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FDA: Do not use infant head shaping pillows

The US Food and Drug Administration has encouraged parents to avoid using infant head shaping pillows to manage head shaping conditions such as flat head syndrome or craniosynostosis.

The US Food and Drug Administration (FDA) recently released a statement urging parents and caregivers not to use infant head shaping pillows.

Infant head shaping pillows are believed by some to change an infant’s head shape to be more symmetrical or treat certain medical conditions, but the FDA has not observed any medical benefits from their use. In fact, the FDA has stated that these pillows can lead to an unsafe sleep environment for infants, potentially causing suffocation and death.

Evidence has not been established on the safety and efficacy of infant head shaping pillows for the prevention of flat head syndrome or craniosynostosis and is not FDA approved. The FDA cautioned that the pillows could lead to sudden unexpected infant death (SUID).

If a parent or caregiver owns an infant head shaping pillow, the FDA urges them to throw it away and not giving it to someone else. Also, the FDA reminded parents and caregivers that flat head syndrome will often dissipate, and it is not lead to developmental risks or cause pain.

In instances where an infant has an unusual head shape, the FDA suggests parents or caregivers talk to that infant’s health care provider. Use of infant head shaping pillows could delay proper evaluation and treatment of head shaping conditions.

The FDA supports the National Institutes of Health’s guidelines for infant sleep, having the infant sleep on their back in a bare crib on a flat surface. In cases where an infant head shaping pillow causes injury, the FDA encouraged parents or caregivers to report it to the FDA and the product manufacturer.

The FDA also encouraged health care providers to discourage the use of infant head shaping pillows and educate communities on the associated risks. Improved awareness can create a safe sleep environment for infants, reducing risk of complications such as SUID.


Do not use infant head shaping pillows to prevent or treat any medical condition: FDA safety communication. US Food and Drug Administration. November 3, 2022. Accessed November 9, 2022. https://www.fda.gov/medical-devices/safety-communications/do-not-use-infant-head-shaping-pillows-prevent-or-treat-any-medical-condition-fda-safety?utm_medium=email&utm_source=govdelivery