Manufacturers of baby products have been warned they can no longer claim that their products can prevent sudden infant death syndrome (SIDS). The notice came in a letter dated yesterday from the US Food and Drug Administration (FDA).
In September 2010, the FDA and the Consumer Product Safety Commission issued a joint warning to the public that infant sleep positioning devices marketed as helping to prevent SIDS actually pose a suffocation risk. The agencies cited reports of 12 infant deaths associated with use of the devices, as well as dozens of reports of near misses. Warning letters were also sent by the FDA to the manufacturers of such sleep positioners, stating that any products making health claims are subject to regulation and manufacturers must submit evidence supporting health claims to the agency and gain approval before making such claims.
At the time, questions arose about why the agency chose only to target sleep positioners when many baby products claim to reduce the risk of sudden infant death—the unexplained death of an infant before age 1 year. The agency is now broadening its efforts to crack down on manufacturers of a range of products, including baby monitors, mattresses, crib tents, pillows, and crib bedding, including bumpers and blankets, that make unsupported SIDS prevention claims.
The agency has never approved a device for the prevention of SIDS and suggests that, rather than buy devices making unproven claims, parents follow the advice from trusted organizations such as the American Academy of Pediatrics, which recently updated its recommendations on preventing SIDS. The update named additional steps to lower the risk of SIDS, including breastfeeding, ensuring infants receive recommended immunizations, and removing crib bumpers.
“The best thing you can do to lower the chance of Sudden Infant Death Syndrome (SIDS) is to place your baby on his or her back to sleep, with nothing else in the crib or bassinet,” the FDA noted in a statement.
The FDA is also urging parents to report baby products that make medical claims, or injuries or malfunctions they have experienced with baby devices.