Parents seeking better sleep for their infants are increasingly turning to weighted sleep sacks and blankets. However, the American Academy of Pediatrics (AAP) and the Consumer Product Safety Commission (CPSC) have raised significant safety concerns. The AAP deems these products unsafe for infants, and the CPSC is investigating “multiple fatalities associated with” weighted infant products, according to CBS News.
Major retailers like Amazon and Walmart have removed products from Dreamland Baby and Nested Bean after receiving warnings from a CPSC commissioner about potential dangers. Both companies, however, assert that their products are safe and that the fatalities under investigation are not linked to their brands.
Companies Defend Product Safety
Nested Bean CEO Manasi Gangan stated that there are no investigations related to her company’s products, nor have any fatalities been linked to them. Gangan, who founded her company in 2011, designed the products to mimic a parent’s comforting hand on a baby’s chest. She commissioned a study that concluded the products did not affect a baby’s breathing or heart rate.
“The study proved our products have always been safe as designed,” Gangan said.
However, the AAP noted that this study only measured the weights on five babies for two minutes and did not test the products in real-world sleeping conditions.
Dreamland Baby CEO Tara Williams, who also started her company after seeking sleep solutions for her child, defended her products, highlighting that a pediatrician leads their medical board. Williams mentioned a study of babies using weighted products in hospitals and is conducting a clinical trial now. However, she acknowledged that no study was done before the products were marketed in 2018. Williams questioned the feasibility of small businesses conducting extensive, peer-reviewed clinical trials before releasing products.
“We’re a small business. How would we have innovation in America? This is how America works,” Williams said.
Health Experts and Parents Voice Concerns
Gloria Gamboa, a new mother of twins, hoped Dreamland Baby’s weighted sleep sack would help her babies sleep but found them too heavy and potentially restrictive for breathing and movement. She decided against using them due to safety concerns.
“My instincts told me, don’t use this,” Gamboa said.
Dr. Ben Hoffman, president of the AAP, emphasized that anything limiting a baby’s movement or affecting their ability to breathe can be risky. The AAP advises against using any weighted blankets or swaddles for infants, citing risks like lower oxygen levels and an increased chance of sudden infant death syndrome (SIDS).
“I cannot imagine a scenario in which [weighted products] are a good thing,” Hoffman said.
The CPSC advises parents against using weighted blankets and swaddles for sleep and recommends consulting with pediatricians before purchasing any product claiming to improve baby health or sleep.
Regulatory Challenges
Dr. Hoffman highlighted a significant regulatory gap, noting that current rules allow products to enter the market without proven safety records. 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,” Hoffman said. “Show me the data that it’s safe. If you can’t show me that it’s safe, I can’t recommend it.”
Senator Richard Blumenthal of Connecticut pointed out that the CPSC lacks the authority to mandate the removal of dangerous products from the market.
“No matter how egregious or severe the dangers, the Consumer Product Safety Commission doesn’t have the power to mandate that companies stop producing or selling them,” Blumenthal said.
Both Dreamland Baby and Nested Bean reported sales dropping by more than 50% following the retailers’ decisions to pull their products. Dreamland Baby’s CEO plans to sue the CPSC over the commissioner’s letter to retailers, claiming the agency violated her constitutional rights.
