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1 1 (September 16, 2024)

handle is hein.crs/goveqqh0001 and id is 1 raw text is: Legal Effect of Marijuana Rescheduling on FDA's Regulation of Cannabis September 16, 2024 Cannabis and its derivatives are regulated under various federal laws, depending on the particular characteristics and uses of the substance or product. Currently, unless an exception applies, cannabis and its derivatives are legally classified as marijuana, which is a Schedule I controlled substance under the Controlled Substances Act (21 U.S.C. §§ 801 et seq.; CSA), meaning that it is in the category of substances subject to the most stringent regulation, and unauthorized activities involving marijuana are subject to significant criminal penalties. On May 21, 2024, the U.S. Department of Justice (DOJ) issued a proposed rule to transfer marijuana from Schedule I to Schedule III of the CSA, which would partially relax the controls of marijuana under federal law. A previous Legal Sidebar outlined the legal consequences of rescheduling marijuana. Regardless of a substance's status under the CSA, if a substance is included in consumer products such as food or drugs, the product containing the substance must also comply with the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.; FD&C Act) in order to be legally distributed in U.S. commerce under federal law. This Legal Sidebar focuses on the U.S. Food and Drug Administration's (FDA's) regulation of products containing cannabis and the effect marijuana's rescheduling, if finalized, may have on this regulation. Background Information Cannabis is a plant that contains chemical compounds known as cannabinoids. The most well-known cannabinoids are delta-9 tetrahydrocannabinols (THC) and cannabidiol (CBD), but there are more than 80 others. Cannabinoids can be derived from cannabis or they can be synthetically created in a laboratory. With certain exceptions, cannabis and products derived from it are classified as marijuana under the CSA. Substances, such as marijuana, become subject to the CSA and oversight by the U.S. Drug Enforcement Administration (DEA) through their placement on five lists, known as Schedules I through V. Substances are placed on schedules based on findings related to the potential for their abuse and likelihood and severity of potential physical or psychological dependence to the drug, as well as whether there are currently accepted medical uses. A lower schedule number reflects a higher likelihood of abuse and dependence and accordingly carries higher restrictions under the CSA, with Schedule I having the most stringent controls. Unlike the other four schedules, Schedule I substances also must have no currently accepted medical use in the United States at the time they are scheduled. Substances that are classified as Congressional Research Service https://crsreports.congress.gov LSB11227 CRS Legal Sidebar Prepared for Members and Committees of Congress

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