So far in 2023, the U.S. Food and Drug Administration, not Congress, has made the biggest waves in the cannabis industry. The FDA announced in late January that it would work with Congress to figure out how to regulate the cannabidiol (CBD) industry, which it has been tasked with doing since 2018, rather than create the rules itself.
Against this backdrop, the Council for Federal Cannabis Regulation (CFCR) hosted a virtual discussion on Thursday titled “Regulating Hemp Cannabinoids: Opportunities and Challenges.” The event brought together Norman Birenbaum, the U.S. Food and Drug Administration’s senior public health advisor, Scott Riefler, SōRSE Technology’s chief science officer, and Chris Murray, principal of FoxNRTH, Inc. CFCR’s Sheri Orlowitz moderated.
The 2018 Farm Bill legalized cannabis plants with .3% THC or less, also known as hemp, and CBD is one of the compounds that can be derived from these plants. The Farm Bill catalyzed theCBD industry, and soon unregulated products lined shelves from coast to coast. After years of considering the possible pathways within the Administration for CBD, such as the ones that exist for foods and supplements, the FDA determined that crafting regulations for CBD within those pathways wasn’t possible.
On Thursday, Birenbaum noted concerns over the potential for CBD to cause liver toxicity or reproductive issues, drug interactions, and metabolic interactions.
“These are concerns that we don’t have in the food category and that we don’t have in the dietary supplement pathway. And it’s not appropriate for these products to be under those regulatory frameworks,” Birenbaum said.
Whatever form the legislation takes that regulates CBD at the federal level, it’s likely that it will bring forward standardization on areas like dosage and testing, with an eye toward protecting public health and safety.
“This industry is a large industry,” Birenbaum said, adding that consumers have “folded these products into their daily lives” and “we need to make sure that consumers are aware of the potential risks.”
The FDA is not only focused on CBD among the many cannabinoids from the cannabis plant, as the Farm Bill didn’t just open the door to CBD.
“It made a new world for all hemp derivatives,” Birenbaum said, referencing delta-8 and delta-10 products, which are “extraordinarily concerning.” These products are synthesized from CBD and cause a high, unlike CBD.
“We’re seeing products that just didn’t exist several months ago come into the market, and they have been associated with adverse events that have resulted in hospitalizations or in some cases even death,” Birenbaum said. “This industry is very innovative. And consumers and industry participants deserve the regulatory certainty that can come with an appropriate regulatory pathway.”
Birenbaum also echoed a sentiment that others at the FDA have said: more cannabis research is needed.
“The real question is how can we encourage research and invest in research without undermining consumer safety and also without undermining the existing drug pathway when it comes to products that are making therapeutic claims?” Birenbaum asked. “Because we do see that products are doing that without the proper evidence to back it up.”
Cannabis Wire asked two questions. The first question asked for an update on the FDA’s work since President Joe Biden in October called on Department of Health and Human Services Secretary Xavier Becerra to explore rescheduling, a process that involved the FDA as well as the Drug Enforcement Administration. We also asked for the status of discussions with members of Congress related to CBD regulations. Neither question was directly answered, but Birenbaum touched on the topic of Congress.
“At the center of what we are hoping to put in place with Congress,” Birenbaum said, “is a regulatory framework that takes into consideration the realities of the market, the realities of consumers right now, and is focused on harm mitigation. It is not saying we need to understand every single facet of the safety profile of this product, but being able to say to consumers, here’s what we don’t know or here’s what we do know, here is what the risk profile may be.”
Birenbaum added, “there is a huge wide open lane to move down in terms of pursuing harm reduction and harm mitigation and not letting the perfect be the enemy of the good.”