String Attached: FDA Battles Over CBD Tampons and Vaginal Diagnostics
This commentary is a repost from “Sex on Wednesdays” by Martha Kempner on Substack. Find her other articles on The Queen Zone here.
Tampons have been a regulated medical device since the 1980s when a series of toxic shock deaths raised questions about their safety. Companies need FDA permission to sell them in the United States. That’s not usually a problem because there’s not a lot of variety in tampons. Some have a plastic applicator, some have a cardboard one, some have none, but for the most part they are a cylindrical wad of cotton with a string.
When a company is trying to sell a product that is basically like all the other products on the market, they file for permission under something called 510(K). It basically says, “here’s another [tampon], it’s like all other [tampons], so you can assume it’s as safe as all other [tampons] and I, the manufacturer, don’t have to offer you independent research to prove that before I can market/sell this [tampon].”
Daye Double Dipping
That’s what Anne Daye, a British Company with factories in Bulgaria, did when they first started selling in this country, and the FDA was totally onboard. The company got clearance to sell Daye tampons which “are indicated for insertion into the vagina to absorb menstrual discharge.” And they sold those tampons.
Apparently, however, the company used the same clearance number to also sell two other products based off of that same-as-all-other-tampons tampon: a CBD-soaked tampon and vaginal microbiome diagnostic kit.
That didn’t sit well with the FDA. In April 2024, the FDA put Daye on notice with a letter, delightfully referred to as an “It Has Come to Our Attention Letter” or an IHCTOA for short. The company sent a reply which the FDA clearly deemed insufficient. On Christmas Eve, the agency sent another letter declaring that it had had enough. The exasperated tone is clear even through all the jargon.
With much poetic license and a bunch of personal experience, I am imagining the back and forth letters as an exchange between a fed-up parent and their teen:
FDA: It has come to our attention that you lied to us.
Tampon Company: We didn’t lie. We said it was a tampon. Look it’s a wad of cotton.
FDA: You said it was an ordinary tampon like every other tampon ever made.
TC: It is, see here’s the string.
FDA: But you soak it in CBD.
TC: So what? It’s still a tampon.
FDA: You say it relieves pain. That puts it in a different category.
TC: I mean it might relieve pain, but really it’s just a tampon.
FDA: On your website, you tell people your tampon features “… special comfort coating that ensures a mellow period experience.” And when one of your customers complained that it didn’t work, you wrote, “We’re really sorry to hear that the CBD tampons didn’t work for you. Research shows that different bodies have different responses to CBD, and just as other forms of pain relief, annoyingly it won’t work for everyone.”
TC: That doesn’t mean anything.
FDA: In an interview you founder says she came up with the idea when she realized that that hemp can “… act as a pain reliever while its fiber is super absorbent. These two properties stuck in my mind and as you can tell, that is how the idea of our pain-relieving tampon was born.” That describes a new invention, not a run-of-the-mill tampon.
TC: Okay, fine, but why are you making such a big deal about it?
FDA: We’re upset because if you told us you were trying to sell a tampon that would relieve period pain, we would have made you show us evidence that it was safe and effective. We know nothing about the CBD you put on your tampon, it could be contaminated, and for that matter, we’ve never studied whether putting a CBD right into the vadge is even safe.
TC: It’s fine.
FDA: Stop saying that. Also, what about this diagnostic kit you’re selling under the same clearance number. That’s not just a tampon.
TC: Well, there’s tampon in it. Consumers use it to collect the vaginal fluids that we test.
FDA: So, it’s a diagnostic test.
TC: That’s not what we said.
FDA: Yes, it is. You say it right here on your website where you promise to diagnose BV and yeast infections.
TC: Whatever, it falls under the FDA guidance for General Wellness: Policy for Low-Risk Device.
FDA: No, it doesn’t, it’s a diagnostic test.
TC: But…
FDA: Enough already, go to your room and study the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299, and then we can talk. In the meantime, we’re taking steps to refuse entry of these devices into the United States.
TC storms away slams door to Bulgarian factory. FDA crumples into a chair exhausted.
END SCENE
