Updated May 07, 2024 at 14:07 PM ET
Three of the nation's largest retailers have pulled weighted infant sleepwear from their shelves over mounting concerns that the products could be unsafe for babies.
The decisions by Amazon, Walmart and Target come amid repeated warnings from federal regulators, medical experts and safe-sleep advocates over the potential dangers of products such as swaddles and sleep sacks that contain added weight.
"This is a strong first step, and infants deserve more," Dr. Ben Hoffman, president of the American Academy of Pediatrics, said in a statement. "Exhausted parents shouldn't have to become part-time product safety regulators, but our current system forces them to by allowing infant products onto the market without evidence they are safe."
Sen. Richard Blumenthal, D-Conn., also announced last week that he is calling for an investigation into two of the top weighted infant sleepwear companies in the U.S. — Dreamland Baby and Nested Bean — over allegations of deceptive marketing claims related to the safety of their products.
"The stakes are simply too high to allow weighted infant sleep products to be advertised as 'safe,' especially without a clear disclaimer explaining the lack of an agreed-upon standard for determining safety," Blumenthal wrotein an April 25 letter to Federal Trade Commission Chair Lina Khan.
Tara Williams, founder and CEO of Dreamland Baby, said that she believes her company's products are safe and that critics of weighted infant sleepwear lack any evidence proving otherwise.
"We're a small business, and at this point it's the United States government against Dreamland Baby and Nested Bean," said Williams. "This is not a new product category. It's been out for over 10 years. There's over 3.5 million [products] sold with no pattern of hazard."
Dreamland Baby has sold more than 1 million weighted sleepwear products, while Nested Bean has sold more than 2.5 million items.
Manasi Gangan, founder and president of Nested Bean, said her company is offering is a "safe, effective sleep tool" that has helped millions of babies.
"Any claims to the contrary are false," she said. "We look forward to working with the FTC and Senator Blumenthal and getting back to what we love: helping families get a great night's rest."
Is weighted infant sleepwear safe?
Weighted infant sleepwear companies say their products can help comfort young babies and soothe them into a restful sleep, similar to how weighted blankets work for older children and adults.
But critics argue that weighted infant sleepwear could harm babies' developing bodies and impede their ability to breathe and pump blood. They warn that the garments may also prevent infants from moving around or waking themselves up if they get into a position that makes them unable to breathe. Skeptics say more research is needed to prove that weighted infant sleepwear is safe.
"It is imperative that products specifically designed for infants undergo rigorous safety testing and meet the most stringent standards prior to being made available in the market," Michelle Barry, founder of the nonprofit Safe Infant Sleep, said in a statement.
The Consumer Product Safety Commission, the Centers for Disease Control and Prevention and the National Institutes of Health have all warned against the use of weighted infant sleepwear.
There has been little scientific research into the safety of weighted infant sleep products. One safety study published in the journal Advances in Neonatal Care in 2020 reported "no adverse events" among babies who slept under a weighted blanket, but their heart rates slowed and sessions lasted only 30 minutes at most.
In a safety study conducted on behalf of Nested Bean, researchers found that a 1-ounce weight applied to an infant's chest did "not present clear indications for or against" potential breathing hazards, but that 3- and 9.5-ounce weights "may increase potential hazard and subsequent risk" due to lower breathing rates and faster pulses.
Williams said Dreamland Baby is currently conducting a safety study involving its products with researchers from Indiana University.
CPSC spokesperson Patty Davis said the commission was aware of multiple deaths associated with a weighted infant sleep product. Richard Trumka, a commissioner with the commission, said he wrote letters to several retailers alerting them to the fatalities.
Williams said she knew of two fatalities involving weighted infant sleep products, but that the autopsy reports for both deaths mentioned unsafe sleep practices and one doesn't mention a weighted product at all.
Gangan said the coroner's report in one death cites "a tragic combination of multiple proven-unsafe sleep practices. It does not mention a weighted product nor a Nested Bean product."
She said she believes Trumka's letters "inaccurately attributed multiple infant deaths" to weighted infant sleep products.
"The death of a child is an unfathomable tragedy, yet such an incident does not give public officials license to spread unsupported claims, particularly when they result in endangering a small, minority female-owned business," Gangan said.
Weighted infant sleepwear pulled from store shelves
Amazon, Target, Walmart and the website Babylist have all confirmed to NPR that they no longer sell weighted infant sleep products.
An Amazon spokesperson said it told sellers in early April that they would no longer be able to offer weighted infant sleep products for sale, a policy change the company said it made "with customer safety in mind."
Natalie Gordon, founder and CEO of Babylist, said in a statement that the company values "doing what is best for growing families and keeping a pulse on the newest industry guidance, which is why we have stopped selling these products."
In a post on X, Trumka said the retailers' actions "could save lives, and I'm grateful for their cooperation."
Trumka also said Nordstrom had stopped selling weighted infant sleepwear, but the company did not immediately reply to an email seeking confirmation.
Williams said she had not heard from any of the retailers that stopped selling weighted infant sleepwear and that Dreamland Baby hadn't had any incidents with any of the companies.
Blumenthal calls for a federal investigation
In his letter to the FTC, Blumenthal said the two manufacturers claim their products are safe, even though there is no standard for weighted infant sleepwear and the American Academy of Pediatrics has said the products are unsafe.
"I believe that there is sufficient evidence of potential harm to warrant an investigation. That is the minimum that this federal agency should do," he told NPR. Referring to past marketing claims by the companies, he added, "other agencies should join in demanding that these companies tell the truth."
The FTC declined to comment.
Blumenthal said he became interested in the topic after hearing parents' anxieties and fears about weighted infant sleepwear. "And the more I learned, the more troubled I became and the more questions I asked that have gone unanswered," he added.
For example, Blumenthal said Dreamland Baby's marketing claim on its website that its products "[exceeded] all CPSC standards" was misleading because there is no standard for weighted infant sleepwear.
Williams said that language referred to existing CPSC standards for things like flammability and lead. She added that although Dreamland Baby's staff didn't believe the claim was misleading, the company removed it so as not to confuse customers.
"With us really trying to work with anybody involved — CPSC, AAP — we want to make this abundantly clear: This is what the product is. This is what it does. Here are your expected results," she said.
Gangan said representatives from Nested Bean shared the research behind their marketing claims with Blumenthal's staff and later changed a few of those claims to make them more specific.
"Calling for a federal investigation of two woman-owned small businesses may not uncover any more than what has been openly and earnestly shared, only burdening our resources and harming our ability to help families achieve safe sleep," Gangan added.
Copyright 2024 NPR