The Short Version:

• Baby neck floats remain legal in the United States.
• The U.S. Consumer Product Safety Commission (CPSC) established a mandatory federal safety standard for neck floats that took effect in 2026.
• The 2022 U.S. Food and Drug Administration (FDA) safety communication is no longer publicly accessible on the FDA’s website.
• Active adult supervision remains essential whenever a baby is in or near water.

A Lot Has Changed Since 2022

In 2022, the FDA issued a safety communication regarding baby neck floats, particularly discussing concerns related to therapeutic use in infants with developmental conditions. The communication received significant media attention and sparked important conversations. Regulators, manufacturers, healthcare professionals, physical therapists, and families have to this day continued discussing how products in this category should be evaluated and regulated, and more broadly, infant water safety.

That communication is no longer publicly accessible on the FDA's website. While we cannot speak to the FDA's internal decision-making, parents researching neck floats today may notice that many articles still reference the communication, despite it no longer being accessible.

The CPSC Established a Federal Safety Standard

In 2025, the CPSC finalized a mandatory federal safety standard for neck floats. The rule includes requirements related to product performance and warning labels, and took effect in 2026.

For families and manufacturers alike, this represents an important milestone. Rather than leaving the category unregulated, or banning it outright, the CPSC established a framework intended to improve consistency and safety across products sold in the United States.

As a company, we support efforts to create clear safety expectations and standards for products used by infants and young children.

For families, the most important takeaway is that neck floats are no longer simply a subject of debate. They are now part of a federally regulated product category with defined safety requirements. While opinions may still differ about the category itself, manufacturers now have a clearer framework for designing, testing, and labeling these products.

Our Relationship With Regulators

Over the years, we have had extensive conversations with both the FDA and the CPSC. While there have been areas where our perspectives differed, we have always shared the same ultimate objective: infant safety.

We appreciate the difficult responsibility regulators carry when evaluating products intended for young children. We also believe that scientific inquiry, product innovation, and open dialogue play an important role in advancing safety. Our commitment has always been to participate in those discussions constructively and transparently.

Continuing Research and Development

Since our inception in 2014, there has been growing interest from clinicians, therapists, and researchers in understanding how aquatic environments may support infant movement and development.

Many families — including families of children with special needs — have shared their personal Otteroo experiences with us, the FDA, and the CPSC. These stories suggest that water, combined with Otteroo’s support, can create unique (and sometimes life-changing) opportunities for exploration and movement. 

This potential deserves further study, and to that end, we continue to pursue research and regulatory pathways to help answer important questions with rigorous data, including our ongoing efforts to generate the evidence needed to support an FDA De Novo classification for a version of Otteroo intended for supervised therapeutic use.

What Hasn't Changed

While regulations evolve and standards improve, one thing has remained constant: any time a baby is in or near water, active adult supervision is essential.

No float, bath seat, inflatable, or water product can replace an attentive caregiver.

Stay within arm's reach. Keep your eyes on your baby. The whole time.

Looking Ahead

We are optimistic about the future of baby neck floats. The establishment of federal standards creates a clearer path forward for manufacturers, regulators, researchers, and families.

We hope to continue contributing to that future through product improvements, safety education, clinical research, and ongoing collaboration with clinicians, researchers, regulators, and families.

Most of all, we hope more families can safely experience the joy that comes when a baby discovers movement, curiosity, and confidence in the water. That simple moment — watching a baby explore, kick, splash, and smile — is what inspired Otteroo from the beginning, and it continues to inspire us today.

Important Safety Information

Otteroo LUMI is intended for supervised water play only. It is not a life-saving device and does not prevent drowning. Always follow all product instructions. Consult your pediatrician before beginning water activities if your baby has developmental concerns or special medical needs.

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