During a recent interview with the Brookings Institution, Scott Gottlieb, the departing head of the Food and Drug Administration (“FDA”), explained it would take several years for the agency to come up with rules that would legalize the use of hemp-derived cannabidiol (Hemp-CBD) in food products, unless Congress steps in.
Gottlieb acknowledged the strong interest among CBD stakeholders and lawmakers in developing a regulatory framework through which Hemp-CBD could be infused to food. The problem, Gottlieb explained, is that CBD has been approved as a drug (i.e., Epidiolex) and was not previously used in the food supply.
The FDA Commissioner further argued that putting a drug that wasn’t previously used in food into the food supply would require the agency to go through a formal rulemaking process.
As we previously discussed, thus far, the FDA has only adopted informal, non-binding guidelines as its primary method of policy making for CBD as they afford the agency more flexibility. Adopting regulations through the formal rulemaking process would take two to three years, possibly longer, given the controversial nature of CBD as a compound closely associated with marijuana and that is used as a drug ingredient. Gottlieb suggested that a more efficient way of clarifying the situation would be for Congress to issue additional legislation that expressly allow the use of Hemp-CBD in foods. While the congressional intend behind the 2018 Farm Bill was to legalize the production of Hemp-CBD, lawmakers failed to define the meaning of “production,” thus, leaving open for interpretation whether the sale of Hemp-CBD and its use in food product was legal.
Similarly to a statement made in front of a House Appropriations subcommittee last month, the Commissioner suggested that the approval of Hemp-CBD infused food may turn on whether the CBD infused to food is an isolate or is used in its naturally-occurring form (see here for more background information on this distinction).
I think you need to come up with a framework that defines concentration levels, where you would create some kind of cut off, and that would be up to the agency to do….CBD in high concentrations isn’t risk-free, and in low concentration, it probably is safe—I don’t want to make a declaration here. It’s also a question of whether it’s providing any kind of therapeutic benefit in those concentrations, although people seem to believe that it has some value.”
During the interview, the Commissioner also shared that the Drug Enforcement Administration (“DEA”) would have to “formally deschedule” Hemp-CBD before moving forward with regulatory changes, even though the 2018 Farm Bill removed Hemp-CBD from the Controlled Substance Act and shifted its regulation from the Department of Justice (which oversees the DEA) to the U.S. Department of Agriculture.
I think the prevailing view is that the plain language of the statute [the Farm Bill] intended for that, but I’m not sure that DEA has done that yet. But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”
For now, Gootlieb explained that the agency is creating a “high-level work group” tasked with identifying “some potential legislative pathways to create a framework for allowing CBD into the food supply.” The work group will soon be formally announced and will hold a public meeting to solicit comments from Hemp-CBD stakeholders. According to the Commissioner, the work group should release recommendations by the summer.