Food and Drug Administration (FDA)
Definition: The Food and Drug Administration (FDA) is the US federal agency, part of the Department of Health and Human Services, that regulates drugs, food, dietary supplements, cosmetics, and medical devices. For cannabis, the FDA approves cannabis-based medicines, polices health claims on CBD products, and advises the DEA on how drugs should be scheduled.
Which Cannabis Drugs Has the FDA Approved?
- Epidiolex (cannabidiol): seizures linked to Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex
- Marinol and Syndros (dronabinol): synthetic THC for chemotherapy-related nausea and appetite loss in people with AIDS
- Cesamet (nabilone): a synthetic THC-like drug for chemotherapy-related nausea
The FDA has not approved the cannabis plant itself as a medicine.
Can CBD Be Sold as a Food or Supplement?
Not legally under current federal law, according to the FDA. Because CBD was first studied and approved as a drug, the FDA says it can’t be added to food or marketed as a dietary supplement. In January 2023, the agency said existing rules for foods and supplements aren’t a good fit for CBD and asked Congress for a new regulatory pathway. Meanwhile, the FDA has sent warning letters to companies claiming CBD can treat diseases like cancer or COVID-19.
What Role Does the FDA Play in Rescheduling Cannabis?
Under the Controlled Substances Act, the Department of Health and Human Services, working through the FDA, gives the DEA a scientific and medical evaluation before a drug’s schedule changes. In 2023, HHS recommended moving marijuana from Schedule I to Schedule III, which kicked off the federal rescheduling process.
Related terms: Controlled Substances Act, Epidiolex, Hemp, Cannabidiol (CBD)
Sources: FDA: Regulation of Cannabis and Cannabis-Derived Products, Including CBD; DEA: Marijuana Rescheduling Regulatory Actions.
