FDA Warns Parents Not to Use Head-Shaping Pillows

Learn why the FDA has taken a hard stance against head-shaping pillows and the risks they present.
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profile picture of Wyndi Kappes
Assistant Editor
November 4, 2022
father holding baby's head
Image: Falcona | Shutterstock

While it may be tempting to fret over baby’s flat head shape during those first few weeks after birth, the Food and Drug Administration (FDA) encourages parents not to fall into the trap of head-shaping pillows.

The FDA defines head-shaping pillows as “typically small pillows, with an indent or hole in the center designed to cradle the back of an infant’s head while the infant lays face up, flat on its back.” As the hype around these products grows on social media, the FDA issued a new statement outlining why parents shouldn’t use and should throw out the pillows.

“The safety and effectiveness of these products have not been established for the prevention or treatment of flat head syndrome (also known as positional plagiocephaly or deformational plagiocephaly), or the more serious condition where the developing infant’s skull bones join together too early (known as craniosynostosis),” the FDA shared in the release.

But it’s not that the pillows are just not effective and not FDA-approved, they also present serious, life-threatening risks. “The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death,” the agency said in the statement, adding, “Do not use infant head shaping pillows due to the risk of sudden unexpected infant death (SUID), inclusive of sudden infant death syndrome (SIDS), and suffocation and death.”

The FDA reminds parents that, in most cases, flat head syndrome will go away naturally as baby grows. It is not painful and doesn’t cause any developmental concerns. If you have concerns about your baby’s head shape, talk with your doctor. They will be able to provide medically appropriate therapies if needed.

When it comes to sleep, the American Academy of Pediatrics reminds parents that, “bare is best.” It’s not just head-shaping pillows; no items should be present in baby’s sleep space. Have more questions about safe sleep? Check out these 10 ways to make sure baby is sleeping safely.

Please note: The Bump and the materials and information it contains are not intended to, and do not constitute, medical or other health advice or diagnosis and should not be used as such. You should always consult with a qualified physician or health professional about your specific circumstances.

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