Sleep Positioning Products for Babies: FDA Issues Warning


FDA Issues a Warning About Infant Sleep Positioner Safety

The FDA has reiterated its warning against sleep positioning products for babies, emphasizing that there is no evidence supporting infant sleep positioner safety to treat certain conditions. In fact, the sleep positioning products that purport to reduce the risk of “flat head syndrome,” infant acid reflux, or Sudden Infant Death Syndrome (SIDS) have been linked to infant fatalities. These products have been on the market despite previous warnings from the FDA regarding infant sleep positioner safety.

Baby sleep positioners, sometimes called nests, cradlers, or anti-roll products, have not been proven to reduce the risk of SIDS but have in fact suffocated infants who were turning from their sides to their stomachs. Though the positioners were designed to keep an infant’s head raised up or wedged in place to prevent rolling or keep them from sleeping in a flat position, the devices do not function as intended and can instead trap an infant in a dangerous position. According to reports, even infants who were placed on their backs in these products were found in compromising positions while in or beside their baby sleep positioners.

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