As a leading expert in the field of cannabis research, I have been closely monitoring the recent developments surrounding the legal status of cannabidiol (CBD) in the United States. In September 2018, the U. S. Food and Drug Administration (FDA) made a groundbreaking decision to approve Epidiolex oral solution as the first and only prescription CBD medication for the treatment of epilepsy.
This decision not only marked a major milestone for patients suffering from this debilitating condition, but it also had significant implications for the legal status of CBD. For many years, CBD was classified as a controlled substance under the federal Controlled Substances Act (CSA). This meant that it was considered to have a high potential for abuse and had no accepted medical use. However, with the FDA's approval of Epidiolex, CBD is no longer considered a controlled substance under the CSA.
This is a significant shift in the legal landscape surrounding CBD and has sparked much discussion and debate among experts and stakeholders. So, what exactly does this mean for CBD? To understand this, we must first take a closer look at the CSA and how it classifies controlled substances. When reviewing the CSA, you will not find the words “cannabidiol” or “CBD” anywhere in its text. In fact, these terms only appear in the code of federal regulations or in enacted legislation.
This is because the CSA uses a system of schedules to categorize controlled substances based on their potential for abuse and accepted medical use. Prior to the FDA's approval of Epidiolex, CBD was classified as a Schedule I substance under the CSA. This is the most restrictive category reserved for drugs with a high potential for abuse and no accepted medical use. Other substances in this category include heroin, LSD, and ecstasy.
However, with the FDA's approval of Epidiolex, CBD has been removed from the list of federally controlled substances altogether. This means that it is no longer subject to the strict regulations and restrictions imposed on Schedule I substances. It is important to note that this change in status only applies to CBD in its pure form as an FDA-approved medication. The CSA still classifies marijuana and its derivatives, including CBD extracted from marijuana, as Schedule I substances.
This means that any CBD products derived from marijuana are still considered illegal under federal law. However, CBD derived from hemp, which contains less than 0.3% THC (the psychoactive compound in marijuana), is now legal at the federal level thanks to the 2018 Farm Bill. So, why did the FDA approve Epidiolex and remove CBD from the list of controlled substances? The answer lies in the extensive clinical trials and research that went into the development of this medication. The FDA reviewed three randomized, double-blind, placebo-controlled trials involving over 500 patients with either Lennox-Gastaut syndrome or Dravet syndrome, two rare forms of epilepsy that are notoriously difficult to treat.
The results showed that Epidiolex significantly reduced the frequency of seizures in these patients compared to placebo. This groundbreaking decision by the FDA has not only opened up new treatment options for patients with epilepsy but has also paved the way for further research into the potential medical benefits of CBD. With CBD no longer classified as a controlled substance, researchers can now more easily access and study this compound without facing the same restrictions and barriers as before. In conclusion, while CBD may have once been considered a controlled substance under federal law, its status has now evolved thanks to the FDA's approval of Epidiolex.
This decision has not only provided much-needed relief for patients with epilepsy but has also sparked new opportunities for research and development in the field of cannabis-based medicine. As an expert in this field, I am excited to see where this new era of CBD research will take us and the potential benefits it may bring for patients in need.
