So apparently, according to our wonderful FDA; homemade cloth pads are now considered dangerous and in need of regulation, before women who are trying to help other women AND feed families, can sell them. This is truly a thing, and I was dubious at first, thinking that this can’t be real, but it sadly is. I read a few articles, and decided to look it up for myself, and went to the FDA website. Sure enough, there it is. I was thinking.. ok some of these are made with synthetic fabrics, maybe they are trying to look out for us for once (even though they allow scented disposable pads, but more about that in a minute). Nope. The really messed up thing is that unscented pads made with the synthetic materials are exempt from the higher fees, but not the re-usable menstrual pads.
From the FDA website:
Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.
Class I Devices
FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with “\#\” are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.
If a manufacturer’s device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM)
IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Class II Devices
The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as “(II)”), subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. Class II devices are annotated “(II)”. Please note that class II devices are NOT exempt from GMP requirements.
Unscented Menstrual Pad. 80
80510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile. Exemption does not include the intralabial pads and reusable menstrual pads.
Color me perplexed. So, women have used cloth pads for eons, in different forms. Then came the “convenience” of putting chemicals in a very blood filled and sensitive area, (and women have had more and more reproductive issues), and we call it progress because “Hey at least their crotch smelled like air freshener, and they didn’t have to embarrass themselves in the women’s’ room with a little blood on their hands.” The endometriosis, and toxic shock is so worth it though, right? I am sure that is exactly what our creator had in mind. But being a woman is dirty and a sin; isn’t that what we are told all of the time? And those horrible cramps (which are made worse by the toxins) are our burden to bear, to pay for Eves betrayal. (Don’t get me started on the carrying of our ancestors pain and burdens! That will be another blog post.)
To embrace our divine feminine and all of it’s wildness, it’s “mess’, it’s smells, it’s desire makes us somehow wrong, bad, or dirty. How incredibly painful to live our entire lives believing that we are bad and dirty just because we happen to be born female. And now, we are trying to change this perspective, trying to liberate women from the shackles of this dis-ease, and we have to face another hurdle.
We have gone from bulky cloth pads to atrocities on women, and called it progress. Women have been shamed for bleeding for too long, and men have controlled our bodies and our power for far too long.
Hey FDA!! Keep your dirty hands out of our honey pots!! Our blood is life, it is power, and it is sacred! We have the right to make and sell cloth pads!
Your body is sacred. If you want to empower your sisters by giving them an alternative to toxins, and make money doing it why not?
Anyone with a sewing machine can go to a fabric or thrift store, buy the materials, and make these. There is no need for regulation. Unless of course my bra, underwear, and clothing are medical devices as well. What about the cloth diapers some women use for their infants? What if I designed a type of bra that didn’t chafe or put pressure on the breasts, and make breast tissue healthier, would that be a medical device as well? And here is another question that I haven’t seen asked yet? If my diva cup and fabric menstrual pad are medical devices, then my doctor can prescribe it and my insurance will cover it right? So the FDA is saying that my medical insurance provider should have to cover my menstrual products? So these home based businesses can then do what other companies do and charge the insurance companies huge amounts of money to cover these huge fees right? Makes sense to me. Sounds like that works out in everyone favor… except the tax payers who already have a hard time with birth control, and abortions. My guess is someone didn’t think this one through. But that seems to be the theme around here lately.
We need to start a petition to get this changed. While we are working on that, here are some links to make your own cloth pads, I hear they make great gifts! If you received a gift in return that would be great!