The Food and Drug Administration has issued a warning letter to Happiest Baby, Inc., the maker of the SNOO Smart Sleeper, citing unauthorized product changes and sanitation concerns. The agency said the company introduced two new sleep sack sizes without FDA evaluation, while also identifying reports of stains, soiling, unsanitary conditions, and mold on some mattresses and covers.
The SNOO Smart Sleeper is a high-profile baby bassinet sold by Happiest Baby, Inc. The device is known for securing infants in a sleep sack attached to the sides of the bassinet while it automatically rocks them when they cry.
According to CBS News, the bassinet sells for about $1,700 and has become one of the more recognizable products in the infant sleep market. The FDA’s warning now places the company under regulatory scrutiny over both product authorization and cleanliness issues.
FDA Cites Product Changes and Unevaluated Sleep Sacks
According to the FDA warning letter reported by CBS News, regulators alleged that Happiest Baby significantly changed or modified the SNOO Smart Sleeper by introducing two new sizes of sleep sacks. The agency identified these as extra-small and extra-large sleep sacks.
The FDA said those two sizes had not been evaluated for safety and effectiveness by the agency. In its letter, the FDA wrote that there was evidence the firm had “significantly changed or modified the SNOO Smart Sleeper” through the introduction of the new sleep sack sizes.
The issue matters because the SNOO system relies on the sleep sack as part of how the bassinet is used. Infants are clipped into the sack, which connects to the sides of the device while the bassinet rocks automatically in response to crying.
Regulators did not say in the CBS News report that the product should stop being used, and the report did not describe any recall. The warning letter focused on alleged violations involving product changes and sanitation concerns. Happiest Baby responded in a statement to CBS News, saying, “We are committed to working with the FDA to address the matters in their letter.”
Reports of Mold and Unsanitary Conditions Raise Further Concerns
The FDA also cited sanitation-related issues. According to CBS News, the agency listed stains, soiling, and unsanitary conditions among the violations, saying these may pose a risk of infection.
The FDA also reported mold on some SNOO Smart Sleeper mattresses and mattress covers. The report did not specify how many products were affected or whether the findings were linked to products sold, rented, refurbished, or returned. Happiest Baby told CBS News that two years ago it ended a relationship with one of its refurbishing partners. The company said that partner was not properly cleaning the products.
That detail places part of the sanitation issue in the context of product refurbishment, though the FDA’s warning letter, as reported, also referred directly to mold and unsanitary conditions on some items. The company’s statement did not dispute that it had received the FDA letter.
The warning adds regulatory pressure to a company whose product is widely associated with automated infant sleep technology. For now, the publicly reported facts are limited to the FDA’s allegations, the listed product and sanitation concerns, and the company’s pledge to work with the agency.
