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"FDA Approved" Menstrual Cups - What Does It Really Mean?

What is the FDA?

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, that is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal feed and veterinary products. Although only products sold in the USA need to be regulated by the FDA, their high standards act as an excellent reference for the rest of the world of the products that are safe for us.

Do Menstrual Cups Have to be Approved by the FDA?

The menstrual cup is considered a medical device. The FDA recognizes three classes of medical devices, based on the level of control necessary to assure that people can use them safely and effectively. Menstrual cups fall under Class II, meaning that general controls alone cannot assure safety and effectiveness, and existing methods are available that provide such assurance. Only Class III devices need to be “approved” by the FDA, as there is not enough existing information available to assure safety and effectiveness.

When brands state that their menstrual cups are “FDA approved”, they usually mean that the cups are cleared for sale in the US by the FDA. Technically, the word “approved” implies that the cup has been tested and approved by the FDA, which is not the case. The FDA considers that "Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding." This means that cup brands cannot use "FDA Approved" as a fact to promote their products.

For a menstrual cup to be “cleared” by the FDA for sale, they need to submit a “510(k) premarket notification”. This means that the new cup is the same in function and design as existing cups already cleared for sale, and does not need to go through a more extensive process called “premarket approval”, which requires clinical trials and testing. A menstrual cup is only cleared for sale after the 510(k) premarket notification process is complete.

Out of all the menstrual cups that we carry, the Lunette has 510(k) clearance (click to see FDA page).

 

Lunette Menstrual Cups are cleared for sale by FDA

(Click to see our range of Lunette menstrual cups)

You can also click here to see a list of all the menstrual cups that have 510(k) clearance.

As of December 2014, it seems that menstrual cups no longer need to go through this process. However, you can consider a 510(k) clearance as further assurance that a cup brand is good quality, as it has undergone some testing and regulation processes.

How, then, do we determine which menstrual cups are high quality and safe for use?

FDA Registration

Now, menstrual cups that are produced or distributed in the US need to be registered with the FDA. Even companies that import cups from China or other countries to sell within the US need to register their device with the FDA. Both the device (menstrual cup) and the establishment (company that makes/sells the cup) need to be registered.

Menstrual cup brands we carry that are registered with the FDA:

Hello Cup FDA Registration Page

Lunette Menstrual Cup FDA Registration Page

Buy Lunette Menstrual Cup | The Period Co.

LENA Menstrual Cup FDA Registration Page

Buy LENA Menstrual Cup | The Period Co.

Lily Cup (distributed by LELO) FDA Registration Page

Buy Lily Cup Menstrual Cup | The Period Co.

Merula Cup FDA Registration Page

Saalt Cup FDA Registration Page

 

You can also click here to find a list of all the menstrual cups that have been registered with the FDA.

“FDA Approved Silicone”

Many menstrual cup brands claim that they are using silicone that has been approved by the FDA. However, the FDA only regulates the end product, not the materials it is made from. Any claims that a cup is made from FDA-approved silicone is therefore false.

In conclusion, we would recommend exercising your due diligence when researching on the menstrual cup you would like to purchase, and make sure they are made of materials you are comfortable to put in your body. Here at The Period Co., we only bring in quality products for your peace of mind.

Sources: 
https://menstrualcups.wordpress.com/2015/03/12/fda/
http://www.fda.gov/

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Menstrual Hygiene Day 2016: Let's Start the Conversation About Menstruation

Menstrual Hygiene Day is celebrated every year on 28 May. This year's theme is "Menstruation matters to everyone, everywhere".

On Menstrual Hygiene Day, we break the silence and build awareness about the fundamental role that good menstrual hygiene management plays in enabling women and girls to reach their full potential. Menstrual Hygiene Day is a global platform for everyone, everywhere to engage in action and advocacy to break taboos and negative attitudes around menstruation.

In an ideal world, everyone who menstruates should be knowledgeable about their menstrual cycle and have access to proper sanitary products and facilities to manage their menstruation, without being shamed or outcast for it.

However, the harsh reality is that many women and girls around the world, especially in developing countries, do not have access to clean private toilets, information on menstrual hygiene, and sanitary products. If you think that managing our periods is a hassle, it's definitely worse for them. :(

How can you help? Break the silence; talk about it! Menstruation should not be a taboo, #MenstruationMatters‬ to everyone.

Menstrual Hygiene Day 2016
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Managing Your Period While Travelling on a Long Holiday

If you are going on extended long-term travels, a menstrual cup is the best way to manage your period. Read our account of a 2-month trip around Southeast Asia (Vietnam, Cambodia, Laos and Thailand) with a menstrual cup in tow!
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The Eco Femme Cloth Pad Movement

For every Eco Femme pad you purchase from us, a pad is donated to an Indian girl through the Pad for Pad Program. In India, education on menstruation is lacking due to the taboo, and a majority of girls are not taught how to properly manage their periods. As many cannot afford disposable pads, cloth pads are still used in many parts of India. Every purchase helps to fund the education programmes organized by Eco Femme, as well as the Pad for Pad Program.
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Why Switch to a Menstrual Cup?

Menstrual cups...

... don't dry you out or disrupt pH levels

Pads create a stifling, moist environment which is ground zero for yeast infections, bacteria and odour. Tampons aren't great for you as well; other than absorbing your menstrual fluid, they also absorb the natural moisture produced by your vagina. This creates an imbalance of moisture and affects the pH levels of your vagina. However, a menstrual cup does not absorb, but rather collects the menstrual fluid to be emptied later. Therefore, the natural fluids produced by your vagina do not get absorbed, and you don't feel uncomfortable and dry.

... are comfortable

Correctly inserted, a menstrual cup is so comfortable that you won't even notice it’s there. It may take a little practice at first to find the angle and position that is right for you. Once you get the hang of inserting the menstrual cup, you will be amazed at how easy it is to use. Say byebye to bulky, uncomfortable pads!

... can go longer between changes

Menstrual cups have a greater capacity than even the most absorbent tampon, so you can go longer between emptying your cup! Menstrual cups can be worn for up to 12 hours (depending on your flow). This means less worrying about changing your pad/tampon every few hours for fear of leakage.

... are better for the environment

The average woman throws away around 125-150 kg of tampons, pads and applicators in her lifetime. Can you imagine the sheer amount of waste created? Unlike pads and tampons, menstrual cups are reusable and should last for several years with proper care. Since you can reuse them every period, there is less waste created to clog up our landfills or improperly disposed of in toilets to block up our sewage systems. Menstrual cups are not just good for your body; it's also good for our planet!

... are convenient

Menstrual cups can be used no matter what physical activities you've planned for the day: doing sports, yoga, dancing, swimming, snorkelling, scuba diving, biking, hiking, camping, travelling, and many more! You no longer have to lug around extra pads or tampons, or worry about leaking. Furthermore, cups are great for people who work long hours or have few chances for toilet breaks! Isn't it great not having to worry about your period?

... are cheaper in the long run

The cost of purchasing a menstrual cup is a one-time cost upfront, which provides you with years of use if you properly take care of it. Compare that to buying a pack of pads or tampons every month. The cup will pay for itself within the first couple of months, and you no longer have to worry about having enough supplies when your period is nearing every month.

Shop our range of menstrual cups now!

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