Did you know it costs over $370,000 (unless you can get waivers) just to file an application to sell a new drug for animal use? This isn’t for attorney’s fees, or consultant’s fees, those would be in addition to this. This is just the FDA user fees. And it doesn’t matter if your “new drug” is really a drug or something else like a whole food product, the classification comes from the simple question “Do you intend to market this to specifically address some form of ailment?” If the answer is yes, then it must go through the whole new drug process regardless of what it is.