^ Jump up to: a b c "FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer's disease, opioid withdrawal, pain and pet anxiety". US Food and Drug Administration. July 23, 2019. Retrieved July 24, 2019. Unlike drugs approved by the FDA, the manufacturing process of these products has not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. cannabidiol oil
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Multiple sclerosis (MS). A prescription-only nasal spray product (Sativex, GW Pharmaceuticals) containing both 9-delta-tetrahydrocannabinol (THC) and cannabidiol has been shown to be effective for improving pain, muscle-tightness, and urination frequency in people with MS. This product is used in over 25 countries outside of the United States. But there is inconsistent evidence on the effectiveness of cannabidiol for symptoms of multiple sclerosis when it is used alone. Some early research suggests that using a cannabidiol spray under the tongue might improve pain and muscle tightness, but not muscle spasms, tiredness, bladder control, mobility, or well-being and quality of life in patients with MS.
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Food and beverage products containing CBD were introduced in the United States in 2017.[dubious – discuss] Hemp seed ingredients which do not naturally contain THC or CBD (but which may be contaminated with trace amounts on the outside during harvesting) were declared by the FDA as GRAS in December 2018. CBD itself has not been declared GRAS, and under U.S. federal law is illegal to sell as a food, dietary supplement, or animal feed. State laws vary considerably as non-medical cannabis and derived products have been legalized in some jurisdictions in the 2010s.
Cannabidiol has low affinity for the cannabinoid CB1 and CB2 receptors, although it can act as an antagonist of CB1/CB2 agonists despite this low affinity. Cannabidiol may be an antagonist of GPR55, a G protein-coupled receptor and putative cannabinoid receptor that is expressed in the caudate nucleus and putamen in the brain. It also may act as an inverse agonist of GPR3, GPR6, and GPR12. CBD has been shown to act as a serotonin 5-HT1A receptor partial agonist. It is an allosteric modulator of the μ- and δ-opioid receptors as well. The pharmacological effects of CBD may involve PPARγ agonism and intracellular calcium release.
The oral bioavailability of CBD is 13 to 19%, while its bioavailability via inhalation is 11 to 45% (mean 31%). The elimination half-life of CBD is 18–32 hours. Cannabidiol is metabolized in the liver as well as in the intestines by CYP2C19 and CYP3A4 enzymes, and UGT1A7, UGT1A9, and UGT2B7 isoforms. CBD may have a wide margin in dosing.
Yes, CBD derived from hemp plants is legal in the U.S. Growing, processing, and selling hemp and hemp-derived products for commercial purposes in the United States is permitted. While previously hemp was only legal to grow for hemp pilot programs and research needs, the passage of the 2018 bill reclassified hemp as an agricultural commodity and made it legal to produce all hemp-derived products, including CBD oil.
Similar to energy drinks and protein bars which may contain vitamin or herbal additives, food and beverage items can be infused with CBD as an alternative means of ingesting the substance. In the United States, numerous products are marketed as containing CBD, but in reality contain little or none. Some companies marketing CBD-infused food products with claims that are similar to the effects of prescription drugs have received warning letters from the Food and Drug Administration for making unsubstantiated health claims. In February 2019, the New York City Department of Health announced plans to fine restaurants that sell food or drinks containing CBD, beginning in October 2019.
In September 2018, following its approval by the FDA for rare types of childhood epilepsy, Epidiolex was rescheduled (by the Drug Enforcement Administration) as a Schedule V drug to allow for its prescription use. This allows GW Pharmaceuticals to sell Epidiolex, but it does not apply broadly and all other CBD-containing products remain Schedule I drugs. Epidiolex still requires rescheduling in some states before it can be prescribed in those states.
Until relatively recently (1980s), scientists believed that CBD was a natural precursor to the formation of THC, and since THC was a strictly controlled substance back then (it still is), it only followed that CBD should be equally strictly regulated. However, CBD is actually unrelated to the chemical chain that results in THC. They share some characteristics but are created via different paths. Again, unlike THC, CBD is considered a legal cannabinoid and is safe to consume in any amount and concentration.