Cannabidiol (CBD) is a compound found in marijuana that is not harmful and does not cause a “high”. Hemp, which is any part of the cannabis sativa plant with no more than 0.3% tetrahydrocannabinol (THC), is used to create CBD products. The Food and Drug Administration (FDA) has approved Epidiolex, a drug containing CBD purified from hemp, to help treat rare seizure disorders. However, other marketed products and uses of CBD may not be approved by the FDA.
Since the negative effects have been associated with the consumption of CBD, people who are breastfeeding are advised to avoid it. 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 reach of children. Currently, we don't know how CBD consumption affects a person over time or how the different modes of CBD are used (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 as they can cause psychoactive effects and adverse events. In addition, most CBD products are not regulated by the FDA. Therefore, consumers should know that products labeled as hemp or CBD may contain other ingredients, such as THC, pesticides, heavy metals, bacteria or fungi. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from using cannabis-derived drugs. The FDA continues to support strong, science-based research on the medicinal uses of drugs containing cannabis or cannabis-derived compounds.
THC (dronabinol) is the active ingredient in approved medications, Marinol capsules (and generics) and Syndros oral solution. The FDA has issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in violation of the Federal Food, Drug and Cosmetic Act (Act FD&C). These research projects would be aimed at taking advantage of the independent quality and safety monitoring efforts currently existing at the state and national levels, data models from observational studies, and novel data sources to develop stronger capacities and methods for collection and analysis of CBD data.