A conference brought together Food and Drug Administration, Federal Trade Commission, and Department of Justice officials, and while no new ground was broken, they lifted the hood a bit on how these federal agencies are thinking about cannabis and cannabidiol.
This week, the Food and Drug Law Institute, a non-profit founded in 1949 and based in Washington, D.C., is hosting a two-day virtual conference focused on cannabis. Or, more specifically, on the “legal and practical issues in the evolving world of cannabis regulation.”
On Tuesday morning, Joseph Franklin, the policy director for Amy Abernethy, the principal deputy commissioner of the FDA, spoke about the Administration’s approach to cannabidiol (CBD). After the passage of the 2018 Farm Bill, which legalized cannabis plants with .3% THC or less, also known as hemp, which is abundant in CBD, the FDA was tasked with crafting regulations for CBD products.
Complicating the FDA’s task is the Administration’s approval of the CBD-based drug Epidiolex, and the reality that CBD products can already be found on the shelves of mainstream stores from coast-to-coast. The FDA formally reopened the public comment window on cannabis and cannabinoid-products in March, and is “extending it indefinitely,” after the first window closed in July 2019.
Suzie Trigg, a partner at Haynes and Boone LLP, first asked Franklin the question on many minds: will the FDA’s long-anticipated CBD regulations be released before the end of the year, or after President-elect Joe Biden takes office?
“The only thing that we can say, from the FDA perspective,” Franklin said, is that “it was submitted in July for OMB review as part of the normal process. That’s the only comment we can provide on that at this time.”
Franklin separately added that comments on FDA draft guidance, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry,” published in the Federal Register in July, have poured in.
“I think many, many comments are supportive of providing clarity through the guidance and I think,” Franklin added, “reflect the need for more clarity in this area.”
Franklin then turned to how the FDA reacted to the passage of the 2018 Farm Bill.
“Suddenly—and I think that it is worth bearing in mind that this was a fairly drastic change when it comes to the legal status of these products—FDA regulatory framework became highly relevant to those products at the federal level,” Franklin said, adding that now “these products could meet the definition of many FDA-regulated products, such as food such as drugs.”
Franklin noted that there remain many unknowns with CBD, including potential interactions with prescription drugs, issues with male reproductivity, and CBD use in special populations, like people who are breastfeeding. The FDA, he said, is “like a broken record at this point” in its calls for “more data.”
“At that time, FDA very quickly recognized that it needed to become much more active in the CBD-related space, and cannabis space more generally,” Franklin said. “We quickly issued public statements and put together internal processes to start developing the science and developing policy on CBD in cannabis.”
Trigg asked about the gaps in data, and what data the cannabis and hemp industries could help to “generate.”
“Industry has an extremely important role in developing data, but it doesn’t have the only role in what I think is a collective challenge that we have as a society to understand a substance that many consumers and patients are ingesting on a regular basis,” Franklin said.
(On this topic, as Cannabis Wire has covered, the FDA has hosted a number of meetings and webinars, for example,Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations, which covered how cannabinoid companies can play a crucial role in federal regulators obtaining important cannabis data and research.)
Franklin added that, in his view, the “most promising area of work that we have at the agency is looking at new ways to efficiently collect data” from the existing sprawling CBD marketplace and “the widespread use of products.” The FDA is also identifying other stakeholders, like government agencies and state regulators that “can perform the studies or collect the data.”
In February, FDA Commissioner Stephen Hahn acknowledged the proliferation of CBD products at the National Association of State Departments of Agriculture Winter Policy Conference. Hahn asked the attendees how many people traveled through Reagan National Airport to the conference and saw the “huge stand for CBD products.”
“We’re not going to be able to say ‘you can’t use these products,’” Hahn said. “Even if we did, it’s a fool’s game to even try to approach that. But what do we need to do? We need to fill the information gaps. We need to understand what it helps with, because we have some evidence on the drug side that it may be beneficial.”
More than a dozen companies, including GW Pharmaceuticals and GNC, have met with the White House this fall to discuss the US Food and Drug Administration’s forthcoming enforcement policy on CBD products. The guidance was sent to the White House Office of Management and Budget for approval in July, a final step before publication.
In June, the FDA released draft guidance that reflects the Administration’s “current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.” The guidance focused on the cannabis supply used for research and the inclusion of hemp, quality control, and calculating THC.
And in March, the FDA submitted a CBD report to Congress. It includes, among other updates, a breakdown of the FDA’s efforts by product type, considering the widespread interest in including CBD in a variety of products, from cosmetics to food.
Later on Tuesday afternoon, the FDLI hosted a panel focused on federal approaches to cannabis and CBD regulation and enforcement, which included: John Claud, assistant director for the consumer protection branch of the Department of Justice; Richard Cleland, assistant director of the bureau of consumer protection, division of advertising practices for the Federal Trade Commission; and Larry Houck, a director of Hyman, Phelps & McNamara, PC, where he gives “counsel on regulatory and enforcement actions by the DEA.”
Claud gave a landscape review, and talked about the recent history as far as the DOJ is concerned.
“The Farm Bill being what it is, when Jeff Sessions became the attorney general, that changed the landscape. Because in Jeff Sessions’ view, I think the quote is that ‘good people don’t smoke marijuana,’” Claud said. “So there was a very limited and restricted view of what DOJ could do with its enforcement powers.”
Claud added that no new cannabis-related policies have come out of the DOJ since 2018, and that in the later years of the Trump Administration, “there hasn’t been as much focus on that.”
“In the light of the pandemic, the Administration hasn’t had that as a main focus. But as I sit here today as an employee of the Department of Justice, there is still that very strict sort of division in the minds of our leadership that is presumably about to change,” Claud said.
This piece has been updated to clarify that when Joseph Franklin referenced public comment, he was referring to those on the topic of FDA guidance titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry.”