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FDA warns against products promising SIDS prevention

Crib and accessories: Make sure your baby has a safe and durable crib to sleep in.
Crib and accessories: Make sure your baby has a safe and durable crib to sleep in. (iStock/poligonchik)

JACKSONVILLE, Fla. – The U.S. Food and Drug Administration is targeting over-the-counter products claiming to cure, treat or prevent sudden infant death syndrome, or SIDS. 

The National Institute of Child Health and Human Development defines SIDS as "the sudden death of an infant under one year of age, which remains unexplained after a thorough case investigation, including performance of a complete autopsy, examination of the death scene, and review of the clinical history."

The FDA has never cleared or approved a baby product to reduce the risk for SIDS or to prevent it. In an online statement, the administration said it is not aware of any scientific studies showing a medical device can reduce the risk for SIDS.

Examples of common over-the-counter products that make such claims include:

  • Baby monitors
  • Mattresses
  • Crib tents
  • Pillows
  • Crib bedding, including bumpers and blankets
  • Infant positioners

Research shows the best way to reduce the risk for SIDS is to create a safe sleep environment for a baby:

  • Alone
  • In their own space with no other people in the crib
  • On their back on a firm sleep surface
  • In a crib or bassinet that is free of pillows, blankets, bumpers, sleep positioners and other objects