FDA

The Food and Drug Administration, within the Department of Health and Human Services, regulates drugs, biologics, medical devices, food, cosmetics, and tobacco under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.). FDA has approved four cannabis-derived or cannabinoid drugs: Epidiolex (cannabidiol oral solution, Dravet/Lennox-Gastaut/TSC; Schedule V since April 2020); Marinol (dronabinol, synthetic THC, Schedule III); Syndros (dronabinol oral solution, Schedule II); and Cesamet (nabilone, Schedule II). FDA has not approved botanical cannabis for any indication. For hemp-derived CBD, FDA announced in January 2023 that existing food and supplement frameworks were inappropriate and that a new regulatory pathway required congressional action; as of April 2026, no new CBD framework has been established. FDA continues to issue warning letters for unapproved CBD therapeutic claims and for delta-8 THC products (especially those marketed to appeal to children). Under CAOA or similar legislation, FDA would become the primary federal cannabis regulator. *→ See also: Epidiolex, CAOA, Recommendation, Prescription