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).
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?
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:
“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.