This report was prepared by the Global Education Group, A Division of Ultimate Medical Academy. To download and read the full PDF, click here.
Cannabidiol (CBD)-based therapies achieved several important regulatory, clinical, and legislative milestones in 2018 removing many barriers to new CBD-based drug approvals in the near future. In June 2018, the FDA approved Epidiolex (CBD) for the treatment of 2 rare childhood epileptic disorders, Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), heralding a new wave of investment and clinical research into the therapeutic potential of cannabis. Over 200 clinical trials are currently investigating CBD for use in more than 40 clinical applications.
The 2018 Farm Bill, passed in December 2018, removed hemp (cannabis containing less than 0.3% -9-tetrahydrocannabinol [THC]) from the definition of marijuana under the Controlled Substances Abuse (CSA) Act, therefore permitting cultivation, processing, marketing, and sale of hemp and its derived products (eg, CBD). At the same time, the FDA reiterated its regulatory oversight of CBD and CBD-containing products making clear that the Agency views CBD as a drug and not as a dietary supplement. To paraphrase the FDA’s stance: Because CBD is marketed as a drug with therapeutic benefits, CBD will be regulated like a drug with therapeutic benefits.
Despite the uncertain legal status of CBD products, economic interest in CBD has ballooned. The recreational marijuana industry is projected to generate $40 billion in total economic output by 2021.4 Consumer sales of CBD in particular are anticipated to reach $1.8 billion by 2022.5 CBD can be found in a variety of consumer products, from edibles like cookies and gummies to topical ointments for pain and niche items like mascara and skin care products. This report will detail the chemical nature of CBD, describe the current conflict between the 2018 Farm Bill and an FDA statutory provision known as the investigational new drug (IND) preclusion, and provide an overview of what to expect based on regulatory trends.