That puts it in perspective. These regulations are totally impossible. Is there any other product/industry held to such a standard? My husband is in OTC drugs, and I don't think their regulations are even this insane. Then, suppose you do your best to jump through these hoops and the FDA either sits on your submission indefinitely or just says, "nope". Litigation is the only way through this. Total insanity.
Now your starting to see the light !!