January 9, 2008
Yonkers, N.Y.— Citing new data about infant formula that was quietly posted by the Food and Drug Administration over the holidays, Consumers Union (CU), publisher of Consumer Reports, today urged FDA to move quickly to expand testing of infant formula for melamine and related compounds, and to recall all contaminated products.
In a letter to HHS secretary-designate Daschle and current FDA commissioner Von Eschenbach, (PDF of letter available here) CU called FDA’s November risk assessment, which allows infant formula containing up to 1 part per million of these chemicals on the market “highly flawed.”
Consumers Union noted that FDA posted new test data on infant formula on December 22, which showed that a melamine derivative, cyanuric acid, had been found in two additional samples of formula– bringing the total to 4 contaminated samples out of 89 tested. “That is almost 5 percent of tested samples contaminated, a relatively high rate,” stated Urvashi Rangan, Ph.D., a senior scientist at Consumers Union. Three of the four positive samples found by the FDA are Enfamil with Iron or Enfamil Lipil with Iron milk-based powder, and the fourth is Nestle Good Start Supreme with Iron milk-based liquid.
“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 said.
FDA states that the amount of melamine and related compounds found in the formula, which range from .137 to .412 parts per million, are safe. However, Consumers Union called the FDA risk assessment from November 2008, which stated that up to 1 part per million of melamine in formula is safe, “flawed” and said it ignored key scientific data. An FDA risk assessment issued just eight weeks previously in October 2008 had stated that no amount of melamine in formula could be considered safe.
“In its October assessment, FDA cited both a cat and a rat study in which a combination of melamine and one of its derivatives, cyanuric acid, caused kidney damage in the test animals at the lowest doses administered. FDA could not identify a ‘no effect’ level for these two compounds in combination, “ stated Michael Hansen, Ph.D., also a Consumers Union senior scientist.
“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,” stated Hansen.
Consumers Union also urged FDA to undertake an expanded and consistent infant formula testing program that examines all brands evenly, to assess the extent of the problem. While FDA tested 21 samples of Mead Johnson/Enfamil formula, and 38 of Abbott/Similac and 25 of PBM (which produced store brands for Walmart and others), it tested only 5 samples of Nestle formula. One of those was positive for melamine.
David Butler, Consumers Union, 202-462-6262