FDA warns against using newborn head-shaping pillows that claim to address a medical issue. The FDA warns that head-shaping pillows may cause newborns to suffocate and die.
The FDA emphasises that pillows designed to cradle an infant's head while they sleep on their back are not FDA-approved.
The FDA has found no medical advantage from using newborn head shaping pillows. "Head-shaping pillows may create an uncomfortable sleep environment for newborns and
increase suffocation and mortality risk."
Flat head syndrome, or plagiocephaly, is a typical condition for newborns who sleep on their backs, according to the UK's National Health Service.
Flat head syndrome is not uncomfortable for newborns and does not cause developmental issues, according to the FDA.
Parents who detect an infant's unique head shape should see a doctor. FDA-approved helmets, headbands, and caps help cure flat head syndrome.