Sleep-deprived new parents are increasingly turning to weighted sleep sacks and blankets to help their infants sleep better and longer. But the American Academy of Pediatrics and the Consumer Product Safety Commission have raised serious safety concerns. The AAP says these products are unsafe for infants, and the CPSC told CBS News investigating "multiple fatalities associated with" weighted infant products. 

Products from Dreamland Baby and Nested Bean are among those that major retailers, including Amazon and Walmart, have pulled from their shelves after a CPSC commissioner wrote letters to the companies warning  about the potential dangers. 

But those two companies say their products were designed with safety in mind, that they consulted with experts and no deaths have resulted from their products and the the deaths being investigated are not associated with products made by those brands

Nested Bean & Dreamland Baby CEOs defend products' safety

Despite these warnings, Nested Bean CEO Manasi Gangan said there is no investigation related to her company's products and noted there have been no fatalities linked to the items. 

Gangan founded her company in 2011 after seeking sleep solutions for her own infant. She says the products, containing a pouch with small plastic beads, mimic a parent's comforting hand on a baby's chest and are safe. She also commissioned a study that she says shows the weight of the products did not affect a baby's breathing or heart rate. 

Gangan says the study proved "That our products have always been safe just as we had designed them, they were designed to be safe."

However, the AAP noted that the study only measured the weights on five babies for two minutes and did not test the products in real-world conditions for babies sleeping for extended periods.

Dreamland Baby CEO Tara Williams, also a mom who started her company after searching for sleep solutions, defended her company's products as well. 

She said that Dreamland Baby has a full medical board, that is led by a pediatrician.

Safety had "always been the heart of what we did," said Williams. 

She said she relied on a study of babies using weighted products in hospitals and is conducting her own clinical trial now. 

However, she acknowledged that no study was conducted before the products hit the market in 2018. When asked whether it's the manufacturer's responsibility to ensure a product's safety before it reaches the market, Williams questioned whether any other businesses  conduct extensive, peer-reviewed clinical trials, which can take years, prior to a product's release."We're a small business. How would we have innovation in America? I mean, this is how America works," said Williams.

Health experts, parents caution against weighted sleep sacks

Gloria Gamboa, a new mom of twin boys, initially hoped that Dreamland Baby's weighted sleep sack would help her babies sleep. But she found the sacks too heavy and was worried that her children wouldn't be able to move or breathe. She decided against using them due to her concerns about the safety of her babies. 

"My instincts told me, don't use this," Gamboa said.

Dr. Ben Hoffman, president of the AAP, said that anything that limits a baby's movement or impacts their ability to breathe can put them at risk. The AAP advises against the use of any weighted blankets or swaddles for infants, citing risks such as lower oxygen levels and an increased chance of SIDS, or sudden infant death syndrome. 

"I cannot imagine a scenario in which [weighted products] are a good thing," said Hoffman.

In a statement to CBS News, the CPSC said it advises parents against using weighted blankets and swaddles for sleep. "CPSC encourages parents to consult with their pediatrician before buying any product that claims to improve baby health or help with sleep."

Regulatory gaps in products

Dr. Hoffman explained that the current system permits products to enter the market without any proven safety record or requirement for safety demonstration. 

He said 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 pointed out a broader regulatory issue, saying that the Consumer Product Safety Commission has no power to take products off the shelves. 

"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.

Both Dreamland Baby and Nested Bean told CBS News their sales dropped more than 50% following the retailers' decisions to remove their products. Dreamland Baby's CEO said she plans to sue the CPSC over the commissioner's letter to retailers, claiming the agency violated her constitutional rights.

Anna Werner

Anna Werner is the national consumer investigative correspondent for CBS News. Since joining CBS News in 2011, she has covered and investigated a wide range of impactful stories, winning numerous awards. Contact her at: wernera@cbsnews.com

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