Almost everywhere you go, whether at a gas station, health store, supermarket, or on the internet, there are advertisements and/or an opportunity to purchase CBD (cannabidiol), a byproduct of hemp that is a non-psychoactive cannabinoid. According to the FDA, cannabidiol occurs in relatively high levels in hemp. Ever since the passage of the Agricultural Improvement Act of 2018 (Farm Bill), which removed hemp from the definition of marijuana in the Controlled Substances Act, unregulated hemp-derived cannabinoid products have become widely available to consumers. These products often contain CBD, raising various, yet unanswered, safety concerns.
The Center for Drug Evaluation and Research (CDER) has approved only one product that contains CBD as an active ingredient, Epidiolex. This product “is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At labeled doses up to 25 mg/kg/day (200-400 mg a day), an increased risk of liver enzyme elevation was observed. Liver enzyme elevations typically occurred after two weeks and were dose-dependent.” According to the Agency, consumer self-reporting (here) of the doses of CBD from over-the-counter products is upward of 200 mg daily, thus sparking the Agency’s concern regarding the potential for adverse events associated with liver function for consumers taking CBD products.
Administering CBD to 201 participants (randomized into two groups, 151 taking CBD and 50 taking a matched placebo) in a range of 250 mg to 550 mg/day over a 28-day period resulted in findings of associated abnormal liver functions. Eight subjects (5.6%) in the active group experienced elevated ALT of three times or greater, and zero in the control arm. In addition, seven participants (4.9%) in the active group met withdrawal criteria for potential drug-induced liver injury, and zero in the control arm. The result of the full study can be found in the JAMA Internal Medicine publication here.
The FDA notes that “[b]y demonstrating that CBD use, at doses representative of those commonly reported by consumers of unregulated consumer products, can lead to liver enzyme elevations in healthy adults not taking any other medications—with a quantifiable 5.6% risk rate—this study provides evidence that can be used to understand the safety of CBD products and inform discussions about appropriate safeguards.”
According to the Agency, “[t]hese findings underscore the need for further investigation on the long-term effects of CBD use, its impact on various populations, and the safety of lower doses commonly used by consumers.” Let’s see where the Agency lands on this issue, especially in the deregulatory climate we’re currently experiencing.
