The Agricultural Improvement Act of 2018 (2018 Farm Bill), expressly removed “hemp” from the definition of “marihuana” under the Controlled Substances Act (CSA), thereby legalizing industrial hemp and industrial hemp-derived compounds. Under the 2018 Farm Bill, FDA’s authority was left intact over cosmetics, dietary supplements, foods, and drugs containing hemp and hemp-derived compounds. Since the passage of the 2018 Farm Bill, the industrial hemp and CBD industry have patiently waited for FDA to provide a regulatory framework for the marketing and sale of CBD products, many of which remain illegal under the Federal Food, Drug, and Cosmetic Act (FDCA). As it currently stands, states are taking matters into their own hands and promulgating CBD regulations, resulting in a patchwork of confusing and conflicting requirements.
On January 26, 2023, more than four years after the passage of the Farm Bill, FDA “concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” In order to achieve that goal, “[t]he agency is prepared to work with Congress on this matter.”