Eco-friendly small business owners sewing and selling reusable cloth menstrual pads are enraged at the rumor that the FDA has classified their hand-sewn feminine pads as medical devices. As a consumer of these “medical devices,” I find the label appalling.
At first, I didn’t believe it. I read an article on Business 2 Community that claimed that the owner of a Work-At-Home-Mom (WAHM) owned small business that sells reusable cloth menstrual pad received a letter from the FDA telling her to pay up or pack it up by the first of the year. I had to find out for myself. Does the FDA really regulate reusable cloth menstrual pads?
I couldn’t find a warning letter to any vendor about reusable cloth menstrual pads on the FDA website, so I can’t verify the Business 2 Community writer’s claims that the FDA is cracking down on WAHMs; however, as it turns out, the FDA has actually considered reusable menstrual pads medical devices for years.
Were Reusable Menstrual Pads Just Reclassified as Medical Devices? http://t.co/2Ffojwhhjs
— Lunapads.com (@Lunapads) December 8, 2014
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter only when the device is made of common cellulosic and synthetic material with an established safety profile. This exemption does not include the intralabial pads and reusable menstrual pads.
According to the FDA, menstrual pads are medical devices, because they “are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.”
Except none of those things are true.
Mine come in beautiful designs of bright colors with a pretty little floral pattern on the bottom layer which is made from a waterproof fabric we call “PUL.” The middle layer is made from an ultra absorbent micro-terry fabric that absorbs the wetness in lieu of the little gel balls of disgusting sodium polyacrylate that you find in many disposable brands of maxi pads. The inside layer is a soft piece of fabric-heaven that wicks wetness away.
Presumably, the FDA would like to pretend that reusable cloth menstrual pads “affect the function of the body,” except that they don’t. With or without the cloth menstrual pads, the uterine lining will still be shed and will still leave the body. Unlike tampons, sponges, and cups, reusable menstrual pads don’t affect whether or not the blood and tissue from the uterus leaves the body.
Nor do reusable menstrual pads cure, mitigate, treat, or prevent diseases. They also do not affect the structure of the female body, though the FDA might want to look into the legality of unregistered bras and corsets.
Reusable menstrual pads are no more than protection for underwear.
Furthermore, normal menstruation is not a medical condition, and women are getting pretty tired of being told that our normal physiological functions are medical conditions.
“So, dear FDA, cloth pads made from fabric available at any craft story are not medical devices,” Heather Johnson explained. “Stop harming small business with the medicalization of a normal physiological function of the human female body.”
I say that reusable menstrual pads are no more than some extra clothing. That’s what they feel like anyway. Perhaps they are more like underwear accessories. One might even call them “panty bling,” if one wanted to market them differently.
One thing is certain to the people women use them: Reusable menstrual pads are not medical devices.
When people try to boss around this same group of crunchy mamas in regards to breastfeeding, nurse-ins spread like wildfire. The FDA needs to deregulate our Mama Cloth, because this crowd will not back down. A petition to the White House was started asking the feds to drop or at least lower the FDA registration fee for reusable cloth menstrual pads, because the thought of charging a WAHM $3,646 in 2015 for the opportunity to be able to sew and sell reusable cloth menstrual pads to other women at Etsy stores, craft markets and boutiques is downright appalling.
lower or eliminate the registration fee for makers of reusable menstrual products. http://t.co/BDqLFlrvWB
— Shawna Miller (@ScrawnyGirlShop) December 8, 2014
While, according to the FDA, most medical devices in this class are exempt from completing a premarket notification application, manufacturers of menstrual pads are still required to register with the agency. Shockingly, seamstresses sewing beautiful reusable mama pads to sell on Etsy don’t even appear to qualify for the premarket notification exemption.
The FDA needs to keep their regulations away from our comfortable, safe, reusable menstrual pads, but if they don’t, I’ll be happy to purchase some re-labeled panty bling next time I’m in the market.