As sleep-deprived parents desperately seek solutions to help their infants sleep better and longer, many are turning to weighted sleep sacks and blankets. These products, offered by companies like Dreamland Baby and Nested Bean, have gained popularity among exhausted caregivers. However, the American Academy of Pediatrics and the Consumer Product Safety Commission have raised alarming safety concerns about these weighted sleepwear items.
The AAP has taken a firm stance, stating that weighted sleep products are unsafe for infants. Dr. Ben Hoffman, president of the AAP, emphasized that anything limiting a baby's movement or impacting their ability to breathe can put them at risk. The organization advises against the use of any weighted blankets or swaddles for infants, citing potential dangers such as decreased oxygen levels and an increased likelihood of Sudden Infant Death Syndrome.
The CPSC has also expressed grave concerns, revealing to CBS News that they are investigating "multiple fatalities associated with" weighted infant products. In response to these safety issues, major retailers, including Amazon and Walmart, have pulled products from Dreamland Baby and Nested Bean from their shelves after a CPSC commissioner issued warning letters to the companies.
Despite the warnings, the CEOs of Dreamland Baby and Nested Bean have defended the safety of their products. Manasi Gangan, founder and CEO of Nested Bean, asserted that there is no investigation related to her company's products and that no fatalities have been linked to their items. Gangan, who started the company in 2011 while seeking sleep solutions for her own infant, explained that the products contain a pouch with small plastic beads designed to mimic a parent's comforting hand on a baby's chest. She commissioned a study that reportedly showed the weight of the products did not affect a baby's breathing or heart rate. However, the AAP pointed out that the study only measured the weights on five babies for two minutes and did not test the products in real-world conditions for extended periods.
Similarly, Tara Williams, CEO of Dreamland Baby, maintained that safety has "always been the heart of what we did." Williams, who founded the company after searching for sleep solutions for her own child, stated that Dreamland Baby has a full medical board led by a pediatrician. She relied on a study of babies using weighted products in hospitals and is currently conducting her own clinical trial. However, Williams acknowledged that no study was conducted before the products hit the market in 2018. When questioned about the manufacturer's responsibility to ensure product safety before release, Williams argued that small businesses might struggle to conduct extensive, peer-reviewed clinical trials prior to launching a product, asking, "How would we have innovation in America?"
Gloria Gamboa, a new mother of twin boys, initially considered using Dreamland Baby's weighted sleep sack to help her babies sleep. However, she found the sacks too heavy and worried that her children wouldn't be able to move or breathe. Trusting her instincts, Gamboa decided against using the products due to concerns for her babies' safety.
Dr. Hoffman from the AAP emphasized that the current regulatory system allows products to enter the market without proven safety records or requirements for safety demonstration. He noted that products can be sold even if they contradict established medical knowledge and scientific evidence about safe sleep practices. "The proof of safety lies with the manufacturer," said Hoffman. "Show me the data that it's safe. If you can't show me that it's safe, I'm not going to be able to recommend it."
Democratic Sen. Richard Blumenthal of Connecticut highlighted a broader regulatory issue, pointing out that the CPSC lacks the power to mandate companies to stop producing or selling dangerous products. "No matter how egregious or severe the dangers from a particular product, the Consumer Product Safety Commission doesn't have any powers to mandate that companies stop producing or selling them," said Blumenthal.
The controversy surrounding weighted sleepwear has taken a toll on the companies involved. Both Dreamland Baby and Nested Bean reported a more than 50% drop in sales following retailers' decisions to remove their products from shelves. Dreamland Baby's CEO announced plans to sue the CPSC over the commissioner's letter to retailers, alleging a violation of her constitutional rights.
As the debate continues, parents are left grappling with the challenge of ensuring their infants' safety while desperately seeking solutions for better sleep. The CPSC advises parents to consult with their pediatricians before purchasing any product claiming to improve baby health or sleep. Until more conclusive evidence emerges, the AAP maintains its stance against the use of weighted sleepwear for infants, prioritizing the well-being and safety of the most vulnerable population.
