FDA warning leads Owlet to stop sales of baby-monitoring Smart Sock

Owlet Baby Care has halted the sale of its Smart Socks, which monitor babies' sleep patterns, after six years on the market in response to a warning letter it received from federal health officials. 

The U.S. Food and Drug Administration (FDA) issued a notice to the company in October saying that the product is marketed as a medical device without approval from the federal agency.

The Owlet Smart Socks are described as being able to track a child's heart rate, oxygen level and sleep trend, which can be read in real-time with the company's Owlet App, according to a version of its website targeted at consumers in another country. 

The socks are marketed for children up to 5 years old, according to the website. The website for U.S. consumers no longer has the product available. 

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In the warning letter, the FDA said Owlet violated the Federal Food, Drug, and Cosmetic Act by marketing the product in the United States "without marketing clearance or approval."

Under the FD&C Act, "these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body," the FDA wrote. 

The FDA says it's been informing the company since 2016 that the Owlet Smart Sock is considered a device under the FD&C Act and "does not fall under the compliance policy for low-risk products that promote a healthy lifestyle." 

Owlet previously acknowledged that it received a letter from the agency saying in an Oct. 4 note that it's been "focused on the well-being of babies and empowerment of parents" since its founding and that it's proud of the technology which has reportedly been used with over 1 million babies. 

At the time, the company also claimed that the product had been evaluated in third-party studies and was shown to be safe.

Additionally, the company's website also explains that Owlet products are not medical devices. 

"They are not intended for use as medical devices or to replace medical devices. They do not and are not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify anatomy or any physiological process," the disclaimer reads. 

However, the FDA requested in the warning letter that the company "cease any activities that result in the adulteration" of all versions of the product and co-branded products. 

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An Owlet spokesperson told FOX Business in a statement that the letter "from the agency did not identify any safety concerns about the Smart Sock." 

Still, Owlet confirmed that it will stop selling the product as a result of the letter and in light of plans to submit a device application to the FDA. Instead, Owlet plans to offer a new sleep monitoring solution, which is expected to be available soon. 

The company says it plans to "continue to support our current customers" and will notify customers about "any updates to the Smart Sock products that have already been distributed." 

The company also reiterated that these actions only impact U.S. customers and that no other countries or regions are affected by this.

"After six years on the market, with four versions launched and over 1 million babies monitored, we are extremely proud of the innovation and technology Owlet has delivered," Owlet said in a statement. "We will continue to stay focused on our mission and are cooperating with the FDA so we can continue to provide sleep monitoring products and solutions to parents and babies."