FAQ: Melamine in U.S. Baby Formula
Questions and Answers About Trace Amounts of Melamine in U.S. Infant Formula
By
Daniel J. DeNoon
WebMD Health News
Reviewed By
Louise Chang, MD
Nov. 26, 2008 -- Tiny "trace" amounts of potentially toxic melamine
reportedly detected in U.S.-made infant formula pose little if any risk to
kids, experts tell WebMD.
Investigative reporters for the Associated Press obtained FDA documents
showing the agency has been testing U.S. made baby formula for melamine.
According to the AP report, one brand of formula contained very small
amounts of melamine. Another brand contained similarly tiny amounts of cyanuric
acid, a related chemical. And a third maker of infant formula told the AP that
its own tests detected small amounts of melamine in its product.
In China, melamine was deliberately added to infant formula to make it
appear to have a higher protein content. Over 52,000 children developed kidney
stones. There were over 13,000 hospitalizations and at least two deaths.
The FDA has not found any Chinese infant formula in the U.S., and has warned
all manufacturers not to use milk products imported from China unless they have
been tested for melamine contamination.
American-made infant formula is not made with milk products from China. The
trace amounts of melamine detected in U.S. infant formula apparently came from
routine contact with melamine-containing substances during the manufacturing
process. There is no reason to suspect the melamine was added deliberately.
Should parents worry? WebMD consulted with experts who answered your
questions.
What is melamine?
Melamine, also known as cyanuramide, is a synthetic chemical product that
forms hard resins when combined with formaldehyde. It is used in a wide range
of products such as cooking utensils, plates, industrial coatings, paper and
paperboard, and flame retardant.
Melamine has also been used as fertilizer, although not in the U.S.
What happens when kids consume melamine?
Humans and animals that consume toxic doses of melamine develop kidney
stones. These hard crystals can block urinary flow and make urination painful.
They can also cause kidney failure and death, pediatric kidney specialist Marc
B. Lande, MD, MPH, of the University of Rochester, N.Y., tells WebMD.
Which brands of U.S. baby formula contain melamine?
According to the Associated Press, FDA tests detected trace amounts of
melamine in Mead Johnson's Infant Formula Powder, Enfamil LIPIL with Iron.
Melamine levels in the product were very low: about 0.14 parts per million.
The deliberately contaminated baby formula in China contained over 250 parts per million of melamine --
at least two thousand times higher than the U.S. contamination.
The AP report also said the FDA detected cyanuric acid in tests of Nestle's
Good Start Supreme Infant Formula with Iron, at about 0.25 parts per million --
again, some thousand-fold less than in Chinese formula.
In addition, the AP report said that while the FDA tests came up negative,
Similac maker Abbott Laboratories said some company tests did find traces of
melamine, at concentrations below 0.05 parts per million.
These three manufacturers -- Mead Johnson, Nestle, and Abbott -- make more
than 90% of the baby formula sold in the U.S.
Is U.S. baby formula safe?
Nobody knows for sure -- but several experts tell WebMD they think U.S. baby
formula is safe, despite containing trace amounts of melamine.
Here's the opinion of Marcel Casavant, MD, chief of clinical
pharmacology/toxicology at Nationwide Children's Hospital in Columbus, Ohio,
medical director of The Central Ohio Poison Center, and director of the Central
Ohio Lead Clinic.
"We don't really know for sure how much melamine is safe," Casavant
tells WebMD. "We do know how much is bad. It's really the dose that makes
something a poison or not. Concentrations of more than 250 parts per million
cause big troubles for some babies. How low does the concentration have to be
to cause no problems for any babies? That's what we don't know for
certain."
Casavant notes that the FDA finds melamine concentrations up to 2.5 parts
per million to be safe in products used to feed sick children in the hospital.
Health Canada says a level of 1.0 part per million is safe in infant formula
and 2.5 parts per million is safe in other foods and beverages.
"They based this on finding the lowest concentration to cause problems
in animals, and then divide by 100," Casavant says. "It's just a guess,
but it's the way these guesses are usually made."
Gary Wasserman, DO, chief of medical toxicology at Children's Mercy
Hospitals and Clinics in Kansas City, Mo., says trace levels of melamine and
other chemicals have probably been present in infant formula for decades. We
find it now because we've just started to test for it.
That's also the opinion of Marvin Wang, MD, assistant professor of
pediatrics at Harvard Medical School and director of newborn nurseries at
Massachusetts General Hospital for Children.
"These formulas have done remarkably well in terms of safety for all the
years they've been on the market," Wang tells WebMD. "We have not seen
reports of the kinds of symptoms you would see in melamine toxicity ... Unless
the infant formula manufacturers declare they recently made a change in the way
they process the formula, or that they obtained milk products from China, there
is no reason to think these infant formulas are any less safe than infant
formulas that have been on the market for many years."
Scientists never say never. None of the experts who spoke with WebMD would
guarantee that all U.S. infant formulas are safe for all babies. But every one
of the experts says the evidence so far strongly indicates that U.S. infant
formula is safe.
"I'm sorry I can't be more specific, and can't guarantee safety at 0.14
parts per million," Casavant says. "The trouble is we really don't have
a lot of experience and data with this poison in infant formula. People smarter
than I are guessing at safe levels, and I'm only able to report their guesses.
But I do think they're guessing right. I don't think 0.14 parts per million in
formula is going to turn out to be a problem."
If I feed my child formula, will melamine build up in his or her body?
Wasserman notes that the body gets rid of melamine in three to four hours,
so it's very unlikely that tiny amounts will build up in a child's system.
"The human body is an amazing organ that has hundreds of mechanisms to
protect itself from toxins," Wasserman tells WebMD. "We are bombarded
every day by lots of chemicals we don't know about, and our bodies just handle
them."
That's true, agrees Ingolf Gruen, PhD, associate professor of food science
at the University of Missouri, Columbia.
"Our ability to analyze foods for specific chemicals is improving all
the time," Gruen tells WebMD. "Of course, when you have infants and
baby formula, I fully understand when moms say I want zero toxins. But in all
honesty, I don't think that is a reasonable expectation. Even if you grow your
own squash and carrots and process it into homemade baby food, don't fool
yourself into thinking it is contaminant free. It probably picked up traces of
something along the way."
Should I switch my child to a different brand of formula?
There's no guarantee that any brand of infant formula is entirely free of
melamine.
"Each of the three big manufacturers -- Abbott, Nestle, and Mead Johnson
-- found similar concentrations of either melamine or one of its relatives in
their products," Casavant says. "These three companies apparently make
almost all of the formula sold in the USA -- so if parents wanted to switch
from Enfamil Lipil to something else, we couldn't really suggest another
product that we know to be safer. Breast milk's always best, but I've not found
whether anyone's tested breast milk for melamine yet."
What are the symptoms of melamine poisoning?
Wang says symptoms of melamine poisoning are related to kidney stones or
bladder stones.
"Infants with these kinds of problems will have severe abdominal pain,
blood in the urine, and/or difficulty urinating," Wang says. "If you
are not seeing that, there is no need to think the child has suffered any ill
effect from his or her formula."
According to the American Society of Pediatric Nephrology, signs and
symptoms of melamine poisoning in infants include:
- Unexplained crying in infants, especially when urinating
- Vomiting
- Unexplained fever due to urinary tract infection caused by urinary
obstruction
- Blood in the urine
- Stones discharged while passing urine
- Signs of kidney infection
- High blood pressure
- Flank pain
- Kidney failure
SOURCES: Mendoza, M. and Pritchard, J. Associated Press, "FDA and Industry Detect
Traces of Melamine in U.S.-Produced Infant Formula," Nov. 26, 2008. FDA, "Interim Safety and Risk Assessment of Melamine and Its Analogues
in Food for Humans," Oct. 3, 2008. American Society of Pediatric Nephrology, "Kidney Disease from Powdered
Infant Formula-Based Melamine Exposure in Chinese Infants," Oct. 22,
2008. Ingolf Gruen, PhD, associate professor of food science, University of
Missouri, Columbia. Marc B. Lande, MD, MPH, associate professor of pediatric nephrology,
University of Rochester Medical Center, N.Y. Marvin Wang, MD, assistant professor of pediatrics, Harvard Medical School;
associate pediatrician and director of newborn nurseries, Massachusetts General
Hospital for Children, Boston. Marcel Casavant, MD, chief of clinical pharmacology/toxicology, Nationwide
Children's Hospital; professor of medicine, Ohio State University College of
Medicine; medical director, Central Ohio Poison Center; director, Central Ohio
Lead Clinic, Columbus, Ohio.
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