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US Version Cups vs. Rest of the World Cups

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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. This is in large part because they are inserted into the body and have prolonged contact with mucus membranes.

MeLuna cups sold in the US have to meet FDA standards which include being made from all medical grade materials.

Not only are the materials medical grade, they also 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.

In fact we currently have a second color in testing that should become available in the summer (beautiful sapphire blue).

We are actually quite thrilled that 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 even more noticable difference though is in the colorants. Colorants for the non-US MeLuna version are food colorants and not medical grade. US colorants are medical grade.

We offer different colorants here in the US because the US version is made from medical grade colorants made specifically to fuse permanently and without leaching with the raw material.

Only the US version is considered 'generally safe for use' by the FDA.

If you are comparing apples to apples you are really getting an exceptional value with the $24.95 medical grade cup! It's made to meet much higher standards and we are really happy to offer our US customers the safest and highest quality MeLuna available anywhere in the world! :)

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

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!

Comments   

0 # Juliette 2016-03-02 14:03
Are your cups vegan? Cruelty-free?
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+1 # Karin with MeLuna 2016-03-02 20:51
MeLuna cups are made from TPE and as such do not contain any animal products.
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:
Are your cups vegan? Cruelty-free?
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+7 # Kathy 2016-04-06 05:57
Do you anticipate offering the soft versions in the U.S. in the future? I would love to purchase from the USA, but have a sensitive bladder which requires the soft. It works very well for me where other cups just do not.
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0 # Karin 2016-04-07 16:29
Sorry we don't. Cups soften over their 3 year use period due to cleaning, disinfection procedures and wear and the soft cups would not meet the 3 year uselife requirements according to FDA standards for usability
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+2 # Keely 2016-06-17 18:13
When will the new sapphire blue cup be in? I want to get a cup or two before the end of july and would like one blue and one purple?
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+1 # Karin 2016-06-17 20:59
we expect to have them available before the end of June
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0 # Kelly 2016-07-14 19:01
I am trying to find out if you ship to Canada
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0 # Karin with MeLuna 2016-07-15 14:27
Sorry no. Unfortunately the annual registration fees with Health Canada are cost prohibitive for us
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0 # Gabriella 2016-10-08 05:49
About when will the purple cups in small, classic, with stem, be available for purchase. In a month, a few or longer?
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0 # Karin 2016-10-11 00:42
The purple have been available for about a year. The blue have been available since this summer. Have a look at our website www.meluna-usa.com
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+2 # Alyssa 2017-01-07 04:54
:lol:
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!
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0 # Jennifer 2017-02-04 19:14
I just received my order but the packaging doesn't indicate if it is a sport or classic cup. It should be a sport. How can I tell I received the correct cup?

Thanks
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0 # Karin 2017-02-09 20:58
Please look inside the rim of your cup. It either has Classic or Sport embossed in it
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0 # Sara G. 2017-05-07 22:45
I want to thank you literally changing my menstruating life! I work in construction and it is gross to deal with your period in the port o potty. I also love that I am no longer contributing to landfills.

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! :lol:

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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+1 # Ivy 2017-08-06 15:55
Hi I just got the glitter one and when I was hold it into my hands the blue glitter come off and I was like oh what happen when the glitter sheds inside my uterus I wonder if glitter particles are safe for the uterus/vagina and if can harm me or injured me in the future
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0 # Karin 2017-08-06 15:57
I am sorry but we only sell the FDA cleared, medical grade versions of the cup here at MeLuna USA. You would have to address your concerns with the source of your glitter cup
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