The Controlled Substances Act defines “marijuana” as: all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.
Just like THC-containing products that are lawful under a state’s marijuana laws, CBD that may be lawful under a state’s marijuana laws, is still federally unlawful if sourced from the parts of the plant included in the definition of marijuana.
Just weeks after Senators Elizabeth Warren (D-Mass) and Cory Gardner (R-Colo) introduced bi-partisan legislation to make marijuana lawful under a state’s marijuana laws also lawful under the Controlled Substances Act (CSA), Senate Minority Leader Chuck Schumer (D-NY) introduced legislation removing marijuana from the CSA altogether on Wednesday, June 27. Schumer’s bill also comes just one day after Oklahoman’s passed legislation legalizing medical marijuana in their traditionally red state, and one day before the U.S. Senate passed legislation legalizing hemp for all purposes, including extracts from hemp, such as cannabidiol.
By removing from the purview of the CSA, state-legal cannabis and proceeds derived therefrom, the Warren/Gardner legislation, if passed, would likely have the effect of nationwide legalization, but state operators and consumers would still need to be concerned about marijuana’s Schedule 1 status under the CSA, whereas the Schumer bill, if passed, would eliminate those concerns by removing marijuana from the CSA.
Authored by Robert Prince, Ph.D, https://www.duanemorris.com/attorneys/robertwprince.html
On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW Pharmaceutical’s cannabis-based drug Epidiolex ® for use in treating two rare types of epilepsy in children- Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex is an oral formulation of a purified form of cannabidiol (CBD) a component found in cannabis. CBD does not have any psychoactive effects as compared to another component of cannabis tetrahydocannabinol (THC). Epidiolex has less than 0.1 percent of THC.
If approved, Epidiolex would be the first botanical cannabis product approved in the U.S. for any indication. The FDA has approved Marinol® and Syndros® for uses in the U.S. for the treatment of anorexia associated with weight loss in AIDS patients. Both products contain dronabinol, a synthetic delta-9-tetrahydrocannabinol. Another FDA approved drug Cesamet® contains nabilone, which is a synthetic drug with a structure similar to THC that is used to treat nausea and vomiting.
The FDA released briefing documents on April 17, 2018, which did not seem to raise any major issues with Epidiolex, resulting in the share price of GW Pharmaceuticals to rise sharply- up 2.27%. The Center for Drug for Drug Evaluation and Research (CDER) indicates that it plans to provide a free of charge, live webcast of the April 19, 2018 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. Information regarding the webcast, including the web address for the webcast, will be made available at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. At the time of writing this note, the FDA has not provided any login information for the webcast.
Several weeks ago, scientists at King’s College London announced exciting preliminary study results involving mental illness and CBD derived from cannabis. The trial involved 88 patients diagnosed as psychotic, meaning they experience hallucinations, paranoia and anxiety. The study found that patients administered CBD saw lower levels of psychotic symptoms than those given just a placebo.
CBD, or cannabidiol, is separate from the psychoactive aspect of cannabis known as THC. Thus, the patients were provided a fully non-psychoactive form of cannabis, the same as is used to treat ailments such as chronic pain or seizures, even in children.
The study results were published in the American Journal of Psychiatry. As reported in the VOA News, one of the trial leaders, Philip McGuire, said, “The study indicated that CBD may be effective in psychosis: patients treated with CBD showed a significant reduction in symptoms, and their treating psychiatrists rated them as having improved overall.” McGuire also noted very few side effects to use of CBD.
A slow but steady drumbeat of study results is beginning to prove what many in the medical community have believed for a number of years: while we still don’t quite know why, CBD and cannabis may indeed provide safe and effective treatment or cure for many illnesses and diseases facing mankind today.
The U.S. Food and Drug Administration (FDA) has recently issued warning letters to four companies concerning the marketing of products containing cannabidiol (CBD). FDA alleged that claims made on websites and social media webpages concerning the health benefits of CBD violated the Federal Food, Drug and Cosmetic Act. The products at issue included CBD-infused oils, edibles, tinctures and creams, and the manufacturers included statements claiming various health benefits from CBD.