FDA Approved Menstrual Cups + How Long Does a Menstrual Cup Last?

FDA Approved Menstrual Cups + How Long Does a Menstrual Cup Last?

When searching for a menstrual cup,  two things people often look for are FDA approval and how long a menstrual cup brand says it lasts for. However, these two things are not what they seem at first glance and may not represent the quality of the menstrual cup or brand reputation.

Here’s the DL on FDA Menstrual Cups and Menstrual Cup Life

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When looking for a reputable menstrual cup many turn to certifications and reputation. When you see a device is registered/approved by the FDA that’s comforting, right?

What if I tell you that some of the poor quality menstrual cup brands that I dislike ARE registered along with more reputable and high-quality brands…but that no cups is actually tested?

A menstrual cup that is FDA “approved” is really just registered. 

MyCup, a quality cup brand that truly gives back, put out an article outlining the facts:

No Menstrual Cup is “approved” by the FDA. A menstrual cup using the endorsement “FDA approved” has not gone through any rigid testing process to deem it safe for use. The word approval is very misleading in this. It should be officially called FDA ClearanceThe FDA does not approve menstrual cups, they only clear them for sale within the USA, via a lengthy application process.”

In fact, to be FDA approved means that the company has paid money and gone through a lengthy process to register with the FDA for sale in the USA. The FDA has not tested the menstrual cups on the list. The FDA does not collect and test cups.

Anyone can do that right?

Yes, in fact, I notice some China manufacturers who product low-quality menstrual cups that I’ve found to be poor quality are registered on the FDA site too. Fill out the paperwork…pay money…boom. You’re listed.

See the full list of FDA registered cups here.

In fact, I searched online and could fill out an electronic registration application and submit a 2019 fee of $4,884 to register a menstrual cup which it classifies as medical devices.

I also called and spoke with an agency who registers devices…for a fee of just over $1300, in addition to the $4,884, who said that the FDA does require high-quality manufacturing standards and can randomly test products. I asked if and when this testing takes place and he said it could happen randomly. I wondered…does it really happen?

What good does this do consumers? I’m not sure if it does any…but it’s there so…

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How long should a menstrual cup last?

Another common question is about cup longevity. How long a menstrual cup should and can be used for. Not that long ago it was common to see 10+ years listed on big brand sites. Then, suddenly, it dropped to just a few years and recently I’ve seen it listed at just one year.

What does this mean? The length of time listed by menstrual cup brands is more than likely a direct reflection of 3rd party testing.

MeLuna reports:

“Depending on appropriate use and maintenance, MeLuna have shown in a wear test conducted by a third party lab that they can withstand a minimum of 3 years of wear. Many users have kept their MeLuna in great shape for many more years! Due to FDA regulations we can only claim use life that has been substantiated in third party testing. Testing is expensive. That’s why we only tested for 3 years.”

So if a brand wants to pay for 10-year testing…they can. If they want to pay for 1…they can. This testing directly reflects the listed cup life each brand reports and your cup can very well last and be viable for much longer.

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Your cup’s lifespan

So what should you do? Monitor your cup’s vitals. Inspect for changes in texture, cracks and signs of breaking down. I’ve spoken to many menstruators who are using a menstrual cup for 10+ years and it’s still going strong!

Also remember: A reputable cup brand will have better quality control and materials than a cup you’re purchasing for just a few dollars.

How long has your cup lasted?



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