FDA Warns Against Products Claiming to Prevent SIDS

Federal health regulators are warning consumers to be careful about baby products that claim to help prevent sudden infant death syndrome (SIDS). 

The FDA has issued a consumer report alerting the public that no product is known to actually be a prophylactic for sudden infant death syndrome (SIDS), despite advertising claims associated with several products.

FDA experts and pediatric experts say the best way to prevent SIDS is to place a baby on its back to sleep in a crib or bassinet that contains nothing else.

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Parents of newborns are being targeted by advertisements for a wide variety of products that claim to lower the risk of SIDS, including baby monitors, crib tents, crib bedding, infant positioners and mattresses. However, the FDA notes that any product that claims to cure, treat or prevent a condition would be considered a medical device, and subject to approval by the FDA. The FDA has never approved any device that has been found to lower the risk of SIDS.

In fact, many of the products call for parents to pay money and buy a product to put into the crib or bassinet with the child, which is the exact opposite of what the FDA and pediatricians indicate that parents should do to prevent SIDS. The only things that should be in the crib are a firm mattress covered by a tight fitted sheet.

SIDS is defined as an unexplained death of a child less than one year of age. In many cases, medical experts believe those deaths are the result of infants smothering on items left with them in the crib, like stuffed animals, blankets and crib bumpers.

The FDA has launched a new SIDS prevention website for parents, caregivers and manufacturers of baby products.


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