Defective: Parents left to be product testers with their babies as subjects

(InvestigateTV) — When a new type of toy or baby invention hits the markets, most parents assume those products have undergone rigorous safety testing.

But the truth is that in the U.S., their homes become the testing labs. Mothers and fathers become unwitting scientists, and their children are the test subjects.

The real safety testing comes later, oftentimes after children have been injured, or worse.

The U.S. Consumer Product Safety Commission tallied at least 154 suffocation and/or asphyxiation deaths associated with nursing pillows before mandatory safety standards were approved for them in September.

It took 20 years – and an act from Congress – to create mandatory design standards for children’s dressers to prevent them from tipping over. In the meantime, hundreds of children died when a dresser fell onto them.

Congress also stepped in to ban the sale of inclined infant sleepers, tied to around 100 deaths. No mandatory safety standards ever existed for that product.

Most recently, federal lawmakers have introduced legislation to ban water beads and weighted infant sleepwear as a non-governmental organization considers safety standards for these products.

“The fact that anyone can just make an infant product and put it on the market is really scary. And there is this assumption that if something’s on the market, then it’s safe,” said Shayna Raphael, who lost her 11-month-old daughter in an unsafe sleep situation at a daycare and is now a consumer advocate. “As a first-time parent, I would have thought the exact same thing too. You wouldn’t think that someone would be able to put something on the market that could potentially kill our infants. And the reality is that absolutely is the case.”

Newly-invested children’s products must meet flammability, lead and a handful of other mandatory standards, but there is no requirement that they must be tested for other hazards such as sleep-related injuries and deaths.

By law, the CPSC must enact mandatory safety standards for all durable infant and toddler products by assessing existing voluntary standards. An organization called ASTM International has various subcommittees that work on those types of standards.

Durable juvenile products include cribs, strollers, swings – basically any item that can be used for years and with multiple different babies and infants.

Although the CPSC regulates more than 15,000 types of household goods from appliances to baby products to tools, it has limited authority and manpower to create safety standards on its own - and must consult with stakeholders and groups such as ASTM.

Currently, there are more than 50 child products with safety standards and third-party testing requirements.

While the CPSC can enact standards in the absence of existing voluntary standards, many federal safety regulations are in effect the formal adoption of ASTM-developed standards - or are heavily influenced by the work done by the independent organization.

The ASTM committees often are run by the manufacturers who are marketing them, sometimes leading to questions about independence. And the standard-setting process oftentimes takes years to develop, leaving consumers at risk as potentially harmful items remain on the market.

Infant support pillows, which are different than nursing pillows and are designed for tummy time or play time, have been on the market for at least 15 years and have been associated with 79 deaths back to 2010. In October, the CPSC commissioners approved draft standards in October.

In a rare move, the CPSC determined that the ASTM committee studying those products was too narrowly focused and is moving ahead with its own mandatory standard.

“Given that the ASTM draft standard for loungers has not been finalized and published and would not cover the same scope of products as the final rule, the Commission finds that no voluntary standard currently exists or will likely exist in the foreseeable future that would adequately address the hazards presented by infant support cushions,” the draft rule said.

There’s also no standard for infant rocking chairs, associated with nearly a dozen deaths and numerous tipover incidents, federal data shows.

In recent years, Congress has been forced to act because of the slow pace of standard development.

“I’m concerned about reliance on any kind of panel or body outside the government’s oversight and supervision,” said Sen. Richard Blumenthal, a Connecticut Democrat who has been among those pushing legislation for specific product bans. “The kind of panels that the FDA has to review new drugs, I think are a better way to conduct this kind of standard setting, and my hope is that the CPSC will be given the resources it needs.. . . so that it can exercise greater oversight and maybe even do the standard setting itself.”

His latest worry centers on weighted infant sleepwear such as swaddles and sleep sacks that have beads sewn into the items. These products have been marketed as aides to help infants sleep longer, giving exhausted parents rest.

But pediatricians, safe sleep advocates and some governmental research agencies are alarmed at the idea of putting weight on an infant, whose rib cage has yet to turn to bone.

“It’s all cartilage. And so, if you put any pressure on the baby’s chest, it’ll just compress. And when you, when you compress the chest, that makes it harder for the baby to breathe,” said Dr. Rachel Moon, a professor of pediatrics at the University of Virginia and chair of the American Academy of Pediatrics Sudden Infant Death Syndrome task force. “Just because something is on the market, and many people have bought it, and . . . it seems to be okay, and parents recommend it, that doesn’t necessarily mean that it’s safe.”

A weighted issue

The concerns about weighted infant sleepwear have brought unusual attention to the ASTM, the standard-setting process and the lack of pre-market safety testing.

Three years ago, the ASTM formed a committee to set standards for infant swaddles and sleep sacks, including those that do not contain weights.

Shayna Raphael is a member of that committee and among several consumer advocates who have raised concerns about the way that group is run.

Tara Williams, CEO of weighted infant sleepwear manufacturer Dreamland Baby, was tapped to co-chair the committee along with a sleep safe advocate.

But as the committee began its work, the American Academy of Pediatrics, the U.S. Centers for Disease Control and Prevention and the National Institutes of Health began raising alarms about putting weights on a sleeping infant.

Adding weights to sleeping infants, the medical experts said, suppresses their natural ability to startle themselves awake. Plus, infants need to feed every two to three hours, not sleep for eight hours stretches.

The AAP said even the act of creating a safety standard may offer false assurances to parents.

Then the CPSC added to its safe sleep guidelines, recommending parents avoid using weighted products on infants. CPSC Commissioner Richard Trumka Jr. asked major retailers to stop selling these products. Most did.

Dreamland Baby’s Williams has since threatened to sue both the CPSC and Trumka for issuing warnings against these products and wants the agency to scrub mentioning them on its safe sleep practices website. The commission voted in August to leave the statement online and added the National Institutes of Health and the U.S. Centers for Disease Control and Prevention as the sources for the warning.

Williams’ representative has declined an interview with InvestigateTV but said in a statement, “DreamlandBaby 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 1,000,000sleep sacks with no reported adverse eventsattributed toour gently weighted sleep solutions.”

Some members of the committee publicly complained to the CPSC about problems with that ASTM committee, prompting Chairman Alexander Hoehn-Saric to write a letter on June 3 to the organization, asking it to investigate.

On July 2, the ASTM responded, in part, “We are confident that ASTM principles for fairness, openness, and transparency have not been violated.”

The letter also noted that 18 consumer advocates serve on the infant sleepwear committee as do more than 100 from the industry side.

The ASTM has declined InvestigateTV’s repeated requests for interviews.

And while it all this may seem like inside baseball, Raphael and other advocates point out that this is a committee that is supposed to be establishing standards to protect babies and save lives that has devolved because of perceived conflicts of interest and other issues.

“My fear is that now it’s just kind of considered the norm, and there’s a sense of apathy around it that I think shouldn’t be there. I can’t think of any other field where a conflict of interest isn’t considered,” Raphael said. “It’s quite shocking to me that when we have something so important with such significance for safety for infants, that there isn’t anything about conflicts of interest within it. Yes, they should be on the committee, but co-chairing a committee is very, very different.”

And it is dragging out an already drug-out process, she said.

Injuries and deaths tallied after-market launch

Sen. Blumenthal also is tired of waiting for ASTM.

Earlier this year, he and other lawmakers introduced a bill in both the House and Senate to ban weighted sleepwear for babies under a year old.

“One reason that I am pushing so hard for a ban on these weighted infant sleepwear products is I don’t want to see a repeat of the Rock ‘N Play debacle, where there were deaths and injuries that could have been prevented, but the sales went on much too long,” he said. “We see the same kind of dangers here. Children, infants may be at risk.”

The Rock ‘N Play, manufactured by Fisher-Price, is an inclined sleeper that has been tied to about 100 deaths spanning more than a decade.

The sleeper also never was subjected to mandatory safety standards because it was recalled in 2019 before an ASTM committee working on them concluded its work.

Because Congress ultimately passed a law, it now is illegal to sell a baby product marketed for sleep in the U.S. with an incline greater than 10 degrees – the Rock ‘N Play had a 30-degree incline.

Raphael continues to ask how many injuries and deaths are too many? ASTM committees – including the infant sleepwear group – heavily rely on CPSC incident data to form safety standards, she and other concerned committee members say

They specifically are looking for hazard patterns, where the incident data shows a repeated issue that caused injuries or deaths.

“I think that one is enough,” Raphael said. “I think the potential for more is horrific, and I think that we should be listening to the experts in this field when they tell us something is not safe.”

A recent review of incident data of injuries and deaths associated with infant sleepwear was conducted by an ASTM employee and a consultant. They reported in a recent ASTM meeting that weighted sleepwear itself does not have a unique hazard pattern. Neither are medical professionals.

They also did not take into account the AAP warnings about weighted infant sleepwear, Raphael said.

“We don’t recommend them at all,” Dr. Moon said.

There have been no peer-reviewed medical studies on weighted sleepwear, which pediatricians have said may lead to SIDS.

“There’s an ethical challenge when you study anything with regards to sudden infant death syndrome or sudden unexpected infant death,” Moon said. “You can’t necessarily randomize babies to sleep on their backs versus sleeping on their stomachs and see what happens.”

Moon said those factors should be taken into account rather than waiting for bad things to happen to a large number of infants.

“[The recommendations are] more theoretical in that nobody has proven or disproven, but they are evidence-based in terms of the physiology and what we would predict in babies,” she said.

The development of baby products isn’t put to the same level of scrutiny as medications regulated by the Food and Drug Administration.

Now, “parents, in general, they think that all of these products have been approved by a governing body, you know, like the FDA does for medications, and there is nothing like that,” Moon said.

Sen. Blumenthal has said in addition to incrementally regulating products through the legislative process, which too can take months or years, an even better task to tackle would be giving the CPSC more authority to quickly regulate products and more power to specifically name products when it has a concern, something it is largely barred from doing under current federal law.

“I’m concerned about reliance on any kind of panel or body outside the government’s oversight and supervision. The kind of panels that the FDA has to review new drugs I think are a better way to conduct this kind of standard setting, and my hope is that the CPSC will be given the resources it needs. Very important - the resources it needs in its budget, which I’ve advocated raising substantially so that it can exercise greater oversight and maybe even do the standard setting itself.”

Even though Claire’s death did not involve a weighted product, Raphael would trade every sleepless moment to have her daughter still with her – a message she hopes that other parents take to heart when considering the use of weighted sleepwear.

“The small amount of time where you’re going to be sleepless and have to function and have this infant who is very needy, that’s such a small blip in time to be able to then enjoy them for the rest of their lives,” she said. “And to know that there are products out there that have taken that away from parents, and that we’re setting standards for products that may continue to do that is unconscionable. It’s just hard to believe.”

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