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

April 26, 2017Approval fda for sale MoonCup USA

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

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Yes we do have FDA Clearance to market our menstrual cups in the USA however according to FDA rules we may not 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.