SAN JOSE, Calif., Nov. 26, 2008

Demands For Baby Formula Recall Mount

FDA Changes Its Story On Melamine Contamination, But Insists Products Are Safe

    • Michael Filigenzi, a chemist at the California Animal Health and Food Safety Laboratory, displays a vial of liquefied pet food that was tested for the industrial chemical melamine Nov. 18, 2008. Melamine has been detected in U.S. infant formula products, just weeks after it killed at least three babies and sickened at least 50,000 in China.

      Michael Filigenzi, a chemist at the California Animal Health and Food Safety Laboratory, displays a vial of liquefied pet food that was tested for the industrial chemical melamine Nov. 18, 2008. Melamine has been detected in U.S. infant formula products, just weeks after it killed at least three babies and sickened at least 50,000 in China.  (AP Photo/Rich Pedroncelli)

    • A worker is seen at a milk processing factory in Chengdu, southwest China's Sichuan province, Sept. 28, 2008.

      A worker is seen at a milk processing factory in Chengdu, southwest China's Sichuan province, Sept. 28, 2008.  (AP Photo/Color China Photo)

    • People wait to get their babies checked for kidney stones in a hospital in Fuyang in central China's Anhui province on Sept. 23, 2008.

      People wait to get their babies checked for kidney stones in a hospital in Fuyang in central China's Anhui province on Sept. 23, 2008.  (AP PHOTO)

    • Chemist Michael Filigenzi demonstrates how vials of liquefied pet food are placed in trays to test for the industrial chemical melamine at the California Animal Health and Food Safety Laboratory, at the University of California, Davis, campus in Davis, Calif., Nov. 18, 2008. Traces of melamine have been detected in samples of top-selling U.S infant formula, prompting widespread calls for a product recall.

      Chemist Michael Filigenzi demonstrates how vials of liquefied pet food are placed in trays to test for the industrial chemical melamine at the California Animal Health and Food Safety Laboratory, at the University of California, Davis, campus in Davis, Calif., Nov. 18, 2008. Traces of melamine have been detected in samples of top-selling U.S infant formula, prompting widespread calls for a product recall.  (AP Photo/Rich Pedroncelli)

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(CBS/AP)  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 group and the Illinois attorney general demanding a Food and Drug Administration recall.

The FDA shunned those calls, but admitted 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 Johnson, 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 said the melamine contamination in U.S.-made formula had occurred during the manufacturing process, whereas melamine was intentionally added to the Chinese products. U.S. Manufacturers say their products are safe.

"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."

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 disclose the formulas' brand names in an investigative report Tuesday.

A spreadsheet the AP obtained from the FDA under a Freedom of Information Act request stated that Mead Johnson'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 Johnson 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 Johnson'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 Johnson 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 Lisa Madigan called on the state's public health department and the FDA to recall both the Nestle and Mead Johnson 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.

Quote

The [FDA] apparently withheld the results of its testing from the public for over three weeks, and then only disclosed the information in response to a [Freedom of Information Act] request by The Associated Press.

Illinois Attorney General Lisa Madigan
"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 Michael 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 Jean 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 Johnson'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 Johnson - manufacture more than 90 percent of all infant formula produced in the United States.

    © MMVIII, CBS Interactive Inc. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.
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    by debinok1 November 29, 2008 1:39 PM EST
    mel7a7mine (ml-mn) KEY

    NOUN:

    A white crystalline compound, C3H6N6, used in making melamine resins and for tanning leather.
    A plastic made from such resin.
    Wiki:Melamine is sometimes illegally added to food products in order to increase the apparent protein content. Standard tests such as the Kjeldahl and Dumas tests estimate protein levels by measuring the nitrogen content, so they can be misled by adding nitrogen-rich compounds such as melamine. [11]
    Chronic toxicity
    Ingestion of melamine may lead to reproductive damage, or bladder or kidney stones, which can lead to bladder cancer.[15][20][21][22][23]

    A study in 1953 reported that dogs fed 3% melamine for a year had the following changes in their urine: (1) reduced specific gravity, (2) increased output, (3) melamine crystalluria, and (4) protein and occult blood.[24]

    And the FDA stated that "there is no safe level of melamine in infant formula" when this happened in China just a few short weeks ago.

    Yet now that it has been found in US infant formulas, it is a safe level.

    Oh well they are just humans, we cant make a judgement call against such large corporations.

    Just 1 more example of how Corporate america comes first and the people last.
    Reply to this comment
    by nonameabc November 29, 2008 10:20 AM EST
    Shame on the government! We had warning not to let baby take the cold medicine, but still can find in the market. Shame on the government! We found some poisons in the formula and STILL can find in market. We only know how to get credit from those who cannot speak, like baby. Chinese government had banned and dumped all the milk as finding the same poison few months ago. We will go back to 3rd country standard with the help of the corruption. Thanks Buxh. God bless America.
    Reply to this comment
    by brianbwb-2009 November 29, 2008 1:05 AM EST
    For that delicious liikong creamy color,

    UN8242 Cromophtal Yellow LA (Pigment Yellow 150)

    Chemical Name: Pigment Yellow 150
    CAS No.: 68511-62-6
    EU No.: 270-944-8
    C.I. NO.: 12764
    Chemical Formula: C8H6N6O6Ni
    Molecular Weight: 340.70

    Equivalent Company Name

    Fanchon Fast Yellow Y-5686 BAY

    FFanchon Fast Yellow Y-5688 BAY

    Helio Fast Yellow 4G BAY

    Pigment Yellow 150 (Press Cake) CPMA

    Pigment Yellow 150 (Powder) CPMA

    PV Fast Yellow H4G SKC

    Yellow EMD-361 SKC

    Yellow EPCF-361 SKC

    Yellow HPA-361 SKC

    Yellow PEO-361
    Reply to this comment
    by impeach___w November 28, 2008 10:16 AM EST
    Move along nothing to see here...The air is safe to breathe.
    Please go back to work.
    Continue shopping,
    Pulling your money out of the stock market is un-patriotic.
    Take your famlies to Disney on Vacation,
    Increase production,
    blessings of the state,
    blessings of the masses,
    Everything will be all right.
    You are in my hands.
    I am here to protect you.
    You have nowhere to go.
    You have nowhere to go.

    The Head of the FDA and EPA for that matter should be the nation''s Food and medicine tester. If a food or drugs safety is in question and the FDA clears it, They should have a live news conference and force feed a gallon of it to whomever is in charge right then and there.
    Reply to this comment
    by humanavance November 28, 2008 5:13 AM EST
    "They poisoned and murdered our children. So we killed them."
    SearingTruth
    Reply to this comment
    by txgrouch2007 November 28, 2008 3:05 AM EST
    "We elected those who had stolen our freedom to restore it."
    SearingTruth, March 2008
    Posted by Humanavance at 11:19 PM : Nov 27, 2008

    The USA will collapse under its own weight like the Soviet Union did. It just took us a few years longer.

    The greatest problem facing humanity is humanity.

    Reply to this comment
    by humanavance November 28, 2008 2:19 AM EST
    Now don''t worry.

    Bush and Obama won''t do anything to alleviate this crime against humanity.

    I mean after all, Obama is recruiting many of the same neocons responsible for our current inhumane police state for continued "service".

    As I warned you he would.

    Just tell your babies that you didn''t believe that old SearingTruth.

    And to drink their milk.
    ST


    "We elected those who had stolen our freedom to restore it."
    SearingTruth, March 2008

    A Future of the Brave
    Reply to this comment
    by txgrouch2007 November 27, 2008 10:58 PM EST
    Us Government killing people since 1776
    Posted by WarDogLRS at 07:56 PM : Nov 27, 2008

    Did you hear that a group claiming to be the descendants of British redcoats is preparing to sue the U.S. government for reparations?
    Reply to this comment
    by txgrouch2007 November 27, 2008 10:56 PM EST
    Let''s not forget, this baby formula was MADE IN USA.

    The melamine didn''t come from China. IT CAME FROM THE USA.

    This isn''t tainted made-in-China formula.

    This is USA industry becoming like China and DOING WHAT CHINA DOES.

    We won''t need to import poisoned baby formula from China anymore.

    WE ARE MAKING IT HERE.
    Reply to this comment
    by wardoglrs November 27, 2008 10:56 PM EST
    Us Government killing people since 1776
    Reply to this comment
    by txgrouch2007 November 27, 2008 10:55 PM EST
    Are we really ready for China to rule the world?
    That''''s where we are headed.
    Posted by LMartinK at 07:03 PM : Nov 27, 2008

    You know how Bill Clinton loved the Chinese, and NAFTA.

    You know how the public flocks to Made-in-China-mart to buy cheap made-in-China products.

    EVERYBODY wishes we could be more like China.

    Everybody is getting their wish.
    Reply to this comment
    by notfooled November 27, 2008 8:16 PM EST
    Typical bought and paid for governmental response.

    We have poison in baby food and they say its alright.

    Stop buying these products.

    We live in hell where humans are simply fodder for the economic machine.

    Curse all politicians. Trust none.
    Reply to this comment
    by kawosa November 27, 2008 8:08 PM EST
    Hey! This could be one of the first big tests for Obama. His foundation is built upon the American people and their trust in government. Let''s just see how this chess game plays out. I''m giving odds on Nestle and the FDA. Go get em tiger!
    Reply to this comment
    by stick1772 November 27, 2008 7:57 PM EST
    If anyone Complains about : PAY SCALE and RETIREMENT Benefits
    Look to the - DEAD BEAT - Federal Employee ! !


    --------------------------------------------------------------------------------

    Posted by lastdance134 at 03:27 PM : Nov 27, 2008

    I agree and now we have a congress and president that loves to increase government size and power. Way to go!
    Reply to this comment
    by petro49l November 27, 2008 3:57 PM EST
    Women should breast feed. The Chinese Government allows poison in the baby formula to reduce the population of infants. Why trust American makers of the baby products? They buy cheap Chinese imports for ingredient.
    Reply to this comment
    by marry8 November 27, 2008 2:43 PM EST
    Why isn''t our society promoting breastfeeding? Because no one makes any money on it. I hope this inspires mothers to breastfeed.
    Reply to this comment
    by marry8 November 27, 2008 2:41 PM EST
    Why isn''t our society promoting breastfeeding? Because no one makes any money on it. I hope this inspires mothers to breastfeed.
    Reply to this comment
    by mirthiam November 27, 2008 2:40 PM EST
    Melamine has no place in baby formula, pet food, or ANY food source for that matter. It is an industrial plastics byproduct which may damage kidney and liver functions-- if the FDA believes a certain level of melamine in food is not a cause for concern, where is the scientific evidence to support this assumption? There is apparently evidence that melamine has killed some children who consumed it in China when parents were unaware of this contaminant in food. It previously may have damaged and killed pets in the United States when it appeared in dog food. Now that government regulators overseas and in the United States are aware of a potential melamine contamination problem with the food supply they are required by U. S. law to address this problem and not just assume that the level of contamination won''t cause health problems in the future for unwary consumers (like infants).
    Reply to this comment
    by perk235 November 27, 2008 2:30 PM EST
    Why are any of these chemicals in the formula? How is it "accidentally" getting into the formula? They won''t tell you what it is from because then you''''''''d find out that it is in a ton of products. Do research on food dyes and then you''ll really freak out. You''ll quickly see that all cereals that you feed your children have toxic levels of food dyes and chemicals to make them pretty.

    It''s all a scam and the FDA doesn''t really care.

    Posted by stick1772 at 06:48 AM : Nov 27, 2008
    --------------
    Yes, the food labels should be expanded to include chemicals found in the food tests beyond the list of ingredients. The list of ingredients tells us what is intended to be in the food, but we need to know what else comes with those ingredients and from the containers (pesticides, herbicides, plastic breakdown products, PCBs, etc.)

    I disgaree with stick1772''s last statement: It''s all a scam and the FDA doesn''t really care.

    As we have seen with the bailouts, those in power desperately care about retaining power and privilege and not about the average citizen.
    Reply to this comment
    by perk235 November 27, 2008 2:22 PM EST
    DO NOT throw anything away.
    DO NOT change anything you are doing.
    There is NO evidence of any threat to anyone. READ the article and DO NOT panic. Based on all available information, there is NO risk. NONE.

    If you are REALLY worried - immediately stop breathing. Oxygen toxicity occurs with EVERY breath. As they taught us in medical school - 100% oxygen causes toxicity in a few days. 21% oxygen (the air we breath) causes toxicity in about 100 years.
    Posted by lf1952 at 01:25 AM : Nov 27, 2008
    -----------------------------------

    The public understands that anything can kill. However, we also understand that small amounts of certain chemicals are more potent in killing than others. This is especially true for babies since they are relying solely on milk and since they are growing, with demands on their systems.

    The advice and example are simple-minded and patronizing. What studies is this advice based on? The medical profession is not all knowing. They were pushing transfats in the form of margarine not too long ago.

    Reply to this comment
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