Tuesday, April 12, 2022
Student presentation: "Putting Marijuana Back in the Bottle: FDA’s Role in Future Marijuana Regulation"
Continuing the Marijuana Law, Policy & Reform seminar students presenting on research topics of their choice. the second topic for this coming week's presentations will be focused on the role of the FDA. Here is how the student describes her take on the topic and some background readings:
So far, FDA has been fairly hands-off when it comes to the state-driven marijuana market even though marijuana falls under many of the agency’s statutory domains. “Marijuana” is a hot commodity as consumers can attest from the plethora of products purporting to contain marijuana derivatives. Many, if not all, of these products fall under FDA’s regulatory regime.
Although FDA has issued some warning letters regarding company actions within the marijuana space, the agency has not developed a consistent theme for regulation. Once it does, some state regulations may be preempted. This would throw the current regulatory landscape into question. Such entry may also change the dynamic of the marijuana industry. For example, as companies face federal regulation, entry into the marijuana space may become more expensive and push small sellers out of the market. Conversely, a dual marijuana marketplace may be established — one that establishes itself nationwide and another that attempts to maintain the current system by only selling intra-state.
FDA does not need to completely reinvent the wheel when it comes to marijuana regulation, although it statutorily may have to consider factors unique to current state regulations. However, given the history of introducing more robust regulations onto new industries, as FDA did with tobacco industry, systems states are already finding successful, and other nations’ marijuana schemes, there are many avenues for FDA to ensure the American public is protected from unsafe products without overly disrupting the current market.
Every year that the federal government declines to implement a regulatory scheme for marijuana products, states are creating their own processes — some more and some less permissive. This paper describes the statutory basis for FDA to regulate marijuana. It also describes how future FDA regulation might interplay with current state regulation or be preempted. Next, it analyzes possible industry challenges as federal regulation becomes more prominent. Finally, it recommends how FDA may enter the regulatory space in tandem with state regulation and avoid stifling an already robust market.
Law review article: "The Surprising Reach of FDA Regulation of Cannabis, Even after Descheduling"
Law review article (by own own Prof Zettler): "Pharmaceutical Federalism"
US Food & Drug Administration webpage: "FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)"