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FDA Criticized Over Melamine Stance

Jan 12, 2009 | Parker Waichman LLP, LLP

A recent report issued by the Consumers Union (CU), a nonprofit consumer advocacy group, has revealed that it has found U.S. Food and Drug Administration (FDA) melamine contamination guidelines to be unsafe.

The report said that the FDA’s allowance of melamine-contaminated baby formula products being sold to consumers is a risk to children’s health.  The CU said in a letter written to FDA Commissioner Andrew C. von Eschenbach and Tom Daschle of the U.S. Department of Health and Human Services (HHS), that the “FDA should regulate infant formula based on an assumption that infants may be exposed to melamine and cyanuric acid in combination

Last week, the FDA announced that melamine and its byproduct, cyanuric acid, were found in more U.S. baby formula, the second time that the industrial chemical turned up in baby formula in this country.  Despite the announcement, the FDA continues to insist that U.S. supplies are safe.

The CU, publisher of Consumer Reports, has asked the FDA to both step up and expand its infant formula testing for melamine, cyanuric acid, and related compounds, as well as to recall all contaminated products, InfoZine reported.  It its letter, the CU described FDA’s melamine risk assessment—in which it allows infant formula to contain up to one part per million (ppm) of melamine and related chemicals—conducted in November as “highly flawed,” said InfoZine.  The CU also noted that the risk assessment ignored key scientific data and that an October 2008 FDA risk assessment stated that no amount of melamine in formula could be considered safe, said InfoZine.

According to the CU, a December 22 FDA posting confirmed that cyanuric acid was found in two formula samples, brining the total to four contaminated samples out of 89, which, said Urvashi Rangan, Ph.D, CU senior scientist, “Is almost five percent of tested samples contaminated, a relatively high rate,” reported InfoZine.  Three of the four samples are Enfamil with Iron or Enfamil Lipil with Iron milk-based powder; the fourth is Nestle Good Start Supreme with Iron milk-based liquid, said InfoZine.  “The FDA needs to step up and expand melamine testing. The failure to properly inform people about these findings undermines consumer confidence in a fundamental product that millions of parents depend on,” Rangan added.

Michael Hansen, Ph.D., another CU senior scientist explained that melamine and cyanuric acid are far more poisonous in combination, noting that “Now FDA has found melamine in one sample of Nestle formula, and cyanuric acid in three samples of Mead Johnson’s Enfamil formula.  What if a parent fed both of these formulas to their baby? These two chemicals appear to be far more toxic in combination than either one is separately.  Yet, FDA has set its safety limit based on exposure to just one of these chemicals alone,” reported InfoZine.  Parents sometimes combine formulas, increasing the likelihood that infants are receiving the more dangerous combination of chemicals.

Melamine is a renal toxin that can cause kidney stones and acute renal failure if ingested in large amounts.  In China, melamine-tainted formula sickened hundreds of thousands of children, killing at least six and was added to milk powder by manufacturers to make diluted baby formula appear more nutritious than it really was.


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