whoa. great find. quick search found this: http
Post# of 15624
https://www.fda.gov/Drugs/DevelopmentApproval...plication/
it is a way to get going w/ FDA trials. legit. Also, it has 30 day window in which the FDA can review and deny the testing or not. This also allows the transport of the product across state lines.
If anyone has the time, please go over the link and let us know what you think.