Myths and Facts: FDA Approvals and what do they Mean?
Often you hear of companies referring to their international accreditation such as FDA Approval, TGA Approval, etc. Here are some explanations about the two main international providers of these approvals and how they impact you as a consumer.
FDA Approval (USA)
MYTH: Menstrual Cups with “FDA Approval” have been rigidly tested and quality checked by the FDA.
FACT: No Menstrual Cup is “approved” by the FDA. A menstrual cup using the endorsement “FDA approved” has not gone through any rigid testing process to deem it safe for use. The word approval is very misleading in this. It should be officially called FDA Clearance. The FDA does not approve menstrual cups, they only clear them for sale within the USA, via a lengthy application process.
Any person or company advertising with FDA Approved cups shows that they actually don’t even have an idea how the FDA Medical Device process works. The FDA also states that Menstrual Cup brands cannot use “FDA approved” to promote their products as they have not actually been endorsed by the FDA as safe for use, they have only been “cleared” by the FDA for sale within the USA. The FDA state:“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. “
So technically if you do not sell menstrual cups to the USA you do not need to register with the FDA, nor require FDA Approval. All companies should be able to provide you with safety certificates on the materials, dyes and colourant they use for manufacturing their menstrual cups. It is more important to know what you are putting inside your body direct from the source. In the past all companies that manufactured a Menstrual cup and wanted to sell into the USA were required to apply for the 510(k) premarket approval and also be registered. Since Dec 2014 this is no longer required and companies now only need to be registered for sale within the USA. However companies may still wish to apply for 510(k) premarket approval if they feel that this endorses their brand in some way, but it is a very expensive process and now quite unnecessary. You may still look to a brand for FDA approval to make yourself feel that you are buying a thoroughly tested brand. Just remember that FDA Approval is only a clearance offered (in the past) by the FDA to be able to sell into the USA. It is no longer required by law.
TGA Approval (Australia)
Menstrual cups are therapeutic products which are exempt from inclusion on the Australia Register of Therapeutic Goods (ARTG). Prior to 1 July 2018, menstrual cups were required to be listed on the ARTG. As a result of recent amendments, menstrual cups became exempt goods and therefore you are no longer required to have an ARTG entry for them. Menstrual cups are still required to comply with certain TGA standards before they can be supplied in Australia.
Not all menstrual cups are created equal. Always make sure you are buying a menstrual cup from a reputable company and make sure of the following:
- Do your research. Read about menstrual cups, watch videos and ask the supplier questions. Work out which cup might suit your body type. Don’t buy a particular cup based on what your friends buy – your body is unique and may require a different cup. Call us if you want a non-biased opinion as we have many different brands available and will recommend the cup we think fits you!
- Buy a Cup that is made of superior materials designed for use inside of the body. Menstrual Cups bought on websites such as AliExpress may be made of inferior materials that may not be good for your body. Check the brand first and customer reviews and decide for yourself! Remember that menstrual cups that have FDA approval have not gone through any special testing so do your own research!
- Buy a Cup that will last the distance and give you confidence! Menstrual Cups with a price tag of under $10.00 may be affordable but they may not seal correctly and may not last as long. You may be disappointed if it does not work and never use a menstrual cup again. We want you to be a successful cup user!
Our team at My Cup are dedicated to keeping you up to date with the latest information we have on menstrual cups and other resuable menstrual products. We base our knowledge on years of research and collaborative work with various professionals in this field. If you would like to contribute to our knowledge base or have a question please contact us HERE