After months of confusion, there’s finally a timeline for when the FDA will consider crafting its hemp and CBD regulations.
U.S. Food and Drug Administration Commissioner Scott Gottlieb told a Congressional panel on Feb. 27 that his agency is planning to hold public hearings in April on regulating cannabidiol (CBD) derived from hemp.
Gottlieb’s comments came in response to questions from House Appropriations subcommittee members Reps. Barbara Lee (D-Calif.), Chellie Pingree (D-Maine), and Mark Pocan (D-Wis.) at a hearing on Wednesday.
Last week, Pingree led a group of 12 members of the House of Representatives including Pocan in sending a letter to Gottlieb, seeking quick clarification from the agency on how CBD would be regulated and made available to the public.
Gottlieb prefaced his comments on CBD at Wednesday’s hearing by saying that he is aware that the intent of lawmakers with the passage of the 2018 Farm Bill was to legalize CBD.
“I’ll say at the outset that we heard Congress loud and clear with respect to that legislation,” Gottlieb said. “I understand Congress wants there to be a pathway for CBD to be available.”
However, Gottlieb said that FDA regulators hadn’t yet determined that hemp CBD is no longer a controlled substance.
“I think we’re going to have a resolution on that very soon about whether or not the CBD derived from hemp doesn’t fall under the scheduling process,” he said.
“I think we’re going to have a resolution on that very soon about whether or not the CBD derived from hemp doesn’t fall under the scheduling process.”Scott Gottlieb, FDA Commissioner
But Gottlieb assured lawmakers that the agency was up to the task of pursuing alternative pathways to regulating CBD and making it available to American consumers.
“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before,” said Gottlieb. “I think we have a good track record of trying to come to resolution on other challenges. You have my commitment that I’m focused on this one.”
The commissioner said that the FDA would hold public hearings including public comment from stakeholders sometime in April. Gottlieb added that he would soon be appointing “a high-level working group that’s going to report to me on this, with some senior officials in the agency who are going to be chairing that.”
Is CBD a Food or a Drug?
CBD, as the active ingredient of the FDA-approved medication Epidiolex, is considered a regulated drug, which generally cannot legally be added to food products. Also, substances which are the “subject of substantial clinical investigation” — like CBD — are normally not allowed to be used as an ingredient in foods. However, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply,” Gottlieb said.
He suggested that a two-tiered regulatory might be established, with pure or highly concentrated forms of CBD reserved for pharmaceutical products while allowing lower levels of cannabidiol to be used in dietary supplements and food products. Gottlieb said the agency could seek the distinction “because we want to preserve the incentive to study CBD as a pharmaceutical product.”
Gottlieb noted that the FDA acknowledges the potential of CBD in health and wellness, but said that there is not a clear precedent for making a substance available as a drug and as an ingredient in foods.
“We believe it does have therapeutic value and has been demonstrated,” he said. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”
Gottlieb told the subcommittee that if it appears CBD regulation will take an extended period of time, the agency could seek further legislation to clarify the issue.
“I will tell you that if we make a determination 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 to have a discussion about whether or not there are other frameworks that could help address this,” he said.
Gottlieb said that the FDA may determine it will “need statute that either addresses this as a whole framework or address CBD specifically.”