A small business owner who has successfully sold millions of infant sleepwear products tells Fox News Digital that her business was derailed by Biden administration actions cracking down on her product category, which she has called "anti-science." 

"We had been successfully in business for more than 10 years when we first heard about any rumblings with the government," Manasi Gangan, owner of Nested Bean, told Fox News Digital about her infant sleepwear company. "We had sold more than 2 million products successfully to families across America and when we heard that the line of products were broadly categorized as unsafe, we couldn't believe it."

Gangan, an immigrant small business owner, told Fox News Digital that she started her "innovative line of sleepwear" that "mimics a parent’s gentle touch" after she had trouble getting her second child to sleep. 

"All we're trying to do is lend a helping hand to parents who much deserve the rest and sleep and we've been very successful in helping these parents get some good night's rest," Gangan said. 

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In May, Nested Bean’s products, along with similar products made by Dreamland Baby, were pulled from shelves at major retailers like Amazon and Target after a letter from the Consumer Product Safety Commission warning of potential dangers of the weighted sleepwear products. 

Gangan told Fox News Digital that the CPSC has not done the necessary due diligence. She said she's done extensive safety research, commissioned a study that showed her weighted products did not hinder infant breathing, and that there has not been a single fatality associated with her product. 

"They're claiming that the product is not safe and we are again at a loss as to why, because in the 13 years that we have been developing and delivering these products, their safety has been our number one priority," Gangan said. "We established these products and this innovation into the industry after speaking with safety experts, after taking inspiration and advice from research, neonatal care research, and yet, when we shared this information with this commission, they refused to take heed and are claiming that these categories of products are not safe."

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Some lawmakers, including Sen. Richard Blumenthal, D-Conn., have gone as far as promoting legislation to ban the category of sleepwear altogether, saying earlier this year, "The stakes are simply too high to allow weighted infant sleep sacks and swaddles to stay on the market without evidence that they are safe."

When reached for comment, Blumenthal told Fox News Digital, "What concerns me most is that these companies may be putting children’s lives at risk. They’ve sold millions of units of products while marketing them as safe in the face of strong opposition from child safety experts."

"Parents and caretakers of newborns are notoriously hard-pressed for rest due to the intermittent sleep patterns of infants, and they need transparent information. Encouraging parents to use these products without clear evidence of their safety and against expert recommendations is dangerous and flat-out irresponsible."

Gangan said she has shared information with Blumenthal’s office and met with his staff to show that her product is not hazardous, but that has "fallen on deaf ears" in what she suggested could be a politically based effort to promote a message that Democrats are looking out for families. 

"Intentionally, the senator is providing disinformation to his constituents based on a political agenda," Gangan said. "That's the only thing that I can surmise, that it's an election year."

Blumenthal's office suggested they were open to looking at a "more comprehensive" study from Nested Bean. 

Critics of the sleepwear company have cited a study from the American Academy of Pediatrics (AAP) warning of potential dangers of weighted sleepwear products and the Consumer Product Safety Commission (CPSC) has claimed that multiple infant deaths have occurred due to weighted sleepwear products.

The AAP study, CBS News reported, did not test the products in question in real world conditions for extended periods and only tested weights on five babies for two minutes.

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Gangan has argued that CPSC Commissioner Richard Trumka Jr. has "inaccurately attributed multiple infant deaths" and cited one coroner’s report in particular that didn’t mention Nested Bean or a weighted product and appears to be related to "a tragic combination of multiple proven-unsafe sleep practices."

"While associations like the American Academy of Pediatrics (AAP) have raised theoretical and hypothetical concerns regarding the potential dangers of added weight, there are no studies or incident data that show how, under what circumstances or under how much weight these potential dangers might manifest in weighted products on the market," Gangan wrote in a February letter to Trumka. "On the other hand, there are studies showing effective and safe use of weighted products in hospital settings with the most vulnerable of infants. Nested Bean and other companies are supporting independent studies that will be peer reviewed, to help develop a better understanding of the potential issues involved."

Gangan told Fox News Digital she has met with every CPSC commissioner except Trumka, who she says "does not take meetings," and pleaded her case to no avail. 

"We met with the chairman and other commissioners of the CPSC, shared our data research tests that we had successfully completed even before bringing out a single product into the market and since then, the tests that had been completed, to share how a safe product can be brought into the market, how innovation can be brought into the market, hoping to influence regulation, hoping to give data, facts, science to guide regulation," Gangan said. "And instead we were shocked that we were being shut down. So as recently as April of 2024. Despite our multiple attempts at sharing information, being open and honest, Commissioner Trumka wrote letters to retailers pressurizing them to stop the sales of our products and this has been based on no data or science. It's an anti-science attempt to spread misinformation based on personal bias."

A study published in Advances in Neonatal Care journal in 2020 concluded that "no adverse events" occurred with babies sleeping under weighted blankets in 30-minute trial sessions.

In another letter to Trumka, Gangan wrote, "In April 2023, CPSC’s own internal Compliance staff completed an investigation of Nested Bean’s products, sending the company a closing letter stating that no further action was warranted."

Trumka's actions on the infant weighted sleepwear category have prompted pushback from the Republican-led House Small Business Committee, which echoed Gangan's concern.

"Commissioner Trumka failed to take ‘reasonable steps’ to meet the requirements of the statute before he disclosed the identities of the manufacturers of the weighted blankets," Committee Chair Rep. Roger Williams, R-Texas, wrote in a July letter to the CPSC. "First, he failed to ensure that the information is accurate. Next, he made allegations without the information being backed up by scientific research."

"The Committee is concerned that a single CPSC Commissioner is exerting undue pressure on entities and forcing them to improperly remove small business’ products from their shelves to the detriment of those small businesses. Small businesses deserve a chance to fairly compete in the marketplace without undue influence from the federal government – whether that be through rulemaking or letters from a rogue CPSC Commissioner. America’s small businesses deserve to have their voices heard and considered."

In a statement to Fox News Digital, the CPSC said, "Commissioner Trumka’s activities in this matter were conducted in his individual capacity as a member of the Commission, and not on behalf of the Commission itself."

Gangan told Fox News Digital that starting her business was a pursuit of the "American Dream" and the regulations from the government have crippled that dream and has her questioning the narrative that Democratic administrations support immigrant and minority businesses. 

"America is the land of possibilities, that's what the whole world knows America for, so when I came to this country, an immigrant just with a degree and a pocketful of dreams, did very well in my career, decided to take a chance and start this business to help more parents like myself and the values that I have stood for supporting women, supporting small businesses, supporting truth, supporting science data, have been significantly challenged by this action," Gangan said.

"So on one hand, when we hear, 'supporting immigrants, minorities, small businesses and standing for science' and on the other hand, when the administration of the exact same party that I believed in is now threatening, my business, has been devastating for my business. I'm questioning my own beliefs right now. It has been devastating. We have lost 80% of our sales and it has stoked so much fear in our consumers that we are left sharing the same information that was never questioned by our customers before."