A new CBD safety study finds zero liver toxicity and no drowsiness. Preliminary results were released this week, renewing calls from the hemp and CBD industries for the FDA to take steps to regulate CBD.
The CBD safety study confirms prior research that orally-ingested cannabidiol (CBD) has a strong safety profile and provides the US Food and Drug Administration (FDA) with the data needed to address its safety concerns regarding the supplement.
The results of the study, which was completed last month, indicate that daily consumption across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels or daytime drowsiness.
Validcare acted as the contract research organisation for the study which involved 1,061 US participants and 17 CBD companies, including Kannaway, Charlotte’s Web, Impact Naturals and Medterra. The project involved gaining feedback from FDA on the protocol, conducting the study and publishing its results.
The first cohort of the CBD safety study, published in Cannabis and Cannabinoid Medicine last year, focused on liver function and observed 839 individuals taking CBD produced by twelve companies. The second cohort included an additional 222 individuals taking CBD produced by an additional five companies. Validcare said this strengthened the statistical reliability of both the liver safety results and achieved statistical relevance for both sleep and testosterone results.
Participants in the study were aged between 18 and 75 years old and recruited from across the United States. Over the course of the study, they took CBD orally for a minimum of 30 days.
It has been over four years since the 2018 Farm Bill legalised hemp and non-intoxicating hemp derivatives like CBD. Although the FDA Commissioner at the time, Scott Gottlieb recognised the “clear interest of Congress in fostering the development of appropriate hemp products” and acknowledged that the FDA “has the authority to issue a regulation”, the FDA has not taken any concrete steps to regulate CBD, claiming that it needs more real-world data to move forward.
In March 2020, the FDA released a Congressional report and public statement on potential regulatory pathways for the sale of hemp-derived CBD products, listing liver injury as the top concern for consumer safety. With this recent study addressing some of the FDA’s primary concerns, key industry players have renewed calls for the FDA to regulate CBD products.
“We hope that these results, paired with the results from the first cohort of the study, will persuade the FDA to take steps to regulate CBD,” said Blake Schroeder, CEO of Medical Marijuana, Inc and Kannaway. “If this were to happen, we could expect the addressable market size to double from present levels as more large chain retailers become more comfortable with the sales of these CBD products upon their shelves and fewer consumers feel hesitant about trying CBD.”
Jonathan Miller, General Counsel to the national advocacy organisation US Hemp Roundtable, said if the FDA continues to delay the organisation will call on Congress to act if necessary.
“We are excited to report that the ‘real-world data’ that FDA has been soliciting addresses the agency’s safety concerns,” he said “The time has come for FDA to regulate CBD and other hemp derivatives. If FDA does not act, we call on Congress to pass legislation such as HR 841, HR 6134 and S. 1698 which would require the FDA to develop regulatory pathways for the sale of hemp extracts like CBD in ingestible form.”
The complete list of CBD brands involved in the study are: Asterra Labs, Cannacraft, CBDistillery, CBD American Shaman, Charlotte’s Web, Columbia Care, Garden of Life, Global Widget, HempFusion, Impact Naturals, Kannaway, Kazmira, Medterra CBD, SunMed CBD, and Tauriga Sciences
