US President Donald Trump is expected to sign an executive order reclassifying marijuana and loosening federal regulations on research that could lead to new medical marijuana products.
“We're looking at it,” Trump told reporters Monday when asked about reports of an impending order.
“A lot of people want reclassification because it would lead to a huge amount of research that wouldn't be possible without reclassification. So we're considering that very strongly.”
Here's what you need to know:
What does the executive order do?
Currently, under the U.S. Controlled Substances Act, marijuana is listed as a Schedule I substance, along with heroin, meaning it has a high potential for abuse and no medical value.
The new executive order would move drugs into the Schedule III classification, which includes controlled substances such as codeine, morphine, certain stimulants, and some steroids.
Reclassification will make it easier for researchers to obtain funding for clinical trials and for drug companies to apply for FDA approval. As a result of Schedule I status, bureaucratic and financial obstacles have largely prevented pharmaceutical companies from conducting the clinical trials necessary for regulatory approval of new marijuana-derived drugs.
Does this mean medical marijuana will become legal?
According to federal law, any form of marijuana is illegal in the United States. Forty US states have laws allowing the sale of cannabis products for medical purposes through dispensaries, and 24 states also allow recreational use by adults. Products approved by these states remain federally illegal under the Controlled Substances Act unless the manufacturer applies to the U.S. Food and Drug Administration for approval.
Manufacturing, distributing, and possessing marijuana without a legal permit would remain illegal, but the penalties would likely be less than those associated with the current Schedule I status.
What is the medicinal part of marijuana?
Marijuana, which comes from flowering plants in the Cannabis genus, contains compounds known as cannabinoids that interact with the body's chemical systems. Two of the most well-known cannabinoids are tetrahydrocannabinol (THC), which causes a high, and cannabidiol (CBD), which produces physiological effects such as potential pain and inflammation reduction without the high. In 2018, the U.S. Congress ruled that cannabis plants (such as hemp) that contain less than 0.3% THC are no longer considered marijuana.
The 10 states that have not legalized marijuana have laws that limit the psychoactive compound THC while allowing access to products rich in the non-intoxicating CBD.
What evidence supports marijuana-derived medicines?
Only three cannabinoid drugs have shown the clinical trial evidence necessary for FDA approval. Jazz Pharmaceuticals JAZZ.O's Epidiolex, which contains purified CBD derived from hemp, is approved for certain seizure disorders. Dronabinol, a synthetic version of THC sold by Alkem Laboratories ALKE.NX as Marinol and by Venuvia as Syndros, is approved to treat anorexia in HIV/AIDS patients and chemotherapy-induced nausea and vomiting.
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All are generally considered safe, but like most drugs, there are some potential side effects.
Even after reclassification, drugs that are ultimately approved by the FDA will still be legally available in commercial pharmacies by prescription. Health care providers who wish to prescribe Schedule III drugs (including marijuana-derived drugs) must have a valid Drug Enforcement Administration registration.
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What conditions can we expect for marijuana-derived medicines?
Dronabinol has also been shown to be effective against sleep apnea syndrome in mid-term trials.
Vertanical's experimental cannabis-derived drug was found to be safer and more effective than placebos and opioids in treating chronic back pain in two late-stage trials in Europe. Clinical trials in the United States are scheduled for 2026.
CNX Therapeutics' oral spray formulation, Sativex, has shown efficacy in late-stage trials to manage muscle spasticity in patients with multiple sclerosis and is approved in more than 30 countries outside the United States.
Cannabinoid drugs are also being tested to treat autism spectrum disorders, anxiety and depression in bipolar disorder, endometriosis, eczema, and alcohol use disorder.
If the federal government changes the cannabis use schedule, it will accelerate research and standardized drug development for these and other conditions.
Is marijuana sold at dispensaries safe?
Even when used for medical reasons, studies have shown that cannabinoid products such as gummies, vape oils, tinctures, and high-potency concentrates can cause dizziness and gastrointestinal symptoms, and can affect cognitive status, mental health, the cardiovascular system, and the lungs. Recent data also links marijuana use to an increased risk of developing type 2 diabetes.
Marijuana interacts with many prescription and over-the-counter medications, including blood thinners, sleeping pills, anti-anxiety medications, antidepressants, and seizure medications. Therefore, the risk is higher for people with heart disease, anxiety, depression, or mental illness, and for older adults who are at higher risk for falls and drug interactions.
Marijuana use is also at increased risk during pregnancy and breastfeeding, as well as in children and adolescents.
But states that allow medical marijuana do so for a wide range of conditions, and many people trust it despite the limited clinical research available. Approved uses include cancer, glaucoma, chronic pain, ulcerative colitis, Crohn's disease, sickle cell disease, multiple sclerosis, Parkinson's disease, and many other conditions. Some states do not list medical conditions, giving doctors wide discretion.
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