FDA finds traces of melamine in US infant formula: Abbott Laboratories, Nestle, Mead

[Guest guest]

Melamine affects kidneys and is associated with kidney stones (1).

Kidney problems and kidney stones are increasingly seen in US children

(2). I have come to trust the FDA to be as consistently evil as was Ted

Bundy. For instance, when the FDA's Graham found that COX-2

inhibitors were associated with ~90,000 deaths, the FDA's response was

to silence him, to fire him. Thus when the FDA says, Not to worry about

melamine in infant formula, I worry severely. Do I think that ALL

pediatric kidney stones are caused by melamine in formula? Of course

not. However, we are wise to be aware of the FDA's tendency to allow

pollutants which cause pathologies whose treatments increase pharma

revenues. Furthermore, we need avoid melamine in other foods. We need

withhold trust in statements of the FDA.

- - - -

*FDA finds traces of melamine in US infant formula*

By MARTHA MENDOZA and JUSTIN PRITCHARD

Associated Press Writers

11/26/2008 08:38:25 AM MST

http://www.denverpost.com/healthcare/ci_11078289

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. "

The tests for detecting melamine are getting more and more precise. The

FDA has said the lowest level it could quantify was 0.25 parts per

million, though the results the agency released to AP were below that.

An agency spokeswoman, Judy Leon, explained the difference by saying,

" Melamine methodologies were developed and verified to test the widest

variety of infant formula and dairy product compositions. Some product

compositions permit testing at lower levels. "

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. "

---------

On the Net:

The FDA's melamine guidance:

http://www.fda.gov/oc/opacom/hottopics/melamine.html

- - - -

..

*1. Melamine*

http://en.wikipedia.org/wiki/Melamine

2. A Rise in Kidney Stones

<http://www.nytimes.com/2008/10/28/health/28kidn.html?8dpc>

Kidney stones are now showing up in children as young as 5 or 6.