It’s official, the FDA has approved the first cannabis derived prescription drug. Based on years of research, Epidiolex has proven benefits in treating two rare forms of epilepsy (Dravet Syndrome and Lennox-Gastaut Syndrome). So what does that mean for everyone else? Epidiolex contains CBD isolate, which is also found in a number of nutraceutical hemp products. Up until now, all forms of CBD (with exception to Farm Bill Compliant hemp derived CBD) have been classified as a Schedule I drug. Although we can’t be certain how the FDA’s approval will affect the cannabis industry, we can offer our thoughts. So, let’s look at the facts.
CBD Isolate vs Full Spectrum Hemp Oil
CBD isolate (the cannabis derived ingredient in Epidiolex) is a refined version of full spectrum hemp oil containing only pure CBD. While proven to show health benefits, CBD isolate is just one of numerous cannabinoids that our body is made to absorb, along with numerous flavonoids and terpenoids that are stripped away in the refining process.
Hemp extract contains a variety of cannabinoids, such as CBD, that target specific cannabinoid receptors throughout the body. When using full spectrum hemp products, multiple cannabinoids, terpenoids and receptors work together to increase the efficacy of cannabis based products. This process is often referred to as the “entourage effect”. Although CBD isolate found in Epidiolex is proven to show health benefits for two specific forms of epilepsy, some will still prefer (and be limited to) wholistic full spectrum hemp oil.
How the FDA’s Approval helps the CBD Industry:
- CBD being reclassified to Schedule II or III (within 90 days)
- Making the cannabinoid industry as a whole more credible
- Higher quality standards and oversight
- Proves that CBD has medicinal value
- Opens the door to more research
Regardless of being FDA approved, the question “How much will it cost?” is still a top concern. A year’s prescription of Epidiolex is estimated to cost upwards of $32,000. Even after insurance, it’s likely that Epidiolex will have a cost comparable to over-the-counter alternatives. Before any of that can happen, the DEA still has to reclassify CBD. Currently marijuana and CBD are considered a Schedule I drug. The FDA granted Epidiolex Fast-Track designation for use with Dravet syndrome, and Orphan Drug designation for both Dravet syndrome and Lennox-Gastaut syndrome. With the FDA’s approval of epidiolex, the DEA now has 90 days (as of June 25, 2018) to reclassify CBD as a Schedule II or Schedule III drug. “We don’t have a choice on that,” DEA public affairs officer Barbara Carreno told Business Insider.
With exception to “off label prescribing”, this new drug will be limited to individuals with either of the two previously mentioned types of epilepsy. This means that for those of you looking to use CBD as a remedy for anxiety, appetite, pain, immunity and memory (among others), you’ll likely have to stick with alternative over-the-counter supplements. And while we’re here, it’s worth mentioning the potential negative side effects of Epidiolex, “sleepiness, sedation and lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, fatigue, malaise and weakness, insomnia, sleep disorder and poor quality sleep, and infections.”
With CBD products now being verified to have medicinal benefits, the industry might be approaching a renaissance. A restructuring of the legalities for CBD in a medical environment just might be the validation this industry needs. The FDA’s approval of the first cannabis derived drug will likely open up new opportunities, especially for brands who’ve gone the extra mile to ensure a quality product. As more cannabis derived FDA drugs are introduced, it will become increasingly harder for cannabinoid supplement companies to guarantee pharmaceutical-grade quality. Early trail blazers will have to adapt, refine processes, and have clear oversight of their supply chain and manufacturing.
Not All Hemp Companies are Equal
The cannabis industry has grown to where it is today because of early pioneers who were able to look passed common misconceptions and saw potential in the complex cannabis plant. Now with tensions lightening up, larger retailers offering natural supplements will likely take on CBD brands as this industry gains more validity. Hemp companies that set higher standards will be positioned for long-term success as the industry continues to grow.
What Cannabinoid Companies Should Focus On:
- GMP manufacturing processes
- Increased self-regulation
- 3rd party testing
- Being open and transparent
- Customer service
Overall, the FDA’s approval of Epidiolex is likely a good move for the cannabis industry as a whole. It helps the industry become more credible, sets higher quality expectations, proves that CBD has medicinal value, and will likely encourage further research on cannabinoids and their potential health benefits. As we always say here at Green Lotus Hemp, #LetsGrowTogether.