New Tampon Cleared by the FDA

And why it's such a big deal

Normally, when I write about a new over-the-counter product, I’m very grumbly because, almost always, there is sketchy science, or over-hyped claims with no backing evidence. Sometimes, these products come from well-intentioned, albeit misguided people, and other times, it’s a straight-out cash grab. 

BUT FOLKS, TODAY IS THE DAY I GET TO WRITE ABOUT A PRODUCT THAT IS AN EXCEPTION! 

(I’m yelling from excitement).

The FDA recently cleared a new tampon called Spiral™ made by the company Sequel, and the tampon has a novel design that is supposed to reduce leakage. And it’s a big deal because it’s rare to see a company do the work needed to bring a new tampon to market.

But before we get into Spiral™, I want to give a little backstory so you understand why I’m so excited, and why this is kind of a big deal. 

The FDA and Tampons and Why Safety Matters

In both the United States and Canada tampons are regulated as medical devices. In the U.S. this is controlled by the Food and Drug Administration (FDA), and in Canada, the agency involved is Health Canada. In the United States, menstrual products are divided into two groups by the FDA, and they are registered or cleared by the Food and Drug Administration (FDA), which is different than being approved, like pharmaceuticals. Unscented pads and scented pads using materials previously cleared by the FDA are Class I devices. These are considered low-risk. The company submits the paperwork and registers the product, and it goes to market. Basically, the FDA knows they exist, but hasn’t reviewed any data. These products can be marketed as FDA-registered.

Class II devices include any product with a material not previously cleared for use or any device inserted vaginally. Hence, all tampons. With a Class II device, there is the potential for a moderate risk. If the manufacturer can show their tampon is not materially different from what is already available, it is cleared and can go to market. This is why I find all the claims about so-called organic tampons hilarious. It is truly ironic to claim your product is somehow special, but to get cleared by the FDA, these products literally just have to show why they are not different from what is already available in any meaningful way. Menstrual cups and discs are an exception as they can hit the shelves without waiting for the go-ahead, but they still must submit the paperwork. 

When any new material, component, or design is introduced for a Class II device, the FDA requires safety data in order for the tampon to be FDA-cleared. The manufacturer must prove, among other things, that their tampon won't fall apart in the vagina, that it doesn’t encourage the growth of the bacteria that produces toxic shock syndrome, and that it isn’t irritating to the vagina. If everything looks good, the device is cleared to be sold. As you can understand, this process is not quick, or cheap. 

Sometimes, I see some online complaining about this review process. Typically, it’s from people who want tampons infused with cannabis or essential oils (ouch) or other medications. However, you should know that this regulation exists for our safety, because in the United States anyway, unfettered capitalism and medical devices are not a good mix for you, the consumer. 

In the early 1970s, it became clear to the FDA that some type of regulation was needed for medical devices, primarily due to issues with cardiac devices as well as IUDs (specifically the Dalkon Shield, but that wasn’t the only problematic IUD, wait until you read all about the IUD shenanigans of the 1970s in my new book, Blood). In 1976, the FDA passed an amendment requiring that all medical devices be registered (the process described above, although we didn’t discuss Class III devices because they don’t apply here), and tampons were included as medical devices. The Rely tampon managed to avoid this requirement because even though it didn’t officially hit the market until 1978, Proctor and Gamble had started working on it in 1974, so it was grandfathered in. Rely was different in some unique ways. Before Rely, tampons were either cotton, rayon, or a blend and their expansion was primarily lengthwise, up and down the vaginal canal. Rely had several key differences: new material (polyester foam in cubes and chips with a carboxycellulose gelling agent all contained in a mesh covering), it had greater absorbency, and it expanded width-wise as well as lengthwise. This was a radically different tampon. To compete, some other tampon manufacturers added polyacrylate, a super absorbent polymer, to their tampons to increase absorbency.

And then, cases of toxic shock syndrome started to appear. Rely was removed from the US market in 1980, and cases of mTSS started to drop, and polyacrylate was removed from tampons in 1985. 

There were several biological ways that the Rely tampon could increase the risk of toxic shock syndrome, but the take-home point here is that different materials and designs can change the vaginal ecosystem in ways that can be harmful, and we can’t predict the behaviors of something that is radically different without good data. Going back to cannabis-infused tampons, for example, we have no idea how that might affect the vaginal ecosystem and the assumption should never be that it is in a beneficial way. Hence, regulations and safety testing for new products are needed. 

How Does Spiral™ Differ from Tampons Currently on the Market? 

I reached out to Sequel, and their CEO, Greta Meyer, told me by email that their design change does not impact the absorbency of a tampon per se; rather it “focuses on grooves designed to extend the flow path to prevent premature leakage.” Basically, it has a spiral design with grooves that are supposed to direct the flow of blood and stop leakage down the side of the tampon. I think we’ve all been there where there has been what I like to call a CTE (critical tampon event), but when you pull the sucker out, it’s not saturated; in fact, half might be bone dry, and blood just leaked down one side. This is called "bypass leakage." The grooves and spiral design are supposed to make the tampon better at achieving its peak absorption performance. 

What is Spiral™ Made From? 

The product that was FDA-cleared is rayon (a.k.a viscose), which is a fiber made from wood pulp. The company is also apparently developing a cotton version. Rayon is safe. Really. There is no data showing any safety concerns with rayon over cotton. I am sure there will be some man screaming about rayon tampons somewhere on TikTok, and this is your gentle reminder that when that time does come, to block hard and fast. 

What Data was Submitted to the FDA? 

Greta Meyer sent me this information via email about what was submitted to the FDA:

• Data proving our product is free of 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)/2,3,7,8-tetrachlorofuran dioxin (TCDF) and any pesticide and herbicide residues.

• Performance 

  • Absorbency range data

  • Data demonstrating the performance characteristics for the following features of tampons: string strength, fiber shedding, and tampon integrity.

• Preclinical Microbiology. Data proving our product does not:

  • Enhance the growth of Staphylococcus aureus

  • Increase the production of Toxic Shock Syndrome Toxin-1 (TSST-1)

  • alter the growth of normal vaginal microflora.

• Biocompatibility, Per ISO 10993-1, data on the following: 

  • Cytotoxicity (proving our product is not cytotoxic)

  • Acute systemic toxicity (proving our product does not cause acute systemic toxicity)

  • Sensitization (proving our product does not cause skin sensitization)

  • Vaginal irritation (proving our product does not cause vaginal irritation)

Yes, that’s a lot, and the Rely saga clearly demonstrates why this is important.

I should also add that it is very unusual for a company to email me back immediately and actually respond directly to every one of my questions. Usually, I either get no response or a delayed response after I suppose they have a discussion with their PR team about the best way to deal with Dr. Gunter since she doesn’t seem to like anything. If I do get a response it is almost always some lame excuse about how they have in-house testing they can’t share with me, or they share some “preclinical data” that has little if anything to do with their product. It’s always a disappointment. Until now!

Once again, Sequel responded directly to every one of my questions. Good on them. Then again, when you have done the work, you can actually respond. 

Why This Is Great

The design is interesting, and the concept makes sense, but until we have peer-reviewed clinical studies, it’s not possible for me to say if Sequel’s tampon will truly leak less than others on the market. However, I’ve spoken to enough menstrual product users over the past 30+ years to know that different people find different products work better for them, so I have no doubt that there will be lots of people who find that Spiral™ is better for them and others for whom that may not be the case. 

While Sequel did come up with a unique design, what is also unique is a small company going through all the testing and regulatory paperwork. It’s expensive, and it’s never a guarantee. Lots of people propose new ideas for tampons, and then they don’t buckle up and raise the funds to take it to the next step. But based on the FDA clearance, I think we can be assured that Spiral™ is as safe as every other tampon on the market. And that’s a big deal, because the more options, the better. 

I’m not a tampon user anymore (yeah team menopause), but when Sequel gets their product on the shelves in 2024 (which is their estimate), I am going to throw them a solid and buy a box because I like to keep my house stocked for guests. I will add Spiral™ to my stash of Tampax, so my guests have choices, but more importantly, I want to put my money where my mouth is and support a company that actually did the leg work (menstrual work?), from design to execution to FDA clearance. 

The next time you see a period product hack, like using sea sponges (you can read why that is a bad idea here) or make-up sponges (don’t), think about all the safety data the FDA required for Spiral™ because you deserve that kind of rigorous testing.

And I’m looking forward to hearing how people like this new tampon when it hits the market. 

References

1. Vostral SL. Rely and Toxic Shock Syndrome: A Technological Health Crisis Yale Journal of Biology and Medicine. 2011;84: 447-459.

2. Oral History of the FDA. Interview with Larry Pilot, Esquire. Dec. 21, 2004.