The Strict Reality of FDA Approval for CBD
The widespread availability of cannabidiol (CBD) products might suggest they are all FDA-approved, but this is not the case. The FDA has approved only one cannabis-derived drug product, Epidiolex.
Epidiolex is a prescription-only CBD oral solution. It treats seizures in specific, severe epilepsies: Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in patients one year or older. Its approval followed rigorous clinical trials.
The FDA has approved synthetic cannabis-related drugs like Marinol, Syndros, and Cesamet, but these relate to THC, not CBD. Epidiolex is the only FDA-approved CBD drug.
The Legal Landscape: The 2018 Farm Bill and Its Limits
The 2018 Farm Bill legalized hemp by removing it from the Controlled Substances Act. Hemp is cannabis with no more than 0.3% delta-9-THC.
This bill made hemp-derived CBD products legal to grow and sell but kept them under FDA regulation via the Federal Food, Drug, and Cosmetic Act (FD&C Act). Thus, while hemp-derived CBD is federally legal, its use in certain products is unlawful without FDA approval.
The FDA considers it illegal to market CBD in food or as a dietary supplement. This is because CBD is an active ingredient in an approved drug (Epidiolex), and the FD&C Act prohibits selling substances as supplements if first studied or approved as a drug.
The Unregulated Market: What Consumers Need to Know
This regulatory gap results in a large, unregulated market for OTC CBD products. The FDA has not evaluated their safety, effectiveness, or dosage. This poses several risks:
- Inaccurate Labeling: Studies show discrepancies in OTC CBD products, with some containing less CBD or unexpected THC.
- Unsubstantiated Health Claims: Companies receive FDA warnings for marketing CBD with unproven claims about treating serious diseases, which can deter consumers from medical treatments.
- Potential Contaminants: Unregulated products may contain harmful substances like pesticides or heavy metals.
- Health Risks: CBD can have side effects like liver injury, drowsiness, diarrhea, and drug interactions. Liver damage is a key concern, manageable with prescription drugs but risky in unregulated products.
Comparison: FDA-Approved vs. Unregulated CBD
Feature | FDA-Approved CBD (Epidiolex) | Over-the-Counter (OTC) CBD |
---|---|---|
Approval Status | Approved by FDA as a prescription drug. | Not FDA-approved; illegal to market as food or dietary supplement. |
Indication | Treatment of specific, rare seizure disorders. | Often marketed with unproven health claims. |
Regulation | Rigorously tested for safety, efficacy, and consistent dosage. | Unregulated; purity, potency, and safety are not guaranteed. |
Availability | Prescription only, dispensed by a specialty pharmacy. | Widely available online and in retail stores. |
Purity | Highly purified, plant-derived CBD with consistent manufacturing. | Potency can be mislabeled; may contain THC or other contaminants. |
Oversight | Medical supervision required, monitoring for side effects like liver injury. | No medical supervision; risks of side effects and drug interactions are higher. |
The Future of CBD Regulation
The FDA is exploring regulatory options for CBD but concluded that existing frameworks for foods and supplements are unsuitable. They plan to work with Congress on a new pathway, which may take years.
Meanwhile, the FDA issues warning letters against illegal health claims and adulterated products, particularly those targeting children. However, enforcement is limited, and the market remains full of products in a legal gray area.
Conclusion
Not all forms of CBD are FDA approved in the US. Only the prescription drug Epidiolex has FDA approval. Most consumer CBD products lack FDA review for safety or effectiveness. The 2018 Farm Bill legalized hemp but not CBD in all product types. Consumers should be cautious, consult healthcare providers, and understand the risks of unregulated products until a clear federal framework exists. Read more on the FDA's public health focus.