FDA Approves Spiral Tampon, First Evolution To The Period Product In 90+ Years

A regular tampon (left) VS the Sequel Spiral Tampon (right). Images 92707420 © Andrianocz | Dreamstime.com and Sequel

The United States Food and Drug Administration (FDA) has opened the floodgates for a new tampon shape to emerge as a medical device.

Sequel, a women-led startup based in San Francisco, wants to paint the town red, or rather, absorb the color off it, with its breakthrough Spiral Tampon. The menstrual product marks the first big change to the modern tampon since Tampax introduced its offerings, in 1931, which means innovation has been clogged for about 90 years.

The spiral tampon was invented by two Stanford classmates and athletes, Greta Meyer and Amanda Calabrese, who often felt self-conscious playing sports in their white uniforms during the time of the month. They sought to revamp the tampon, which has long promised to sop up blood flow, and presented their new and improved design for a class project.

Screenshot via Sequel

Since then, Sequel’s helical tampon—the brand’s first product—has received US$5 million in funding, and to top it all off, the FDA has now given the innovation its seal of approval.

The iconic design features diagonal grooves in place of vertical ones, which makes the tampon more proficient at absorbing liquid and impeding leakage.

Screenshots via Sequel

Sequel says it has developed a proprietary process to make mass production for the spiral tampon possible. Its work comprises 11 approved patents in the US and worldwide, with seven more awaiting evaluation.

During their research, Meyer and Calabrese—who appeared on Forbes’ 2023 30 Under 30 list—spoke to several menstruators who said they would secure their tampons with the added layer of pantyliners to avoid monthly inconveniences, which proved the need for a better design.

Their invention has undergone extensive testing and yielded a great amount of documentation to determine its safety for women’s health, ultimately convincing the FDA to clear the product for sale.

Screenshots via Sequel

“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,” acknowledges Meyer, Sequel’s CEO. “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.”

The brand will now commence with consumer trials, and it expects to make the Spiral Tampon more readily available by the beginning of 2024.

[via New York Post, The Guardian, NBC News, Business Wire, images via various sources]