🌿 FDA Position on Cannabis and Cannabinoids
(Here is my take on this article Therapeutic Use of Cannabis and Cannabinoids A Review JAMA Network, 11/26/25. On a personal side, I use CBD to help me sleep, and with a little (5%) addition of THC, it is a great anxiety calmer – Sally Torgeson, AnCan Blood Cancer Moderator & Multiple Myeloma Coach)
Unapproved Cannabis
- The FDA has NOT approved the cannabis plant (botanical marijuana) for any medical use or indication.
- Because it is classified as a Schedule I controlled substance under federal law, the FDA has not found it to be safe or effective for the treatment of any disease or condition [1.1, 1.7].
- It is currently illegal to market CBD by adding it to food or labeling it as a dietary supplement in interstate commerce [2.1, 2.5].
FDA-Approved Cannabinoid Drugs
The FDA has approved a small number of prescription drugs containing either a purified cannabis-derived compound or synthetic cannabinoids:
- Epidiolex (Cannabidiol or CBD): The only FDA-approved drug that contains a purified substance derived directly from the cannabis plant. It is approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex in patients one year of age and older [1.8, 2.1].
- Marinol and Syndros (Dronabinol): Contain synthetic Δ9-
tetrahydrocannabinol (THC). Approved for: - Nausea and vomiting associated with cancer chemotherapy in patients who have not responded to conventional antiemetic treatments [2.2, 2.3].
- Anorexia associated with weight loss in patients with HIV/AIDS [2.3].
- Cesamet (Nabilone): Contains a synthetic substance that is chemically similar to THC. Approved for chemotherapy-induced nausea and vomiting [1.1, 2.3].
Regulatory Context
- The FDA maintains its authority to regulate products containing cannabis or cannabis-derived compounds, even those derived from hemp (cannabis with less than 0.3% THC), under the Federal Food, Drug, and Cosmetic (FD&C) Act [1.4].
- The FDA supports the development of new drugs through proper clinical trials to ensure they meet standards for safety and effectiveness [1.1, 2.4].
FDA-Approved Cannabinoid Drugs and Their Conditions
| Drug Name (Active Ingredient) | Source | FDA-Approved Condition(s) |
| Epidiolex (Cannabidiol or CBD) | Purified, plant-derived CBD | Seizures associated with: * Lennox-Gastaut syndrome (LGS) * Dravet syndrome (DS) * Tuberous Sclerosis Complex (TSC) |
| Marinol and Syndros (Dronabinol) | Synthetic THC ($ \Delta9 $-tetrahydrocannabinol) | * Nausea and vomiting caused by cancer chemotherapy (when other antiemetics have failed) * Anorexia (loss of appetite) associated with weight loss in patients with HIV/AIDS |
| Cesamet (Nabilone) | Synthetic cannabinoid (similar to THC) | * Nausea and vomiting caused by cancer chemotherapy (when other antiemetics have failed) |
Key Takeaway
- Epidiolex is the only drug approved that contains a substance derived directly from the Cannabis plant (CBD). It represents the strongest evidence for cannabinoid efficacy in reducing seizure frequency in certain rare forms of epilepsy [1.1, 1.2].
- The synthetic THC compounds (Dronabinol and Nabilone) are used primarily as a last resort for severe nausea/vomiting related to chemotherapy and for appetite stimulation in AIDS patients [1.2, 2.8].
The FDA has not approved the use of the whole cannabis plant for any medical condition, stressing the importance of standardized, tested pharmaceuticals for patient safety and proven effectiveness [1.7].1
Off-Label Use vs. Unapproved Use
1. Off-Label Use (Legal and Regulated)
This applies only to drugs that the FDA has already approved.
- What it is: Using an FDA-approved drug (like Epidiolex, Marinol, or Cesamet) for a condition, dose, or patient population that is not specifically listed on the drug’s official label.
- Legality: It is legal for a licensed physician to prescribe an approved drug for an off-label use if they believe it is medically appropriate for their patient.
- FDA Position: The FDA does not regulate the practice of medicine; however, the manufacturer cannot market or promote the drug for the off-label use. The safety and efficacy for the off-label use have not been verified by the FDA’s rigorous testing process.
Example: A doctor prescribing Marinol (Dronabinol), which is approved for nausea from chemotherapy, to a patient for chronic pain. The drug is approved, but the condition (chronic pain) is not on the label.
2. Unapproved Use (Non-FDA Approved Products)
This applies to the cannabis plant itself and most CBD/cannabinoid products on the market.
- What it is: Using the whole cannabis plant (botanical marijuana) or non-FDA-approved cannabis-derived products (like most CBD oils, edibles, or topicals) for any medical purpose.
- Legality:
- Federal: The whole plant is a Schedule I controlled substance and is not federally approved for any medical use.
- State: Use may be legal under state medical or recreational cannabis laws, but this does not change its status as an unapproved drug under federal FDA law.
- Federal: The whole plant is a Schedule I controlled substance and is not federally approved for any medical use.
- FDA Position: The FDA considers these products unapproved drugs and/or illegally marketed products (especially when CBD is added to food or marketed as a dietary supplement), as they have not been tested for safety, effectiveness, or quality assurance.
Example: A patient using a CBD tincture (which is not Epidiolex) to treat anxiety, or using THC flower to help with multiple sclerosis symptoms.
To correspond with Sally, please send an email to info@ancan.org, and we’ll be sure to send along.