Validcare Study Finds No Link Between CBD Use and Liver Issues

Concerns over the safety of CBD products are as old as the public’s interest in the substance.  The lack of research surrounding the safety of CBD products is often mentioned when the popularity of the substance is discussed in public forums, and it is one of the main reasons why some US states limit or prohibit the sale of CBD products within their borders. The general lack of information on the safety of CBD products is a problem, and this latest Validcare study takes an important step in rectifying that problem.

Validcare conducted a months-long human-safety study on hemp-derived CBD consumption. The research study collected data from 839 participants over approximately 6 months, starting in August of 2020 and ending in February of 2021. Early results of the study show no evidence of liver toxicity or liver disease in its participants.

Liver problems are one of the main health concerns associated with CBD use. The only FDA-approved CBD drug in the market, Epidiolex, was shown to cause an increase in liver enzymes during clinical trials. But given the seriousness of the conditions that Epidiolex can help treat, combined with the fact that the drug is used in controlled medical conditions, the FDA ruled that the benefits of the drug outweighed the potential risks and approved the drug as a controlled substance.

Right as the CBD craze started, critics pointed to the Epidiolex clinical trials as evidence that CBD use could be dangerous. A consumer update published on the official FDA website in 2020 states that CBD can harm users, and it can cause liver injury.

Currently, the FDA and other regulatory agencies are looking for scientific data they can use to determine the appropriate path for hemp-derived products like CBD and potentially others, like CBG and Delta-8 THC. The Validcare study was requested by the FDA, and it was sponsored by the CBD industry.

The primary goal of the study was to observe potential liver effects in those who used oral forms of hemp-derived CBD for at least 60 days. They found no clinical evidence of liver disease in any of the participants.

“We observed slight, clinically insignificant elevations of liver function tests in less than 10% of consumers irrespective of age, product consumption and form and the amount consumed,” said Dr. Jeff Lombardo. He is a New York-based pharmacist who specializes in toxicology and is the study’s co-investigator.

“Three of the 839 participants had 3X normal levels of the liver enzyme ALT. Those three consumers were taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.”

Other studies have looked into the health effects of CBD, specifically where liver health is concerned. But they have seldom had this many participants. Twelve CBD brands sponsored the Validcare study. The brands involved not only provided funding but also helped the medical research firm recruit adult participants.

Previous studies found an 11% elevation in liver function numbers, but the Validcare study demonstrated about 9% elevation among its participants.

Studies of similar populations demonstrate an 11% elevation in liver function numbers, but this CBD study demonstrated about 9% elevation.

“This unexpected, positive finding makes the data even more compelling and provides significant data to consider secondary safety measures in the general population,” said co-investigator Dr. Keith Aqua. “We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions.”

Safety results from this study will be shared with participating brands and the FDA. The researchers also plan to publish their findings in a peer-reviewed journal.