A few moths ago, CBD Oil Geek reported that the FDA had given Epidiolex® the greenlight, subject to DEA approval. This medication, made by GW Pharmaceuticals, is a CBD based drug for the treatment of rare forms of childhood epilepsy that are resistant to other forms of antiseizure treatments.
The move was subject to DEA approval since its primary active ingredient is cannabidiol, also known as CBD, a component of cannabis. Since cannabis is a schedule I drug according to the Controlled Substance Act, the DEA was prompted to reinvestigate how they have scheduled CBD, leaving some in the industry to be hopeful that CBD, at least, would potentially be reclassified.
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DEA Approval is Narrow in Scope
Unfortunately, hopes were dashed when, after review, the DEA chose instead to approve the sale of drugs made from CBD in the U.S. under very narrow circumstances that favor commercial sale of brand name pharmaceuticals, rather than rescheduling this non-psychoactive compound. Many see it as a win for Big Pharma and a loss for the growing CBD industry.
In a statement released on September 28, 2018, the DEA issued an order that places “FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V.”
In addition to the Controlled Substances Act (CSA), the order alluded to the Single Convention on Narcotic Drugs, a 1961 international treaty of the United Nations. The spirit of this act establishes international guidelines for the manufacture and trade of medical and scientific drugs as well as the discouragement of illegal drug trafficking.
From Schedule I to Schedule V
The CSA has five schedule levels that are supposed to reflect the abuse potential as well as the drug’s ability to produce “severe psychological and/or physical dependence.” As the number goes down, the danger of the drug goes up – well – in theory anyway.
Cannabis has been classified as a Schedule I drug according to the CSA. According to the DEA, these are substances with no accepted medical use that also have a high potential for abuse. This means that cannabis is classified alongside heroin in the most restrictive category defined by law.
For a point of reference, Cocaine, Methamphetamine and fentanyl are actually lower on the DEA’s list, coming in as Schedule II drugs. Another point of reference, the CSA specifically exempts both alcohol and tobacco from scheduling.
So, in a landmark decision, CBD, as long as it is made into a drug by a pharmaceutical company and approved by the FDA, can be a schedule V drug. Thus, the decision is not about the substance CBD, but rather the context in which it is distributed. Interesting.
Some Good News
Despite the clear effort to approve the sale of CBD based drugs under only the narrowest of circumstances, there is some good news. Hope remains alive that the breakthrough change in drug enforcement policy may still spur additional research into the medical uses of cannabis and the many compounds found in this plant, including the potential health benefits of CBD oil.
By moving Epidiolex® into schedule V (they could have made it schedule II and it would still legalize the sale of the pharmaceutical), the DEA is also essentially admitting that CBD has little or no dependence potential, opening the door for legal challenges concerning cannabidiol more generally down the road.
Furthermore, The World Health Organization, spurred on by the approval of Epidiolex® has issued a report in June 2018 citing numerous scientific studies that show CBD has no psychoactive properties, is not addictive, and poses no public health problem. Industry insiders hope that this may changes its current classification under the Single Convention, removing the only reasonable barrier to completely rescheduling CBD oil as a schedule V under the CSA.
What About CBD Oil Made from Hemp?
CBD oil derived from hemp has some special protection thanks to the 2014 Farm Bill which effectively defined and protected the cultivation of hemp and products derived from hemp, which most products labeled CBD oil are (although interstate distribution remains a bit of a legal quagmire).
Finally, the DEA has been hampered in taking action against CBD manufacturers operating legally in their states thanks to congress stripping any funding for such questionable enforcement in a subsequent appropriations bill.
If you are unsure about laws in your state, be sure to check out my comprehensive state by state guide here.
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