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The defining difference between hemp and marijuana is their psychoactive component: tetrahydrocannabinol, or THC. Hemp has 0.3% or less THC, meaning hemp-derived products don’t contain enough THC to create the “high” traditionally associated with marijuana.
Full spectrum CBD products for sale, including tinctures, topical creams, edible gummies and pet products. Smith Collection/Gado/Getty Images
Note that CBD oil is different from hemp oil – which comes from pressing cannabis seeds, and may not contain CBD – and hempseed oil, which is a source of essential fatty acids and contains no CBD. It’s a nutritional supplement, more like fish oil than CBD oil.
The Drug Enforcement Agency categorizes cannabis as a Schedule 1 substance, meaning it handles cannabis as if there is no accepted medical use and a high potential for abuse. Scientists don’t know exactly how CBD works, nor how it interacts with other cannabinoids like THC to give marijuana its added therapeutic effects.
Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”
The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )
A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.
17. Does the FDA object to the clinical investigation of cannabis for medical use?
FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.
Research suggests that CBD may provide relief for chronic pain. Sativex is a proprietary medication that combines THC and CBD and may be prescribed for the relief of pain associated with multiple sclerosis. There is also some evidence suggesting that CBD may be a promising support for people with opioid use disorders. The researchers noted that CBD reduced some symptoms associated with substance use disorders including anxiety, mood-related symptoms, pain, and insomnia.
After researching the safety and effectiveness of CBD oil for treating epilepsy, in 2018, the United States FDA approved CBD (Epidiolex) as a therapy for two rare conditions characterized by epileptic seizures. Other evidence suggests that CBD may be useful in the treatment of schizophrenia, though further research is needed before introducing CBD into medical practice.
What is the legal status (and evidence) of CBD oil?
There is some initial evidence that CBD may help people in the early stages of Alzheimer’s disease keep the ability to recognize the faces of people that they know, and thus slow progression of the illness. Again, more research is needed in this area.
Because of the way cannabis and its products are metabolized, scientists believe there is a potential for interaction with other drugs, although nothing significant has yet been recorded. CBD has been found to be generally safe. Reports from patients indicate that negative drug interactions are not common. As with any other treatment, it is important to monitor your use of CBD and seek assistance if you experience any problems or have questions or concerns about its use.
Author: Canadian Institute for Substance Use Research