The parents of a Missouri child who suffered brain damage in March plan to file a Similac infant formula lawsuit, alleging that additional batches of powered formula have been contaminated since a massive recall last year.
Researchers note that infection rates have declined as better infection controls among premature infants see wider use in the U.S., but more could be done
Decision came after FDA determined Similac Probiotic Tri-Blend is an unadulterated drug product, which could put preterm infants' lives at risk.
Bellwether NEC lawsuit trials will include one complaint against Abbott, one complaint against Mead Johnson, and two complaints that name both infant formula manufacturers as defendants.
Abbott is using unproven ingredients in Similac Probiotic Tri-Blend that may not be safe for infants, and is marketing the infant formula in a way that makes it an unapproved drug product, according to FDA
The new infant formula regulations focus on manufacturers immediately notifying the FDA of any nutritional deficiencies or contamination problems.
Infant probiotics are classified as dietary supplements and not approved by the FDA as a form of medical treatment.
Federal regulators have recently taken steps to ban a number of dangerous nursery products, including inclined sleepers and crib bumpers, following alarming reports of infant deaths that could have been avoided
Women who suffered numerous miscarriages after exposure to Camp Lejeune water contamination say they have been ignored by efforts to compensate victims.
The AAP is calling for mandatory safety standards for any weighted infant sleep products, indicating they are unsafe by design.
