FDA publishes review on oral toxicity of CBD in animal models

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A recent study published by the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, of the U.S. Food and Drug Administration (FDA) reviewed the published literature which found that oral CBD consumption resulted in developmental and reproductive toxicity, as well as hepatotoxicity, in animal models. The animals studied in the review include non-human primates, rats, and mice.

Based on the review, the authors concluded: “The studies and data reviewed herein show potential hazards associated with oral exposure to CBD for the general population… Available data from multiple oral toxicity studies raise serious safety questions about the potential for reproductive and developmental toxicity effects, which could be irreversible, and support particular concerns about the use of CBD during pregnancy or in combination with other drugs.”

The Natural Products Association (NPA; Washington, D.C.) has released a statement criticizing the review for being misleading by using data for dosages well beyond the scope of dietary supplement ingredients. “Using drug standards to conduct a ‘supplement study’ is at the very least disingenuous and at the worst very harmful for the foundering and rudderless regulatory process on CBD,” said Daniel Fabricant, PhD, president and CEO of NPA in the statement. “Instead of using actual dietary supplement data and research like the data we supplied to the agency in our citizen’s petition, the FDA instead chose to use drug data to draw conclusions that are three times the dose of the CBD drug Epidiolex. This is extremely troubling, confusing and sets us back even further on one of our top priorities for the past several years: which is meaningful progress on a regulatory path for something that’s ubiquitous in the market.”

Numerous CBD brands have made an effort to demonstrate the safety of their products products through independent conclusions of GRAS (such as CV Sciences and Hemp Fusion) as well as new dietary ingredient notifications (such as Irwin Naturals, Charlotte’s Web, and cbdMD). Independent safety studies have also been conducted by ValidCare and Radicle Sciences demonstrating the safety of daily CBD supplementation. While FDA has expressed concern for the safety of CBD, the question of CBD’s status as a dietary ingredient has been largely legal, with the agency citing the drug preclusion clause, specifically the IND and subsequent approval of the CBD epilepsy drug Epidiolex.