Epidiolex

Epidiolex is the prescription oral solution of highly purified cannabidiol that the FDA has approved for certain rare, severe seizure disorders.

It is approved for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and tuberous sclerosis complex in qualifying patients, and it is available only by prescription and under medical supervision. Approval followed controlled clinical trials that established a specific dose range, safety profile and set of drug interactions for that purpose. The product is manufactured to pharmaceutical standards with a defined amount of CBD in each milliliter.

It is the only cannabidiol product with FDA approval, and its existence shapes the regulation of every other CBD product on the market. Because CBD is the active ingredient in an approved drug, the FDA has taken the position that CBD cannot be added to foods or marketed as a dietary supplement without a rulemaking. The approved indications belong to the drug, not to the molecule, and they do not support any claim for a consumer hemp product.