melamine: Calls for national infant formula recall spread

[Guest guest]

Major concern: inter-individual differences in the ability to detoxify

pollutants. Some individuals have weak alleles in detox pathways. Other

folks have higher than average exposures to numerous pollutants. Every

individual thus far tested has numerous intra-body pollutants. These

various factors indicate that some infants and toddlers will be more

affected than will others. Allowing melamine to remain in food, in

infant formula seems likely to induce pathologies in at least some who

ingest melamine with the FDA's blessing.

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Calls for national infant formula recall spread

By MARTHA MENDOZA, JUSTIN PRITCHARD

AP

Friday, November 28, 2008

http://www.ajc.com/health/content/health/stories/2008/11/28/infant_formula_recal\

l.html

Disclosure that laboratory tests have detected traces of contamination

in several major brands of infant formula generated concern and

confusion Wednesday, with a national consumer's group and the Illinois

attorney general demanding a Food and Drug Administration recall and the

federal agency saying it had released inaccurate information on what

chemicals were found in which top selling products.

As worried parents called manufacturers looking for guidance about the

presence of melamine and a key byproduct in U.S.-made formula, the FDA

reiterated its position that the baby food is safe and parents should

continue feeding it to their babies, contending the extremely low levels

of contamination do not present a health danger.

Also, a spokesman for one major manufacturer criticized the FDA for its

release of the inaccurate information.

" We're getting inundated by calls from moms confused about the

situation, " said Pete Paradossi, a spokesman for Mead , one of

the three major manufacturers of U.S.-made formula involved in the

problem detections.

Melamine is the industrial 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.

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

formula had occurred during the manufacturing process, rather than

intentionally as was done in Chinese production. The manufacturers

insist their products are safe.

" 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. "

Part of the confusion Wednesday stemmed from the FDA's own statements.

While proclaiming that the very low concentrations detected of melamine

and a similar compound called cyanuric acid pose no health danger to

infants, the FDA has maintained it is unable to identify any exposure

level of melamine in infant formula " that does not raise public health

concerns. "

Further complicating the situation was inaccurate data that FDA released

to The Associated Press, which was first to disclose the formulas' brand

names and other details in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of

Information Act request stated that Mead 's Infant Formula

Powder, Enfamil LIPIL with Iron contained traces of melamine.

On Wednesday, FDA spokeswoman Judy Leon said that spreadsheet contained

an error --- that the FDA had incorrectly switched the names of the Mead

product with Nestle's Good Start Supreme Infant Formula with

Iron. That meant, Leon said, that the Nestle's Good Start had melamine

while Mead 's Enfamil had traces of cyanuric acid.

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

study, but that in the meantime it is " prudent " to assume that its

potency is equal to that of melamine.

Problems with melamine-spiked formula surfaced this fall in China, where

unscrupulous manufacturers intentionally dumped it into watered-down

milk to falsely elevate protein levels. The concentrations in China were

as much as 2,500 parts per million --- about 10,000 times greater than

what the FDA found in the U.S.

The FDA said there have been no reports in the United States of human

illness from melamine. The chemical, which legally can be used in

product packaging and a solution to clean manufacturing equipment, can

bind with other chemicals in urine, potentially causing damaging stones

in the kidney or bladder and, in extreme cases, kidney failure.

Mead spokesman Paradossi said he was frustrated that the FDA had

provided inaccurate information for worldwide distribution by the AP. He

said the FDA informed his company of the test results, as well as the

inaccurate disclosures only Wednesday, during an emergency conference

call the agency staged with major manufacturers and the industry's trade

group. During a similar call Monday, the FDA told the industry about the

upcoming AP investigative report.

Nestle did not returns calls seeking comment Wednesday.

At the same time, Illinois Attorney General Madigan called on the

state's public health department and the FDA to recall both the Nestle

and Mead products --- and urged the companies to take that step

regardless of what any government agency does.

Madigan also criticized the FDA's handling of its test results.

" The agency apparently withheld the results of its testing from the

public for over three weeks, and then only disclosed the information in

response to a FOIA request by The Associated Press, " she wrote in a

letter to Leavitt, the secretary of the U.S. Department of

Health and Human Services, which oversees the FDA.

As for possible consideration of a recall, the FDA's Leon said: " The

agency would only seek to remove a product on the basis of a risk, based

on scientific evidence. That's not what we're talking about here. "

Consumers Union said that the FDA's assurances are of small comfort to

parents and caregivers.

" The FDA originally said there was no safe level for these contaminants

in infant formula. So this formula is contaminated, " said Halloran,

the group's director of Food Policy Initiatives. " It is very disturbing

to us that no recall has been requested. "

She urged the FDA " to immediately make public all of the results of its

tests for melamine contamination in food, " even those with levels below

what would trigger agency action. "

Rep. Bart Stupak, D-Mich., a frequent critic of the FDA, also has called

for recalls.

During a series of calls with formula manufacturers starting Monday ---

put together hurriedly, according to several participants, as the AP was

preparing to publish its story --- the FDA has told manufacturers it has

taken 230 samples of various products, including pediatric supplements

and ingredients used in infant formula. Leon said that 87 of those

samples are of infant formula, and that 77 of those have been analyzed.

Under the corrected information she relayed Wednesday, the results were:

--- Nestle's Good Start Supreme Infant Formula with Iron had two

positive tests for melamine on one sample, with readings of 0.137 and

0.14 parts per million.

--- Mead 's Infant Formula Powder, Enfamil LIPIL with Iron had

three positive tests for cyanuric acid, at an average of 0.247 parts per

million.

Separately, a third major formula maker --- Abbott Laboratories, whose

brands include Similac --- told AP that in-house tests had detected

trace levels of melamine in its infant formula. Those levels were below

what FDA found in the other formulas, an Abbott spokesman said, and

below any nation's safety guidelines.

The three firms --- Abbott Laboratories, Nestle and Mead ---

manufacture more than 90 percent of all infant formula produced in the

United States.

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Associated Press Writer Alonso-Zaldivar contributed to this

report from Washington, D.C.

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On the Net:

The FDA's melamine guidance:

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

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