Infant

Xanthan gum, a common food additive on the FDA’s GRAS list (generally regarded as safe) is suspected as a possible cause of serious illness and death in infants.

According to the New York Times, a product called SimplyThick, which has been “widely used at all in neonatal intensive care units,” is the possible culprit, particularly the ingredient xanthan gum. The product was given to infants with feeding issues. Infants began developing necrotizing enterocolitis, or NEC after consuming the product.

The Times reports, SimplyThick which easily mixed with breast milk and maintains its consistency and efficacy was widely recommended: “Doctors in newborn intensive care units often ask non-physician colleagues like speech pathologists to determine whether an infant has a swallowing problem. And those auxiliary feeding specialists often recommended SimplyThick for neonates with swallowing troubles or acid reflux.”

When the FDA learned of more than a dozen cases of NEC connected with SimplyThick use, the agency issued a warning. That was in 2011. An FDA investigation was published in The Journal of Pediatrics in 2012, reports the Times, and found a distinct illness pattern “in 22 instances that suggested a possible link between SimplyThick and NEC. Seven deaths were cited; 14 infants required surgery.”

Possible reasons for the illnesses may be that the delicate digestive systems of newborns are not able to handle xanthan gum at that stage in their development. And an audit of the SimplyThick manufacturing facility also found violations and possible bacterial contamination risks that eventually led to company recalls.

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