US Version Cups vs. Rest of the World Cups
A question we get frequently is:
Why are the US cups more expensive and why don't we have the same colors as are offered in the rest of the world?
Let's explore!
In Europe menstrual cups are considered a hygiene article and therefore do not have to meet medical device standards.*
In the US however the cups are considered a medical device. MeLuna cups sold in the US have to meet FDA standards which include being made from all medical grade materials.
For our FDA clearance our cups have been tested to ensure no leaching or other adverse effects occur before they are made available to the public.
Medical grade materials and testing are expensive.
The Meluna USA cups are now available in clear, amethyst purple and sapphire blue after having passed all required testing.
Even with the high cost of testing and the higher cost of materials our US version is made from, we are able to keep the price at only $24.95 for a medical grade, FDA cleared cup. If you compare it to other FDA cleared cups on the market the US MeLuna generally comes out about $15 less than comparable cups!
The TPE that is used in the US cups even in the clear version is slightly different to meet FDA standards of 'medical grade'. The US version colorants are medical grade colorants made by Clariant.
Only the US version is considered 'generally safe for use' by the FDA.
In addition to the differences mentioned above there are some other perks that come with the US cups:
* each US cup also comes with a free cleaning brush - the overseas versions do not
* each 2-cup US combo comes with 2 cups packaged separately with 2 bags and 2 cleaning brushes and 2 brochures. The overseas 2-cup combos come with 2 cups, 1 bag, 1 brochure and 0 brushes
* fast shipping without import duties
* US based customer support
We are working hard at making more color choices available in the future.
If you live in the US and support MeLuna USA by purchasing the FDA cleared version of the cup, you not only get a higher quality cup for yourself, you are also helping bring more color choices in medical grade cups on the market in the future.
We appreciate your support!
*The European version of the MeLuna meets or exceeds European menstrual cup guidelines.
Comments
In regards to cruelty-free please know that ANY cup -regardless of manufacturer-that is FDA cleared for sale here in the US has at some point been in some capacity tested for biocompatibility whether that be the raw materials used in the cups or the cups themselves.
Since we use raw materials for the US cups that are already registered with the FDA and have been tested extensively already we are fortunate in that we were able to have vaginal irritation and systemic toxicity testing requirements for the colored cups waived because the cups show no leaching of colorants in the analytical testing phase.
Analytical testing is when the colored cups are subjected to high temperature and/or solvents and then whatever leaches out of the cup is analyzed under special equipment. Analytical testing does not require animals.
Quoting Juliette:
I LOVE MY CUP!! I have a classic amethyst cup with a ring in the size M and it fits me perfectly and is super comfortable! It is a lifesaver because my vaginal tissue was aggravated by the tampons and pads I would use. Now, I have less pain to worry about! Thank YOU MeLuna! I am considering buying a sapphire cup to complete the collection!
Thanks
It only took a few tries to get my cup to work properly. My first try I was angling it up instead of back. My second try, I did not push it up far enough to create a seal. Third time was the charm!
I am so grateful my Meluna Classic in Large purple with the ball stem was the perfect cup on the first try! I'm about to buy a blue one.
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