The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.
The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:
Potential harm, side effects and unknowns
Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.
Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.
In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).
This is particularly important if you are experiencing any concerning symptoms, if you have any pre-existing conditions or if you are taking any medication including statins, blood thinning medication and calcium channel blockers.
Although the use of CBD is controversial, it does seem to be tolerated by most people. It has, however, caused hypotension and light-headedness in a small number of patients. As it does not contain the THC part of the cannabis plant, the oil will not induce a ‘high’.
A small number of patients in the UK may be prescribed a cannabis-based medicine to treat epilepsy or nausea during chemotherapy. Visit the NHS website for more information on medical cannabis.
Is it safe to use CBD oil?
This article was reviewed on 4th December 2019.
Contrary to popular belief, CBD oil is legal in the UK as it is not a controlled substance. There are, however, strict restrictions over its THC content. CBD oil that isn’t medically prescribed can only have a maximum THC content of 0.2%. CBD oil products that have a higher THC content may be available to buy online, but not legally.
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Supporters of CBD oil believe it may help a number of clinical conditions, including refractory epilepsy, chronic pain, depression, anxiety and acne. However, further robust evidence is required as much of the research is carried out on animal models.
Potential Interactions With Other Meds
Last month, a U.S. Food and Drug Administration advisory panel unanimously recommended approval of the CBD medication Epidiolex to treat two rare forms of childhood epilepsy.
“CBD is kind of a tricky drug because it’s not very well absorbed orally,” Welty explained. “Less than 20 percent of the drug is absorbed orally. If it isn’t made in the right way, you may not be getting much drug into your systemic circulation.”
“There’s no control, so it’s basically how do you know if we’re dealing with the true effect of the drug or just simply a placebo effect because somebody thinks they’ve been given a drug that will be beneficial?” Welty said.
“There have been clinical trials in adults, but a lot smaller than the epilepsy studies that have been done in kids,” Bonn-Miller said.
For example, epilepsy studies found that “there were very clearly increases in the blood levels of some other anti-epileptic drugs when people were on CBD,” Welty said.
CBD’s usefulness as an anti-inflammatory medication is the next most promising, but those results come mostly from animal studies, experts said.