FDA Policy/General

FDA Study: CBD Linked to Elevated Liver Enzymes

An FDA-conducted clinical trial has found that daily use of cannabidiol (CBD) at levels similar to those reported by consumers can cause elevated liver enzymes in otherwise healthy adults, raising fresh safety questions about the popular products. The study by CDER scientists is the first randomized, placebo-controlled trial to directly assess liver and hormone effects of CBD at consumer-level doses, an FDA notice says. Researchers said the findings fill an important regulatory gap left after the 2018 Farm Bill legalized hemp and led to a surge of unregulated CBD products.

In the trial, which was published recently in JAMA Internal Medicine, 201 participants were randomized to receive either a placebo or an oral CBD solution dosed at 250–550 mg per day over four weeks. Results showed that 5.6% of participants taking CBD experienced elevations in liver enzymes — specifically alanine aminotransferase (ALT) levels — above three times the upper limit of normal, the agency says. No participants in the placebo group showed this effect.

FDA says seven participants, or 4.9% of those in the CBD group, met withdrawal criteria for potential drug-induced liver injury, though none developed symptoms or lasting impairment. Enzyme levels returned to normal within one to two weeks after stopping CBD. No significant changes were observed in hormone measures such as testosterone, inhibin B, or thyroid function. “These results demonstrate that even in healthy adults not taking other medications, CBD at doses consistent with unregulated consumer products can lead to measurable liver effects,” the FDA researchers write.

FDA notes that the study underscores the agency’s concerns about the widespread availability of CBD products that have not undergone safety review. Although the only FDA-approved CBD drug, Epidiolex, carries a known risk of liver enzyme elevations at prescription doses, little data have existed on the risks at lower, self-administered levels.

The agency says the findings highlight the need for more research into long-term CBD safety, especially in older adults and people taking other medications. The results are also expected to inform ongoing FDA discussions about how to regulate CBD products and protect consumers.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome