The regulatory landscape
According to the Agriculture Improvement Act of 2018 (available at govtrack.us), which is often referred to as the “2018 Farm Bill,” “[t]he term ‘hemp’ means 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.” Pursuant to that legislation, which became U.S. law in December 2018 (read more at reedsmith.com), “hemp” was expressly removed from the definition of “marihuana” in the U.S. Controlled Substances Act and its regulations.
At the same time, the U.S. Food and Drug Administration (FDA) (1) reiterated that before a product containing CBD is marketed as a drug (read more at reedsmith.com), it must go through new drug approval and (2) stated that it remains currently illegal to put into interstate commerce a food containing CBD or to market CBD as, or in, a dietary supplement. The U.S. Department of Agriculture (USDA) recently issued an interim final rule (read more at reedsmith.com) for domestic hemp production, including requirements for testing hemp, licensing growers, disposing of noncompliant hemp, and collecting and storing information related to hemp production. However, the FDA still has not issued any regulations concerning the sale of CBD in food, dietary supplements, drugs, or cosmetics.
In the absence of federal guidance, some states have developed their own requirements for the sale and marketing of CBD products, including rules for testing and labeling CBD products. However, only a handful of states have developed such rules, while other states are either working to develop rules or have merely accepted the realities of an unregulated CBD market while awaiting further FDA guidance.