New study confirms the safety of CBD

A new comprehensive study involving more than 1,000 people has confirmed the safety of orally ingested cannabidiol products and provides data that address 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 function tests, low testosterone levels, or daytime sleepiness.

To conduct the study, research firm Validcare commissioned 17 CBD companies to investigate safety concerns previously raised 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 matters a great deal and the likelihood of it being wrong is very, very small,” said Dr. Robert Kaufmann, Validcare’s director of research and a former professor at Southern Illinois University School of Medicine, in a statement from the US Hemp Roundtable. “I am very confident that this data will allow the FDA to regulate these popular CBD products.”

The study’s first cohort, which was peer-reviewed last year and published in Cannabis and Cannabinoid Medicine, looked at how CBD products from 12 different manufacturers affected liver function in 839 study participants. The second cohort included 222 other people taking CBD products manufactured by five other companies. The participation of the additional study participants strengthened the statistical reliability of both the liver safety results and the statistical relevance for both the sleep and testosterone results, according to the researchers.

The participants in the study were all adults between the ages of 18 and 75 who had taken oral CBD products for at least 30 days. Participants were recruited for the decentralized observational study from the 17 CBD companies involved in the research. The companies provided participants with their standard CBD treatment throughout the study period. All product companies provided a third party Certificate of Analysis (COA) verified by a neutral third party to ensure that the composition of the delivered product matched both the label and the delivered COA.

The FDA still hasn’t regulated CBD

After hemp was legalized with the signing of the 2018 Farm Bill, the FDA recognized Congress’ “clear interest in promoting the development of appropriate hemp products” and noted that the agency “has the authority to issue a regulation” that would do so would allow the legal marketing of CBD as a dietary supplement. The FDA said it will work to further clarify a regulatory approach to CBD products “using science as a guide and adhering to our strict public health standards.” The agency hasn’t taken any significant steps to regulate CBD, however, and claims it needs more real-world data to move forward.

In March 2020, the FDA released a congressional report and public statement on possible regulatory avenues for the sale of hemp-derived CBD products, listing liver damage as a top consumer safety concern, along with “male reproductive toxicity or damage to fertility in males or males descendants of women.”

“We are pleased to report that the ‘real world data’ requested by the FDA resolves the agency’s safety concerns,” said Jonathan Miller, general counsel of the US Hemp Roundtable, the national hemp industry advocacy group. “The time has come for the FDA to regulate CBD and other hemp derivatives.”

The study’s findings have led to renewed calls from CBD producers and the hemp industry for the FDA to expedite regulation of CBD products.

“Participating in this study has enabled us to provide regulators, scientists, product formulators and other stakeholders with the evidence needed to demonstrate the safety profile of CBD,” said Blake Schroeder, CEO of Medical Marijuana Inc. and its subsidiary Kannaway. one of the companies involved in the study. “We hope that this, in addition to our other research efforts in Brazil and Mexico, will not only help break the stigma surrounding CBD, but also help lawmakers understand the importance of free, legal access to the entire cannabis plant.”

If the FDA still doesn’t act to regulate CBD products, the US Hemp Roundtable urges Congress to pass legislation. There are currently three pending bills, HR 841, HR 6134, and S. 1698, that would require the FDA to develop regulatory avenues for the sale of hemp extracts, such as CBD, in ingestible form.

“We are proud to have participated in this groundbreaking study of CBD products and feel empowered by the excellent test results our products have received. These results bode well for supporting the hemp industry against concerns that the FDA had previously expressed, which has been a hurdle in their regulatory process,” said Vince Sanders, owner of CBD American Shaman. “We are pleased that you can now rely on this study to confirm that CBD products are safe for the human liver, have no effects on daytime sleepiness, and have no adverse effects on low testosterone levels or reproductive harm in male participants or theirs male offspring have females in the study.”