As of this writing, GW Pharma’s CBD drug Epidiolex has been approved for treating profound refractory pediatric epilepsy syndromes (Dravet syndrome and Lennox Gastaut syndrome) as well as seizures associated with tuberous sclerosis complex (TSC) in patients one year of age or older.  The product is a very simple, orally-administered formulation comprised of 100mg/ml cannabidiol (CBD), dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose – basically, an alcohol-based solution with same seed oil to help solubilize the CBD oil, flavoring, and sweetener.

GW Pharma Performed a Regulatory Miracle

On April 6th, 2020 GW Pharma performed a regulatory miracle when they succeeded in convincing the DEA to deschedule Epidiolex for all indications – including indications for which it has not yet been approved by the FDA.   The benefit to GW of having their product descheduled is incalculable.  It removed potential barriers to insurance reimbursement and made the need to set up and administer an expensive REMS  drug safety program less likely.  In part because of this regulatory coup d’etat, the drug recently posted yearly earnings of nearly $300 million dollars.  

CBD and The DEA

It’s important to note that the DEA descheduled the Epidiolex formulation and not CBD itself.  Thus, GW Pharma is in the enviable position of being the only company that can legally sell CBD.  More importantly, because the DEA descheduled the formulation and not the active ingredient, other companies who wish to market CBD pharmaceutical formulations will have to repeat whatever it is that GW did to get Epidiolex descheduled, it effectively gave the company a huge head start with respect to competitors who are developing other CBD formulations that would compete with Epidiolex.  That advantage will remain in place unless and until CBD itself is descheduled or marijuana is legalized at the federal level.

Epidiolex Clinical Trails Implications for CBD Packaged Goods Industry

In addition to the CSA, the Epidiolex clinical trials have serious implications for the CBD packaged goods industry by way of the Federal Food Drug and Cosmetics Act.  Because CBD was and is still the subject of clinical trials, even hemp-derived CBD is illegal to use as a food additive or dietary supplement under the FDCA.   The FDA has only recently begun the process of providing a regulatory pathway for CBD to be used as a food additive – something that would seemingly be a straightforward matter given the copious amounts of safety data being generated from all of GW Pharma’s clinical trials.

long as the FDA continues to drag their feet in providing a regulatory pathway for CBD CPG products, CBD will remain illegal to use as a food additive or supplement under the FDCA despite the existence of safety data obtained through the Epidiolex clinical trials.  If, as many people in the industry believe, the agency decides to begin enforcement action, this could have a hugely negative impact on the industry.  

Hemp-derived CBD is chemically identical to CBD derived from cannabis.  Despite that identity, the 2018 Farm Bill nonsensically exempts only hemp-derived CBD from the Controlled Substances Act.  If a regulatory pathway is created, but the DEA insists on maintaining cannabis-derived CBD as a schedule 1 substance, then the same molecule will be subject to two different regulatory schemes.  This scenario would require tracking and certifying CBD sources and thereby impose regulatory and economic burdens that are entirely unnecessary from a public health point of view. 

FDA And The Use of CBD

Given the pharmaceutical industry’s formidable lobbying power, it is entirely possible that the FDA will decide to reserve the use of CBD to prescription drugs.  This would kill the entire CBD CPG industry.

Overall, the current state of affairs is unfair, expensive, uncertain, and entirely unworkable over the long term.  The CSA must be amended, ideally to deschedule both hemp and cannabis entirely, but at least in the short term, to deschedule CBD and preferably all non-THC cannabinoids regardless of their source.  Further, the FDA must provide a regulatory pathway to allow the use of low doses of cannabinoids shown to be safe, either by existing clinical trial data or future testing pursuant to the NDIN submission process.  

A recent Gallup poll found that 14% of Americans – 1 in 7 – use CBD products.  The demand is there, the industry is thriving, and adequate safety data exists to justify a regulatory system that allows low-dose OTC CBD products provided those products are produced using GMP and undergo testing that demonstrates they are safe, unadulterated, and accurately labeled.  It is probably time for the industry to collectively fund a NDIN submission that would provide safety data sufficiently compelling to force the FDAs to either recognize CBD and other non-THC cannabinoids as being GRAS substances or in the alternative create a regulatory path for low-dose CBD products.

[1] Clincialtrials.gov lists 256 different clinical trials in which Epidiolex has been, is being, or will be tested for a wide variety of other indications, including but not limited to opioid use disorder, several types of prostate cancer, alcohol use disorder, musculoskeletal pain, and a host of others. https://clinicaltrials.gov/ct2/results?term=epidiolex&Search=Apply&age_v=&gndr=&type=&rslt=

 

[2] REMS – risk evaluation and mitigation strategy – are drug safety programs that the FDA requires in cases where mediations pose serious safety concerns with respect to potential abuse and other adverse effects.

 

[3] Exactly what they did isn’t clear, and won’t for a long while given the snail’s pace at which FOIA requests are filled.

 

[4] The Federal Food Drug and Cosmetics Act prohibit using any substance that has or is currently the subject of clinical trials as a food additive or dietary supplement.