Kai (kuradi8) wrote in menstrual_cups,

A LEGAL Question about Cups (USA)

A question for those in the legal field:

There have been several instances of US-based sellers (for example) on ebay selling non-FDA approved cups such as Green Donnas and others.  My questions don't apply just to ebay -- but to selling non-FDA cups in general.

I've poked around the web but I haven't found any sort of penalty associated with doing so.  I would assume there is, but then I started thinking about the Dollar Stores that sell non-FDA gray market toothpastes, etc.  Sure, they're different classes and categories but apparently it's just a case of "buyer beware" about those (quote-unquote) "substandard" products -- not that it's illegal to do so.  As Class II Medical Devices, the rules about cups are most likely different.

So my questions are:
Is it a (for lack of a better phrase) "punishable offense" to sell non-FDA approved cups in/from the US?  And if so, what is the penalty?  Being told to cease and desist?  Or else what?  A slap on the wrist?  Having to pay a fine?  Jail???  Just how much (or little) hot water could these sellers find themselves in?

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