How, and to what extent, will the federal government regulate cannabis once its prohibition ends?
Over the last decade, the conversation has shifted from whether cannabis will be federally legal, to when, and, now, to how. In that time, the number of states with legal adult use cannabis has risen from zero to 19, with Rhode Island joining the list just this week. By 2020, that state-by-state momentum reached the national stage in Congress, where the U.S. House voted for the first time to end cannabis prohibition, and it did so again this year.
It is against this backdrop that the Food and Drug Law Institute (FDLI), a Washington, D.C.-based nonprofit that focuses education and training on food and drug law, held a two-day conference this week on Legal and Practical Issues in Cannabis Regulation. Speakers included cannabis regulators from Connecticut and Massachusetts, lawyers and academics focused on cannabis issues, and board members of entities like the National Animal Supplement Council and the Michael J. Fox Foundation for Parkinson’s Research.
“We certainly have a lot to talk about, including recent FDA warning letters to companies making unsubstantiated medical claims, the continuing evolution of state level regulation, and the growing number of markets with legalized medical or recreational cannabis,” said Amy Comstock Rick, the president and CEO of FDLI, as she kicked off the event.
The FDA – or U.S. Food and Drug Administration – letters referenced are a piece of the federal regulation puzzle, as Cannabis Wire has reported. The agency, along with the U.S. Department of Agriculture, has had a head start on regulating cannabis ever since the 2018 Farm Bill legalized hemp, defined as cannabis plants with .3% THC or less.
This has put the regulation of cannabis cultivation in the hands of the USDA while tasking the FDA with determining what to do with products, like foods and cosmetics, containing compounds derived from cannabis, like the increasingly popular CBD. As the FDA assesses a path forward, CBD products have hit shelves from coast to coast, and the FDA has been playing warning letter whack-a-mole with bad actors making all kinds of claims, including that their products can fight COVID-19.
Another FDA headache that came up repeatedly during the event was the legal gray area around delta-8-THC, which, like CBD, can be derived from hemp but, unlike CBD, causes a high. These products have become widely available in the last couple of years, prompting the Centers for Disease Control and Prevention (CDC) and the FDA to issue warnings to consumers in September.
The FDA’s work on CBD extends beyond human consumption, as there is rising interest in CBD for household pets and farm animals, as Cannabis Wire has reported. Like CBD products for humans, these are already widely available. For this reason, one panel was entitled “The New Scooby Snacks? Animal and Veterinary Products Containing CBD and Cannabinoids.” During its presentation, the NASC said it kicked off a “safety study for CBD in dogs” this month with 32 dogs, and it aims to provide the data to the FDA.
All of this is complicated not only by the fact that states are moving ahead with cannabis reforms amid federal prohibition, but also by the lack of uniformity in cannabis policy between states. One area where there is significant divergence among states is in lab testing and other quality control measures, which came up repeatedly during the event as well.
“We’re here today because legalization of cannabis is coming and we have to be ready. It may not come tomorrow. It may not come soon enough, but it’s coming. And when legalization happens, we need to be able to move quickly. And so we need to remove any obstacles to interstate commerce that may exist. One of those obstacles is 37 different sets of lab standards. We need national standards so that everyone is testing for the same things,” said Andrew Kline, senior counsel at Perkins Coie LLP, at the start of the event’s second day.
One entity at work on standards is the United States Pharmacopeia (USP), a non-profit focused on standards in medicines, supplements, and foods. During one panel focused on this issue, Nandakumara Sarma, the director of dietary supplements and herbal medicines at the USP, pointed to the work of its Cannabis Expert Panel, which included a study on cannabis flower attributes published in the Journal of Natural Products in 2020.
Sarma stressed the importance of “common ground for consensus,” adding that this study was one of USPs contributions toward that goal.
The inconsistencies in testing at the state level has become a point of interest at the FDA, too, and Sarma pointed to recent research from the FDA on the issue. As Cannabis Wire reported, the study was the FDA’s first on comparing cannabis quality control among states.
“We knew that there would be differences between the 37 programs that we looked at. So, that finding wasn’t particularly surprising to us,” lead researcher Schuyler Pruyn told Cannabis Wire. “I think probably the biggest surprise really was that, to our knowledge, nobody has done this exercise before. We were unable to find a comparison like this, across a program specifically for quality related testing regulations.”
This research is part of a multi-pronged effort as the FDA determines how best to proceed with cannabis products already on the market, albeit unregulated, like CBD, and the federally-legal ones on the horizon.
The FDA’s new commissioner, Robert Califf, spoke on May 19 about CBD during a House subcommittee hearing on FDA’s FY 2023 budget, noting that he is “committed” to figuring out what to do with CBD, even if it involves some “creativity,” as Cannabis Wire reported.
The FDA’s new commissioner, Robert Califf, spoke on May 19 about CBD during a House subcommittee hearing on FDA’s FY 2023 budget, noting that he is “committed” to figuring out what to do with CBD, even if it involves some “creativity,” as Cannabis Wire reported.
“I am very committed to taking a path on this,” he said. “And just to put a marker down, I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward. We’re going to have to come up with something new.”
