A new comprehensive study of more than 1,000 people has confirmed the safety of orally-ingested cannabidiol products and provides data that addresses the U.S. Food and Drug Administration’s concerns about the safety of CBD. The two-part study found that daily consumption of CBD across a range of typical retail products and serving sizes is not associated with elevated liver tests, low testosterone levels, or daytime drowsiness.
To conduct the study, the research firm Validcare contracted with 17 CBD companies to study safety concerns previously expressed by the FDA. Validcare acted as the contract research organization, which included obtaining feedback from the FDA on the research protocol, conducting the study and publishing the results.
“The data in this study looks really good; it’s highly significant, and the chances of it being wrong are very, very small,” Dr. Robert Kaufmann, director of research for Validcare and a former professor at Southern Illinois University School of Medicine, said in a statement from the U.S. Hemp Roundtable. “I am very hopeful that this data will allow the FDA to regulate these popular CBD products.”
The first cohort of the study, which was peer-reviewed and published in Cannabis and Cannabinoid Medicine last year, studied how CBD products from 12 different manufacturers affected the liver function of 839 study participants. The second cohort included 222 additional individuals taking CBD products produced by five additional companies. The participation of the additional study subjects strengthened the statistical reliability of both the liver safety results and achieved statistical relevance for both sleep and testosterone results, according to the researchers.
The participants in the research were all adults aged 18 to 75 who had been taking oral CBD products for at least 30 days. Participants were recruited by the 17 CBD companies involved in the research for the decentralized observational study. The companies provided participants with their standard CBD regimen during the study period. All product companies supplied a third-party certificate of analysis (COA), which was confirmed by a neutral third party to ensure the composition of the supplied product matched both the label and the supplied COA.
FDA Still Has Not Regulated CBD
After hemp was legalized with the signing of the 2018 Farm Bill, the FDA recognized the “clear interest of Congress in fostering the development of appropriate hemp products” and noted that the agency “has the authority to issue a regulation,” which would allow for the legal marketing of CBD as a dietary supplement. The FDA said it would work to further clarify a regulatory approach for CBD products, “using science as our guide and upholding our rigorous public health standards.” However, the agency has not taken any substantial 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, along with “male reproductive toxicity, or damage to fertility in males or male offspring of women.”
“We are excited to report that the ‘real-world data’ that FDA has been soliciting addresses the agency’s safety concerns,” stated Jonathan Miller, general counsel to the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization. “The time has come for FDA to regulate CBD and other hemp derivatives.”
The results of the study have renewed calls from CBD producers and the hemp industry for the FDA to expedite the regulation of CBD products.
“Participating in this study has allowed us to help provide regulators, scientists, product formulators, and other stakeholders with the evidence needed to prove the safety profile of CBD,” said Blake Schroeder, CEO of Medical Marijuana Inc. and its subsidiary, Kannaway, one of the companies that participated in the research. “We hope that this, in addition to our other research efforts in Brazil and Mexico, will not only help break the stigma around CBD but that it will also help legislators understand the importance of free, legal access to the entire cannabis plant.”
If the FDA still does not act to regulate CBD products, the U.S. Hemp Roundtable is calling on Congress to pass relevant legislation. There are currently three pending bills, H.R. 841, H.R. 6134 and S. 1698, that would require the FDA to develop regulatory pathways for the sale of hemp extracts such as CBD in ingestible form.
“We are proud to have participated in this ground-breaking study on CBD products and feel verified in our products’ excellent results in the testing. These results bode very well for supporting the hemp industry against the fears that FDA had previously stated which had been a hurdle in their regulatory process,” said Vince Sanders, the owner CBD American Shaman. “We are excited they can now rely on this study in verifying CBD products as safe for the human liver, have no effects of day-time drowsiness, and no negative effect on low testosterone levels or reproductive harm of male participants or the male offspring of women in the study.”