Melamine Levels in Contaminated Infant Formula Safe Says FDA

The FDA confirmed on November 27, 2008, that several samples of infant formula in the United States have tested positive for trace amounts of the chemical melamine, which is the same chemical that hospitalized more than 12,000 babies in China. However, the FDA has indicated that the trace levels of contamination found in the United States were very low and the baby formula remains safe for use.

Melamine is an industrial chemical used in the manufacture of can liners, pesticides, cleaning products and fertilizers.

In China, it has been discovered that large quantities of melamine were added to watered down milk to make it appear protein rich. Approximately 53,000 babies in China have been sickened by the contaminated formula and at least 4 deaths have been linked to the chemical.

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According to the FDA, none of the infant formula from China has been imported into the United States and no ingredients from China are contained in formula made in the United States.

Following the problems in China, the FDA initiated a testing program for infant formula in the United States, and recently disclosed that some samples tested positive for trace levels (defined as amounts less than 2,500 parts per billion) of melamine and cyanuric acid, which is produced from the breakdown of melamine.

Mead Johnson’s infant powder, Enfamil LIPIL with Iron, had three samples that tested positive for cyanuric acid in trace amounts of 247 parts per billion. Nestle’s Food Start Supreme Infant Formula with Iron had trace levels of melamine, of 137 and 140 parts per billion.

The FDA has indicated that the positive samples may have been contaminated in the manufacturing process or via contact with can liners.

In October 2008, the FDA set the safe level for melamine consumption at 2,500 parts per billion for other foods, but indicated that insufficient data was available to set a safety level for infant formula because it is not known how babies’ kidneys are affected by the chemical.

During a conference call with reporters on Friday, the agency changed their stance and indicated that the small amounts found in the samples do not pose health risks. The trace amounts found in the samples tested in the U.S. were below levels viewed as safe for infants by other countries such as Canada, Hong Kong, New Zealand, Malaysia, China and the Philippines.

The FDA has indicated that parents may continue using baby formula manufactured in the United States, warning that switching away from one of these baby formulas to alternate diets or homemade formulas could cause infants too receive insufficient nutrients.

9 Comments

  • NicoleOctober 11, 2010 at 10:08 pm

    My story is a bit different, my two daughters were very sick after taking Tylenol. One of my daughters didn’t make it. My other hasn’t been the same since she has taken it. Please help! Does any one know if there is a case action for Johnson & Johnson?

  • TrinidySeptember 3, 2010 at 5:34 pm

    back in 2006 my daughter got salmanella. She was almost a year old and i had switched her to enfamil next step when she got it. it was horribly scary. she had blood in her stool and was on antibiotics and we went to the doctor several times a week for testing. it took a month for us to get her better. we had no idea where she got it from. then a year later there was a lawsuit against enfamil becau[Show More]back in 2006 my daughter got salmanella. She was almost a year old and i had switched her to enfamil next step when she got it. it was horribly scary. she had blood in her stool and was on antibiotics and we went to the doctor several times a week for testing. it took a month for us to get her better. we had no idea where she got it from. then a year later there was a lawsuit against enfamil because babies were getting salmanella from it. i truelly believe that is where my daughter got it from.

  • WilliamMay 26, 2009 at 1:15 am

    Should there be a class action lawsuit against Enfamil? I trusted Enfamil Next Step Lipil to give to my son inbetween meals. I NEVER thought that there would be hazardous chemicals in my baby's formula. Now I am afraid that there might be health complications with him in the future.

  • BethanyJanuary 22, 2009 at 10:34 am

    I just gave birth to a baby boy but unfortunately he died with kidney and renal falure. when i was pregnant 2 months before till almost the third month of my pregnancy i used to work in contact with melamine which contains formaldehyde, 8 hours daily in contact with my skin and even inhaling fumes and possible the dust. melamine could be the cause of my son's death

  • Topaz Wafer Rolls Recall: Risk of Melamine Contamination : AboutLawsuits.comJanuary 6, 2009 at 3:07 pm

    [...] than 2,500 parts per billion) of Melamine and cyanuric acid. However, the FDA indicated that the trace levels of Melamine in U.S. infant formula was not toxic and remained safe to [...]

  • lapang2007December 2, 2008 at 5:20 pm

    FDA actions on melamine in US infant formula are irresponsible Trace level is misleading In some scientific areas, ppm (parts per million) is not a trace level at all. ppb (parts per billion) is more generally referred to a trace level. For example, air pollution, most federal air quality standards are ppb level. So, these current melamine concentrations may be harmful if just based on concentrat[Show More]FDA actions on melamine in US infant formula are irresponsible Trace level is misleading In some scientific areas, ppm (parts per million) is not a trace level at all. ppb (parts per billion) is more generally referred to a trace level. For example, air pollution, most federal air quality standards are ppb level. So, these current melamine concentrations may be harmful if just based on concentration levels. Current china and Hongkong infant formula standards are 1 ppm and Taiwan's is 0. However, those standards all are developed based on FDA 2.5 ppm melamine adult standard. It is questionable to say that current melamine concentrations in infant formula (0.2 ppm) are low as FDA implied. Which level of melamine is safe? As FDA indicated "FDA is currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns". It is clear to state that any levels of melamine is possible to be harmful. Since melamine is a new food safety issue, the long term effects of melamine, especially on baby is totally unknown and will needs long time to determine. As a parent of baby and a person in science for 20 years, I strongly disagree with any "scientists" who claim that current level of melamine in US in infant formula (0.1 ppm) is safe, especially for infants. Where are their scientific data to demonstrate such safety? 1ppm Standard Is Irresponsible Such standard is just based on an animal short term exposure study. Even though 1 ppm has some scientific base, it has extreme high uncertainty. Long-term exposure study on baby is a better approach to establish such standard. All scientists only agree that we are not sure which level is safe for the baby. Experience in China, honkong, and taiwan as well FDA data clearly indicate that it is not difficult to control the Melamine level lower than 0.05 ppm. So, 1 ppm standard is irresponsible. It is a " Profit first, Baby safety last" approach. All parents should call your congress members to force FDA change their altitudes. FDA should publish these data immediately I am very disappointed that FDA only disclosed such data because of the request of The Associated Press under the Freedom of Information Act. Since FDA can not determine the safety level of melamine in infant formula, they should publish current available information to let parents to decide what actions they should take . FDA actions are irresponsible Melamine can be controlled no matter that it comes from intentional addition and formula produce processes. China, Taiwan, and Hongkong all demonstrate that. Most of current china, Taiwan and Hongkong infant formula are much lower than 0.1 ppm now. Because FDA did not take any action, all American baby might still eat such formula with higher melamine concentration, which is possible to be removed.

  • ElizabethDecember 2, 2008 at 4:02 pm

    This just disgusts me that this chemical is allowed in INFANT FORMULA, this is rediculous. I have a 11 month old son and I am going to stop giving him formula now because of this and I plan on encouraging my friends with infants to do the same. What is wrong with the world today??

  • Rare Powdered Baby Formula Associated Illness Reported in Two Infants in New Mexico : AboutLawsuits.comDecember 2, 2008 at 2:23 pm

    [...] latest baby formula scare follows news last week that trace amounts of the industrial chemical melamine was discovered in samples of some formula manufactured in the United St.... High levels of melamine which contaminated baby formula in China this year, has been associated [...]

  • NaniDecember 1, 2008 at 10:23 pm

    Why is any amount of melamine in baby formula acceptable????? This is an outrage....the food and drug administration is supposed to protect us from hazardous materials. If we can't trust them who do we trust???

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