Cannabidiol (CBD) is a compound found in the Cannabis sativa plant, better known as marijuana. Unlike THC, the main psychoactive component of marijuana, CBD does not cause intoxication or euphoria. The FDA has approved Epidiolex, a drug containing purified CBD from hemp, to help treat rare seizure disorders. The FDA has concluded that this medication is safe and effective for its intended use.
Hemp is defined as any part of the cannabis sativa plant with no more than 0.3% tetrahydrocannabinol (THC). Scientists are still learning how CBD affects the body, and the potential health effects of using CBD products during pregnancy are currently unknown. In animals, high doses of CBD have caused negative effects on developing fetuses. Therefore, people who are breastfeeding are advised to avoid CBD.
We don't know the effects of CBD on children's developing brains, so it is important to store products that contain CBD or THC in child-proof containers and out of the reach of children.Currently, we don't know how CBD consumption affects a person over time or the different ways of using CBD (smoking, vaping, eating, applying it to the skin, etc.). Many companies that sell hemp and CBD products also sell products that contain THC. People should be careful not to confuse THC products with hemp or CBD products. Products containing THC can cause psychoactive effects and adverse events.In addition to safety risks and unproven claims, the quality of many CBD products may also be in question.
Most CBD products are not regulated by the FDA, so consumers should keep in mind that products labeled as hemp or CBD may contain other ingredients such as THC, pesticides, heavy metals, bacteria or fungi. If consumers experience adverse effects from products containing THC or CBD that pose an immediate health hazard, they should call their local or regional poison control center at 1-800-222-1222 or 911 or seek medical attention at their local emergency room.The FDA approved Epidiolex for the indications of Dravet syndrome and Lennox-Gastaut syndrome. The effectiveness of Epidiolex was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with these syndromes. Epidiolex taken together with other medications has been shown to be effective in reducing the frequency of seizures compared to placebo.The FDA granted Fast-Track designation for Dravet syndrome and Orphan drug designation for Dravet syndrome and Lennox-Gastaut syndrome.
The Department of Health and Human Services performs a medical and scientific analysis of substances subject to the list such as CBD and provides recommendations to the Drug Enforcement Administration (DEA) on controls within the framework of the CSA. DEA is required to make a scheduling determination.Thanks to the adequate and well-controlled clinical studies that supported this approval, prescribers can rely on the consistent concentration of the drug and its consistent administration, supporting the appropriate dosage needed to treat patients with these complex and serious epileptic syndromes.The FDA is working to answer questions about CBD through ongoing efforts including comments from a recent FDA hearing and collecting information and data through a public registry. Misleading, unproven or false claims related to CBD products can lead consumers to stop receiving important medical care such as adequate diagnosis, treatment and supportive care.
