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1 1 (June 12, 2019)

handle is hein.crs/govbaap0001 and id is 1 raw text is: Cogesoa Resarc Sev1 0 June 12, 2019 FDA Regulation of Cannabidiol (CBD) Products Cannabidiol (CBD) is promoted as treatment for a range of conditions, including epileptic seizures, post-traumatic stress disorder, anxiety, and inflammation-despite limited scientific evidence to substantiate many of these claims. In the United States, CBD is marketed in food and beverages, dietary supplements, and cosmetics-products that are regulated by the Food and Drug Administration (FDA). CBD is also the active ingredient in an FDA-approved pharmaceutical drug, Epidiolex@. CBD is a plant-derived substance from Cannabis sativa, the species of plant that includes both hemp and marijuana, but from different plant varieties or cultivars. CBD is the primary nonpsychoactive compound in cannabis, whereas tetrahydrocannabinol (THC) is cannabis's primary psychoactive compound. Regulation of CBD Products Hemp and marijuana have separate definitions in U.S. law and are subject to different statutory and regulatory requirements. Marijuana is a Schedule I controlled substance under the Controlled Substances Act (CSA, 21 U.S.C. §§802 et seq.) and is regulated by the Drug Enforcement Administration (DEA). The unauthorized manufacture, distribution, dispensation, and possession of marijuana is prohibited. Marijuana-derived CBD is illegal at the federal level, with the exception of use as an active ingredient in the FDA-approved drug Epidiolex@. Despite the federal prohibition on growing, selling, or possessing the drug, marijuana-derived CBD that has not been approved by FDA has been made available in states where medical and/or recreational cannabis is legal under state law. In some states, buying CBD may require obtaining a medical cannabis prescription; elsewhere, CBD may be sold only at a licensed dispensary. As a result of recent legislative changes enacted in the 2018 farm bill (Agriculture Improvement Act of 2018, P.L. 115-334), hemp-derived CBD is not subject to regulation and oversight as a controlled substance at the federal level. Legislative Changes in the 2018 Farm Bill Legislative changes related to hemp enacted as part of the 2018 farm bill were widely expected to generate additional market opportunities for the U.S. hemp market. The 2018 farm bill removed long-standing federal restrictions on the cultivation of hemp, making it no longer subject to regulation and oversight as a controlled substance by the DEA. Instead, hemp production is now subject to regulation and oversight as an agricultural commodity under the U.S. Department of Agriculture (USDA). The 2018 farm bill also expanded the statutory definition of what constitutes hemp to include all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, as long as it contains no more than a 0.3% concentration of delta-9 THC (7 U.S.C. §1639o). All other cannabis is considered to be marijuana under the CSA and remains regulated by DEA. Some stakeholders expected that these changes would eliminate one obstacle to production and marketing of hemp and hemp-derived compounds, including CBD. However, the farm bill explicitly preserved FDA's authority under the Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.) and Section 351 of the Public Health Service Act (PHSA, 42 U.S.C. §262), including for hemp-derived products. According to FDA, because the 2018 Farm Bill did not change FDA's authorities, cannabis and cannabis- derived products are subject to the same authorities and requirements as FDA-regulated products containing any other substance, regardless of whether the products fall within the definition of 'hemp' under the 2018 Farm Bill. FDA Regulation of CBD Products FDA, under the FFDCA, regulates many of the products marketed as containing cannabis and cannabis-derived compounds, including CBD. Hemp-derived CBD is generally marketed and sold as an ingredient in food or beverages, cosmetics, personal care products, and dietary supplements. Epidiolex@ is the first (and only) FDA- approved prescription drug formulation of highly purified, marijuana-derived CBD in the United States. There are several provisions of the FFDCA that FDA believes restrict the use of CBD in food and dietary supplements. Under the FFDCA, it is a prohibited act to introduce into interstate commerce a food to which has been added an approved drug or a drug for which substantial clinical investigations have been instituted and made public. There are several exceptions to this: (1) if the drug was marketed in food before approval as a drug or before clinical investigations were instituted; (2) if the Secretary has issued a regulation approving the use of such drug in the food; (3) if the use of the drug in the food is to enhance the safety of the food and not to have independent biological or therapeutic effects on humans, and the use is in conformity with specified requirements; or (4) if the drug is a new animal drug whose use is not unsafe (21 U.S.C. §331(11)). FDA has concluded, based on available evidence, that these exceptions do not apply to CBD. However, according to FDA, cannabis-derived ingredients that do not contain CBD (or THC) may fall outside the scope of the prohibition in §331(11). More specifically, foods containing parts of the hemp plant that include only trace amounts of CBD (e.g., hemp seed and hemp-seed derived ingredients) may be lawfully marketed under certain circumstances- pursuant to FDA approval as a food additive (by regulation) or a determination that the substance is generally recognized as safe (GRAS). FDA has not approved hemp as a food additive but has evaluated three GRAS notices related to hemp seed-derived ingredients (hulled hemp seeds, hemp seed protein, and hemp seed oil), allowing them to be added to human food under specified conditions. https:I/crsreports.conc -- _-_

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