Scott Gottlieb, the current Food and Drug Administration Commissioner recently discussed the agency’s plans to pursue alternative pathways for CBD regulations. He also discussed how the federal ban on marijuana research is causing medical marijuana research to go overseas.
During the hearing, which took place on Wednesday of the last week of February, Gottlieb stated that the FDA will be holding a public meeting in April to discuss how regulation will best serve hemp-derived CBD, which was legalized by the 2018 Farm Bill.
Representative Mark Pocan (D-WI) asked Gottlieb how active the FDA was in considering different pathways for food and dietary supplement regulation.
Gottlieb answered,
”I’ll say at the outset that we heard Congress loud and clear with respect to that legislation. I understand that Congress wants there to be a pathway for CBD to be available.”
He also added, though, that the issue is not straightforward. The only FDA approved CBD drug is Epidiolex, and of course, it cannot be added to food and it is also the subject of clinical investigations.
However, he added the current laws,
“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,”
and that the agency will work to that end starting with the public meeting in April.
Further, CBD ma eventually exist,
“in a high concentration, pure formulation as a pharmaceutical product” and “at a different concentration as a food product or dietary supplement.”
The agency promotes the separation to,
“preserve the incentive to study CBD as a pharmaceutical product.”
Gottlieb continued,
“We believe it does have therapeutic value and has been demonstrated. But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”
However, the process is certainly complicated. The FDA must have discussions with Congress on how it may work together on further legislation.
Representative Andy Harries (R-MD) added to Pocan’s question and stated that when he looks at the CBD market, he notices,
“displays of CBD-containing products, and it’s not at the pharmacy behind the counter obtained with a prescription.”
Gottlieb stated,
“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before. 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.”
Further, Gottlieb mentioned that he will announce soon,
“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. 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 added that the FDA may,
“need statute that either addresses this as a whole framework or address CBD specifically.”
The Co-Chair of the Congressional Cannabis Caucus, Barbara Lee, stated that she was excited to discuss two her of favorite topics, “Cuba and cannabis.” Concerning cannabis, Lee stated that a UK company received drug approval for Epidiolex and that the company was interested in the drug’s final approval so that it could grow strains of cannabis for drug development. Lee asked whether it is possible for a US-based company to bring plant-derived cannabis through the FDA review and approval process.
Gottlieb answered,
“With respect to cannabis-derived compounds, it really depends on which active ingredient you’re talking about—whether you’re talking about THC or CBD and whether or not it’s being derived from marijuana or hemp.”
He continued that it is an “active question” as to,
“whether hemp-derived CBD was legalized under the 2018 Farm Bill, which would mean the compound “can be studied in a more fluid fashion.”
Gottlieb concluded that he would certainly support more research.
