On December 20, President Donald Trump signed the Agriculture Improvement Act of 2018 (Farm Bill), which in part removes hemp and hemp-derived products, including cannabinoids, with less than 0.3% tetrahydrocannabinol (THC), from the definition of marijuana in the Controlled Substances Act (CSA). The Farm Bill continues to chip away at the criminalization of cannabidiol (CBD)-based products but does not address the US Food and Drug Administration (FDA) position that CBD and THC-containing products are active drug products that cannot be sold as dietary supplements or foods. Shortly after the passage of the Farm Bill, FDA issued a statement that the agency will continue to take the position that it is unlawful to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements regardless of whether the product is hemp-derived.
Prior to the 2018 Farm Bill, legal hemp production in the United States was restricted to research and pilot programs, and the legal status of CBD-containing products was unclear. The lack of clarity occurred because the CSA regulated both hemp and marijuana, which are the same species of plant, Cannabis sativa L., as controlled substances unless the part of the hemp plant used was the mature stalks or oil or cake made from the plant seeds.
Therefore, prior to the 2018 Farm Bill, the only products containing hemp or CBD that could be legally marketed were products, including textiles, papers, and body care items, made from parts of the hemp plant outside of the definition of marijuana (i.e., mature stalks and seeds). Other CBD-based products were within the definition of marijuana and therefore a Schedule I controlled substance.
The 2018 Farm Bill legalizes the production of hemp and products made from hemp, hemp derivatives including CBD oil and extracts, and establishes that these products are no longer controlled substances, as long as the cannabis plant and products derived from the plant contain no more than 0.3% THC. The 2018 Farm Bill also allows the US Department of Agriculture (USDA) to transfer to states and Native American tribes the primary jurisdiction over hemp production in their states and reservations as long as they submit a hemp management plan that is approved by the Secretary of Agriculture. States that choose to regulate hemp production will need to track where hemp is produced, develop a method for testing the THC concentration of hemp, and have procedures for destroying hemp that is produced with a THC concentration of more than 0.3%, as well as license hemp producers. States can also choose to have more stringent requirements than those in the Farm Bill. Hemp growers in states and tribal jurisdictions that do not submit a plan will be subject to a comparable plan established by USDA.
While the removal from the CSA of “hemp” and cannabinoids as defined in the Farm Bill will mean the sale of the product no longer constitutes a criminal act under the CSA, there are still legal and regulatory challenges to marketing CBD-based products that are regulated by FDA, e.g., foods, dietary supplements, drugs, and cosmetics. FDA’s current position is that CBD is an active pharmaceutical ingredient that can only be marketed as a new drug subject to an approved New Drug Application. Based on FDA’s affirmation of its policy following the signing of the Farm Bill, FDA does not intend to modify its position regarding the marketing of CBD and THC products in food and dietary supplements. However, FDA also agreed that dehulled hemp seed, which contains little or no THC, is considered GRAS and can be used as an ingredient in a wide range of food products.
Below is a brief analysis of issues arising from the Farm Bill for FDA-regulated products containing CBD ingredients.
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 Agriculture Improvement Act of 2018, H.R. 2, 115th Cong. (2018).
 CBD or cannabidiol is a class of cannabinoids.
 Food & Drug Admin., Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds, (December 20, 2018).
 The CSA excluded from the definition of marijuana the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination” (emphasis added); 21 U.S.C. § 802(16).
 Section 2971 defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”
 Food & Drug Admin., FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food, (December 20, 2018).
 Drug Enforcement Admin., Schedule of Controlled Substances: Placement in Schedule V of Certain FDA-Approved Drugs Containing Cannabidiol; Corresponding Change to Permit Requirements, 83 Fed. Reg. 48950 (Sept. 28, 2018).
 FFDCA, §§ 201(ff)(3)(A)-(B).
 See Food & Drug Admin., FDA and Marijuana: Questions and Answers (last visited Dec. 10, 2018).
 Drug Enforcement Admin., Exemption From Control of Certain Industrial Products and Materials Derived From the Cannabis Plant (Oct. 9, 2001).
 US Customs and Border Protection, Importing hemp products into the U.S. (last updated May 11, 2018).