Is CBD About to Come Off The Schedule 1 List? - RxLeaf
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Is CBD About to Come Off The Schedule 1 List?

Emily Robertson
Box of Epidiolex

Since the FDA approved GW Pharmaceutical’s CBD extract, Epidiolex, what about the rest of the CBD sitting on the Schedule I list?

Cannabis, under US federal law, falls under the legalese of the Controlled Substances Act (CSA).The whole plant, and all of its possible extracts, which includes CBD, are designated as Schedule 1. This category of substances, including cocaine and heroin, have “no currently accepted medical use and a high potential for abuse.”  Therefore, all use is illegal on the federal level.

CBD’s legal history is a bit convoluted. In 2016, the DEA released a “clarifying rule” to outline that CBD is an illegal drug because it is extracted from cannabis flower. Hemp farmers and producers balked, say that CBD can also be extracted from legal hemp crops and there was no way to tell the point of origin by looking at the CBD product. They argued that the DEA was attempting to add a new substance to the Controlled Substances Act, which is does not have the authority to do.

Court Gavel

Image Credit: Valeriyn n Eviakhov

It was just this past May (2018) that a three-judge panel of the 9th Circuit agreed with the DEA and subsequently made CBD an official resident on Schedule I for the Controlled Substances Act.
The hemp industry can still appeal that decision, but if the 9th circuit continues to side with the DEA, the next appeal will be at the Supreme Court.

So, what is fascinating is that Big Pharma was able to get FDA to approve their CBD extract, despite the DEA saying it’s an illegal substance. Epidiolex, which treats epilepsy, will be available for prescription and purchase in all states, whether that state has legalized cannabis or not.

Box of Epidiolex

Image Credit: GW Pharmaceuticals

The DEA now has 90 days to remove Epidiolex CBD from Schedule 1 status. The DEA will then be able to decide if they would like to declassify Epidiolex on its own, or CBD in general.

This could be a major step toward legalizing cannabis OR it could be a major coup for Big Pharma who will be permitted to peddle their products to the populace, unlike cannabis producers. If CBD is declassified, companies across the country would have the option to apply to register CBD-only products with the DEA. If they become registered, they will have the ability to sell their products nationwide – even in states where whole cannabis remains illegal.

FDA Approved Rubber Stamp

Image Credit: Castleski

The process to apply for this status isn’t too difficult. Companies simply have to fill out and mail in a form, pay a small fee, and wait! After about 4-6 weeks, they’ll know if the DEA has registered their product. It’s worth it, particularly from a business perspective. Registration allows businesses to expand their client base across the country. And from a patient perspective, millions more patients will gain legal access to some form of their medicine.

Will these legal proceedings and classificaitons push other products to reach for scientific vigour? It’s hard to say. We should continue to be cautious of mislabeling for those products that haven’t garnered FDA approval. Some companies will bank on the CBD declassification and won’t bother to go ahead to see registration with the DEA. To avoid all the hoops they’d have to jump through, some companies may simply market in a way that reminds consumers of Epidiolex’s approval.

Close up of cannabis bud

Image Credit: Yarygin

It is going to be interesting to watch how this CBD scheduling is handled by all parties.

Emily Robertson

Emily Robertson has been writing freelance and contract work since 2011. She has written on a variety of topics, including travel writing of North America and the growing legalized cannabis industry across the globe. Robertson has a master’s degree in literature and gender studies, and brings this through in her writing by always trying to explore different perspectives. Born and raised in southwestern Ontario, Robertson moved to Glasgow, Scotland in 2016 to undergo her doctorate in Scottish Literature. She lives in the West End with her dog, Henley.

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