FDA uncertain over infant melamine limits

By Neil Merrett

- Last updated on GMT

Related tags Infant formula Risk Food

The US Food and Drug Administration (FDA) says it is unable to set a safe level of melamine contamination in infant formulas after issuing a wider ruling on the chemical’s presence in food products containing milk.

As part of a scientific safety and risk assessment of the chemical, which has been linked to kidney problems in thousands of Chinese children, the regulator used both available data and scientific assumptions to ascertain a level where the chemical is a long-term health hazard.

As part of the interim findings, any food product other than infant formula that contains less than 2.5 parts per million (ppm) of the industrial chemical does not pose safety risks for consumers, the regulator said.

However, the FDA claimed that establishing a limit on the chemical’s presence in infant formula was currently impossible, owing to uncertainty over the specific impacts of melamine in an infant’s body.

The regulator added that this did not necessarily suggest that any exposure to the chemical in infant formula would definitely harm infants, but that there was too much uncertainty to outline specific guidelines for consumers.

Infant uncertainty

According to the FDA, this uncertainty has been created by a number of specific factors related to infant formula and their consumption. These include:

  • The consequences of continuous use of infant formulas as a sole nutrition source
  • Unknown impacts of the presence and co-ingestion of different types of melamine
  • Premature infants with immature kidney infections that have been kept solely on formula resulting in a greater levels of intake over a longer time than term infants

‘Worst case scenario’

The FDA added that its conclusions from the assessment of approved food levels was based on a ‘worst-case scenario’, where 50 percent of a consumer diet was contaminated with the maximum allowance level for melamine.

On top of the 2.5 ppm limit of the chemical, the regulator said it had also applied a 10-fold safety factor to the Tolerable Daily Intake (TDI) to offset potential uncertainties.

“The TDI is an estimate of the maximum amount of an agent to which an individual could be exposed on a daily basis over the course of a lifetime without an appreciable health risk,”​ the FDA stated.

Ongoing consultation

As an interim assessment, the FDA said that it would continue screen products, while working with other foreign governments and agencies to prevent contaminated products entering into the food supply chain.

If products are adulterated because they contain melamine and/or a melamine-related compound, the agency will take appropriate actions to prevent the products from entering commerce,”​ the regulator stated.

Related topics Regulation GMPs, QA & QC

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