hand made cloth pads under attack

Save hand made! It will now cost over $3000 to make reusable menstrual pads

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hand made cloth pads under attack
Save hand made cloth pad cottage industry!

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.

https://petitions.whitehouse.gov/petition/lower-or-eliminate-registration-fee-makers-reusable-menstrual-products/WPPWMmZ0

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41 comments

  1. I think it’s sad that they are considering this a medical device, but part of me has to wonder who would use such a thing.

     
  2. I like the idea, but I’ll be honest in admitting that I probably wouldn’t use such a thing. Let alone since it’d be considered a medical device, I’m sure insurance companies will have a field day with it all.

     
  3. You have just opened my eyes to a world I never knew about… I know all about the struggles of small businesses and big government doing what they do best.. making it hard for us.. BUT reusable ‘period’ pads? I am amazed at this whole new world. I just googled it and yes.. this will affect a lot of people.. Unless you wrote it and I missed , I curious as to the FDA’s reasoning.. I can sort of see both sides.. possibly.

     
  4. Money is always a big part of why rules and laws are enacted. Sad to say. I tried to sign the petition but got a page not found error. I am hoping for those women who would like to take advantage of reusable pads, they are able to do so without exorbitant cost.

     
  5. Although I no longer need these products I went in and signed the petition. There is something seriously wrong with this and it smells distinctly of lobbyists for that industry!! I guess the small makers of these products are actually making an indent and are being noticed.

     
  6. That is so sad that they would take advantage of people who like that. Why in heavens would that be considered a medical device is beyond me…it’s menstruation for crying out load!

     
  7. Wow that is interesting. I have been hearing of a crackdown on homemade goods. I know that if you create children items they have to be approved. I guess everyone wants a cut.

     
  8. This is the same problem with the homemade toys and clothes that people were selling. They had to get random testing in each lot that would cost thousands of dollars, which was more expensive than the toys themselves. I’ve never reused pads, never thought about it, but this is really sad that the governmental standards would negate the ability for those who would want to use them.

     
  9. This is totally crazy!!! I have used cloth pads for over two years now. This fee that they are going to charge is going to put a lot if SAHM out of business. I refuse to use disposable pads because they put so many chemicals in them.

     
  10. This might be great for some but I personally couldn’t use cloth pads. I like throwing things away that I have no need for.

     
    1. I can understand that. The issue here is that this tax/fee is a huge burden on the market. Very few large companies make these, so there’s a good chance that if this is enforced, there will be no options for those who do choose to use cloth pads.

       
  11. This was passed years ago. The fee was just enforced as part of the ACA . When you ask for something, there has to be a payment for it somewhere. As a Children’s clothing maker, I have been involved with the Children’s product safety law since 2008 when the outcry over tainted toys was an issue. People wanted something done to insure safe children’s products. A lot of WAHMs went out of business. Some of use stayed in the fight and after 3 yrs, we did get a small batch manufacturer change in the law. We still have hoops to jump thru and registration, but it is a lot better. You need to learn to read and understand the government legalese. I have a huge number of folders on my computer about gov regulations It’s probably not going to be an overnight fix. If your representatives are changing in Jan, find out who they are going to be and start drafting cogent non emotional letters that you can write them For those that are incumbents, start writing them now. I understand your dismay.

     

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