United States: for the FDA, CBD should not be a controlled substance, but international treaties require it to be
DEA's decision last week to place Epidiolex, an oil-based drug containing cannabidiol (CBD), The FDA's decision to remove the product from Schedule 1 of the Controlled Substances Act was based in part on the recommendations of the FDA, the Food and Drug Administration. But the recent publication an internal report showed that the FDA had concluded that there were no criteria to justify placing CBD under federal control.
CBD is a non-psychotropic cannabis compound, and the main component of Epidiolex, the first cannabis-based medicine to be approved for sale on the US market. Before it could be marketed, Epidiolex had to pass several clinical tests and summer FDA-approved for its medical efficacy.
And while the federal health agency has concluded that CBD should not be classified as a controlled substance, the DEA, citing the international treaty obligations, has placed Epidiolex in Schedule 5, the most flexible, while CBD itself remains in Schedule 1, the most restrictive category.
Nonsense? Probably not. The DEA considers that any cannabis extract should be placed in Schedule 1, but that FDA-approved cannabis-based medicines containing less than 0.1% THC could be classified in Schedule 5.
However, the pharmaceutical company behind Epidiolex is now poised to break this deadlock. Justin Gover, CEO of GW Pharmaceuticals, has just announced its intention to market Sativex in the United States. Sativex is composed of an almost equal ratio of CBD and THC (2.7mg THC and 2.5mg CBD per 100 µL spray), i.e. 2.7% THC and 2.5% CBD.
Sativex is «a very advanced opportunity for which we've generated a lot of data,» explains Justin Gover. «And it has a lot of potential for multiple sclerosis and neuropathic pain, and potentially for other neurological pathologies.»
«We now intend to meet with the FDA and determine the way forward,» he added.
The Cannabis plant and all its cannabinoids will probably remain in Appendix 1.
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