SimplyThick Manufacturer Changes Product Warnings in Light of Potential Catastrophic Infant Injury or Death
In February SimplyThick, LLC, the manufacturer of SimplyThick, announced online a major change to its product warnings. The new warning will state that SimplyThick is “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.” This action follows two advisories by the U.S. Federal Drug Administration (“FDA”) that infant’s fed SimplyThick may develop necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, which can be fatal. In May 2011, the FDA advised against feeding SimplyThick to infants born before 37 weeks gestation because it could cause NEC. In September 2012, the FDA expanded its warning to all infants under the age of 12 months.