Despite FDA approval of CBD only for specific epilepsy syndromes in children, parents are increasingly using unregulated CBD products for a range of pediatric conditions — often without clinical guidance or quality assurance.
Read this if you're a parent considering CBD for your child or a clinician encountering pediatric CBD use — the gap between what's marketed and what's proven is substantial.
What the researchers found
CBD has one FDA-approved pediatric use: Epidiolex for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. Beyond that, the evidence for CBD in children is limited. But that hasn't stopped a growing number of parents from giving their children unapproved, over-the-counter CBD products for conditions ranging from anxiety to autism to ADHD.
This review maps the current landscape of unapproved pediatric CBD use. The problems are layered. Unregulated CBD products have no quality assurance — they may contain more or less CBD than labeled, may include THC above the legal 0.3% threshold, and may contain contaminants like heavy metals, pesticides, or solvents. Multiple studies of commercial CBD products have found that actual content frequently doesn't match labels.
The pharmacology review highlights that CBD in children has a different pharmacokinetic profile than in adults — different absorption, distribution, metabolism, and excretion rates. Pediatric dosing extrapolated from adult data may be inappropriate. CBD's known inhibition of CYP450 enzymes is particularly concerning in children taking other medications for epilepsy, ADHD, or psychiatric conditions.
The legal landscape adds confusion: CBD derived from hemp (containing <0.3% THC) is legal at the federal level, but the FDA hasn't approved any over-the-counter CBD product for any condition in any age group. Parents may not understand the distinction between a regulated pharmaceutical (Epidiolex) and the CBD oil from a health food store.
Why it matters
Children are not small adults — they metabolize drugs differently, their brains are still developing, and they can't consent to or self-manage their own treatment. The proliferation of unregulated CBD products being given to children creates risks that most parents aren't equipped to evaluate: variable product quality, unknown drug interactions, and the absence of pediatric efficacy data for conditions other than specific epilepsy syndromes.
The numbers in context
1 FDA-approved pediatric CBD product (Epidiolex) for 3 epilepsy syndromes. Studies of commercial CBD products consistently find label inaccuracy — some containing more THC than labeled. CBD inhibits CYP2C9, CYP2C19, and CYP3A4, affecting metabolism of many common pediatric medications. No FDA-approved OTC CBD product for any condition at any age.
How the study worked
Narrative review addressing CBD pharmacology, legal and regulatory factors, usage patterns, current efficacy data, and safety concerns for pediatric CBD use. Includes recommendations for clinicians, public health officials, and researchers.
Who was studied
Review of current literature on CBD use in children and adolescents.
What this study cannot tell us
Narrative review — not a systematic search. The pace of CBD product innovation and regulatory change means the landscape may shift quickly. Usage patterns are based on surveys that likely underestimate the true prevalence of pediatric CBD use. The review focuses on the U.S. regulatory environment; other countries have different frameworks. The absence of evidence for most pediatric conditions doesn't prove absence of benefit — it means the studies haven't been done.
How to read the evidence
Narrative review synthesizing pharmacological, regulatory, and clinical evidence. Provides a comprehensive overview but doesn't present original data. The safety concerns are well-grounded in pharmacology; the efficacy gaps are accurately described.
When this study was published
Published in 2025. The CBD product market and regulatory landscape continue to evolve.
The bigger picture
This review connects the drug interaction evidence (RTHC-00091, 00112, 00123) to the specific vulnerability of pediatric patients. It also echoes the gap between access and evidence seen in RTHC-00142 (Alzheimer's qualifying condition) and RTHC-00139 (Canada's surveillance gaps) — CBD products are widely available and widely used in populations where the evidence doesn't support the use, and the regulatory framework doesn't protect the user.
Replication
Not stated in abstract.
Funding
Not reported in abstract.
Conflicts of interest
Not reported in abstract.
Questions still open
- Would well-designed clinical trials show CBD benefit for pediatric anxiety, autism, or ADHD? How much THC are children inadvertently consuming from mislabeled CBD products? Are pediatricians routinely asking about CBD use, and are parents disclosing it? Would FDA regulation of the CBD supplement market improve product quality enough to make unapproved pediatric use less risky?
Read the original research
The Current State of Unapproved Cannabidiol Product Use in Children.
The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 30(5), 564-579
The Journal of Pediatric Pharmacology and Therapeutics is a reputable source focusing on medication use in children.
Citation
Cowell, Braden; Van de Roovaart, Hannah; Beck, Melissa; Chen, Aleda M H; Cole, Justin W. (2025). The Current State of Unapproved Cannabidiol Product Use in Children.. The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG, 30(5), 564-579. https://doi.org/10.5863/JPPT-24-00081
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