Home Health Parents News Now FDA Warning Changes Feeding Treatment for Some Premature Babies FDA Warning Changes Feeding Treatment for Some Premature Babies By Holly Lebowitz Rossi February 05, 2013 Advertisement Save Pin FB More Tweet Mail Email iphone Send Text Message Print shutterstock_997530 30159 An F.D.A. investigation of 84 cases, published in The Journal of Pediatrics in 2012, 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. Last September, after more adverse events were reported, the F.D.A. warned that the thickener should not be given to any infants. But the fact that SimplyThick was widely used at all in neonatal intensive care units has spawned a spate of lawsuits and raised questions about regulatory oversight of food additives for infants. SimplyThick is made from xanthan gum, a widely-used food additive on the F.D.A.'s list of substances "generally recognized as safe." SimplyThick is classified as a food and the F.D.A. did not assess it for safety. John Holahan, president of SimplyThick, which is based in St. Louis, acknowledged that the company marketed the product to speech language pathologists who in turn recommended it to infants. The patent touted its effectiveness in breast milk. However, Mr. Holahan said, "There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established." Image: Infant holding a bottle, via Shutterstock By Holly Lebowitz Rossi Save Pin FB More Tweet Mail Email iphone Send Text Message Print Comments Add a Comment Be the first to comment! Advertisement Close this dialog window Add a comment FDA Warning Changes Feeding Treatment for Some Premature Babies Add your comment... Cancel Submit Success! Thanks for adding your feedback.