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Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.1 Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.2
In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.1
With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.
FDA-approved treatments
To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):
Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.1,4 There are no other FDA-approved medications that contain CBD.
Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.1
Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.1
Continue to: Questionable claims about CBD
Questionable claims about CBD
Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.1 The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.5
Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.1 Cannabidiol products cannot be sold as dietary supplements.1 In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.1 Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.1 Also, CBD products can affect the therapeutic effectiveness of prescription medications.
Discuss CBD with your patients
Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.
1. US 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-questions-and-answers. Updated August 3, 2020. Accessed September 1, 2020.
2. Daniller A. Two-thirds of Americans support marijuana legalization. Pew Research Center. https://www.pewresearch.org/fact-tank/2018/10/08/americans-support-marijuana-legalization/. Updated November 14, 2019. Accessed September 1, 2020.
3. Agricultural Improvement Act of 2018, HR 2—115th Cong, Public L No. 115-334 (2018). https://www.congress.gov/bill/115th-congress/house-bill/2/text?overview=closed. Accessed September 1, 2020.
4. US Food and Drug Administration. FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare. Published July 31, 2020. Accessed September 1, 2020.
5. US Food and Drug Administration. Warning letters and test results for cannabidiol-related products. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Updated August 20, 2020. Accessed September 1, 2020.
Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.1 Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.2
In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.1
With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.
FDA-approved treatments
To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):
Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.1,4 There are no other FDA-approved medications that contain CBD.
Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.1
Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.1
Continue to: Questionable claims about CBD
Questionable claims about CBD
Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.1 The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.5
Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.1 Cannabidiol products cannot be sold as dietary supplements.1 In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.1 Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.1 Also, CBD products can affect the therapeutic effectiveness of prescription medications.
Discuss CBD with your patients
Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.
Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.1 Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.2
In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.1
With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.
FDA-approved treatments
To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):
Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.1,4 There are no other FDA-approved medications that contain CBD.
Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.1
Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.1
Continue to: Questionable claims about CBD
Questionable claims about CBD
Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.1 The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.5
Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.1 Cannabidiol products cannot be sold as dietary supplements.1 In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.1 Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.1 Also, CBD products can affect the therapeutic effectiveness of prescription medications.
Discuss CBD with your patients
Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.
1. US 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-questions-and-answers. Updated August 3, 2020. Accessed September 1, 2020.
2. Daniller A. Two-thirds of Americans support marijuana legalization. Pew Research Center. https://www.pewresearch.org/fact-tank/2018/10/08/americans-support-marijuana-legalization/. Updated November 14, 2019. Accessed September 1, 2020.
3. Agricultural Improvement Act of 2018, HR 2—115th Cong, Public L No. 115-334 (2018). https://www.congress.gov/bill/115th-congress/house-bill/2/text?overview=closed. Accessed September 1, 2020.
4. US Food and Drug Administration. FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare. Published July 31, 2020. Accessed September 1, 2020.
5. US Food and Drug Administration. Warning letters and test results for cannabidiol-related products. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Updated August 20, 2020. Accessed September 1, 2020.
1. US 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-questions-and-answers. Updated August 3, 2020. Accessed September 1, 2020.
2. Daniller A. Two-thirds of Americans support marijuana legalization. Pew Research Center. https://www.pewresearch.org/fact-tank/2018/10/08/americans-support-marijuana-legalization/. Updated November 14, 2019. Accessed September 1, 2020.
3. Agricultural Improvement Act of 2018, HR 2—115th Cong, Public L No. 115-334 (2018). https://www.congress.gov/bill/115th-congress/house-bill/2/text?overview=closed. Accessed September 1, 2020.
4. US Food and Drug Administration. FDA approves new indication for drug containing an active ingredient derived from cannabis to treat seizures in rare genetic disease. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-drug-containing-active-ingredient-derived-cannabis-treat-seizures-rare. Published July 31, 2020. Accessed September 1, 2020.
5. US Food and Drug Administration. Warning letters and test results for cannabidiol-related products. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Updated August 20, 2020. Accessed September 1, 2020.
