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?