MEHEK COOKE And LOREN SEEHASE: When Bureaucracy Tramples Innovation, Families Pay The Price

While the federal government shutdown did not close federal courts, it did halt funding for the Department of Justice. It is everyday Americans seeking to vindicate their rights who pay the price, including one small business and millions of exhausted parents.

This is the story of Nested Bean, a small Massachusetts-based company that should be the kind of American success story we love to celebrate. Founded in 2011 by Manasi Gangan, an engineer and entrepreneur who immigrated from India, the company was born out of her personal struggle: a baby who would not sleep unless cradled by her touch.

Tapping into her background in technology and product development, Gangan created a line of lightly weighted infant sleepwear designed to mimic a parent’s gentle hand. This innovation allowed babies to rest safely on their backs in cribs without the risky improvisations to which many exhausted parents resort.

Over the next decade, parents responded in droves. Nested Bean sold more than 2.5 million products, collected tens of thousands of glowing reviews, and never recorded a single injury or fatality attributed to its products.

Retailers such as Target, Babylist, and Amazon stocked their sleepwear nationwide. The company became a trusted ally for families navigating the lonely, sleepless nights of early parenthood.

But in 2023, the federal government decided to crush it.

Without conducting any scientific review, establishing formal safety standards, or even defining what constitutes this category of products, the Consumer Product Safety Commission (CPSC) — along with the Centers for Disease Control and Prevention and the National Institutes of Health — abruptly updated its “Safe Sleep” guidelines to tell parents: “Don’t use weighted blankets or weighted swaddles.” That language wasn’t based on new findings but on the borrowed judgment of other health agencies.

Soon, Commissioner Richard Trumka Jr. amplified the warning. In letters to retailers and posts on social media, he declared that weighted infant sleep products “pose serious threats” and urged parents not to use them. He incorrectly attributed infant deaths to weighted sleep sacks and swaddles.

Retailers panicked. Target pulled Nested Bean’s products from its shelves. Investors and lenders recoiled. A once-thriving, beloved brand, built on a record of safety, innovation, transparency, and trust, found itself decimated almost overnight.

So, Nested Bean went to court to save the company and vindicate its products. The federal agencies bypassed the rigorous, science-driven process required by law before making determinations about consumer product safety. The CPSC never identified a hazard pattern, issued a recall, ban, or stop-sale order, or even defined what counts as a “weighted” infant product. Ironically, many standard baby sleep sacks weigh more than Nested Bean’s carefully designed sleepwear yet escape scrutiny simply because they aren’t labeled “weighted.”

This was especially damaging because Nested Bean built its reputation on safety. Before selling a single product, Gangan spent over a year working with accredited labs, neonatal safety experts, and pulmonologists to ensure her design did not restrict airflow or pose suffocation risks. The company exceeded voluntary testing requirements, adopting international safety standards and labeling best practices. It even commissioned an independent study showing that the light pressure of its garments — typically no more than 30 to 90 grams — was comparable to what an infant experiences from a car seat harness, pacifier holder, or winter clothing.

And yet, instead of being treated as a partner in innovation, Nested Bean has been branded an outlaw.

The human cost is hard to miss. For parents, these products weren’t just another gadget; they were a lifesaver — often the only safe way to get their infants to sleep through the night. Many families turned to Nested Bean after leaving the neonatal intensive care unit, where weighted aids are routinely used to comfort premature babies. To suddenly tell these parents that the very products that gave them relief are “dangerous,” without data to back it up, sows confusion, fear, and guilt where none is warranted.

For entrepreneurs, the message is chilling: why invest years of work, millions of dollars, and your own reputation into developing a safer product if a government official can, with a tweet, erase your life’s work?

No one disputes the importance of safeguarding infants. But safeguarding requires science, not sound bites. The law is clear: before banning or maligning a product, the CPSC must gather evidence, identify hazard patterns, weigh costs and benefits, and consult with stakeholders. That process didn’t happen here. Instead, Nested Bean and the parents it serves are being punished for innovation that regulators didn’t take the time to understand.

Nested Bean’s lawsuit is not simply about one company’s survival. It is about the principle that government should not destroy businesses — or deprive families of safe, useful products — through shortcuts and overreach. In a nation that prides itself on entrepreneurship and opportunity, we cannot allow bureaucratic carelessness to become a death sentence for small businesses.

But the government shutdown means Nested Bean’s case is frozen — stuck in judicial limbo for an unknown time. Each day the shutdown continues, parents lose access to a safe option to help their babies sleep, Nested Bean moves closer to closure, and justice for one small company is delayed.

Mehek Cooke, an attorney and political strategist, was a surrogate for the Trump for President Campaign and the Republican National Convention.Loren Seehase is an attorney at Pacific Legal Foundation and represents Nested Bean, free of charge.

 The views and opinions expressed in this commentary are those of the author and do not reflect the official position of the Daily Caller News Foundation.