A federal safety agency on Wednesday banned a range of infant sleep products that currently slip between gaps in regulations, an attempt to fix a loophole blamed for at least 90 accidental deaths.
The Consumer Product Safety Commission voted 3-1 to pass the new rule. It requires any product designed for sleeping babies to meet within one year the mandatory federal standards already in place for cribs, bassinets, bedside sleepers and play yards. Dozens of products currently for sale don’t fit into one of those categories, so they don’t need to measure up. Yet they are popular with parents.
The list includes a plethora of products marketed to parents desperate to get their babies to sleep, including devices that claim to help a baby sleep safely in a parent’s bed, along with baby tents and small sleepers known as travel beds or portable bassinets.
Supporters of the new rule said it will address an explosion in untested infant sleep products that conflict with federal safe sleep guidelines. The American Academy of Pediatrics and advocacy groups such as Consumer Reports pushed for the measure.
“I think this is a proud moment for the commission,” CPSC chairman Robert Adler said after the rule was passed.
Critics worried the agency was moving ahead despite a lack of evidence.
John Konsin, a scientist who helps develop voluntary industry safety standards for baby products, wrote a letter to the CPSC pointing out that babies still accidentally die in approved devices and that the new rules provide “no clear understanding of what is safe or a threshold for an unreasonable risk of injury.”
Peter Feldman, a CPSC commissioner, criticized the rule as “overly broad” and said it would likely be tied up in the courts.
“While I have some misgivings,” Feldman said, as the commission prepared to vote, “the safety benefits outweigh them.”
The new rule started out two years ago with a far more limited scope.
It was designed to ban just inclined sleepers after Fisher-Price was forced to recall 4.7 million of its Rock ‘n Play inclined sleepers in 2019 when the product was connected to dozens of infant deaths. Another company, Kids II, recalled nearly 700,000 of its own inclined sleepers.
Inclined sleepers had been controversial ever since Fisher-Price invented the product category in 2009 because they allowed babies to sleep at a 30-degree angle. Federal guidelines say babies should sleep on flat surfaces. But the inclined sleeper was allowed to stay on the market because it was not classified as a crib or a bassinet, which are required by federal safety rules to have flat sleep surfaces.
It turned out that Fisher-Price had invented its inclined sleeper without medical safety testing or input from a pediatrician, according to a Washington Post investigation.
A later CPSC-funded study found that the product’s design - especially the angle - was dangerous because it increased the risk of infant suffocation.
The agency moved to ban inclined sleepers by requiring they comply with existing safety rules - which would’ve limited the incline to 10 degrees, instead of 30.
The CPSC then decided to apply the same rule to any product intended for sleeping infants younger than 5 months old.
The goal is to make sleep safer for babies, said Nancy Cowles, executive director of the advocacy group Kids in Danger, which for years has advocated for tougher rules. With baby sleep products, “a parent assumes someone has made sure it’s safe,” Cowles said. “But so many of these don’t meet any standard.”
That’s what happened to Sara Thompson, whose 15-week-old son Alex died in a Rock ‘n Play in 2011. The mother from Reading, Pa., said she never considered the potential for danger. Earlier this year, she wrote to the CPSC urging the agency to pass the new safety rule.
“If you don’t,” Thompson wrote, “babies will continue to die.”
The four agency commissioners - evenly split between Democrats and Republicans, with one vacant seat - appeared to agree the that lack of regulation was dangerous. But they clashed over the proposed solution.
Feldman, a Republican, wanted to “hit the pause button” and clear up what he said was confusion about the kinds of products that would be affected by the regulation.
Adler, a Democrat, warned of “paralysis by analysis.”
“I think it’s well past time to address this critical safety gap that has unfortunately existed for too long,” Democratic commissioner Elliot Kaye said.
Dana Baiocco, a Republican commissioner, said banning products could cause parents to try homemade solutions. “And that leaves parents in a situation where babies will be in an even more unsafe situation,” Baiocco said.
The CPSC’s decision comes just days before a congressional hearing on infant product safety failures, focused on the Rock ‘n Play. The House Committee on Oversight and Reform hearing is set for Monday. Executives from Fischer-Price and its parent company, Mattel, are expected to testify.
Correction: An early version of this story incorrectly reported that CPSC vote was 4-0. It was 3-1.