Our Common Thread
Every woman over the age of 14 has something in common. We all have monthly cycles. Most of us wouldn’t consider it glamorous, but most of us also wouldn’t describe it as a medical problem. Our bodies are not malfunctioning when they begin their cycle each month with a cleansing. We aren’t broken and medically in need of a fix. Or are we?
According to the FDA of the United States of America, women are in need of a monthly medical device for dealing with their period. According to the FDA, we have a medical problem that needs a medical solution. Don’t agree? Neither do I.
A menstrual pad is a medical device?
After attempting to buy my favorite brand of cloth pads off of Etsy (LillyaPads), I found out a new regulation that has been slipped into FDA playbook without the awareness of the women of America. In the 1990’s, the FDA decided to begin regulating menstrual pads by calling them “medical devices.” Did you know that you were using a medical device when you were wearing a pad?
Cloth Menstrual Pads and FDA Regulation
Regardless of the concern the FDA may have about the plastic chemical-laden menstrual products on the market, cloth menstrual pads have been used by women for centuries. They are literally a piece of cloth. In 2014, the FDA decided to begin regulating cloth menstrual pads by having all of the small businesses who made cloth reusable menstrual pads begin to pay a yearly registration fee of $3,646. In 2015, the registration fee for the upcoming 2016 year increased to $3,872. First women have a medical problem and now women’s businesses are being extorted as a result.
Rather than being classified as a risk or a FDA concern, cloth pads need to be completely left out of the menstrual pad/medical device category. Is underwear a medical device? Goodness, I hope not.
Let me point out that diapers for babies are not classified as a “medical device.”2
I refuse to allow the FDA to tell me that I have a medical problem that needs a medical device. They can regulate to their heart’s (or greed’s) content a myriad of things, but I refuse to let them tell me that I have a medical condition, because I was born a WOMAN.
Join me on my Facebook page to continue to get updates about the development of the FDA Cloth Pad Regulation Revolt.
Continuing the Revolt
I am going to continue to research this issue and I plan to fight the FDA’s decision to regulate cloth menstrual pads and categorizing menstrual pads as a medical device. Please join me as I stand up for our rights as women to be women with cycles who are not classified as having a medical condition.
Until the FDA stops regulating cloth pads, let’s support the small businesses who were able to stay in business and had to pay the FDA registration fee.
Thank you for reading and continue to shop cloth, eat healthy, and breathe!
THE Boholistic Mom
1. Lunapads | FDA COMPLIANCE & THE COST OF DOING BUSINESS
2. FDA | Protective garment for incontinence
3. GladRags | Cloth Pads & the FDA: the real scoop
4. Cloth Pads – Live Journal | Cloth Pad Companies: Complied or Shut Down
6. Business 2 Community | Dear FDA: Cloth Pads Are Not Medical Devices
7. Shew Knows | Reausable Cloth Pad Makers Hit with Huge FDA Registration Fee
11. FDA | CDRH Office of Device Regulation