Do the MCUK and the Mooncup have FDA Approval for sale in the USA?

We do have FDA clearance to market our menstrual cups in the USA.

According to FDA rules, however, we can’t use this fact to promote our products.

The FDA Code of Federal Regulations, Title 21, Volume 8 (21CFR807.96) states:

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 is why we do not say that we have ‘FDA Approval’ anywhere on our website.

In case you need it, the Facility Registration Number allocated to Mooncup Ltd by the FDA is 3009117944.

You can read more about this on the FDA website

Want to hear from us? Sign up to our newsletter