CBD Oil Products Were Already Readily Available – How is Epidiolex Different?
July 2, 2018
With the recent FDA approval of Epidiolex(marijuana derived cannabidiol (CBD)), a number of questions have been asked about how the product differs from the many CBD products already on the market. There are a number of differences both from a product standpoint and from a legal standpoint.
GW Pharma's Epidiolex, approved for Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older, is the first drug approved by the FDA that is derived from marijuana. Lennox-Gastaut syndrome and Dravet syndrome are rare, severe forms of epilepsy. By contrast, non-prescription CBD oil is used for many complaints and diseases.
Some of the conditions for which CBD is used include: inflammatory conditions, autoimmune disorders, neurodegenerative disorders, cancer, MS symptoms, psychosis, epilepsy, anxiety, pain, arthritis, etc.
One way OTC CBD and Epidiolex can differ markedly is by what the products contain. Epidiolex contains only CBD as an active ingredient. A number of CBD products do make believable claims of purity (though they are not validated by an FDA-approved manufacturing process). Some CBD products claim greater efficacy because they intentionally include additional cannabinoids other than CBD.
So consumers who are taking an OTC CBD product are relying on the company to determine if the product they are taking contains the amount of CBD specified. They are also relying on the manufacturer to use safe manufacturing procedures and to derive the CBD from a source that is grown in a safe manner (ie: without the use of harmful pesticides, etc). Having said that, this is the case with most foods we consume. However with Epidiolex, consumers have the comfort of knowing that the FDA has approved and monitors the manufacturing of the drug.
The legal status of CBD an Epidiolex is a complex issue. If you Google the legal status of CBD you will find many conflicting statements. Often these statements are delivered with an air of authority that might not be supported by the law and legal decisions.
We spoke with attorney Daniel Shortt to get a professional's take on the legal questions. Daniel is with Harris Bricken in Seattle, WA and deals solely with issues surrounding the cannabis industry.
CP: I imagine there was a lot of concern among your clients when the Trump administration began to discuss the changes the intended to make to the existing arrangement that allowed the marijuana industry to exist in certain states.
Daniel: There was a ton of concern when the Cole memo was rescinded. That has settled down somewhat now.
There have been no prosecutions of licensed businesses. And now we have Trump publicly stating that he is going to support the State's Act that would allow the states to legalize marijuana as they see fit. We also have budgetary protections for medical marijuana and industrial hemp where Congress has said we haven't changed the law but, Department of Justice, you can't use any money to go after these businesses. So there are some protections.
CP: With reference to CBD and its legal status - there is a lot of conflicting information about the DEA's stance on CBD – whether the CBD is derived from industrial hemp, marijuana, etc. What is the legal status of CBD products?
Daniel: The best way to think about this is where is the CBD derived from. There are different pathways to get CBD product and that is how the DEA makes its determination. The Controlled Substances Act definition of marijuana includes certain portions of the plant that are exempt from the definition. Those are generally mature stalks of the plant and products derived from the mature stalks with one exception. If there is resin on the mature stalks that is back in the marijuana category. So based on this definition there is now some authority that the exempt plant material is outside the DEA's jurisdiction. There are two cases from the 9th Circuit that limited the DEA's ability to regulate products that are derived from those portions of the plant.
Recently the DEA issued a clarification reiterating that products derived from the exempt plant material are outside of its jurisdiction. So if you have a CBD product at it comes from those portions of the plant then it is not the DEA's concern. That is probably the most solid way to create a legal CBD product.
Now with reference to industrial hemp. Industrial hemp is defined in the 2014 Farm Bill (CP notes: “industrial hemp” includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis. Source: https://nifa.usda.gov/industrial-hemp). It allowed for states and research institutes to implement agricultural pilot programs to grow hemp. The DEA has issued a policy statement that says the 2014 Farm Bill may allow the cultivation of industrial hemp but it doesn't allow the commercial sale or interstate transfer of industrial hemp.
While the DEA is free to interpret law, that is not necessarily the end of the story. There is also an argument that says, because the Farm Bill allows research into the marketing of hemp that it allows for commercial sale - because how do you research a market without sales? So there is tension between the DEA and the industry. But there is the Congressional spending provision that prevents the DEA from using funds to go after the interstate sale or transfer of industrial hemp. Though that is temporary. It only runs through September 28th.
So arguably if you are growing industrial hemp grown pursuant to a state program – normally that means there is a license issued by a state department of agriculture then you have protection under the Farm Bill. So CBD derived from that source of industrial hemp should be legal. But there is another wrinkle.
States vary on how they interpret the Farm Bill or whether they have implemented the Farm Bill. Not all states allow industrial hemp. So you have to look at legality under State law. That is constantly changing. Almost once a week there is some controversy regarding whether or not hemp and CBD are legal in that state. So it can be very complex.
CP: With respect to Epidiolex, where are we in terms of legality?
Daniel: The headline has been that the FDA has approved this drug that is derived from cannabis plant. A few products are out there that contain synthetic versions of THC that have been approved but this is the first product directly derived from the cannabis plant. Now the DEA will have to schedule this product somewhere. CP notes: Marijuana is currently a schedule I drug. Information about drug scheduling can be found here (https://www.dea.gov/druginfo/ds.shtml) What is significant here is that GW Pharmaceutical has extracted a very specific CBD isolate. This is one way that Epidiolex can be different from OTC CBD. My belief is that the DEA will schedule the specific CBD isolate something lower than schedule III. But I don't think the DEA or the FDA will push to change rules on marijuana or CBD on a more general sense. I don't think this will result in marijuana being rescheduled. End of interview
So we have an unusual situation where there are CBD products available on the market that at least have some claims to being legally sold, but we have an FDA approved product that at this point is not legal at this point.
Later in the conversation, Daniel said that the enforcement issues around CBD have not come from the DEA, but the FDA. And this has been related to specific medical claims for CBD products.
The legal landscape for medical and recreational marijuana is in a continual state of flux. Whether this will lead to broad legalization or possible re-scheduling of marijuana will have to be seen. However it is clear that patients are very interested in gaining access to cannabis-derived drugs to treat a variety of challenging medical conditions.