Product disclosures for Owlet Baby Care’s Smart Sock baby monitor should be modified to make clear to consumers the “information-gathering nature of the device,” the National Advertising Division (NAD) recommended in a new decision.

The NAD requested that Owlet substantiate its express claims for the product, which wraps around an infant’s foot to track heart and oxygen levels and sends “real-time insights” to parents’ phones, and its implied claims that use of the Owlet can prevent SIDS or save a baby’s life.

Considering the claims as part of its ongoing monitoring program, the NAD determined that the advertiser needed to improve its disclosure to ensure that it accurately conveyed to consumers the nature of the Owlet, without overstating the extent to which the product can actually prevent adverse medical events.

Based on confidential studies submitted by the advertiser, the NAD found that although Smart Sock provided accurate oxygen and heart rate readings, the context of the advertising claims, including statements that the product will “reassure you baby is okay” and “Peace of Mind at a Glance,” exaggerated Smart Sock’s capabilities.

The NAD was concerned that “the advertising conveys unsupported messages regarding the capability of the Smart Sock, which is essentially an information gathering device that parents can use as a tool to take action and make decisions regarding their baby’s care (e.g. call a doctor or visit an emergency room).”

“One message reasonably conveyed by this advertising is that because of the technological capabilities of the Smart Sock monitor, babies will ‘be okay’ and thus allow parents to achieve ‘peace of mind,’” according to the decision. “Claims that parents will be reassured that baby is ‘ok’ and that the Smart Sock gives ‘peace of mind’ can reasonably imply that use of the Owlet can prevent SIDS to save your baby’s life.”

In light of the messages conveyed by the advertising, the NAD recommended that Owlet update its claims to more clearly disclose the information-gathering nature of the device and move the disclosure closer to the product’s performance claims.

Owlet’s existing disclosure—which could be reached only after finding the correct page of the website, reviewing various topics and affirmatively uncollapsing a button—featured important statements such as “The Smart Sock is not a FDA-approved medical device and is not intended to diagnose, cure, treat, alleviate or prevent any disease or health condition or investigate, replace or modify any physiological process” and “the notification thresholds on the Owlet Smart Sock are not as stringent as a medical monitor”—but they still needed tweaks, the self-regulatory body said.

“NAD was concerned … that the principal function of the disclosure is to disclose the limitations of the product, yet it begins with an assurance that parents will achieve ‘peace of mind each time the parent puts their child down for a nap or to sleep at night,’” the NAD wrote. “NAD concluded that reiterating this statement of assurance at the same time as it is warning consumers about the limitations of the product sends a confusing message.”

Nor was the disclosure readily noticeable or likely to actually convey the information to consumers, the NAD added, because of the navigation required to find the Smart Sock’s limitations.

The self-regulatory body recommended four changes to the disclosure: limit use of the Smart Sock for information purposes only as it does not prevent SIDS (including a warning to follow pediatrician-recommended sleep guidance); limit use of the Smart Sock to healthy babies as it does not replace a medical monitor; eliminate assurances in the disclosure that the product provides peace of mind; and move the disclosure to the product purchasing page in close proximity to the product performance claims, placed in such a manner that it is easy to notice, read and understand.

As for the Owlet stories, the NAD concluded that they accurately reflected how the Smart Sock was meant to be used.

“Parents in the stories received a notification and then sought medical attention for their children, resulting in treatment and medical diagnoses,” the NAD wrote. “Accordingly, NAD did not find that the testimonials were misleading—the parents did not rely on the Smart Sock, alone, to ensure that their babies were ‘okay,’ rather, they used the information generated by the device to make a decision to seek medical care.”

To read the NAD’s press release about the case, click here.

Why it matters: The NAD concluded that the Owlet disclosure was insufficient to overcome the assurances that the Smart Sock provides peace of mind to parents. The advertiser should modify its disclosure to provide clearer limits on what the product can—and can’t—do, the self-regulatory body recommended, and move it closer to the product performance claims.