USDA, FDA take steps on hemp CBD. For FDA, this could be a long road.

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Following the passage of the Agricultural Improvement Act of 2018 (2018 Farm Bill), which removed hemp from Schedule I of the Controlled Substances Act, suppliers and manufacturers of hemp and hemp-derived products celebrated, but many questions remained. Regulatory agencies are hard at work updating regulations and guidance on hemp. On February 27, 2019, the U.S. Department of Agriculture (USDA) released an update on its timeline for establishing regulations and announced a Farm Bill listening session on industrial hemp production to take place on March 13, 2019.

In its statement, USDA explained that the agency’s intention is to issue regulations in the fall of 2019 to accommodate the 2020 planting season. In the meantime, the 2018 Farm Bill allows states, tribes, and institutions of higher education to continue operating under the authority of the 2014 Farm Bill. USDA also explained that states and tribes did not need to submit plans for hemp cultivation until after USDA has issued its regulations, and that USDA would hold onto submissions until regulations have been promulgated. The statement was short on details for the listening session, but it will be in the form of a webinar and open to the public.

The biggest question mark regarding hemp has been the use of hemp-derived constituents, most notably cannabidiol (CBD), in dietary supplements and food. Currently, CBD is not authorized to be a dietary supplement or used in food because CBD was an Investigational New Drug (IND) and has since been approved as a treatment for epilepsy (via the FDA-approved drug Epidiolex). However, hemp extracts and functional foods with hemp-derived CBD have become a thriving industry, skirting regulation. With the passage of the 2018 Farm Bill, FDA has to come up with a solution to this disparity, and FDA Commissioner Scott Gottlieb acknowledged this much in his recent testimony on February 27 at a hearing of the House Appropriations Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

In response to a question from Rep. Mark Pocan (D-WI) regarding FDA’s intention to pursue pathways for the inclusion of CBD in food, Gottlieb stated, “We heard Congress loud and clear with respect to that legislation. I understand Congress wants there to be a pathway for CBD to be available.”

In addition to the passage of the 2018 Farm Bill, on January 15, 2019, Senators Ron Wyden (D-OR) and Jeff Merkley (D-OR) sent a letter to Commissioner Gottlieb urging him to update federal regulations governing the use of hemp-derived CBD in foods, beverages, and dietary supplements. Therefore, the pressure on FDA is substantial. 

In his February 27 testimony, Gottlieb acknowledged, however, that FDA’s path forward on CBD is not straightforward. “Congress specifically preserved our authorities with respect to CBD – our drug authorities – and CBD as you know exists in a higher formulation as a pharmaceutical products and can’t be legally put in the food supply at this time, not only because it’s a drug product, but it’s also subject to substantial clinical investigation; we have active INDs [Investigational New Drug applications],” he explained. “Now, the law does allow us to go through a regulatory process, go through notice and comment rulemaking, to establish a framework to allow it to be put in the food supply.”

To discuss potentially establishing a new regulatory framework for CBD, Gottlieb announced a public meeting to take place in April, and the solicitation of public comment. However, the comments FDA receives may only verify the complexity of the issue, requiring a potential legislative solution. “There is not a good proxy for us to do this through regulation, and if we get comments back and find this is sufficiently complicated for the Agency, we will come back and have a discussion with Congress about how we might be able to work together on this,” Gottlieb said.

A Long Road for FDA on CBD?

When asked by Rep. Chellie Pingree (D-ME) about the potential timeline for a new regulatory framework for CBD, Gottlieb said, “I will tell you that if we make a determination [based on public input] that the pathway here is going to be a multi-year regulatory process that could take two, three, four years, I will come back to Congress, and have a discussion about whether or not there are other frameworks that could help address this.”

He added, “I want to preserve the pharmaceutical opportunity here, while recognizing that Congress intended for there to be a pathway for this product to be available in other forms. I think that there are things we can contemplate scientifically. I don’t want to get too ahead of myself, but you could think about concentration and formulation at other thresholds: that might or might not be something we can do in regulation. We need [a] statute that either addresses this as a whole framework or addresses CBD specifically; if that’s the case, we will work through a process to have a discussion around that.”

The fact that FDA is making a serious effort to find a pathway for CBD to be used as a dietary supplement or in food is very positive for the industry, but the potential for a long, drawn-out process is less than ideal for industry.

Michael McGuffin, president, American Herbal Products Association (AHPA; Silver Springs, MD), commented on this in a recent press release. “AHPA appreciates the FDA’s commitment to promptly explore all regulatory options to properly regulate CBD in dietary supplement and food products, and we will participate actively in the public meeting in April,” he said. “The suggestion that this could be a multi-year process, however, should be of concern to consumers, industry, and the Agency, and we encourage FDA to consider interim options in the form of guidance or a statement of enforcement discretion. But if FDA ultimately determines that a Congressional action is necessary, we hope the legislature will move quickly to resolve this issue in a manner consistent with the prior Congress’s obvious intent to ensure Americans access to hemp and all its constituents, including CBD.”

Complicating matters further, Commissioner Gottlieb has resigned from the Agency, effective in a month. It’s unknown whether his successor will follow through with Gottlieb’s intended plans for hemp and CBD, considering that the commissioner has been short on details, and no official announcements have been made.