The FDA has no right to ban infant sleepwear containing an additional weight, but it’s a “right now” time for the public to take seriously baby safety seriously

There have been warnings from federal regulators, medical experts and safe-sleep advocates over the dangers of 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.”

Dreamland Baby’s claim that its products “exceeded all CPSC standards” was misleading, because there is no standard for weighted infant sleepwear, according to Blumenthal.

Tara Williams, founder and CEO of Dreamland Baby, states that she believes her company’s infant sleepwear is safe and that critics haven’t proved 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 isn’t 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.”

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’re going to be working with the FTC and Senator Blumenthal to help families get a great night’s rest.

Babylist, CPSC and AAP Revisited: A Safety Study on a Weighted Baby Sleep Product and its Comptroller

Weighted infant sleep products have not had a lot of scientific research on their safety. The baby who slept under a weighted blanket had no adverse events in the study, but their heart rates slowed and it lasted less than 30 minutes.

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.

Gangan said the coroner’s report cites a tragic combination of proven-unsafe sleep practices. It does not mention a weighted product nor a Nested Bean product.”

“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.

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.”

“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.”

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.

Nested Bean changed a few of their marketing claims after sharing their research with Blumenthal’s staff, according to Gangan.

Can We Learn More about Women’s Business Through Their Investigations?” A Comment on Gangan, DS, 73, PJM, USA

“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.