12-10-2014
This is an issue I’m still trying to wrap my head around and track down details, so if you have some, please share. This is what I understand at this point:
Did you know that menstrual pads are considered medical devices by the FDA? That’s been the case, it turns out, for about three decades. Who knew? One more example of the messes created when the government writes more regulations in a month than most people can read in a year. Why, if this has been the classification of menstrual pads (both disposable and reusable, corporate manufactured and home-made by your kids’ Sunday School teacher as her cottage industry) for years, is this suddenly an issue? What’s the big deal?
So, they’ve been ‘medical devices’ for decades. But ObamaCare now puts a special tax on medical devices – and menstrual pads aren’t the only thing that the FDA considers a medical device. Your toothbrush is a medical device. The fee doesn’t make anybody safer. It’s about funding Big Government.
So is it the fee that’s the problem, or the classification? Well, why just one or the other? For me, it’s both.
Admittedly, for most people, it’s the fee, because that’s hitting them immediately and where it hurts- cottage industries are having to scramble to come up with, probably, more money than most of them even make in a year. It’s hitting their customers, people who love to support SAHMs while also using a more natural product, one that doesn’t add to landfills and fill our trashcans with products that attract pests.
It wasn’t an issue until now because most people had no idea that menstrual pads, reusable or otherwise, were classified as medical devices until the fee came up- which happened just this year. So the fee is what brought the classification to people’s attention, but it’s still a stupid classification that defies common sense. Without the fee, most of us still would have no idea about it, because has time to read millions of pages of regulatory gobbledy gook? It really highlights the regulatory chokehold constricting the ‘land of the free.’
So, recently the FDA basically informed a lot of SAHMs that they were out of business- at least, that is the natural result of the regulatory window smashing – they issued the order to pay premarket fees in late 2014, giving companies until January 1st to pay nearly $4,000 or lose their right to sell their product legally in the United States.
The pads have been classified as a “Class 1 Medical Device” for years. However, recently the FDA started sending letters to an increasing number of Work At Home Moms and small businesses, demanding that they pay a premarket notification fee to continue the sale of their products. The FDA oftentimes finds itself faced with questions about products from competing firms. The pads do not require regular monthly purchases, and many mom bloggers and work-at-home moms (WAHMs) have used the pads as a means to speak out about the potentially dangerous and irritating chemicals placed inside many commercially available pads. The reusable pads produced by most companies are actually better for women as they do not contain the dangerous chemicals that are found in many disposable pads. Many companies sell pads that are made of fabrics that can be purchased at any fabric store. Typically the pads contain nothing more than cotton, minky, flannel, PUL, silk, and other similar products.News of the payment requirement was made by a small company founded by a WAHM. The company was notified on Friday that it must pay more than $3800 in annual fees in order to sell their simple reusable menstrual pads as a “Class 1 Medical Device.” The owner of the menstrual pad company notes that the FDA did not once attempt to place charges on her product over the last seven years by requiring premarket notification fees on her company’s menstrual pads. In most cases I would personally blame the company for not investigating FDA regulations, but let’s be honest for a moment, this is a pad made of standard store bought fabrics, not a “medical device” in the eyes of most individuals.The FDA is not claiming that reusable menstrual pad companies need to invest in further studies for their products to determine their safety. The FDA is not even claiming cloth pads are unsafe. Rather, that company’s must “pay to play” — handing over their hard earned money to the FDA in order to sell a product that really is not that much different than underwear, in fact it is just as non-obtrusive. The FDA argues that the money is needed to regulate the market from products that might contain dangerous chemicals and other components.Making matters worse, the FDA issued the order to pay premarket fees in late 2014, giving companies until January 1st to pay nearly $4,000 or lose their right to sell their product legally in the United States. Keep in mind that many of the companies selling the pads are run by WAHMs and other small businesses. One company owned by a mother of six, was forced to ask their loyal customers to help fund its payment. Within 4 hours their loyal customers pitched in $320 of the $4,000 required to keep the company in business.Clarification Update: The original draft of this article spoke about the recent changes to the medical classification of menstrual pads. Please note that reusable pads have actually be classified as a Class 1 Medical Device for more than a decade. The WAHM’s notification from the FDA as now described in the article was based on their tightening grip over premarket notification requirements which are likely to cripple many of the smaller manufacturers (WAHMS, etc) or reusable menstrual pads. We apologize if that was not clear in the first originally published draft.
Initially when somebody pointed this out to me, I thought it was a mistake. Then I thought that reusable cloth pads are exempt- but I read it wrong:
“Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter only when the device is made of common cellulosic and synthetic material with an established safety profile. This exemption does not include the intralabial pads and reusable menstrual pads.” (emphasis added)
A reader on FB looked it up and found some companies hav registered with the FDA and paying the user fees for a while now (Domino, Lunapads, and Glad Rags), so maybe what is new is the FDA cracking down on cottage industries.
Lunapads in 2008 wrote this: “…we take on responsibilities and large expenses such as annual registration with the US FDA (menstrual pads are classified as medical devices and resellers must comply with a myriad of regulations) securing product liability insurance, paying for medical and dental benefit policies for our staff, and donating hundreds of pads to women and girls in developing nations – all of which adds up to a small fortune.”
But at any rate, this is the first that that cottage industries heard about it, apparently, and they only heard when some of them got a notification from the FDA telling them they had a month to pay or play. But I’m a little confused about that, too.
“FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
What does that even mean? And how likely is it that a mom and pop level business can afford to ignore the FDA ?
The FDA claims that menstrual pads are medical devices, because they “are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.”
Are any of these things true of menstrual pads? Put another way, if this is an accurate description of pads and what they do, it is also an accurate description of toilets and what they do, or handkerchiefs and what they do. All three are used to catch natural emissions from the human body for more convenient (and sanitary) targeted disposal.
Menstruation is not a disease. Pads don’t change the structure of function of a woman’s body.
Okay, and if they are medical devices, are they tax deductable? If you have a Health Savings Account can you use that to purchase pads?
“The degree to which these products are monitored by the FDA depends on their classification and level of risk, according to an industry spokesperson. Tampons and pads are classified as medical devices and subject to more regulation—particularly tampons because of the threat of Toxic Shock Syndrome. Other feminine-hygiene products like douche solutions and deodorizers are classified as over-the-counter drugs or as cosmetics, depending on the claims being made, and they are subject to less regulation. These are not generally reviewed by the FDA prior to marketing.The FDA does routinely monitor dioxin levels in tampons, and the agency says concerns are largely unfounded. While the agency has found trace dioxin levels in these products, the risk of negative health impacts is “negligible,” it says.”
So these are medical devices, but liquids you spray or insert into and around your most intimate areas are cosmetics? And underwear, which comes into even more daily contact with said intimate lady parts, are just clothing. This makes no sense.
How did they get classified as medical devices in the first place? I have no idea, but I do have some totally speculative guesses. The fact that they are classed as medical devices means they do not have to disclose their ingredients. I can’t help but think that the corporate makers of feminine hygiene products see that as a good thing and I would not be surprised to learn that they lobbied for it.
One line of argument about this seems to be basically to shrug and say, “So what? It’s been this way for a while now, so what’s the big deal.”
If any of you reading this feel that way, let me put this as tactfully as I know how: ARE YOU INSANE? Or do you just love fascism?
The fact that the government, OUR government, which is supposed to be a REPRESENTATIVE government, has a habit of acting as a boa constrictor on its citizens, constricting us in a bewildering array of pettifogging laws, rules, bureaucratic red tape, encroaching on every area of our lives, poking its nose in our bedrooms, bathrooms, kitchens, punishing people with entrepreneurial spirit that was once the bedrock of the nation, and does it so much and so often that we don’t even know about it and can’t do anything about it when we do- this is not proof that it doesn’t matter!! It’s evidence that this has been going on too long, too much, and the government protects itself as an institution and protects its crony capitalist pals by creating so many regulations each year that nobody can keep up with them. Honestly, it makes me think of this article on the Garner case (I know- they seem unrelated, but are they? Aren’t both ultimately about the force of an overbearing government?):
“There are people who think Eric Garner’s resistance means that he’s to blame for how he died,” wrote Walker. “And then there are those of us who think that just might be the most horrifying possible lesson anyone could draw from this terrible story.”More at http://reason.com/blog/2014/12/04/eric-garners-final-words
I guess I just don’t follow the logic of ‘it’s been that way for years, why now?” To me, it’s more, “IT’s been this way for YEARS? WHY DID WE NOT KNOW? STOP IT NOW.”
Now,what I do get is the lack of sympathy and some strong eye-rolling over the fact that some of those same people crying large mock turtle tears over this are in general fans of every larger and more encroaching, bone crushing, business killing, Boa Constrictor regulatory government.
To them, though, rather than shrugging and saying ‘why now?’ I want to say, “This is the natural poisoned fruit from your poisoned tree. Do you think you are a special snowflake who should be exempt from the same regulatory burdens you are anxious to inflict on others? THIS is what Big Government does. THIS is why libertarians and conservatives- as well as true classic Jeffersonian and Jacksonion Democrats all favor smaller government, more personal responsibility, and fewer regulations.”
Only Politicians, Crony Capitalists, and Progressives love this tangled regulatory mess, and they only love it when it’s not their ox being gored. Unfortunately, they never really make the connection, draw the obvious conclusions, and learn from their surprise.Their solution to the problems caused by overbearing government is just to request more government entanglement. Hence, the petition.
Yes.
This is a petition you can sign about it. I’m not really expecting anything to come of that, because I don’t think anybody in Congress really represents constituents or cares about cottage industries or understands that a fee of 4K a year will put many businesses out in the cold or cares whether their legal definitions reflect anything in the real world or not.
What I’d like to see is the American public suing our Lords and Masters for being dunces, and kicking them out of power and downsizing the regulations- by about 90%.
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