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Mon Dec 15 23:25:24 MST 2008
FDA Discounts Danger From Melamine in U.S.-Made Infant Formula
Audio: Stephen Sundlof, D.V.M., Ph.D., Director of the FDA’s Center for
Food Safety & Applied Nutrition
ROCKVILLE, Md., Dec. 1 -- Levels of melamine found in a sample of
U.S.-made infant formula do not pose a safety risk, the FDA said.
The agency detected trace amounts of the toxic chemical in a single
sample of Nestle Nutrition's Good Start Supreme Infant Formula with
Melamine was found in concentrations of 137 and 140 parts per billion.
In an updated risk assessment, the FDA said that concentrations less
than 1,000 parts per billion do not raise safety concerns. Earlier the
FDA had said no level of melamine was safe. (See: FDA Says No Safe Level
of Melamine in Baby Formula)
Agency testing also found cyanuric acid -- a chemical relative of
melamine -- at concentrations of 247, 245, and 249 parts per billion in
a single sample of Mead Johnson's Enfamil Lipil with Iron. Levels below
1,000 parts per billion are considered tolerable, according to the
updated risk assessment.
The FDA is still awaiting results from 13 of the 87 samples tested.
Agency officials stressed that U.S.-made infant formula is safe and that
there have been no reported illnesses stemming from its use.
"Switching away from one of these infant formulas to alternate diets or
homemade formulas could result in infants not receiving the complete
nutrition required for proper growth and development," said Stephen
Sundlof, D.V.M., Ph.D., director of the FDA's Center for Food Safety &
The updated risk assessment does not address the safety of a combination
of melamine and one of its chemical relatives. Such a combination has
not been found in any U.S.-made formula, Dr. Sundlof said.
The agency believes the chemical was not deliberately placed in the
Trichloromelamine is approved for use as a cleaner for food processing
equipment and utensils and breaks down into melamine when used. Melamine
is also approved for use in objects such as can liners and packaging
On Oct. 3, the FDA issued a risk assessment saying that it could not
determine a safe level of melamine in infant formula. The agency
released an updated risk assessment last week after completing further
The information released by the FDA corrected a report from the
Associated Press last week that said that melamine was found in the Mead
Johnson product and cyanuric acid was found in the Nestle Nutrition
product. (See: Melamine Found in U.S.-Made Baby Formula)
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