What is CBD?
Cannabidiol or CBD for short is made from either the marijuana plant that contains tetrahydrocannabinol (THC) or hemp which contains little to any THC. “Hemp-derived” means that the CBD generally contains less than 0.3% THC while “marijuana-derived” contains higher amounts of THC. It is THC — and not CBD — is the primary psychoactive or intoxicating component of marijuana. CBD can also be manufactured synthetically.
CBD is routinely sold as an oil extract commonly referred to as CBD oil.
Overall, CBD is used by consumers as an over-the-counter alternative medicine to self-treat a variety of ills such as acne, addiction, anxiety or stress, chronic pain, depression, epilepsy, glaucoma, insomnia, loss of appetite, muscle spasms, Parkinson’s disease and more. Additionally, it is used as an additive in some food and beauty products to address the above conditions and also used in some forms to treat certain animal conditions.
What’s the FDA’s view?
This past June, the FDA approved the first-ever CBD drug, Epidiolex, a Schedule V medication to help treat two rare forms of epilepsy, Dravet syndrome and Lennox-Gestaut syndrome in patients two years of age and older. Epidiolex contains less than 0.15% THC with a list price around $32,500 annually, however, its insurance costs are significantly lower.
On June 25, 2018, FDA Commissioner Scott Gottlieb M.D. released a statement citing the agency’s approval of Epidiolex by stating: “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”
In the same statement, Dr. Gottlieb cautioned that the FDA is also “prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
What about the CDC?
According to the CDC, “Cannabis-based products, such as man-made cannabinoid-based medications, may help prevent and ease nausea caused by chemotherapy.” Short-term use has been shown to help adults with multiple sclerosis-related muscle spasms.
Regarding its use for chronic pain, the CDC finds that uncertainty remains about its effectiveness and that “more information is needed to know if pain relief from cannabis is any better or worse than other pain management options, such as over over-the-counter drugs like ibuprofen or alternative treatments like occupational therapy.”
How about the DEA?
When Epidiolex was approved in 2018, DEA concluded its press announcement on September 27, 2018 with the following statement: “Marijuana and CBD derived from marijuana remain against the law, except for the limited circumstances that it has been determined there is a medically approved benefit. In those instances, such as here, the drug will be made appropriately available to the public for medical use. ”
The DEA’s view of CBD is that the drug is illegal due to the definition of “marihuana” found in Title 21 United States Code §802 (16). Two things to keep in mind, the Controlled Substances Act (“CSA”) was made law in 1970 and has changed little in almost 50 years and secondly, with the DEA’s focus on cartels, gangs, fentanyl and the opioid crisis, CBD oils and products may likely never be on DEA’s radar due to the agency’s limited resources.
Is it legal?
The federal Agriculture Improvement Act of 2018 that was signed into law on December 20, 2018, removed hemp or low content THC cannabis from the Controlled Substances Act, which means that it is no longer an illegal substance under federal law. The same act defined hemp as cannabis that contained less than 0.3% of THC but made no mention of CBD.
CBD is currently legal in 30 states that have legalized marijuana use and 17 other states that have legalized some type of CBD.
Standard dosage unit?
There are currently no established standards for safely producing CBD oil or a standard dosage unit. As a 2017 published JAMA study found, “Among CBD products purchased online, a wide range of CBD concentrations was found, consistent with the lack of an accepted dose. Of tested products, 26% contained less CBD than labeled, which could negate any potential clinical response.”
“The over labeling of CBD products in this study is similar in magnitude to levels that triggered warning letters to 14 businesses in 2015-2016 from the US Food and Drug Administration, suggesting that there is a continual need for federal and state regulatory agencies to take steps to ensure label accuracy of these consumer products.”
CBD oil derived from hemp (marijuana with a THC content of less than 0.3% as defined federally) looks promising as a medicine especially as evidenced by the FDA’s recent approval of Epidiolex.
Medical professionals considering utilizing CBD oil should review the latest scientific studies and ensure that their preferred product is manufactured to the highest standards, legal in their state and the exact contents of the drugs are known.
Dennis Wichern is a retired DEA agent.
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