3 Years, 5 Years, 10 Years…How Cup Use-Life is Determined

Are you factoring in use-life of your cup when deciding what menstrual cup to purchase?

Box labeling may be less of an indicator of actual longevity of the product than you think.

Let me explain!

Left: A MeLuna package insert from 2013 Right: a MeLuna package insert from 2014

For many countries menstrual cups are simply hygiene products similar to a tooth brush. Very little is regulated in regards to what goes on the package. Manufacturers in these countries can make use-life claims on the packaging based on estimates.

The standard for all menstrual cups (silicone and TPE) has generally been 5-10 years.

For FDA clearance in the US prior to 2015 box labeling was part of the clearance process. Cups achieving FDA registration in 2015 or later still theoretically have to meet all of the same standards however the agency is not reviewing documentation to verify this.

The first time to verify that the newer cups have done the required testing would be during the first FDA inspection…which could be years after the actual registration.

In the above example you can see a package insert of a menstrual cup from 2013 prior to FDA registration and package labeling for the SAME product from 2014 after FDA clearance.

What changed?

Did the product become less durable? No. What changed is that to achieve FDA clearance all claims made on the packaging have to be substantiated through testing.

Testing as you can imagine is expensive. In this case the cups underwent a use simulation of the equivalent of 3 years of use. At the end of the simulation the cups were tested by a third party lab to verify that they are still in ‘safe for use’ condition. ‘Safe for use’ in this case means they can be adequately cleaned and are not porous and that the material still has the desirable properties for use.

The cups were found to meet this criteria. The manufacturer was then allowed to place this claim on the packaging. Only after proving the testing of 3 years use-life was the packaging cleared by the FDA.

With a larger testing budget the cups could have been tested for additional years. Longer testing would have allowed for higher use-life claims on the packaging.

Many manufacturers that comply with the use-life testing requirement have settled on a 3 year testing period to limit cost.

Can you guess who tested and who didn’t?

Testing will end at a definite time. If you see use-life claims with a specific number like ‘3 years’ it’s likely that this estimate is linked to third party testing.

Box labels that give a range like ‘5-10’ years are generally based on estimates rather than test results.

Does it matter?

As you can see above testing budget and labeling requirements are often more the determining factor of what goes on the box than actual use-life expectation.

In general you can assume that all man-made cups will last 5 years or more. Care and storage can make a difference so be sure to follow manufacturer instructions. Keep a close eye on your cup. If it becomes difficult to adequately clean it or it shows signs of wear and tear, please consider replacement.