2020 is a year that will never be forgotten. The COVID-19 global pandemic indiscriminately touched every aspect of life, impacting families, communities, and industries around the world. The effects continue into 2021 and likely far beyond. For the cannabis industry, the impact of the global pandemic has been noted in numerous articles and unfounded claims by cannabis-based product companies surrounding the use of cannabidiol (CBD) to treat the virus, without randomized, placebo-controlled clinical research to back these claims.¹

While some CBD companies attempted to leverage the COVID-19 pandemic to elevate their products to the potential detriment of consumers, there was also quite a bit of positive movement by legislators in 2020. With every step forward, there were also continued delays in progress towards federal oversight for CBD for the benefit of patients. Below is a recap of some of the biggest milestones of the last year.

CBD Regulation:

As 2020 began, there was a considerable push for the U.S. Food and Drug Administration (FDA) to establish and begin enforcing regulations surrounding the abundance of CBD products on the market. This call for regulatory oversight started in 2019 as companies manufacturing and marketing CBD products made unfounded claims around a variety of health benefits following the passage of the 2018 Farm Bill. As the COVID-19 pandemic took hold, CBD oversight understandably took a back seat to more pressing regulatory needs related to virus treatments and vaccine development. However, the FDA did make progress towards the development of CBD policy and oversight in 2020 by gathering stakeholder and industry input in July to better understand the challenges surrounding quality, safety, and monitoring of the current marketplace. The FDA also hosted a multidisciplinary scientific conference in November to review scientific evidence supporting the presence or absence of sex and gender differences in use and response to CBD and other cannabinoids.²

The FDA announced within the first week of 2021 its plans to work with government, academia, and industry to begin collecting and analyzing real world data (RWD) surrounding the use of CBD in an effort to better develop regulatory frameworks and encourage traditional clinical studies. The FDA acknowledged the challenges ahead but noted that in the coming months they will move forward with research that examines the extent of CBD use and products, systematic adverse event data collection and analysis, coding of data specific to CBD products and longitudinal studies that seek to understand the long-term implications of CBD use.²

Cannabis Legalization:

The 2020 elections, like the COVID-19 pandemic, will be remembered throughout history as one of the most tumultuous ever. The elections brought big ballot wins for cannabis pro-legalization movements in states including Arizona, New Jersey, Montana, and South Dakota* which legalized both medical and adult recreational cannabis use. Mississippi also legalized medical cannabis. These ballot initiatives overwhelmingly passed, demonstrating Americans’ desire for legal use of cannabis-based products both for medicine and recreation. With these passages, the number of states now allowing some legal form of cannabis sales has risen to 36.³ Some would argue these milestones further demonstrate the need for legislative action at the federal level because even with state level legalization, there remains a need for comprehensive oversight of cannabis products to ensure public safety.

Late in 2020 following the November elections, and while the country waited for the runoff races in Georgia that ultimately secured Congress for the Democrats, the House passed the Marijuana Opportunity Reinvestment and Expungement Act (MORE).⁴ The vote came days after the United Nations reclassified cannabis as a less dangerous drug.⁵ While the MORE act would not necessarily change how states are currently operating when it comes to medical or recreational cannabis laws, it would decriminalize and deschedule the drug, potentially opening doors for more and easier research in 2021 and beyond.

Cannabis Medical Research:

The need for more research of the medicinal value of the cannabis plant is clear as seen by two separate, but similar, bills passed by the U.S. House and Senate in the waning days of 2020. While neither passed both chambers, the votes and presence of each bipartisan bill demonstrates the commitment moving forward to expand cannabis research.

On December 16, the Senate approved a bipartisan bill meant to promote studies of the effects of cannabis and marijuana derivatives including CBD and streamline the application process for researchers who want to study the plant for FDA approval. The passage of the Senate bill, known as Cannabidiol and Marihuana Research Expansion Act,⁶ came one week after the House passed separate cannabis research legislation, known as the Medical Marijuana Research Act.⁷ The House bill focused on increasing the number of federally approved suppliers of cannabis grown for research, and effectively streamlining the approval processes.

As of the close of the 2020 Congressional session, the House had not taken up the Senate bill. But the hope is that lawmakers will work together towards development of a compromised bill in 2021 to ultimately ease the research process for those looking to advance cannabis-based therapies through the FDA process.

Covering Cannabinoids will continue to provide updates on these efforts in future issues.

*As of publication, the voter approved ballot initiative in South Dakota continues to be challenged by legislators.