Until then, CPSC chair Inez Tenebaum told reporters, the warning "is a way for us to communicate directly and quickly with consumers."
Tenebaum noted that Wednesday's action is the latest step taken as part of CPSC's "Safe Sleep" initiative, a national campaign designed to educate parents about federal safety standards for cribs and potential bedding hazards.
Sharfstein explained that infant sleep positioners first came to the U.S. market in the 1980s, as a sleep aid that promised to help reduce infant gastroesophageal reflux disease (GERD), as well as the risk for "plagiocephaly."
Also known as "flat head syndrome," plagiocephaly occurs when a baby develops a flat spot or an asymmetrical head shape in response to external pressure. The immobility promised by a sleep positioner was advertised as a way to prevent the type of infant movement that could cause such a complication.
But many parents have turned to the device because of suggestions that by keeping infants on their backs sleep positioners actually reduced the risk of SIDS.
Sharfstein stressed that "the FDA has never approved an infant sleeper to prevent SIDS."
Dr. Rachel Moon, chair of the Sudden Infant Death Syndrome Task Force with the American Academy of Pediatrics, told reporters that, as a pediatrician and a parent, she understands the impetus to place an infant in a positioner if there is some inkling that it might prevent SIDS.
But she was adamant that there was "no scientific evidence" to support such a claim, while mounting indications strongly suggest that positioner devices actually threaten babies with "at least a risk of injury and even a risk of death."
"To me," she said, "the
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