace levels would not

pose a health risk to infants, " DeLauro said.

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, said: " If no

safe level of melamine has been established for consumption by

children, then the FDA should immediately recall any formula that has

tested positive for even trace amounts of the contaminant. "

Several medical experts said trace concentrations would be diluted

even in an infant, and are highly unlikely to be harmful.

" It's just a tiny amount, it's very unlikely to cause stones, " said

Stanford University Medical School pediatrics professor Dr.

Grimm.

Dr. Jerome son, 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. "