Retailers Halt Sales of Weighted Infant Sleep Sacks, Swaddles and Blankets After ‘Multiple Infant Deaths’ Reported

Several major retailers including Amazon, Target, Walmart, Nordstrom and Babylist have announced that they will stop selling weighted infant sleep sacks, swaddles and blankets after receiving a letter from Richard L. Trumka, Jr., a commissioner at the U.S. Consumer Product Safety Commission (CPSC), alerting them that these products have been involved in “multiple infant deaths.”

Dreamland Baby and Nested Bean are the two main manufacturers of weighted sleep products for babies. Weighted sleep sacks and swaddles are marketed to parents who are desperate to solve the age-old problem of how to get a fussy baby to fall and stay asleep. The products contain weighted beads sewn into their fabric to mimic the sensation of human touch. Dreamland Baby products distribute the weight evenly over the baby’s entire body, while Nested Bean products concentrate the weight on the baby’s chest. Both companies describe the weight in their products as “gentle.” Depending on the sleepwear size, Dreamland Baby says its products contain 0.8 lbs. of beads to 1.5 lbs. of beads. Nested Bean says its sleepwear contains added “filling” of one to two ounces.

In 2020, the founder of Dreamland Baby sought start-up funding on the reality television show “Shark Tank,” where she shared her story of inventing the product to soothe her 6-month-old son who would wake up every 90 minutes during the night. She told the “sharks” that when her son used her first prototype, he began sleeping 12 hours at a time.

While 12 hours of sleep may sound good to sleep-deprived parents, the Consumer Product Safety Commission, American Academy of Pediatrics, National Institutes of Health, and Centers for Disease Control and Prevention all advise that weighted sleep products are not safe for infants.

Trumka wrote to major U.S. retailers on April 15, 2024. He did not provide details about the “multiple infant deaths” or identify the associated product(s). Federal law limits what the CPSC can tell the public about hazardous products without first getting the company’s permission.

A review of the CPSC’s SaferProducts.gov public database shows a report made of a 2-month-old girl who died in 2023 when she was placed in a Dreamland Baby swaddle as well as an infant swing. Experts agree that infant swings are not a safe product for infant sleep. With two unsafe sleep practices at play, it is unclear from the available information as to how (or if) the Dreamland Baby swaddle contributed to the infant’s death.

In a subsequent statement, Trumka praised the retailers who pulled the weighted infant sleep products for “prioritizing safety over profits” and said that he was expecting to hear back from additional retailers soon.

Why Are Weighted Infant Sleep Products Unsafe?

The American Academy of Pediatrics (AAP) cites several significant health concerns associated with weighted infant sleepwear.

First, an infant’s ribcage is not rigid, so prolonged weight and pressure from weighted sleepwear may compress their chest, making it harder for the baby to breathe and for their heart to beat. The AAP also explained that weighted infant sleep products are associated with “concerning reductions in oxygen saturation levels,” which may be harmful to the infant’s developing brain.

Second, weighted sleepwear can make unsafe sleep positions harder to get out of. The AAP recommends that babies be put to bed on their back to reduce the risk of Sudden Infant Death Syndrome (SIDS). Infants who roll over onto their stomach may not be able to roll back over into a safer position. Also, there is a possibility that the sleepwear can shift position, causing the weighted part to cover the baby’s mouth or nose, which poses an asphyxiation hazard.

A review of the SaferProducts.gov database shows that in 2021 a parent reported that their 3-month-old son squirmed in a Nested Bean weighted sleep sack, causing the product to bunch up around his throat and mouth. The parent described the incident as having a “serious potential for asphyxiation.” Another parent reported in 2023 that their 2-month-old daughter experienced difficulty breathing when a Nested Bean weighted swaddle bunched up around her neck while she was moving during light sleep. The parent described what happened as a “potential strangulation incident.” A third parent reported in 2024 that their baby was being held in a sitting-up position in a Dreamland Baby sleep sack when his neck became “bunched into the sack,” causing him to lose oxygen, gasp for air and vomit.

Finally, medical experts believe that impaired arousal may contribute to the risk of SIDS. The deep sleep that is promoted by weighted sleepwear may inhibit babies’ natural ability to startle themselves awake and re-stabilize their system, thus increasing the risk.

It is also worth mentioning that babies have small stomachs. As much as sleep-deprived parents may not like it, babies are expected to wake up every 2-5 hours to feed in their early months, according to the Centers for Disease Control and Prevention.

In light of these concerns, in 2022, the AAP released updates to its safe sleep guidelines to state that weighted blankets, weighted sleepers, weighted swaddles and other weighted objects should not be placed “on or near” a sleeping infant.

Were Weighted Infant Sleep Products Safety-Tested by the U.S. Government Before They Were Brought to Market?

Many consumers are shocked to learn that there is no government agency charged with safety-testing children’s products — or most other products, for that matter — before they are brought to market. And while many consumer products are subject to voluntary safety standards established primarily by industry players, there are no voluntary safety standards in place for weighted infant sleepwear. In fact, the AAP opposes the creation of a voluntary safety standard for the stated reason that it would “send parents and caregivers the incorrect message that these unnecessary products are safe.”

In the absence of any applicable federal regulations or safety standards, Dreamland Baby and Nested Bean have made broad safety claims even though they apparently bypassed the hazard analysis and rigorous testing that any product — let alone a product for vulnerable infants — should undergo by its manufacturer before it hits store shelves. Some of the research that they have touted to the public in support of the safety of their products is of questionable value and relevance.

For instance, in 2023, 12 years after Nested Bean was founded, the company commissioned a study conducted by a private engineering firm to better understand the effects on respiration when an incremental weight is applied to an infant’s body. According to news reports, the study, which was not peer-reviewed, encompassed five babies from newborn to 6 months old, who were observed at 2-minute intervals as researchers put oval weights (similar to the design of the Nested Bean products) on their chests. The weight gradually increased from 1 ounce to about 9.5 ounces. The results showed that the babies’ pulse rates increased, and their oxygen saturation generally decreased, as weight was added to their chests. The engineering firm recommended that “further study be conducted on the long-term exposure in a sleep state,” according to CPSC records.

Citing this study, as well as the experience that Nested Bean has had with its products in the marketplace, the founder and CEO has maintained that while the heavier weights may be cause for concern, the lighter Nested Bean weight is not.

With respect to Dreamland Baby, the company at one point backed its safety claims by citing to a 2020 clinical trial that examined 16 infants suffering from neonatal abstinence syndrome who used weighted blankets for 30-minute-long sessions under constant supervision in the neonatal intensive care unit (NICU). Among the reasons why the study is of dubious value to the matter at hand is that it did not address use of weighted sleep products outside of the hospital setting, nor did it examine overnight sleep sessions. Reference to the study appears to have been removed from the Dreamland Baby website after U.S. Senator Richard Blumenthal contacted both companies in December 2023 to request more information about their safety claims. Dreamland Baby has indicated that it is currently conducting a study involving its products with researchers at Indiana University.

On April 25, 2024, Blumenthal sent a letter to the Federal Trade Commission requesting that the agency investigate whether the two companies have engaged in deceptive advertising in representing their products as safe for infants.

If Weighted Infant Sleep Products Are Unsafe, Why Haven’t They Been Recalled?

Pursuant to federal law, the CPSC cannot unilaterally recall unsafe products without a company’s cooperation. If a company refuses to cooperate, the CPSC must engage in protracted litigation or administrative proceedings to force a recall. Unfortunately, due to legal restrictions on what information the CPSC can publicly share without a product manufacturer’s permission, the status of the CPSC’s efforts (if any) to get Dreamland Baby and Nested Bean to recall their weighted sleepwear products is unknown.

What is known is that Dreamland Baby has sold more than one million weighted sleep products, while Nested Bean has sold more than 2.5 million, according to news reports. In 2021, about 18 months after her appearance on “Shark Tank,” the founder of Dreamland Baby reported that the company reached $10 million in revenue. Nested Bean had $19 million in sales in 2019, according to Forbes. Celebrities such as power couple Chrissy Teigen and John Legend, actress Mandy Moore, and football player Patrick Mahomes are touted on the Dreamland Baby website for using its weighted sleepwear on their babies.

With so much at stake, it is not surprising that Dreamland Baby and Nested Bean have doubled down on their claims that their products are safe. That has child safety advocates worried that we are about to repeat the mistakes that were made with the Fisher-Price Rock ‘n Play Sleeper.

For years, Fisher-Price claimed that the Rock ‘n Play was safe despite a lack of safety testing, concerns by pediatricians, and its knowledge of related deaths. Millions of Rock ‘n Plays entered the marketplace before it was finally revealed that more than 100 babies had died in this product. All the while, the CPSC was barred by federal law from revealing what it knew about the safety (or lack thereof) of the Rock ‘n Play.

While the Rock ‘n Play was eventually recalled, and inclined sleepers are now banned under the Safe Sleep for Babies Act, it will be many years before infants are truly safe from this dangerous product. An untold number of Rock ‘n Plays remain in use in people’s homes and in childcare centers and are available for purchase online from resale marketplaces.

For the sake of vulnerable infants, we cannot afford to let history repeat itself.

What Should I Do If My Baby Has Been Injured by Weighted Infant Sleepwear?

Alan M. Feldman, a co-founding shareholder and product liability attorney at Feldman Shepherd, recommends contacting a product liability attorney as soon as possible if your child has been seriously injured or killed in weighted infant sleepwear.

Feldman observed that product liability law requires that all products be safe for their expected as well as intended use. Regarding weighted infant sleepwear, he said, “the failure of manufacturers to conduct rigorous safety testing before releasing their products into the marketplace is appalling. We commend those retailers who have stopped the sale of these unsafe products.”

Feldman and his team, which includes shareholder Daniel J. Mann and partner Edward S. Goldis, have secured substantial recoveries on behalf of infants and young children who have been seriously injured or killed by children’s products, including baby slings, unstable furniture and magnetic toys. They presently represent five families whose babies died in separate incidents in infant loungers, rockers and inclined sleepers, which do not comply with the safe sleep recommendations of the American Academy of Pediatrics.