Things that make you go "hmm".
Fritz Chess, Founder, Eden Labs, John MacKay, formerly mad scientist @ Waters, and now an extraction consultant, and Bryce Berryessa of La Vida Verd talk about extraction and isolating compounds. Extraction equipment has a long history in the natural products space.
Recently, the U.S. Drug Enforcement Agency (DEA) categorized Epidiolex (cannabidiol) as a Schedule 5 drug, a classification for medications with lower abuse potential that Schedule 4 (e.g., Xanax, Darvon, Ambien).
Schedule 5, the DEA's lowest category for controlled substances, includes cough suppressants containing modest amounts of codeine (e.g., Robitussin AG), Lyrica and Motofen.
I'm sure other cannabis companies would love to have their products rescheduled by the federal Drug Enforcement Agency from 1 to 5.
But wait, there's more. GW Pharmaceuticals filed a NDI (New Dietary Ingredient ) for Epidiolex (CBD) in 2014 and received an NDI number.
It's kind of like a patent that GW doesn't have to enforce themselves. The FDA will enforce it for them. It's like GW discovered a new herb (CBD), which they obviously didn't.
According to attorney Rod Kight, "full spectrum hemp extract products are best and properly viewed as dietary supplements, much like Red Yeast Rice (RYR). For this reason, they will almost certainly find their way to the supermarket shelves and become mainstream dietary supplements alongside RYR, Saint John’s Wort, turmeric, etc. Similarly, and using the RYR Cholestin case as a guide, products that are enhanced with CBD, by which I mean enriched with CBD isolate, and promoted for their health benefits, eventually may be regulated as drugs and not authorized for sale OTC."
A counter argument, provided by Rod Kight:
"In order for an ingredient to be precluded from being used in a food or dietary supplement substantial clinical trials studying it as a new drug must have been made public prior to the marketing of any food or dietary supplements containing it. The FDA contends that substantial clinical trials of CBD were undertaken and made public prior to marketing of it as a food or dietary supplement ingredient. As discussed by the Hemp Roundtable in a letter written to the California Department of Public Health (DPH) on July 19, 2018 regarding the DPH’s stance on CBD:"
“[W]e firmly disagree that the referenced clinical trials are in fact “substantial,” as the trials were extremely limited in scope, and funding and the publication of these trials were limited. The FDA also seems to misinterpret the IND Preclusion in that it believes the preclusion date is simply the date in which it authorized CBD as an IND, without giving deference to the remaining portion of the statute, which requires that substantial clinical investigation be commenced and that such substantial clinical investigation be made public.”
Kight continues, "In other words, it appears that the FDA may not have met all of the statutory elements to preclude CBD from being used as an ingredient in food or dietary supplements because the Epidiolex trials were not sufficiently substantial."
"The next big battleground for CBD is the extent to which it will be regulated by the FDA. Based on the FDA’s treatment of RYR and lovastatin it is likely that products enhanced with CBD isolate and which promote its efficacy in treating medical issues will be regulated as drugs and that hemp extracts containing naturally occurring phytonutrients, including CBD, will be regulated as dietary supplements. This is not a certain outcome. It is possible that the FDA may take a strong stance and assert that all products containing CBD are “drugs”, in which case litigation will be required to sort it out. On the other hand, and based on the WHO’s extensive reports about CBD’s safety, the FDA may ultimately choose not to regulate it as a drug, notwithstanding its approval of Epidiolex."