At a House Oversight and Accountability Committee hearing last week, the discussion on rescheduling marijuana took center stage as FDA Commissioner Robert Califf faced intensive questioning about cannabis-related matters.
The focus on regulating CBD as a food and dietary supplement, along with the rescheduling of marijuana, has captured the attention of both the cannabis industry and policymakers, who are eager for clear guidance. This exploration into the FDA’s stance on cannabis sheds light on future expectations for these sectors.
The Quest for Rescheduling Marijuana
Rep. Nancy Mace (R-SC) brought the question of rescheduling marijuana front and center during her exchange with Commissioner Califf. Mace’s query sought to find out when the DEA would decide to move cannabis from Schedule I to Schedule III, following the recommendation from the Department of Health and Human Services and the FDA.
“My first question today is, I understand this issue now rests with the DEA. I’m curious if you have an update on the timing of their decision?” asked Rep Mace.
“I don’t even know but if I did, I couldn’t tell you anyway so the timing of a regulatory decision is something that would be up to the DEA.” responded Califf.
When asked if it the decision would come within in the year, Califf said “There’s no reason for DEA to delay. I think they just have to take into account all the regulations that are in play,”
“Without revealing too much about my age, I’m a child of the 60s, so it’d be nice if in my lifetime we came up with a regulatory scheme where whatever your belief is about use of the product, where these safety issues you referred to are written into law so that we have a scheme whereby we can regulate it,” Califf added. “We’re referees who write the rules. We need the right rulebook in order to play the referee role.”
Navigating New Regulatory Responsibilities
The conversation took a deeper dive into the potential shift in regulatory landscapes should cannabis undergo rescheduling. Commissioner Califf acknowledged the complexity of the FDA assuming additional regulatory duties amidst this change.
Highlighting the convoluted relationship between federal and state laws regarding cannabis, he pointed out the dominant role state regulations have played so far. Califf emphasized the need for clear directives from Congress to guide the FDA’s approach, especially distinguishing between medical and recreational usage of cannabis.
“This is an area where I believe we would be better off if we had guidance from Congress about how to proceed,” Califf stated, underscoring the distinction between medical marijuana — which could be validated through existing medical protocols — and recreational use, which falls outside the FDA’s traditional purview.
The CBD Conundrum
Committee Chair Rep. James Comer (R-KY) added cannabis-related questions, focusing on the FDA’s reluctance to regulate CBD products.
Expressing frustration over the perceived bureaucratic obstruction, Comer highlighted the detrimental impact on both consumer safety and the market’s integrity. Conventional thinking would suggest that regulation implies a standardization of product quality and safety, something glaringly absent in the unregulated CBD marketplace.
“The FDA’s refusal to regulate hemp products is creating significant confusion in the market and resulting in products with intoxicants that can be dangerous to Americans who use these products,” Comer said. “It has also halted business trying in good faith to enter the market while bad actors continue to thrive.”
He agreed on the need for a new regulatory approach, emphasizing the importance of establishing clearer rules for the content and management of these products. The Commissioner acknowledged the consumer interest in CBD access and the need for a system that offers clear information and protects users.
FDA Needs Guidelines
In emphasizing the need for guidance from Congress, FDA Commissioner Califf used an analogy that illustrates the current regulatory predicament concerning cannabis. Comparing the FDA’s role to that of a referee in a sporting event, he underscored the necessity of having a clear, comprehensive rulebook to effectively govern the playing field.
This analogy underscores a critical point: while the FDA can enforce regulations, the effectiveness of its enforcement relies on the clarity and comprehensiveness of the guidelines it must enforce. Without a coherent set of rules, similar to a rulebook that Congress writes, the FDA’s ability to regulate faces fundamental constraints.
Just as a referee cannot adequately officiate a game without understanding the rules, the FDA is handicapped in its regulatory efforts without clear directives from lawmakers.
Its evident that the FDA finds itself in a regulatory limbo, particularly with the HHS recommendation to reclassify cannabis from a Schedule I to a Schedule III drug.
The decision now rests squarely with the DEA, with no clear timeline in sight for action. Commissioner Califf’s call to lawmakers underscores a significant gap in the legal framework governing CBD products. Without explicit rules crafted by Congress, the FDA’s hands are tied, unable to fully invoke its legal mandate to regulate these products.
This scenario underscores the urgent need for legislative action to clarify the landscape, not just for the benefit of regulatory bodies like the FDA and the DEA, but also for consumers, manufacturers, and the broader cannabis community.
The path forward requires a concerted effort from all stakeholders to establish a regulatory environment that supports public health and safety while fostering innovation and growth within the industry.
