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New Infant Formula Safety Rules Set by FDA

No Longer Accepting Cases

June 10, 2014 — Manufacturers of infant formula will have to comply with a new set of safety rules enacted by the U.S. Food and Drug Administration (FDA).

The agency has given manufacturers until September 8 to comply with the requirements, which were announced in a Consumer Update:

  • Manufacturers must test infant formula for disease-causing pathogens, including Salmonella and Cronobacter, and comply with current good manufacturing practices specific to infant formula.
  • Manufacturers must demonstrate that the infant formula they product supposed the normal physical growth of an infant.
  • Manufacturers must test infant formula for nutrient content before the products are marketed and at the end of the product’s shelf life.

In recent years, infant formula has come under scrutiny. In October 2012, a lawsuit was filed on behalf of three children who were infected with Cronobacter sakazakii, a rare infection, after being given different types of Enfamil-brand infant formula. The products were not recalled because the FDA found no evidence that the illnesses were linked.

Lawsuits continue to be filed on behalf of children who were injured by SimplyThick, a thickening agent that is marketed as a way to make breast milk and infant formula easier for babies to swallow. In 2011, the FDA warned that premature infants could develop necrotizing enterocolitis (NEC) from SimplyThick. At the time, they had 15 reports of NEC and two reports of death linked to SimplyThick. In 2012, the FDA warned that infants of any age could develop NEC from SimplyThick.


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