With regards to CBD health risks, the NDA seems to contradict the findings of other studies.

A two-part study conducted by US-based research firm Validcare LLC found no evidence of liver toxicity in over 1,000 subjects aged 18 to 75 taking CBD products orally for a minimum of 30 days.

Split into two cohorts, the results from the first cohort study, which involved 839 participants taking oral CBD products from 12 companies, were published in December in the Cannabis and Cannabinoid Research journal.

The study met its primary endpoint of liver enzyme levels, finding that the amount of elevated liver enzyme levels was the same as the general population.

The second study, currently pending peer-review publication, included 222 other participants who took oral CBD products from five additional companies. The study found oral CBD wasn’t associated with elevated liver enzymes, low testosterone or daytime drowsiness.

These results confirm CBD has a “strong safety profile,” and are a direct answer to the US Food and Drug Administration’s specific safety concerns with regards to the ingredient, the Hemp General Roundtable has argued. (Also see "Hemp Roundtable Says Safety Study Data Should Convince Congress On Lawful CBD Use" - HBW Insight, 17 May, 2022.)

As the NDA notes, FDA stated in 2020 that the safety profile for products containing CBD or cannabis-derived compounds like CBG is still limited and has also highlighted the need for additional data to address uncertainties and data gaps related to the ingredient. (Also see "Confidentiality For Proprietary Information Drives FDA Plan To Generate More CBD Safety Data" - HBW Insight, 6 March, 2020.) (Also see "Cultivating Cannabinoid Safety Data In US: Principles, Projects And Problems" - HBW Insight, 8 January, 2021.)

The FDA’s position mirrors that of the UK, where the Food Standards Agency’s Advisory Committee on Novel Foods and Processes (ACNFP) also concluded that toxicological data is currently inadequate. (Also see "Existing CBD Safety Data Not Good Enough, Warns UK Novel Foods Committee" - HBW Insight, 3 November, 2020.)

According to minutes from an FSA meeting in 2020, the ACNFP reviewed two CBD dossiers informally submitted to the regulator as a training exercise to prepare for when it assumed responsibility for reviewing novel food risk assessments after the UK’s exit from the EU.

In general, the ACNFP found both the safety data submitted by the two applicants to be wanting, and specifically expressed concern that both applications relied entirely on data from Epidiolex.

As a result, the committee agreed that applicants “should carry out their own toxicological data where their CBD substance differed from medical grade or provide bridging studies to make sure the toxicology data being used to assure safety was relevant for the purity and composition of their CBD product.”

Another study comparing CBD availability across in nine countries – Australia, Canada, Germany, Ireland, Japan, New Zealand, Switzerland, UK and US – also reviewed the scientific literature on side effects, concluding CBD has a “favorable safety profile” in humans and is generally well-tolerated at doses up to 6,000mg in single doses or 1,500mg in multiple doses. (Also see "Global CBD Study Calls For Tighter Regulation And Clinical Trials" - HBW Insight, 6 October, 2020.)

“Outside of clinical trials involving epilepsy, the only adverse event more prominent with CBD over placebo is diarrhea,” the researchers said. “Pharmacokinetic interactions between CBD and prescription medications remain possible but the likelihood of such interactions at the low CBD doses obtained from non-prescription products remains to be established” they added.

EU CBD Novel Food Applications On Hold As EFSA Considers Health Risks

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