Is CBD About to Come Off The Schedule 1 List?
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.
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.
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.
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.
It is going to be interesting to watch how this CBD scheduling is handled by all parties.