• Infant sleep positioners are dangerous and should never be used.
  • These products, also known as baby anti-roll pillows or nests, create considerable risk of Sudden Infant Death Syndrome (SIDS).
  • Scientific studies have never shown baby sleep positioners to offer any medical benefit for infants.
  • Despite the FDA’s warnings, some major companies, including Amazon, still have these products available for purchase.
  • A bare crib with a firm surface and no loose, soft materials — summarized as “Alone on the Back in a bare Crib” (ABC) — is the safest way for an infant to sleep.

The U.S. Food and Drug Administration (FDA) issued a reminder this month to parents that baby sleep positioners are unsafe and should not be used. While FDA can advise parents, they cannot recall the products or pull them from shelves, and some retailers, including Amazon, continue to sell these dangerous items.

What Are Baby Positioners? Why Are They Dangerous?
Baby sleep positioners may also be advertised as “nests,” “baby anti-roll pillows,” or “baby crib wedges,” and they feature built-in raised supports, called bolsters, that are intended to help keep an infant in one position during sleep. These products are usually marketed for infants up to 6 months old. But having any kind of soft item — including toys, quilts, and other baby products — in the crib with an infant is dangerous. If the baby moves in the wrong way, the bolsters can cause suffocation and Sudden Infant Death Syndrome (SIDS). Every year, over 4,000 children die of SIDS, and the FDA has identified 12 cases of infant death tied directly to the use of sleep positioners. Numerous other consumers have noted instances in which infants, after having been placed in a sleep positioner, had moved into a new position that could raise the risk of suffocation. These events underline the importance of avoiding these products for parents and caregivers of very young children.

Are There Benefits to Sleep Positioners?
In the past, some sleep positioners were advertised as offering potential health benefits for infants. In its most recent announcement, the FDA emphasizes that there is no scientifically-sound evidence for any of these health claims. This includes advertisements about baby sleep positioners and preventing acid reflux (gastroesophageal reflux disease (GERD)) or flat head syndrome (plagiocephaly). GERD is a condition in which stomach acid backs up into the esophagus, and plagiocephaly is a deformation of the skull that can occur from the disproportionate application of pressure to an infant’s head. Again, there is no evidence that baby crib wedges offer these benefits, and there is considerable evidence that they significantly increase the risk of infant suffocation.

Will Sleep Positioners Still Be Sold?
While the FDA can issue notices and guidance to parents and can crack down on any companies that market sleep positioners as health devices, the FDA does not have the ability to forcibly remove these products from stores. As a result, it is important for parents to be especially vigilant about staying informed and about avoiding these products. Despite recommendations from FDA and the American Academy of Pediatrics, some major retailers, including Amazon, still have sleep positioners or similarly marketed sleep nests available for purchase. Amazon has also not issued any comment about whether they will continue to allow these types of baby anti-roll products to be sold on or through their website. Many other retailers and online marketplaces, however, including eBay, are in the process of removing sleep positioners after the FDA’s recent announcement.

What Are the Recommendations for Infant Cribs?
Instead of using a sleep positioner, parents and caregivers are encouraged to follow the ABC of infant sleep: “Always on the Back in a bare Crib.” A bare crib means a crib devoid of any kind of soft product, including pillows, blankets, quilts, loose sheets, and toys. By dressing an infant for sufficient warmth, these products are unnecessary and can be kept out of the crib in order to create a safer sleep environment. More details and tips about safe cribs and infant sleep can be accessed from the U.S. National Institutes of Health at https://www.nichd.nih.gov/sts/about/environment/Pages/look.aspx.

How Can Customers Be Involved?
Further regulation of these products may be possible through the Consumer Product Safety Commission (CPSC), an independent federal agency that has different regulatory powers than FDA. At this time, no action has been taken by CPSC, but CPSC makes information about cribs available at https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/cribs. Concerned parents and caregivers can contact the CPSC about this issue through their website at https://www.cpsc.gov/About-CPSC/Contact-Information/.

In addition, if consumers see any baby sleep positioners being marketed with claims about their potential health benefits for infants, or if consumers want to report adverse impacts from these products, those can be reported to the FDA at https://www.fda.gov/Safety/MedWatch/default.htm. The full FDA announcement can be found at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm227575.htm.


by: Sarah Winfrey