FDA (Food and Drug Administration)
The US federal agency responsible for regulating drugs, biologics, medical devices, and food. Has approved three cannabinoid-based drugs: Epidiolex, Marinol (dronabinol), and Cesamet (nabilone).
In Depth
The FDA's drug approval pathway requires demonstration of safety and efficacy through controlled clinical trials. The FDA approved Epidiolex in 2018 — the first plant-derived cannabinoid drug approval. The FDA has repeatedly stated that CBD cannot be legally marketed as a dietary supplement or food additive because it was first studied as a drug (Epidiolex). The FDA is developing a regulatory framework for CBD products but has not finalized it as of 2024.
Related Terms
More in Regulatory
Schedule I
The most restrictive classification under the US Controlled Substances Act (CSA), applied to substances deemed to have high abuse potential, no accepted medical use, and lack of accepted safety under medical supervision.
IND (Investigational New Drug)
An application submitted to the FDA allowing a pharmaceutical company or researcher to begin clinical trials of an unapproved drug in humans.
NCT Number
A unique identifier assigned by ClinicalTrials.gov to every registered clinical study. Format: NCT followed by 8 digits (e.g., NCT04849910).
GMP (Good Manufacturing Practice)
A system of regulations ensuring that products are consistently produced and controlled according to quality standards. Required for pharmaceutical-grade cannabinoid products.
DEA (Drug Enforcement Administration)
The US federal agency responsible for enforcing controlled substances laws. Administers the scheduling system under the Controlled Substances Act.