I do not know the process for sure, nor do I have the details but follow me on this..
If CVSI were just adding CBD to chewing gum then probably no FDA approval would be needed. Somehow I don't think this is the case. If they are creating a new drug that uses CBD as the active ingredient then I would think they would need FDA approval then.
But the above is outside my normal realm and I do not know. Better answered by someone else that is in the know.
Pure hemp oil, safely grown and extracted, delivered to the front doorstep of Americans across all 50 states
After opening the U.S. market and shipping CBD hemp oil to over 40 countries internationally, HempMeds® set their sights on Latin America, a region long opposed to any form of cannabis legalization.
Yep...the world is just waiting for that GRAS thing, then business starts.
CVSI is pursuing a patent using synthetic CBD, so the FB, IMHO, does not help with the process.
That being said, chewing tobacco addiction is a world wide health problem. It has been shown that other current products on the market, gum mainly targeted for tobacco SMOKING, do not help break the chewing addition at all. Using this approach, with synthetic CBD in a gum, the company hopes to develop a product which will show positive and lasting results. [I won't even try to explain the technical, as my knowledge there is limited]
Here's hoping the trials will commence in 2019! GLTA, go CVSI!