Note from the publisher: Since the publication of this article, the FDA has approved a CBD-based prescription drug for two special types of epilepsy.
Getting cannabidiol (CBD) approved as a medicine in the U.S. has been an uphill battle from the start. The idea of cannabinoid as medicine is repeatedly blocked by federal departments, most vocally by the Food and Drug Administration (FDA). That is, until recently, with GW Pharmaceuticals completing Phase 3 of their clinical trials for Epidiolex, a CBD isolate. Very soon, they are anticipated to move through the final regulatory hurdles of the FDA approval process and finally get it to market.[1]
This coming June (2018), the FDA will finally be confronted with an issue they have long been ignoring. GW, a London-based company, received both a Rare Pediatric Disease and Orphan Drug Designation, as well as Fast Track Designation from the FDA, for Epidiolex. They are now awaiting a response from the federal agency to their New Drug Application; the deadline is in June. [2]
With this deadline looming, current producers and marketers in the CBD industry are holding their breath. There is much debate on what ramifications the anticipated FDA approval for Epidiolex will have on the rest of the industry.
GW Pharmaceutical: Laboratory Cannabinoids
The commercialization of cannabinoids as medicine is nothing new for GW; they’ve long been in the business of turning natural plants into patented pharmaceutical formulations. Sativex was GW’s first foray into isolated cannabinoids, and it now has widespread regulatory approval. Sativex is approved for use in over 20 countries across Europe, as well as in many others around the world. This 1:1 ratio of THC and CBD is approved for the treatment of muscle spasticity related to Multiple Sclerosis. [3]
Epidiolex represents the latest move by GW, a CBD extraction targeting the treatment of rare forms of childhood epilepsy. According to their website, it is targeting, “adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.” [2]
RELATED: Proven Again: CBD Reduces Seizures in Rare Epilepsy
The FDA’s Stance On CBD
The FDA's opinion on hemp-based CBD should not be confused with the DEA’s opinion on the same matter. Cannabis products, derived from plants containing more than 0.3 percent THC remain classified as a Schedule I Drug. But, thanks to Section 7606 of the 2014 US Farm Bill, hemp is legal to grow, process and sell, under certain circumstances.
Today hemp farmers and cannabidiol producers across the U.S. are operating under this specific revision. Legally, producers across the U.S. may source CBD from hemp instead of marijuana and circumnavigate the legal classification of latter.[4]
RELATED: THC vs CBD - Know The Differences
Lately, rumblings are spreading through the industry. Small-scale producers and marketers of hemp-based CBD products are feeling the pressure. Between 2015 and 2016, the FDA issued warning letters to a handful of CBD oil companies.
Many CBD oil companies advertised their CBD products as medicine by making many claims, others as a dietary supplement with a specific amount of CBD, which was not accurate after the FDA got those products tested. Many experts see this as the first attempt to crack down on the growing market for CBD products.
If we dive into exactly what the FDA has to say on CBD, it's very unclear. They state that “based on available evidence, (the) FDA has concluded that THC and CBD products are excluded from the dietary supplement definition,” and yet their position remains relatively vague when it comes to whether or not they will prosecute producers of cannabinoids who misrepresent their products.
When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.[5]
Interestingly, the FDA isn’t giving a yes or no response to natural hemp-based CBD products. Companies are left to wade through the murky waters on their own, only finding out too late if they’ve crossed over an unknown line.
Industry Impact of A CBD Pharmaceutical Approval
If the GW approval goes through as expected, what will happen to the rest of the industry? From the mom and pop producers to the commercial hemp-based online retailers, are they a target for future FDA actions? These are the questions looming over the industry at large.
According to comments by Stephen Schultz, vice president of investor relations at GW Pharmaceuticals, they believe patients need access to drugs which follows the “hallmarks of a medicine.” In other words, medicines which have gone through extensive clinical trials and that meet accepted scientific standards. [6]
It's no secret that for many years, cannabis and even for a time, hemp-based CBD businesses, operated in a legal grey area. Unlike the traditional pharmaceutical industry, there are no governing bodies regulating the production of CBD oil. Due to this, many companies started producing CBD products with mislabeled cannabinoid contents, questionable ingredients and often filled with toxins, pesticides that can cause more harm than good when taken regularly.
That's why we always we always recommend reading How To Choose A High-Quality CBD Oil article before buying any CBD products.
If the FDA goes through with the approval of Epidiolex, Big Pharma might decide that everyone will require a prescription for any CBD products. That would be an absolute disaster for many companies, farmers as well as customers like you.
We truly hope that no harm will come from an FDA approval of a CBD formulation. Perhaps, it will even open the door to broad acceptance of cannabinoids as medicine. Good or bad, the industry as a whole will quickly find out, as the FDA is set to release their final review of Epidiolex in June.
--------------
Sources:
[1] https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-announces-second-positive-phase-3-pivotal-trial-epidiolex
[2] https://www.gwpharm.com/about-us/news/gw-pharmaceuticals-and-its-us-subsidiary-greenwich-biosciences-completes-rolling-new
[3] https://www.gwpharm.com/products-pipeline/sativex-delta-9-tetrahydrocannabinol-and-cannabidiol
[4] https://www.cannalawblog.com/dea-clarification-on-cbd-extracts/
[5] https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm#notapproved
[6] https://www.naturalproductsinsider.com/litigation/fda-enforcement-against-cbd-trade-more-likely-following-gw-drug-approval
[7] https://www.thecannabist.co/2017/10/06/cbd-epidiolex-gw-pharmaceuticals-fda-hemp-industry/89387/
