It Has Come To Our Attention

FDA Takes Tampon Company to Task

I’m back on antibiotics. Like many others, I’d managed to avoid them for a number of years even post-pandemic, but this flu/cold/Covid/general crud season has gotten me. I’m currently on amoxicillin for a sinus infection. The pills are giant, and my stomach already hurts. (The inevitable yeast infection is still a few days off, but don’t worry, I know better than to leave Urgent Care without a prescription for Diflucan.)

In November, when my youngest and I both had walking pneumonia, I was on a 14-day course of Doxycycline, and it made me absolute miserable. I mean, I was glad to be cured of pneumonia, but the gastrointestinal distress was real. I joked that people must really hate condoms if they are willing to put up with this instead.

My antibiotic/STI/bathroom humor made my colleagues and, thankfully, my urgent care doc laugh (which gave me more faith in my urgent care doc), but I realize that it’s not exactly a a zinger in all crowds.

Doxy PEP is a new(ish) STI prevention strategy that has people taking the eponymous antibiotic after condomless oral or anal sex to prevent bacterial STIs. Studies have shown that it reduces the risk of getting syphilis and chlamydia by 80% and gonorrhea by 50% in men who have sex with men and transgender women who have sex with men. The strategy has not been shown to be effective in cisgender women who have penis-in-vagina sex.

Just last week, two new studies were published in JAMA Internal Medicine suggesting that doxy PEP might be to thank for falling STI rates in California where some early studies and pilot programs were conducted.

One of the new studies looked at bacterial STI rates in San Francisco after the introduction of doxy PEP (the city was an early adopter of this strategy). Researchers compared those numbers to projected rates based on past data. They found that chlamydia was down 50% compared to projections and early syphilis was down 51%. Gonorrhea cases, however, were higher than the projected rates for that period.

The other study was conducted among Kaiser Permanente patients in Northern California. It included 11,551 people who were taking PrEP to prevent HIV. The researchers found that those who also took doxy PEP had fewer cases of all bacterial STIs. Specifically, quarterly positive tests were down by 79% for chlamydia, 80% for syphilis, and 12% for gonorrhea. In contrast, rates of these STIs remained stable among those participants who took PrEP but did not use doxy PEP.

This research is very promising, but there are some concerns about doxy PEP. We’ve all been told to limit our antibiotic use (read: don’t ask your doctor for one when you have a virus like a cold or the flu) so as not to increase antibiotic resistance. The authors of both studies acknowledge that it’s too soon to tell whether more people taking doxy more often will increase antibiotic resistance. The bacterium that causes gonorrhea, for example, has already shown resistance to most antibiotics we’ve thrown at it. In fact, existing resistance to doxycycline may be why doxy PEP is not as effective against gonorrhea. (One of the studies found doxy PEP did not work for gonorrhea of the throat which is a common infection site).

Antibiotic resistance is important, and I’ve been writing about it for years, but I want to talk about something way more basic. Who wants to have sex when they have this bad a tummy ache?

The Post-Roe Snip & Go

Two new studies show that the fall of Roe v. Wade has changed young people’s reproductive and residential behaviors. Researchers at George Washington University found that rates of permanent sterilization for both women and men went up everywhere after the Dobbs decision in 2022 with more increases seen in states that restrict abortion. A study of the same time period by the National Bureau of Economic Research, a nonprofit economic research organization, found that young people have increasingly fled states with strict abortion laws.

While these are two separate, unrelated studies, I’ve decided to dub their joint result “The Old Post-Roe Snip & Go” because I can never resist a rhyme.

For the sterilization study researchers did two things. First, they looked at national medical claims data for vasectomies and tubal sterilizations and compared the number of procedures across states. They found that in August 2022 (two months after Dobbs) there were 799 (or 70%) more tubal sterilizations and 346 (or 95%) more vasectomies compared to May 2022 (the month before Dobbs) among young adults between the ages of 19 to 26. They also found a greater increase in both tubal sterilization and vasectomies in states that had bans or were seen as likely to adopt an abortion ban than in states where abortion rights seemed safe.

While insurance data can’t tell us why these people chose to get snipped, the researchers also conducted qualitative surveys with over 600 young people. Survey participants expressed fears about their reproductive health in this environment. Some confirmed that their interest in permanent contraception was, in fact, motivated by concerns about losing access to abortion and not being able to make pregnancy-related decision in the future.

These fears are legitimate in today’s political landscape where more states are imposing stricter abortion regulations, and court cases are actively trying to resurrect Comstock laws. Surgical approaches to contraception—whether it’s sealing off the vas deferens or tying/removing the fallopian tubes—are very effective methods of avoiding all pregnancy now or in the future.

These could be great methods for young people who are really sure about their decision not to have biological children in the future. Anyone who might be on the fence, however, should stick with Long-Acting Reversible Contraception. The IUD and the Implant have effectiveness rates that rival sterilization (though they are only available for those of us with uteri).

The second study looked not at medical records but rather at postal records in the months after Dobbs. By examining change of address forms filed with the USPS, researchers were able to determine how many people left states with strict abortion bans or states that were perceived to be hostile to reproductive rights.

The analysis found that the 13 states with strict abortion bans lost about 36,000 residents each quarter post Dobbs. Single person households, which tend to be young people, were the most likely to move across state lines (or across multiple state lines until they reached abortion safety). This makes sense as single person households are by definition more mobile (only one person has to find a new job, living situation, or school).

The researchers calculated that if this trend continues for five years, it will lead to a 0.98% loss of population for states banning abortion. This may not sound like a lot, but it’s equivalent to the impact that a 10% increase on local crime rates would have on a community.

This isn’t good news for red states. As the researchers note, “States with abortion bans may face challenges in attracting and retaining workers, especially… younger workers who represent future economic potential. These population flows and demographic shifts could affect a wide range of economic factors from tax bases to housing markets to the availability of workers in key industries.”

Red state politicians want us to believe that their goals are improved economies and lots of healthy {white} babies, but the policies they are putting in place will lead to neither. (Oops did I say the racist part out loud?)

No Hemp for Your Hoo-hah? No Vape for Your Vijayjay?

Before the holidays I promised you the list of what we stuck up our butts last year, and I will make good on that promise. I’m saving that for next week, however, when inauguration will have us depressed, and we’ll be wanting to tell people exactly where they can shove “it.” In the meantime, here’s a story about what the FDA does not want us to stick up our vaginas: CBD tampons.

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].”

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. (Yes, the FDA actually uses the acronym.) 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 your 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: [Takes a deep, slow breath before speaking.] 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. You’re grounded!

TC storms away slams door to Bulgarian factory. FDA crumples into a chair exhausted, considers pouring a stiff drink and then remembers the Surgeon General’s report on alcohol and sighs.

END SCENE