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. Two-part studies found CBD consumption in a variety of retail products is not linked to elevated liver test levels, low testosterone levels or daytime sleepiness.

Validcare was contracted by 17 CBD-related companies in order to carry out the study. Validcare was contracted as the contract researcher. They received feedback from FDA about the research protocol, conducted the study, and published 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.”

This was the first cohort, peer-reviewed, and published in Cannabinoid Medicine and CannabisLast year, 839 participants were studied on how CBD products made by 12 manufacturers affect their liver function. A second cohort of 222 people was formed by CBD products from five more companies. According to researchers, the participation of additional subjects in the study increased the statistical reliability of both liver safety and sleep results.

All participants were adults between the ages of 18 and 75, who had taken oral CBD for at least 30 consecutive days. Participating CBD companies recruited the participants to the decentralized observational research study. During the research period, participants were provided with standard CBD products by each company. To ensure that the product supplied was consistent with the provided COA and label, all product companies submitted a third-party certificate to analyze (COA).

FDA has not yet approved 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.”

CBD manufacturers and hemp producers are reiterating their call for FDA expedited 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.”

The U.S. Hemp Roundtable calls on Congress to adopt relevant legislation if the FDA does not take action to regulate CBD products. Three bills are currently pending, H.R. 841, H.R. 6134, S. 1698. This would oblige the FDA to create regulatory pathways for sale of CBD-rich hemp extracts in an 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.”