Over the past couple of years, the U.S. Food and Drug Administration has loomed large in discussions about the future of cannabis and cannabinoids in the United States.
Last year, the FDA announced that it would seek to work with Congress on a path forward to regulate the cannabidiol (CBD) industry. And, more recently, the FDA worked hand-in-hand with the U.S. Department of Health and Human Services in its determination that cannabis should move from Schedule I to Schedule III.
The FDA’s role in the review of how the federal government classifies cannabis was an “elephant” in the room during a fireside chat, hosted by the Food & Drug Law Institute (FDLI), a nonprofit focused on food and drug law, on Thursday. The panel, called Federal Cannabis Regulation: Current FDA and Stakeholder Perspectives, included several FDA officials with far-reaching experience on cannabis.
The group included: Norman Birenbaum, a Senior Public Health Advisor within the FDA’s Center for Drug Evaluation and Research (CDER); Charlotte Conway, Deputy Director of FDA’s Division of Animal Food Ingredients in the Center for Veterinary Medicine; Patrick Cournoyer, the FDA’s Cannabis Product Committee lead; and Cara Welch, the Director of the Office of Dietary Supplement Programs in FDA’s Center for Food Safety and Applied Nutrition.
Over time, FDA officials have since reiterated not just their willingness to work with Congress, but the need to do so. However, whether Congress will act on CBD, which is not federally regulated but widely available – or any other cannabis legislation, for that matter – is anyone’s guess.
“If any one of us could read the minds of Congress or their members, I think that we’d be doing something else,” Birenbaum said. “Or maybe we’d already have a pathway.”
The FDA is “not able to comment on any conversations or progress that may or may not be happening with Congress,” Birenbaum continued. “What we have seen, I think, is an overwhelming response, an acknowledgment that this is a problem that needs a solution.”
Welch highlighted some of the narrow regulatory hurdles that CBD presents. For example, a dietary settlement has to be in an ingestible form, but CBD can come in other forms, too, such as inhalable products. It also must be ingested by humans, but CBD is marketed and sold for ingestion by animals, too.
“We do not believe that the supplement authorities are protective enough to accommodate these products that do present a risk,” Welch said.
But, as Conway pointed out, the “pet market is really interested in having CBD available.”
“I keep saying ‘pet’ because we do not think that food-producing species should have a path to market outside of the drug approval pathway for cannabis products, because we really don’t fully understand the risk of residues and the potential human food safety implications there,” Conway said.
More broadly, the cannabis industry is evolving quickly — in many ways faster than regulations, certainly at the federal level.
“We are twisting ourselves up trying to evaluate these products. And we’re spending a lot of time on it, trying to figure out how all of these cannabinoids fit into supplements, how they fit into foods,” Welch said. “Are they a safe food additive?”
Welch said that “a lot of resources” are going toward answering these questions.
“You can see just on this panel the number of centers that we have, represented. And I think that’s just another reason why a holistic approach for cannabis-derived cannabinoids is so important,” she said.
Birenbaum echoed the moving target of cannabis regulation. While the plant is most commonly associated with THC, and, more recently, CBD, these are just two of the dozens of cannabinoids in the plant. And, while CBD does not cause a high, it can be derived from hemp, which is legal, and then synthesized into products like delta-8, which do cause a high. A recent study found that one in 10 high school seniors uses delta-8 products.
“The universe of cannabinoids for which these assessments and determinations are trying to be made is constantly changing because now we have the bathtub gin equivalent of cannabinoids being created and introduced into the market every few months,” Birenbaum said. “The list of cannabinoids, mostly which are intoxicating, that are being introduced into the market keeps growing and growing and growing. Right now, I think we’re tracking 24.”
The FDA is now “collaborating” with states, including on warning letters and compliance actions, Birenbaum said. He added that a technical information sharing agreement, called a 20.88 agreement, was newly launched for cannabis products last year. They exist for areas like dietary supplements and animal products, and are the “vehicle” that the FDA uses to “share information with states, which otherwise would be nonpublic.”
“We have four states that we’ve already executed those with. We’re looking forward to signing more up and especially as states are consolidating regulatory authority within brand new cannabis-specific agencies, which may not historically have existed, let alone have these types of agreements with the FDA,” Birenbaum said.
During the next panel, which included former FDA officials, regulators, and lawyers, hemp-derived products ended up being a recurring theme.
Andrew Kline, co-chair of the Cannabis Industry Group for the law firm Perkins Coie, said that it “just dawned” on him that hemp-derived products create a major wrinkle if someone takes a closer look at the eight priorities in the Cole Memo, specifically the three “most significant” ones: sales to minors, avoiding diversion and interstate commerce.
The memo, which laid out federal priorities that, if met, would keep enforcement at bay, was issued by former President Barack Obama’s Department of Justice, but rescinded in 2018 by Attorney General Jeff Sessions. Attorney General Merrick Garland has said the DOJ is working on similar guidance.
“We have a Cole Memo problem with hemp-derived products. It’s exactly what the Justice Department wanted to prevent in the first place. And it’s happening right in front of us,” Kline said.
