In an effort to be more sustainable, many women are choosing reusable menstrual products. From various cups to cloth pads, the idea is less trash the better.
Well, now the FDA has decided that reusable menstrual products are medical devices, this was decided a while back but apparently now they will be enforcing this. The FDA has determined that to make reusable menstrual products, makers, including cottage industry home-sewers must REGISTER with the FDA. Fine, right? FDA Regulation #884.5435 states that a reusable menstrual pad maker must be FDA compliant (pay a yearly registration fee) because they are now considered makers of medical devices!
The fee is $3,646 for 2015; and an est. fee of $3,872 for 2016. You see, the FDA has a Medical Device Exemptions 510(k) and GMP Requirements, and reusable sanitary pads are NOT exempt from the registration requirement.
There are many great reusable cloth pad makers. I’ve worked with a few very great ones (see their links below), and highly recommend reusable pads as an alternative to disposable pads and tampons. But, cottage industries are hit hard when registration fees are high!
So at $10 a pad, and let’s say $2.50 for material (top material, an absorbent material and a waterproof backing), then buying a serger, a press, and snaps… Let’s say cost of production is $4. Mailing materials are another $.50. Often people want discounts… Can you imagine HOW many pads an individual maker will have to sell (not to mention some are imperfect, so are sold at cost, or less than cost)… to make back the registration fee?
These are home-sewers whose customers trust them, and honestly, I’ve never heard of a lady at home making pads and inserting toxic chemicals into them!
So under exemption 80, unscented pads are exempt, but look at the footnote: 510(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.
So disposable pads that are “established” are exempt, but cottage industries again will be pushed out of the market with the high fees. For those who wonder if this is real, see this link on “Medical Device” registration on the FDA’s own website. (and that exemption is directly from their site.)
Plus, if someone has maybe one person help out and cut, they can’t do that “outside” as it is PER facility. See that link and look under “Register a Medical Device Facility.”
Oh and waivers? Look at this: The law requires that all registration and listing information be submitted electronically unless FDA grants a waiver.
To apply for a waiver from submitting your registration and listing information electronically, please submit your request with a complete explanation of why you cannot submit your information electronically to: Food and Drug Administration CDRH – Office of Compliance Registration & Listing 10903 New Hampshire Avenue Building 66 Room 2621 Silver Spring, MD 20993-0002
Note: If you are granted a waiver, you will still be responsible for the establishment registration fee. If you’re even more unsure, check this link.
So even more, WHY is this a medical device? And if so, can you bill your insurance when you buy reusable cloth pads?
There are crowd funding options for some of the cottage makers – and fundraisers are great, but let’s be honest.. donations for businesses are down this time of year. Yes, we donate food and a toy or two to the “boxes” but very few makers will have the cash set aside or the donations come through to make it for the over $3500 fee to register for 2015. There are known “trace” dioxins in tampons, they are inserted into the body and can lead to TSS. These aren’t being inserted into the body. Help save hand-made! To help save this industry, sign the petition below. You’ll need to prove you are a US citizen and then click the email to confirm your signature.