US infant formula safe from melamine, says FDA

01-Dec-2008 - Last updated on 01-Dec-2008 at 16:12 GMT

The domestic supply of infant formula in the United States is safe for consumption, the FDA has said following an investigation into contamination with the industrial chemical melamine.

FDA’s melamine update, published last week, follows its risk assessment in October that had cleared all foods except infant formula from posing a risk.

At the time, the agency had said it was impossible to establish a limit on the chemical’s presence in infant formula, owing to uncertainty over the specific impacts of melamine in an infant’s body. This did not necessarily suggest that any exposure to the chemical in infant formula would harm infants, but that there was too much uncertainty to outline specific guidelines for consumers, said FDA at the time.

US formula safe

Further to the first interim assessment, the agency has confirmed the safety of US-manufactured infant formula, and recommends consumers can continue to use it.

“Levels of melamine alone or cyanuric acid alone, at or below 1 part per million (ppm) in infant formula do not raise public health concerns,” wrote FDA in the update to its risk assessment.

This is up to 10,000 times less than the levels of melamine reported in Chinese-manufactured infant formula.

The agency said it had been collecting and analyzing samples of domestically manufactured infant formula for the presence of melamine and melamine-related compounds. So far, tests have found “extremely low” levels of melamine in one infant formula sample and “extremely low” levels of cyanuric acid in another, it said.

“The levels were so low (well below 1 ppm) that they do not pose a health risk to infants,” it said. To view the test results, click here.

Tighter scrutiny

The focus on melamine came to light in September, after it emerged that milk powder for infants was found to have been contaminated with melamine in China.

The contamination in China led to the death of four Chinese children, and the hospitalisation of thousands more.

Melamine is a chemical that can make it appear there is more protein in a product, and has been linked to causing kidney stones and other health problems.

The compound alone is of low toxicity, but studies with animals have suggested that combination of melamine with cyanuric acid, a potential impurity of melamine, may lead to the kidney problems observed in China.

More research

FDA said it is continuing to sponsor and conduct animal studies to assess the potential toxicity from co-ingestion of melamine and cyanuric acid.

The agency said that once this is completed, it will update its interim safety/risk assessment for melamine and its analogues.

For the time being, the agency states: “The safety/risk assessment assumes the analogues to have equal effect. Thus, levels of melamine or one of its analogues alone below 1.0 ppm in infant formula do not raise public health concerns.”