"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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Green is the New Black Pop-Up

On Menstrual Hygiene Day, our team will be at Green is the New Black Pop-Up, organised by The Wedge Asia and The Working Capitol. Come join us for a lovely morning of Conscious Living, Learning, and Connection!

Learn how you can manage your periods more consciously by taking notice of the waste created every month and what you are putting in your body. See how reusable menstrual products can help you get more in touch with your own body, while reducing waste at the same time. 

We will also be accepting donations of unused disposable supplies, that we'll be donating to HOME Singapore's shelter for migrant workers. The shelter, which houses migrants that have experienced abuse, exploitation or have suffered injuries in the workplace in Singapore, need supplies for both new and current female residents, who are staying to assist with ongoing investigations or to stand as prosecution witnesses. 

  • Venue: The Working Capitol
  • Date: Saturday, 28 May 2016
  • Time: 9.30am - 3pm

Green is the New Black Pop-Up | LiveLoveLuna

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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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LENA Menstrual Cup Reviews - What the Web is Saying About It

If you are looking for reviews of the LENA menstrual cup, look no further! We have compiled a list of helpful online reviews from all over the world.

LENA Cup - A Better Period | LiveLoveLuna

menstrualcups.wordpress.com

+ Stem tab design allows for it to be unnoticeable during use
+ Smooth exterior allows for easy cleaning
- Only limited to one colour, pink

reusablemenstrualcup.com

+ Pops open easily and most users have no issues with insertion and removal
- It is stiffer than the Lunette cup

Just Doula

+ Smooth matte texture with nice textured grip on the bottom of the cup

Dirty Diaper Laundry

+ Suction holes are slanted and appears larger than other brands, which makes it easier to wash
+ Bell shape allows for larger volume while maintaining a shorter cup
+ Base of cup has enough firmness to allow for easier insertion

Decided on the LENA cup? Get it here! 

 

Click here for the Lunette & Merula Cup reviews.

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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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