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.
Just before Thanksgiving, the Associated Press reported that the FDA had been testing U.S.-made baby formula for melamine.
On the Friday after Thanksgiving, the FDA admitted that 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.
As recently as last October, the FDA said it did not know of any safe level of melamine in baby formula. Last Friday, the agency said that melamine and cyanuric acid are safe in baby formula at levels up to 1 part per million.
All of the baby formula that tested positive for melamine or cyanuric acid had levels of the toxins well below 1 part per million.
In China, melamine was deliberately added to infant formula to make it appear to have a higher protein content. This resulted in melamine levels vastly higher than those found in U.S. formula. More than 52,000 children developed kidney stones. There were more than 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.
All melamine and melamine-related contaminants detected in baby formula have been well below the 1 part per million level deemed safe by the FDA in its Nov. 28 update to its risk assessment of melamine and melamine analogs.
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."
One potential problem would be if both melamine and cyanuric acid are present in formula, says melamine expert Mengshi Lin, PhD, assistant professor of food science at the University of Missouri, Columbia.
"One part per million is a very low level of melamine -- if no other chemical is included," Lin tells WebMD. "But if you have 1 part per million of melamine and 1 part per million of cyanuric acid, that is a big problem. The two chemicals react to form crystals, and that can be a big risk, especially for infants."
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
- 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