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Do doctors ever prescribe CBD? A breakdown of FDA approvals and regulations

5 min read

While cannabidiol (CBD) products derived from hemp became federally legal in 2018, only one pharmaceutical-grade CBD medication has received FDA approval. This critical distinction explains when and why a doctor would ever prescribe CBD, clarifying the difference between regulated medication and consumer wellness products.

Quick Summary

Doctors can prescribe one specific FDA-approved CBD medication, Epidiolex, for certain severe seizure disorders. Other CBD products, including oils and gummies, are not regulated as drugs by the FDA, meaning doctors cannot prescribe them, though they may discuss or recommend their use.

Key Points

  • One FDA-approved CBD exists: Epidiolex is the only pharmaceutical-grade CBD that doctors can legally prescribe.

  • FDA approval is for specific conditions: Epidiolex is prescribed for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.

  • OTC CBD is unregulated: Most other CBD products are not FDA-approved, and their purity, potency, and safety are not guaranteed.

  • Doctors can recommend, not prescribe, OTC CBD: In states with medical cannabis programs, doctors can authorize or recommend CBD products from dispensaries, but this is distinct from a prescription.

  • CBD can cause side effects and drug interactions: High doses can cause liver issues, and CBD can interact with common medications like blood thinners, making medical consultation essential.

In This Article

Yes, One Type of Prescription CBD Exists

The short answer to the question, "Do doctors ever prescribe CBD?" is yes, but only in one highly specific instance. The vast majority of CBD products widely available online and in stores are not medications and, therefore, cannot be prescribed by a doctor. The exception is a drug called Epidiolex, a purified cannabidiol oral solution that received FDA approval for treating specific, severe seizure disorders.

The federal landscape for cannabis products shifted significantly with the 2018 Farm Bill, which legalized hemp and its derivatives, including CBD, with a THC content of less than 0.3%. This change led to a boom in the CBD market, with products ranging from edibles and oils to topical creams becoming commonplace. However, this federal legalization of hemp-derived products did not automatically grant them medicinal status or regulatory oversight from the Food and Drug Administration (FDA). It is crucial to understand that CBD is regulated very differently based on how it is marketed and used.

Epidiolex: The Prescription CBD Medication

Epidiolex is the only FDA-approved medication containing purified CBD. Its approval was based on extensive clinical trials that demonstrated its safety and efficacy for specific medical conditions. The rigorous process Epidiolex went through is what distinguishes it from the largely unregulated consumer CBD market and allows doctors to write a legal prescription for it.

Conditions treated with Epidiolex

As of now, Epidiolex is indicated for the treatment of seizures associated with three rare and severe forms of epilepsy:

  • Lennox-Gastaut syndrome (LGS): A type of childhood epilepsy characterized by multiple seizure types.
  • Dravet syndrome (DS): A rare genetic epileptic encephalopathy that begins in the first year of life.
  • Tuberous Sclerosis Complex (TSC): A genetic disorder that causes benign tumors to grow throughout the body, often affecting the brain and leading to seizures.

For these conditions, Epidiolex is typically used as an add-on therapy for patients aged one year and older who have not responded well to other anti-seizure medications.

Prescription vs. Over-the-Counter CBD

To clarify the landscape of CBD products, it is helpful to compare the regulated prescription medication, Epidiolex, with the vast assortment of over-the-counter (OTC) CBD products available to consumers.

Aspect Prescription CBD (Epidiolex) Over-the-Counter CBD Products
Regulation FDA-approved and strictly regulated. Largely unregulated by the FDA.
Purity & Consistency Guaranteed purity and concentration; tested for contaminants. Purity and concentration can be inconsistent; some products contain less CBD than labeled or even unlisted THC.
Safety & Efficacy Proven safe and effective for specific conditions through clinical trials. Limited scientific evidence for many claimed health benefits; safety data is not as extensive.
Prescription Requires a doctor's prescription. Available without a prescription.
THC Content Purified to contain no significant levels of THC. Legally required to contain less than 0.3% THC, though some tests show contamination.
Intended Use Treatment for severe seizure disorders. Marketed for a wide range of wellness purposes like anxiety, pain, and sleep.

Can Doctors Recommend Other CBD Products?

While a doctor cannot write a formal prescription for a non-FDA-approved CBD oil, they can discuss and recommend its use. The legal distinction is key: a "prescription" is a direct order for a specific medication, while a "recommendation" is a suggestion for a treatment that is not officially approved for a particular use.

In states with medical cannabis programs, a doctor's recommendation is often the gateway for patients to access a wider range of cannabis products, including those with higher THC levels, through a regulated dispensary. However, this is governed by state law and is not the same as prescribing an FDA-approved drug.

Risks and Considerations

For those considering OTC CBD, consulting a healthcare provider is essential for several reasons:

  • Lack of regulation: The unregulated nature of the market means products may contain inaccurate levels of CBD, unlisted contaminants, or higher-than-legal amounts of THC.
  • Drug interactions: CBD can interact with other medications, potentially affecting their efficacy or increasing the risk of side effects. For example, it can affect how the liver processes certain medications, including blood thinners.
  • Side effects: While generally well-tolerated, potential side effects include drowsiness, diarrhea, and decreased appetite. In clinical trials for Epidiolex, liver damage was also a noted side effect at high doses.

Conclusion: Navigating the CBD Landscape with Your Doctor

Yes, doctors can and do prescribe one form of CBD, Epidiolex, for specific, severe seizure disorders, a decision supported by extensive clinical evidence and FDA regulation. However, when it comes to the vast market of unregulated over-the-counter CBD products, doctors cannot legally prescribe them but can offer valuable guidance. For consumers, this highlights the critical difference between a scientifically validated pharmaceutical and a dietary supplement with inconsistent quality. To safely explore CBD, always inform your doctor, especially about any other medications you are taking, and choose reputable products with transparent third-party testing.

The FDA's stance on CBD

The FDA has consistently voiced its concerns about the unregulated nature of the CBD market, particularly the marketing of CBD in foods and dietary supplements. The agency has prioritized enforcement against companies making unsubstantiated health claims, highlighting the lack of scientific information regarding CBD's safety and long-term effects. The FDA's cautious approach is designed to protect public health, especially for vulnerable populations like children and pregnant or breastfeeding individuals, and underscores the need for robust clinical research before broader medical claims can be made.

Considerations for medical cannabis patients

For individuals in states with legal medical cannabis programs, the process is different. While a doctor's recommendation is needed to obtain a medical cannabis card, which grants access to a wider variety of CBD and THC products from dispensaries, this is not a prescription in the traditional sense. The quality and potency of products from dispensaries are typically more regulated than general OTC products but still do not have the same federal approval as a pharmaceutical drug. These state-specific programs reflect a different regulatory pathway from the FDA's drug approval process.

How to talk to your doctor about CBD

If you are considering using CBD for any condition, it is vital to have an open conversation with your healthcare provider. Your doctor can assess potential drug interactions with your current medications and discuss the potential risks and benefits. They can also offer guidance on what to look for when choosing a product from the unregulated market, such as checking for third-party lab testing and certificates of analysis (COAs). By involving your doctor, you can make a more informed decision and prioritize your safety while navigating the complexities of CBD products.

Frequently Asked Questions

Yes, doctors can prescribe Epidiolex, a pharmaceutical-grade CBD oil, for specific, severe seizure disorders like Lennox-Gastaut syndrome, Dravet syndrome, and Tuberous Sclerosis Complex.

No, doctors cannot write a prescription for over-the-counter CBD products, such as those sold in stores or online. These products are not FDA-approved medications.

The main difference is regulation. Epidiolex is a highly purified, FDA-approved drug that has undergone rigorous clinical testing for safety and efficacy. Regular CBD products are largely unregulated, and their content and potency can vary.

No. In states with legal medical cannabis, a doctor may provide a 'recommendation' or authorization for a medical cannabis card, which allows you to purchase products from a dispensary. This is not the same as a formal prescription for an FDA-approved drug.

Potential side effects of CBD include drowsiness, diarrhea, and decreased appetite. Higher doses, particularly with Epidiolex, have been associated with potential liver damage.

Yes, CBD can interact with certain medications by affecting the liver's ability to process them. It is crucial to discuss your CBD use with your doctor, especially if you take blood thinners or other prescription drugs.

The FDA is concerned because many OTC products are marketed with unproven health claims and have inconsistent potency and purity. The lack of federal regulation means there is no guarantee of what's in the product, posing potential safety risks.

Yes, you should always inform your doctor about any CBD products you are using. This helps them monitor for potential drug interactions and side effects and ensure your overall safety.

References

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Medical Disclaimer

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