FDA approves ‘breakthrough’ spiral tampon

The US Food and Drug Administration (FDA) has approved a new design of tampon in a move that could shake up the period care market.

The tampon, developed by California-based start-up Sequel, has diagonal grooves that spiral down the product to allow it to absorb more fluid and offer a more reliable experience.

Developed by athletes and Stanford engineers – Greta Meyer and Amanda Calabrese, the tampon was inspired by the founders’ lived experience in sport.

Its prototype was invented during a class project in 2018 with the aim of raising the standards for women’s period products.

As a part of the FDA clearance process, Sequel performed testing and documentation of the safety and efficacy of the product. It said this validated its confidence in the design of the tampon.

Meyer, co-founder and CEO of Sequel, said: “FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category.

“However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Sequel.”

Claudia Kotchka, Sequel advisor and former vice president of design, innovation and strategy at Procter & Gamble, added: “From the beginning, I’ve been impressed with Sequel’s mission to raise the standard of women’s health and wellness, and with this first product, they’ve brought meaningful innovation to a category ready for change.”

Approval from the FDA marks a critical step in enabling Sequel bring its tampon to market and “reinvigorate” the period care industry.

The company has been granted 11 patents in the US and globally with seven additional patents pending internationally.

The news comes on the heels of significant momentum for the start-up. In December 2021, Sequel secured US$5m in seed funding and opened a new San Francisco headquarters.