I know there is interest here regarding CBD (& THC of course).
I was very interested to read of the FDA approval recommendation for Epidiolex.
"Its active ingredient, cannabidiol, also called CBD, is one of the chemical compounds found in the cannabis plant, but it does not contain the properties that make people high." [1]
"The panel recommended approval of the drug to treat two rare forms of epilepsy — Lennox-Gastaut syndrome and Dravet syndrome. They are among the most difficult types of epilepsy to treat, with nearly all patients continuing to have seizures despite currently available medications, according to the F.D.A."
It must be an interesting situation for U.S. CBD producers.
Back in 2009, the FDA banned Pyridoxamine, an alternative form of vitamin B6. Supplements generally contain pyridoxine, but pyridoxamine had been freely available for some years. A pharmaceutical company wanted to patent it for use in kidney disease.
The situation with CBD is somewhat murkier at present. When questioned a couple of years ago, the FDA stated that CBD fell under the jurisdiction of the DEA - not the FDA - but will that now change?
What's in it for GW Pharmaceuticals? The two diseases are rare. Presumably, Epidiolex will be prescribed off-lable for other conditions. Insurance may even pay for it? In the interim, CBD sellers might be prevented from mentioning cannabidiol or CBD in their products.
When Lovastatin was approved by the FDA, red yeast rice was not banned. The FDA attempted to do so in 1998, but the case was thrown out because red yeast rice was marketed as a dietary supplement, not as a drug. But there must be no mention by sellers that lovastatin is a component. One must rely on a third party to discover how much a product contains.
Do CBD products have the same protection under the 1994 Dietary Supplement Health and Education Act, I wonder?
-Patrick