Earlier this week, Scott Gottlieb, commissioner of the Food and Drug Administration, announced that he is stepping down within the next month. As Cannabis Wire previously reported in a newsletter-only post, the timing of his resignation is significant because the FDA is working through its regulations on cannabidiol (CBD) in food.
In response to questions about how Gottlieb’s resignation will affect FDA developments around CBD, FDA spokesperson Michael Felberbaum told Cannabis Wire that the promised public meeting is still in the works—but he could not provide a timeframe. Stakeholders, Felberbaum added, are typically informed of the date 30 days in advance.
Some background:
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The day President Donald Trump signed the Farm Bill, Gottlieb issued a statement clarifying that even though hemp was removed from the Controlled Substances Act, the law preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds.
In that statement, and during a speech at the National Association of State Departments of Agriculture’s annual conference on February 26, the Commissioner promised to hold a public meeting “in the near future for stakeholders to share their experiences and challenges with [CBD] products.”
“We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD,” said Gottlieb. “But we know that this process could take time. So, we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches; to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.”
Days earlier, on February 19, a bipartisan group of Congress members signed a letter to the FDA, calling on the Commissioner to “provide guidance on lawful pathways for food products containing hemp-derived CBD in interstate commerce,” as well as indicate when the public meeting would take place.
When Gottlieb appeared before Congress last Wednesday, February 27, he made his final public statement on CBD before stepping down from his position. Representative Chellie Pingree (D-Maine) addressed him saying, “I realize this is complicated, but I just want to emphasize the need for some sense of urgency around it.”
“My own state legislature is working on legislation around it right now,” added Pingree, “but the role of the FDA confuses everyone, I think.” Regarding the potential for a fix, she then asked the Commissioner: “I guess I’m wondering: how soon you can do this, are there resources available, or do you need further assistance to get this done?”
The Commissioner, in turn, provided a long-winded response:
“I’m going to announce, shortly, a high level working group that’s going to report to me on this with some senior officials in the agency, we’re going to be sharing that. We want to wait for the public meeting and solicit comments and get input. I will tell you that if we make a determination that the pathway here is going to be a multi-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.
Again, 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. And I think that there are different things that we can contemplate scientifically. I don’t think that I want to get too far ahead of myself, but you can think about concentration and formulation and other thresholds. That might or might not be something we can do in regulation. We might need a statute that addresses this as a whole framework or addresses CBD specifically. If that’s the case, we will work through a process and have a discussion around that.”
This piece has been updated to reflect that stakeholders are typically informed 30 days in advance of public meetings.
