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Melamine In U.S. Formula “Acceptable”?

©iStockphoto.com/TayaCho

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Common Food Allergies

by Heidi Green
December 01, 2008

Last we heard regarding the issue of melamine in food products, the problem was more widespread than initially believed but did not affect U.S.-made infant formula or other food products. Although a few melamine-containing items had been found in U.S. stores, these products were specialty imports unlikely to affect the vast majority.

FDA said melamine not okay
You may also recall that the Food and Drug Administration (FDA) stated then that the agency was “currently unable to establish any level of melamine and melamine-related compounds in infant formula that does not raise public health concerns.” (Emphasis ours.) After all, the effects of such chemicals on infants’ underdeveloped kidneys are unknown, and formula-fed infants typically consume only formula.

How quickly times change!

FDA says “trace” amounts okay
When the Associated Press (AP) filed a Freedom of Information Act request for information related to the FDA’s testing of U.S.-made infant formula, AP reporters found that the FDA seemed quite willing to accept some melamine and related compounds in infant formula. As reported by Martha Mendoza and Justin Pritchard, the FDA “has detected melamine in a sample of one popular formula and the presence of cyanuric acid, a chemical relative of melamine, in the formula of a second manufacturer.” In addition, a third leading formula maker told AP that its own testing had detected trace levels of melamine in its formula, too.

Yes, Abbott Laboratories (makers of Similac), Nestle, and Mead Johnson (makers of Enfamil)—which, together, manufacture more than 90 percent of U.S.-made infant formula—all have a melamine problem. The AP reports that the FDA has stated that this contamination has occurred during the manufacturing process and not—as was the problem in China—intentionally, to artificially inflate the results of tests to assess the protein levels of milk there.

Still, it is troubling to find that the FDA seems to be backpedaling on its position with regard to this potentially dangerous compound. Dr. Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition denies that the agency ever said or “implied that domestic infant formula was going to be entirely free from melamine.” However, many parents, manufacturers, and news agencies believed initial statements to mean that infant formula containing any melamine would not be sold.

FDA fails parents—and infants?
Even more troubling is the fact that the FDA did not provide this information quickly to U.S. parents. As of this writing, I can find no recent update about melamine on the FDA’s web site—even though news accounts report that the FDA began testing infant formula for melamine in September. In addition, the New York Times’ coverage yesterday, based on the comments of FDA officials, failed to note specific manufacturers or products by name. Do FDA officials, including Dr. Sundlof, need to be reminded that part of their agency’s mission is to provide such information to the public? To quote directly, the FDA is charged with “helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

Oh, yeah. It’s also “responsible for protecting the public health by assuring the safety, efficacy, and security of … our nation’s food supply.” I do wonder if they are fulfilling that responsibility as they test formula, find it to contain low levels of melamine, fail to disclose that information to U.S. parents and decide that these levels are acceptable in spite of the absence of any science about its impact on infant health.

I’m frustrated on behalf of formula-fed babies and their formula-feeding parents. I’m also frustrated on behalf of parents who have made decisions about how to feed their babies without having this information!

If you can, breastfeed early and breastfeed often.

  • Maggie Honnold

    Recent information from our state WIC program indicates that “U.S. Food and Drug Administration has confirmed that no melamine has been detected in Enfamil LIPIL infant formula products and that recent media reports indicating that trace levels were detected are inaccurate.” I would suggest contacting STEPHANIE.BESS@illinois.gov with the Illinois WIC program for confirmation. Thanks, Maggie Honnold, RN/CLC

  • Heidi Green

    Hi, Maggie! I appreciate your response. I started working on an update on the melamine issue earlier today, but it seems appropriate to note this correction here:

    What the FDA found in Enfamil LIPIL infant formula products was not melamine but, rather, cyanuric acid. Melamine and cyanuric acid are “compounds in the same chemical family.” (to quote from Mead-Johnson’s web site)

    This is used by Mead-Johnson in the cleaning of its equipment and, the company admits, trace amounts can then make their way into the formula produced on that equipment. To date, Mead-Johnson says their own testing has not shown any cyanuric acid in their formula. The FDA has stated that it is not concerned about current levels of melamine or cyanuric acid alone in formula. They would be more concerned, even at current levels, if a formula contained both compounds.

    Now, as a parent, I am still not completely reassured, for the reasons I detail above. I am frustrated because this is not the first problem with formula (e.g., metal shavings has been found in packaging; independent testing has shown the actual nutritional content to be very different from that reported on the label; etc.), and I am disappointed that the FDA doesn’t seem to be paying more attention to it or sharing its findings with the public. I hope new and expectant parents are made aware of the issues with formula so that they are making truly informed decisions if they choose to give it to their babies.

    Thanks again!
    Heidi

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