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Are all forms of CBD FDA approved in the US?

3 min read

To date, the U.S. Food and Drug Administration (FDA) has approved only one drug product derived from cannabis: Epidiolex. So, are all forms of CBD FDA approved in the US? The answer is a definitive no, creating a complex market for consumers to navigate.

Quick Summary

A detailed look into the FDA's stance on CBD. The article clarifies that only one prescription CBD drug, Epidiolex, has received FDA approval, while the vast majority of consumer CBD products exist in a legal gray area without federal oversight.

Key Points

  • Only One is Approved: The only FDA-approved CBD product is Epidiolex, a prescription drug for specific seizure disorders.

  • Unregulated Market: Most consumer CBD products (oils, edibles, topicals) are not FDA-approved and exist in a legal gray area.

  • 2018 Farm Bill: This bill legalized hemp (cannabis with <0.3% THC) but did not legalize CBD in foods or dietary supplements.

  • Consumer Risks: Unregulated products carry risks of inaccurate labeling, contamination, and unproven health claims.

  • Health Concerns: The FDA warns of potential side effects from CBD, including liver injury and drug interactions.

  • Illegal Marketing: It is illegal under the FD&C Act to market CBD as a dietary supplement or add it to food.

  • Future Regulation: The FDA is working with Congress to create a new regulatory pathway for CBD, but this will take time.

In This Article

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.

Frequently Asked Questions

Hemp-derived CBD products (with less than 0.3% THC) are federally legal to sell and purchase thanks to the 2018 Farm Bill. However, the FDA prohibits them from being marketed as dietary supplements or food additives, creating a legal gray area. State laws also vary.

Epidiolex is the only FDA-approved prescription drug made from a purified, plant-derived form of CBD. It is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex.

The FDA requires extensive clinical trials to prove a product is safe and effective for a specific use. OTC CBD products have not gone through this rigorous process. Furthermore, because CBD is an active ingredient in an approved drug (Epidiolex), it cannot be legally marketed as a dietary supplement under current law.

Yes. The primary risks include inaccurate dosage, the presence of undisclosed THC, contamination with pesticides or heavy metals, and potential side effects like liver damage or interactions with other medications.

Since the market is unregulated, you can't be certain. However, look for products that provide a Certificate of Analysis (COA) from a third-party lab. This document verifies the product's potency and checks for contaminants. Even with a COA, it's crucial to consult a healthcare provider.

No, the FDA has not approved CBD for any use in animals. The agency warns against using such products due to a lack of data on safety, proper dosage, and effectiveness for pets.

The legal difference lies in the THC content of the source plant. Hemp is cannabis with 0.3% or less THC, making its derived CBD federally legal. Marijuana has more than 0.3% THC, and its derived CBD remains federally illegal, though state laws may permit it.

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.