SNOO bassinets have a reputation among parents for helping soothe babies to sleep with motion, white noise, and a secured sleep sack that keeps them on their backs. But yesterday, the U.S. Food and Drug Administration (FDA) issued a warning letter to SNOO's parent company, Happiest Baby, and its CEO, pediatrician Dr. Harvey Karp.
The warning letter included multiple concerns, including selling sleep sacks and hospital SNOO bundles without first undergoing FDA review and obtaining authorization for those specific products. (The FDA has approved other SNOO products to help babies sleep on their backs.)
The letter also cautioned potential customers about problems with the refurbished SNOO program, sharing reports of stains, soiling, and unsanitary conditions.
If you have a SNOO at home or you're considering using one, you might wonder what this means for your family. Here's what you need to know in order to get your baby safely to sleep.
What does the FDA's warning letter to SNOO mean?
The FDA sends warning letters to companies when they believe there has been a "significant violation" of federal requirements. In this case, the FDA wants Happiest Baby to get approval before selling its extra-small and extra-large SNOO sleep sacks and its "hospital bundle." (Learn more on that below.)
The warning letter shares the FDA's concerns with products and gives the company 15 days to come up with a plan to address them. If the company disagrees with the warning, it can respond with proof to the contrary.
The FDA had previously authorized the SNOO bassinet and its three original sleep sack sizes (small, medium, and large) as effective at keeping babies asleep on their backs, which is the safest sleeping position for infants. However, the two additional sizes and the hospital bundle weren't included in the original authorization, and the FDA says that SNOO needs to do more research on them. SNOO also can't claim that these new products have FDA authorization when they don't.
"We take this letter seriously and will engage fully and promptly with the FDA, as we have at every stage of this process," Happiest Baby, SNOO's parent company, tells What to Expect. "We are committed to working with the FDA to address the matters in their letter. In addition, we look forward to sharing with the Agency the progress we have made and will continue to make to strengthen our processes to meet their requirements for record keeping, reporting, and quality management."
Importantly, an FDA warning letter is different from a recall — it stops short of telling consumers to stop using the product. However, the FDA says that the extra-small sleep sack "could be too tight on the infant and compress vital organs," while the extra-large one "could ride up and cover the infant’s mouth or neck."
Most bassinets and sleep sacks do not have FDA authorization for promoting back sleeping, but they also don't make the same claims.
What is the refurbished SNOO program?
Because the original SNOO costs around $1,700, some parents opt to rent or buy a refurbished one to save money. A certified "pre-loved" SNOO costs just under $900 to buy, so it's significantly less expensive.
"Why take a chance on a stranger's used SNOO? Get a safe, clean, and certified Pre-Loved SNOO right from Happiest Baby!" the website states. “Happiest Baby’s special 5-step refresh + recondition process ensures that every Pre-Loved SNOO meets our rigorous standards for safety, cleanliness, and quality." The website further describes the details of each step in the reconditioning process, including replacing the sleep sacks, the mattress, the mattress cover, and the sheet.
However, the FDA says that "stains, soiling and unsanitary conditions have been reported on refurbished SNOOs distributed to customers, which may pose risk of infection … [and] mold has been reported on SNOO Smart Sleeper mattresses and/or mattress covers."
Pre-loved SNOOs do come with a one-year warranty, so if you've recently bought one or you're considering purchasing one, you can return it if you notice any issues like the ones listed in the FDA letter. You can also report any problems to the FDA's MedWatch Voluntary Reporting Program.
What is the SNOO hospital bundle?
The SNOO hospital bundle is for babies in clinical settings like neonatal units. On the Happiest Baby Health Partnerships webpage, the company states that it partners with hospitals, universities, and community-based organizations, and shares data about how the SNOO saves clinicians time each shift.
However, the warning letter says the FDA had only approved the SNOO for home use by caregivers, and that using one in a NICU, for example, would necessitate a change in cleaning protocols that could potentially degrade the product. It also took issue with other parts of the hospital bundle, including the fact that the SNOO is on a wheeled cart, which could potentially tip over.
Is it still safe to use a SNOO?
The FDA warning letter is different from a recall, and it doesn't tell parents to stop using the SNOO or that it's unsafe. The letter is also only about size extra-small and extra-large sleep sacks, the hospital bundle, and refurbished SNOOs. So if you have a new SNOO and are using a small sleep sack with it, your products are completely unaffected by the FDA warning letter.
"If you have an extra-small or extra-large sleep sack, hold onto it, but don't use it until SNOO gets it approved or figures out what to do," advises Gina Posner, M.D., a pediatrician and member of the What to Expect Medical Review Board. "If you have a used one, I would just check it and if you have any issues with cleanliness, talk with SNOO."
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