In late June, the FDA granted final approval for GW Pharmaceuticals to market Epidiolex as a treatment for two severe, childhood, seizure disorders called Lennox-Gastaut syndrome and Dravet syndrome.
The new drug is derived directly from the cannabis plant. It contains cannabidiol, or CBD, rather than tetrahydrocannabinol, or THC. GW Pharmaceuticals will have to wait to market the treatment until after the Drug Enforcement Administration scrutinizes the treatment, which is expected to take about 90 days.
In other action, the US Senate officially passed the Agriculture Improvement Act of 2018 (i.e. the Farm Bill). The 2018 Farm Bill included a provision moving the US Industrial Hemp laws from a research and development pilot to a full agricultural commodity-status and effectively removed hemp-derived CBD (cannabidiol), and all naturally occurring cannabinoids therein, from the controlled-substance list. Now the fate of CBD is in the hands of legislators as they negotiate the final form of the bill before it can be sent to the President for his signature.
Now is the time to push for research concerning the application of CBD as a supplement. Recently Maggie Frank, a national educator for CV Sciences, stressed the research potential of CBD and makes no claims when discussing CBD-rich, whole hemp oil. She positions CV Sciences products as the best food we know to feed the endocannabinoid system. For many customers, she needs to educate them on the endocannabinoid system, what it supposed to do, when it is healthy, and how healing it can guide users in other areas of wellbeing.
Growing hemp in the US should stabilize availability of the raw material and create more efficient supply. However, CBD represents just one of a group of compounds called phytocannabinoids, which currently number over 100. Some of these phytocannabinoids occur in such low concentrations that advancing their medicinal potential requires chemical syntheses.
What does change mean for cannabinoid products?
The market has witnessed an explosion of CBD products and consumers can access them via Internet sales. Unfortunately, many of these products offer low quality, and as a result, provide little therapeutic support. As dietary supplements, producers cannot make health claims about these products, so beware of magic-bullet promises. Instead, rely on trusted brands that produce cannabinoid products combining the power of the phytocannabinoids with other ingredients.
Designs for Health added Omega-3 to hemp oil, creating a supplement to support cardiovascular health. Similarly, Omax Health has combined the company’s patented omega-3 formula with phytocannabinoid-rich hemp oil and AlphaWave L-Theanine from green tea leaves to create a product that provides stress relief. Terry Naturally recently released a hemp-oil product designed to support immune function, brain health, and the endocrine system. These products use hemp oil not CBD oil.
CV Sciences has approached hemp oil as a dietary ingredient, going as far as ensuring it’s hemp-derived CBD/ phytocannabinoid-rich product is affirmed GRAS (meaning generally recognized as safe) based on scientific procedures. To achieve this safety standard on it’s product, comprehensive toxicological, pre-clinical studies investigate the safety of oral consumption of the CV Sciences, hemp-derived CBD oil. This safety standard is determined by the FDA and covered under 21 CFR 170.30 as providing with reasonable certainty that the substance causes no harm under conditions of intended use and is found in the conventional food supply, in a form that is not chemically altered. Hector L. Lopez, MD, FAAPMR, FISSN (a key opinion leader for CV Sciences) discussed the advantages CV Sciences’ CBD oil products. According to Dr. Lopez, CV Sciences’ products contain a full-sprectrum of other phytocannabinoids, like CBDA, THCA, CBDV, CBC and CBG to name a few. The products also contain terpenes, flavonoids, vitamin E tocooherols, and other bioactive compounds. CV Sciences continues to commit to growing the body of evidence supporting phytocannabinoids, sponsoring clinical trials and research investigating the efficacy (and safety) of hemp-derived CBD oil with a complex of phytocannabinoids that may have unique therapeutic benefits.
These examples cover just a few of the trends occurring in the phytocannibinoid supplement market. The most important issue facing the category, though, lies in educating consumers and healthcare practitioners about the differences between medical and recreational marijuana, hemp and marijuana, the endocannabinoid system and nutritional supplements supporting it.
Can CBD exist as a drug and a dietary supplement? Evan DeMarco, product innovator for Omax Health, sees battles over this topic continuing for the next several years but feels it could settle in, much like the omega-3 market, where products like Lovaza or VASCEPA exist as prescription-based products while many other brands are sold off the shelf. In the event that the FDA issues broad, sweeping regulation that categorizes CBD as a pharmaceutical product, education will need to focus on helping consumers understand that a product labeled “full-spectrum phytocannabinoids” provides the same therapeutic benefit.
Where does that leave us?
The legislative issue should be resolved in the next 6 to 12 months. Agricultural concerns may need 5 years to turn soil over for growing pure hemp stock that can produce hemp oil. And we need research. You can find a lot of anecdotal evidence concerning the healing power of the plant. Now we need research to convert this data to evidence-based solutions for supporting treatment of chronic health issues. The next several years will provide excitement, but remember, if the claims a product makes seem too good to be true—they probably are.
Author: Dick Benson Editorial Director InnoVision Health Media