I will be back on this on Sunday or Monday . . . have to go now.
Michael--I have done much research, beginning with your citations. I am still looking for information I can't find. One of your cites provided that to accomplish a New Drug Application before the FDA can require many years and a 100,000 page application, all manner of clinical and ohter testing, etc. But that is as to newly developed prescription drug. I am interested in what amounts to a homeopathic, all natural ingredient product which is technically a drug under FDA regs but is a far less complicated analysis. I'd like to believe that the application process is in the months rather than years . . .but I can't find a thing.
I suggest you check out this website and call them. They will give you all the information you need regarding homeopathic products and or medications
I think you should call the fda they might be the ones to contact , perhaps they can help you more. You might also try calling vitamin or general nutrition stores and ask them . Unless you can tell me exactly what your product falls under, if its vitamin , or health cream, really the fda is the only place and at least they can guide you.