Defective: Baby product industry insiders questioned over involvement with setting own safety standards

(InvestigateTV) — With the sting of the now-banned Fisher-Price Rock ‘N Play still fresh, parents, consumer advocates, pediatricians and others are sounding alarms about another baby product named in death reports: weighted infant sleepwear.

At least eight babies have died while wearing these weighted sleepers, swaddles and sleep sacks, according to an InvestigateTV analysis of U.S. Consumer Product Safety Commission data and documents.

Critics charge that a non-governmental committee that is tasked by CPSC law to create voluntary design and safety standards for baby sleepwear is fraught with potential conflicts of interest and accountability issues.

They also say that the committee, largely run by industry insiders, is dismissing injury and death reports from the CPSC as the fault of other factors and not the weighted products that they sell. The CPSC is aware of “multiple deaths,” according to Commissioner Richard J. Trumka Jr. But the agency refuses to make public the exact number.

That safety committee looking at sleepwear is part of the standards-setting organization ASTM International, which has been creating design and safety specifications for consumer products under the CPSC jurisdiction since 1973.

The U.S. Centers for Disease Control and Prevention, the National Institutes of Health and the American Academy of Pediatrics each have called weighted infant sleepwear unsafe because they can potentially suppress a baby’s respiratory system.

Connecticut’s Sen. Richard Blumenthal, a Democrat, has asked the Federal Trade Commission to investigate two companies that make these weighted baby products for claims they made about safety.

“I don’t understand how these companies can become millionaires off of these products, off of our children, while promising that they’re safe,” said committee member Mayra Thomas-Romero.

Her 6-month-old daughter Ali died in 2022 in what a coroner ruled was an unsafe sleep environment that included a weighted sleep sack.

In April, the CPSC warned that weighted sleepwear did not meet safe sleep guidelines and put babies at risk.

A co-chair of the ASTM committee evaluating infant sleepwear is Tara Williams, the CEO and founder of one of those companies that makes weighted sleep sacks. She has threatened to sue the CPSC and Trumka Jr. for issuing public warnings about weighted infant products.

Williams, whose company is called Dreamland Baby Co., would not agree to an interview with InvestigateTV but issued a statement through a public relations representative saying that her weighted infant products are safe.

“Dreamland Baby proudly stands behind the safety and efficacy of its gently weighted sleep sacks, which have been on the market since 2019. During that time, we have sold over 1,000,000 sleep sacks with no reported adverse events attributed to our gently weighted sleep solutions,” the statement says.

Some members of that ASTM committee who are attempting to set standards for wearable infant blankets are concerned that industry insiders such as Williams have too much influence.

“I just really struggle with the conflict of interests of people who are making these decisions,” said another committee member, Shayna Raphael. “I think…that if you would directly benefit financially from a certain type of product coming through that there should be some reflection on, ‘Hey, is it ethical?’”

Raphael’s daughter Claire was 11 months old when she died while napping in an adult bed at a daycare. Although her death didn’t involve a weighted product, her mother has filtered her grief through advocacy related to safe sleep.

It’s what led her to volunteer to sit on the ASTM committee developing voluntary standards for infant sleepwear, which included weighted baby products.

“It’s been a contentious process that has been a couple of years in the making already,” she said. “I and other consumer safety advocates definitely see some red flags, seem to be repeats of what we’ve seen in history where we have manufacturers that have a clear financial interest in these products being allowed to chair the committees that set the standards for these products.”

A public warning leads to threats of a lawsuit and allegations of unfairness

ASTM International is a little-known entity with a huge impact on Americans’ everyday lives.

It creates voluntary standards for everything from concrete and roofing materials to coffee pots and strollers.

And under recent changes in consumer product safety laws, the CPSC must use ASTM standards when enacting many regulations for toys and baby products.

“Our statute requires us to defer to an industry written, voluntary standard as long as it’s good enough to protect people,” Trumka said. “If that happens, we defer to it; we can’t make our own rule. And so there’s a lot of power in that process.”

The CPSC also has no role in selecting who serves on these committees or their day-to-day operations. But the CPSC does have staff that sits on many of the committees in an advisory capacity.

“CPSC has traditionally had a very collaborative relationship where they provide information. They sit with . . . these committees. They work out solutions together, and we see what product comes out of these voluntary standards,” Trumka said.

But the wearable blanket committee has several committee members concerned about fairness, especially in wake of the lawsuit threat lodged by Williams against the CPSC and Trumka.

After the CPSC added weighted sleep products to its list of unsafe sleep practices, Trumka issued a direct warning - and urged large retailers to stop selling weighted sleepwear. Many did.

“I write to inform you of a consensus among public health agencies, pediatricians, and Safe Sleep proponents: that weighted infant products, like sleep sacks, swaddles, and blankets are not safe for infant sleep. I am aware of multiple infant deaths involving weighted infant sleep sacks,” Trumka wrote in his letters to retailers.

After many retailers pulled the products from their shelves and online stores, Williams sent a letter to the CPSC and Trumka, notifying them of her intent to sue for violating a provision that generally prevents the agency from disclosing information about specific companies without their consent.

The CPSC warnings pertained to all infant-weighted products and did not name specific brands.

While ASTM committees welcome industry insiders because of their expertise with the specific product under review, the organization’s bylaws require chairs to be impartial.

Shayna Raphael sent her concerns to the ASTM about Williams.

“I am writing to express and document the significant concerns that someone who is chairing a committee for a specific product is now suing an entity that works to keep consumers safe. Throughout this process, this person has not demonstrated impartiality or a neutral approach when it comes to the standard and what should be included in the standard. This person has also worked to undermine votes that we have taken,” she wrote in an email that she shared with InvestigateTV.

But ASTM allowed Williams to remain as a co-chairwoman of the committee. The other co-chair is a consumer advocate for safe infant sleep.

After a recent CPSC commissioners meeting, where several members of the weighted sleepwear committee raised concerns about transparency and accountability, Trumka said that he believes an investigation is in order.

“They are very serious allegations. And so I think we should take them very seriously and make sure that they’re properly evaluated,” he told InvestigateTV. “I think that ASTM or the commission should do an investigation to see what’s there and to act accordingly.”

ASTM did not respond to InvestigateTV’s request for comment.

An innovative product caught the eye of investors and worried doctors

Williams founded Dreamland Baby in 2019 with the idea of putting some weight in a swaddle to mimic a parent’s hand or hug to help soothe a baby or help them sleep for hours at a time.

In 2020, she became a start-up success story on the ABC television program Shark Tank when one of the five investors on the show bit on her pitch.

“I can’t believe I made a deal. I feel amazing,” Williams said as she exited the Shark Tank stage after securing a deal.

As her ASTM committee has considered issues such as how big neck holes in swaddles should be to prevent injury and other design-related issues, Williams’ company has made tens of millions of dollars selling the very products she is attempting to set standards for.

The committee has yet to tackle the issue of how much weight should be allowed.

For infants up to 8 pounds, Dreamland’s sleepwear, for example, adds nearly a pound of weight to the baby’s body.

The weight increases as a baby grows, with two pounds added to sleepwear for those who are 20 pounds or heavier.

The American Academy of Pediatrics says there is no safe weight to place on a baby and doesn’t even want the ASTM committee to consider a voluntary standard because it might send a message to parents that these products are safe.

“We oppose the development of any voluntary standard for these products,” Dr. Sandy L. Chung, academy president at the time wrote to the ASTM and the CPSC last spring. “There is no evidence in the peer-reviewed scientific literature evaluating the safety of weighted sleep products on typical, healthy infants, and there is also nothing published regarding their use in an unmonitored setting.”

She said that even non-peer-reviewed studies suggested that weighted items can lead to lower oxygen levels in infants.

“The AAP, the CPSC, the NIH, they’ve all been very clear that weighted infant products are not safe, we’re putting direct weight on even newborns’ bodies right over the respiratory system, and that they should not be used,” Raphael said.

Williams’ written statement to InvestigateTV said that “the statements being made by the AAP, CPSC, NIH and CDC are rooted in theory not fact.” She further criticized the AAP for not having its own peer-reviewed studies proving the specific product is unsafe.

‘We know of incidents’

In setting voluntary standards, the ASTM sleepwear committee evaluates injury and death reports supplied by the CPSC.

The CPSC compiles those reports from death certificates, hospital surveillance, coroners, local death review committees and consumers.

“We have the industry in this case telling us they have no incidents. Yet we know of incidents,” Nancy Cowles recently told CPSC commissioners.

Cowles is a member of the ASTM committee and the executive director of Kids in Danger, which advocates for children’s product safety. “I had no idea there was even such a thing as a weighted sleep sack because it is such a ridiculous idea that you would put weight on a vulnerable child’s chest,” she said.

Cowles also told the commissioners that the sleepwear committee has “devolved because one of the makers of them was the chair.”

Thomas-Romero is one of the few parents who serve on that committee and is the only member who lost a child wearing a weighted sleep sack.

Ali was found unresponsive in a flat toddler bed, wearing a weighted sleep sack with a folded blanket next to her head.

No one can say which of those items, if any, led to her death. But, on the flip side, none of those products can – or should be ruled out, Cowles said.

Thomas-Romero said she fought for the committee to count Ali’s death.

InvestigateTV obtained internal data used by the committee that shows the tally of the babies who should and shouldn’t be counted when considering how to regulate weighted sleepers.

The spreadsheet used by the committee is essentially a hazard analysis –a way to figure out if there is a pattern of problems by reading the narratives of incidents supplied to the committee from the CPSC. The committee marks which to count.

The spreadsheet, with nearly 90 incidents related to infant sleepwear including weighted products, is made up of incidents including deaths between 2011 and 2022 and collected by the CPSC.

InvestigateTV was able to match eight deaths to government reports of babies dying in a weighted sleep sack.

But as of January, members said the committee only counted one death – Ali’s.

“Consumers who are profoundly impacted by the outcomes of our meetings deserve transparency and accountability. It is disheartening to witness a failure to uphold these principles,” committee member and non-weighted swaddle inventor Hindi Zeidman told CPSC commissioners at a recent meeting.

Thomas-Romero served as the co-chair of the committee’s task force that was examining the incident data. But she says when she tried to compare reports to incidents that she received from CPSC, she was kicked out of her leadership position.

“I was just scanning SaferProducts,” she said. “Anytime there was a new (incident) one, I would just copy and paste it. And that was deemed inappropriate and malicious towards manufacturer interests.”

In the past two years, four additional deaths have been reported to SaferProducts.gov, the CPSC’s public database of incidents. The babies were wearing products made by either Dreamland Baby or Nested Bean.

Raphael, a committee member, questions why the group is interpreting data and doing hazard analysis.

“When they are manufacturers or textile specialists, they are not forensic pathologists, and it is wildly inappropriate for them to decide on their own what the contributing factors were for infant death or why or why not they should be on the fatality or incident chart,” Raphael told InvestigateTV. “I think that that’s incredibly problematic.”

Congressman calls for an investigation into claims made by makers of weighted sleepwear

Dreamland Baby and Nested Bean dominate the market for weighted sleepwear.

Together, they have sold more than 3.5 million infant weighted sleepers, according to Williams.

In December, U.S. Sen. Richard Blumenthal called out both companies, saying that they were making false claims about their products.

Nested Bean said in a statement “Over the last 13 years Nested Bean has made safe sleep solutions that are trusted by millions of parents and loved by infants. Safety is our #1 priority and an ongoing commitment. Nested Bean sought guidance from experts right from the design phase. In 2023 CPSC conducted a four month review of our products and deemed them to be safe. An independent fundamental research study indicated that the one ounce of weight we use is safe, with no adverse effects. We have sold over 2.5 million units with zero safety incidents or injuries resulting from our minimally weighted design that mimics a parent’s gentle touch.”

Nested Bean said it would provide InvestigateTV with a copy of that CPSC review saying its products were safe.

The Connecticut Democrat said that both companies were advertising that their products met or exceeded CPSC standards even though no such government standards for weighted infant sleep products exist.

And both companies, he wrote, cite and often discuss in ASTM committee meetings a study of 16 babies with neonatal abstinence syndrome as scientific proof that their products work and are safe.

Blumenthal noted in his letter that that study has not been peer reviewed. He said that it involved 16 infants who were were born with drugs in their system and was conducted under constant supervision of NICU staff as a weighted blanket was placed on the babies for 30-minute intervals.

He asked each company to respond to his questions about how they market their products, prove their safety and other issues.

After Blumenthal’s letter, Dreamland Baby scrubbed CPSC safety claims from its website and removed a list of hospitals that it said it had partnerships with, prompting a further rebuke from the senator.

“Your website claimed that Dreamland Baby held multiple partnerships with hospitals across the country using weighted sleep sacks and swaddles in their neonatal intensive care units. However, when I asked for details about these partnerships, you declined to respond and removed the listed hospitals from your website,” Blumenthal wrote. “This lack of transparency is deeply troubling.”

In April, he called up the Federal Trade Commission to investigate both companies for potential unlawful, unfair or deceptive advertising practices.”

In May, a California mother filed a class action lawsuit against Nested Bean for making false claims about safety. She said in the lawsuit that she used the sleep sack twice and noticed that her baby struggled to breathe both times.

Federal law prohibits CPSC from calling out companies by name

In the past three years, the CPSC has become much more aggressive about issuing public warnings when it begins to see a pattern of injuries or deaths across a category of products.

The agency has alerted consumers about the dangers of water beads, nursing pillows, certain battery types, to name a few. It made those announcements without naming any companies who made those items.

The weighted infant sleepwear deserved the same treatment, Trumka said, especially after warnings from other government agencies and the pediatricians’ association.

“I’m proud of the action that I took to echo the agency’s message and warn the American public about this product category,” he told InvestigateTV. “I’ve spoken to parents whose children have died in products like this. And it’s my fear, it’s my great fear, that I never want to have a conversation with somebody else.”

A provision of the federal consumer protection law known as section 6(b) prevents the CPSC from publicly naming a specific company or issuing a recall without first receiving consent from the manufacturer.

Many consumer advocates and the pediatrics academy say this provision, sometimes called the gag rule, unnecessarily hamstrings the CPSC and leaves consumers at risk.

“Make no mistake. This policy has and continues to put infants and children at real risk of injury and death,” Dr. Benjamin Hoffman, the current president of AAP, recently told the CPSC.

On June 7, the CPSC released a list of 397 injuries and deaths tied to infant sleepwear or blankets. Most of the reports – 333 – were fatalities. But the agency did not indicate which of those incidents involved weighted sleepwear.

Trumka’s warning about the potential dangers of weighted infant blankets, swaddles and sleep sacks did not mention any company by name.

But Williams hired an attorney, who notified the CPSC and Trumka in May that she intends to sue for violating section 6(b).

“As a result of Commissioner Trumka’s unlawful statements and actions, Dreamland has suffered tremendous financial losses. In fact, one retailer has stopped the sale of all of Dreamland’s products, not just its weighted products,” a letter written by Dreamland’s attorney says.

Fears mount that history is repeating

Critics of weighted sleepers repeatedly have referenced the similarities to the Rock ‘N Play, which has been tied to about 100 infant deaths.

Fisher-Price was the first to create the inclined sleeper. Other manufacturers followed. All are now banned.

The Rock ‘N Play and weighted sleepwear both were envisioned and designed by moms who had difficulties with their babies sleeping.

Both hit the market without any safety standards but with medical claims and/or non-peer reviewed studies that have been questioned by the American Academy of Pediatrics.

Both had injuries and deaths reported to the CPSC not long after hitting the market.

Both had or have a seat at the ASTM table with a top executive co-chairing their respective safety standards committee.

And both refuted reports of injuries and deaths, with Fisher-Price blaming parents for not using the inclined sleeper as intended.

“Any time we have infant deaths in a product, I am terrified that we might have the next Rock ‘N Play on our hands,” said Commissioner Trumka, who was not at the CPSC during that time but used that Fisher-Price inclined sleeper for his own children. On the day the recall was announced in 2019, he said he took it to the dumpster.

Zeidman, another member of the infant sleepwear ASTM committee, recently told her fellow members that history may be repeating itself.

“In order to effectively enhance safety and prevent the recurrence of historical tragedies such as the instances of unnecessary deaths associated with inclined sleepers . . . it is essential to acknowledge that our present meeting environment may not be optimally aligned with these objectives,” she said.

But the committee soldiers on. CPSC staffers told the committee in May that it soon will be delivering a batch of 150 incidents tied to wearable blankets – including those with weights – for it to analyze.

The CPSC did not say how many of those reports involved a weighted sleeper.

Thomas-Romero remains dismayed by her experience with the ASTM committee, she said she will continue to fight to make sure that Ali’s death is a statistic.

“I’m so defeated and worried about what I’m going to do the next day,” she said.

As the ASTM continues to look at weighted sleepwear, Shayna Raphael worries that babies might be in danger as the process drags on because the products remain on the market.

She’s asked how many babies have to die before the process is halted.

“Because there aren’t enough dead infants that we can’t keep this (weighted sleepwear) out of the standard,” she said. “It’s really upsetting to see.”

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