Saturday, March 2, 2013

John L. Holahan Issues SimplyThick® Necrotizing Enterocolitis Advisory


SimplyThick® 2013 Necrotizing Enterocolitis Risk Update

John L. Holahan is currently apprising customers that his 2001 SimplyThick® xanthan gum based product is contraindicated for infants and for those with a history of necrotizing enterocolitis.
WARNING - [SimpyThick] NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC [necrotizing enterocolitis].
Although no definitive link between NEC and SimplyThick® brand products has been found or established, in an abundance of caution, anyone at risk for or with a significant risk factor for developing NEC should not use SimplyThick® products.
It is note worthy that Mr. Holahan's 2013 advisory is more encompassing than the SimplyThick® infant safety alerts issued by the FDA in May 2011 and September 2012.

SimplyThick® Adverse Infant Medical Events

Mr. Holahan states that there is insufficient evidence to implicate SimplyThick® as a disease-causing agent but the following reports indicate that there is a causal relationship between the xanthan gum infant formula thickener and necrotizing enterocolitis.

 Warning Too Late for Some InfantsThe New York Times

SimplyThick Neonatal Intensive Care Practices

FDA "SimplyThick" Infant Health Risk Warnings are Complicated

Thermo Pac, LLC—SimplyThick— Processing Deficiencies

Infant— SimplyThick—Alert: Health Canada October 18, 2012

John L. Holahan—SimplyThick—Xanthan Gum—Necrotizing Enterocolitis

John L. Holahan: Burdock Group SimplyThick Safe for Infant Formula Approval 2001

SimplyThick Infant Formula Experiment



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