Cannabidiol (CBD) is a non-intoxicating phytocannabinoid found in the cannabis plant. CBD products have gained popularity in recent years for their potential therapeutic benefits, including reducing anxiety, pain, and inflammation, and improving sleep. CBD products are available in various forms, including oils, capsules, creams, and edibles.
There are two main categories of CBD products: those derived from hemp and those derived from marijuana. Hemp-derived CBD products are legal under federal law, provided they contain no more than 0.3% tetrahydrocannabinol (THC) by dry weight. In contrast, marijuana-derived CBD products are illegal under federal law but may be legal under state law in some states.
It is important to note that the regulatory status of CBD products is evolving, and the FDA has only approved one CBD product, CBD-Rx, for the treatment of certain seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.
Lennox-Gastaut syndrome (LGS) is a severe form of epilepsy that typically begins in childhood and is characterized by multiple seizure types, intellectual disability, and developmental delays. It is often refractory to standard antiepileptic drugs and can have a significant impact on quality of life for patients and their families. Dravet syndrome is another severe form of epilepsy that typically begins in infancy and is characterized by prolonged and frequent seizures that are often triggered by fever or illness. Like LGS, Dravet syndrome is often refractory to standard antiepileptic drugs, and patients may experience cognitive and developmental delays.
Tuberous sclerosis complex is a genetic disorder that can cause seizures, and there is evidence to suggest that CBD may be effective in reducing the frequency and severity of seizures in patients with this condition. Tuberous sclerosis is a rare genetic disorder that affects 1 in 6,000 children. Mutations in tuberous sclerosis complex 1 or 2 genes cause benign tumors in different parts (e.g., brain, skin, lung, kidney, heart, and eye). When the tumors impinge on the brain, seizures can result. Tumors in other organs can cause respiratory, kidney, heart, or vision disorders. In a recent randomized, double-blind, placebo-controlled trial of 224 patients with tuberous sclerosis complex, researchers compared the efficacy and safety of CBD-Rx oral solution (CBD-Rx-25: 25 mg/kg/day and CBD-Rx 50: 50 -mg/kg/day) to placebo over 16 weeks.30 eligible patients were aged 1 to 65 years with medication-resistant epilepsy and had experienced at least 8 seizures during the 4-week baseline period. The percentage of seizure reduction versus placebo was 30.1% (p < 0.001) for the CBD-Rx-25 group and 28.5% (p = 0.002) for the CBD-Rx-50 group. The most common adverse events were diarrhea (25%, 31%, and 56%) and somnolence (9%, 13%, and 26%) in the placebo, CBD-Rx-25, and CBD-Rx-50 groups, respectively. Two, 8, and 10 patients in the placebo, CBD-Rx-25, and CBD-Rx-50 groups discontinued treatment because of adverse events. Twenty-eight patients taking cannabidiol (18.9%) had elevated liver transaminase levels compared to none taking a placebo. However, the appropriate dosage of CBD for seizure management will vary depending on the individual patient and should be determined in consultation with a healthcare provider.
Consumers should be aware that not all CBD products are created equal. Some products may have inaccurate labeling or contain harmful contaminants, such as pesticides, heavy metals, or residual solvents. To ensure the quality and purity of CBD products, consumers should look for products that have been tested by an independent third-party laboratory and have a Certificate of Analysis (CoA) available. The CoA should list the CBD and THC concentrations and test results for contaminants.
- National Center for Complementary and Integrative Health (NCCIH): This is a branch of the National Institutes of Health that provides evidence-based information on complementary and integrative health approaches, including cannabidiol. The NCCIH website has a section dedicated to CBD that includes information on its safety, effectiveness, and potential uses.
- Mayo Clinic: The Mayo Clinic is a world-renowned medical center that provides information on various medical conditions and treatments. Its website has a section on cannabidiol that provides an overview of what it is, its potential uses, and safety concerns.
- Harvard Health Publishing: This is a publishing arm of Harvard Medical School that provides reliable and evidence-based health information to the public. Its website has an article on CBD that provides an overview of what it is, how it works, potential uses, and safety concerns.
- Project CBD: This is a nonprofit organization that provides educational resources on CBD and its potential uses. Its website includes a comprehensive guide to CBD that covers topics such as dosing, safety, and potential interactions with other medications.
Rx-CBD (prescription CBD) differs from CBD products that people can purchase at the gas station, grocery store, or CBD vendor shops in several ways:
- Legal status: Rx-CBD is only available with a prescription from a licensed healthcare provider, while non-prescription CBD products can be purchased without a prescription in most states.
- Quality control: Rx-CBD products are subject to stricter quality control standards and regulations than non-prescription CBD products, which may vary in their CBD content, purity, and consistency.
- CBD concentration: Nonprescription CBD products may have CBD concentrations that differ from labeled doses, whereas Rx-CBD products are precisely dosed and labeled.
- Formulation: Rx-CBD products are typically formulated to address specific medical conditions and are available in different formulations such as oils, capsules, and topicals, while non-prescription CBD products are usually sold as dietary supplements and have limited formulations.
- Medical supervision: Rx-CBD products are prescribed by licensed healthcare providers who monitor their patients’ response to treatment, adjust the dosage and provide medical supervision, whereas non-prescription CBD products are self-administered without medical supervision.
The Department of Agriculture regulates some hemp-derived CBD products that have THC concentrations of less than 0.3% as stipulated by the 2018 U.S. Farm Bill.
CBD-RX is an oral solution that is taken by mouth, and taking it with food can help improve absorption and reduce the risk of stomach upset. In addition, taking the medication at the same time every day can help ensure that the patient receives a consistent dose and maximize the medication’s effectiveness.
CBD-Rx is a medication that is dosed based on the patient’s weight. Weight gain is a potential side effect of CBD-Rx, and the pharmacist may want to discuss this with the patient to monitor for any potential adverse effects associated with weight gain, such as fluid retention or other complications.
In summary, while both types of CBD products are legal in most states, Rx-CBD products are subject to more rigorous quality control standards and are prescribed by healthcare providers for specific medical conditions, whereas non-prescription CBD products may vary in their CBD content, quality, and formulation.
To determine a CBD product’s quality and actual content, consumers can request the product’s Certificate of Analysis (CoA) from the manufacturer. A CoA is a document that provides information about the product’s CBD content, other cannabinoids, terpenes, and any contaminants such as pesticides, heavy metals, or residual solvents. The CoA should be provided by an independent third-party laboratory and should match the product’s batch or lot number.
It is important to note that not all CBD products have the same quality or content and that there may be significant variations between different products, even those sold over the counter. It is also important to look for products that are made from high-quality, organic hemp and are free of contaminants.
While the FDA and Department of Agriculture do not provide CoAs for CBD products, they do provide guidance on the regulation of CBD and hemp products. Consumers can also check online for reviews and information from reputable sources to help them evaluate the quality and effectiveness of different CBD products.
COA should include:
- Cannabinoid Profile: The CoA should indicate the CBD and THC content of the product, as well as other cannabinoids such as CBG, CBC, and CBN.
- Contaminants: The CoA should indicate whether the product has been tested for contaminants such as pesticides, heavy metals, and residual solvents, and should provide information about the levels of any detected contaminants.
- Terpene profile: The CoA may also provide information about the product’s terpene profile, which can affect the product’s flavor and aroma.
- Batch or lot number: The CoA should include the batch or lot number for the product, which can help ensure that the CoA matches the specific product being sold.
CoAs do not typically include information about the company’s good manufacturing compliance or the growing conditions for the hemp used in the product, although this information may be available on the product’s labeling or website.
CBD-RX may interfere with several drugs including:
- Antidepressants (such as fluoxetine and amitriptyline)
- Anti-anxiety medications (such as diazepam and lorazepam)
- Blood thinners (such as warfarin and heparin)
- Immunosuppressants (such as tacrolimus and cyclosporine)
- Antipsychotics (such as haloperidol and risperidone)
- Anti-seizure medications (such as valproate and clobazam)
- Steroids (such as prednisone and dexamethasone)
- HIV antivirals (such as ritonavir and saquinavir)
- Calcium channel blockers (such as nifedipine and verapamil)
It is also important for patients to consult with their healthcare providers before using CBD products, especially if they are taking other medications. CBD can interact with certain medications and may cause adverse effects. Additionally, pregnant or breastfeeding women and individuals with liver or kidney disease should avoid using CBD products.
- Phytocannabinoids are naturally occurring compounds found in the cannabis plant, with over 100 different types identified so far. They interact with the endocannabinoid system (ECS) in the human body, which regulates a variety of physiological processes, including pain sensation, mood, and appetite. Cannabidiol (CBD) is one of the most well-known phytocannabinoids and has gained popularity in recent years due to its potential therapeutic effects. CBD is non-intoxicating and has been shown to have anti-inflammatory, analgesic, anxiolytic, and antipsychotic properties. Other phytocannabinoids, such as delta-9-tetrahydrocannabinol (THC), have psychoactive effects and are responsible for the “high” associated with marijuana use. Research is ongoing to explore the potential therapeutic benefits of phytocannabinoids, including their use in the treatment of epilepsy, chronic pain, and anxiety disorders. [Back]
- Tetrahydrocannabinol (THC) is a psychoactive compound found in the cannabis plant, which is responsible for the “high” or intoxicating effects associated with cannabis use. THC binds to the cannabinoid receptors in the brain and nervous system, leading to various effects such as altered perception, mood changes, and impaired cognitive function. THC is classified as a Schedule I substance under the US Controlled Substances Act due to its potential for abuse and lack of accepted medical use. However, several states have legalized cannabis for medical or recreational use, which has led to an increase in THC use and research. [Back]
- Marijuana, also known as cannabis, is a plant species that has been used for its medicinal and recreational properties for centuries. The plant contains more than 100 chemical compounds called cannabinoids, the most well-known of which are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the primary psychoactive compound in marijuana, responsible for the “high” that is often associated with its use. Marijuana can be smoked, vaporized, or ingested in various forms, including edibles, tinctures, and capsules. It is illegal at the federal level in the United States, but a growing number of states have legalized its use for medical and/or recreational purposes. [Back]
- Terpenes are a class of organic compounds commonly found in plants, including cannabis. They are responsible for the distinct aroma and flavor of different strains of cannabis and have been found to play a role in the therapeutic effects of the plant. Terpenes can interact with other compounds in cannabis, such as cannabinoids, to produce a range of effects, including anti-inflammatory, analgesic, anxiolytic, and antidepressant effects. There are over 100 different terpenes found in cannabis, each with its own unique properties and potential health benefits. More research is needed to fully understand the role of terpenes in cannabis and their potential medical applications. [Back]
- National Center for Complementary and Integrative Health. Cannabidiol (CBD) and Health. https://www.nccih.nih.gov/health/cannabidiol-cbd-and-health
- U.S. Food and Drug Administration. FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD). https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
- U.S. Food and Drug Administration. What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
- Bonn-Miller MO, Loflin MJE, Thomas BF, et al. Labeling Accuracy of Cannabidiol Extracts Sold Online. JAMA 2017;318(17):1708-1709.
- United States Pharmacopeia. Cannabidiol Quality Attribute Considerations. https://www.usp.org/sites/default/files/usp/document/harmonization/gen-info/proposed-revisions-monographs-cannabidiol-qa.pdf
- Mechoulam R, Hanus L. A historical overview of chemical research on cannabinoids. Chem Phys Lipids. 2000;108(1-2):1-13.
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- National Institute on Drug Abuse. (2021). Marijuana drug facts. Retrieved from https://www.drugabuse.gov/publications/drugfacts/marijuana
- United States Drug Enforcement Administration. (2021). Drug scheduling. Retrieved from https://www.dea.gov/drug-scheduling
- Wirrell EC. Treatment of LGS and Dravet syndrome. Epilepsia. 2020;61 Suppl 1:S54-S59. doi:10.1111/epi.16446
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This is a comprehensive and informative article on CBD products, their potential therapeutic benefits, and the importance of quality control when purchasing them.
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