Cannabidiol (CBD) is a compound found in the Cannabis sativa plant that has been promoted as a potential treatment for a variety of conditions, including seizures, post-traumatic stress disorder, anxiety, inflammation and insomnia. However, there is limited scientific evidence to support or refute the effectiveness of CBD in treating these conditions. In the United States, CBD is marketed in foods and beverages, dietary supplements, cosmetics and tobacco products, such as electronic nicotine delivery systems (ENDS). It is also the active ingredient in Epidiolex, an FDA-approved drug used to treat seizures associated with two rare and serious forms of epilepsy.
CBD is derived from the Cannabis sativa plant, which includes both hemp and marijuana. THC, a psychoactive compound, is found at high levels in marijuana and low levels in hemp. The regulation of marijuana and hemp (CBD) is derived from the Controlled Substances Act (CSA), which classifies marijuana as a Schedule I controlled substance. This means that growing, selling or possessing marijuana is a federal offense, except for federally approved investigations.
Hemp, on the other hand, can be legally cultivated under federal law with U. S. Department of Agriculture (USDA) supervision. The FDA regulates the safety and effectiveness of prescription and nonprescription drugs sold in the United States.
Prescription drugs require the supervision of a health professional to be considered safe and can only be dispensed with a prescription. Over-the-counter drugs may be used without a prescription if they have an acceptable margin of safety and are properly labeled so that consumers can self-diagnose their condition and self-manage it. The FDA also regulates foods and beverages, dietary supplements, cosmetics and tobacco products such as ENDS. Before conducting human tests (called clinical trials), the sponsor of the drug (usually its manufacturer) must file an application for a new investigational drug (IND) with the FDA.
Once the manufacturer completes clinical trials, it sends the results of those investigations to the FDA in a new drug application (NDA). If a sponsor wants to transfer an approved drug from prescription state to over-the-counter (called a change from prescription to over-the-counter), the sponsor must submit a confidentiality agreement with data supporting the change to the FDA. The FFDCA requires that all foods for humans and animals be safe for consumption, are produced in accordance with current good manufacturing practices (CGMPS), contain no harmful substances and are truthfully labeled. In general, foods intended for human or animal consumption are not approved by the FDA prior to sale.