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.
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.
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, Lena, Lily 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
- Canack Technology may be this company? (Selling a variety of flat tab, hollow tube and valve stem cups)
- KDL Precision Molding – Could be any of the USA manufactured cups, but since it’s been registered for a while I’m wondering if it’s Cup USA?
- Linmed may be this company? (Selling clear collapsible cups as well as the Yuuki lookalikes)
- Salud Femenina Alternativa – which (according to a photo on their facebook page) may be Lunacup ?
- QURE – listed as making a cup for export only (here)
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. “
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.
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:
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
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 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.
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.”
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.