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Medical Grade Material vs FDA Cleared

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Browsing Amazon, Ebay or other online retailers you will frequently see the claim that a cup was made with medical grade silicone.

It is not surprising that we frequently get the question: Is the MeLuna USA cup made with medical grade material?

Today I would like to take some time to discuss how much (or little) value there is in the medical grade material claims of some manufacturers as well as how much is involved in getting a cup FDA cleared. By the way there are no FDA 'approved' cups. The FDA does not approve cups. If you see this term in any kind of cup advertising, it should immeditatley raise a red flag.

First things first though: ALL components of the MeLuna USA cups are medical grade materials. In fact the materials, including the colorants, were registered with the FDA and used in other medical device applications long before we started applying for FDA clearance and producing MeLuna USA cups made with these components.

It is not likely that one could achieve FDA clearance without using these registered medical grade materials.

So why the emphasis on medical grade materials in online ads for cheap, unregistered cups?

It's easy to use the term to advertise with and put consumers at ease about a product that is NOT FDA cleared and may contain other components that are not medical grade as well as be manufactured in conditions not meeting medical device manufacturing standards... in a way it's misleading and taking advantage of consumers.

Think of it this way: I could make you a pie and use organic apples in it. I could claim the organic apples when I advertise for my pies. But you still would have no idea what other ingredients are in the pie or if the pie was made in a clean kitchen, etc. Medical grade silicone is just one component of a cup and no indication of the quality or safety of the finished product.

FDA clearance goes much beyond medical grade materials. It also means the cup is manufactured in an FDA registered facility as well as imported by an FDA registered facility. FDA registered facilities are inspected by the FDA on a regular basis to ensure good manufacturing practices are being observed and quality control systems are in place.
Both the US distribution facility in Texas as well as the state-of-the art manufacturing facility in Germany have been thouroughly inspected by the FDA. An FDA agent is on site for four days to observe during each inspection.

There is no oversight at all over factories in Asia or elsewhere that distribute cups with just the medical grade silicone claim.

We strongly suggest you do not fall for these claims and instead choose a cup with a proven safety standard. Maybe MeLuna is not the cup that appeals to you the most? There are many quality cups out there with FDA clearance to choose from. If you don't choose MeLuna, please do consider choosing another cup of equal quality. If in doubt you can actually do a search for menstrual cups on the FDA website to see if a cup brand you are interested in is FDA registered.*

...and if you do choose a MeLuna USA cup: THANK YOU SO MUCH! We put a lot of work into bringing these cups to you and take pride in providing you with an outstanding, quality, safe product!

 

Karin

CEO MeLuna USA

 

*If you live in a different country, your country may have their own health agency that you can check.

MeLuna USA is partnering with Organizations supporting the Homeless

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We have received too many requests for donations to meet the need by company donations alone. I believe we have come up with an idea that would result in ZERO cost cups for organizations supporting the homeless and women's shelters!
MeLuna cups are one of the lowest cost FDA cleared cups on the market at $24.95 retail. That is still out of reach for many women in our country.

MeLuna USA has been trying to respond to inquiries with donations but our resources are too limited to reach as far as we would like.

To expand on how many people we can help we will now partner with organizations that serve the homeless as well as women's shelters.
We will do this by adding a 'cup donations page' to our online shop where we will feature several different organizations. The public will have an opportunity to purchase cups for the organization of their choice for only $10 per cup. We will not make any profit off of this, in fact we will incur administrative, labor and shipping costs but at least it will cover the material cost of the cups.

Once a month MeLuna USA will then tally up the cup orders for the different organizations and ship the cups directly to the organizations.

A preliminary survey amongst MeLuna users showed that many of our lovely customers would be very willing to purchase a cup for a woman in need as long as the process is simple and the cost low.

Since cleaning is so very important with reusable products all we ask in return from participating organizations is that the organizations agree to provide adequate training in regards to disinfection procedures to each cup recipient to ensure cup users can enjoy the cups risk free.

We have come up with a modified cleaning regimen that does not require boiling the cups.

If you are involved in an organization that could benefit from this, please don't hesitate to contact us for further details!

MeLuna Featured on Cup Comparison in Independent Blog Post

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In December of 2016 we were surprised and overwhelmed by a HUGE order increase.
We then found out that MeLuna was featured on this fantastic blog post by The Wire Cutter - a New York Times Company.

The WireCutter just updated the blog again January 2018 and they stand by their initial evaluation: MeLuna USA cups are still their #1 choice out of 18 cups.

To read the full review click HERE

sweethomecover

 

Have a look and tell us what you think!

The Current Regulatory Status of Menstrual Cups

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This past week we completed our first FDA Inspection here at MeLuna USA headquarters in Texas.

One of our lovely retailers, Ova Woman, brought up an interesting topic: Why just why would there even be an inspection since menstrual cups are now 510(k) exempt?

We thought this would be a great topic to write about on our new blog. Here's what's happening in regards to menstrual cups and the FDA: