I have read Abernethy's comments made yesterday.
First it's important to understand that this agency moves very deliberately and is known for its careful but painfully slow decision process.
I see the concerns they have. One being safety of what is being sold out there. She states in her testimony that the FDA did random tests of some CBD products and found a number of variances of THC levels and other components which are not disclosed on the packaging. Not to mention the various claims health claims made, such as what Curaleaf was cited for.
The other concern is that people would believe the claims and rely on "non scientific " data as a substitute for a prescribed drug with exact dosage and a named side effects that would be FDA approved.
The other concerns are the clinical studies that drug companies would put forth in the advancement of CBD and other research may be jeopardized by the easy availability of CBD being everywhere in the market place.
She hints in her testimony that at some point, CBD companies may have to submit certification of safety data to ensure safety of their product. Along with a disclaimer about what CBD does and does not do.
Now it will come down to dosage, strains of hemp and details of exactly what you (your company) are putting in your CBD products.
The FDA may have to require a GRAS report (such as the one CV Sciences has done) or set regulations regarding the CBD derivative (whether Hemp CBD or Marijuana CBD) and the dosage which appears to be set at 0.3 THC which is what the consensus has been.
This is what Duffy MacKay has told them in his testimony. Hemp is an agriculturally approved product. Which was approved with the passing of the Farm Bill.
As I had mentioned in an earlier post, hemp farming does not help the farmers without the ability of CBD as being part of the deal. The amount of money between harvesting hemp for (rope and other commodities) versus CBD and its extraction potential is enormous.
McConnell is on this as well as Wyden and other people in Congress. He has met with the FDA as recently as two weeks ago and is putting pressure on the agency. Pressure will continue until the FDA comes up with something.
The FDA is going to shake out the shady operators. You can see that coming.
Bottom line is we are going to see one of a number of things occur very shortly...
Either the FDA will agree to a strain of hemp (its source), a GRAS report, (proving your products safety) a dosage of 0.3 THC as an acceptable pathway for retail distribution. Food and beverage hopefully will be included.
States will and are now taking their own action with CBD and will begin writing their own regulations with regard to CBD. A huge market in California is about to unleash CBD in this regard. This is happening already in other states ( I believe OHIO)
McConnell could and may modify and file an amendment to the 2018 Farm Bill with some sort of provision regarding CBD...
CBD is not going to cease being sold.....shady operators will pay the price for unsafe products on the market. There is too much money involved here folks...plain and simple
And finally, the company would not expand to a 45,000 sq. foot processing facility, engage in partnerships with hemp farmers if it did not see the retail blitz that is coming...
Know what you own.
Successful investors have one thing over the amateurs......
its called PATIENCE
