Menstrual Cups

FDA Approval & Registration

There are some cups on the market that are giving misleading information on their FDA clearance/approval/registration.

So I thought I would contact the FDA to find out exactly what the situation is with FDA approval on both menstrual cups and silicone used to make menstrual cups.

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Basically, there are 2 ways the FDA has involvement with menstrual cups.  The cups can have “FDA Clearance” for sale and/or the cups can be “Registered with the FDA”.  All cups being sold in the USA are required to be Registered, though very few actually are.

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FDA registration

Any menstrual cup being produced or distributed (sold or given away) in the US, is required to be registered with the FDA.  There are some exemptions, but they would appear not to be valid for most cup brands.  Even the people who appear to be importing cups from China and renaming them, would (from what the FDA told me) be required to register their device with the FDA, as they would classify as an importer or repackager.

The “device” (cup) and “establishment” (the business making and/or selling it) are both required to be registered.

To find a list of the brands/cups that are currently registered with the FDA (that would seem to be those who have paid their yearly registration fee to be allowed to sell cups to/in the US), you can search the “Establishment and device” register for the “HHE” product code again [Search results here]

As of 20th November 2016, the following appear to be the only cup brands that are currently registered with the FDA:

Blossom Cup, Casco Cup, Easy Life, Ella Cup, EvaCup, Diva, Femmycycle, Flex (Another brand of Insteads Softcups), Green Cup of Maine, Insteads Softcups, Keeper, LenaLily Cup, Life Cup, Lincup, Lunette, MCUK (Mooncup UK)MeLuna (Classic & Sport), Mooncup (USA), Monzcare/Rainbow, Nora Cup, Rockbrook (makers of Anytime, iCare and others), Sckoon, Super Jennie, V-cups.

There is also a few manufacturers listed with just “menstrual cup” – so I am unsure of which brand names they manufacture

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Now, on the topic of a cup being “FDA approved

NONE of the cups are “approved” by the FDA.  Menstrual cups are a class II device, and the FDA only gives “Approval”  to class III devices.  So cups cannot be “approved” by the FDA.

What some of them have however, is “Clearance” for sale.  It is largely just a case of which term is used, but “approval” implies the cup has been tested and “approved” by the FDA, which is not the case, so they are not allowed to use that term.  The FDA considers that:

Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=807.97

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For a menstrual cup to be “cleared” by the FDA, they need to submit a “510(k) premarket notification“.  In layman’s terms what this means that since a new cup is basically the same in function and design as existing cups that are already cleared for sale by the FDA – the new cup doesn’t need to go through the more extensive “premarket approval” process (which would require clinical trials and extensive testing).  But it does need to go through the slightly less extensive “Premarket Notification” process.

It seems that as of Dec 2014, menstrual cups (as well as cloth pads) no longer need to go through the 510(k) Premarket Notification process to be allowed to be sold in the USA, but do still need to be registered with the FDA (unless they have an exemption)

I assume that cups that have come to the market since the premarket notification was stopped, would not be considered “FDA cleared” like those who have passed that process.  I also assume a cup brand could choose to become cleared if they wanted to submit the notification (though that is an expense they possibly won’t want to have to spend)?

So, no cups are “FDA approved”, the most they can be is “cleared” by the FDA.  All cups being sold in the US need to be “Registered” with the FDA.

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Menstrual cups are regulated under the product code “HHE”.  To find a list of all the menstrual cups that have the 510(k) Clearance, you can search the FDA database for the “HHE” product code [Click here for the search results]

As of 12th March 2015, the following appear to be the only cup brands that have 510(k) clearance:

Alicia (defunct*), Bellecup (defunct?), Divacup, Femmycycle, Insteads Softcups, Keeper, Lunette, MeLuna (classic and sport), Mooncup (UK), Mooncup (US), Rheacup, Sckooncup, Tassaway (defunct)

Though, as I said, there now is no requirement for cups to have 510(k) clearance.  You may however consider a 510(k) clearance as further assurance that a cup brand is good quality, as it has undergone some testing/regulation processes.

*Alicia isn’t being sold as an Alicia any more, but it appears that the same cup is being sold for stem cell collection (rather than menstrual use), and has been renamed Hygenia

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So brands like the Blossom Cup, who claimed to be FDA approved, are in fact, not (because no cups are) and at the time weren’t even FDA registered.

fda_blossom

 

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FDA approved silicone“.

Quite a few brands (pretty much all of them actually) are claiming that they are using silicone that has been “approved” by the FDA.  This is something I have had trouble finding the answer to.

For example:

fda_dutchess

fda-sckoon

fda_lunette

When I contacted the FDA to check to see if this was a valid claim, they told me that the FDA only regulates the end product, not what it is made from.

To quote a portion of the e-mail from the FDA:

“Please be aware that the FDA regulates the “finished” medical device and the manufacturers of the finished device. Therefore, the Center for Devices and Radiological Health (CDRH) does not maintain a list of ingredients or materials that are certified or approved for use in medical devices.”

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However, there are many silicone manufacturers who likewise claim their silicone is FDA approved or compliant (link, link), though I notice generally they seem to be referencing the FDA “rubber articles intended for repeated use“.  When I asked the FDA about that, they basically told me that was not part of the “CDRH”.

So I wonder if the FDA does approve/register/clear  the food-safe silicone used for various things (like perhaps food containers), but the “CDRH” branch (which appears to be the medical device section) of the FDA doesn’t approve silicone specifically for medical devices?  I don’t know.

I have asked why cup manufacturers would be making the claim that their silicone is FDA approved, if it isn’t…. but the FDA stopped replying to my e-mails 😛

I also do not know if the FDA requires each coloured cup to be separately cleared (as some cup manufacturers have told me), or not (as another cup company I’ve spoken to implies)… I asked about that also and received no reply.

I do know that the reason MeLuna is only registered for their “Sport” and “Classic” styles is that the “soft” version is too soft for the FDA requirements for clearance on those.

I have actually found it quite difficult to get answers from the FDA about these issues.  I’d been trying for about a month. I first contacted the Medical device department, who answered some of my questions.  I then asked more questions and was asked to contact the registration section for answers – who then told me to ask the medical devices section, when I commented that I’d already done that, they passed me on to the compliance/complaints section.  I asked the questions again and haven’t had any response.

So I have been getting a bit of a run-around.

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March 12, 2015 - Posted by | news |

15 Comments »

  1. Looks like LenaCup has a nice-looking website but, oddly, it doesn’t show any pictures of the actual product. I wonder if they, like La Luna Cup, are just rebranding some other pre-manufactured cup? http://www.lenacup.com

    Comment by MC Community Member | March 12, 2015

  2. Wow! Thanks for doing all this legwork with the FDA. This is really valuable information. Maybe once you have a more clear picture, you could email some companies and ask why their websites are claiming false information.

    Comment by goodfamiliesdo | March 12, 2015

  3. Since you’ve mentioned Lena, I will just say that Lena are not a rebranding, they are a new brand… but I really cannot say anything more than that at this stage.

    Comment by obsidian | March 14, 2015

  4. I appreciate all the research you’ve done! I had been planning on buying a cheap menstrual cup for a couple of weeks now and decided on the blossom cup. I’m glad I found your blog before actually buying it! I’d prefer to not take any risks when it comes to my vagina, so a misleading company is not the one for me.

    Comment by Stephanie | July 16, 2015

  5. I just recently purchased a Meluna small and a Blossom small for my daughter, and a Blossom L and femmycycle for myself. These are her first cups, and I am already using a Lunette. Amazon’s current info no longer says “food grade” for the Blossom (of course they’re still not on the FDA approved list, I’m now finding out), but now I’m reading here that not even the Meluna soft is good? 😦 UGH.

    Comment by sylvie | December 9, 2015

  6. From what I’ve heard, the FDA testing for the cups (for those that got the premarket notification clearance [that isn’t required any more])

    …. required that the silicone retained a certain degree of firmness after a simulated period of use (off the top of my head I can’t recall if that was equivalent of 3 years worth of use or 1 year)… So the silicone normally softens with use, and if that can stay at a firmness the FDA would allow, then the cup can get FDA clearance…. but Meluna being an already very soft cup to begin with, it was not going to have that minimum firmness required for the FDA to grant clearance on.

    Why that matters to the FDA, I don’t know… I’m not sure if it’s because they consider the product wouldn’t function as well if it was too soft, or if it’s something to do with the silicone composition being a problem…..(which I could understand if the silicone became too soft over time – as that could mean it’s breaking down or something, but if it’s started out very soft, then I’m not sure that’s the same issue)

    It likely also means that the other very soft cups wouldn’t have been able to get clearance either…. But that’s all a moot point now since cups don’t require clearance any more, just registration (which doesn’t require testing)….

    So it’s not necessarily any indication that the soft MeLuna (or any other soft cup) isn’t good – it just means it was not able to pass the FDA requirement because it was too soft.

    Comment by obsidian | December 9, 2015

  7. When I first started with these products, it seemed that the ones that would work best (for me, anyway) aren’t even sold here in the USA yet. I bought mine from the FW website, and that one (the siBell) for sure isn’t on the approved list.. but then again, it’s not a “made in USA” product. My concern was mostly the medical grade silicone part. But one might assume these other countries have (somewhat) different standards for what is medical grade. I rarely use that cup because it is so soft.. So it sounds to me like we buy one that sounds good, that we have good luck with, and hope for the best. LOL

    Comment by sylvie | December 9, 2015

  8. Does this mean that menstrual cups no longer need to be registered/cleared: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=3666

    Comment by springpeonies | February 15, 2016

  9. actually this is the correct link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=3667

    it’s scary, so no one is really regulating menstrual cups if i’m reading this right.

    Comment by springpeonies | February 15, 2016

  10. Hi, thank’s a lot for sharing all this valuable info! You know, I live in Mexico, and here in my country there are a lot of people selling all kinds of menstrual cups (including chinese cheap cups), all of them claiming they are “FDA approved” or even lying about the origyn countries, and this is also due to the buyers who always keep asking to the sellers: “Is this cup FDA approved? If it’s not, I’m not buying it”. “Is this cup chinese? If it is, I’m not buying it”. So, as you can see, people here is really misinformed. Here in Mexico we have an institution called PROFECO (similar to FDA), which should be taking care of this topic. I tried to contact PROFECO about all these issues, but I have never received any response to my mails or any PM left on their facebook account. Ok, while PROFECO keeps turning a blind eye to all these irregularities (irregular selling/importing and nonexistent quality analysis, which should be made by them), I think this info you are providing is of utmost importance to share. I’m asking for your permission to share this post, translated to spanish language for any spanish speaker woman. Of course, you will have all the credits for it, and I will share a direct link to the original post. Please let me know what do you think. I thank you for all your reviews, they have helped me a lot :). Nice weekend!

    Comment by Karlita Kacris | May 6, 2016

  11. Sure, share away 🙂

    Comment by obsidian | May 14, 2016

  12. Thank’s a lot! Nice evening! 🙂

    Comment by Karlita Kacris | May 15, 2016

  13. I can not possibly say how much I truly, greatly, deeply appreciate your research and caring for untold numbers of women out here, especially those of us desperate for a better solution than tea towels, but who lack the ability / follow-through to do what you have done for us. I know I’m not the only one who cares enough about what I put in my body to do research before buying anything, and you’ve made this one easy (and I mean careful in every aspect, from food and the containers it’s in, to my meds, sunscreen, even the lights in my home; I’m not a melodramatic hippie, but I’m progressively disabled after a life of chronic illness, with far too many “true” allergies that cause anaphylaxis- and many “sensitivities”- so if there’s a way to support your website, I’d be glad to help. Please email me).

    Comment by T. M. | July 13, 2016

  14. One comment on the material… materials can be registered with the FDA if the manufacturer maintains what’s called a Master File. However, the intended use of these materials can vary from ” temporary food contact” to implantable grades. Colorants can also be registered, but this is atypical. Generally a manufacturer should perform/maintain testing to ensure that the device materials and any associated colorants are not cytotoxic (damaging to cells) and can be cleaned appropriately (some materials are more difficult to clean than others.) (In addition to many other requirements.) There can be additional requirements depending on the type of device.

    Nice article – I stumbled across it while trying to find out if my lunette had ever been tested for bioburden reduction using their recommended cleaning method

    Comment by Megan | January 6, 2017

  15. Thank you so much for your research and this information.

    Comment by Jess | February 13, 2017


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