By Daisy Luther
Well, our good friends at the FDA are looking out for us again. Thank goodness we have them to fine us, charges us fees, regulate perfectly natural things, and keep us safe. Heck, who knew that women couldn’t even safely menstruate without them?
The FDA has decided that reusable menstrual pads are Class I Medical Devices. That means those who manufacture these products must pay an annual fee of THREE TO FOUR THOUSAND DOLLARS to continue doing so. Not only must these ladies armed with sewing machines pay taxes on their income, they must pay a fealty charge to the FDA to continue making a living this way. FDA Regulation #884.5435 states that a reusable menstrual pad maker must be “FDA compliant” – which means they must pay a yearly registration fee of $3,646 to remain in business for 2015 and a fee of $3,872 for 2016.
This is part of the Medical Device User Fee and Modernization Act…also known as “The government gets a piece or they put you out of business.” As people strive for more independence from Big Business, this will serve to put them firmly in their places. Self-sufficiency creates a competitive model and provides options other than paying for the lavish vacations and 19 bedroom homes of the CEOs and major stockholders of corporations who find the fees a nominal cost of doing business – if they are even subject to them at all.
Go read the mindblowing list of things that will be exempted: included are the little lights that go on urethral catheters and esophagal dilators. These things don’t require oversight but a cloth pad does????????????? The FDA is terribly concerned for women, because reusable pads are considered “gynecological or obstetrical devices” that require their intervention. And fees. Don’t forget the fees.
Women opt for natural reusable menstrual products for a variety of reasons:
- These products are non-toxic, unlike the bleached white, chemical-laden store-bought varieties.
- These products aren’t piling up in landfills.
- These products allow women to be self-sufficient – they don’t have to rely on a trip to Walmart every month.
Let’s talk about Class I Medical Devices. According to the FDA:
Class I means the class of devices that are subject to only the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the act. A device is in class I if (i) general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (ii) there is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining or for a use which is of substanial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness of injury. (source)
Are you freakin’ kidding me? For that, people involved in cottage industries must pay thousands of dollars per year? Why are they trying to medicalize the regular shedding of uterine tissue, something that has been occurring since the beginning of time?
If you want to talk about something that needs oversight, how about the feminine hygiene products you can purchase at the store? Do you have any idea what carcinogenic materials those things contain? Here’s a quick primer on the contents of sanitary napkins:
In August Women’s Voices for the Earth (WVE) commissioned STAT Analysis to analyze volatile and semi-volatile organic compounds in scented, unscented, and Infinity versions of ultra-thin pads sold under the Always brand, which is manufactured by consumer-product giant Procter & Gamble (P&G).
The results of the testing indicate that both scented and unscented Always pads emit toxic chemicals, including chemicals identified by the U.S. Department of Health and Human Services’ National Toxicology Program, the Agency for Toxic Substances and Disease Registry, and the State of California Environmental Protection Agency, as carcinogens and reproductive and developmental toxins. The manufacturer discloses none of these chemicals on the product.
Some chemicals of concern detected include styrene (a human carcinogen), chloromethane (a reproductive toxicant), chloroethane (a carcinogen), chloroform (a carcinogen, reproductive toxicant, and neurotoxin), and acetone (an irritant). These chemicals also have industrial uses such as in the manufacturing of car tires, nail-polish remover, and Styrofoam, as well as in petroleum refining. (source)
This doesn’t even get into the vast amount of plastic in intimate contact with your body:
Each conventional sanitary pad contains the equivalent of about four plastic bags! With everything we now know about the hazardous nature of plastic chemicals, this alone is cause for concern.
For example, plasticizing chemicals like BPA and BPS disrupt embryonic development and are linked to heart disease and cancer. Besides crude oil plastics, conventional sanitary pads can also contain a myriad of other potentially hazardous ingredients, such as odor neutralizers andfragrances. Synthetics and plastic also restrict the free flow of air and can trap heat and dampness, potentially promoting the growth of yeast and bacteria in your vaginal area. (source)
For women who use tampons instead of pads, the content of those is even more grim:
Phthalates — which give paper tampon applicators that smooth feel and finish — are known to dysregulate gene expression, and DEHP may lead to multiple organ damage.
Furthermore, to give tampons and pads that pristine, “clean” white look, the fibers used must be bleached. Chlorine is commonly used for this, which can create toxic dioxin and other disinfection-by-products (DBPs) such as trihalomethane. Studies show that dioxin collects in your fatty tissues, and according to a draft report by the US Environmental Protection Agency (EPA), dioxin a serious public health threat that has no “safe” level of exposure! Published reports show that even low or trace levels of dioxins may be linked to:
- Abnormal tissue growth in the abdomen and reproductive organs
- Abnormal cell growth throughout the body
- Immune system suppression
- Hormonal and endocrine system disruption
Meanwhile, the FDA’s official stance regarding trace amounts of dioxins is that there are no expected health risks associated with trace amounts of dioxins in tampons…
So wait a minute…according to our noble guardians at the FDA, dioxin is okay, but by golly, they’ve got to monitor those women who use flannel and organic cotton!!!! They must keep those women safe – and of course, dependent on a monthly trip to pay their dues at the altar of Proctor and Gamble, and companies like them. (Learn more from the World Health Organization about the dangers of the dioxin they say is okay to place in your private areas.)
Sellers of these products have been notified that they must scramble to come up with over $3600 by December 31 to remain in business.
Prices of these products are sure to rise in order for the makers to be able to stay in business. Support them by checking out this set of 5 pads or going for the gusto and getting a supply of 20 pads
. You can also keep the FDA out of your panties by making your own pads – here are simple instructions.
If you agree that this is a ridiculous example of overreach that supports the interests of Big Business over the cottage industries that allow families to be independent and help to build a healthy economy, please sign this petition on the We the People website.
Resources
Natural Cotton Cloth Menstrual Pads
Fight for Your Health: Exposing the FDA’s Betrayal of America
Well you know who’s behind this?? The manufacturers of the disposable pads, Kimberly Clark etc…
Kimberly Clark and Proctor and Gamble are not behind this. Obamacare and its medical device tax is behind it. They have labeled everything even remotely having anything to do with daily care a ‘Medical Device’ so they can tax it.
Ugh. Sounds kinda. . .I’d rather not go there, but I disagree with the added extortion fees. I used to use a Keeper when I went on the rag. Mooncup relative.
Thanks Daisy.
For those interested in making their own pads, a selection of tutorials can be found at:
http://tipnut.com/free-pattern-for-washable-feminine-menstrual-pads/
Awesome! You just saved me a trip to Google to look for exactly this. Thank you! 🙂
Wow. Just wow. Thank you Daisy for doing your homework on this one and sharing what you’ve discovered. This is just “another thing” that more than ever, we need our voices to be loud and clear. Shared, tweeted, and pinned.
Unfortunately, the “homework” done here isn’t done very well. yes, the FDA covers reusable menstrual pads. They also cover multiple other menstrual and incontinence items including pads, cups, and tampons. This is not something new at all. The “new” regulation is simply the FDA decreasing compliance regulations. Daisy, were you aware that the cost to be compliant through the FDA was actually closer to $7k? The FDA decided to include NUQ and HDD in the large group of Class I medical devices up for consideration to eliminate the requirement for Premarket Notification and/or PMA, which was an additional $3-$4k. Thankfully, we have citizens that do their research when starting a business and they were able to comment their concerns and recommendations during the public commenting period.
If you are going to complain about something, please do the “homework” appropriately and research more fully on a topic you wish to express your concerns about. Once you’ve done that, perhaps you can better understand why the regulations are in place and what parts of the regulations can be further altered to enable small batch manufacturers and distributors to continue their businesses while still being compliant and successful.
I can see why the FDA may get involved with commercially made pads since they use chemicals to make them but how can the FDA get involved if you use material to absorb? Homemade cotton pads are not a medical ‘device’ and never should be labeled as such. However you say it, it is government overreach.
What’s next….the FDA regulates coats, scarves and gloves because they keep the skin warm? Not any different so don’t start yelling apples and oranges. Skin is an organ after all.
I am utterly disgusted by this move by our regulators which is blatently aimed at helping big business and squashing the cottage industry. Years ago I switched to reusable pads for myself and my young daughters- I buy Yurtcraft’s pads on Etsy. They are the absolute best. Looks like I better go buy a bunch from her before the US Government slaps her hand and outlaws them. What’s next – time to outlaw the reusable nursing pads that I buy too? UGH. Disgusted.
Or cloth diapers…
Here’s a link to the etsy store that I mentioned above. I’m not affiliated with her in any way, this is just me sharing the source where I buy my reusables from.
https://www.etsy.com/shop/yurtcraft
This is not a new regulation. The fees, terms and regulation have been around for a very long time.
Companies have not done due diligence when starting up, to research regulations. http://lunapads.com/blog/2014/12/fda-compliance-cost-business/
The age of the regulation in no way validates the regulation.
I agree that the FDA should oversee chemically processed commercially purchased pads but the point is, using homemade cotton pads should NEVER fall under the heading of a “Medical Device”. I’m sure you know why it’s’ called ‘on the rag’. I can just imagine my mother or grandmother paying the government a tax for using rags back in the day.
It’s land of the fee, home of the slave! Everything our government does is about the corporations it represents, period! United States of America, Inc… one nation, incorporated, with slavery and injustice for all!
OMG! I am so very concerned that a multinational corporation earning billions of dollars per year in profits might be subject to a four thousand dollar regulatory fee. The whole fabric of American democracy will fall if these few corporations are forced to pony up so a huge amount of money compared to their annual profit.
Let’s try and make this issue about personal freedom even though clearly it is not. All so some company owned mostly by foreign investors can save a few thousand dollars a year.
They pass the cost on to the consumer.
I have yet to hear of a cottage business that makes reusable pads making billions of dollars a year. Perhaps you have misunderstood this article. Such a fee could amount to a significantly large portion of a small business income. And quite possibly force them out of business. Which is, quite frankly, what the large corporations want.
I totally agree with Crystal. As a seller of handmade goods on Etsy I can tell you that if the FDA were to levy fees on handmade eye pads that I make as part of kids pirate costumes or felt Halloween masks, just because they may somehow fall under the umbrella that they call ‘Medical Devices’, I would be out of business.
Sorry, those in control. At a certain age, I became absolutely allergic to the disposable pads. I decided to make my own as I had no choice. Not only did they work better, but I had no “allergic reaction.” What are they putting in these things??? This, of course, makes me wonder about disposable diapers.
While I am very sorry concerning cottage industries–my family has a strong history of self employment; it is the key to a strong economy, it is a wake up call for the average person to realize that you can only rely on yourself. While this is not the forum to describe my simple, yet efficient design (I always thought the cottage industry sewers made them too complicated),I will advise this much. A high solution of BIZ in warm water makes many “things” disappear after soaking overnight (or longer if needed).
Increase your skill base! The future does not look pretty.
The FDA is total garbage now that they think a piece of cloth is going to harm us. What is it gonna do, poison us? Oh wait, we should be looking at disposable pads and tampons instead. Really all they want is to make money, and I feel like our community of women is so small that our voice may not be heard loud enough.
Unbelievable. (Or rather, I *can* believe it. These guys are relentless busybodies. I just loathe it immensely.)
Thanks, Daisy, for this information and also for the link to another version of the homemade sanitary pad. (I just thanked another commenter for the version that they just posted, too. I like options. Both links look good.)
time to post plans for making your own set.
I also found a site that talks about how to sew and crochet your own tampons. I’m still not sure *reusing* those tampons is a good idea (but I’m not sure if it’s a BAD idea, either), but for at least a one-time use, it doesn’t seem like a bad idea.
http://www.labyrinth.net.au/~obsidian/clothpads/reusabletampon
More government involvement in a matter which should be a purely personal choice. Too much!!!!
Well said!
They can’t arrest everyone who owns a sewing machine.
For that matter, such things can be hand-sewn.
My country is over.
Can you post a link directly to the site that connects FDA’s regulations on Class 1 devices to reusable pads? I can’t extract that information from the links in your article, which cover FDA regulations more broadly. Perhaps I haven’t read thoroughly enough. Also, has any seller of reusable pads received a letter from FDA warning them of noncompliance? That would be very interesting.
Bobbi, this page will allow you to find the codes for the products classified under “medical device”:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
type “Menstrual” for items such as cups, pads, and tampons
type “incontinence” for items such as protective garments
type “nursing” for items such as pads
You can also look up the businesses who have registered here (updated weekly):
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
most popularly, the NUQ and HHD product codes for resusable menstural pads.
Thank you Misty.
I’m confused by the list of exemptions. Reusable pads are on that lost, page 7, iirc. Is this the wrong list linked and there are the things that ARE classified rather than exempt?
I wonder if changing ‘pads’ into another form like ‘super absorbent underwear’ would negate the fee? I’m thinking specifically of this new company (the product actually looks pretty darn cool). http://www.shethinx.com
What if the pads were constructed into the underwear? I know this doesn’t touch on the silliness of the FDA, just thinking of ways around it.
Nothing new here except the Internet outrage machine working.
This is a quote from one of the people behind GladRags, “These are not new regulations at all and we have paid the fees every year since 1993 (when it was still a spare bedroom business). Of course it’s a little silly that cloth pads are medical devices, but that has been the name of the game for years in regards to selling in the USA and nobody is exempt. It’s a shame that this is news to people and getting stuck with a 4,000 fee you didn’t know about before year’s end sucks!”
Here’s the real scoop: http://blog.gladrags.com/3533/cloth-pads-the-fda-the-real-scoop/
p.s. from the link above, “Disposable pads and tampons are also classified as medical devices. Disposable pads and reusable pads are both Class I medical devices, while tampons and menstrual cups are both Class II medical devices.”
in the paragraph regarding the toxic material in the commercial pads you state that acetone is an irritant. No, it is much more than that. It is absorbed and then through processes in the body is converted to formaldehyde which is a preservative. A most dangerous substance that should be avoided as much as possible.