The whole CBD legalization issue is confusing to many. It is legal in 29 states so why are medications illegal?
Don’t get this confused with hemp derived CBD, which is legal in all 50 states.
Well, for a product to be used as medication it has to be approved by the FDA. Meaning that a product needs approval by the federal government to be used specifically for treatment of a disease.
The process includes provision of publicized research and trials. These also have to support the claims of the company seeking approval.
Cannabis being legal in these states means that the residents of these states can use CBD at home for making products.
It also means that CBD products like oil and edibles can be sold in these states.
Note the difference between products and drugs or medications in this context.
Currently, CBD and other cannabis constituents are classified as Schedule 1. Cannabis is up there with heroin and cocaine.
This means that the federal government holds the opinion that cannabis cannabinoids such as THC and CBD, have no medical benefit whatsoever and hold a high risk of dependence and abuse.
Epidiolex: FDA Approved CBD Treatment
In the first quarter of 2018, the CBD community was rocked with news of new developments in the approval process of a GW Pharmaceuticals drug.
The Food and Drug Administration panel recommended the drug unanimously for approval.
Epidiolex would be the first ever CBD drug to get this far in the process.
The panel convened in June 2018 to make a final decision on whether the FDA will allow distribution. And on June 25th, 2018 the FDA approved the use of the first CBD based medication.
Epidiolex is an oral medication aimed at the treatment for two types of childhood epilepsy, and is developed from 100% CBD.
Dravets Syndrome is a type of epilepsy with seizures triggered by fever and high temperatures. This is common in infancy.
About 10-20% of patients die before adulthood with a good portion of this number dying before the age of 10.
The other form of epilepsy is Lenox Gastaut Syndrome (LGS), typically LGS is realized in early childhood or infancy.
It may bring about learning disabilities and developmental delays. This is characterized by several kinds of frequent seizures.
When this news hit the wire, the stock of GW Pharmaceuticals skyrocketed and continued after the approval of Epidiolex.
This gives hope that more large pharmaceutical companies will be involved in CBD business.
The process to get Epidiolex where it is now to receive FDA approval took a lot of work. There are rigorous bureaucratic hoops to jump through to arrive before a panel.
The DEA and FDA insist on special infrastructure for trials and research. All these require deep pockets.
These large pharmaceutical companies would provide the resources required to go through the processes of getting approved CBD drugs.
Hopefully, this has opened up the field for further CBD advancements in terms of FDA approved drugs.
Epidiolex already has Orphan Drug Designation from the FDA. This means that it is already on the roster as a drug that treats a rare disease.
To the rest of the world, it looks as if the federal government has underscored the medical benefits of CBD.
The DEA has given no indication that it will reschedule cannabis but there is hope that the stringent measures put in place for cannabis research will be loosened a little bit.
Sativex
Sativex is another GW Pharmaceutical drug that was developed for Multiple Sclerosis and neuropathic cancer pain.
It has THC and CBD in equal measure and is legally distributed in 30 countries around the world.
The company, in conjunction with another, received approval from the FDA to conduct trials in advanced cancer patients.
The trials for neuropathic cancer pain begun in 2007 and in March of 2010, Phase 2 results were reported and were positive.
Therefore, they continued to phase 3 trials.
Preliminary results have shown a trend towards reduction in spasticity.
In April of 2014, the FDA granted GW Pharmaceuticals a Fast Track. This is process devised to facilitate developmental and expedited review of drugs.
This is meant to be a jerk reaction to fill unmet medical needs in the field. Sativex is still under review awaiting FDA action.
Marinol and Syndros
In March of 2017, Syndros was down-scheduled. The new classification holds that Syndros has a lower physical and psychological dependence.
This drug is developed from cannabis derived pharmaceutical elements. Dronabinol is a synthetic form of THC.
Both Marinol and Syndros are made from this element. They are meant for the treatment of nausea and vomiting caused by cancer therapies.
It is also aimed at stimulating appetite in AIDS patients and as an analgesic for Multiple Sclerosis.
The FDA approved both of these drugs. Neither is scheduled as Schedule 1, unlike cannabis. So if a cannabis derived FDA approved product is not a schedule 1 then why on earth is THC and CBD still a schedule 1?
This progress is recent and gives even more hope for CBD drugs currently awaiting approval from the FDA.
Scenarios Which CBD Can Be Considered Federally Lawful
If you cross state lines with a CBD product like oil into a state that has not legalized it yet, you can face jail time or whatever other punishment there is in that state for possession of the schedule 1 drug.
According to an L.A attorney, it is possible to be free of legal action.
There are scenarios in which you could be pardoned. The first way to legally access CBD is if the CBD oil is derived from hemp.
The hemp must be legally grown under section 7606 of the 2014 US Farm Bill. Which is what allows companies like Wellicy to legally sell their hemp derived CBD products across the nation!
Another scenario would require that the hemp be imported. The latter is a more complicated defense but one that an attorney can easily maneuver.
The 3rd scenario is if the CBD has been derived from cannabis stalk. The cannabis stalk is not covered in the Controlled Substances Act and would therefore pass.
However, the product cannot have a higher CBD content than what can be derived from a cannabis stalk.
If the percentage is deemed higher, that would render the CBD oil unlawful. These scenarios offer a way around federal law.
Implications of the Epidiolex Situation
The news of the FDA granting approval for Epidiolex is great news for every other stakeholder in the CBD field.
There will be lessons to learn and hints to look out for during proceedings. The proceedings will set the tone for future proceedings for CBD based medications.
The process taken by GW Pharmaceuticals will also set a stage for future drugs and companies.
1) Formulation
The FDA and DEA have put in place some very rigorous processes for a drug to get from a simple idea to a legally distributable product.
The formulation of Epidiolex will be especially interesting to other players in the industry. They will want to know the process of manufacturing and chemical formulations.
These will shine a light on the requirements of the federal government as pertains to CBD drugs.
The players will also keep an eye out for hints that GW Pharmaceuticals might want to bar others from using the same formulation and processes for development of new drugs.
2) Safety and Efficacy
The FDA requires that a significant number of trials and research to be publicized. The FDA also requires that the research and trials sufficiently support the claims.
The aim of this is to ascertain the exact safety and efficacy of CBD and the drug in particular for the specified diseases.
Other players in the industry will be on the look out to see how GW Pharmaceuticals handles this part. They will want to see exactly how Epidiolex was able to get through the FDA wringer.
In some reports, it has been implied that availability of the drug will be a factor. However, as per precedent a drug can get FDA approval without evidence of capability to produce enough units for the demographic.
3) DEA Plans to Reschedule CBD
The CBD conversation has prevailed for decades. Since the FDA approved Epidiolex, it’s now being viewed as a judge for the DEA to reschedule cannabis or maybe just the medical cannabinoid CBD.
Even a simple-down schedule would work. Maybe get it from 1 to 3.
For this reason, the stakeholders will pay special attention to the questions asked during the proceedings. The federal government official will be under the spotlight for a hint that DEA action is on the horizon.
4) Patents
GW Pharmaceuticals has applied for several patents with regards to their advancements in CBD drug development.
The government also has a patent of its own. They even own the patent that acknowledges the medical benefits of cannabis.
The company has gone on record to say that the CBD molecule cannot be patented but this remains to be seen.
It could change stance and challenge similar cannabinoid treatments. The stakeholders will therefore be listening for hints on whether there will be no-go zones as far as CBD drugs for the same illnesses go.
A Turning Point for The CBD Industry
This FDA approval for Epidiolex is a historical event. But there is still a lot riding on this for the CBD industry, as this could make or break the industry in the sense that all other non-FDA approved CBD products could be outlawed.
It is not so much that the drug is approved but more about the process and the proceedings. The stakeholders will gain a lot from just following every step of this first of its kind drug approval process.
What are your thoughts? Do you think an FDA approved CBD based medication will be good for the CBD industry or do you think it will have negative consequences? Let me know in the comments section below!
