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# FDA Study Finds Liver Risks Associated with CBD
- URL: https://www.fdaweb.com/fda-study-finds-liver-risks-associated-with-cbd/
- Published: 2025-07-08T12:00:00.000Z
- Updated: 2026-09-14T15:15:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159464

A new FDA clinical trial has found that cannabidiol (CBD) at doses typical of common consumer use may cause liver enzyme elevations in otherwise healthy adults — raising new concerns about the safety of unregulated CBD products widely available in the U.S.

The study, published this week in [*JAMA Internal Medicine*](https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2836267?ref=fdaweb.com), enrolled 201 healthy adults in a randomized, double-blind, placebo-controlled trial to examine the effects of 28 days of daily CBD use. Participants received a prescription-grade oral CBD solution at 5 mg/kg per day—approximately 400 mg daily for an average adult—roughly equivalent to doses reported by some frequent CBD users, it says.

By the end of the four-week trial, 8 participants (5.6%) in the CBD group developed liver enzyme elevations greater than three times the normal limit, according to the FDA researchers. Seven individuals met criteria for potential drug-induced liver injury, prompting discontinuation of treatment.

“These findings are important because they show that liver effects can occur even at moderate CBD doses similar to those taken by consumers,” said CDER regulatory scientist and lead author **Jeffry Florian**. “Many users may not realize they’re at risk, particularly without symptoms or routine monitoring.”

While no serious or life-threatening events occurred, several of the participants with elevated liver enzymes also developed eosinophilia—an increase in a type of white blood cell that can indicate inflammation or allergic reaction. In most cases, liver enzymes returned to normal within two weeks of stopping CBD. Additionally, the study found no significant differences between CBD and placebo groups in hormone levels related to the thyroid or male reproductive system. However, researchers caution that the short duration and limited monitoring period may not capture potential long-term endocrine effects.

The authors noted that while most liver enzyme elevations were asymptomatic and reversible, they raised concerns about undetected harm — especially in consumers with underlying conditions or those taking other medications metabolized by the liver. “Given the potential for liver toxicity, even in healthy individuals, CBD use should be part of the medical history taken by clinicians—particularly when evaluating unexplained liver enzyme elevations,” the authors wrote.

FDA has long warned about the safety uncertainties of CBD products, citing concerns over liver injury, reproductive harm, and drug interactions. The study adds to its growing evidence base as it considers whether and how to regulate CBD in food, supplements, and over-the-counter health products.