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.”
The press release indicated that FDA has only limited tools at its disposal “for managing many of the risks associated with CBD products,” and has failed to “find adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.” Thus, FDA intends to develop a “cross-strategy” agency with Congress to regulate CBD products. FDA did, however, confirm that it will continue to take action against CBD and other cannabis-derived products that are perceived to be a risk to the public.
The fact that FDA is looking for a grant of new statutory authority indicates that the agency believes that significant changes are required to the current FDCA framework. Whatever this may be, ultimately, this is a disappointing development for the CBD industry as a major barrier to the industry’s success is the lack of uniform guidance and regulations. Given how long it took FDA to reach this latest “conclusion,” it is unlikely that Congress and FDA combined will be issuing a framework for a new regulatory pathway anytime in the near future. For now, those in the CBD space will need to ensure that their products comply with all relevant state laws and are not packaged or marketed in such a way as to draw the ire of FDA.
Client Alert 2023-026